FDA set to announce stricter criteria for COVID-19 vaccines to receive Emergency Use Authorization
pharmafile | September 23, 2020 | News story | Research and Development |
The FDA is set to release new guidelines that would raise safety and efficacy requirements required for a COVID-19 vaccine to be granted Emergency Use Authorization.
This has been revealed by The Washington Post. The guidance is to be far more rigorous than the criteria used to award hydroxychloroquine and convalescent plasma emergency clearance to treat coronavirus. It will ask manufacturers who seek an emergency authorisation to follow participants in late-stage clinical trials for a median of at least two months, beginning when they received a second vaccine shot, according to two people who spoke to The Post anonymously.
The FDA will also assess at least five severe coronavirus patients in the placebo group of each trial. It is also expected that they will require data for an emergency clearance which is nearly as extensive as the information needed for a general approval.
These new guidelines mean it will take extra time for pharmaceutical companies to prepare their applications and for the regulatory body to review the data. This makes it highly unlikely that a vaccine would be available before the US election on 3rd November. Back in July, the agency said that any vaccine would have to be 50% more effective compared to a placebo.
The FDA has only granted Emergency Use Authorization for a vaccine once before. In 2005, it cleared an anthrax vaccine for military personnel who were at high risk of being exposed to an anthrax attack.
These new guidelines are part of the FDA’s strategy to win over more of the public in the fight to get the country vaccinated. A poll released on 10th September by the Kaiser Family Foundation found that even if a vaccine was available before the election, 54% of respondents said they would not take it, while 62% said they were concerned about the FDA approving it before it was proven to be safe and effective.
Conor Kavanagh
