Vaccine Regulators Resign

Explainer

Top FDA vaccine officials resign amid booster shot rollout

By Annie Andersen (Political Editor)

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.”

Within weeks of the Biden administration’s proposed vaccine booster shot rollout, the food and drug administration’s two highest vaccine research officials are stepping down. 

Reports say it’s because they felt pressure from the white house to approve the booster shots before the science was ready. 

Let me explain

The two people leaving are Marion Gruber… the director of the FDA’s Office of Vaccine Research and Review and her deputy, Phil Krause.

A source close to them told the website BioCentury, the pair said they didn’t think there was enough research to justify booster shots yet… saying they took Biden’s announcement last month as a way to force their hand.  

President Joe Biden: <<”Earlier today, our medical experts announced a plan for booster shots to every fully vaccinated American — adult American.”>>

Annie Andersen: Biden added the caveat  —  this would depend on the FDA. 

President Joe Biden: <<”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”>>

Annie Andersen: But In an interview with CBS, Dr. Anthony Fauci, the Chief Medical Officer to the President, said it may not happen by that date. . 

Dr. Anthony Fauci: <<”we’ve said right from the very beginning, we’re not going to do anything unless it gets the- the appropriate FDA regulatory approval. And then the recommendation from the Advisory Committee on Immunization Practices.”>>

Annie Andersen: Response to the resignations came with concern…

Luciana Borio, the former FDA Acting Chief Scientist tweeted, the FDA “is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”

While a reporter with the website EndPoints News called the resignations a “red alert”.

The FDA issued a statement of their own, saying it is “confident in the expertise and ability of our staff to continue our critical public health work.”

Will this change how you feel about the president, the FDA or booster shots? Let me know in the comments below and be sure to rate this story on our website using the Straight Arrow Bias Meter. 

Straight Arrow Bias Meter™ rating: neutral
ElideguySeptember 10, 2021, 8:55am CT

Shocker. Politicians trying to grab a win at the expense of deliberative process.

Straight Arrow Bias Meter™ rating: neutral
ElideguySeptember 10, 2021, 8:55am CT

Shocker. Politicians trying to grab a win at the expense of deliberative process.

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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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Straight Arrow Bias Meter™ rating: neutral
ElideguySeptember 10, 2021, 8:55am CT

Shocker. Politicians trying to grab a win at the expense of deliberative process.