COVID-19 booster shots: Fauci stresses need for FDA approval amid White House spat

Fauci indicated that only the Pfizer shot may be approved by Sept. 20

Dr. Anthony Fauci has stressed the need for approval from the Food and Drug Administration (FDA) before proceeding with COVID-19 vaccine booster shots amid a spat between the White House and health officials. 

President Biden announced in mid-August that the government planned to offer booster shots starting the week of Sept. 20. 

Reports last week, though, indicated that two FDA officials planned to step down due to continued frustration that the Biden administration appeared to be following the direction of the Centers for Disease Control (CDC) and Advisory Committee on Immunization Practices (ACIP) for guidance on booster shots. 

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, listens during a Senate Health, Education, Labor, and Pensions Committee confirmation hearing in Washington, D.C., U.S., on Tuesday, July 20, 2021. Photographer: Stefani Reynolds/The New York Times/Bloomberg via Getty Images (Stefani Reynolds/The New York Times/Bloomberg via Getty Images)

However, Fauci has claimed that the FDA approval remains the most important step in devising any plan for distributing booster shots. 

"We were hoping that we would get the both the candidates, both products Moderna and Pfizer rolled out by the week of the 20th, it is conceivable that we will only have one of them out, but the other would likely follow soon thereafter," Fauci said on CBS’s "Face the Nation." 

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"And the reason for that is that we, as we've said right from the very beginning, we're not going to do anything unless it gets the appropriate FDA regulatory approval and then the recommendation from the Advisory Committee on Immunization Practices," he added. 

Current guidance says that only individuals with moderately or severely compromised immune systems should receive a booster shot as such individuals might not build the appropriate immunity from the initial two shots. 

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Biden, however, suggested that individuals should receive a shot eight months after their final dose of vaccine. 

The FDA supposedly did not endorse this plan. 

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Fauci continued to highlight the FDA’s role in the process before moving forward with any plan, including the need for the FDA to review data – a significant complaint reportedly lodged by the FDA when the Biden administration announced the use of booster shots. 

The White House’s decision comes amid the surge of the highly transmissible delta variant of COVID-19, which studies have shown to double the risk of hospitalization for unvaccinated individuals. 

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"We have data now that when you give a third boost to either the Moderna or Pfizer it's very effective against any variant that we've tested, so that's the good news about our vaccines," Fauci explained. "If you get the level of antibody high enough, which booster's actually do, then you can feel pretty confident that you're going to be protected against virtually any variant."

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