US may approve Astrazeneca vaccine in April, even as EU states ban jab over blood clot fears
Results of Astrazeneca’s Covid-19 vaccine trial are being reviewed by independent monitors, and emergency authorisation could come in about a month, a top US official told Reuters today.
The independent monitors are analysing data from the 32,000-person US study to determine whether the vaccine is safe and effective. If the results are positive and all goes well, the US Food and Drug Administration would review the data and issue the authorization, Dr. Francis Collins, director of the National Institutes of Health (NIH), said in an interview.
Collins estimates that the FDA would need about three weeks to analyse the trial data, after which an expert advisory panel will meet and vote on whether to recommend authorisation.
“We expect data from our US Phase Three trial to be available soon, and we plan to file for emergency use authorization shortly thereafter,” Astrazeneca spokeswoman Michele Meixell said in a statement.
Independent monitoring boards periodically review data during clinical trials to make sure no safety problems crop up, and can halt studies early if it determines a drug or vaccine is likely to fail or is clearly going to be a success.
The Astrazeneca vaccine, developed with the University of Oxford, has been authorized for use in the European Union and many countries based on separate trial data. USregulators have been waiting for the US data.
Several EU countries have halted administering the AstraZeneca vaccine after reports from Denmark and Norway of possible serious side effects, including bleeding and blood clots.
Asked about those issues, Collins said he has not personally seen the data but has been “pretty reassured” by statements from European regulators that the problems could be occurring by chance, and are not related to the vaccine.
With so many people being vaccinated, Collins said, some are bound to experience a blood clot around the same time they receive a vaccine.
A World Health Organization expert said today he sees no association between reports of blood clots and the AstraZeneca vaccine and urged people not to panic.