Serum Institute of India

The Serum Institute of India was founded in 1966 in the city of Pune, India. The company set out to produce immunobiologicals, which were then being imported into India at high prices. Among the first products the Serum Institute of India manufactured in large quantities were the tetanus antitoxin, snake antivenom, DPT vaccine, and MMR vaccine. The company's product lines was expanded to include different types of vaccines against bacterial or virus infections, combination vaccines, influenza vaccine, and meningococcal vaccine. Besides vaccine, the company also manufactures antisera, blood plasma, and hormone products. As of 2014, the vaccines manufactured by the Serum Institute of India have been used in international vaccination programmes run by the World Health Organization (WHO), UNICEF, and the Pan American Health Organization (PAHO). The Serum Institute of India is run by the Poonawalla Group and engages in research, development, and manufacturing.{{cite book|last=Burns|first=Lawton R. |title=India's Healthcare Industry: Innovation in Delivery, Financing, and Manufacturing|publisher=Cambridge University Press|year=2014|isbn=9781316021217|pages=488–489}}

In 2009, the company began developing an intranasal swine flu vaccine.{{cite news|url=http://timesofindia.indiatimes.com/life-style/health-fitness/health/India-developing-indigenous-swine-flu-vaccine/articleshow/4873696.cms?referral=PM|title=India developing indigenous swine flu vaccine|work=The Times of India|access-date=1 February 2015}}{{cite journal |last1=Kulkarni |first1=Prasad S. |last2=Raut |first2=Sidram K. |last3=Dhere |first3=Rajeev M. |title=A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac ®) in India |journal=Human Vaccines & Immunotherapeutics |date=27 October 2014 |volume=9 |issue=1 |pages=122–124 |doi=10.4161/hv.22317 |pmid=23442586|pmc=3667925 |doi-access=free }} In 2012, the company's first international acquisition was Bilthoven Biologicals, a biopharmaceutical company in Netherlands.{{Cite web|last=Unnikrishnan|first=C. H.|date=2012-07-04|title=Serum Institute buys Bilthoven Biologicals|url=https://www.livemint.com/Companies/nIr4bpmcCvQMrtuY3pQexI/Serum-Institute-buys-Bilthoven-Biologicals.html|access-date=2020-07-01|website=Livemint|language=en}} In 2016, with support from US-based Mass Biologics of University of Massachusetts Medical School, the Serum Institute of India invented a fast-acting anti-rabies agent, Rabies Human Monoclonal Antibody (RMAb), also known as Rabbishield.{{Cite news|url=http://timesofindia.indiatimes.com/city/pune/Fast-acting-anti-rabies-drug-set-for-India-launch/articleshow/51114312.cms|title=Fast-acting anti-rabies drug set for India launch - Times of India|website=The Times of India|date=24 February 2016 |access-date=2016-06-12}}{{cite journal |last1=Kulkarni |first1=Prasad S. |last2=Sahai |first2=Ashish |last3=Gunale |first3=Bhagwat |last4=Dhere |first4=Rajeev M |title=Development of a new purified vero cell rabies vaccine (Rabivax-S) at the serum institute of India Pvt Ltd |journal=Expert Review of Vaccines |date=3 March 2017 |volume=16 |issue=4 |pages=303–311 |doi=10.1080/14760584.2017.1294068 |pmid=28276304|s2cid=3382124 }}

{{As of|2023|}}, the company is the world's largest vaccine producer by number of doses produced,{{Cite news|date=2020-11-23|title=Serum Institute to focus on supplying COVID-19 vaccine to India first|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-india-vaccine-idUSKBN28321S|access-date=2020-11-26}} manufacturing around 1.9 billion doses of vaccines each year with plans to produce 4 billion doses of vaccines.{{Cite web|last=Krishnan|first=Murali|date=2020-09-29|title=Coronavirus vaccine: Why does India's Serum Institute have a head start?|url=https://www.dw.com/en/coronavirus-vaccine-why-does-indias-serum-institute-have-a-head-start/a-55089750|access-date=2020-11-26|website=Deutsche Welle|language=en-GB}}{{cite news |last1=Choo |first1=Olivia |title=How this millennial CEO steered the world's largest vaccine maker during the pandemic |url=https://www.cnbc.com/2022/12/16/how-this-millennial-ceo-steered-serum-institute-of-india-during-covid.html |access-date=9 October 2023 |work=CNBC |date=16 December 2022 |language=en}} The products developed include tuberculosis vaccine Tubervac (BCG), Poliovac for poliomyelitis, and other vaccinations for the childhood vaccination schedule.{{Cite web|url=https://www.seruminstitute.com/product_ind_tubervac.php|title=Serum Institute Tubervac (BCG)|website=Serum Institute of India|access-date=2020-06-15}}{{Cite web|url=https://www.seruminstitute.com/product_ind_poliovac.php|title=Serum Institute Poliovac|website=Serum Institute of India|access-date=2020-06-15}}{{Cite web|url=https://www.iitk.ac.in/hc/vaccination-schedule|title=Vaccination Schedule|website=Vaccination as per the National Immunization schedule by Government of India|access-date=2020-06-15}}

File:Oxford AstraZeneca vaccine (Indian version) 2021 B.jpg

Serum Institute of India partnered with the British-Swedish multinational pharmaceutical company AstraZeneca for developing AZD1222 (Covishield) in partnership with the University of Oxford.{{Cite news|url=https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/astrazeneca-serum-institute-of-india-sign-licensing-deal-for-1-billion-doses-of-oxford-vaccine/articleshow/76202016.cms|title=AstraZeneca & Serum Institute of India sign licensing deal for 1 million doses of Oxford vaccine|work=The Economic Times|access-date=2020-06-15}} It was reported that Serum Institute of India would provide 100 million (10 crore) doses of the vaccine for India and other low and middle-income countries.{{cite news |title=Covid-19 vaccine: Serum Institute signs up for 100 million doses of vaccines for India, low and middle-income countries |url=https://www.financialexpress.com/lifestyle/health/covid-19-vaccine-serum-institute-signs-up-for-100-million-doses-of-vaccines-for-india-low-and-middle-income-countries/2047884/ |work=The Financial Express |date=7 August 2020}}{{cite news |last1=Banerjee |first1=Shoumojit |title=Oxford COVID-19 vaccine at least 6 months away from launch: Serum Institute CEO |url=https://www.thehindu.com/news/national/oxford-covid-19-vaccine-at-least-6-months-away-from-launch-serum-institute-ceo/article32015508.ece |work=The Hindu |date=7 July 2020 |language=en-IN}}{{cite news |title=Coronavirus (Covid-19) vaccine latest update: Oxford-AstraZeneca corona vaccine production starts; US says 2 billion doses 'ready to go' |url=https://indianexpress.com/article/coronavirus/corona-covid-19-vaccine-update-june-oxford-astrazeneca-moderna-serum-institute-of-india-6447030/ |work=The Indian Express |date=10 June 2020 |language=en}} This target was later increased to 1 billion doses by the end of 2021.{{Cite news|title=Indian company aims for a billion Covid vaccines|language=en-GB|work=BBC News|url=https://www.bbc.co.uk/news/av/world-asia-india-55091890|access-date=2021-03-21}} It was estimated to be priced at ₹225 (around $3) per dose.{{cite news |title=Serum Institute of India to provide Covid-19 vaccines through COVAX at Rs 225 a dose |url=https://indianexpress.com/article/india/sii-to-provide-covid-19-vaccines-through-covax-at-rs-225-a-dose-india-6544158/ |work=The Indian Express |date=7 August 2020 |language=en}} In September 2020, trials were halted by DCGI after a volunteer in Oxford developed illness following vaccination, but were soon resumed after consent by the British regulators.{{Cite web|last=Sharma|first=Milan|title=Serum Institute halts coronavirus vaccine trials in India after notice from DCGI over volunteer's illness in UK|url=https://www.indiatoday.in/india/story/serum-institute-halts-coronavirus-vaccine-trials-in-india-1720423-2020-09-10|access-date=2020-09-10|website=India Today|language=en}}{{Cite news|date=2020-09-09|title=Oxford vaccine trial paused as participant falls ill|language=en-GB|work=BBC News|url=https://www.bbc.com/news/world-54082192|access-date=2020-09-10}}{{cite news |last1=Ghosh |first1=Poulomi |title=Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod |url=https://www.hindustantimes.com/india-news/serum-institute-to-resume-covid-19-vaccine-trial-after-dgci-gives-nod/story-1pT8EeMSdwYmUyOJBnz29I.html |work=Hindustan Times |date=12 September 2020 |language=en}} In December 2020, the Serum Institute of India sought emergency approval for the vaccine developed with AstraZeneca,{{Cite web|date=2021-12-31|title=India will have Covid-19 vaccine within days: AIIMS director|url=https://www.hindustantimes.com/india-news/india-will-have-covid-19-vaccine-within-days-aiims-director/story-IIoECY3cPkFMh3THZNfz3M.html|access-date=2020-12-31|website=Hindustan Times|language=en}} which was approved a month later.{{cite news | first1=Emily | last1=Schmall | first2=Sameer | last2=Yasir | title=India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other | website=The New York Times | date=3 January 2021 | url=https://www.nytimes.com/2021/01/03/world/asia/india-covid-19-vaccine.html | access-date=3 January 2021 | name-list-style=vanc}} In March 2021, an agreement was reached to supply some doses to the UK.{{cite web |website =BBC News|title =Covid vaccine: India shortfall behind UK's supply delay|url=

https://www.bbc.co.uk/news/uk-56438629|date =18 March 2021}}

Serum Institute of India also reached an agreement with Novavax for the production of Novavax's NVX-CoV2373 (Covovax) vaccine for India and other low and middle-income countries.{{cite news |title=Serum Institute, Novavax in covid vaccine deal, may produce 100 crore doses |url=https://www.livemint.com/science/health/serum-institute-novavax-in-covid-vaccine-deal-may-produce-100-crore-doses-11596772315738.html |work=Livemint |date=7 August 2020 |language=en}}{{cite news |title=Novavax signs COVID-19 vaccine supply deal with India's Serum Institute |url=https://in.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A |archive-url=https://web.archive.org/web/20200806031243/https://in.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A |url-status=dead |archive-date=6 August 2020 |work=Reuters |date=5 August 2020 |language=en}} The company would also produce Codagenix's nasally administered COVID-19 vaccine CDX-005{{cite news |title=Serum Institute starts manufacturing Codagenix's nasal COVID-19 vaccine |url=https://www.livemint.com/science/health/serum-institute-of-india-starts-manufacturing-codagenix-s-nasal-covid-19-vaccine-11600779086792.html |work=mint |date=22 September 2020 |language=en}}{{cite news |title=India's Serum Institute starts manufacturing Codagenix's potential Covid-19 vaccine |url=https://www.hindustantimes.com/india-news/india-s-serum-institute-starts-manufacturing-codagenix-s-potential-covid-19-vaccine/story-zGhIAtCJN1tc9etIC34PDN.html |work=Hindustan Times |date=22 September 2020 |language=en}} (tradename COVI-VAC).{{cite web |title=Codagenix and Serum Institute of India Announce Commencement of First-in-Human Trial of COVI-VAC, A Single Dose, Intranasal Live Attenuated Vaccine for COVID-19 |url=https://codagenix.com/news/codagenix-and-serum-institute-of-india-announce-commencement-of-first-in-human-trial-of-covi-vac-a-single-dose-intranasal-live-attenuated-vaccine-for-covid-19/ |website=Codagenix |access-date=22 April 2021}}

The company also manufactured Sputnik V vaccine in India in collaboration with Gamaleya Research Institute of Epidemiology and Microbiology after receiving approval from DCGI.{{cite news |title=Serum Institute gets DCGI's nod to manufacture Covid vaccine Sputnik V in India |url=https://www.livemint.com/news/india/serum-institute-gets-dcgi-s-nod-to-manufacture-covid-vaccine-sputnik-v-in-india-report-11622818500423.html |work=mint |date=2021-06-04 |language=en}} On 13 July 2021, RDIF published a press release saying SII is starting the production of Sputnik V doses in September 2021, with the intention to produce over 300 million doses of the vaccine in India per year.rdif.ru: [https://rdif.ru/Eng_fullNews/6934/ press release]

In March 2021, Reuters reported that Chinese state-backed cyber-espionage group Red Apollo targeted the Serum Institute of India's intellectual property for exfiltration.{{Cite news|last=Das|first=Krishna N.|date=2021-03-01|title=Chinese hackers target Indian vaccine makers SII, Bharat Biotech, says security firm|language=en|work=Reuters|url=https://www.reuters.com/article/health-coronavirus-india-china-idUSKCN2AT21O|access-date=2021-03-01}}

On 8 October 2023, the R21/Matrix-M malaria vaccine received a recommendation for use by the Strategic Advisory Group of Experts (SAGE) of the World Health Organization and the Malaria Policy Advisory Group (MPAG).{{cite news |title=What is the new anti-malaria vaccine cleared by WHO all about? Will it work for India? |url=https://indianexpress.com/article/health-wellness/who-clears-anti-malaria-vaccine-sii-work-india-know-8967057/ |access-date=9 October 2023 |work=The Indian Express |date=3 October 2023 |language=en}} The vaccine, jointly developed by The University of Oxford{{cite web |title=Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out {{!}} University of Oxford |url=https://www.ox.ac.uk/news/2023-10-02-oxford-r21matrix-m-malaria-vaccine-receives-who-recommendation-use-paving-way-global |website=www.ox.ac.uk |access-date=9 October 2023 |language=en |date=2 October 2023}}{{cite web |title=Serum Institute Of India. Press Release - 02 October 2023 |url=https://www.seruminstitute.com/press_release_sii_021023.php |website=www.seruminstitute.com |language=English}} and the Serum Institute of India in collaboration with Novavax's adjuvant technology, demonstrated notable efficacy along with a positive safety profile. Furthermore, the Serum Institute of India had successfully established production capacity for 100 million doses annually, with plans to double this capacity over the next two years.

The R21/Matrix-MTM malaria vaccine was jointly developed by the Jenner Institute at Oxford University and Serum Institute of India, with support from various organizations including the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB). As of now, the vaccine has obtained licenses for use in Ghana, Nigeria, and Burkina Faso.

• Bharat Biotech
• Biological E. Limited
• Biotechnology in India

{{Reflist}}

• [http://www.seruminstitute.com Official website]

{{Authority control}}

Category:Biotechnology companies of India

Category:Vaccine producers

Category:Manufacturing companies based in Pune

Category:Indian companies established in 1966

Category:Biotechnology companies established in 1966

Category:1966 establishments in Maharashtra

Category:Pharmaceutical companies

Category:Immunology organizations

Category:Pharmaceutical companies of India

Category:COVID-19 vaccine producers