Gamaleya Research Institute of Epidemiology and Microbiology
{{Short description|Public-private organization for vaccine development}}
{{Use dmy dates|date= August 2020}}
{{coord|55.8017|37.4576|display=title}}
{{Infobox organization
| name = Gamaleya Research Institute of Epidemiology and Microbiology
| image =Logo-rus-gray.svg
| alt =
| caption =
| abbreviation =
| formation = {{start date and age|1891|df= yes}} (as N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology)
| type =
| status =
| purpose = Fund vaccine development
| headquarters = 18 Gamaleya Street
Moscow, Russia 123098
| location =
| leader_title = Director General
| leader_name = Alexander Gintsburg
| key_people =
| parent_organization = Ministry of Health of the Russian Federation
| affiliations =
| budget =
| num_staff = 379 (including 92 professors)[http://gamaleya.org/index.php/home Национальный исследовательский центр эпидемиологии и микробиологии имени почётного академика Н. Ф. Гамалеи, основанный в 1891 году, является ведущим в своей сфере исследовательским учреждением в мире.] (tr. "The National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya, founded in 1891, is a leading research institution in the world") gamaleya.org, accessed 23 June 2021{{Cite web|url=https://gamaleya.org/index.php/home/50-2009-12-03-11-05-35|title=НИЦЭМ им. Н. Ф. Гамалеи|website=gamaleya.org}}
| num_volunteers =
| website = {{URL| gamaleya.org}} {{in lang|ru}}
{{URL|gamaleya.org/en}}{{in lang|en}}
| remarks =
| former name =
| membership =
}}
The Gamaleya Research Institute of Epidemiology and Microbiology,{{langx|ru|Национальный исследовательский центр эпидемиологии и микробиологии имени почётного академика Н. Ф. Гамалеи|Natsional’nyy isslyedovatyel’skiy tsentr epidyemiologii i mikrobiologii imyeni pochetnogo akadyemika N. F. Gamalyei}} previously the N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology, is a Russian medical-research institute within the Ministry of Health of the Russian Federation.Other names include the Gamaleya Scientific Research Institute or Gamaleya National Research Center for Epidemiology and Microbiology
Founded in 1891 by Filipp Markovich Blyumental,
[https://gamaleya.org/about/istoriya-tsentra/ "1891 г.[:] Частный химико-микроскопический и бактериологический кабинет Ф.М. Блюменталя."] (tr. "1891 [:] Private chemical-microscopic and bacteriological study of FM Blumenthal.") gamaleya.org it is named after Soviet scientist Nikolay Fyodorovich Gamaleya (1859–1949), famed as a pioneer in microbiology and in vaccine research. The institute is best known internationally for developing the earliest vaccine for SARS-CoV-2, in collaboration with the 48th Central Research Institute of the Ministry of Defence and the Vector Institute of the Rospotrebnadzor, in response to the COVID-19 pandemic.{{Cite web|title= COVID-19 vaccines by Gamaleya Center, Vektor are most promising|url= https://tass.com/science/1183689|access-date= 2020-08-11|website= TASS}}
{{Cite web|date= 2020-07-13|title= Russia's COVID-19 vaccine successfully completes first phase of human clinical trials |url= https://www.firstpost.com/health/russias-covid-19-vaccine-successfully-completes-first-phase-of-human-clinical-trials-8591001.html|access-date= 2020-08-11|website= Firstpost}}
History
The institution was founded in 1891 as a private bacteriology- and chemical-microscopy-oriented laboratory, which later became the Blumenthal Institute for Bacteriology and Chemistry. It was nationalised in 1919.{{cite web |url=https://gamaleya.org/en/about/istoriya-tsentra/ |title=History |publisher=Gamaleya Research Institute of Epidemiology and Microbiology |access-date=23 August 2021}}
Research
= Ebola =
{{Main|GamEvac-Combi}}
In May 2017, the Institute announced that it would deliver 1,000 doses of its vaccine candidate, GamEvac-Combi,{{cite journal | vauthors=Dolzhikova IV, Zubkova OV, Tukhvatulin AI, Dzharullaeva AS, et al.| title=Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia | journal=Human Vaccines & Immunotherapeutics | volume=13 | issue=3 | date=2017-02-02 | issn=2164-5515 | pmid=28152326 | pmc=5360131 | doi=10.1080/21645515.2016.1238535 | pages=613–620}} to Guinea for Ebola testing. According to a Xinhua report, it was considered to be an approved Ebola vaccine,{{Cite web|title=Russia to deliver Ebola vaccines to Guinea by end of June|publisher=Xinhua, New China|date=18 May 2017|url=http://news.xinhuanet.com/english/2017-05/18/c_136293017.htm|access-date=11 August 2020}} although GamEvac-Combi was licensed only in Russia, and did not have a multinational license approved by the World Health Organization, as of November 2019.{{cite web |title=WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries |url=https://www.who.int/news-room/detail/12-11-2019-who-prequalifies-ebola-vaccine-paving-the-way-for-its-use-in-high-risk-countries |publisher=World Health Organization |accessdate=15 August 2020 |date=12 November 2019}}
= COVID-19 vaccine =
{{Main|Sputnik V COVID-19 vaccine|Sputnik Light}}
In May 2020, the centre announced that it had developed a COVID-19 vaccine candidate.{{cite web |title=Russia plans to start producing coronavirus vaccine in September |url=https://www.dailysabah.com/world/europe/russia-plans-to-start-producing-coronavirus-vaccine-in-september |publisher=Daily Sabah |accessdate=10 August 2020 |language=en |date=2020-08-11}} The project was funded by the Russian National Wealth Fund.{{Cite web|last=Foy|first=Henry|date=22 July 2020|title=Russia races for vaccine as Covid-19 nonchalance spreads|url=https://www.ft.com/content/1288c8ed-7888-4e17-ab4a-1d7477411b93|access-date=2020-08-16|website=www.ft.com}} A Phase I trial was completed on 18 June 2020 and Phase II was reported as completed in July 2020.{{Cite web|title=Russian University Says It Has Finished Human Trials For Covid-19 Vaccine|url=https://www.outlookindia.com/website/story/world-news-russia-becomes-first-country-to-finish-human-trials-for-covid-19-vaccine/356565|access-date=2020-08-11}}
On 11 August 2020, the Russian President Vladimir Putin declared that the institute registered a COVID-19 vaccine called Gam-COVID-Vac.{{Cite web|date=2020-08-11|title=Putin announces first 'registered' COVID-19 vaccine from Russia's Gamaleya Institute; his daughter among those inoculated |url=https://www.firstpost.com/health/putin-announces-first-registered-covid-19-vaccine-from-russias-gamaleya-institute-his-daughter-among-those-inoculated-8695031.html|access-date=2020-08-11|website=Firstpost}}
Protest developed in the international scientific community over the announcement of the vaccine registration in Russia, mainly because there has been no publication of results from clinical trials on Gam-COVID-Vac.{{cite journal |last1=Callaway |first1=Ewen |title=Russia's fast-track coronavirus vaccine draws outrage over safety |journal=Nature |date=11 August 2020 |volume=584 |issue=7821 |pages=334–335 |doi=10.1038/d41586-020-02386-2 |pmid=32782400 |s2cid=221107555 |language=en|quote=This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.|doi-access=free }}{{cite news |url=https://www.science.org/content/article/russia-s-approval-covid-19-vaccine-less-meets-press-release |title=Russia's approval of a COVID-19 vaccine is less than meets the press release |last=Cohen |first=Jon |magazine=Science |date=11 August 2020 |access-date=13 August 2020}} At the time of registration, there was no evidence for the safety, effective dose, biomarkers of an immune response, or efficacy against COVID-19 infection. As of 8 August 2020, no reputable scientific report on the Gam-COVID-Vac candidate had been published.{{cite news |title=Scientists ask: Without trial data, how can we trust Russia's COVID vaccine?|author=Kate Kelland |url=https://www.reuters.com/article/us-health-coronavirus-vaccine-russia-exp/scientists-ask-without-trial-data-how-can-we-trust-russias-covid-vaccine-idUSKCN2571TL |work=Reuters |accessdate=11 August 2020 |language=en |date=11 August 2020}}
On 4 September 2020, data on 76 participants in the Phase I-II trial were published, indicating preliminary evidence of safety and an immune response.{{cite journal | last1=Logunov | first1=Denis Y | last2=Dolzhikova | first2=Inna V |display-authors=etal | title=Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia | journal=The Lancet | year=2020 | volume=396 | issue=10255 | pages=887–897 | issn=0140-6736 | doi=10.1016/s0140-6736(20)31866-3 | pmid=32896291 | pmc=7471804 | doi-access=free }} Days later, however, the results were challenged by 27 international vaccine scientists as being incomplete, suspicious, and unreliable, when identical data were reported for many of the trial participants.{{cite news |author1=Holly Ellyatt |title=Scientists question 'strange' data in Russian coronavirus vaccine trial after 'unlikely' patterns |url=https://www.cnbc.com/2020/09/10/scientists-question-russian-vaccine-trial-data-on-unlikely-patterns.html |accessdate=2020-09-10 |work=CNBC |date=2020-09-10}}
On 2 February 2021, results of Phase III clinical trials involving 21,977 participants in Moscow were published in The Lancet, showing 91.6% efficacy of the vaccine,{{cite journal |last1=Logunov |first1=Denis Y |display-authors=etal |journal=The Lancet |title=Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia|year=2021 |volume=397 |issue=10275 |pages=671–681 |doi=10.1016/S0140-6736(21)00234-8 |pmid=33545094 |pmc=7852454 |doi-access=free}} and therefore responding, even if with considerable delays, to previous criticism. The study was subject to considerable criticism by researchers, citing restricted access to research data and inconsistencies in the published data.{{cite journal |last1=Bucci |first1=Enrico M |display-authors=etal |journal=The Lancet |title=Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial|year=2021 |volume=397 |issue=10288 |pages=1881–1883 |doi=10.1016/S0140-6736(21)00899-0|issn=0140-6736 |pmid=33991475 |pmc=9751705 |doi-access=free}} The authors replied that access had been granted and that inconsistencies were due to typing errors.{{cite journal |last1=Logunov |first1=Denis Y |display-authors=etal |journal=The Lancet |title=Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial – Authors' reply|year=2021 |volume=397 |issue=10288 |pages=1883–1884 |doi=10.1016/S0140-6736(21)00894-1 |pmid=33991474 |pmc=8115943 |doi-access=free}} As registration of the vaccine with Europe's medical regulator EMA dragged on, discussions about data gaps related to the vaccine continued through July 2021.{{cite news |last1=Rose |first1=Michel |last2=Ivanova |first2=Polina| last3=Parodi |first3=Emilio |title=European efforts to assess Russia's Sputnik V vaccine stymied by data gaps |url=https://www.reuters.com/world/the-great-reboot/exclusive-european-efforts-assess-russias-sputnik-v-vaccine-stymied-by-data-gaps-2021-07-13/ |work=Reuters |date=2021-07-15 |access-date=2021-07-15}}
Notes
{{reflist|group=note}}
References
{{Reflist}}
{{Gamaleya Research Institute of Epidemiology and Microbiology}}
{{Authority control}}
Category:Infectious disease organizations
Category:Organizations based in Moscow
Category:Medical and health organizations based in Russia
Category:1891 establishments in the Russian Empire
Category:COVID-19 vaccine producers
Category:Medical research institutes in the Soviet Union
Category:Cultural heritage monuments of regional significance in Moscow