Two long-planned vaccine meetings — one at the US Centers for Disease Control and another at the US Food and Drug Administration — have now been disrupted under the watch of US Health and Human Services Secretary Robert F. Kennedy Jr., stirring questions about whether seasonal flu shots or other lifesaving vaccines will be delayed or harder to access.
The February meeting of the CDC’s Advisory Committee on Immunization Practices, or ACIP, was postponed “to accommodate public comment,” according to a note online. The three-day meeting, which had been scheduled for this week, was to review the safety and effectiveness of vaccines for meningococcal disease, which is seeing a resurgence, as well as RSV, flu, chikungunya and mpox. It also included two votes related to Vaccines for Children, the government program that buys and distributes vaccines to state and local health departments for children whose families wouldn’t otherwise be able to pay for them.
ACIP typically meets three times a year, in February, June and October. There’s no word on whether or when the February meeting will be rescheduled and it’s unclear whether the delay will hinder access to shots.
On Wednesday, the FDA canceled a March 13 meeting of its Vaccines and Related Biological Products Advisory Committee, which was to discuss the recipe manufacturers must follow to make this fall’s flu shots. No explanation was given for the cancellation.
“The FDA will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season,” the statement said.
The uncertainty around the government’s process for regulating and recommending vaccines comes as the US is in the grips of a brutal flu season and experiencing a resurgence of measles, a vaccine preventable disease. Experts say these infections are increasing because of growing hesitancy to use vaccines, something they fear the new HHS director will only encourage.
Kennedy casts doubt on vaccine advisers
Kennedy maintains that he is not anti-vaccine, but he has repeatedly cast doubt on the safety and effectiveness of immunizations and questioned the research and regulations that allow them to be used.
Kennedy, whose financial disclosures show he has made money from law firms that sue vaccine manufacturers, has also impugned some of the experts who advise federal agencies on vaccines. During his confirmation hearings, Kennedy incorrectly stated that 97% of the members of the CDC’s vaccine advisory committee had conflicts of interest. In fact, the panel has strict policies to guard against conflicts, and a screening process for members to ensure they are impartial when they vote.
Members of FDA’s vaccine committee are also subject to strict conflict of interest rules and are required to disclose potential conflicts during meetings.
This week, former CDC Director Dr. Tom Frieden wrote that false claims that ACIP members vote based on their financial ties is among the “most damaging” falsehoods about vaccines.
Frieden said the 97% figure comes from a 2009 report, issued when he was CDC director. He is now president and CEO of the nonprofit Resolve to Save Lives.
It was an audit of lengthy and detailed conflict of interest forms submitted by all experts who served as CDC advisers in 2007. He said 97% had at least one missing response, which could have meant someone forgot to do something as simple as initial a page. He said it is not the same thing as a conflict of interest.
Frieden also raised alarm about the postponed ACIP meeting, writing in a recent post on LinkedIn, “It’s certain there will be misleading, inaccurate information claiming ACIP members have conflicts of interest. Here’s the plain truth: ACIP, made up of pediatricians, public health specialists, and parents, is the gold standard for open, transparent recommendations on vaccine safety and effectiveness.”
Without either vaccine committee weighing in on vaccine regulation or recommendations, health-care providers worry there will be delays on vaccines or limits on people’s ability to access them.
“Cancelling this meeting means vaccine makers may not have the vital information and time they need to produce and distribute targeted vaccines before the next flu season,” Dr. Tina Tan, president of the Infectious Diseases Society of America, said after the cancellation of the FDA flu shot meeting. “If the FDA meeting is not immediately rescheduled, many lives that could be saved by vaccination will be lost.”
In a February 20 open letter to Kennedy, Acting CDC Director Dr. Susan Monarez and Sen. Bill Cassidy, a doctor and chairman of the Senate Health, Education, Labor, and Pensions Committee, a coalition of groups called the Partnership to Fight Infectious Disease pushed for the “prompt rescheduling” of the ACIP meeting.
“Each ACIP meeting holds tremendous weight and relevance. Infectious diseases are constantly evolving opponents; vaccines are among the best tools for constantly adapting and responding to the latest public health threats,” the letter said.
“Making America healthy requires healthy discussion and timely, evidence-based decisions. This meeting should be no different.”
Flu shot decision in limbo
There are several different ways to make flu vaccines, but the most common is to grow the selected candidate viruses in chicken eggs — a painstaking operation that takes months to finish.
For that reason, selection of the strains that will be included in flu vaccines is carefully orchestrated to be sure that manufacturers can deliver their shots to doctor’s offices and pharmacies in time.
In order for flu vaccines to be sold in the US, they must contain strains that are officially selected by the FDA.
That decision typically comes after a meeting of the World Health Organization’s Global Influenza Surveillance and Response System, a network of seven collaborating centers and four essential regulatory labs, which are based in the US, UK, Japan, China, Russia and Australia. Both the CDC and FDA are members, and representatives from both agencies participated in the deliberations which got underway this week, WHO said.
“The US did participate in this meeting,” Dr. Maria Van Kerkhove, WHO’s technical lead for Covid-19, said at a news briefing on Friday.
“I want to be very clear that the US is still contributing. I know that there’s a lot of attention on the US right now, but we are going to continue to emphasize the importance of this global system that’s in place.”
These experts meet twice a year — in the fall and spring — to choose strains for countries in the Southern and Northern Hemispheres.
On Friday, WHO announced the strains that it thinks will most closely match the viruses that will be making people sick next fall. Those picks would swap out the H3N2 component of this years vaccine, which was only a partial match to the circulating viruses, for a new one.
“I think the match is not perfect, but it is a reasonable match, and is still the best preventative we have against infection with influenza,” said Prof. Ian Barr, deputy director at the Victorian Infectious Diseases Reference Laboratory, and a member of GISRS, in a new briefing after the strain selection
What typically happens next is that the 17-member FDA vaccine committee would meet and publicly discuss the recommendation, and then make its own endorsement. The agency ultimately makes the final decision, which can differ from its advisers’, although they generally align.
This year, there won’t be an advisory meeting. The FDA said it would still make recommendations to manufacturers but didn’t specify how it would come to a decision or when.
“If there’s no FDA recommended strains, the US manufacturers are kind of stuck,” said Dr. LJ Tan who is chief policy and partnerships officer for nonprofit vaccine advocacy group Immunize.org.
GSK also said it will continue to work with FDA on its flu strain recommendation in the US.
But canceling the VRBPAC meeting will deprive Americans of public discussion and debate that happens when these experts meet. It makes the process less transparent, Immunize.org’s Tan said.
“It’s very dangerous to bypass your expert advisory committee,” Tan said.
When experts are out of the conversation
In his Senate confirmation hearings, Kennedy promised “radical transparency” at HHS.
“Public health agencies should be transparent and if we want Americans to restore trust in the public health agencies, we need transparency,” Kennedy said.
Vaccine advocates say canceling advisory committee meetings undermines that goal.
“You heard what we thought. We disagreed on some things, and for people who are interested, you can see how we arrived at the conclusion that we did,” said Dr. Stanley Perlman, a member of FDA’s VRBPAC who is also a pediatrician and immunologist at the University of Iowa.
Perlman said he was also worried that skipping committee meetings would deprive the public of a window into the government’s vaccine decisions.
Other experts agreed the committees are an important layer of independent review.
“It’s kind of taking experts out of the conversation,” said Dr. William Moss, a pediatrician who directs of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. “Many of these decisions are tricky and nuanced, and having the opportunity for a group of experts who are familiar with these vaccines and familiar with these diseases. You know, have an open discussion is critically important.”
The FDA has not said how it will choose vaccine strains for the fall, but if it follows WHO’s recommendation, it will mean that the US will be relying on data from the organization despite President Donald Trump’s order that the US withdraw its support from WHO and stop sharing information.
“It’s part of the chaos, whether it’s planned or not, or just incompetence,” Moss said.