March 18, 2021
Russia’s Sputnik V COVID-19 vaccine should be judged by the same safety and efficacy standards applied to jabs made by Moderna, Pfizer, AstraZeneca, and J&J according to industry group BIO.
The Amsterdam-based EMA began reviewing the vaccine – also called Gam-COVID-Vac – last week after R-Pharm Germany GmbH submitted an approval application.
A spokeswoman told us “The CHMP’s decision to start the rolling review of the Sputnik V COVID-19 vaccine is based on results from laboratory studies and clinical studies in adults. This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to EMA.”
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She added, “The Agency will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorization application.”
The EMA cooperates with many of the world’s largest regulatory bodies outside the EU in areas such as inspections, safety of medicines and exchange of information on issues of mutual concern.
At present the agency chairs the International Coalition of Medicines Regulatory Authorities (ICMRA), which is coordinating global COVID-19 vaccine review efforts.
“ICMRA is holding bi-weekly meetings to allow medicine regulatory authorities worldwide to discuss COVID-19-related policy approaches and regulatory flexibility, with the aim of expediting COVID-19 medicine and vaccine development and approval and avoiding medicine shortages.”
Russia has been administering Sputnik V since December, based on data from clinical trials that began in June.
In December, Belarus approved the vaccine. According to the Russian Government-backed Russian Direct Investment Fund, Belarussian approval was based on studies carried out in the country.
More recently – according to the Lancet – the Czech Republic and Slovakia (both EU member States) have received batches of the Sputnik V vaccine that they will begin administering in the next few weeks.
Others are yet to be convinced of Sputnik V’s efficacy. Biotechnology Innovation Organization (BIO) chairman, Jeremy Levin, told us “We simply don’t know how effective or ineffective that vaccine is.”
He added that the Russian Government and the Gamaleya National Centre of Epidemiology and Microbiology – which developed Sputnik V – need to provide the same types of data as Moderna, Pfizer, AstraZeneca and J&J did for their products.
“Well controlled and curated data from a formal trial design which is double-blinded, powered appropriately and with endpoints a structure the FDA deems appropriate.”
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