Janssen COVID-19 vaccine

The Janssen COVID{{nbhyph}}19 vaccine is used to provide protection against infection by the SARS-CoV-2 virus in order to prevent COVID{{nbhyph}}19 in people aged eighteen years and older.

The vaccine is given by intramuscular injection into the deltoid muscle. The initial course consists of a single dose.{{cite tech report |type=Guidance |title=Interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine |id=WHO/2019-nCoV/vaccines/SAGE_recommendation/Ad26.COV2.S/2021.2 |institution=World Health Organization |date=15 June 2021 |url=https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-Ad26.COV2.S-2021.1 |access-date=3 July 2021 |archive-date=29 June 2021 |archive-url=https://web.archive.org/web/20210629154609/https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-Ad26.COV2.S-2021.1 |url-status=live }}

There is no evidence that a second booster dose is needed to prevent severe disease in healthy adults. In October 2021, the US Centers for Disease Control and Prevention (CDC) began recommending a booster dose.{{cite news |title=CDC Expands Eligibility for COVID-19 Booster Shots |url=https://www.cdc.gov/media/releases/2021/p1021-covid-booster.html |access-date=19 November 2021 |publisher=U.S. Centers for Disease Control and Prevention (CDC) |date=21 October 2021 |archive-date=7 December 2021 |archive-url=https://web.archive.org/web/20211207000758/https://www.cdc.gov/media/releases/2021/p1021-covid-booster.html |url-status=live }}

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.{{cite journal | vauthors = Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R | title = COVID-19 vaccine trials should seek worthwhile efficacy | journal = Lancet | volume = 396 | issue = 10253 | pages = 741–743 | date = September 2020 | pmid = 32861315 | pmc = 7832749 | doi = 10.1016/S0140-6736(20)31821-3 | quote = WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure. }} Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.{{cite journal | vauthors = Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, Subbarao K, Kent SJ, Triccas JA, Davenport MP | title = Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection | journal = Nature Medicine | volume = 27 | issue = 7 | pages = 1205–1211 | date = July 2021 | pmid = 34002089 | doi = 10.1038/s41591-021-01377-8 | s2cid = 234769053 | title-link = doi | doi-access = free }}

In October 2021, Janssen reported at a meeting of the US Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC) that a single dose produced durable protection against severe disease and hospitalization for at least 6 months in the United States, even when Delta emerged, but also a global decrease in protection against moderate disease attributed to emerging variants outside the US. Janssen also reported that a booster dose given 2 months after the primary dose increased efficacy against symptomatic disease to {{Estimate|75|55|87|unit=%|mini=no}} globally and to {{Estimate|94|59|100|unit=%|mini=yes}} in the US and that it also increased efficacy against severe disease to nearly {{Estimate|100|33|100|unit=%|mini=yes}} globally.{{cite conference |url=https://www.fda.gov/media/152954/download |title=COVID-19 Vaccine Ad26.COV2.S |author=Janssen Biotech |author-link=Janssen Biotech |date=15 October 2021 |conference=Vaccines and Related Biological Products Advisory Committee 14–15 October 2021 |conference-url=https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-14-15-2021-meeting-announcement#event-information |publisher=U.S. Food and Drug Administration (FDA) |format=PDF |access-date=11 November 2021 |type=Briefing |archive-date=13 November 2021 |archive-url=https://web.archive.org/web/20211113004215/https://www.fda.gov/media/152954/download |url-status=live }}{{cite news |vauthors=Katella K |title=Did You Get the Johnson & Johnson Vaccine? Your Booster Is Coming |url=https://www.yalemedicine.org/news/johnson-and-johnson-covid-booster |access-date=11 November 2021 |publisher=Yale Medicine |date=28 October 2021 |archive-date=11 November 2021 |archive-url=https://web.archive.org/web/20211111094209/https://www.yalemedicine.org/news/johnson-and-johnson-covid-booster |url-status=live }}

The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) viral vector expressing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein in a stabilized conformation. The PER.C6 cell line derived from human embryonic retinal cells is used in the production (replication) of the Ad26 adenovirus vector.{{cite web|url=https://www.janssenmd.com/janssen-covid19-vaccine/product-properties/product-technology/advac-and-perc6-technology-of-the-janssen-covid19-vaccine|title=Janssen COVID-19 Vaccine (Ad26.COV2.S)|date=14 October 2021|quote=The PER.C6 cell line is used in the production of adenovirus vectors. Derived from human embryonic retinal cells, PER.C6 has been successfully used in Good Manufacturing Practices (GMP) and grow to high densities in serum-free suspension culture. Ad26 vectored COVID-19 vaccine encoding the SARS-CoV-2 spike (S) protein is produced in the PER.C6 TetR Cell Line and by recombinant DNA technology|access-date=23 August 2021|archive-date=24 August 2021|archive-url=https://web.archive.org/web/20210824025239/https://www.janssenmd.com/janssen-covid19-vaccine/product-properties/product-technology/advac-and-perc6-technology-of-the-janssen-covid19-vaccine|url-status=live}} It is similar to the approach used by the Oxford–AstraZeneca COVID-19 vaccine and the Russian Sputnik V COVID-19 vaccine{{cite book | title=COVID-19 vaccines | chapter=Drug Levels and Effects | publisher=National Library of Medicine (US) | publication-place=Bethesda (MD) | year=2006 | pmid=33355732 | url=http://www.ncbi.nlm.nih.gov/books/NBK565969/ | access-date=15 October 2021 | archive-date=30 June 2021 | archive-url=https://web.archive.org/web/20210630022547/https://www.ncbi.nlm.nih.gov/books/NBK565969/ | url-status=live }}{{cite journal | vauthors = Mishra SK, Tripathi T | title = One year update on the COVID-19 pandemic: Where are we now? | journal = Acta Tropica | volume = 214 | pages = 105778 | date = February 2021 | pmid = 33253656 | pmc = 7695590 | doi = 10.1016/j.actatropica.2020.105778 | publisher = Elsevier BV }} which use human embryonic kidney (HEK) 293 cells for adenovirus vector replication.{{cite web |url=https://fullfact.org/online/foetal-cells-covid-vaccine/ |title=There are no foetal cells in the AstraZeneca Covid-19 vaccine |website=fullfact.org |date=26 November 2020 |access-date=21 September 2021 |archive-date=8 September 2021 |archive-url=https://web.archive.org/web/20210908115433/https://fullfact.org/online/foetal-cells-covid-vaccine/ |url-status=live }}{{cite journal | vauthors = Moutinho S, Wadman M |date=April 2021 |title=Is Russia's COVID-19 vaccine safe? Brazil's veto of Sputnik V sparks lawsuit threat and confusion |title-link=doi |journal=Science |doi=10.1126/science.abj2483 |s2cid=241258399 | doi-access= }}

The Ad26 viral vector lacks the E1 gene required for replication. Therefore, it cannot replicate in the human organism.{{cite journal | vauthors = He TC, Zhou S, da Costa LT, Yu J, Kinzler KW, Vogelstein B | title = A simplified system for generating recombinant adenoviruses | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 95 | issue = 5 | pages = 2509–2514 | date = March 1998 | pmid = 9482916 | pmc = 19394 | doi = 10.1073/pnas.95.5.2509 | title-link = doi | doi-access = free | bibcode = 1998PNAS...95.2509H }}{{cite journal | vauthors = Kovesdi I, Hedley SJ | title = Adenoviral producer cells | journal = Viruses | volume = 2 | issue = 8 | pages = 1681–1703 | date = August 2010 | pmid = 21994701 | pmc = 3185730 | doi = 10.3390/v2081681 | title-link = doi | doi-access = free }}

The vaccine contains the following excipients: citric acid monohydrate, trisodium citrate dihydrate, ethanol (alcohol), 2-hydroxypropyl-β-cyclodextrin (HBCD){{cite journal | vauthors = Yokoo M, Kubota Y, Motoyama K, Higashi T, Taniyoshi M, Tokumaru H, Nishiyama R, Tabe Y, Mochinaga S, Sato A, Sueoka-Aragane N, Sueoka E, Arima H, Irie T, Kimura S | title = 2-Hydroxypropyl-β-Cyclodextrin Acts as a Novel Anticancer Agent | journal = PLOS ONE | volume = 10 | issue = 11 | pages = e0141946 | date = 2015 | pmid = 26535909 | pmc = 4633159 | doi = 10.1371/journal.pone.0141946 | title-link = doi | doi-access = free | bibcode = 2015PLoSO..1041946Y }} (hydroxypropyl betadex), polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid.

Unpunctured vials may be stored between {{Convert|9|and|25|C|F|abbr=on}} for up to twelve hours, and the vaccine can remain viable for months in a standard refrigerator.{{cite news|date=4 February 2021|title=Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine|newspaper=The Washington Post|url=https://www.washingtonpost.com/health/2021/02/04/jj-vaccine-fda/|vauthors=Johnson CY, McGinley L|access-date=5 February 2021|archive-date=5 February 2021|archive-url=https://web.archive.org/web/20210205160208/https://www.washingtonpost.com/health/2021/02/04/jj-vaccine-fda/|url-status=live}}{{cite web|title=One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds|url=https://www.usatoday.com/story/news/health/2021/02/24/fda-finds-one-dose-j-j-covid-vaccine-meets-criteria-safe-effective/4535542001/|access-date=25 February 2021|website=USA Today|vauthors=Weintraub K|archive-date=25 February 2021|archive-url=https://web.archive.org/web/20210225000748/https://www.usatoday.com/story/news/health/2021/02/24/fda-finds-one-dose-j-j-covid-vaccine-meets-criteria-safe-effective/4535542001/|url-status=live}}{{cite web|date=29 January 2021|title=COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%|url=https://arstechnica.com/science/2021/01/covid-variants-throw-jj-vaccine-a-curveball-lowering-efficacy-to-66/|access-date=26 February 2021|website=Ars Technica|vauthors=Mole B|archive-date=2 March 2021|archive-url=https://web.archive.org/web/20210302063754/https://arstechnica.com/science/2021/01/covid-variants-throw-jj-vaccine-a-curveball-lowering-efficacy-to-66/|url-status=live}}[https://www.fda.gov/media/156787/download Archived copy] {{Webarchive|url=https://web.archive.org/web/20220313115120/https://www.fda.gov/media/156787/download |date=13 March 2022 }}[https://www.fda.gov/media/157554/download Archived copy] {{Webarchive|url=https://web.archive.org/web/20220409021903/https://www.fda.gov/media/157554/download |date=9 April 2022 }} It is not shipped{{cite news|date=4 February 2021|title=J&J files COVID-19 vaccine application with U.S. FDA|publisher=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-vaccines-johnson-j-idINKBN2A430V|access-date=4 February 2021|vauthors=Chander V|archive-date=5 February 2021|archive-url=https://web.archive.org/web/20210205065415/https://www.reuters.com/article/us-health-coronavirus-vaccines-johnson-j-idINKBN2A430V|url-status=live}} or stored frozen.

In April 2020, Johnson & Johnson entered a partnership with Catalent to provide large-scale manufacturing of the Johnson & Johnson vaccine at Catalent's Bloomington, Indiana facility.{{cite web|vauthors=Vecchione A|date=29 April 2020|title=Catalent to lead US manufacturing for J&J's lead COVID-19 vaccine candidate|url=https://njbiz.com/catalent-lead-us-manufacturing-jjs-lead-covid-19-vaccine-candidate/|access-date=13 November 2020|website=NJBIZ|archive-date=19 November 2020|archive-url=https://web.archive.org/web/20201119131151/https://njbiz.com/catalent-lead-us-manufacturing-jjs-lead-covid-19-vaccine-candidate/|url-status=live}} In July 2020, the partnership was expanded to include Catalent's facility in Anagni, Italy.{{cite web|title=J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility|url=https://www.fiercepharma.com/manufacturing/j-j-expands-covid-19-vaccine-pact-catalent-for-finishing-work-at-italian-facility|access-date=13 November 2020|website=FiercePharma|date=6 July 2020|archive-date=25 October 2020|archive-url=https://web.archive.org/web/20201025143810/https://www.fiercepharma.com/manufacturing/j-j-expands-covid-19-vaccine-pact-catalent-for-finishing-work-at-italian-facility|url-status=live}}

In September 2020, Grand River Aseptic Manufacturing agreed with Johnson & Johnson to support the manufacture of the vaccine, including technology transfer and fill and finish manufacture, at its Grand Rapids, Michigan facility.{{cite web|url=https://www.contractpharma.com/contents/view_online-exclusives/2020-11-03/ramping-up-covid-19-vaccine-fill-and-finish-capacity/|title=Ramping Up COVID-19 Vaccine Fill and Finish Capacity|website=Contract Pharma|date=3 November 2020|access-date=1 February 2021|archive-date=28 January 2021|archive-url=https://web.archive.org/web/20210128053930/https://www.contractpharma.com/contents/view_online-exclusives/2020-11-03/ramping-up-covid-19-vaccine-fill-and-finish-capacity/|url-status=live}}

File:View of a production line at the Reig Jofre company's headquarters.jpg

In December 2020, Johnson & Johnson and Reig Jofre, a Spanish pharmaceutical company, entered into an agreement to manufacture the vaccine at Reig Jofre's Barcelona facility.{{cite news|url=https://www.reuters.com/article/us-reig-jofre-johnson-johnson-vaccine-idUSKBN28P0V2|title=Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine, shares soar|vauthors=Faus J, Allen N|date=15 December 2020|publisher=Reuters|access-date=29 January 2021|archive-date=9 February 2021|archive-url=https://web.archive.org/web/20210209173836/https://www.reuters.com/article/us-reig-jofre-johnson-johnson-vaccine-idUSKBN28P0V2|url-status=live}}

In February 2021, Sanofi and Johnson & Johnson struck a deal for Sanofi to provide support and infrastructure at Sanofi's Marcy-l'Étoile, France facility to manufacture approximately twelve million doses of the Johnson & Johnson vaccine per month once authorized.{{cite news | title=France's Sanofi to help Johnson & Johnson manufacture COVID-19 vaccine | website=Reuters | date=22 February 2021 | url=https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-sa-idUSKBN2AM126 | access-date=1 April 2021 | archive-date=15 April 2021 | archive-url=https://web.archive.org/web/20210415154342/https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-sa-idUSKBN2AM126 | url-status=live }}

In March 2021, Johnson & Johnson and Aspen Pharmacare made a deal to manufacture 220 million vaccines at Aspen's Gqeberha facility in Eastern Cape, South Africa. They plan to distribute the vaccine to other countries, mainly in Africa, and also through the COVID-19 Vaccines Global Access (COVAX) program.{{cite web|title=Covid-19: SA plans to vaccinate 200 000 people a day - report|url=https://www.news24.com/news24/southafrica/news/covid-19-sa-plans-to-vaccinate-200-000-people-a-day-report-20210328|access-date=31 March 2021|website=News24|archive-date=30 April 2021|archive-url=https://web.archive.org/web/20210430154055/https://www.news24.com/news24/southafrica/news/covid-19-sa-plans-to-vaccinate-200-000-people-a-day-report-20210328|url-status=live}}{{cite web|title=COVID-19 vaccine: J&J commits 30 million doses for SA|url=https://www.enca.com/news/jj-commits-30-million-vaccine-doses-sa|access-date=31 March 2021|website=eNCA|archive-date=30 April 2021|archive-url=https://web.archive.org/web/20210430154056/https://www.enca.com/news/jj-commits-30-million-vaccine-doses-sa|url-status=live}}{{cite web|title='No setbacks.' SA factory on track to produce J&J vaccine|url=https://www.businessinsider.co.za/johnson-vaccine-preparation-at-pe-factor-on-track-2021-3|access-date=31 March 2021|website=BusinessInsider|archive-date=30 April 2021|archive-url=https://web.archive.org/web/20210430154055/https://www.businessinsider.co.za/johnson-vaccine-preparation-at-pe-factor-on-track-2021-3|url-status=live}}

In March 2021, Merck & Co and Johnson & Johnson struck a deal for Merck to manufacture the Johnson & Johnson vaccine at two facilities in the United States to help expand the manufacturing capacity of the vaccine using provisions of the Defense Production Act.{{cite press release | title=Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines | website=HHS | date=2 March 2021 | url=https://www.hhs.gov/about/news/2021/03/02/biden-administration-announces-historic-manufacturing-collaboration-between-merck-johnson-johnson-expand-production-covid-19-vaccines.html | access-date=4 March 2021 | archive-date=3 March 2021 | archive-url=https://web.archive.org/web/20210303203739/https://www.hhs.gov/about/news/2021/03/02/biden-administration-announces-historic-manufacturing-collaboration-between-merck-johnson-johnson-expand-production-covid-19-vaccines.html | url-status=live }} That same month, human error at a plant run by Emergent BioSolutions in Baltimore resulted in the spoilage of up to fifteen million doses of the Johnson & Johnson vaccine. The error, which was caught before the doses left the plant, delayed expected shipments of the Johnson & Johnson vaccine within the United States.{{cite news|vauthors=LaFraniere S, Weiland N|date=31 March 2021|title=Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson|work=The New York Times|url=https://www.nytimes.com/2021/03/31/us/politics/johnson-johnson-coronavirus-vaccine.html|access-date=1 April 2021|archive-date=1 April 2021|archive-url=https://web.archive.org/web/20210401001259/https://www.nytimes.com/2021/03/31/us/politics/johnson-johnson-coronavirus-vaccine.html|url-status=live}} As the error had involved combining ingredients of the Johnson & Johnson vaccine with the AstraZeneca vaccine, the Biden administration gave control of the plant to Johnson & Johnson and said the plant should produce only the Johnson & Johnson vaccine to avoid further mix-ups.{{cite news| vauthors = Stolberg SG |date=3 April 2021|title=U.S. Taps Johnson & Johnson to Run Troubled Vaccine Plant|work=The New York Times|url=https://www.nytimes.com/2021/04/03/us/politics/emergent-vaccine-plant-johnson-johnson.html|access-date=4 April 2021|name-list-style=vanc|archive-date=4 April 2021|archive-url=https://web.archive.org/web/20210404013323/https://www.nytimes.com/2021/04/03/us/politics/emergent-vaccine-plant-johnson-johnson.html|url-status=live}} In July 2021, the FDA authorized Emergent to resume production (but not distribution) of the Janssen vaccine.{{cite news |vauthors=Condon C |title=Troubled Emergent BioSolutions plant in Baltimore approved to resume production of Johnson & Johnson vaccine |url=https://www.baltimoresun.com/coronavirus/bs-md-emergent-biosolutions-fda-approval-resuming-janssen-20210729-ibxm7q5h5najnlilkxso4ic4n4-story.html |access-date=30 July 2021 |work=The Baltimore Sun |date=29 July 2021 |ref=resumemer |archive-date=29 July 2021 |archive-url=https://web.archive.org/web/20210729123715/https://www.baltimoresun.com/coronavirus/bs-md-emergent-biosolutions-fda-approval-resuming-janssen-20210729-ibxm7q5h5najnlilkxso4ic4n4-story.html |url-status=live }} 400{{nbsp}}million doses were destroyed.{{cite news | vauthors=Banco E, Owermohle S | title=Emergent's Covid vaccine problems more extensive than previously known | website=Politico | date=10 May 2022 | url=https://www.politico.com/news/2022/05/10/emergent-covid-vaccine-problems-00031266 | access-date=12 May 2022 | name-list-style=vanc | archive-date=11 May 2022 | archive-url=https://web.archive.org/web/20220511181350/https://www.politico.com/news/2022/05/10/emergent-covid-vaccine-problems-00031266 | url-status=live }}{{cite news | title=Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says | website=The New York Times | date=10 May 2022 | url=https://www.nytimes.com/2022/05/10/us/politics/emergent-fda-vaccine-covid-contaminated.html | access-date=12 May 2022 | vauthors=Gay S, Stolberg C, LaFraniere S | archive-date=11 May 2022 | archive-url=https://web.archive.org/web/20220511225500/https://www.nytimes.com/2022/05/10/us/politics/emergent-fda-vaccine-covid-contaminated.html | url-status=live }}

Review of Vaccine Adverse Events Reporting System (VAERS) safety monitoring data by the US Centers for Disease Control and Prevention (CDC) through 21 April 2021, (by which time 7.98{{nbsp}}million doses of the Janssen COVID{{nbhyph}}19 vaccine had been administered), showed that "97% of reported reactions after vaccine receipt were nonserious, consistent with preauthorization clinical trials data."{{cite journal | vauthors = Shay DK, Gee J, Su JR, Myers TR, Marquez P, Liu R, Zhang B, Licata C, Clark TA, Shimabukuro TT | title = Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine - United States, March-April 2021 | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 70 | issue = 18 | pages = 680–684 | date = May 2021 | pmid = 33956784 | doi = 10.15585/mmwr.mm7018e2 | pmc = 9368748 | doi-access = free | s2cid = 233983181 | url = https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7018e2-H.pdf | access-date = 14 July 2021 | archive-date = 4 November 2021 | archive-url = https://web.archive.org/web/20211104205145/http://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7018e2-H.pdf | url-status = live }} {{PD-notice}}

The most common side effects of the vaccine in the trials were usually mild or moderate, occurred within two days after vaccination, and got better within 1 or 2 days.{{cite web|date=19 March 2021|title=Janssen COVID-19 Vaccine|url=https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine|access-date=7 April 2021|website=U.S. Food and Drug Administration (FDA)|archive-date=7 April 2021|archive-url=https://web.archive.org/web/20210407155853/https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine|url-status=live}} {{PD-notice}}{{cite web|date=31 March 2021|title=Johnson & Johnson's Janssen COVID-19 Vaccine: Overview and Safety|url=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html|access-date=7 April 2021|publisher=U.S. Centers for Disease Control and Prevention (CDC)|archive-date=7 April 2021|archive-url=https://web.archive.org/web/20210407000636/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html|url-status=live}} {{PD-notice}}

The most common side effects are pain at the injection site, headache, tiredness, muscle pain, and nausea, affecting more than 1 in 10 people. Coughing, joint pain, fever, chills, redness, and swelling at the injection site occurred in less than 1 in 10 people. Sneezing, tremor, throat pain, rash, sweating, muscle weakness, pain in the arms and legs, backache, weakness, and feeling generally unwell occurred in less than 1 in 100 people. Rare side effects (that occurred in less than 1 in 1,000 people) are hypersensitivity (allergy) and itchy rash.

An increased risk of the rare and potentially fatal thrombosis with thrombocytopenia syndrome (TTS) has been associated with mainly younger female recipients of the vaccine.{{cite journal | vauthors = Cines DB, Bussel JB | title = SARS-CoV-2 Vaccine-Induced Immune Thrombotic Thrombocytopenia | journal = The New England Journal of Medicine | volume = 384 | issue = 23 | pages = 2254–2256 | date = June 2021 | pmid = 33861524 | pmc = 8063912 | doi = 10.1056/NEJMe2106315 | title-link = doi | doi-access = free }} This syndrome, marked by formation of blood clots in the blood vessels in combination with low levels of blood platelets 4–28 days after the vaccines administration, occurred at a rate of about 7 per 1 million vaccinated women aged 18–49 years old and it occurs more rarely in other populations (i.e., women 50 years and older and men of all ages).{{cite web |title=Safety of COVID-19 Vaccines |date=11 February 2020 |url=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html |publisher=U.S. Centers for Disease Control and Prevention (CDC) |access-date=13 July 2021 |archive-date=10 May 2021 |archive-url=https://web.archive.org/web/20210510054056/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html |url-status=live }}

Allergic reactions, including anaphylaxis, can occur in rare cases within a few minutes to one hour after receiving a dose.

In May 2021, with 7.98 million doses administered, the CDC reported four cases of anaphylaxis after vaccination (none of which resulted in death) and 28 cases of cerebral venous sinus thrombosis (of which three resulted in death).

In July 2021, the US fact sheet for the vaccine was updated to indicate that there may be an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.{{cite news | title=F.D.A. Attaches Warning of Rare Nerve Syndrome to Johnson & Johnson Covid Vaccine | website=The New York Times | date=12 July 2021 | url=https://www.nytimes.com/2021/07/12/us/politics/fda-warning-johnson-johnson-vaccine-nerve-syndrome.html |archive-url=https://ghostarchive.org/archive/20211228/https://www.nytimes.com/2021/07/12/us/politics/fda-warning-johnson-johnson-vaccine-nerve-syndrome.html |archive-date=28 December 2021 |url-access=limited | access-date=13 July 2021 | vauthors = LaFraniere S, Weiland N | url-status=live }}{{cite web | title=Janssen Letter Granting EUA Amendment | url=https://www.fda.gov/media/150723/download | format=PDF | date=12 July 2021 | access-date=13 July 2021 | publisher=U.S. Food and Drug Administration (FDA) | quote=Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination. | archive-date=12 July 2021 | archive-url=https://web.archive.org/web/20210712235101/https://www.fda.gov/media/150723/download | url-status=live }} The European Medicines Agency (EMA) listed Guillain-Barré syndrome (GBS) as a very rare side effect of COVID{{nbhyph}}19 Vaccine Janssen and added a warning in the product information.{{cite press release | title=COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect | website=European Medicines Agency (EMA) | date=22 July 2021 | url=https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-guillain-barre-syndrome-listed-very-rare-side-effect | access-date=22 July 2021 | archive-date=22 July 2021 | archive-url=https://web.archive.org/web/20210722140617/https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-guillain-barre-syndrome-listed-very-rare-side-effect | url-status=live }}

In August 2021, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating the product information to the European Medicines Agency (EMA) that "cases of dizziness and tinnitus (ringing or other noises in one or both ears) are linked to the administration of COVID{{nbhyph}}19 vaccine Janssen."{{cite web|date=5 August 2021|title=Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021|url=https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-august-2021|website=European Medicines Agency (EMA)|access-date=18 August 2021|archive-date=14 January 2022|archive-url=https://web.archive.org/web/20220114204127/https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-august-2021|url-status=live}} Tinnitus was later labeled as "very rare" in a final safety study by the manufacturer.{{cite journal | vauthors = Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Van Dromme I, Spiessens B, Vingerhoets J, Custers J, Scheper G, Robb ML, Treanor J, Ryser MF, Barouch DH, Swann E, Marovich MA, Neuzil KM, Corey L, Stoddard J, Hardt K, Ruiz-Guiñazú J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M | title = Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S | journal = The New England Journal of Medicine | volume = 386 | issue = 9 | pages = 847–860 | date = March 2022 | pmid = 35139271 | pmc = 8849184 | doi = 10.1056/NEJMoa2117608 | collaboration = ENSEMBLE Study Group | s2cid = 246701307 }}

In December 2021, the CDC accepted the recommendation from a panel of experts for a preference of using the Pfizer-BioNech and Moderna vaccines over the Janssen vaccine due to rare but serious blood clotting events.{{cite news|vauthors=Romo V, Hensley S|date=16 December 2021|title=CDC advisers vote to narrow use of J&J vaccine due to concerns about rare blood clots|work=NPR|url=https://www.npr.org/sections/coronavirus-live-updates/2021/12/16/1064909742/cdc-vote-narrow-use-of-johnson-and-johnson-covid-vaccine|access-date=16 December 2021|name-list-style=vanc|archive-date=16 December 2021|archive-url=https://web.archive.org/web/20211216212529/https://www.npr.org/sections/coronavirus-live-updates/2021/12/16/1064909742/cdc-vote-narrow-use-of-johnson-and-johnson-covid-vaccine|url-status=live}} In May 2022, the FDA limited the use of the Janssen vaccine to those over eighteen unable to access other vaccines or who are otherwise "medically ineligible" for other vaccine options.{{cite press release | title=Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals | website=U.S. Food and Drug Administration (FDA) | date=5 May 2022 | url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals | access-date=5 May 2022 | archive-date=7 May 2022 | archive-url=https://web.archive.org/web/20220507001000/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals | url-status=live }}{{cite news |vauthors=Jones D |date=5 May 2022 |title=FDA limits Johnson & Johnson's COVID vaccine to some people due to blood clot risk |work=NPR |url=https://www.npr.org/2022/05/05/1097009813/johnson-and-johnson-covid-vaccine-limited-fda |access-date=6 May 2022 |name-list-style=vanc |archive-date=6 May 2022 |archive-url=https://web.archive.org/web/20220506000143/https://www.npr.org/2022/05/05/1097009813/johnson-and-johnson-covid-vaccine-limited-fda |url-status=live }}

The stabilized version of the spike protein{{snd}}that includes two mutations in which the regular amino acids are replaced with prolines{{snd}}was developed by researchers at the National Institute of Allergy and Infectious Diseases' Vaccine Research Center and the University of Texas at Austin.{{cite news|title=The tiny tweak behind COVID-19 vaccines|work=Chemical & Engineering News|url=https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38|access-date=1 March 2021|date=29 September 2020|archive-date=16 February 2021|archive-url=https://web.archive.org/web/20210216151009/https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38|url-status=live}}{{cite news|vauthors=Kramer J|date=31 December 2020|title=They spent 12 years solving a puzzle. It yielded the first COVID-19 vaccines.|work=National Geographic|url=https://www.nationalgeographic.com/science/article/these-scientists-spent-twelve-years-solving-puzzle-yielded-coronavirus-vaccines|url-status=dead|access-date=1 March 2021|archive-date=28 February 2021|archive-url=https://web.archive.org/web/20210228164324/https://www.nationalgeographic.com/science/article/these-scientists-spent-twelve-years-solving-puzzle-yielded-coronavirus-vaccines}}{{cite journal | vauthors = Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, Liu J, Peter L, McMahan K, Tostanoski LH, He X, Martinez DR, Rutten L, Bos R, van Manen D, Vellinga J, Custers J, Langedijk JP, Kwaks T, Bakkers MJ, Zuijdgeest D, Rosendahl Huber SK, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Hoffman E, Jacob-Dolan C, Kirilova M, Li Z, Lin Z, Mahrokhian SH, Maxfield LF, Nampanya F, Nityanandam R, Nkolola JP, Patel S, Ventura JD, Verrington K, Wan H, Pessaint L, Van Ry A, Blade K, Strasbaugh A, Cabus M, Brown R, Cook A, Zouantchangadou S, Teow E, Andersen H, Lewis MG, Cai Y, Chen B, Schmidt AG, Reeves RK, Baric RS, Lauffenburger DA, Alter G, Stoffels P, Mammen M, Van Hoof J, Schuitemaker H, Barouch DH | title = Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques | journal = Nature | volume = 586 | issue = 7830 | pages = 583–588 | date = October 2020 | pmid = 32731257 | pmc = 7581548 | doi = 10.1038/s41586-020-2607-z | bibcode = 2020Natur.586..583M | s2cid = 220893461 | title-link = doi | doi-access = free }}

During the COVID{{nbhyph}}19 pandemic, Johnson & Johnson committed over {{US$|1{{nbs}}billion}} toward development of a not-for-profit vaccine in partnership with the Biomedical Advanced Research and Development Authority (BARDA) Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).{{cite web|url=https://njbiz.com/jj-collaborates-accelerate-covid-19-vaccine-development/|title=J&J collaborates to accelerate COVID-19 vaccine development|vauthors=Vecchione A|date=13 March 2020|website=NJBIZ|access-date=22 April 2020|archive-date=22 January 2021|archive-url=https://web.archive.org/web/20210122050240/https://njbiz.com/jj-collaborates-accelerate-covid-19-vaccine-development/|url-status=live}}{{cite web|url=https://www.wspa.com/news/prisma-health-collaborates-with-ethicon-inc-to-make-distribute-vesper-ventilator-expansion-splitter-device/|title=Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device|date=6 April 2020|website=WSPA 7News|access-date=22 April 2020|archive-date=22 January 2021|archive-url=https://web.archive.org/web/20210122191226/https://www.wspa.com/news/prisma-health-collaborates-with-ethicon-inc-to-make-distribute-vesper-ventilator-expansion-splitter-device/|url-status=live}} Johnson & Johnson said its vaccine project would be "at a not-for-profit level" as the company viewed it as "the fastest and the best way to find all the collaborations in the world to make this happen".{{cite web|url=https://news.sky.com/story/coronavirus-johnson-johnson-vows-to-make-not-for-profit-vaccine-11966292|title=Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine|website=Sky News|access-date=22 April 2020|archive-date=21 January 2021|archive-url=https://web.archive.org/web/20210121042014/https://news.sky.com/story/coronavirus-johnson-johnson-vows-to-make-not-for-profit-vaccine-11966292|url-status=live}} In November, Johnson & Johnson announced that Janssen would commit about $604 million and BARDA would commit $454 million to fund the ENSEMBLE trial.{{cite press release |date=14 November 2020 |title=Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development |url=https://www.jnj.com/johnson-johnson-and-u-s-department-of-health-human-services-expand-agreement-to-support-next-phase-of-covid-19-vaccine-candidate-research-and-development |location=New Brunswick, New Jersey |publisher=Johnson & Johnson |access-date=14 August 2021 |archive-date=14 August 2021 |archive-url=https://web.archive.org/web/20210814140315/https://www.jnj.com/johnson-johnson-and-u-s-department-of-health-human-services-expand-agreement-to-support-next-phase-of-covid-19-vaccine-candidate-research-and-development |url-status=live }}

File:Ad26.COV2.S production facility.jpg facility where, in collaboration with Johnson & Johnson, vaccines are produced]]

Johnson & Johnson subsidiary Janssen Vaccines, in partnership with Beth Israel Deaconess Medical Center (BIDMC), was responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine.{{cite news | title=A Beth Israel researcher helped create a COVID-19 vaccine that awaits approval. It could be a 'game changer' | website=The Boston Globe | date=16 January 2021 | url=https://www.bostonglobe.com/2021/01/16/nation/beth-israel-researcher-awaits-approval-covid-19-vaccine-he-helped-create/ | access-date=28 February 2021 | archive-date=1 March 2021 | archive-url=https://web.archive.org/web/20210301003948/https://www.bostonglobe.com/2021/01/16/nation/beth-israel-researcher-awaits-approval-covid-19-vaccine-he-helped-create/ | url-status=live }}{{cite web | title=FDA grants third COVID-19 vaccine, developed in part at BIDMC, emergency use authorization | website=Beth Israel Deaconess Medical Center (BIDMC) | date=27 February 2021 | url=https://www.bidmc.org/about-bidmc/news/2021/01/data-shows-bidmc-vaccine-collab-met-co-primary-endpoints | vauthors = Mitchell J, Meck C | access-date=28 February 2021 | archive-date=27 February 2021 | archive-url=https://web.archive.org/web/20210227234558/https://www.bidmc.org/about-bidmc/news/2021/01/data-shows-bidmc-vaccine-collab-met-co-primary-endpoints | url-status=live }}{{cite news| vauthors = Watts M |date=28 May 2021|title=Single shot Johnson & Johnson Covid vaccine approved for use in the UK|work=London Evening Standard|url=https://www.standard.co.uk/news/health/johnson-and-johnson-covid-vaccine-approved-use-uk-b937784.html|access-date=29 May 2021|archive-date=28 May 2021|archive-url=https://web.archive.org/web/20210528130647/https://www.standard.co.uk/news/health/johnson-and-johnson-covid-vaccine-approved-use-uk-b937784.html|url-status=live}}

Preclinical trials indicated that the vaccine effectively protected hamsters and rhesus macaques from SARS‐CoV‐2.{{cite journal | vauthors = Calvo Fernández E, Zhu LY | title = Racing to immunity: Journey to a COVID-19 vaccine and lessons for the future | journal = British Journal of Clinical Pharmacology | volume = 87 | issue = 9 | pages = 3408–3424 | date = September 2021 | pmid = 33289156 | pmc = 7753785 | doi = 10.1111/bcp.14686 }}

In June 2020, Johnson & Johnson and the National Institute of Allergy and Infectious Diseases (NIAID) confirmed that they planned to start clinical trials of the Ad26.COV2.S vaccine in September 2020, with the possibility of phase{{nbs}}I–IIa human clinical trials starting at an accelerated pace in the second half of July.{{cite web|vauthors=Coleman J|date=10 June 2020|title=Final testing stage for potential coronavirus vaccine set to begin in July|url=https://thehill.com/policy/healthcare/501999-final-testing-stage-for-coronavirus-vaccine-could-begin-in-july-report|access-date=11 June 2020|website=The Hill|archive-date=10 January 2021|archive-url=https://web.archive.org/web/20210110124831/https://thehill.com/policy/healthcare/501999-final-testing-stage-for-coronavirus-vaccine-could-begin-in-july-report|url-status=live}}{{cite web|title=Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ|url=https://www.fiercepharma.com/vaccines/nih-preps-late-stage-studies-moderna-az-and-j-j-coronavirus-vaccines-wsj|access-date=11 June 2020|website=FiercePharma|date=10 June 2020|archive-date=21 January 2021|archive-url=https://web.archive.org/web/20210121042714/https://www.fiercepharma.com/vaccines/nih-preps-late-stage-studies-moderna-az-and-j-j-coronavirus-vaccines-wsj|url-status=live}}{{cite web|title=Johnson & Johnson to start human testing of COVID-19 vaccine next week|url=https://www.fiercepharma.com/vaccines/j-j-to-start-human-testing-covid-19-vaccine-next-week-exec|access-date=20 July 2020|website=FiercePharma|date=16 July 2020|archive-date=22 January 2021|archive-url=https://web.archive.org/web/20210122044104/https://www.fiercepharma.com/vaccines/j-j-to-start-human-testing-covid-19-vaccine-next-week-exec|url-status=live}}

A phase I–IIa clinical trial started with the recruitment of the first subject in July 2020 and enrolled study participants in Belgium and the US. Interim results from the phase{{nbs}}I–IIa trial established the safety, reactogenicity, and immunogenicity of Ad26.COV2.S. With one dose, after 29 days, the vaccine ensured ninety percent of participants had enough antibodies required to neutralize the virus. After 57 days, that number reached one hundred percent. 1x10{{sup|11}} viral particles (high dose) provided an increase in the neutralizing-antibody titers compared to 5×10{{sup|10}} (low dose). After the second dose 56 days after the first dose among participants between the ages of 18 and 55 years, the incidence of grade 3 solicited systemic adverse events was much lower than that after the first immunization in both the low-dose and high-dose groups, a finding that contrasts with observations with respect to messenger RNA–based vaccines, for which the second dose has been associated with increased reactogenicity. A substudy with 20 participants found that humoral and cell-mediated immune responses, including cytotoxic T cells, lasted for at least 8 months.{{cite press release |date=1 July 2021 |title=Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response |url=https://www.jnj.com/positive-new-data-for-johnson-johnson-single-shot-covid-19-vaccine-on-activity-against-delta-variant-and-long-lasting-durability-of-response |location= |publisher= |agency= |access-date=2 July 2021 |archive-date=22 August 2021 |archive-url=https://web.archive.org/web/20210822190303/https://www.jnj.com/positive-new-data-for-johnson-johnson-single-shot-covid-19-vaccine-on-activity-against-delta-variant-and-long-lasting-durability-of-response |url-status=live }}{{unreliable medical source|date=July 2021}}

A phase III clinical trial called ENSEMBLE started enrollment in September 2020 and completed enrollment in December 2020. It was designed as a randomized, double-blind, placebo-controlled clinical trial intended to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults aged 18 years of age and older. Study participants received a single intramuscular injection of Ad26.COV2.S at a dose level of 5×10{{sup|10}} virus particles on day one.{{cite press release |title=Fourth large-scale COVID-19 vaccine trial begins in the United States |url=https://www.nih.gov/news-events/news-releases/fourth-large-scale-covid-19-vaccine-trial-begins-united-states |access-date=30 January 2021 |publisher=National Institutes of Health |date=22 September 2020 |archive-date=30 January 2021 |archive-url=https://web.archive.org/web/20210130164337/https://www.nih.gov/news-events/news-releases/fourth-large-scale-covid-19-vaccine-trial-begins-united-states |url-status=live }} The trial was paused in October 2020, because a volunteer became ill,{{cite news|vauthors=Hughes V, Thomas K, Zimmer C, Wu KJ|date=12 October 2020|title=Johnson & Johnson halts coronavirus vaccine trial because of sick volunteer.|work=The New York Times|url=https://www.nytimes.com/live/2020/10/12/world/coronavirus-covid|access-date=12 October 2020|issn=0362-4331|archive-date=22 February 2021|archive-url=https://web.archive.org/web/20210222101459/https://www.nytimes.com/live/2020/10/12/world/coronavirus-covid|url-status=live}} but the company said it found no evidence that the vaccine had caused the illness and announced in October 2020 that it would resume the trial.{{cite press release|date=23 October 2020|title=Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.|url=https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us|access-date=28 October 2020|website=Johnson & Johnson|archive-date=16 February 2021|archive-url=https://web.archive.org/web/20210216195947/https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us|url-status=live}}{{cite web|vauthors=Edwards E, Miller SG|date=23 October 2020|title=AstraZeneca, Johnson & Johnson resume late-stage Covid-19 vaccine trials|url=https://www.nbcnews.com/health/health-news/astrazeneca-johnson-johnson-resume-late-stage-covid-19-vaccine-trials-n1244579|access-date=28 October 2020|website=NBC News|archive-date=26 January 2021|archive-url=https://web.archive.org/web/20210126032335/https://www.nbcnews.com/health/health-news/astrazeneca-johnson-johnson-resume-late-stage-covid-19-vaccine-trials-n1244579|url-status=live}} In January 2021, Janssen announced safety and efficacy data from an interim analysis of ENSEMBLE trial data, which demonstrated the vaccine was 66% effective at preventing the combined endpoints of moderate and severe COVID{{nbhyph}}19 at 28 days post-vaccination among all volunteers. The interim analysis was based on 468 cases of symptomatic COVID{{nbhyph}}19 among 43,783 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. No deaths related to COVID{{nbhyph}}19 were reported in the vaccine group, while five deaths in the placebo group were related to COVID{{nbhyph}}19. During the trial, no anaphylaxis was observed in participants.

A second phase III clinical trial called ENSEMBLE{{nbs}}2 started enrollment in November 2020. ENSEMBLE{{nbs}}2 differed from ENSEMBLE in that its study participants received two intramuscular (IM) injections of Ad26.COV2.S, one on day{{nbs}}1 and the next on day 57. Early results indicated 85% efficacy against severe/critical disease.{{cite journal | vauthors = Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guiñazú J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M | title = Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19 | journal = The New England Journal of Medicine | volume = 384 | issue = 23 | pages = 2187–2201 | date = June 2021 | pmid = 33882225 | pmc = 8220996 | doi = 10.1056/NEJMoa2101544 }} Plasma from 8 participants showed greater neutralization activity against the Delta variant than against Beta.

{{#section:List of COVID-19 vaccine authorizations|janssenauthmap}}

{{See also|List of COVID-19 vaccine authorizations#Janssen}}

Beginning in December 2020, clinical trial of the vaccine candidate has been undergoing a "rolling review" process by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), a step to expedite EMA consideration of an expected conditional marketing authorization.{{cite news|url=https://www.reuters.com/article/us-health-coronavirus-vaccine-eu-johnson-idUSKBN29I1EM|title=J&J COVID-19 vaccine could be available in Europe in April: source|vauthors=Guarascio F|date=13 January 2021|publisher=Reuters|access-date=29 January 2021|archive-date=30 January 2021|archive-url=https://web.archive.org/web/20210130000814/https://www.reuters.com/article/us-health-coronavirus-vaccine-eu-johnson-idUSKBN29I1EM|url-status=live}}{{cite press release|url=https://www.jnj.com/our-company/johnson-johnson-announces-initiation-of-rolling-submission-for-its-single-dose-janssen-covid-19-vaccine-candidate-with-the-european-medicines-agency|title=Johnson & Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines Agency|publisher=Johnson & Johnson|date=1 December 2020|access-date=5 February 2021|archive-date=27 January 2021|archive-url=https://web.archive.org/web/20210127221955/https://www.jnj.com/our-company/johnson-johnson-announces-initiation-of-rolling-submission-for-its-single-dose-janssen-covid-19-vaccine-candidate-with-the-european-medicines-agency|url-status=live}} In February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine.{{cite press release | title=EMA receives application for conditional marketing authorization of COVID-19 Vaccine Janssen | publisher=European Medicines Agency (EMA) | date=16 February 2021 | url=https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen | access-date=16 February 2021 | archive-date=16 February 2021 | archive-url=https://web.archive.org/web/20210216152545/https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen | url-status=live }}{{cite web|url=https://www.janssen.com/emea/sites/www_janssen_com_emea/files/jj_announces_submission_of_european_cmaa_to_the_ema_for_its_investigational_janssen_covid-19_vaccine_candidate.doc.pdf|title=Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Janssen COVID-19 Vaccine Candidate|access-date=17 February 2021|archive-date=28 February 2021|archive-url=https://web.archive.org/web/20210228155458/https://www.janssen.com/emea/sites/www_janssen_com_emea/files/jj_announces_submission_of_european_cmaa_to_the_ema_for_its_investigational_janssen_covid-19_vaccine_candidate.doc.pdf|url-status=live}} The European Commission approved the COVID{{nbhyph}}19 Vaccine Janssen in March 2021. In Finland, the Janssen vaccine is only offered for those aged 65 and over.{{cite web |title=Use of AstraZeneca coronavirus vaccine to end in Finland in November - News - THL |url=https://thl.fi/en/web/thlfi-en/-/use-of-astrazeneca-coronavirus-vaccine-to-end-in-finland-in-november |website=Finnish Institute for Health and Welfare (THL), Finland |access-date=5 December 2021 |archive-date=5 December 2021 |archive-url=https://web.archive.org/web/20211205155743/https://thl.fi/en/web/thlfi-en/-/use-of-astrazeneca-coronavirus-vaccine-to-end-in-finland-in-november |url-status=live }}{{cite web | title=Getting vaccinated against COVID-19: how, why and when? | website=Finnish Institute for Health and Welfare (THL), Finland | date=8 March 2022 | url=https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/vaccines-and-coronavirus/getting-vaccinated-against-covid-19-how-why-and-when- | access-date=14 March 2022 | archive-date=14 March 2022 | archive-url=https://web.archive.org/web/20220314032806/https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/vaccines-and-coronavirus/getting-vaccinated-against-covid-19-how-why-and-when- | url-status=live }}

In February 2021, Janssen Biotech applied to the US Food and Drug Administration (FDA) for an emergency use authorization (EUA), and the FDA announced that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) would meet in February to consider the application.{{cite press release |title=FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate |date=4 February 2021 |url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-janssen-biotech-incs |publisher=U.S. Food and Drug Administration (FDA) |access-date=4 February 2021 |url-status=live |archive-date=5 February 2021 |archive-url=https://web.archive.org/web/20210205003850/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-janssen-biotech-incs}}{{cite web | title=Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement | publisher=U.S. Food and Drug Administration (FDA) | url=https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcement | access-date=19 February 2021 | archive-date=16 February 2021 | archive-url=https://web.archive.org/web/20210216224508/https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcement | url-status=live }} In February, ahead of the VRBPAC meeting, briefing documents from Janssen and the FDA were issued; the FDA document recommends granting the EUA, concluding that the results of the clinical trials and the safety data are consistent with FDA EUA guidance for COVID{{nbhyph}}19 vaccines.{{cite report |title=FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 |publisher=U.S. Food and Drug Administration (FDA) |url=https://www.fda.gov/media/146217/download |format=PDF |date=26 February 2021 |access-date=24 February 2021 |archive-url=https://web.archive.org/web/20210429162601/https://www.fda.gov/media/146217/download |archive-date=29 April 2021 |url-status=live }} {{PD-notice}}
{{cite web |title=FDA scientists endorse J&J's Covid vaccine, as new data shed light on efficacy | vauthors = Herper M, Branswell H |date=24 February 2021 |website=Stat |url=https://www.statnews.com/2021/02/24/new-data-shed-light-on-efficacy-of-jjs-single-dose-vaccine-against-covid-19/ |access-date=28 February 2021 |archive-date=27 February 2021 |archive-url=https://web.archive.org/web/20210227235022/https://www.statnews.com/2021/02/24/new-data-shed-light-on-efficacy-of-jjs-single-dose-vaccine-against-covid-19/ |url-status=live }}{{cite report |title=Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document |publisher=Janssen Biotech |format=PDF |date= |url=https://www.fda.gov/media/146219/download |access-date=25 February 2021 |archive-date=25 February 2021 |archive-url=https://web.archive.org/web/20210225010605/https://www.fda.gov/media/146219/download |url-status=live }}{{cite report |title=Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document Addendum |publisher=Janssen Biotech |url=https://www.fda.gov/media/146218/download |format=PDF |date= |access-date=25 February 2021 |archive-date=24 February 2021 |archive-url=https://web.archive.org/web/20210224233750/https://www.fda.gov/media/146218/download |url-status=live }}{{cite web|vauthors=Christensen J|url=https://www.cnn.com/2021/02/24/health/johnson-vaccine-fda-analysis/index.html|title=FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization|publisher=CNN|date=24 February 2021|access-date=24 February 2021|archive-date=13 May 2021|archive-url=https://web.archive.org/web/20210513111638/https://www.cnn.com/2021/02/24/health/johnson-vaccine-fda-analysis/index.html|url-status=live}} At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that an EUA for the vaccine be issued.{{cite web|vauthors=Lovelace Jr B|date=26 February 2021|title=FDA panel unanimously recommends third Covid vaccine as J&J wins key vote in path to emergency use|website=CNBC |url=https://www.cnbc.com/2021/02/26/johnson-and-johnson-covid-vaccine-fda-panel-recommends-emergency-use.html|access-date=27 February 2021|archive-date=27 February 2021|archive-url=https://web.archive.org/web/20210227235011/https://www.cnbc.com/2021/02/26/johnson-and-johnson-covid-vaccine-fda-panel-recommends-emergency-use.html|url-status=live}} The FDA granted the EUA for the vaccine the following day.{{cite news|url=https://www.washingtonpost.com/health/2021/02/27/johnson-and-johnson-covid-vaccine-fda/|newspaper=The Washington Post|date=27 February 2021|title=FDA authorizes Johnson & Johnson's single-shot coronavirus vaccine, adding to the nation's arsenal against the pandemic|vauthors=McGinley L, Johnson CY |access-date=27 February 2021|url-status=live|archive-date=28 February 2021 |archive-url=https://web.archive.org/web/20210228005521/https://www.washingtonpost.com/health/2021/02/27/johnson-and-johnson-covid-vaccine-fda/}} In February, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommended the use of the vaccine for those aged 18 and older.{{cite news | vauthors=Feuer W | title=CDC panel recommends use of J&J's single-shot Covid vaccine, clearing way for distribution | website=CNBC | date=28 February 2021 | url=https://www.cnbc.com/2021/02/28/cdc-panel-recommends-use-of-jjs-single-shot-covid-vaccine.html | access-date=28 February 2021 | url-status=live | archive-date=28 February 2021 | archive-url=https://web.archive.org/web/20210228201952/https://www.cnbc.com/2021/02/28/cdc-panel-recommends-use-of-jjs-single-shot-covid-vaccine.html}}{{cite press release | title=Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices' Recommendation to Use Janssen's COVID-19 Vaccine in People 18 and Older | publisher=U.S. Centers for Disease Control and Prevention (CDC) | date=28 February 2021 | url=https://www.cdc.gov/media/releases/2021/s0228-JJ-vaccine.html | access-date=1 March 2021 | archive-url=https://web.archive.org/web/20210323115538/https://www.cdc.gov/media/releases/2021/s0228-JJ-vaccine.html | archive-date=23 March 2021 | url-status=live }}

In April 2021, the CDC and the FDA issued a joint statement recommending that use of the Janssen vaccine be suspended, due to reports of six cases of cerebral venous sinus thrombosis—a "rare and severe" blood clot—in combination with low levels of blood platelets (thrombocytopenia), in six women between the ages of 18 and 48 who had received the vaccine.{{cite press release|date=13 April 2021|title=Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine|url=https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html|access-date=13 April 2021|publisher=U.S. Centers for Disease Control and Prevention (CDC)|archive-date=13 April 2021|archive-url=https://web.archive.org/web/20210413083217/https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html|url-status=live}} The symptoms occurred 6–13 days after they had received the vaccination, and it was reported that one woman had died and a second woman had been hospitalized in critical condition.{{cite news| vauthors = Weiland N, LaFraniere S, Zimmer C |date=13 April 2021|title=Johnson & Johnson Vaccinations Halt Across Country After Rare Clotting Cases Emerge|work=The New York Times|url=https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html|access-date=13 April 2021|name-list-style=vanc|archive-date=7 June 2021|archive-url=https://web.archive.org/web/20210607003343/https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html|url-status=live}}{{cite news| vauthors = Erman M, Mishra M |date=13 April 2021|title=U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe|publisher=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-va-idUSKBN2C01BC|access-date=13 April 2021|name-list-style=vanc|archive-date=13 April 2021|archive-url=https://web.archive.org/web/20210413112309/https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-va-idUSKBN2C01BC|url-status=live}}{{cite news | vauthors = Howard J |title=CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns|url=https://www.cnn.com/2021/04/13/health/johnson-vaccine-pause-cdc-fda/index.html|access-date=13 April 2021|publisher=CNN|name-list-style=vanc|archive-date=7 June 2021|archive-url=https://web.archive.org/web/20210607002846/https://www.cnn.com/2021/04/13/health/johnson-vaccine-pause-cdc-fda/index.html|url-status=live}}

In April, the FDA and the CDC determined that the recommended pause regarding the use of the Janssen COVID{{nbhyph}}19 Vaccine in the US should be lifted and use of the vaccine should resume.{{cite press release | title=FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review | website=U.S. Food and Drug Administration (FDA) | date=23 April 2021 | url=https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough | access-date=23 April 2021 | archive-date=23 April 2021 | archive-url=https://web.archive.org/web/20210423230511/http://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough | url-status=live }} {{PD-notice}}{{cite press release | title=FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review | publisher=U.S. Centers for Disease Control and Prevention (CDC) | date=23 April 2021 | url=https://www.cdc.gov/media/releases/2021/fda-cdc-lift-vaccine-use.html | access-date=23 April 2021 | archive-date=23 April 2021 | archive-url=https://web.archive.org/web/20210423231201/https://www.cdc.gov/media/releases/2021/fda-cdc-lift-vaccine-use.html | url-status=live }} {{PD-notice}} The EUA and the fact sheets were updated to reflect the risks of thrombosis-thrombocytopenia syndrome (TTS).

The FDA granted an emergency use authorization and the CDC issued a standing order for the use of the vaccine.{{cite press release |title=FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine |website=U.S. Food and Drug Administration (FDA) |date=27 February 2021 |url=https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine |access-date=27 February 2021 |archive-date=18 March 2021 |archive-url=https://web.archive.org/web/20210318174827/https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine |url-status=live }}{{cite web | url=https://www.fda.gov/media/146303/download | format=PDF | title=FDA Letter of Authorization | website=U.S. Food and Drug Administration (FDA) | quote=...letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA)... | date=27 February 2021 | access-date=28 February 2021 | archive-date=10 March 2021 | archive-url=https://web.archive.org/web/20210310103959/https://www.fda.gov/media/146303/download | url-status=live }}{{cite web | url=https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/downloads/Janssen-Standing-Orders.pdf | title=Janssen COVID-19 Vaccine (Johnson & Johnson) Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older | publisher=U.S. Centers for Disease Control and Prevention (CDC) | access-date=16 April 2021 | archive-date=16 April 2021 | archive-url=https://web.archive.org/web/20210416214154/https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/downloads/Janssen-Standing-Orders.pdf | url-status=live }}

In June 2023, the FDA revoked the emergency use authorization for the Janssen COVID-19 vaccine at the request of its manufacturer.

In February 2021, Saint Vincent and the Grenadines issued an emergency authorization for the Janssen COVID{{nbhyph}}19 vaccine, as well as the Moderna COVID{{nbhyph}}19 vaccine, the Pfizer–BioNTech vaccine, the Gam-COVID-Vac vaccine (Sputnik V), and the Oxford–AstraZeneca vaccine.{{cite web |title=Public Health (Emergency Authorisation of COVID-19 Vaccine) Rules, 2021 |url=https://www.gov.vc/images/pdf_documents/SRO-Public_Health_Emergency_Authorisation_of_Covid-19_Vaccine.pdf |date=11 February 2021 |access-date=12 February 2021 |website=Government of Saint Vincent and the Grenadines |archive-date=13 February 2021 |archive-url=https://web.archive.org/web/20210213124358/https://www.gov.vc/images/pdf_documents/SRO-Public_Health_Emergency_Authorisation_of_Covid-19_Vaccine.pdf |url-status=dead }}

In December 2020, Johnson & Johnson entered into an agreement in principle with the GAVI vaccine alliance to support the COVAX Facility. In February 2021, Johnson & Johnson submitted its formal request and data package to the World Health Organization for an Emergency Use Listing (EUL); an EUL is a requirement for participation in COVAX. Johnson & Johnson anticipated providing up to five hundred million doses through 2022 for COVAX.{{cite press release |title=Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate|url=https://www.prnewswire.com/news-releases/johnson--johnson-announces-submission-to-world-health-organization-for-emergency-use-listing-of-investigational-single-shot-janssen-covid-19-vaccine-candidate-301231645.html|via=PR Newswire|publisher=Johnson & Johnson|date=19 February 2021|access-date=25 June 2021|archive-date=19 February 2021|archive-url=https://web.archive.org/web/20210219161712/https://www.prnewswire.com/news-releases/johnson--johnson-announces-submission-to-world-health-organization-for-emergency-use-listing-of-investigational-single-shot-janssen-covid-19-vaccine-candidate-301231645.html|url-status=live}}{{cite web|vauthors=Heeb G|title=Johnson & Johnson Applies For Emergency Use Vaccine Approval At W.H.O.|url=https://www.forbes.com/sites/ginaheeb/2021/02/19/johnson--johnson-applies-for-emergency-use-vaccine-approval-at-who/|access-date=25 February 2021|website=Forbes|archive-date=20 February 2021|archive-url=https://web.archive.org/web/20210220140403/https://www.forbes.com/sites/ginaheeb/2021/02/19/johnson--johnson-applies-for-emergency-use-vaccine-approval-at-who/|url-status=live}} The World Health Organization issued an EUL for the Janssen COVID{{nbhyph}}19 vaccine Ad26.COV2.S vaccine in March 2021.{{cite press release | title=WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19 | publisher=World Health Organization (WHO) | url=https://www.who.int/news/item/12-03-2021-who-adds-janssen-vaccine-to-list-of-safe-and-effective-emergency-tools-against-covid-19 | access-date=30 May 2021 | archive-date=1 June 2021 | archive-url=https://web.archive.org/web/20210601172128/https://www.who.int/news/item/12-03-2021-who-adds-janssen-vaccine-to-list-of-safe-and-effective-emergency-tools-against-covid-19 | url-status=live }}{{cite web | title=WHO recommendation Janssen–Cilag International NV (Belgium) COVID-19 Vaccine (Ad26.COV2-S [recombinant]) | publisher=World Health Organization (WHO) | date=12 March 2021 | url=https://extranet.who.int/pqweb/vaccines/who-recommendation-janssen-cilag-international-nv-belgium-covid-19-vaccine-ad26cov2-s | access-date=30 May 2021 | archive-date=8 May 2021 | archive-url=https://web.archive.org/web/20210508195419/https://extranet.who.int/pqweb/vaccines/who-recommendation-janssen-cilag-international-nv-belgium-covid-19-vaccine-ad26cov2-s | url-status=live }}

In February 2021, the vaccine received emergency authorization in South Africa.{{cite web|date=17 February 2021|title=SA is the first country to roll out Johnson & Johnson vaccine – what you need to know about the jab|url=https://www.businessinsider.co.za/covid-19-vaccine-johnson-johnson-what-we-know-2020-12|access-date=4 March 2021|website=BusinessInsider|archive-date=1 March 2021|archive-url=https://web.archive.org/web/20210301185218/https://www.businessinsider.co.za/covid-19-vaccine-johnson-johnson-what-we-know-2020-12|url-status=live}}{{cite news|date=20 February 2021|title=South Africa to be first to use Johnson Johnson Covid-19 vaccine|website=Quartz|url=https://qz.com/africa/1973285/south-africa-to-be-first-to-use-johnson-johnson-covid-19-vaccine/|access-date=4 March 2021|vauthors=Browdie B|archive-date=3 March 2021|archive-url=https://web.archive.org/web/20210303131756/https://qz.com/africa/1973285/south-africa-to-be-first-to-use-johnson-johnson-covid-19-vaccine/|url-status=live}} In April 2021, South Africa suspended its rollout of the vaccine.{{cite web| vauthors = Turner KJ |date=13 April 2021|title=This is why SA is suspending its J&J vaccine roll-out|url=https://www.iol.co.za/news/politics/this-is-why-sa-is-suspending-its-j-and-j-vaccine-roll-out-84618c38-ab59-490e-af76-ff732fe43912|access-date=14 April 2021|website=IOL|archive-date=14 April 2021|archive-url=https://web.archive.org/web/20210414024006/https://www.iol.co.za/news/politics/this-is-why-sa-is-suspending-its-j-and-j-vaccine-roll-out-84618c38-ab59-490e-af76-ff732fe43912|url-status=live}} The program resumed in April 2021.

In February 2021, Bahrain authorized the vaccine for emergency use.{{cite news |title=Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use |website=Reuters |date=25 February 2021 |url=https://www.reuters.com/article/health-coronavirus-bahrain-idUSS8N2I4021 | vauthors = Barrington L |access-date=25 February 2021 |archive-date=10 March 2021 |archive-url=https://web.archive.org/web/20210310014026/https://www.reuters.com/article/health-coronavirus-bahrain-idUSS8N2I4021 |url-status=live }}{{cite news | title=Bahrain becomes 1st nation to grant J&J shot emergency use | website=ABC News | date=25 February 2021 | url=https://abcnews.go.com/International/wireStory/bahrain-1st-nation-grant-jj-shot-emergency-76112143 | access-date=25 February 2021 | archive-date=10 March 2021 | archive-url=https://web.archive.org/web/20210310012735/https://abcnews.go.com/International/wireStory/bahrain-1st-nation-grant-jj-shot-emergency-76112143 | url-status=live }}

In February 2021, the South Korean Ministry of Food and Drug Safety began a review of Johnson & Johnson's application for approval of its vaccine.{{cite news |url=https://www.reuters.com/article/us-health-coronavirus-southkorea-vaccine/south-korea-launches-review-of-johnson-johnsons-covid-19-vaccine-idUSKBN2AR03K | vauthors = Kim C, Cha S |title=South Korea launches review of Johnson & Johnson's COVID-19 vaccine |work=Reuters |date=26 February 2021 |access-date=27 February 2021 |archive-date=27 February 2021 |archive-url=https://web.archive.org/web/20210227173305/https://www.reuters.com/article/us-health-coronavirus-southkorea-vaccine/south-korea-launches-review-of-johnson-johnsons-covid-19-vaccine-idUSKBN2AR03K |url-status=live }}

In late November 2020, Johnson & Johnson submitted a rolling review application to Health Canada for approval of its vaccine.{{cite news | vauthors = Haig T |url=https://www.rcinet.ca/en/2021/02/01/another-vaccine-submits-a-bid-for-health-canada-approval/ |title=Novavax submits its vaccine for Health Canada approval |work=Radio Canada International |date=1 February 2021 |access-date=27 February 2021 |archive-date=16 February 2021 |archive-url=https://web.archive.org/web/20210216193558/https://www.rcinet.ca/en/2021/02/01/another-vaccine-submits-a-bid-for-health-canada-approval/ |url-status=live }}

In March 2021, the vaccine received emergency authorization in Colombia.{{cite news |vauthors=Acosta LJ |location=Bogotá |title=Colombia grants emergency use for J&J coronavirus vaccine |url=https://www.reuters.com/article/health-coronavirus-colombia/colombia-grants-emergency-use-for-jj-coronavirus-vaccine-idUSL1N2LO01O |access-date=25 March 2021 |work=Reuters |date=25 March 2021 |archive-date=25 June 2021 |archive-url=https://web.archive.org/web/20210625093324/https://www.reuters.com/business/healthcare-pharmaceuticals/colombia-grants-emergency-use-jj-coronavirus-vaccine-2021-03-26/ |url-status=live }}

In March 2021, the vaccine was authorized under interim order in Canada.{{Cite web |date=5 March 2021 |title=Regulatory Decision Summary - Janssen COVID-19 Vaccine - Health Canada |url=https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00779 |url-status=live |archive-url=https://web.archive.org/web/20230610012949/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00779 |archive-date=10 June 2023 |access-date=10 June 2023 |website=Government of Canada}}

In April 2021, the Australian government stated that it would not be purchasing the Janssen vaccine, as it "does not intend to purchase any further adenovirus vaccines at this time".{{cite news | vauthors = Lowrey T |title=Johnson & Johnson's one-dose COVID-19 vaccine won't be coming to Australia due to AstraZeneca similarities |url=https://www.abc.net.au/news/2021-04-13/johnson-johnson-covid-19-vaccine-australia/100064454 |work=ABC News |date=13 April 2021 |access-date=13 April 2021 |archive-date=13 April 2021 |archive-url=https://web.archive.org/web/20210413013022/https://www.abc.net.au/news/2021-04-13/johnson-johnson-covid-19-vaccine-australia/100064454 |url-status=live }}{{cite news | vauthors = Karp P | title=Australia won't buy Johnson & Johnson's one-dose Covid vaccine due to AstraZeneca similarities | work=The Guardian | date=12 April 2021 | url=http://www.theguardian.com/society/2021/apr/13/australia-wont-buy-johnson-johnsons-one-dose-covid-vaccine-due-to-astrazeneca-similarities | access-date=12 April 2021 | archive-date=12 April 2021 | archive-url=https://web.archive.org/web/20210412224207/https://www.theguardian.com/society/2021/apr/13/australia-wont-buy-johnson-johnsons-one-dose-covid-vaccine-due-to-astrazeneca-similarities | url-status=live }} The Therapeutic Goods Administration granted provisional approval for use of the Janssen vaccine in Australia in June 2021.

In April 2021, the vaccine received emergency use authorization in the Philippines.{{cite news |title=Covaxin, Janssen approved for emergency use in PH |url=https://cnnphilippines.com/news/2021/4/19/covaxin-janssen-emergency-use-authorization.html |publisher=CNN Philippines |date=19 April 2021 |access-date=19 April 2021 |archive-date=20 April 2021 |archive-url=https://web.archive.org/web/20210420034939/https://cnnphilippines.com/news/2021/4/19/covaxin-janssen-emergency-use-authorization.html |url-status=dead }}{{cite news | title=Philippines approves emergency use of J&J, Bharat BiotechCOVID-19 vaccines | publisher=Reuters | date=19 April 2021 | url=https://www.reuters.com/business/healthcare-pharmaceuticals/philippines-approves-emergency-use-jj-bharat-biotechcovid-19-vaccines-2021-04-19/ | access-date=29 April 2021 | archive-date=29 April 2021 | archive-url=https://web.archive.org/web/20210429175509/https://www.reuters.com/business/healthcare-pharmaceuticals/philippines-approves-emergency-use-jj-bharat-biotechcovid-19-vaccines-2021-04-19/ | url-status=live }}

In May 2021, the vaccine received conditional marketing authorization in the United Kingdom.{{cite news |title=Janssen single-dose Covid vaccine approved by UK |url=https://www.bbc.com/news/health-57283837 |publisher=BBC News Online |date=28 May 2021 |access-date=28 May 2021 |archive-date=21 June 2021 |archive-url=https://web.archive.org/web/20210621174917/https://www.bbc.com/news/health-57283837 |url-status=live }}

In June 2021, the vaccine received emergency use authorization in Chile. The vaccine will be provided via COVAX.{{cite web|url=https://www.ispch.cl/noticia/isp-valida-uso-de-emergencia-de-la-vacuna-janssen-de-johnson-johnson-a-traves-de-mecanismo-covax/|title=Instituto de Salud Pública de Chile|access-date=10 June 2021|archive-date=12 June 2021|archive-url=https://web.archive.org/web/20210612004858/https://www.ispch.cl/noticia/isp-valida-uso-de-emergencia-de-la-vacuna-janssen-de-johnson-johnson-a-traves-de-mecanismo-covax/|url-status=live}}

In June 2021, Malaysia's National Pharmaceutical Regulatory Agency (NPRA) issued conditional registration for emergency use of the vaccine.{{cite web|url=https://codeblue.galencentre.org/2021/06/15/malaysia-approves-pfizer-jab-for-teens-cansino-and-jj-covid-19-vaccines/|title=Malaysia Approves Pfizer Jab For Teens, CanSino And J&J Covid-19 Vaccines|publisher=CodeBlue|date=15 June 2021|access-date=17 July 2021|archive-url=https://web.archive.org/web/20210625173150/https://codeblue.galencentre.org/2021/06/15/malaysia-approves-pfizer-jab-for-teens-cansino-and-jj-covid-19-vaccines/|archive-date=25 June 2021|url-status=live}}

In June 2021, COVID{{nbhyph}}19 Janssen Ad26.COV2.S was granted provisional approval in Australia.{{cite web | title=COVID-19 vaccine: Janssen | website=Therapeutic Goods Administration (TGA) | date=27 August 2021 | url=https://www.tga.gov.au/covid-19-vaccine-janssen | access-date=28 August 2021 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828183704/https://www.tga.gov.au/covid-19-vaccine-janssen | url-status=live }}

In July 2021, the vaccine received provisional approval for use for people aged 18 and above in New Zealand.{{cite web|title=Government agrees in principle to buy Janssen vaccines|url=https://covid19.govt.nz/alert-levels-and-updates/latest-updates/government-agrees-in-principle-to-buy-janssen-vaccines/|access-date=7 July 2021|website=Unite against COVID-19|date=19 November 2020 |archive-date=30 January 2022|archive-url=https://web.archive.org/web/20220130112136/https://covid19.govt.nz/news-and-data/latest-news/government-agrees-in-principle-to-buy-janssen-vaccines/|url-status=live}}{{cite web|date=7 July 2021|title=Single-dose Janssen Covid-19 vaccine approved for use in New Zealand|url=https://www.stuff.co.nz/national/politics/300351663/singledose-janssen-covid19-vaccine-approved-for-use-in-new-zealand|access-date=7 July 2021|website=Stuff|archive-date=7 July 2021|archive-url=https://web.archive.org/web/20210707005422/https://www.stuff.co.nz/national/politics/300351663/singledose-janssen-covid19-vaccine-approved-for-use-in-new-zealand|url-status=live}}

In August 2021, Health and Family Welfare Minister of India announced that Johnson and Johnson single-dose vaccine was approved for emergency use in India through a supply agreement with homegrown vaccine maker Biological E. Limited.{{cite news |vauthors=Kumar P |title=Johnson & Johnson's Single-Dose Covid Vaccine Approved In India |url=https://www.ndtv.com/india-news/johnson-and-johnsons-single-dose-covid-vaccine-gets-approval-for-emergency-use-in-india-tweets-health-minister-2504931 |work=NDTV.com |date=7 August 2021 |access-date=9 August 2021 |archive-date=20 October 2021 |archive-url=https://web.archive.org/web/20211020045619/https://www.ndtv.com/india-news/johnson-and-johnsons-single-dose-covid-vaccine-gets-approval-for-emergency-use-in-india-tweets-health-minister-2504931 |url-status=live }}

In September 2021, National Agency of Drug and Food Control (BPOM) issued emergency use authorization in Indonesia.{{cite web|date=7 September 2021|title=BPOM Terbitkan Izin Penggunaan Darurat Vaksin Covid-19 Produksi Johnson & Johnson dan Cansino|url=https://nasional.kompas.com/read/2021/09/07/18330171/bpom-terbitkan-izin-penggunaan-darurat-vaksin-covid-19-produksi-johnson|access-date=7 September 2021|website=KOMPAS.com|language=id|archive-date=7 September 2021|archive-url=https://web.archive.org/web/20210907113812/https://nasional.kompas.com/read/2021/09/07/18330171/bpom-terbitkan-izin-penggunaan-darurat-vaksin-covid-19-produksi-johnson|url-status=live}}

In November 2021, the vaccine's authorization under interim order in Canada was transitioned to approval for use under the country's Food and Drug Regulations.{{cite web | title=Regulatory Decision Summary - Janssen COVID-19 Vaccine | website=Health Canada | url=https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00890 | access-date=24 November 2021 | archive-date=25 November 2021 | archive-url=https://web.archive.org/web/20211125150525/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00890 | url-status=live }}

In August 2023, the COVID-19 Vaccine Janssen was removed from the Australian Register of Therapeutic Goods at the request of Janssen-Cilag Pty Ltd. The vaccine was never supplied in Australia.{{cite web | title=Voluntary cancellation of COVID-19 vaccine Janssen | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/news/news/covid-19-vaccine-janssen | access-date=9 October 2023 | archive-date=30 October 2023 | archive-url=https://web.archive.org/web/20231030064423/https://www.tga.gov.au/news/news/covid-19-vaccine-janssen | url-status=live }}

{{See also|COVID-19 vaccine clinical research#Homologous prime-boost vaccination}}

In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses.{{cite web | title=Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines | website=U.S. Food and Drug Administration (FDA) | date=21 October 2021 | url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines | access-date=22 October 2021 | archive-date=7 December 2021 | archive-url=https://web.archive.org/web/20211207201028/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines | url-status=live }} {{PD-notice}}{{cite web | title=CDC Expands Eligibility for COVID-19 Booster Shots | publisher=U.S. Centers for Disease Control and Prevention (CDC) | date=21 October 2021 | url=https://www.cdc.gov/media/releases/2021/p1021-covid-booster.html | access-date=22 October 2021 | archive-date=7 December 2021 | archive-url=https://web.archive.org/web/20211207000758/https://www.cdc.gov/media/releases/2021/p1021-covid-booster.html | url-status=live }} {{PD-notice}}{{cite press release | title=Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters | website=U.S. Food and Drug Administration (FDA) | date=19 November 2021 | url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-covid-19-vaccine-boosters | access-date=19 November 2021 | archive-date=19 November 2021 | archive-url=https://web.archive.org/web/20211119144009/https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-covid-19-vaccine-boosters | url-status=live }} {{PD-notice}}

{{For|use as a heterologous booster dose|Oxford–AstraZeneca COVID-19 vaccine#Heterologous prime-boost vaccination}}

{{See also|COVID-19 vaccine clinical research#Heterologous prime-boost vaccination}}

In October 2021, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) authorized the use of either homologous or heterologous vaccine booster doses. The authorization was expanded to include all adults in November 2021.

About 19.4{{nbsp}}million doses of the Janssen COVID-19 vaccine were administered in the EU/EEA from authorization to 26 June 2022.{{cite web | title=COVID-19 vaccines safety update | date=3 August 2022 | url=https://www.ema.europa.eu/documents/covid-19-vaccine-safety-update/covid-19-vaccines-safety-update-14-july-2022_en.pdf | access-date=3 August 2022 | archive-date=3 August 2022 | archive-url=https://web.archive.org/web/20220803225933/https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccines-safety-update-14-july-2022_en.pdf | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Given the Janssen vaccine is a single dose and has a lower cost, it was expected to play an important role in low and middle-income countries.{{cite news|vauthors=Grady D|date=29 January 2021|title=Which Covid Vaccine Should You Get? Experts Cite the Effect Against Severe Disease|work=The New York Times|url=https://www.nytimes.com/2021/01/29/health/Covid-vaccine-explainer.html|access-date=9 February 2021|archive-date=10 February 2021|archive-url=https://web.archive.org/web/20210210014801/https://www.nytimes.com/2021/01/29/health/Covid-vaccine-explainer.html|url-status=live}} Since it is a single dose vaccine, it has been a popular vaccine to distribute to the homeless,{{cite web |url=https://www.usnews.com/news/health-news/articles/2021-04-27/trust-johnson-johnson-shot-key-to-vaccinating-homeless-people |title=Trust and Johnson and Johnson Key To Vaccinating Homeless People|access-date=18 May 2021 |archive-date=18 May 2021 |archive-url=https://web.archive.org/web/20210518050737/https://www.usnews.com/news/health-news/articles/2021-04-27/trust-johnson-johnson-shot-key-to-vaccinating-homeless-people |url-status=live }}{{cite web|url=https://www.huffpost.com/entry/johnson-johnson-vaccine-homeless-single-dose-california_n_60414ee7c5b613cec15c5756|title=Johnson & Johnson Vaccine Could Be A 'Game Changer' For Homeless People | vauthors = Ruiz-Grossman S |date=4 March 2021|website=HuffPost|access-date=18 May 2021|archive-date=18 May 2021|archive-url=https://web.archive.org/web/20210518050737/https://www.huffpost.com/entry/johnson-johnson-vaccine-homeless-single-dose-california_n_60414ee7c5b613cec15c5756|url-status=live}}{{cite news|url=https://www.wsj.com/articles/johnson-johnsons-covid-19-vaccine-emerges-as-preferred-shot-for-homeless-11617530400|title=Johnson & Johnson's Covid-19 Vaccine Emerges as Preferred Shot for Homeless| vauthors = Wernau J |newspaper=The Wall Street Journal|date=4 April 2021|access-date=18 May 2021|archive-date=18 May 2021|archive-url=https://web.archive.org/web/20210518051546/https://www.wsj.com/articles/johnson-johnsons-covid-19-vaccine-emerges-as-preferred-shot-for-homeless-11617530400|url-status=live}}{{cite web| vauthors = Tiffany K |date=30 April 2021|title=The Hot-Person Vaccine|url=https://www.theatlantic.com/technology/archive/2021/04/pfizer-gang-and-sadness-vaccine-culture/618755/|url-status=live|access-date=19 May 2021|website=The Atlantic|archive-date=19 May 2021|archive-url=https://web.archive.org/web/20210519150212/https://www.theatlantic.com/technology/archive/2021/04/pfizer-gang-and-sadness-vaccine-culture/618755/}} the incarcerated,{{cite web|url=https://www.dallasobserver.com/news/some-north-texans-upset-dallas-county-is-vaccinating-homeless-and-incarcerated-populations-11992422|title=Some North Texans Upset COVID-19 Vaccines Going to Homeless, Jailed Populations | vauthors = Carter S |date=8 March 2021|website=Dallas Observer|access-date=18 May 2021|archive-date=18 May 2021|archive-url= https://web.archive.org/web/20210518050738/https://www.dallasobserver.com/news/some-north-texans-upset-dallas-county-is-vaccinating-homeless-and-incarcerated-populations-11992422|url-status=live}}{{cite web|url=https://www.cnbc.com/2021/04/17/jj-vaccine-pause-could-make-it-harder-for-some-groups-to-get-a-shot.html|title=Johnson & Johnson vaccine pause makes it tougher to immunize hard-to-reach populations against Covid | vauthors = Rattner N |date=17 April 2021|website=CNBC|access-date=18 May 2021|archive-date=18 May 2021|archive-url=https://web.archive.org/web/20210518052528/https://www.cnbc.com/2021/04/17/jj-vaccine-pause-could-make-it-harder-for-some-groups-to-get-a-shot.html|url-status=live}} and refugee populations.{{cite web|url=https://cruxnow.com/church-in-the-usa/2021/05/vaccination-clinic-aimed-at-refugees-immigrants/|title=Vaccination clinic aimed at refugees, immigrants|date=17 May 2021|access-date=18 May 2021|archive-date=18 May 2021|archive-url=https://web.archive.org/web/20210518050738/https://cruxnow.com/church-in-the-usa/2021/05/vaccination-clinic-aimed-at-refugees-immigrants/|url-status=live}}{{cite news|url = https://www.npr.org/2021/08/27/1031827480/afghan-evacuees-vaccination-dulles-virginia|title = The U.S. Has Set up a Mass Vaccination Site for Afghans Arriving in Virginia|newspaper = NPR|date = 27 August 2021|vauthors = Treisman R|access-date = 29 August 2021|archive-date = 1 January 2022|archive-url = https://web.archive.org/web/20220101065612/https://www.npr.org/2021/08/27/1031827480/afghan-evacuees-vaccination-dulles-virginia|url-status = live}} This is due to the fact that it is difficult for these aforementioned demographics to be contacted for vaccines that require a second dose. With lower costs and lower requirements of storage and distribution in comparison to the COVID{{nbhyph}}19 vaccines by Pfizer and Moderna, the Janssen vaccine is more easily transported, stored, and administered.{{cite web|vauthors=Brueck H|title=Moderna vaccine creator calls Johnson & Johnson's competing shot a 'darn good' tool to fight the pandemic|url=https://www.businessinsider.com/moderna-scientist-kizzy-johnson-and-johnson-covid-shot-darn-good-2021-1|access-date=9 February 2021|website=Business Insider|archive-date=8 February 2021|archive-url=https://web.archive.org/web/20210208080156/https://www.businessinsider.com/moderna-scientist-kizzy-johnson-and-johnson-covid-shot-darn-good-2021-1|url-status=live}} South African health minister Zweli Mkhize announced on 9{{nbs}}February 2021 that the country would sell or swap its one million doses of AstraZeneca vaccine.{{cite news |vauthors=Winning A, Roelf W |title=South Africa may sell AstraZeneca shots as it switches to J&J vaccine to fight variant |url=https://www.yahoo.com/news/south-africa-says-j-j-055836230.html |access-date=11 February 2021 |work=Yahoo! |agency=Reuters |date=9 February 2021 |archive-date=10 February 2021 |archive-url=https://web.archive.org/web/20210210213248/https://www.yahoo.com/news/south-africa-says-j-j-055836230.html |url-status=live }} Once it did so, South Africa began vaccination using the Janssen vaccine in February 2021,{{cite news |url=https://www.wsj.com/articles/south-africa-rolls-out-j-j-covid-19-vaccine-to-healthcare-workers-11613564630 |newspaper=The Wall Street Journal |date=17 February 2021 |vauthors=Steinhauser G |title=South Africa Rolls Out J&J Covid-19 Vaccine to Healthcare Workers |url-access=subscription |access-date=18 February 2021 |archive-date=18 February 2021 |archive-url=https://web.archive.org/web/20210218182220/https://www.wsj.com/articles/south-africa-rolls-out-j-j-covid-19-vaccine-to-healthcare-workers-11613564630 |url-status=live }} marking the vaccine's first use outside of a clinical trial.{{cite news | title=Johnson & Johnson applies to WHO for emergency use listing of COVID-19 vaccine | publisher=Reuters | date=19 February 2021 | url=https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-wh-idINKBN2AJ1DE | access-date=19 March 2021 | archive-date=9 May 2021 | archive-url=https://web.archive.org/web/20210509080329/https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-wh-idINKBN2AJ1DE | url-status=live }}

In July 2020, Johnson & Johnson pledged to deliver up to three hundred million doses of its vaccine to the US, with one hundred million upfront and an option for twenty million more. The deal, worth more than $1{{nbs}}billion, is funded by the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense.{{cite press release|date=5 August 2020|title=HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses|url=https://www.hhs.gov/about/news/2020/08/05/hhs-dod-collaborate-with-johnson-and-johnson-to-produce-millions-of-covid-19-investigational-vaccine-doses.html|access-date=6 August 2020|website=HHS.gov|archive-date=12 December 2020|archive-url=https://web.archive.org/web/20201212113629/https://www.hhs.gov/about/news/2020/08/05/hhs-dod-collaborate-with-johnson-and-johnson-to-produce-millions-of-covid-19-investigational-vaccine-doses.html|url-status=live}}{{cite press release|title=Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine|url=https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine|access-date=6 August 2020|website=Johnson & Johnson|archive-date=18 February 2021|archive-url=https://web.archive.org/web/20210218142154/https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine|url-status=live}} The deal was confirmed on 5{{nbs}}August.{{cite web|url=https://www.voanews.com/a/covid-19-pandemic_us-pay-johnson-and-johnson-1-billion-covid-19-vaccine/6193967.html|title=US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine|access-date=5 August 2020|website=Voice of America|date=5 August 2020 |archive-date=24 January 2021|archive-url=https://web.archive.org/web/20210124115349/https://www.voanews.com/covid-19-pandemic/us-pay-johnson-and-johnson-1-billion-covid-19-vaccine|url-status=live}}

In August 2020, Johnson & Johnson signed a contract with the US federal government for $1{{nbs}}billion, agreeing to deliver one hundred million doses of the vaccine to the US following the Food and Drug Administration (FDA) grant of approval or emergency use authorization (EUA) for the vaccine. Under its agreement with the US government, Johnson & Johnson was targeted to produce twelve million doses by the end of February 2021, more than sixty million doses by the end of April 2021, and more than one hundred million doses by the end of June 2021. However, in January 2021, Johnson & Johnson acknowledged manufacturing delays would likely prevent it from meeting its contract of twelve million doses delivered to the US by the end of February.{{cite news| url=https://www.nytimes.com/2021/01/13/health/covid-vaccine-johnson-johnson.html| title=Johnson & Johnson Expects Vaccine Results Soon but Lags in Production| work=The New York Times| date=13 January 2021| vauthors=Zimmer C, LaFraniere S, Weiland N| access-date=15 January 2021| archive-date=15 January 2021| archive-url=https://web.archive.org/web/20210115133230/https://www.nytimes.com/2021/01/13/health/covid-vaccine-johnson-johnson.html| url-status=live}} In February 2021, through congressional testimony by a company executive, Johnson & Johnson indicated that the company could deliver twenty million doses to the US government by the end of March and one hundred million doses in the first half of 2021.{{cite web | vauthors=Owermohle S | title=Johnson & Johnson says it can provide 20M vaccine doses by late March | website=Politico | date=22 February 2021 | url=https://www.politico.com/news/2021/02/22/johnson-johnson-vaccine-march-470994 | access-date=1 April 2021 | archive-date=23 March 2021 | archive-url=https://web.archive.org/web/20210323163912/https://www.politico.com/news/2021/02/22/johnson-johnson-vaccine-march-470994 | url-status=live }}

In February 2021, Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization.

In March 2021, the Canadian government placed an order with Johnson & Johnson for ten million doses, with an option to purchase up to twenty-eight million more; on 5{{nbs}}March, the vaccine became the fourth to receive Health Canada approval.{{cite web|url=https://www.cbc.ca/news/politics/johnson-johnson-covid19-vaccine-approved-1.5937900|title=Johnson & Johnson COVID-19 vaccine becomes 4th to receive Health Canada approval|website=CBC|access-date=5 March 2021|archive-date=19 March 2021|archive-url=https://web.archive.org/web/20210319010051/https://www.cbc.ca/news/politics/johnson-johnson-covid19-vaccine-approved-1.5937900|url-status=live}}

Shipments of the vaccine were scheduled to start in the second half of April 2021, with a commitment to deliver at least two hundred million doses to the EU in 2021.{{cite news | vauthors=Muvija M, Aripaka P | title=Europe clears J&J's single-shot COVID-19 vaccine as roll-out falters | website=Reuters | date=11 March 2021 | url=https://www.reuters.com/article/us-health-coronavirus-eu-johnson-johnson-idUSKBN2B31SW | access-date=16 March 2021 | archive-date=15 March 2021 | archive-url=https://web.archive.org/web/20210315223644/https://www.reuters.com/article/us-health-coronavirus-eu-johnson-johnson-idUSKBN2B31SW | url-status=live }}

The European distribution of the vaccine was slightly delayed until the EMA decided that rare cases of vaccine-induced blood clots did not outweigh the benefits of helping to fight the COVID{{nbhyph}}19 pandemic.{{cite web |url=https://www.cnbc.com/2021/04/20/covid-vaccine-ema-says-jj-shot-can-be-rolled-out-across-eu.html |date=20 April 2021 |title=EU regulator finds possible blood clot link with J&J vaccine, but says benefits outweigh risks |publisher=CNBC |access-date=24 April 2021 |archive-date=24 April 2021 |archive-url=https://web.archive.org/web/20210424002105/https://www.cnbc.com/2021/04/20/covid-vaccine-ema-says-jj-shot-can-be-rolled-out-across-eu.html |url-status=live }}

The United States Conference of Catholic Bishops expressed concern about the vaccine because the cell line Per.C6, which is used in development and production, was originally derived from the retinal tissue of an 18-week-old fetus electively aborted in 1985.{{cite news |title=Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available |url=https://www.cnn.com/2021/03/03/health/bishops-catholics-johnson-and-johnson-vaccine/index.html |access-date=20 March 2021 |publisher=CNN |date=3 March 2021 |archive-date=11 March 2021 |archive-url=https://web.archive.org/web/20210311004829/https://www.cnn.com/2021/03/03/health/bishops-catholics-johnson-and-johnson-vaccine/index.html |url-status=live }}{{cite web|title=You asked, we answered: Do the COVID-19 vaccines contain aborted fetal cells? |url=https://www.nebraskamed.com/COVID/you-asked-we-answered-do-the-covid-19-vaccines-contain-aborted-fetal-cells|access-date=24 March 2021|website=Nebraska Medicine |archive-date=24 March 2021|archive-url=https://web.archive.org/web/20210324020756/https://www.nebraskamed.com/COVID/you-asked-we-answered-do-the-covid-19-vaccines-contain-aborted-fetal-cells|url-status=live}}{{cite web |title=PER.C6 Cell Lines |url=https://www.gmp-creativebiolabs.com/per-c6-cell-lines_74.htm |access-date=21 August 2021 |website=Creative Biolabs |archive-date=21 August 2021 |archive-url=https://web.archive.org/web/20210821143832/https://www.gmp-creativebiolabs.com/per-c6-cell-lines_74.htm |url-status=live }}{{cite web | title=AdVac and PER.C6 Technology of the Janssen COVID-19 Vaccine | website=Janssen | date=5 August 2021 | url=https://www.janssenmd.com/janssen-covid19-vaccine/product-properties/product-technology/advac-and-perc6-technology-of-the-janssen-covid19-vaccine | access-date=22 August 2021 | archive-date=24 August 2021 | archive-url=https://web.archive.org/web/20210824025239/https://www.janssenmd.com/janssen-covid19-vaccine/product-properties/product-technology/advac-and-perc6-technology-of-the-janssen-covid19-vaccine | url-status=live }} Although the use of fetal tissue in vaccine development has become common since the 1930s, especially with cell-based vaccines, there are currently alternatives that do not carry the same potential ethical concerns as the Janssen vaccine.{{cite news |title=COVID-19 Vaccines and Fetal Tissue: The Science and Controversy Explained |url=https://www.newsweek.com/covid-19-vaccines-fetal-tissue-science-controversy-explained-1575863 |access-date=12 April 2021 |work=Newsweek |date=13 March 2021 |archive-date=11 April 2021 |archive-url=https://web.archive.org/web/20210411083153/https://www.newsweek.com/covid-19-vaccines-fetal-tissue-science-controversy-explained-1575863 |url-status=live }}{{cite news |title=Johnson & Johnson COVID vaccine morally wrong? Catholic bishops caution just that |url=https://www.foxnews.com/us/catholic-bishops-johnson-janssen-coronavirus-vaccine |access-date=12 April 2021 |publisher=Fox News |date=2 March 2021 |archive-date=11 April 2021 |archive-url=https://web.archive.org/web/20210411065609/https://www.foxnews.com/us/catholic-bishops-johnson-janssen-coronavirus-vaccine |url-status=live }} Some bioethicists dismiss that ethical concerns to using cells derived from ethically compromised sources should be addressed or alternatives sought.{{cite journal |title=Abortion opponents protest COVID-19 vaccines' use of fetal cells | vauthors=Wadman M |journal=Science |date=June 2020 |doi=10.1126/science.abd1905 | doi-access= | title-link=doi | s2cid=219908618 }} Others advance the view that the cells used for COVID{{nbhyph}}19 vaccines are thousands of generations removed from their source material and do not contain any fetal tissue.

In December 2020, the Vatican published a note approved by Pope Francis, stating that "...{{nbs}}all [COVID-19] vaccinations recognized as clinically safe and effective can be used in good conscience{{nbs}}..."{{cite web|title=Note on the morality of using some anti-Covid-19 vaccines (21 December 2020)|url=https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20201221_nota-vaccini-anticovid_en.html|access-date=24 March 2021|website=www.vatican.va|archive-date=24 March 2021|archive-url=https://web.archive.org/web/20210324211936/https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20201221_nota-vaccini-anticovid_en.html|url-status=live}} However, the key objection to using these vaccines still remains.{{cite magazine |title=How making a COVID-19 vaccine confronts thorny ethical issues |url=https://www.sciencenews.org/article/coronavirus-covid19-vaccine-ethical-issues |access-date=12 April 2021 |magazine=Science News |date=7 July 2020 |archive-date=13 April 2021 |archive-url=https://web.archive.org/web/20210413004252/https://www.sciencenews.org/article/coronavirus-covid19-vaccine-ethical-issues |url-status=live }}{{cite news|date=3 March 2021|title=Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available|publisher=CNN|url=https://www.cnn.com/2021/03/03/health/bishops-catholics-johnson-and-johnson-vaccine/index.html|url-status=live|access-date=20 March 2021|archive-url=https://web.archive.org/web/20210311004829/https://www.cnn.com/2021/03/03/health/bishops-catholics-johnson-and-johnson-vaccine/index.html|archive-date=11 March 2021}}

In September 2021, after criticism that doses of its single-shot COVID{{nbhyph}}19 vaccine produced in Aspen Pharmacare's facility in South Africa were being exported to Europe, millions of doses that had been shipped to Europe and stored in warehouses will be returned to Africa, and newly manufactured doses will be shipped to African countries.{{cite news|vauthors=Steinhauser G|date=2 September 2021|title=EU to Return Millions of Doses of J&J's Covid-19 Vaccine Imported From Africa|work=The Wall Street Journal|url=https://www.wsj.com/articles/eu-to-return-millions-of-doses-of-j-js-covid-19-vaccine-imported-from-africa-11630591429|access-date=9 September 2021|issn=0099-9660|archive-date=9 September 2021|archive-url=https://web.archive.org/web/20210909023310/https://www.wsj.com/articles/eu-to-return-millions-of-doses-of-j-js-covid-19-vaccine-imported-from-africa-11630591429|url-status=live}}

{{see also|COVID-19 misinformation}}

Videos on video-sharing platforms circulated around May 2021 showing people having magnets stick to their arms after receiving the vaccine, purportedly demonstrating the conspiracy theory that vaccines contain microchips, but these videos have been debunked.{{cite web | vauthors = Lee J |title=Do Videos Show Magnets Sticking to People's Arms After COVID-19 Vaccine? |url=https://www.snopes.com/fact-check/magnets-covid-vaccine/ |website=Snopes.com |access-date=7 June 2021 |date=14 May 2021 |archive-date=9 November 2021 |archive-url=https://web.archive.org/web/20211109064851/https://www.snopes.com/fact-check/magnets-covid-vaccine/ |url-status=live}}{{cite web | vauthors = Fichera A |title=Magnet Videos Refuel Bogus Claim of Vaccine Microchips |url=https://www.factcheck.org/2021/05/scicheck-magnet-videos-refuel-bogus-claim-of-vaccine-microchips/ |website=FactCheck.org |publisher=Annenberg Public Policy Center |access-date=7 June 2021 |date=14 May 2021 |archive-date=17 May 2021 |archive-url=https://web.archive.org/web/20210517203524/https://www.factcheck.org/2021/05/scicheck-magnet-videos-refuel-bogus-claim-of-vaccine-microchips/ |url-status=live}}{{cite web |title=COVID-19 VACCINE MYTHS AND FACTS |url=http://publichealth.lacounty.gov/media/coronavirus/docs/vaccine/VaccineMythsAndFacts.pdf |publisher=Los Angeles County Department of Public Health |access-date=27 August 2021 |archive-date=25 August 2021 |archive-url=https://web.archive.org/web/20210825132839/http://publichealth.lacounty.gov/media/Coronavirus/docs/vaccine/VaccineMythsAndFacts.pdf |url-status=live }}{{cite web |title=COVID-19 Vaccine Facts |url=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html |publisher=U.S. Centers for Disease Control and Prevention (CDC) |access-date=27 August 2021 |date=18 August 2021 |archive-date=11 December 2021 |archive-url=https://web.archive.org/web/20211211232204/https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html |url-status=live }}

{{notelist}}

{{reflist|refs=

{{cite press release |url= https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate |title= Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate |access-date= 23 September 2020 |website= Johnson & Johnson |archive-date= 23 September 2020 |archive-url= https://web.archive.org/web/20200923122026/https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate |url-status= live }}

{{cite press release |title=Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine |url=https://www.jnj.com/johnson-johnson-covid-19-vaccine-candidate-interim-phase-1-2a-data-published-in-new-england-journal-of-medicine |access-date=16 January 2021 |website=Johnson & Johnson |archive-date=17 January 2021 |archive-url=https://web.archive.org/web/20210117005941/https://www.jnj.com/johnson-johnson-covid-19-vaccine-candidate-interim-phase-1-2a-data-published-in-new-england-journal-of-medicine |url-status=live }}

{{ClinicalTrialsGov|NCT04436276|A Study of Ad26.COV2.S in Adults (COVID-19)}}

{{cite journal | vauthors = Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H | title = Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine | journal = The New England Journal of Medicine | volume = 384 | issue = 19 | pages = 1824–1835 | date = May 2021 | pmid = 33440088 | pmc = 7821985 | doi = 10.1056/NEJMoa2034201 | title-link = doi | doi-access = free }}

{{ClinicalTrialsGov|NCT04614948|A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)}}

{{ClinicalTrialsGov|NCT04505722|A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)}}

{{cite press release|title=Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial|url=https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial|access-date=1 February 2021|website=Johnson & Johnson|archive-date=31 January 2021|archive-url=https://web.archive.org/web/20210131233737/https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial|url-status=live}}

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{{Wikinews|New study analyzes the varying levels of protection offered by COVID-19 vaccines}}

• {{cite news | vauthors = Corum J, Zimmer C |title=How the Johnson & Johnson Vaccine Works |url=https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html |work=The New York Times |date=18 December 2020 }}
• {{cite web | title=The Story of One Dose | website=New York | date=5 April 2021 | url=https://nymag.com/intelligencer/2021/04/the-story-of-one-dose.html | name-list-style=vanc }}
• {{cite web | title=Jcovden Safety Updates | website=European Medicines Agency (EMA) | date=December 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen#ema-inpage-item-safety-updates }}
• {{cite report | url=https://www.tga.gov.au/sites/default/files/auspar-ad26-cov2-s-210625.pdf| title=Australian Public Assessment Report for Ad26.COV2.S | date=June 2021 | publisher=Therapeutic Goods Administration (TGA) }}
• {{YouTube|id=FAMFH3tHWks|title=M.I.T. Lecture 12: Dan Barouch, Covid-19 Vaccine Development}}

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