CDC Vaccine Guidance Freezes After New Flu Shot Approval

TL;DR: The FDA approved the mRNA flu shot mFlusiva, but the CDC issued no guidance on its use because the federal vaccine-recommendation system stopped functioning.

Federal guidance stops after new flu shot approval

The Food and Drug Administration recently approved a new flu vaccine that tested well in older adults, but the federal agency responsible for telling doctors and the general public how to use it has made no recommendation on it, according to the Associated Press.

The Centers for Disease Control and Prevention's inaction on the mFlusiva vaccine marks a break in longstanding practice, according to the Associated Press.

The episode illustrates how the agency's vaccine review-and-recommendation process has been disrupted in the past year, grinding decision-making to a halt, according to the Associated Press.

Efforts by vaccine-wary officials in President Donald Trump's administration to scale back shot recommendations have been put on hold, according to the Associated Press.

Federal guidance on new vaccines has stopped, according to the Associated Press.

Public discussion of vaccine policy questions that might cross political divides has diminished, including whether there is solid evidence to justify giving fewer shots to kids, according to the Associated Press.

Health Secretary Robert F. Kennedy Jr.'s effort to upend vaccine policy and the legal action opposing it have disrupted longstanding systems that deliver health guidance to Americans, according to the Associated Press.

That disruption affects whether people are getting the best available protection against vaccine-preventable diseases, according to the Associated Press.

How the 60-year advisory system worked

For 60 years, the Advisory Committee on Immunization Practices guided the CDC's vaccine recommendations, according to the Associated Press.

The committee met publicly, reviewed vaccine data and sought input from various health groups, according to the Associated Press.

The panel voted on recommendations that went to the CDC director, who almost always adopted them as the government's guidance, according to the Associated Press.

Those CDC decisions led public and private insurers to pay for the shots, according to the Associated Press.

Trump, a Republican, appointed Kennedy to oversee federal health agencies, including the CDC, according to the Associated Press.

Kennedy last year dismissed the committee and replaced it with a group that included several anti-vaccine voices, according to the Associated Press.

Controversial decisions followed, leading to a lawsuit from the American Academy of Pediatrics and some other medical groups, according to the Associated Press.

In March, a federal judge said Kennedy likely violated federal procedures, stopped Kennedy's panel from holding further meetings and suspended Kennedy's decision to reduce the number of vaccines recommended for children, according to the Associated Press.

Many in the medical and public health communities celebrated the decision and took the order as a respite from what they saw as the Trump administration's assault on vaccines, according to the Associated Press.

Court order halted replacement panel

The March ruling blocked further meetings of the replacement panel installed by Kennedy, according to the Associated Press.

The same order suspended Kennedy's decision to reduce the number of vaccines recommended for children, according to the Associated Press.

Dr. Jason Goldman, president of the American College of Physicians, said he hoped "it will mean a return to a transparent and evidence-driven process that safeguards the health of all communities and the best interests of our patients," according to the Associated Press.

Jason Schwartz, a Yale University health policy researcher who studies government health agencies, said, "We find ourselves at a point where even if credible evidence (for a new vaccine policy) has reached a tipping point, we don't have an obvious mechanism that can formalize that change," according to the Associated Press.

Schwartz also said, "The credibility of the Trump administration, when it comes to vaccine recommendations, is so compromised in the eyes of the mainstream medical and public health communities, that even recommendations that might align with where the public health community was trending are likely to be viewed with scepticism or distrust," according to India Today.

The court order did not restore the old system, according to India Today.

Instead, the process stalled and splintered after Kennedy's committee was shut down by the court order, according to the Associated Press.

Medical groups built a separate review track

With Kennedy's committee shut down by the court order, doctors' groups that used to collaborate with the ACIP have gone their own way, according to the Associated Press.

Working with a University of Minnesota researcher, they have debated — not publicly — the kind of medical evidence formerly presented at ACIP meetings and issued their own recommendations, according to the Associated Press.

The trade association for private health insurers decided to heed the medical societies' choices, according to the Associated Press.

Insurers have continued to pay for shots recommended by those organizations, according to the Associated Press.

Many of the groups' recommendations match prior ones made by ACIP and the CDC before Kennedy's arrival, according to the Associated Press.

But they also made their own updates, according to the Associated Press.

Private health insurers decided to follow those recommendations and continued to pay for shots backed by those organisations, according to India Today.

Some of those recommendations have updated earlier federal advice, according to India Today.

RSV timing shows the split in guidance

ACIP previously recommended that a new shot be given to women late in pregnancy: a vaccine against respiratory syncytial virus, or RSV, which can be dangerous to newborns, according to the Associated Press.

The government panel recommended that the vaccine be given between September and January in most of the U.S., to coincide with the time of year when RSV infections are most common, according to the Associated Press.

But RSV season sometimes remains active longer, according to the Associated Press.

For that reason, the medical groups recently said the shot should be offered to those women through the beginning of March, according to the Associated Press.

ACIP had recommended that a vaccine against respiratory syncytial virus, or RSV, be given to women late in pregnancy between September and January in most of the U.S., when RSV infections are usually most common, according to India Today.

But as RSV season can stay active for longer, medical groups recently said the shot should be offered through the beginning of March, according to India Today.

Chris Regal, director of clinical innovation at America's Health Insurance Plans, the health insurance trade association, said in a recent webinar, "We all recognized this needs to evolve," according to the Associated Press.

The official CDC guidance remains unchanged, according to the Associated Press.

The official CDC guidance, however, has not changed, according to India Today.

mFlusiva exposes the flu-policy gap

The mFlusiva flu shot is another example of the unusual way vaccine policy updates have stalled, according to the Associated Press.

The shot is the first flu vaccine made with the mRNA technology that was key to ending the COVID-19 pandemic, according to the Associated Press.

Kennedy has criticized mRNA vaccines and last year canceled contracts for the development of new ones, according to the Associated Press.

The shots also took a tortuous path through the FDA, which finally granted full approval in people ages 50 to 64, according to the Associated Press.

The vaccine was eventually fully approved by the FDA for people aged 50 to 64, according to India Today.

But the CDC this month quietly posted that it has decided to maintain its flu vaccine endorsements from last year due to "legal uncertainties and inquiries," according to the Associated Press.

That means mFlusiva is not among the listed flu vaccines recommended to the public this fall, according to the Associated Press.

The CDC said this month that it was keeping last year's flu vaccine endorsements because of "legal uncertainties and inquiries", leaving mFlusiva off the list of flu shots recommended to the public this autumn, according to India Today.

The medical societies are recommending it as an option, however, according to the Associated Press.

Medical societies, however, are recommending it as an option, according to India Today.

MFlusiva is the first flu vaccine made with mRNA technology, which was central to the response to the COVID-19 pandemic, according to India Today.

Childhood programs face delays and unanswered questions

Another ACIP function was to vote on whether certain vaccines should be covered by Vaccines for Children, a government program that pays for shots for children who have no health insurance, according to the Associated Press.

Although updated COVID-19 vaccines were approved by the FDA, the government took until this week to confirm that orders for those shots could be placed through Vaccines for Children, a programme that covers children without health insurance, according to India Today.

Questions are also piling up over the HPV vaccine, which is given to preteens to help prevent certain cancers, according to India Today.

Two doses are currently recommended, but some recent research has suggested one shot may be enough, at least for girls, according to India Today.

ACIP had formed a working group in 2024 to review that evidence, but the effort stopped when Kennedy dismissed the committee, according to India Today.

In January, he moved on his own to reduce the recommended number of doses to one as part of a broader cut to the childhood vaccination schedule, but that decision was suspended by the judge, according to India Today.

Experts are still studying the timing and duration of protection from a single dose, especially in boys, and the American Academy of Pediatrics is considering whether to change its advice later this year, according to India Today.

At the same time, the administration is considering changes to the federal categories for vaccine recommendations, though no detailed proposal has been released, according to India Today.

An alliance of 15 Democratic state governors said the move could add to confusion, according to India Today.

Full source accounts are available from the Associated Press and India Today.