It's time to talk COVID vaccines.

What in the Health!? June 2, 2025

OK, let’s talk COVID vaccines.

Are you confused about whether you will be able to get a COVID vaccine this fall, if you want one?

If so, you’re not alone.

It’s confusing because this government and the communication from various leaders is a MESS. Let’s look at the timeline:

May 20: FDA Commissioner Marty Makary and the new head of FDA’s Center for Biologics Evaluation and Research Vinay Prasad—two recent political appointees—wrote a perspective piece in the New England Journal of Medicine and held a live FDA event. (For those who are keeping track, Vinay Prasad has been an outspoken critic of the FDA and is the replacement for Peter Marks, who resigned in March after 13 years, citing his inability to remain in the role since RFK Jr. didn’t value science or transparency. Prasad is also an oncologist, with no advanced training in infectious diseases or vaccinology.) The bottom line of these statements was that moving forward, COVID-19 vaccines would only be approved by FDA for people over age 65, or people who have at least one chronic condition. They said that if manufacturers wanted their vaccines to be more widely available (e.g. to healthy younger adults) they must run a new placebo-controlled trial after a variant arrives.

This may seem reasonable to you, but the reality is that it’s impractical and would effectively mean these vaccines will no longer be available for healthy younger people. COVID-19 mutates a lot, and these trials are laborious and expensive. That’s why early on, the CDC’s Advisory Committee on Immunization Practices (ACIP) started using reviews of real-world data on protection, safety, and impact to make decisions each year about who should receive the vaccines. More importantly, it is well accepted that clinical trials are only ethical if “equipoise” exists—a fancy word that essentially means you can’t offer people placebos if you know the treatment you’re testing is better for their health. We know that vaccines offer protection. No research ethics board would (or should) approve these types of placebo-controlled trials they’re saying the FDA will now require, regardless of the opinions of Makary and Prasad in their article.

Importantly, ACIP is already scheduled to meet June 25-27 to have this discussion, so Makary and Prasad releasing this decision preempts this scientific review. Stand by for hypocrisy: On Jan 1, 2022, Makary posted on X that FDA bypassing their advisory committee to authorize boosters for kids was “unconscionable.” But that’s exactly what Makary and Prasad did. No vote by FDA’s external advisory committee (VRBPAC—which was scheduled to meet only 2 days later), no ACIP meeting.

May 27: RFK Jr. announced in a 1-minute video on X that HHS had decided to remove the COVID vaccine from the CDC’s recommended immunization schedule for healthy children and healthy pregnant women. No data was provided to justify this recommendation. This surprised a lot of people, since pregnant women face elevated risks from COVID-19, and vaccination provides protection for both mother and baby. It was also ironic that in the NEJM piece Makary and Prasad had specifically listed people who are pregnant or recently pregnant as a group that should continue to receive COVID vaccinations because of their increased risk of severe COVID.

May 28: Both the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists issued statements in response, highlighting the uncertainty surrounding these new recommendations to not vaccinate these groups.

May 29: The CDC released a new adult immunization schedule for the US that—despite what Makary, Prasad, and RFK Jr. said in the days prior—in fact says that healthy adults can get the vaccine if they want it. (It does, however, leave the recommendation for pregnant people shaded gray, indicating “no guidance.”) They also released a new pediatric immunization schedule; for kids age 6 months to 17 years, it specifically says “Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.”

Your Local Epidemiologist summed it up clearly, stating that as of now:

• 65+ are eligible.

• Under 65 with certain health conditions are eligible. (Although this is very unclear right now, and largely depends on how FDA changes the licenses.) BUT (and this is important): Recommendations are self-attestation at pharmacies. This means pharmacists are not permitted to ask for proof of underlying conditions.

• Everyone else, including kids and pregnant women, may get the vaccine if they and their clinician agree it’s appropriate (called shared clinical decision-making). This was a really important change that the CDC overrode RFK Jr. on. While there is a legitimate debate around annual boosters, there is clear evidence on the importance of a primary vaccine series for kids and for immunity passed to babies from pregnant mothers. [Note: Insurance may not cover your vaccine under this category. Unfortunately, some payers have a long history of not covering shared clinical decision-making, so I would expect variability in coverage.]

OK, so that’s where we stand right now. At least for today.

Let’s talk about kids for a minute.

On April 6, Vinay Prasad referred to COVID-19 as “now a common cold respiratory virus” on his YouTube channel. For some, that’s how it seems. But for many—including some kids—it’s just not.

Dr. Paul Offit (Director of the Vaccine Education Center at Children’s Hospital of Philadelphia) wrote about this on his Substack:

On April 15, 2025, one month before RFK Jr.’s announcement, Fiona Havers from the CDC presented data to the Advisory Committee on Immunization Practices (ACIP), an independent group of experts that advises the CDC on vaccines. The committee learned that during the past year:

• About 165,000 people were hospitalized with Covid and 40,000 died.

• About 4.3 percent of Covid hospitalizations occurred in children.

• About 150 children died from Covid, most were less than 4 years old.

• About 50 percent of children less than 4 years old who were hospitalized or died from Covid were otherwise healthy.

• About 1 in 5 children hospitalized with Covid were admitted to the intensive care unit.

• More than 90 percent of children who were hospitalized or died from Covid weren’t vaccinated.

• More young children died from Covid than died from influenza.

• A disproportionate number of children who died from Covid were less than 6 months old. The only way these children could have been protected from Covid would have been if their mothers had been vaccinated during pregnancy, which would have allowed those babies to acquire protective antibodies through the placenta.

Some final thoughts.

A few weeks ago, I had COVID for the first time. It was miserable! Way worse than any “common cold.” But thankfully, I’ve made a full recovery. My original fears of the possibility of Long COVID or other severe complications were dramatically decreased compared to the early days of the pandemic, in large part because I’ve been vaccinated, and repeatedly boosted each fall.

To be clear, I don’t think we should have vaccine mandates anymore. In the beginning it made sense, because we didn’t know how the vaccines would work in the real world. Would they offer sterilizing immunity (like the polio or measles vaccine does), which means if you’re vaccinated you are protected against infection, and therefore won’t transmit it to anyone else, either? Or would they simply offer functional immunity, protecting you from severe disease or death? It quickly become clear that the COVID vaccines offered outstanding functional immunity, but were not sterilizing. This made it more of a personal decision, not one that had great bearing on the greater community. OK, so let’s recommend and advise, but not require. I’m good with that. And except in a few rare cases, that’s where we are now.

So fine, do what you want. But why prevent me from protecting myself, if I so choose? Without a CDC recommendation that says I should get the vaccine, even if I can talk with my doctor and use shared decision-making to get one, there’s no guarantee that my insurance will pay for it. Will it be worth it to me to get a booster this fall, even if I have to pay out of pocket? Probably. But for a lot of people that will simply be financially out of reach.

For now, the CDC vaccine schedule says I can talk with my doctor and we can decide together. I’m hoping that after the ACIP meeting at the end of this month we get some clarity on whether that will be the actual recommendation this fall. I trust these experts to evaluate the science and make a decision about what’s actually best for me and my loved ones. I also trust them not to try to issue sweeping changes to policy recommendations with a unilateral tweet. Wouldn’t that be nice?