Senadores: “We intend to use your nomination hearing next week to understand whether you support this ill-informed measure to slow critical public health decision making.”
Washington DC - Today, U.S. Senator Patty Murray (D-WA), a senior member and former Chairof the Senate Health, Education, Labor and Pensions (HELP) Committee, U.S. Senator Tammy Baldwin (D-WI), and U.S. Senator Angela Alsobrooks (D-MD) sent a carta to Dr. Marty Makary, President Trump’s nominee to lead the Food and Drug Administration (FDA), expressing extreme concern with the FDA’s unprecedented decision to abruptly cancel the March 13th planned meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which is the annual opportunity for FDA to hear expert advice and make recommendations on the selection of influenza strains to be included in the flu vaccines this coming fall. The cancellation of the VRBPAC’s meeting to consider flu shot characteristics for the upcoming flu season comes while the U.S. is experiencing the worst flu season in 15 years. As of February 15, 2025, the Centers for Disease Control and Prevention (CDC) estimates that there have been at least 33 million illnesses, 430,000 hospitalizations, and 19,000 deaths from flu so far this season.
Dr. Makary is set to appear before the HELP Committee on Thursday, March 6th, for a audiencia on his nomination to lead FDA. “We intend to use your nomination hearing next week to understand whether you support this ill-informed measure to slow critical public health decision making,” Murray, Baldwin, and Alsobrooks—all members of the HELP Committee—wrote.
“The cancellation of next week’s VRBPAC meeting is unprecedented. This Committee has met every year for the past 30 years to discuss the influenza virus vaccines for the upcoming flu season and make recommendations to the FDA. It is essential for this meeting to occur, and its expert recommendations to be issued, in a timely, routine manner,” prosiguieron los senadores. “Any delay in the Committee meeting and issuing recommendations may impact flu vaccine availability and effectiveness, if manufacturers do not have sufficient time to prepare the correct vaccines.”
“While we acknowledge you are not yet at the agency, we expect you to answer questions about whether you will adopt a position of responsible public health leadership or continue the Trump Administration’s current, troubling trajectory into vaccine skepticism should you be confirmed to lead FDA,” Murray and her colleagues wrote, asking that Dr. Makary be prepared to address the following questions:
- Will you reschedule FDA VRBPAC meeting to consider influenza virus vaccines for the 2025-2026 flu season? If not, why not?
- Are you planning to remove or otherwise change the membership of the FDA VRBPAC?
- Will FDA accept the expert, independent recommendations of the FDA VRBPAC, for influenza virus vaccines and all other vaccine types?
- Do you commit to convening the FDA VRBPAC on its established annual basis to discuss and issue recommendations on flu shot characteristics?
El texto completo de la carta está debajo y AQUÍ:
Dear Dr. Makary:
Next week, you are scheduled to appear before the Senate Health, Education, Labor, and Pensions (HELP) Committee for your nomination to serve as the Commissioner of the Food and Drug Administration (FDA). We write today to express our extreme concern with the decision to abruptly cancel the planned meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which is the annual opportunity for FDA to hear expert advice and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2025 to 2026 influenza season. We intend to use your nomination hearing next week to understand whether you support this ill-informed measure to slow critical public health decision making.
The cancellation of the VRBPAC’s meeting to consider flu shot characteristics for the upcoming flu season comes while the U.S. is experiencing the worst flu season in 15 years. The Centers for Disease Control and Prevention (CDC) has classified the United States’ 2024-2025 influenza season as “high severity” overall and for all age groups. As of February 15, 2025, the CDC estimates that there have been at least 33 million illnesses, 430,000 hospitalizations, and 19,000 deaths from flu so far this season. The flu vaccine is one essential tool for prevention of flu illness, complications, hospitalizations, and untimely deaths.
The VRBPAC is comprised of independent experts and is critical for ensuring that public health decisions, including the development and approval of vaccines, are based on the best available science and expert, independent review. VRBPAC members are experts in vaccines, infectious diseases, and epidemiology, among other relevant areas, and are essential to conducting these independent reviews and evaluating the data concerning the safety, effectiveness, and appropriate use of vaccines. The Committee typically meets in March to make recommendations for which strains should be included in the flu vaccines for the upcoming flu season.
The cancellation of next week’s VRBPAC meeting is unprecedented. This Committee has met every year for the past 30 years to discuss the influenza virus vaccines for the upcoming flu season and make recommendations to the FDA. It is essential for this meeting to occur, and its expert recommendations to be issued, in a timely, routine manner. This is integral to give vaccine manufacturers this information to start production on flu vaccines for the upcoming flu season. Any delay in the Committee meeting and issuing recommendations may impact flu vaccine availability and effectiveness, if manufacturers do not have sufficient time to prepare the correct vaccines.
In FDA’s response concerning the cancellation of the March 13 VRBPAC meeting, FDA stated that the agency “will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season.” This suggests FDA plans to forgo any independent expertise from the Committee when making its determinations for flu shot strains, and it remains unclear who will be making this critical public health decision.
The options are not inspiring. The newly confirmed Secretary of Health and Human Services Robert F. Kennedy, Jr. has stated “there is no vaccine that is safe and effective” and called vaccines “sham science.” He refuses to believe the definitive science showing vaccines are not linked to autism. You have promoted natural immunity as “at least as effective as vaccinated immunity, and probably better” and stated, “The greatest perpetrator of misinformation during the pandemic has been the United States government.” President Trump’s nominee to lead CDC has a long history of championing the false connection between vaccines and autism.
While we acknowledge you are not yet at the agency, we expect you to answer questions about whether you will adopt a position of responsible public health leadership or continue the Trump Administration’s current, troubling trajectory into vaccine skepticism should you be confirmed to lead FDA. Please be prepared to address the following questions:
- Will you reschedule FDA VRBPAC meeting to consider influenza virus vaccines for the 2025-2026 flu season? If not, why not?
- Are you planning to remove or otherwise change the membership of the FDA VRBPAC?
- Will FDA accept the expert, independent recommendations of the FDA VRBPAC, for influenza virus vaccines and all other vaccine types?
- Do you commit to convening the FDA VRBPAC on its established annual basis to discuss and issue recommendations on flu shot characteristics?
Whether it’s influenza, COVID-19, measles, or other threats facing our nation’s public health, I call on you to recognize the immense responsibility placed on you if confirmed as one of the nation’s public health leaders. It will be incumbent upon you to maintain FDA’s credibility as the nation’s leading agency for ensuring the safety of our vaccines, diagnostics, medicines, foods, and more.
Atentamente,
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