European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps

Reuters

13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process, according to five people with knowledge of European efforts to assess the drug, providing new insight into the country’s struggle to win foreign acceptance of its product.

Reuters reported last month that the EMA’s review of the drug’s safety and efficacy was delayed because a 10 June deadline to submit data on the vaccine's clinical trials was missed, according to one of those people, who is close to the agency, and another person familiar with the matter.

Read Reuters article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Regulation , Vaccine , Data , Russia , COVID-19