Covid-19 vaccine license change: 12 key questions answered

And an important note about the ousted CDC leaders

A few hours ago, RFK Jr. ousted the CDC Director for refusing to rubber-stamp unscientific and reckless directives. In its wake, three senior CDC officials also resigned. The United States lost remarkable leaders today—people who devoted decades, across many administrations, to protecting the health of families and communities. They weren’t just experts; they were steady hands and trusted voices, showing up in moments of crisis with clarity, compassion, and an unwavering commitment to the public good.

When leaders like this are pushed out, it’s not just the agency that suffers; it’s all of us. A weaker CDC means more vulnerable communities. Public health only works when the people leading it are strong, principled, and supported in their duty to protect and serve individuals and communities. Right now, that foundation is eroding at a speed I never thought possible. The nation’s health security is at risk.

Thank you for your service, Demetre, Dan, Deb, and Susan. I’m beyond heartbroken by what is happening at CDC and the public health field as a whole.

Simply put: This is not okay.

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Now, for Covid-19 vaccine news…

At CVS the other day, a pregnant woman—glowing, excited for her first baby—stepped up to the counter and asked for the Covid-19 vaccine. She knew the shot could pass antibodies to her newborn, protecting during those fragile first months of life. The most basic human instinct: a mother protecting her child.

But the pharmacist shook his head. “We have no idea what’s happening. The guidelines keep changing. We can’t give you a vaccine.”

Tears welled up as she asked for the older Covid-19 vaccine formula. Again, no. She walked out without the protection she came for.

I wish I could have answered all of her questions (and the pharmacists!) right there in that moment. Instead, I’m hoping to equip you with the clarity she—and so many others—deserve. This scene is likely repeating across the country.

Here are the top 12 questions we got from you, answered with what I know today.

1. Who is eligible for the Covid-19 vaccine this fall?

This is a simple question with a complicated answer, as it depends on whom you want to turn to for guidance.

The federal government (FDA) changed the license (i.e., “label”) for the Covid-19 vaccine today. FDA’s job is to determine whether a vaccine is safe, effective, and properly manufactured. So each year, before fall vaccines go in arms, the FDA updates the fall vaccine labels after inspecting production and before they reach shelves.

Today, the FDA announced that the Covid-19 vaccine is ready for use, but it has limited the vaccine label to individuals ages 65 and over and those between 6 months and 64 years old with at least one condition that puts them at high risk for severe outcomes from Covid-19. This is different from previous years, when it was labeled for everyone over 6 months. It is highly unusual for the FDA to restrict its approval for a drug in this way.

Regardless, last week, professional organizations started releasing their own recommendations (which they’ve done for more than 90 years), and some do not align with FDA’s new label:

• Kids: The American Academy of Pediatrics (AAP) recommends that all children under 2 years old get vaccinated, as well as high-risk children or those living with someone who is high-risk. Notably, the guidance includes permissive language that children not in the risk groups “whose parent or guardian desires their protection from Covid-19” should be offered a vaccine.

• Pregnant women: The American College of Obstetricians and Gynecologists (ACOG) published guidance last week recommending that pregnant women receive the vaccine at any point during pregnancy, when planning to become pregnant, in the postpartum period, or while lactating.

• Adults: American College of Physicians (ACP) and the Infectious Diseases Society of America (IDSA) have yet to give input regarding their recommendations for adults and immunocompromised patients. However, IDSA did put out a strong reactive statement today: “narrow[ing] the Covid-19 vaccine label ignores science and puts millions of lives at risk”

To make things even more confusing, the federal government will weigh in again this September through ACIP—an external advisory committee to the CDC that sets vaccine policy—on who they believe should receive the Covid-19 vaccine. Typically, this guidance is issued in June (before the license change), so this delay is unusual and leaves insurance companies uncertain about who should be covered.

Bottom line: If someone is not within the FDA label (for example, a healthy 1-year-old) but still wants the Covid-19 vaccine this fall (for example, because AAP recommends it), they will need to get the Covid-19 vaccine “off-label.”

2. What qualifies as high risk?

“High risk” appears undefined by the FDA. This is normal and indicates that it defaults to this CDC review, which remains unchanged from earlier this year. CDC’s “high risk” list covers a significant portion of the U.S. adult population, including pregnant people and people with diabetes, a disability, overweight/obesity, cancer, or a mental health condition.

This list could (and likely will) be changed in September during the ACIP meeting by the committee that RFK Jr. replaced. We will update you if that happens.

3. Will we need documentation to prove we’re “at risk?”

Pharmacies will likely go with something called “self-attestation.” In other words, you need to check a box that says you have a high-risk condition. It’s unlikely that insurance will check this against your medical records, but it’s possible.

4. If I’m not high risk, can I get the vaccine off-label? Could I pay out of pocket if I want it?

It will likely be hard to get it “off-label,” but not impossible. There are three reasons for this:

1. Pharmacists can’t give vaccines off-label in most states. This is a problem because more than 90% of Covid-19 vaccines were given in pharmacies last year.

2. Physicians will need to administer the vaccine, though many may be uncomfortable doing so (although it is legal; see next question).

3. It’s unclear whether insurance will cover off-label vaccines. If they do not, you can pay out of pocket.

5. What about physician liability?

Despite what RFK Jr. has implied in the most heinous way, doctors are not suddenly at risk for doing their jobs if they follow AAP or ACOG guidance. Prescribing off-label happens every day in medicine. One in five medications is prescribed off-label. The FDA label change may impact the additional liability immunity provided by the PREP Act for use of Covid-19 vaccines. Regardless, providers are covered by the same professional liability and malpractice standards that apply to their other medical decisions. Physicians remain free to recommend what they believe is best for their patients.

6. When should I get the Covid-19 vaccine?

Technically, you can get it right now. However, please note that it may take a few days to a week for your pharmacy to receive the new vaccine shipment.

If you have recently had a Covid-19 infection, it’s best to wait at least 6 months.

If you’re at high risk and more than 6 months have passed since your last vaccine, I recommend getting the vaccine now. This will help protect you against severe disease, and we are in the middle of a Covid-19 wave.

7. What is happening with the pediatric vaccine?

Pfizer will not have a vaccine for children under 5. But Moderna will. As a result, the supply may be more limited, but technically, a vaccine is still available for this age group. Specifically:

• Pfizer’s COMIRNATY COVID-19 vaccine for those 5 years and older

• Moderna’s SPIKEVAX for those 6 months and older

• Novavax’s NUVAXOVID for those 12 years and older

8. Is the vaccine formula being updated this year?

Yes, to better match the variants currently circulating.

9. Is it okay not to get the Covid-19 vaccine anymore? Does having had a vax + some boosters provide any long-term protection? For how long?

The science hasn’t changed: The vaccine is still safe and effective. What has changed is the environment: most of us now have some level of immunity, which is why Covid-19 is no longer an emergency.

Immunity has two layers: short-term antibodies and long-term memory cells (T cells). Covid-19 antibodies fade within about 4 months, so without a recent vaccine (or infection), you’re more likely to get infected and more likely to spread it to others. Memory cells last longer and help prevent severe illness—this doesn’t seem to fade for healthy or young individuals, but not everyone’s immune system holds onto that protection equally well. That’s why high-risk groups are prioritized for ongoing vaccinations, like pregnant women, children under 2, adults over 65, and those with chronic conditions.

10. Does this situation apply to all brands of vaccines?

Yes. mRNA vaccines (Pfizer, Moderna) and the protein vaccine (Novavax) are all part of the same regulatory and policy tangle.

11. What will you be doing?

For my family, I will look to medical societies whose recommendations are evidence-based, trustworthy, and consistent.

12. What should I do right now?

Consider getting vaccinated for Covid-19 this fall. People who meet the new label indications should seek vaccines in ways similar to past years—through a pharmacist, physician, nurse, or other health care provider.

For those who aren’t within the label:

• Parents: Ask your child’s pediatric practice about their plans to follow AAP recommendations, particularly given the irregular process for ACIP for 2025-26.

• Adults: Call your physician’s office and pharmacy and ask who will be able to get the Covid-19 vaccine at their practices.

• Everyone: Call your insurance company to inquire what they will be covering for the fall, and for whom.

If you have trouble finding a vaccine and want to share your story, fill out this YLE form. We can’t help you find a store, but we would like to hear your story and share it with others, if you’re comfortable with it.

Bottom line

Today, the FDA changed the Covid-19 label, but the good news is that the high-risk list is still broad for now, and an off-label vaccination is possible. Many professional organizations are stepping in to recommend what the scientific evidence supports.

Love, YLE

*The original copy said 16, which was a mistake. The correct age is 6 months.

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Your Local Epidemiologist (YLE) is founded and operated by Dr. Katelyn Jetelina, MPH PhD—an epidemiologist, wife, and mom of two little girls. YLE is a public health newsletter that reaches over 380,000 people in more than 132 countries, with one goal: to translate the ever-evolving public health science so that people are well-equipped to make evidence-based decisions. This newsletter is free to everyone, thanks to the generous support of fellow YLE community members. To support the effort, subscribe or upgrade below: