COVID-19 Vaccine: Russia Announces Approval of “Sputnik V” Despite Concerns Over Safety

Vaccine development is traditionally a slow process, due to the rigorous preclinical testing, lead optimization, and subsequent clinical trials performed on healthy volunteers and patients. Hence the announcement of Russia’s “Sputnik-V”, a ready-to-use COVID-19 vaccine approved even prior to Phase 3 evaluations comes as a huge surprise.

By Pavel Ryzhov, Ph.D.

As the number of global COVID-19 cases continues to increase, many biopharma in collaboration with governments and academic institutions are making substantial progress in developing their vaccine candidates. At the onset of COVID-19, analysts predicted that the first vaccine would not be commercially available until the beginning or middle of 2021, citing previous R&D and testing timelines. However, the pace with which the industry has been tackling this issue has progressively exceeded expectations.

For example, Moderna was one of the first companies to initiate Phase 1 clinical trials of its mRNA vaccine candidate, recruiting patients back in March and now amid Phase 3. Other companies are also rapidly advancing their respective candidates through the development stages. State-run development initiatives in countries such as China and Russia are also underway. Overall, the accelerated vaccine testing timeline has been a widely debated topic over the last several months, mainly due to the legitimate concerns over safety and efficacy for a candidate that has been potentially rushed through the testing stages.

This is now a subject of renewed speculation and discussion due to the recent announcement from Russia, where President Vladimir Putin has announced that Russia became the first country with an approved and ready-to-use COVID-19 vaccine. The vaccine was named “Sputnik-V,” in homage to the world’s first satellite, made and launched by the USSR. Interestingly, the announcement comes after less than two months of human testing and prior to the completion of the final Phase 3 clinical trial. In his speech, Vladimir Putin remarked that the vaccine “works quite effectively, forms strong immunity, and I repeat, it has passed all the necessary checks.” He also mentioned that one of his daughters has participated in receiving the vaccine, and since then is feeling fine. The vaccine is expected to be available before the end of the year, starting with voluntary inoculation of medical personnel, teachers as early as the end of August or beginning of September.

The approved vaccine, administered in two doses, has been developed by Gamaleya Institute and consists of two serotypes of human adenovirus, carrying S-antigen of the novel coronavirus. Upon inoculation and entry into human cells, the immune response is produced. The requests for the vaccine have come to Russia from other countries, including the United Arab Emirates and the Philippines. In the wake of the announcement, many experts have raised their concerns over the timing, the lack of Phase 3 data, and possible side effects that may be uncovered in extensive population studies, typically required for regulatory approval. Besides, some have also questioned whether there could be political motives behind the announcement, and the safety and efficacy of the data must have to be firmly established before the mass distribution of the vaccine.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Novavax’s COVID-19 Vaccine is Safe and Immunogenic in Early Trial

References

1. https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-spu/russia-names-new-covid-19-vaccine-sputnik-v-in-reference-to-cold-war-space-race-idUSKCN2571FV

Author

Pavel Ryzhov