Sputnik V Vaccine Production to Begin a Month after 3rd Stage

17 August 2020

GMP News

The third (post-registration) stage of research on the coronavirus vaccine Sputnik V, which is expected to be launched within 7-10 days, can be called mass vaccination because it will involve tens of thousands of people, Director of the N. F. Gamaleya Federal Research Center for Epidemiology and Microbiology of the Russian Health Ministry Alexander Gintsburg told TASS.

“According to the law, civilian circulation can begin now but the vaccine won’t be enough for both things [post-registration research and mass vaccination]. So, in the first place, the vaccine will enter post-registration research and this is also mass vaccination. It is called so because there is tougher control over those vaccinated. The civilian circulation [will start] when the demand for vaccine is met for post-registration [stage] – this is nearly 30,000 doses of drug, and then civilian circulation will begin immediately – with a delay of 3-4 weeks [since the start of the third stage],” the scientist said.

Gintsburg noted that the third stage could start within 7-10 days after the Health Ministry approves a certain protocol. The trials will be carried out in the Moscow Region and some 20,000 – 30,000 people will get the vaccine.

The post-registration research can take 4-5 months on average,” he said.

“The civilian production will be launched in parallel [with post-registration research] but with some delay because there is not enough vaccine…I think this will be a delay of one month at maximum after the post-registration research begins,” Gintsburg said.

The scientist said it was difficult to predict how many doses of the drug could be produced in the coming weeks because the production would be expanded. Thanks to the money allocated by the Russian government on the president’s order the production capacity will grow 10-fold in the coming 1.5 or 2 months, Gintsburg noted.

In the near future 3-4 more facilities will be launched and by December they will produce 4 mln-5 mln doses per month or a bit more and this will allow to ensure the necessary amount of the vaccine for the entire country for 9-12 months,” the scientist said.




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