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FDA Accelerates Timetable for Final Approval of Pfizer-BioNTech COVID-19 Vaccine

Sources say the FDA has set an unofficial deadline of Labor Day to render a decision.

Video source: YouTube, TODAY

The US Food and Drug Administration (FDA) is speeding up its timeline for final approval of Pfizer-BioNTech’s (NYSE: PFE ) (Nasdaq: BNTX ) COVID-19 vaccine and is expected to do so by early September.

Sources told The New York Times on Tuesday that the regulatory agency set an unofficial deadline of Labor Day to render a decision on the Biologics License Application (BLA) for the double-dose shot.

Initially, the FDA had targeted early January 2022 for action on the application, but commissioner Dr. Janet Woodcock recently said it would likely come much sooner because the review is one of the agency’s highest priorities.

The FDA declined to comment Wednesday on a specific timetable for the expected approval but confirmed it has expedited its review amid a steady rise in new cases across the US due to the Delta variant.

“Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach," an FDA spokesperson told Politico, adding that the agency has diverted additional personnel and resources toward the effort.

Public health officials believe full approval could boost vaccine-hesitant individuals' confidence in getting the shot. 

None of the three vaccines authorized for emergency use in the US — by Pfizer-BioNTech, Moderna and Johnson & Johnson — has been fully licensed by the FDA. Moderna applied for full approval in June for its two-shot vaccine, and Johnson & Johnson is expected to begin the process soon.

A recent survey from the Kaiser Family Foundation found that 31% of unvaccinated adults said they would be more likely to get a vaccine if one of the shots currently authorized for emergency use got the full stamp of approval from the FDA.  

Pollsters noted that many respondents did not know the difference between the two types of authorization or if the vaccines were already approved, suggesting the findings could be a proxy for skeptics’ broader concerns.

As of Wednesday, 165 million Americans (49.8% of the population) are fully vaccinated and 192 million (58% of the country) have received at least one dose of a vaccine, according to the US Centers for Disease Control and Prevention.  

Vaccination rates have crept up in recent weeks as the more transmissible Delta variant has spread, causing a surge in hospitalizations and a reinstatement of mask mandates in COVID-19 hot spots. 

Vaccine hesitant individuals still represent tens of millions of Americans, many of them in hard-hit Southern and Midwest states where the latest wave in cases has strained hospitals and public health resources. 

Final approval could also help shape vaccine mandates and prompt requirements from employers, schools and other institutions.

A growing number of companies, including Microsoft Corporation, Tyson Foods and Facebook, along with several state and local governments, such as California and New York City, have already taken a hard line against vaccine holdouts by issuing mandates to get the shot

President Joe Biden enacted a similar mandate for federal workers last week.


Source: Equities News

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