Experts from the Advisory panel to the US Food and Drug Administration (FDA) have voted in favor of the Pfizer-BioNtech COVID19 vaccine. They have recommended the agency to grant emergency use authorization (EUA) to the vaccine. Now, Pfizer (PFE) and BioNtech (BNTX) vaccine has come one step closer to be given to health workers and nursing home residents. As per the report, around 17 members of the Vaccines Advisory Committee have said yes to the vaccine, nearly four of the experts have opposed it, and one expert has remained abstained. The recommendation, which has come from the committee, might result in the FDA granting authorization to the vaccine within days. It will lead to mass vaccination across the 64 jurisdictions in the US. Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER) has said that the agency might take days to weeks for granting EUA to the vaccine.
FDA Commissioner Stephen Hahn has said that they understand the need to provide a vaccine to people as soon as possible. However, they need to follow the mandate to protect public health; therefore, they need to ensure that authorized vaccines meet the standards of rigorous safety and efficacy set by the agency. As per the report, COVID19 has outpaced heart disease and has become a leading cause of death in the US. Heart disease has been one of the top causes of death in the US. The officials from the US Center for Disease Control and Prevention have said to the FDA’s advisory committee that the SARS-CoV-2 virus is seven times more prevalent than people, who have been tested positive for COVID19. The CDC officials have estimated more than 14.8 million people might be infected with the virus.
Health authorities around the nation have started scheduling shots of COVID19 for frontline workers. Some shots have already been scheduled for December 15. However, officials will adjust the timings as the vaccine gets approval. On the other hand, the Chief of operations at Operation Wrap Speed, Gen Gustave Perna has said that no dose of vaccine has been sent to any state or health system though Pfizer has completed stress tests for its logistics chain. Perna has said that the vaccine is with Pfizer right now and it will not be forwarded until it gets a EUA. If the federal agency grants EUA to the vaccine, it will have approval for four countries, said the expert.
