U.S. Government Asks Vaccine Makers To Hold Filing for Authorization Until They Have Enough Doses to Distribute

As the COVID-19 pandemic enters its 10th month, the pressure to develop an effective vaccine, or vaccines, continues to mount. Speaking at the Johns Hopkins University and University of Washington Vaccine Symposium online, Dr. Moncef Slaoui, scientific head of Operation Warp Speed—the government organization funding and supporting development and distribution of COVID-19 vaccines—provided the latest updates on when a vaccine (and how many doses) might be available in coming months. Perhaps most strikingly, Slaoui said that the government has told vaccine manufacturers not to seek authorization of their drugs from the Food and Drug Administration (FDA) until they have enough doses to provide to a desperate public. “We have recommended to companies that if they achieve efficacy demonstration while no vaccine doses are available at industrial scale of several million doses to at least immunize a relevant fraction of the population, then they should refrain or consider refraining from filing an emergency use authorization, because the populations would have a major disappointment [over] expectation of the availability of the vaccine,” he said. Emergency use authorization (EUA) is an accelerated review and authorization process by the FDA that would allow vaccine makers to distribute vaccines that are safe and effective but not fully approved by the agency. Slaoui also supported the FDA in its recent conflict with the White House over stringent guidelines ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news