Skvortsova: Convasel vaccine can be registered before the end of the first quarter of 2022

“We plan to submit a report by the end of this year. Here, of course, the regulator will decide, there are different approaches. If we say that everything was, this is six months of observation after the introduction. If so, then it will be until the end of the first quarter, [due to] the need to monitor those whom we started vaccinating in August – September,” she said.

Skvortsova also noted that the recombinant drugs workshop created on the basis of the St. Petersburg Institute of Vaccines and Serums “fully meets any GMP requirements, the highest, and it allows you to easily scale up to 30 million doses [of vaccines] per year, that’s for sure, and maybe more.”

“If some kind of re-profiling is needed, there is an opportunity to quickly carry out re-profiling. Therefore, an industrial site is ready for the vaccine,” she added.

Skvortsova said that not a single person vaccinated with the Convacel vaccine as part of clinical trials of this drug has contracted a coronavirus infection.

“We started our clinical trials on July 19. This is a combined first and second phase. Throughout this period, we regularly monitor the state of immunity and the condition of the vaccinated. First of all, no one is sick yet. Although people are on a free regime, and this is very important, because the protection is in force, although this is a small number, it is now a little more than 150 people,” she said.

The developer of the vaccine is the St. Petersburg Research Institute of Vaccines and Serums of the FMBA of Russia. In June 2021, preclinical studies of the vaccine were completed, as a result of which its safety, immunogenicity and protective potential were proved.



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