Top FDA vaccine officials resign amid booster shot rollout


Summary

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fda resign coronavirus booster

Full story

In the midst of a vaccine booster shot rollout, the FDA’s two highest-ranking vaccine research officials are stepping down from their positions. Sources say it’s because they don’t think President Biden is following the science when it comes to booster shots for the COVID-19 vaccine.

The two people leaving are Marion Gruber, the director of the FDA’s Office of Vaccine Research, and Review and her deputy, Phil Krause. Together the pair have more than 40 years of experience at the FDA. 

According to BioCentury, the outlet that broke the news, a source close to the pair says one of the reasons the pair is leaving is the COVID-19 vaccine booster shots the Biden administration is now recommending, if the FDA approves them. 

A reporter with the biomedical outlet EndPoints News called the resignations a “red alert”.

BioCentury’s reporting says the pair didn’t think there was enough research to justify booster shots yet. It went on to say they took Biden’s announcement as a way to pressure the FDA into authorizing them. 

“Earlier today, our medical experts announced a plan for booster shots to every fully vaccinated American — adult American,” Biden announced on August 18. Pending approval from the Food and Drug Administration and the CDC’s Committee of outside experts, we’ll be ready to start these booster — this booster program during the week of September 20.”

In an interview with CBS on September 5, Dr. Anthony Fauci, the Chief Medical Officer to the President, said they may not reach that target date.

“We’ve said right from the very beginning, we’re not going to do anything unless it gets the appropriate FDA regulatory approval,” Dr. Fauci said. “And then the recommendation from the Advisory Committee on Immunization Practices. Looks like Pfizer has their data in, likely would meet the deadline. We hope that Moderna would also be able to do it so we could do it simultaneously, but if not, we’ll do it sequentially.”

In that same interview, Fauci said part of the delay is making sure the boosters are safe.

“You want to make sure when you’re dealing with allowing the American public to receive an intervention, you want to make sure you are absolutely certain,” he said. “The other is the immunogenicity or efficacy. Immunologists would predict it would be protective.”

The other issue is whether or not it is effective. Scientists in Israel are researching the effectiveness of the two and three dose Pfizer vaccines. Their research found that the protection against viral load started going down after two months of Pfizer’s second dose, followed by a complete reduction after 6 months.

Gruber and Krause will be leaving in October and November. Dr. Peter Marks, the FDA’s director of the Center for Biologics Evaluation and Research, will serve as the acting director of the vaccines office. 

Dr. Luciana Borio, the former FDA Acting Chief Scientist, responded on social media.

A spokesperson for the FDA issued a statement about the resignations, saying the FDA is “confident in the expertise and ability of our staff to continue our critical public health work.”

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Why this story matters

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Bias comparison

  • The Left habitasse per tincidunt aliquet facilisi mollis vestibulum dolor nam aenean ligula urna rutrum, magna taciti accumsan efficitur himenaeos metus primis proin hac quam.
  • Not enough coverage from media outlets in the center to provide a bias comparison.
  • Not enough coverage from media outlets on the right to provide a bias comparison.

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Key points from the Center

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fda resign coronavirus booster

Summary

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Erat volutpat praesent felis

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Full story

In the midst of a vaccine booster shot rollout, the FDA’s two highest-ranking vaccine research officials are stepping down from their positions. Sources say it’s because they don’t think President Biden is following the science when it comes to booster shots for the COVID-19 vaccine.

The two people leaving are Marion Gruber, the director of the FDA’s Office of Vaccine Research, and Review and her deputy, Phil Krause. Together the pair have more than 40 years of experience at the FDA. 

According to BioCentury, the outlet that broke the news, a source close to the pair says one of the reasons the pair is leaving is the COVID-19 vaccine booster shots the Biden administration is now recommending, if the FDA approves them. 

A reporter with the biomedical outlet EndPoints News called the resignations a “red alert”.

BioCentury’s reporting says the pair didn’t think there was enough research to justify booster shots yet. It went on to say they took Biden’s announcement as a way to pressure the FDA into authorizing them. 

“Earlier today, our medical experts announced a plan for booster shots to every fully vaccinated American — adult American,” Biden announced on August 18. Pending approval from the Food and Drug Administration and the CDC’s Committee of outside experts, we’ll be ready to start these booster — this booster program during the week of September 20.”

In an interview with CBS on September 5, Dr. Anthony Fauci, the Chief Medical Officer to the President, said they may not reach that target date.

“We’ve said right from the very beginning, we’re not going to do anything unless it gets the appropriate FDA regulatory approval,” Dr. Fauci said. “And then the recommendation from the Advisory Committee on Immunization Practices. Looks like Pfizer has their data in, likely would meet the deadline. We hope that Moderna would also be able to do it so we could do it simultaneously, but if not, we’ll do it sequentially.”

In that same interview, Fauci said part of the delay is making sure the boosters are safe.

“You want to make sure when you’re dealing with allowing the American public to receive an intervention, you want to make sure you are absolutely certain,” he said. “The other is the immunogenicity or efficacy. Immunologists would predict it would be protective.”

The other issue is whether or not it is effective. Scientists in Israel are researching the effectiveness of the two and three dose Pfizer vaccines. Their research found that the protection against viral load started going down after two months of Pfizer’s second dose, followed by a complete reduction after 6 months.

Gruber and Krause will be leaving in October and November. Dr. Peter Marks, the FDA’s director of the Center for Biologics Evaluation and Research, will serve as the acting director of the vaccines office. 

Dr. Luciana Borio, the former FDA Acting Chief Scientist, responded on social media.

A spokesperson for the FDA issued a statement about the resignations, saying the FDA is “confident in the expertise and ability of our staff to continue our critical public health work.”

Tags: ,

Why this story matters

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Tempus tempor augue eget

Id eget eu torquent sodales velit litora mauris habitant proin nisi nascetur ante urna, efficitur viverra faucibus mi varius inceptos maximus mattis feugiat natoque nulla felis.

Get the big picture

Synthesized coverage insights across 13 media outlets

Context corner

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Bias comparison

  • The Left venenatis ornare mus conubia semper vitae primis eu fringilla maecenas adipiscing curabitur pharetra, ligula eleifend ad massa varius dignissim molestie faucibus hac sit.
  • Not enough coverage from media outlets in the center to provide a bias comparison.
  • Not enough coverage from media outlets on the right to provide a bias comparison.

Media landscape

Click on bars to see headlines

113 total sources

Key points from the Left

  • Class nulla donec imperdiet convallis sit dignissim porttitor risus vehicula cursus velit lobortis, rhoncus et luctus amet quam litora vivamus feugiat lectus euismod est.
  • Class dictumst accumsan suscipit etiam lacus fusce himenaeos inceptos magnis bibendum nec, urna taciti feugiat eros ut vivamus ex scelerisque lobortis massa.

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Key points from the Center

  • Sed ultrices pulvinar faucibus laoreet hendrerit penatibus ullamcorper pellentesque lobortis aliquet facilisi conubia ad congue dui finibus diam porttitor varius mollis, tempus accumsan vel nunc parturient tortor tellus orci sagittis fusce ac ligula natoque quam nascetur tempor tristique class.
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Key points from the Right

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