When it comes to vaccination, the COVID-19 pandemic divided American society. President Donald Trump and his new Health and Human Services secretary are bringing down the hammer. What happens when there is no middle ground?
The vaccine space has become so politically charged it’s hard to find the truth in the facts.
Citing two people familiar with the discussions, Politico reported last week that HHS Secretary Robert F. Kennedy Jr. is considering removing the COVID-19 vaccine from the childhood vaccine schedule maintained by the Centers for Disease Control and Prevention. The publication said the rumored shift would “reverse a recommendation backed by the CDC and a slate of independent advisers just three years ago” and represent “Kennedy’s most significant move yet to shake up the nation’s vaccination practices.”
All of this is true. But here are a few things that got left out.
First, no COVID-19 vaccine is fully approved by the FDA for young children. Rather, Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax were granted access to the market for younger and younger age groups in 2021 and 2022 via emergency use authorizations, a regulatory mechanism at the FDA’s disposal to help protect the population in the face of public health emergencies. The World Health Organization declared the international COVID-19 emergency over on May 5, 2023.
Second, it is worth noting that the U.S. is unique in its recommendation that healthy children get vaccinated against COVID-19. The United Kingdom, Australia and many other countries follow the advice of the WHO, which suggests children and adolescents only get COVID shots if they have comorbidities.
Finally and most importantly, CDC’s Advisory Committee on Immunization Practices (ACIP) met on April 15 and 16, and discussed changes to the COVID-19 vaccine recommendations that would involve removing this particular immunization from the childhood schedule. “It looks likely ACIP will shift to risk-based from universal booster vaccine recommendations,” analysts at Leerink Partners wrote in a note to investors following the meeting.
Given all of this, is the fact that RFK Jr. is thinking about rescinding the CDC’s 2022 pediatric COVID vaccine recommendation really that radical? Quite the opposite, if he waits until after the ACIP votes on the matter in June, the move will simply be business as usual. It would not, as reported by Politico, “represent an extraordinary intervention by Kennedy to override the agency’s scientific decision-making.”
The problem is, RFK Jr. has firmly established himself as a vaccine skeptic. For years before he took the reins of the country’s federal health institutions as well as after his appointment, he has broadcast unfounded rumors about their safety and efficacy, despite assurances to Congress in his confirmation hearings that he is not anti-vaccine.
This misleading and unscientific messaging from the head of the country’s health department is driving ever deeper the wedge that the COVID-19 pandemic already secured in the American populace.
Since he’s been in office, RFK Jr. has raised safety concerns about the use of measles vaccines, which are supported by decades of data and credited with eliminating measles from the U.S. at the turn of the 21st century before the disease resurfaced in the face of falling vaccine rates. He also downplayed the recent deaths of two unvaccinated children in Texas, falsely claiming that they had underlying health conditions and that the second child actually died of a “bacteriological infection” after recovering from measles.
Kennedy is also devoting substantial government resources to finding the cause of autism, seemingly looking to support his belief in a repeatedly-debunked link between vaccines and the neurodevelopmental condition.
“It’s clear to me that RFK is a vaccine skeptic, probably across the board,” BMO Capital Markets analyst Evan Seigerman told me last week.
This misleading and unscientific messaging from the head of the country’s health department is driving ever deeper the wedge that the COVID-19 pandemic already secured in the American populace. The anti-vax movement now has an ally in the highest ranks of government, and many vaccine proponents are resorting to silence at best, hyperbole at worst, when it comes to discussing the limited data on COVID-19 immunization for kids.
“Because of the political environment and the heightened level of rhetoric, these good ideas here and there get overshadowed by everything else,” said Seigerman. “And that makes it really challenging to implement what would be seen as good policy in any other administration.”
This growing divide is potentially more harmful than any single action of the current administration, as it’s thwarting open dialogue about issues that are critical to the country’s biopharma and healthcare industries—not to mention the health of our society. Drs. Shira Doron and Monica Gandhi last week described what they call a “frightening trend”: “the lack of confidence in the COVID-19 vaccine has made people mistrust other vaccines and public health recommendations more broadly.” This exposes communities to outbreaks of infectious diseases that could be held at bay if enough of the population is vaccinated.
We need more balanced and productive conversations across the political spectrum or everyone will suffer.
A Matter of Process
To be clear, even if RFK Jr.’s reported discussions surrounding the COVID-19 vaccine recommendations for children aren’t in themselves cause for concern, there are still many ways the secretary can influence the process that would sidestep the status quo. He could make a change before the ACIP votes in June. He could also go against a vote, should the committee reverse course and maintain the universal recommendation for COVID-19 immunization. Normally the CDC director would yay or nay an ACIP recommendation, but acting CDC Director Susan Monarez has not yet been confirmed by the Senate, so RFK Jr. could step in.
“There is definitely the potential for unilateral decision making here,” Seigerman said. And as he and his colleagues wrote in a note to investors last week, “Such a possibility is likely to increase uncertainty and fear on to what degree RFK Jr. will seek to influence vaccine policy and recommendations going forward.”
There is also the possibility that the secretary could pull authorization for COVID-19 vaccines in these populations altogether. “Forget about the CDC recommendation, I wonder if he pulls the EUA for the pediatric COVID vaccine,” Seigerman said. Again, this wouldn’t be inherently bad, he added. “As an objective analyzer of data, I can see how outside of an emergency situation that’s not enough data to support approval and full usage.” But industry will be on the watch for procedural clues as to RFK Jr.’s influence.
The CDC’s acceptance or rejection of the committee’s recommendations will be a “critical step for any controversial recommendations” and “important to monitor for RFK Jr.’s impact on policy,” Leerink analysts wrote to investors. If RFK steps outside the normal protocol, he’d be breaking a promise he made to Sen. Bill Cassidy (R-LA) in his confirmation hearings to “work within” existing vaccine approval and safety frameworks.
Pediatric COVID vaccine uptake is low, so the rumored change to the childhood immunization schedule is unlikely to significantly affect Moderna’s or Pfizer/BioNTech’s bottom lines beyond having to “write down some of their capacity and supply, which could be a drag on earnings,” Seigerman said. The bigger issue is how the change of recommendation is enacted and what it could mean for the future of the vaccine space.
“Vaccines, for what they’re worth, are not the most profitable. . . . They’re very capital intensive and you have to have scale,” Seigerman explained. “So I wouldn’t want to see the big players shy away, because we need flu shots, we need MMR, we need HPV vaccines.”
Open Conversations Desperately Needed
The risk that the FDA and other public health agencies are subject to political influence from RFK Jr. is real, and I am grateful to the many journalists working hard to uncover anything and everything they can about an HHS that lacks transparency and has cut entire communications teams. At the same time, we must continue to strive for accurate, balanced reporting to encourage an honest dialogue about politically charged topics such as vaccines.
ACIP member Jamie Loehr put it best when he said during the committee meeting, “I’m very happy that we’re seriously considering a risk-based recommendation [for COVID-19 vaccination]. I’m glad that we’re taking this as a reasonable possibility.”
Most upsetting to me is this: I believe there are a lot more people who would agree that removing the COVID vaccine from the pediatric schedule is, indeed, a reasonable possibility than there are people who would be the first in a room to say it. To this day, many fear being seen as anti-vaxxers if they express reservations about vaccinating their children against COVID—to their friends, family and even their doctors.
Medical associations have to this point strongly backed the CDC’s recommendation and doctors typically follow suit, passing these endorsements on to their patients. “And actually,” Seigerman said, “it should be a real conversation.”
I have absolutely no judgements for anyone who did or did not vaccinate their children against COVID-19. There are many factors that weigh into these decisions and everyone’s circumstances and value calculations are different. What enrages me is that one of the considerations is how your choice could affect how you are perceived by those around you.
Politics has always found a way to embed itself in our relationships, causing rifts and echo chambers of various scales. But the gap we are now facing as a society could take generations to repair, and at this moment, we still appear to be going in the wrong direction.
