vaccine mandates

FDA Accelerates Timeline for Final Pfizer Vaccine Approval

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As states, cities, and private companies issue limited coronavirus vaccine mandates to encourage more Americans to sign up for a shot, the Food and Drug Administration is now speeding up its timeline for final approval of the Pfizer vaccine. Such a development would clear a legal hurdle to order official vaccine mandates for many federal employees, including over 1.3 million active-duty military personnel.

Last week, President Biden announced that the FDA decision could be expected some time in the early fall. But on Tuesday, the New York Times reported that the regulatory agency has an unofficial deadline of Labor Day or sooner. Pfizer first applied on May 7 for final FDA approval, an upgrade from the emergency-use authorization currently granted to its shot and the candidates produced by Moderna and Johnson & Johnson. Pfizer applied for final approval roughly a month before Moderna, which is still submitting data; Johnson & Johnson intends to file later this year.

While the approval will provide new power to some employers’ vaccine mandates, there has been some polling suggesting that final FDA authorization could convince some vaccine skeptics to sign up for a shot. Polls this summer conducted by the Kaiser Family Foundation found that three in ten unvaccinated Americans said they would be more likely to get vaccinated once one of the shots has received final approval. (The numbers are encouraging, but they may not offer the full picture: KFF cautions that many respondents were not familiar with how FDA regulation works and may have been searching for a “proxy” answer to stall on their decision.) Though an internal Centers for Disease Control document leaked last week suggested that vaccinated people can spread the Delta variant, vaccines offer significant protection against severe coronavirus cases. According to CDC data, 97 percent of those currently hospitalized with COVID-19 are unvaccinated.

Following some public pressure to devote more resources to the process amid the Delta surge, the FDA told STAT News last week that it would begin a “sprint” to fully authorize the Pfizer shot. Many are waiting: The State University of New York (around 400,000 students) and the City of San Francisco (around 44,500 staffers) have stated that their enrollees and employees must get vaccinated shortly after FDA approval.

In a press conference on Tuesday — the day after the U.S. belatedly hit the goal of 70 percent of adults with at least one shot — President Biden described the summer’s alarming surge in cases as “a pandemic of the unvaccinated.” With a surplus of vaccines available in the U.S., he described the rise in hospitalizations and deaths as “a tragedy. People are dying and will die who don’t have to die.” On Thursday, the president is reportedly expected to announce a vaccine mandate for federal employees, though the administration is still determining if they can opt out by getting tested frequently — the clause that currently allows many vaccine mandates to operate. Once final approval has been cleared, that option may no longer be on the table.

FDA Shortens Timeline for Final Approval of Pfizer Vaccine