Gamaleya Research Institute of Epidemiology and Microbiology

55°48′06″N 37°27′27″E / 55.8017°N 37.4576°E / 55.8017; 37.4576

Gamaleya Research Institute of Epidemiology and Microbiology

Formation	1891; 132 years ago (1891) (as N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology)
Founder	Filipp Blymenthal^[1]
Purpose	Fund vaccine development
Headquarters	18 Gamaleya Street Moscow, Russia 123098
Director General	Alexander Gintsburg
Parent organization	Ministry of Health of the Russian Federation
Staff	379 (including 92 professors)^[2]^[3]
Website	gamaleya.org (in Russian) gamaleya.org/en(in English)

The Gamaleya Research Institute of Epidemiology and Microbiology,^{[note 1]} 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.^{[note 2]}

Founded in 1891 by Filipp Markovich Blyumental,^[4] 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.^[5][6]

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.^[7]

Research

Ebola

Main article: GamEvac-Combi

In May 2017, the Institute announced that it would deliver 1,000 doses of its vaccine candidate, GamEvac-Combi,^[8] to Guinea for Ebola testing. According to a Xinhua report, it was considered to be an approved Ebola vaccine,^[9] 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.^[10]

COVID-19 vaccine

Main articles: Sputnik V COVID-19 vaccine and Sputnik Light

In May 2020, the centre announced that it had developed a COVID-19 vaccine candidate.^[11] The project was funded by the Russian National Wealth Fund.^[12] A Phase I trial was completed on 18 June 2020 and Phase II was reported as completed in July 2020.^[13]

On 11 August 2020, the Russian President Vladimir Putin declared that the institute registered a COVID-19 vaccine called Gam-COVID-Vac.^[14]

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.^[15][16] 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.^[15] As of 8 August 2020, no reputable scientific report on the Gam-COVID-Vac candidate had been published.^[15][17]

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.^[18] 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.^[19]

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,^[20] 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.^[21] The authors replied that access had been granted and that inconsistencies were due to typing errors.^[22] 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.^[23]

Notes

1. Russian: Национальный исследовательский центр эпидемиологии и микробиологии имени почётного академика Н. Ф. Гамалеи, romanized: Natsional’nyy isslyedovatyel’skiy tsentr epidyemiologii i mikrobiologii imyeni pochetnogo akadyemika N. F. Gamalyei
2. Other names include the Gamaleya Scientific Research Institute or Gamaleya National Research Center for Epidemiology and Microbiology

References

1. - "BLJUMENTAL', Filipp Markovič [...] 1891-1917 [:] Gründer und Direktor des privaten „Chemisch-Mikroskopischen und Bakteriologischen Kabinetts“ bzw. „Chemisch-Bakteriologischen Instituts von Dr. Philipp Blumenthal“ [...] in Moskau [...]." drw.saw-leipzig.de
2. 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
3. "НИЦЭМ им. Н. Ф. Гамалеи". gamaleya.org.
4. "1891 г.[:] Частный химико-микроскопический и бактериологический кабинет Ф.М. Блюменталя." (tr. "1891 [:] Private chemical-microscopic and bacteriological study of FM Blumenthal.") gamaleya.org
5. "COVID-19 vaccines by Gamaleya Center, Vektor are most promising". TASS. Retrieved 11 August 2020.
6. "Russia's COVID-19 vaccine successfully completes first phase of human clinical trials - Health News, Firstpost". Firstpost. 13 July 2020. Retrieved 11 August 2020.
7. "History". Gamaleya Research Institute of Epidemiology and Microbiology. Retrieved 23 August 2021.
8. Dolzhikova IV, Zubkova OV, Tukhvatulin AI, Dzharullaeva AS, et al. (2 February 2017). "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". Human Vaccines & Immunotherapeutics. 13 (3): 613–620. doi:10.1080/21645515.2016.1238535. ISSN 2164-5515. PMC 5360131. PMID 28152326.
9. "Russia to deliver Ebola vaccines to Guinea by end of June". Xinhua, New China. 18 May 2017. Retrieved 11 August 2020.
10. "WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries". World Health Organization. 12 November 2019. Retrieved 15 August 2020.
11. "Russia plans to start producing coronavirus vaccine in September". Daily Sabah. 11 August 2020. Retrieved 10 August 2020.
12. Foy, Henry (22 July 2020). "Russia races for vaccine as Covid-19 nonchalance spreads". www.ft.com. Retrieved 16 August 2020.
13. "Russian University Says It Has Finished Human Trials For Covid-19 Vaccine". Retrieved 11 August 2020.
14. "Putin announces first 'registered' COVID-19 vaccine from Russia's Gamaleya Institute; his daughter among those inoculated - Health News , Firstpost". Firstpost. 11 August 2020. Retrieved 11 August 2020.
15. Callaway, Ewen (11 August 2020). "Russia's fast-track coronavirus vaccine draws outrage over safety". Nature. 584 (7821): 334–335. doi:10.1038/d41586-020-02386-2. PMID 32782400. S2CID 221107555. 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.
16. Cohen, Jon (11 August 2020). "Russia's approval of a COVID-19 vaccine is less than meets the press release". Science. Retrieved 13 August 2020.
17. Kate Kelland (11 August 2020). "Scientists ask: Without trial data, how can we trust Russia's COVID vaccine?". Reuters. Retrieved 11 August 2020.
18. Logunov, Denis Y; Dolzhikova, Inna V; et al. (2020). "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". The Lancet. 396 (10255): 887–897. doi:10.1016/s0140-6736(20)31866-3. ISSN 0140-6736. PMC 7471804. PMID 32896291.
19. Holly Ellyatt (10 September 2020). "Scientists question 'strange' data in Russian coronavirus vaccine trial after 'unlikely' patterns". CNBC. Retrieved 10 September 2020.
20. Logunov, Denis Y; et al. (2021). "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". The Lancet. 397 (10275): 671–681. doi:10.1016/S0140-6736(21)00234-8. PMC 7852454. PMID 33545094.
21. Bucci, Enrico M; et al. (2021). "Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial". The Lancet. 397 (10288): 1881–1883. doi:10.1016/S0140-6736(21)00899-0. ISSN 0140-6736. PMC 9751705. PMID 33991475.
22. Logunov, Denis Y; et al. (2021). "Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial – Authors' reply". The Lancet. 397 (10288): 1883–1884. doi:10.1016/S0140-6736(21)00894-1. PMC 8115943. PMID 33991474.
23. Rose, Michel; Ivanova, Polina; Parodi, Emilio (15 July 2021). "European efforts to assess Russia's Sputnik V vaccine stymied by data gaps". Reuters. Retrieved 15 July 2021.