FDA Set to Approve Pfizer Vaccine Ahead of Schedule

The Food and Drug Administration (FDA) is set to approve Pfizer-Biotech’s two-dose COVID-19 vaccine a bit earlier than anticipated. According to the New York Times, the administration is aiming to approve the use of Pfizer’s COVID-19 vaccine by Monday. The publication noted that this would be an earlier timeline for licensing the vaccine, as they previously set an unofficial deadline for its approval for Labor Day.

The NYT reported that they were originally eyeing to have the vaccine approved by the FDA by Friday. However, the FDA and Pfizer were still in negotiations at that point. While they are aiming to have it approved by Monday, the NYT noted that some who are close to the case (who are not authorized to speak about it publicly) have said that it could go beyond Monday if they still have details to figure out. The NYT reached out to the FDA regarding this report, but they declined to comment.

Once the Pfizer vaccine is approved by the FDA, many public and private organizations can begin to implement vaccination mandates. More specifically, universities and hospitals will be able to mandate vaccinations once Pfizer’s vaccine is approved by the FDA. This approval will also help pave the way for Pfizer to ask the FDA to approve the use of a third dose as a booster shot. By Sept. 20, Pfizer is expected to finish their data regarding the use of this third vaccine dose as a way to protect from illness amid the ongoing COVID-19 pandemic.

On Wednesday, President Joe Biden’s administration shared that vaccinated adults should get a third dose as a booster shot eight months after they have been fully inoculated. NBC News reported that the United States would begin to distribute booster shots in September. In a statement that was signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci, and other U.S. health leaders, they noted that immunity against COVID-19 waned months after the initial vaccination.

They stated that amid the rise of the delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease.” Their statement continued, “Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.” Americans will likely become eligible to receive a third COVID-19 vaccine dose beginning on the week of Sept. 20.

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