SAHPRA turns down Sputnik application
SA Health Products Association (SAHPRA) has turned down Lamar Internationals’ emergency-use authorisation application for Russia’s Sputnik V Covid-19 vaccine. In a statement, SAPHRA said it had decided not to approve the Section 21 application, as it had yet to be provided with data demonstrating Sputnik V was safe to use in the context of SA’s high HIV burden.
“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant
safety data in support of the application,” according to the statement.
Meanwhile, the Gamaleya Centre said SAPHRA’s concerns about HIV acquisition were “completely unfounded”.