Post #50834 by wzambon on the US Policy board

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No. of Recommendations: 11

This comes from “Your Local Epidemiologist”, on Substack, written by Katelyn Jetelina

It’s August, which means school is starting and fall is just around the corner. Normally, I’d be putting together a one-pager with everything you need to know about this year’s flu, Covid-19, and RSV vaccines: what’s available, who should get them, and when.

But this year is different: we don’t know these answers yet, which is highly unusual and could cause massive disruptions to your access in a few weeks.

Still, more than 60% of you said you wanted a deep dive into this topic. So here’s my best attempt to offer clarity amid the chaos: where things stand, what’s broken, and what you can do now, even as the system recalibrates or reinvents itself.

Buckle up.

What usually happens?

Think of our annual respiratory vaccine rollout as a giant domino setup. When the first domino falls—usually in February—the rest follow in a smooth, synchronized sequence, ending with shots in arms by early fall.

The fall respiratory vaccine process. Figure by Your Local Epidemiologist.
This system is designed for consistency and predictability, as there are many players who rely on the previous step to continue forward:

February: Fall vaccine formulas are selected by FDA advisors.
Spring: Expert advisory groups recommend which versions to use based on strain.
Summer: Manufacturers scale up production; CDC defines eligibility.
August: FDA finalizes labeling; insurers confirm coverage.
Fall: Providers stock shelves. Patients show up. Shots go in arms (or butts, for babies).
This carefully timed cascade has been fine-tuned for more than half a century. Most years, it runs so smoothly that you never even hear about it.

What’s different in 2025?

Dominoes are missing, wobbling, and/or stalled. And now, the rest of the chain is backed up, driving confusion and potentially leading to changes in access. There are three main reasons for this:

1. Federal leadership is ideologically opposed to the system itself.

For the first time in modern history, the federal leadership overseeing vaccines doesn’t fully support their broad public health value.

HHS Secretary Robert F. Kennedy Jr.—a longtime vaccine critic—is now in charge of coordinating this entire system, and this has brought immense change:

Experts are being sidelined. The CDC has just removed key professional organizations, such as the American Academy of Pediatrics, from advisory roles. In June, the 17 expert members of ACIP were dismissed and replaced.
Federal agencies are no longer aligned. The CDC, FDA, and HHS are issuing conflicting signals on who will be eligible for COVID-19 vaccines, undermining confidence and paralyzing planning.
Major decisions are being made in non-transparent ways. In May, RFK Jr. announced a new COVID-19 vaccine policy by video that reversed longstanding recommendations for healthy children and pregnant people without a clear scientific rationale.
2. Flu and RSV vaccines have yet to be signed off on.

Flu and RSV vaccines have been relatively smooth this year, as they were reviewed and recommended by ACIP (CDC’s external advisory committee) in June. But the final sign-off for these typically straightforward vaccines still hasn’t happened. RFK Jr. did revoke authorization for flu shots with thimerosal (based on disproven claims) but has yet to sign off on other flu formulations or the new RSV monoclonal antibody for infants. That delay is highly unusual and potentially troubling, as it could signal plans to restrict access. It could be due to the CDC leadership vacuum (CDC just got a CDC Director last week), but it’s unclear why RFK Jr. would sign off on one thing but not the others.

3. Covid-19 has the biggest policy vacuum.

This is where the dominoes have completely stopped:

There is no national recommendation on who should get the updated Covid-19 vaccine this fall. This typically happens in June, but ACIP—the committee of external advisors that RFK Jr. replaced—chose not to vote on it. This is a big deal because the ACIP recommendation is linked not only to insurance coverage requirements but also to the number of doses health systems order in July (to be at clinics by the end of August). It is also linked to standing orders for pharmacists and other state-based authorities to administer the Covid-19 vaccine this fall.
FDA is expected to narrow eligibility to “high-risk” groups only. That’s a shift from previous years, which encouraged widespread uptake to reduce community spread and increase ease of use.
The revised label likely won’t be finalized until mid-to-late August, leaving insurers, providers, and the public in the dark.
This is a problem because insurers don’t know who to cover. Doctors are unsure who to prioritize. Pharmacies are uncertain about the number of doses to order and whether their staff can administer them. Vaccine campaigns are stalled.

What’s next?

A lot will unfold in the next few weeks:

An outside group of experts (called the Vaccine Integrity Project) is meeting in August to review evidence of fall vaccines.
In August, several professional medical societies will issue their own fall vaccine recommendations, regardless of what the federal government says. The American Academy of Pediatrics has already issued its flu recommendations, and the Society for Maternal Fetal Medicine has issued its fall vaccination recommendations for pregnancy.
We will likely see an FDA label change for Covid-19 vaccines by end of August.
Insurers will need to inform members about coverage for vaccines.
Some states and insurers may fill the gaps to help maintain broader access.
The outcome of this effort will be consequential because it’s ultimately a test run for what’s to come next. RFK Jr. has signaled interest in reevaluating other routine vaccines like HPV, Hepatitis B, and measles.

The fall vaccine process changes in 2025 (indicated by red). Figure by Your Local Epidemiologist.
Naturally, this leads to more questions.

Will I be able to get a Covid-19 shot this fall, and if so, when?
Probably, but it may be hard. The FDA will likely change the Covid-19 vaccine label to restrict use to individuals 65+ years and who are at high risk. We don’t know what constitutes “high risk,” yet. If this happens, only people in that category would be officially eligible, and others would need to get the vaccine “off label.”

Can I get it off-label?
Technically, yes, but it’s complicated. Off-label prescribing is legal and common for many drugs, but vaccines are different because:

Pharmacies often won’t—or can’t—administer vaccines off-label, based on corporate policies and state laws governing scope of practice. More than 90% of fall vaccines come from pharmacies.
Insurers may not cover off-label use as this type of coverage currently varies widely by insurer, even when deemed medically appropriate by a physician.
Although physicians should be able to prescribe and administer off-label, many won’t because of perceived liability challenges and confusion.
Many electronic systems (like immunization registries) may block documentation or reimbursement.
So while a provider could prescribe it off-label, in practice, it’s likely that most people won’t be able to access it that way.

Will insurance cover it if I’m not “high-risk”?
Unclear, which is a significant concern. If the FDA updates the label to include only those with “high risk” conditions, insurers may only choose to cover the vaccine for those defined as high-risk. If you fall outside that group, you could face barriers to access—or end up paying out-of-pocket.

In June, AHIP and ACHP reaffirmed their commitment to access to affordable vaccines. Members of Congress have sent letters to major insurers urging continued access and coverage without cost-sharing, and 80 medical societies have called for the same. Still, much remains uncertain until we see confirmatory public statements and/or finalized policies from the payers.

Will pharmacies and doctors even have enough supply?
Manufacturers have been preparing for a fall rollout, and the vaccine supply itself is not expected to be a bottleneck. But pharmacies and providers are hesitant to place orders or schedule appointments without knowing who is eligible, what insurers will cover, or whether regulations will change at the last minute.

What should you do?

You can’t tip all the dominoes yourself, but you can help advocate to reset the missing and shaky pieces.

Most importantly, you can be a vaccine champion for yourself, your colleagues, your family, and your friends:

Ask your health care providers and your pharmacy about their plans to stock and administer vaccines for all three viruses.
Ask your insurance company about their coverage for these vaccines. If you’re insured through your employer, talk to them about what your plan will cover this season.
When the time is right, get your fall vaccines and encourage people in your networks to do the same.
Tell us what you need: what kind of information, talking points, or data points would help with these conversations?
If you’re a provider or public health professional:

Start outreach to high-risk groups, like older adults for Covid-19 and infants for RSV.
Secure inventory for fall vaccinations.
Coordinate with local pharmacies if you don’t stock them yourself. Have a plan in place to direct people to where they can get a vaccine.
Co-administer vaccines where possible to save time and increase uptake.
Work with state medical societies and hospital associations to ensure there is clarity around professional liability, standing order impact, and “off-label” use.
Bottom line

What vaccines will be available this fall, who will be eligible, and where can you get them? We still don’t have clear answers. The usual chain of decisions—from recommendations to insurance coverage to provider readiness—has been disrupted.

But with clarity, coordination, and trusted messengers, the system can still protect millions if there’s a united front. It won’t be business as usual, but we can rebuild the line—one domino at a time.

Love, YLE

https://open.substack.com/pub/yourlocalepidemiolog...

Like so many things in our country that will have to be rebuilt- “one domino at a time”.

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