RFK Jr. Halts COVID-19 Oral Vaccine Trial for 90 Days, Ends Flu Vaccine Ad Campaign

HHS Secretary Robert F. Kennedy Jr. paused a clinical trial funded by the Biomedical Advanced Research and Development Authority (BARDA) for a COVID-19 oral vaccine made by Vaxart. Kennedy said, “While it is crucial that the Department [of] Health and Human Services (HHS) support pandemic preparedness, four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production, including Vaxart’s. I look forward to working with Vaxart and medical experts to ensure this work produces safe, effective, and fiscal-minded vaccine technology.”

There is currently a 90-day pause on the trial that was set to begin on Monday with 10,000 clinical trial participants. The oral vaccine would be evaluated against the existing mRNA COVID-19 vaccines currently available under Emergency Use Authorization (EUA).

Kennedy was named the chair of the new Make America Health Again (MAHA) commission, created by an executive order signed by President Donald Trump just after Kennedy was confirmed as HHS secretary.

The executive order states, “It shall be the policy of the Federal Government to aggressively combat the critical health challenges facing our citizens, including the rising rates of mental health disorders, obesity, diabetes, and other chronic diseases.  To do so, executive departments and agencies (agencies) that address health or healthcare must focus on reversing chronic disease.”

The commission will work to provide transparent “open-source” data to the American people. This includes funding “gold-standard” research through the NIH and ensuring that the “United States food is the healthiest, most abundant, and most affordable in the world.”

In October, Kennedy said “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.” According to recent reports, firings have begun within HHS.

Earlier this week, the conflict of interest discussion ramped up when Patrizia Cavazzoni was hired as chief medical officer for Pfizer about a month after leaving her position with the FDA. She joined the FDA in 2018 and became the director of the FDA’s Center for Drug Evaluation and Research (CDER) in 2021. She resigned from the position in January, shortly before Donald Trump was sworn in as the 47th president of the United States.

The Pfizer press release states, “Before joining CDER, Dr. Cavazzoni held several senior executive positions in the pharmaceutical industry for nearly two decades, including at Pfizer, Eli Lilly, and Sanofi. During her prior tenure at Pfizer, Dr. Cavazzoni led clinical sciences and development operations for the company across multiple senior roles.”

Pfizer received full EUA approval for its COVID-19 vaccine in August 2021 while Cavazzoni was the director of CDER within the FDA. The Daily Mail reported that Cavazzoni’s new role with Pfizer could pay up to $500,000 per year before bonuses, according to job posting sites.

Kennedy has promised to root out conflicts of interest, and the latest move by Cavazzoni reflects the ongoing revolving door between big pharmaceutical companies and federal health agencies.

During Kennedy’s address to HHS staff, he said, “I’m not going to come in here and impose my belief over any of yours. Instead, we’re going to work together to launch a new era of radical transparency. We will convene representatives of all viewpoints to study the causes for the drastic rise in chronic disease. Some of the possible factors we will investigate were formerly taboo or insufficiently scrutinized: the childhood vaccine schedule, electromagnetic radiation, glyphosate, other pesticides, ultra-processed foods, artificial food additives, SSRIs and other psychiatric drugs, PFAS, PFOAs, microplastics—nothing is going to be off limits. Whatever belief or suspicion I have expressed in the past, I’m willing to subject them all to the scrutiny of unbiased science.”

Kennedy also halted the CDC’s “wild to mild” flu vaccination marketing program that has been running since 2023. Reports say Kennedy wants future vaccine ads to focus on “informed consent.” In this case, the ads would mention the risks and benefits of getting the flu vaccine.

Yesterday on The HighWire, Jefferey Jaxen reported on the halt to the flu vaccination campaign. He presented a 2012 study that shows risks associated with flu vaccinations that could potentially be mentioned in future ads if they focus on informed consent. A randomized placebo study with 115 children found those who received the trivalent inactivated influenza vaccine were 440% more likely to be infected with “virologically-confirmed non-influenza” or upper respiratory infections.

The flu vaccination ad program attempted to show the public that flu vaccinations can prevent severe outcomes from infection and don’t necessarily prevent transmission. The ads did not provide the information that the vaccines can increase the likelihood of infection with other non-flu illnesses. Running ads that focus on informed consent could include both of these messages so individuals can make an informed decision with their doctors.

Shirin A. Mazumder, MD, an infectious disease expert in Memphis, Tennessee, said, “A shift in the messaging away from the benefit of vaccines has the potential to affect public perception and lead to an increase in vaccine-preventable illnesses and deaths in a population where vaccine uptake for flu and other respiratory viruses is already low.”

Jeff Goad, PharmD, MPH, president of the National Foundation for Infectious Diseases (NFID) said the current flu season is the “most severe” since 2017-2018.

The flu season peak typically ends in late February, with most people receiving their flu vaccinations in September or October, before the season officially begins. Medscape reported, “Many clinicians already discuss issues related to informed consent before administering any vaccines, Mazumder said.”

It is not possible to know how many clinicians provide informed consent before administering a vaccine, and it is not possible to know the specific details they provide.

Kennedy promised radical transparency as the HHS secretary, which involved presenting all of the science for the public to make informed decisions. It has not yet been reported if the “wild to mild” flu vaccine campaign will continue this season with a balanced description of the risks and benefits of taking the vaccine.