FDA Panel Recommends Approval of Pfizer Vaccine
Final emergency use authorization for the vaccine is anticipated from the agency in the coming days
A panel of health experts Thursday sent a recommendation for the Food and Drug Administration to grant an emergency use authorization for the COVID-19 vaccine developed by drug maker Pfizer and German biotech firm BioNTech.
In a 17-4 vote with one abstention, the Vaccines and Related Biological Products Advisory Committee, which included members from the FDA’s Center for Biologics Evaluation and Research, outside vaccine experts and Pfizer representatives, concluded that the vaccine appears to meet safety and efficacy standards.
In late-stage clinical trials, the vaccine proved 95 percent effective, according to data released by the companies. Another vaccine candidate developed by biotechnology firm Moderna has also proven to be effective in large-scale trials, leading its developer to file for an EUA days after Pfizer. The committee is scheduled to take up that application on Dec. 17.
A third vaccine candidate, this one from a collaboration of Astrazeneca and Oxford University, has also returned favorable results in clinical trials. So far, the makers have not filed for any emergency use authorizations.
Although the Pfizer vaccine has cleared this hurdle, the committee’s recommendation now needs to be acted on by the FDA. While the agency is not bound to follow the advisory committee’s recommendation, it often does.
The EUA approval could come as early as Friday, according to reports by CNBC, making the Pfizer-BioNTech candidate the first COVID-19 vaccine to be OK’d by US regulators. The vaccine has already been approved for emergency use in the UK and Bahrain, and Canada has given full approval.
Inoculations for some health care workers and nursing home residents could begin within 24 hours of authorization, according to US officials. Charter flights carrying the vaccine from production facilities in Europe have already been underway to pre-position the product for distribution, once the EUA is granted.
In a recent survey, over half of consumers asked say the availability of an effective vaccine is key to assuring them it would be safe to travel again. In all, over a dozen vaccine candidates are in late-stage large scale clinical trials worldwide and seven have been approved for limited use in different countries, according to the New York Times.
