fda

fda-reverses-surprise-rejection-of-moderna’s-mrna-flu-vaccine

FDA reverses surprise rejection of Moderna’s mRNA flu vaccine

Anti-vaccine agenda

Agency insiders told reporters that a team of career scientists was ready to review the vaccine and held an hourlong meeting with Prasad to present the reasons for moving forward with the review. David Kaslow, a top career official responsible for reviewing vaccines, also wrote a memo detailing why the review should proceed. Prasad rejected the vaccine application anyway.

According to today’s announcement, the FDA reversed that rejection when Moderna proposed splitting the application, seeking full approval for the vaccine’s use in people aged 50 to 64 and an accelerated approval for use in people 65 and up. That latter regulatory pathway means Moderna will have to conduct an additional trial in that age group to confirm its effectiveness after it’s on the market.

Andrew Nixon, spokesperson for the US Department of Health and Human Services, confirmed the reversal to Ars Technica. “Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted,” Nixon said in a statement. “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”

The FDA typically takes a levelheaded approach to working with companies, rarely making surprising decisions or rejecting applications outright. While Prasad claimed the rejection was due to the control vaccine, the move aligns with Health Secretary Robert F. Kennedy Jr.’s broader anti-vaccine agenda.

Kennedy and the allies he has installed in federal positions are particularly hostile to mRNA technology. Moderna has already lost more than $700 million in federal contracts to develop pandemic vaccines. Next month, Kennedy’s MAHA Institute is hosting an anti-vaccine event that alleges there’s a “massive epidemic of vaccine injury.” The event description claims without evidence that use of mRNA vaccines is linked to “rising rates of acute and chronic illness.”

Vaccine makers and industry investors, meanwhile, are reporting that Kennedy’s relentless anti-vaccine efforts are chilling the entire industry, with companies abandoning research and cutting jobs. In comments to The New York Times, Moderna’s president, Stephen Hoge, said, “There will be less invention, investment, and innovation in vaccines generally, across all the companies.”

FDA reverses surprise rejection of Moderna’s mRNA flu vaccine Read More »

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Trump official overruled FDA scientists to reject Moderna’s flu shot

Still, while Moderna largely stuck with its plan to use a standard dose for all participants, it altered its plans based on the feedback. Specifically, it added a comparison of a high-dose vaccine to some older participants and provided the FDA with an additional analysis.

This wasn’t enough for Prasad, who, according to the Journal’s sources, told FDA staff that he wants to send more such refusal letters that appear to blindside drug developers. The review staff apparently pushed back, noting that such moves break with the agency’s practices and could open it up to being sued. Prasad reportedly dismissed concern over possible litigation. Trump’s FDA Commissioner Marty Makary seemed similarly unconcerned, suggesting on Fox News that Moderna’s trial may be “unethical.”

A senior FDA official suggested to Stat, meanwhile, that the door might not be entirely closed for Moderna’s flu vaccine. The official said that the company could toss the data for the 65 and up participants and, perhaps, grovel.

“It is entirely feasible that if they come back, maybe even show some humility and say, ‘Yes, we didn’t follow your recommendation. Just take a look at the 50 to 65 group, where there’s a little more equipoise,’” the official told Stat. “Then the review team could say, ‘We’ll consider that cohort.’”

The Journal notes that Moderna is at least the ninth company to have received a surprise rejection from Prasad and his team. The unpredictability is raising fears about the industry’s ability to obtain investments and innovate.

Prasad, a blood cancer specialist who has no expertise or experience in vaccine regulation, is also facing internal problems at the agency. His management style has created an environment “rife with mistrust and paranoia,” according to Stat. The Journal reports that several complaints have been filed against him, including some involving sexual harassment, retaliation against subordinates, and verbally berating staff.

Trump official overruled FDA scientists to reject Moderna’s flu shot Read More »

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Newborn dies after mother drinks raw milk during pregnancy

A newborn baby has died in New Mexico from a Listeria infection that state health officials say was likely contracted from raw (unpasteurized) milk that the baby’s mother drank during pregnancy.

In a news release Tuesday, officials warned people not to consume any raw dairy, highlighting that it can be teeming with a variety of pathogens. Those germs are especially dangerous to pregnant women, as well as young children, the elderly, and people with weakened immune systems.

“Raw milk can contain numerous disease-causing germs, including Listeria, which is bacteria that can cause miscarriage, stillbirth, preterm birth, or fatal infection in newborns, even if the mother is only mildly ill,” the New Mexico Department of Health said in the press release.

The health department noted that it could not definitively link the baby’s death to the raw milk the mother drank. But raw milk is notorious for transmitting Listeria monocytogenes bacterium. The Food and Drug Administration has a “Food Safety for Moms-to-Be” webpage about Listeria, in which it poses the question and answer: “How could I get listeriosis? You can get listeriosis by eating raw, unpasteurized milk and unpasteurized milk products… .”

Listeria is a particular danger during pregnancy. When exposed, pregnant people are 10 times more likely to develop a Listeria infection than other healthy adults because altered immune responses during pregnancy make it harder to fight off infections. Further, Listeria is one of a few pathogens that are able to cross the placental barrier and infect a developing fetus.

Newborn dies after mother drinks raw milk during pregnancy Read More »

fda-deletes-warning-on-bogus-autism-therapies-touted-by-rfk-jr.‘s-allies

FDA deletes warning on bogus autism therapies touted by RFK Jr.‘s allies

For years, the Food and Drug Administration provided an informational webpage for parents warning them of the dangers of bogus autism treatments, some promoted by anti-vaccine activists and “wellness” companies. The page cited specifics scams and the “significant health risks” they pose.

But, under anti-vaccine Health Secretary Robert F. Kennedy Jr.—who has numerous ties to the wellness industry—that FDA information webpage is now gone. It was quietly deleted at the end of last year, the Department of Health and Human Services confirmed to Ars Technica.

The defunct webpage, titled “Be Aware of Potentially Dangerous Products and Therapies that Claim to Treat Autism,” provided parents and other consumers with an overview of the problem. It began with a short description of autism and some evidence-based, FDA-approved medications that can help manage autism symptoms. Then, the regulatory agency provided a list of some false claims and unproven, potentially dangerous treatments it had been working to combat. “Some of these so-called therapies carry significant health risks,” the FDA wrote.

The list included chelation and hyperbaric oxygen therapy, treatments that those in the anti-vaccine and wellness spheres have championed.

Dangerous detoxes

Chelation is a real treatment for heavy metal poisoning, such as lead poisoning. But it has been co-opted by anti-vaccine activists and wellness gurus, who falsely claim it can treat autism, among other things. These sham treatments can come in a variety of forms, including sprays, suppositories, capsules, and liquid drops. Actual FDA-approved chelation therapy products are prescription only, the agency noted, and chelating certain minerals from the body “can lead to serious and life-threatening outcomes.”

Many anti-vaccine activists promote the false and thoroughly debunked claim that vaccines cause autism, and more specifically, that trace metal components in some vaccines cause the neurological disorder. For years, anti-vaccine activists like Kennedy focused on thimerosal, a vaccine preservative that contains ethylmercury. Thimerosal was largely removed from childhood vaccines by 2001 amid unfounded concerns. The removal made no impact on autism rates, and many studies have continued to show that it is safe and not a cause of autism. Anti-vaccine activists moved on to blame other vaccine components for autism, including aluminum, which is used in some vaccines to help spur protective immune responses. It too has been found to be safe and not linked to autism.

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ai-starts-autonomously-writing-prescription-refills-in-utah

AI starts autonomously writing prescription refills in Utah

Caution

The first 250 renewals for each drug class will be reviewed by real doctors, but after that, the AI chatbot will be on its own. Adam Oskowitz, Doctronic co-founder and a professor at the University of California, San Francisco, told Politico that the AI chatbot is designed to err on the side of safety and escalate any case with uncertainty to a real doctor.

“Utah’s approach to regulatory mitigation strikes a vital balance between fostering innovation and ensuring consumer safety,” Margaret Woolley Busse, executive director of the Utah Department of Commerce, said in a statement.

For now, it’s unclear if the Food and Drug Administration will step in to regulate AI prescribing. On the one hand, prescription renewals are a matter of practicing medicine, which falls under state governance. However, Politico notes that the FDA has said that it has the authority to regulate medical devices used to diagnose, treat, or prevent disease.

In a statement, Robert Steinbrook, health research group director at watchdog Public Citizen, blasted Doctronic’s program and the lack of oversight. “AI should not be autonomously refilling prescriptions, nor identifying itself as an ‘AI doctor,’” Steinbrook said.

“Although the thoughtful application of AI can help to improve aspects of medical care, the Utah pilot program is a dangerous first step toward more autonomous medical practice,” he said.”The FDA and other federal regulatory agencies cannot look the other way when AI applications undermine the essential human clinician role in prescribing and renewing medications.”

AI starts autonomously writing prescription refills in Utah Read More »

12-former-fda-chiefs-unite-to-say-agency-memo-on-vaccines-is-deeply-stupid

12 former FDA chiefs unite to say agency memo on vaccines is deeply stupid

On Friday, Vinay Prasad—the Food and Drug Administration’s chief medical and scientific officer and its top vaccine regulator—emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.

On Wednesday evening, a dozen former FDA commissioners, who collectively oversaw the agency for more than 35 years, responded to the memo with a scathing rebuke. Uniting to publish their response in the New England Journal of Medicine, the former commissioners said they were “deeply concerned” by Prasad’s memo, which they framed as a “threat” to the FDA’s work and a danger to Americans’ health.

In his memo, Prasad called for abandoning the FDA’s current framework for updating seasonal flu shots and other vaccines, such as those for COVID-19. Those updates currently involve studies that measure well-characterized immune responses (called immunobridging studies). Prasad dismissed this approach as insufficient and, instead, plans to require expensive randomized trials, which can take months to years for each vaccine update.

FDA staff who disagree with the plans can “submit your resignation letters,” Prasad wrote. And airing concerns or criticisms is  seen as “unethical” and “illegal.”

Together, the former commissioners called Prasad’s memo the “latest in a series of troubling changes at the FDA,” and the planned policy updates “not … coherent.” Prasad’s arguments against immunobridging, they add, “misrepresent both the science and the regulatory record, especially in the case of vaccines that target well-understood pathogens through an established mechanism of action.”

12 former FDA chiefs unite to say agency memo on vaccines is deeply stupid Read More »

meet-cdc’s-new-lead-vaccine-advisor-who-thinks-shots-cause-heart-disease

Meet CDC’s new lead vaccine advisor who thinks shots cause heart disease


Milhoan has a history of touting unproven COVID cures while disparaging vaccines.

Kirk Milhoan, James Pagano, and Robert Malone are seen during a meeting of the CDC’s Advisory Committee on Immunization Practices on September 18, 2025 in Chamblee, Georgia. Credit: Getty | Elijah Nouvelage

When the federal vaccine committee hand-picked by anti-vaccine Health Secretary Robert F. Kennedy Jr. meets again this week, it will have yet another new chairperson to lead its ongoing work of dismantling the evidence-based vaccine recommendations set by the Centers for Disease Control and Prevention.

On Monday, the Department of Health and Human Services announced that the chairperson who has been in place since June—when Kennedy fired all 17 expert advisors on the committee and replaced them with questionably qualified allies—is moving to a senior role in the department. Biostatistician Martin Kulldorff will now be the chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS said. As such, he’s stepping down from the vaccine committee, the Advisory Committee on Immunization Practices (ACIP).

Kulldorff gained prominence amid the COVID-19 pandemic, criticizing public health responses to the crisis, particularly lockdowns and COVID-19 vaccines. He was a co-author of the Great Barrington Declaration that advocated for letting the deadly virus spread unchecked through the population, which was called unethical by health experts.

As ACIP chair, Kulldorff frequently made false and misleading statements about vaccine safety and efficacy that were in line with Kennedy’s views and statements. While Kulldorff presided over the committee, it made a series of decisions that were sharply denounced by scientific and medical groups as being based on ideology rather than evidence. Those include voting for the removal of the vaccine preservative thimerosal from some flu vaccines, despite well-established data indicating it is safe, with no evidence of harms. The committee also added restrictions to a combination measles, mumps, rubella, and varicella (chickenpox) MMRV vaccine and made an unprecedented effort to prevent Americans from getting COVID-19 vaccines, though the moves were largely ineffective.

In his new role, Kulldorff will be working with ASPE to provide analyses on health policy options, coordinate research efforts, and provide policy advice.

“It’s an honor to join the team of distinguished scientists that Secretary Kennedy has assembled,” Kulldorff said in a press release announcing his new role. “I look forward to contributing to the science-based public health policies that will Make America Healthy Again.”

The new chair, Kirk Milhoan

With Kulldorff moving on, ACIP will now be chaired by Kirk Milhoan, a pediatric oncologist with a track record for spreading COVID-19 misinformation and anti-vaccine views. In August 2021, the Hawaii Medical Board filed a complaint against Milhoan after he appeared on a panel promoting ineffective COVID-19 treatments, downplaying the severity of the disease, and spreading misinformation about COVID-19 vaccines, according to the Maui News. The complaint was dropped in April 2022 after state regulators said they had insufficient evidence to prove a violation of statutes regarding the practice of medicine.

While Milhoan claimed at the time that he is “pro-vaccine,” his statement, affiliations, and prescribing practices suggest otherwise. Milhoan is a member of the Independent Medical Alliance (formerly the Front Line COVID-19 Critical Care Alliance), a group of dubious health care providers set up amid the pandemic to promote the use of the anti-malaria drug hydroxychloroquine and the de-worming drug ivermectin to treat COVID-19. Both drugs have shown to be ineffective and potentially harmful when used to treat or prevent COVID-19.  The IMA also emphasizes vaccine injuries while pushing vitamins and other unproven treatments.

In 2024, Milhoan appeared on a panel set up by Rep. Marjorie Taylor Greene (R-Ga.) to discuss alleged injuries from COVID-19 vaccines alongside other prominent anti-vaccine and COVID-19 misinformation voices. In his opening statement, Milhoan suggested that COVID-19 vaccines were causing severe cardiovascular disease and death in people aged 15 to 44—an unsubstantiated claim he frequently echoes. In his bio for the IMA, he touts that he offers treatment for “vaccine-related cardiovascular toxicity due to the spike protein.”

CDC data has found that boys and young men, aged 12 to 24, have a heightened risk of myocarditis (inflammation of the heart) after COVID-19 vaccination. However, the cases are rare, relatively mild, and almost always resolve, according to CDC data. In a COVID-19 safety data presentation in June, CDC staff scientists reported that its vast vaccine safety monitoring systems indicated that in males 12–24, there are 27 myocarditis cases per million doses of COVID-19 vaccine administered (roughly one case in 37,000 doses). In cases identified during 2021, 83 percent recovered within three months, with more than 90 percent recovering within the year. The monitoring data found no instances of cardiac transplant or death from COVID-19 vaccination.

While anti-vaccine activists have seized on this minor risk from vaccination, health experts note that the risk of myocarditis and other inflammatory conditions from a COVID-19 infection is significantly greater than the risk from vaccination. Exact estimates vary, but one CDC study in 2021 found that people with COVID-19 infections had a 16-fold higher risk of myocarditis than people without the infection. Specifically, the study estimated that there were 150 myocarditis cases among 100,000 COVID-19-infected patients versus just nine myocarditis cases among 100,000 people without COVID-19 infections and who were also unvaccinated. Similar to what’s seen with vaccination, the study found that young males were most at risk of myocarditis.

Kennedy’s allies attack on COVID-19 shots

Kennedy and his allies, like Milhoan, have consistently inflated the risk of myocarditis from COVID-19 vaccination, with some claiming without evidence that they have caused sudden cardiac arrest and deaths in young males, though studies have found no such link. In 2022, Milhoan and fellow ACIP member and conspiracy theorist Robert Malone were featured in a viral social media post suggesting that 50 percent of college athletes in the Big Ten athletic conference had myocarditis linked to COVID-19 vaccines, which could lead to deaths if they played. But the two were referencing a JAMA Cardiology study that examined subclinical myocarditis in Big Ten athletes after COVID-19 infection—not vaccination. In fact, researchers confirmed for an AFP fact check that none of the athletes in the study were vaccinated. And the rate of subclinical myocarditis in the group was 2.3 percent, not 50 percent.

Milhoan’s misinformation about the cardiovascular harms from COVID-19 vaccines seems particularly pertinent to the direction of Kennedy’s anti-vaccine allies. On Friday, Vinay Prasad, the Food and Drug Administration’s top vaccine regulator, sent a memo to staff claiming without evidence that COVID-19 vaccines have killed 10 children. The memo provides little information about the extraordinary claim, but it hints that the deaths were linked to myocarditis and found among reports submitted between 2021 and 2024 to the CDC’s Vaccine Adverse Event Reporting System (VAERS).

VAERS is a system by which anyone, including members of the public, can report anything they think could be linked to vaccines. The reports are considered a type of early warning system, but the vast majority of the reports submitted are not actually related to vaccines. Further, CDC scientists have thoroughly evaluated VAERS reports and ruled out deaths attributed to COVID-19 vaccines. Prasad’s memo—which experts have speculated was designed to be leaked to produce alarming headlines about child deaths—claimed that before Trump administration officials with anti-vaccine views began sifting through the data, these deaths were “ignored” by FDA and CDC scientists. Prasad also claimed that there could be many more deaths that have gone unreported, despite the fact that healthcare providers have been legally required to report any deaths that occurred after COVID-19 vaccination, regardless of cause.

This week’s ACIP meeting

In this week’s scheduled ACIP meeting on Thursday and Friday, COVID-19 vaccines don’t appear on the draft agenda. Instead, ACIP is expected to vote to remove a recommendation for a birth dose of the hepatitis B vaccine. That dose protects newborns from contracting the highly infectious virus from their mothers during birth or from other family or acquaintances shortly after birth. About half of the people infected with hepatitis B are not aware of their infections, and testing of mothers before birth is imperfect. That can leave newborns particularly vulnerable, as infections that start at or shortly after birth almost always develop into chronic infections that can lead to liver disease, liver transplant, and cancer. In a previous ACIP meeting, CDC staff scientists presented data showing that there are no significant harms of birth doses and there is no evidence that delaying the immunization offers any benefit.

The committee is also taking on the childhood vaccine schedule as a whole, though the agenda on this topic is not yet clear. In his memo, Prasad attacked the common practice of providing multiple vaccinations at once, hinting that it could be a way in which the committee will try to dismantle current childhood vaccination recommendations. On Tuesday, The Washington Post reported that the committee will examine whether the childhood vaccine schedule as a whole is causing allergies and autoimmune diseases, something Kennedy and his anti-vaccine organization have long floated despite evidence refuting a link.

Under clear attack are aluminum salt adjuvants, which are used in many vaccines to help spur protective immune responses. Aluminum salts have been used safely in vaccines for more than 70 years. The FDA notes that the most common source of aluminum exposure is from food and water, not vaccines.

Photo of Beth Mole

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

Meet CDC’s new lead vaccine advisor who thinks shots cause heart disease Read More »

formula-with-“cleanest-ingredients”-recalled-after-15-babies-get-botulism

Formula with “cleanest ingredients” recalled after 15 babies get botulism

Infant botulism

The US sees around 100 cases of botulism in infants each year. The potentially deadly disease is caused by a potent neurotoxin produced by Clostridium botulinum and related species. These bacteria can form hardy spores that are ubiquitous in the environment, including in dust, water, and soil. When the spores germinate, the growing bacteria produce the toxin. This toxin can kill by blocking the neurotransmitter acetylcholine in motor neurons that would activate muscle movement. The result is flaccid paralysis that spreads down the body.

People can develop botulism in a variety of ways, including via infected wounds or by inhaling spores. Generally, foodborne botulism occurs when people eat the toxin directly, such as in improperly canned foods where the bacteria grew. But babies have their own unique form of botulism when they ingest just the spores.

In humans older than about 12 months, the stomach’s acidity is usually enough to kill off botulism-causing spores. But infants have lower gastric acidity, and their immune responses and protective gut bacterial communities aren’t fully established yet. Thus, if they ingest the spores, the bacteria can start growing in their gastrointestinal tracts—and start producing toxin, causing infantile botulism. Symptoms usually develop 10 to 30 days after ingestion. About 70 percent of all botulism cases are in infants.

Honey is one of the most well-known sources of botulism-causing spores for infants, accounting for about 20 percent of cases. But environmental sources are also key culprits, such as living near construction sites as well as dust debris from vacuum cleaners.

The common early symptoms of botulism in infants are constipation, poor feeding, loss of head control, and difficulty swallowing. As the disease progresses, shallow breathing and overall floppiness develops. About half of all babies with botulism will need to be intubated, even if they’re treated with BabyBIG. A century ago, infant botulism had a 90 percent fatality rate, but today most infants make a full recovery, though it can take weeks to months.

Formula with “cleanest ingredients” recalled after 15 babies get botulism Read More »

“it’s-only-a-matter-of-time-before-people-die”:-trump-cuts-hit-food-inspections

“It’s only a matter of time before people die”: Trump cuts hit food inspections


American inspections of foreign food facilities hit historic lows this year.

Credit: Biswa1992/iStock via Getty Images

American inspections of foreign food facilities—which produce everything from crawfish to cookies for the US market—have plummeted to historic lows this year, a ProPublica analysis of federal data shows, even as inspections reveal alarming conditions at some manufacturers.

About two dozen current and former Food and Drug Administration officials blame the pullback on deep staffing cuts under the Trump administration. The stark reduction marks a dramatic shift in oversight at a time when the United States has never been more dependent on foreign food, which accounts for the vast majority of the nation’s seafood and more than half its fresh fruit.

The stakes are high: Foreign products have been increasingly linked to outbreaks of foodborne illness. In recent years, FDA investigators have uncovered disturbing lapses in facilities producing food bound for American supermarkets. In Indonesia, cookie factory workers hauled dough in soiled buckets. In China, seafood processors slid crawfish along cracked, stained conveyor belts. Investigators have reported crawling insects, dripping pipes, and fake testing data purporting to show food products were pathogen free.

In 2011, Congress—concerned about the different standards of overseas food operations—gave the FDA new authority to hold foreign food producers to the same safety standards as domestic ones. Although the agency’s small team remained unable to visit every overseas facility, inspections rose sharply after the mandate—sometimes doubling or tripling previous rates.

Now, the US is on track to have the fewest inspections on record since 2011, except during the global pandemic.

Inspections began to decline early in the administration, after 65 percent of the staff in the FDA divisions responsible for coordinating travel and budgets left or were fired in the name of government efficiency.

Investigators suddenly had to book their own flights and hotels, obtain diplomatic passports and visas, and coordinate with foreign authorities, former and current FDA staffers told ProPublica. After workers tasked with processing expenses were laid off, investigators waited as a backlog of unfulfilled reimbursements climbed to more than $1 million, a former staffer said. (Investigators are responsible for paying off their own credit cards.) Senior investigators close to retirement also took the opportunity to get out.

Played out on a large scale, this combination of firings and voluntary departures has left the agency scrambling to make up for the loss of 1 out of every 5 of its workers responsible for ensuring the safety of America’s food and drugs.

Susan Mayne, the former director of the FDA’s Center for Food Safety and Applied Nutrition and an adjunct professor at Yale School of Public Health, expressed alarm at the drop in foreign inspections.

“It’s very concerning that we are seeing these kinds of reductions,” said Mayne, who emphasized the administration’s cuts have hamstrung an agency that has long struggled to retain investigators who conduct both foreign and domestic inspections. In an attempt to maintain its numbers, the agency had been working on initiatives to elevate pay and adopt specialized training for investigators. “The plans that were in place to address staffing have now been undermined.”

The gutting of the workforce coincides with other actions the administration has taken that are poking holes in the nation’s food safety net. In March, the FDA announced it was delaying compliance with a rule to speed up the identification and removal of harmful products in the food system, to give more time for companies to follow the rules. The next month, it suspended a quality control program that ensured consistency and accuracy across its 170 pathogen and contaminant labs as a result of staffing cuts.

Then in July, the administration quietly scaled back the Foodborne Diseases Active Surveillance Network, also known as FoodNet, shrinking its surveillance to just two pathogens: salmonella and a common type of E. coli. The program—a partnership between the FDA, the Centers for Disease Control and Prevention, the Department of Agriculture, and state health departments—was responsible for the critical monitoring of eight foodborne illnesses, including infections caused by the deadly bacteria Listeria. In response to the change, a CDC spokesperson previously claimed that the program’s surveillance had been duplicative.

The administration did not respond to ProPublica’s questions about these actions.

“There are going to be things that fall through the cracks, and these things aren’t negligible,” said a current FDA investigations official who spoke on the condition of anonymity, fearing reprisal. The same was true of other current and former agency staffers; those who still had jobs risked losing them, while former employees worried about their chances of being rehired or the security of their severance or retirement packages.

The Department of Health and Human Services refused to respond to any of ProPublica’s questions about the decrease in foreign food inspections, citing the government shutdown. “Responding to ProPublica is not considered a mission-critical activity,” said Emily Hilliard, the department’s press secretary. The FDA and the White House also did not respond to requests for comment.

“Basic regulatory oversight functions have been decimated,” said Brian Ronholm, the director of food policy at Consumer Reports. “There’s an enhanced risk of more outbreaks.”

An agency already struggling

The FDA has long been one of the main protectors of the American food supply. The federal agency oversees about 80 percent of what people eat, including fruits, vegetables, processed goods, dairy products and infant formula, and most seafood and eggs. It regulates more than 220,000 farms, food plants, and distributors, inspecting facilities, testing for pathogens, tracing outbreaks, and issuing recalls.

Only 40 percent of the facilities that the FDA regulates are within the nation’s borders. While the agency examines some products at ports of entry, those reviews are often cursory; workers cannot manually inspect every import or uncover whether a foreign plant properly cleans its equipment, conducts adequate salmonella testing, or has a rat infestation. In-person facility inspections are necessary for that kind of insight.

For example, in 2023, an FDA investigator inspected a Chinese manufacturer of soy protein powder, a common additive in shakes and other beverages. While the company had previously imported its products into the United States without scrutiny, the investigator’s thorough visit found numerous violations, according to an agency report obtained through a federal records request.

Live insects crawled through the facility’s production workshop, while dead ones lay on the floor. Condensation from rust-covered pipes dripped into a water tank waiting to be mixed with raw ingredients. Just outside the plant, the investigator found processing waste and stagnant water coated with a green biofilm, attracting a swarm of bugs too numerous to count.

When the investigator reviewed the firm’s bacteria testing records, which purportedly verified the products were free of salmonella and E. coli, he discovered the company was providing fake data to “satisfy the customer specifications,” according to his inspection report.

Company officials also tried to obstruct his inspection, blocking him from entering a packaging room when he tried to photograph the pest infestation. After the three-day review, the federal agent censured the company, Pingdingshan Tianjing Plant Albumen Co. Ltd., which promised to take corrective actions. The company did not respond to ProPublica’s emailed questions.

If investigators find a foreign food facility is unable to comply with American safety requirements or refuses to permit the FDA to inspect its establishment, the agency can block its products from entering the country.

These crucial foreign inspections are neither easy nor cheap. They typically last longer than domestic ones and cost nearly $40,000 a visit, and they can require months of logistical planning, special visas, and diplomatic approval from the host country.

In part because of these challenges, there was a time when the FDA conducted only a few hundred foreign inspections annually.

Then Congress passed the Food Safety Modernization Act of 2011, which set firm targets for the agency: It needed to conduct more than 19,000 foreign food inspections annually by 2016 and increase the number of food field staff to no fewer than 5,000 workers.

The FDA has never fulfilled this congressional mandate. Even before the second Trump administration, the agency was inspecting less than 10 percent of its target each year.

Dr. Stephen Ostroff, a former acting commissioner of the FDA who also served as the deputy commissioner for foods and veterinary medicine, said that the agency’s foreign food inspections have long been hindered by a lack of resources.

“It’s not because the agency isn’t interested in doing more overseas inspections—they are,” said Ostroff, who retired from the agency in 2019. “They simply don’t have the resources to be able to meaningfully do large numbers of overseas inspections.”

One major obstacle has been a lack of financial support. “Congressional appropriators have never provided the funding that FDA has determined it would need to do those foreign inspections,” said Mayne, who retired from the agency in 2023. Before the food safety act passed, the Congressional Budget Office estimated that the agency would need about $1.4 billion over five years to comply with the new requirements, which included the expansion of field staff and foreign inspections. But lawmakers approved only a fraction of that amount.

As of last year, the agency had about 430 employees conducting both foreign and domestic food inspections, with only 20 investigators dedicated solely to international assignments.

With such limitations, the agency’s inspections have often been reactive instead of proactive. In 2023, for example, FDA investigators did not descend on a Mexican strawberry farm until about 20 people had been hospitalized with hepatitis A, a highly contagious infection that causes liver inflammation and, in some cases, liver failure and death.

Hepatitis A is spread through the consumption of small or even microscopic bits of feces. Farm workers can shed the virus when picking fruit, or it can be transmitted through contaminated water.

At the Mexican berry farm, federal investigators found significant safety violations, including sanitation facilities with hand-washing water that was dirty, gray, and leaking throughout the growing area; one toilet offered no ability to wash one’s hands. The FDA censured the company, citing 11 violations of American food safety regulations. According to public data, the agency did not reinspect the farm to ensure it had made corrections even as its products kept entering the United States.

In January, less than two weeks before the second Trump administration came in, a report by the Government Accountability Office rebuked the FDA for consistently falling short of its foreign food inspection targets. The oversight office, recognizing the vital importance of the FDA’s food safety mission, urged Congress to direct the agency to assess how many foreign inspections are needed to keep the country’s food supply safe.

The FDA said in response that, in 2025, it would increase staffing levels and prioritize the training and development of investigators.

Then Donald Trump was inaugurated.

Reversing a decade of gains

During the first few weeks of the new Trump administration, foreign inspections carried on as usual. But the sudden hemorrhaging of FDA workers through firings, retirements, and buyouts quickly foiled the agency’s plans to ramp up staff and inspections.

While the administration had vowed that food safety inspectors would be spared, it began to cut critical investigative support staff in March, a move that would eventually incapacitate foreign inspections, current and former FDA staffers told ProPublica.

As the agency lost support staff, their responsibilities shifted to investigators, who were quickly overwhelmed by the new burdens. Passports, visas, and travel were all delayed.

“Support staff are not just there to bide time—they have a meaningful role,” said Sandra Eskin, who served as a top USDA food safety official in the Biden administration and is now the CEO of advocacy group Stop Foodborne Illness. “It’s like a game of Jenga: If you pull out one from the middle or the bottom, the whole tower collapses.”

In recent years, the agency has typically been able to conduct about 110 foreign food inspections each month, but in March, the number of inspections dropped almost in half compared with the monthly average in the previous two years.

As specialists who handled reimbursements were also fired, some investigators waited months for repayment, which made them reluctant to take on other foreign assignments, former and current staffers said.

The cuts and growing work burden quickly collapsed morale across the investigative division, leading many senior investigative officials with decades of experience to retire.

“We already had a significant percentage of our workforce that was eligible for retirement,” said a current FDA employee in the investigations division, “so reading the writing on the wall, they decided to exit.” These departures also interrupted the development of new investigators, as some of the senior staff members who left had been tasked with training new hires, a process that can take up to two years.

“There’s been such a brain drain,” said food safety expert Jennifer McEntire, founder of consulting firm Food Safety Strategy, “when inspectors do go out and are observing things, there’s no phone-a-friend.”

Instead of addressing the shortfall, in May, FDA Commissioner Dr. Marty Makary announced that the agency would expand the number of unannounced foreign inspections, in which investigators show up at facilities without alerting them first. Given the limited staff and resources, several current and former staffers told ProPublica that the prospect of conducting unannounced visits was impractical and even “comical.”

“A foreign unannounced trip is like an accelerated coordination process,” said a current FDA investigations official. “If you’re going to increase the number and not increase the staff, we don’t know how to make some of that stuff work.”

By the end of July, the number of foreign food inspections conducted by the agency was nearly 30 percent lower compared with similar periods in the previous two years. The administration refused to provide ProPublica with up-to-date inspection numbers, so we relied on data from the FDA’s public inspection dashboard to conduct this analysis.

Foreign inspections are not the only tool for overseeing food from abroad. The agency has developed partnerships with counterparts in other countries to ensure comparable oversight and required importers to verify that their foreign suppliers are following American standards. However, former and current agency staffers said that these initiatives also have been impacted by the administration’s cuts and recent departures.

While the administration’s cuts were ostensibly ordered to maximize efficiency and productivity, they have had an opposite effect, several former and current FDA employees said, reversing years of progress.

“The goal is to accomplish as much and more with less resources,” said a former high-level FDA investigations official. “Less inspections translate to less regulatory oversight, and that, from a public health perspective, never benefits the public.”

Scott Faber, senior vice president for government affairs at the nonprofit advocacy organization Environmental Working Group, said the fallout is simple:

“When you take a wrecking ball to the federal government, you are going to wind up undermining important government functions that keep all of us safe, especially our food,” he said. “It’s only a matter of time before people die.”

How we calculated foreign food inspections

To understand how inspections of foreign food facilities have changed, we used a publicly available dashboard where the FDA publishes the results of those inspections. This database also includes inspections for manufacturers of drugs, medical devices, cosmetics, tobacco, biologics, and veterinary products.

Beginning in May, we downloaded the entire database weekly and tracked the number of newly added foreign food facility inspections.

The dashboard is continually updated, with data added after inspections are finalized. That typically occurs 45 to 90 days after the close of an inspection, though some reports may not be posted until the agency takes a final enforcement action. Through an analysis, we determined that few reports are added more than 90 days after an inspection date.

Our story therefore only includes inspections through July. In an accompanying chart, we show the more provisional data through September. We asked HHS for recent figures, but the department refused to share them.

We considered the possibility that the downtrend in foreign food inspections was solely due to a lag in inspections being added to the dashboard. To check this, we performed the same analysis on domestic inspections. This analysis showed that while the rate of foreign inspections had significantly decreased, domestic inspections have continued almost uninterrupted.

This story originally appeared on ProPublica.

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“It’s only a matter of time before people die”: Trump cuts hit food inspections Read More »

fda-slows-down-on-drug-reviews,-approvals-amid-trump-admin-chaos

FDA slows down on drug reviews, approvals amid Trump admin chaos

Amid the chaos of the Trump administration’s haphazard job cuts and a mass exodus of leadership, the Food and Drug Administration is experiencing a slowdown of drug reviews and approvals, according to an analysis reported by Stat News.

An assessment of metrics by RBC Capital Markets analysts found that FDA drug approvals dropped 14 percentage points in the third quarter compared to the average of the six previous quarters—falling from an average of 87 percent to 73 percent this past quarter. In line with that finding, analysts noted that the delay rate in meeting deadlines for drug application reviews rose from an average of 4 percent to 11 percent.

The FDA also rejected more applications than normal, going from a historical average of 10 percent to 15 percent in the third quarter. A growing number of rejections relate to problems at manufacturing plants, which in turn could suggest problems with the FDA’s inspection and auditing processes.

With the government now in a shutdown—with no end in sight—things could get worse for the FDA. While the regulatory agency is still working on existing drug applications, it will not be able to accept new submissions.

FDA slows down on drug reviews, approvals amid Trump admin chaos Read More »

rfk-jr.’s-cdc-may-limit-covid-shots-to-75-and-up,-claim-they-killed-kids

RFK Jr.’s CDC may limit COVID shots to 75 and up, claim they killed kids

While some experts and health care providers had hoped that next week’s ACIP meeting would add clarity to the situation and allow healthy adults and children better access to the shots, the Post’s reporting suggests that’s unlikely. According to their sources, Kennedy’s ACIP is considering recommending the vaccines to those 75 and older, while instructing those 74 and younger to speak with their doctor about getting a shot. Another reported option is to not recommend the vaccine to people under the age of 75 at all, unless they have a preexisting condition.

Backlash

Such additional restrictions would likely intensify the backlash against Kennedy’s anti-vaccine agenda. Already, medical organizations have taken the unprecedented action to release their own evidence-based guidances that maintain COVID-19 vaccine recommendations for healthy children, particularly those under age 2, pregnant people, and healthy adults. Many medical and health organizations, as well as lawmakers, and over 1,000 current and former HHS employees have also called for Kennedy to resign.

Criticism of Kennedy’s actions has spread across party lines. Sen. Bill Cassidy (R-La.), a vaccine-supporting physician who cast a critical vote for Kennedy’s confirmation, had accused Kennedy of denying people vaccines and called for next week’s ACIP meeting to be postponed.

“Serious allegations have been made about the meeting agenda, membership, and lack of scientific process being followed for the now announced September ACIP meeting,” Cassidy said. “These decisions directly impact children’s health, and the meeting should not occur until significant oversight has been conducted. If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership.”

Meanwhile, in a clear rebuff of Kennedy’s cancellation of mRNA vaccine funding, the Republican-led House Committee on Appropriations this week passed a 2026 spending bill that was specifically amended to inject the words “including of mRNA vaccines” into a sentence about pandemic preparedness funding. The bill now reads: “$1,100,000,000, to remain available through September 30, 2027, shall be for expenses necessary to support advanced research and development, including of mRNA vaccines, pursuant to section 319L of the PHS Act and other administrative expenses of the Biomedical Advanced Research and Development Authority.”

RFK Jr.’s CDC may limit COVID shots to 75 and up, claim they killed kids Read More »

who-can-get-a-covid-vaccine—and-how?-it’s-complicated.

Who can get a COVID vaccine—and how? It’s complicated.


We’re working with a patchwork system, and there are a lot of gray areas.

Vaccinations were available at CVS in Huntington Park, California, on August 28, 2024. Credit: Getty | Christina House

As fall approaches and COVID cases tick up, you might be thinking about getting this season’s COVID-19 vaccine. The annually updated shots have previously been easily accessible to anyone over 6 months of age. Most people could get them at no cost by simply walking into their neighborhood pharmacy—and that’s what most people did.

However, the situation is much different this year with an ardent anti-vaccine activist, Robert F. Kennedy Jr., as the country’s top health official. Since taking the role, Kennedy has worked diligently to dismantle the country’s premier vaccination infrastructure, as well as directly hinder access to lifesaving shots. That includes restricting access to COVID-19 vaccines—something he’s done by brazenly flouting all standard federal processes while providing no evidence-based reasoning for the changes.

How we got here

In late May, Kennedy unilaterally decided that all healthy children and pregnant people should no longer have access to the shots. He announced the unprecedented change not through official federal channels, but via a video posted on Elon Musk’s X platform. Top vaccine and infectious disease officials at the Centers for Disease Control and Prevention—which sets federal vaccination recommendations—said they also learned of the change via X.

Medical experts—particularly the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG)—immediately slammed the change, noting that data continues to indicate pregnant women and children under age 2 are particularly vulnerable to severe COVID-19. Both medical groups have since released their own vaccination guidance documents that uphold COVID-19 vaccine recommendations for those patient groups. (AAP here, ACOG here)

Nevertheless, in line with Kennedy, officials at the Food and Drug Administration signaled that they would take the unprecedented, unilateral step of changing the labels on the vaccines to limit who could get them—in this case, people 65 and over, and children and adults with health conditions that put them at risk of severe COVID-19. Kennedy’s FDA underlings—FDA Commissioner Martin Makary and top vaccine regulator, Vinay Prasad—laid out the plans alongside a lengthy list of health conditions in a commentary piece published in the New England Journal of Medicine. The list includes pregnancy—which is evidence-based, but odd, since it conflicts with Kennedy.

What was supposed to happen

When there isn’t a zealous anti-vaccine activist personally directing federal vaccine policy, US health agencies have a thorough, transparent protocol for approving and recommending vaccinations. Generally, it starts with the FDA, which has both its own scientists and a panel of outside expert advisors to review safety and efficacy data submitted by a vaccine’s maker. The FDA’s advisory committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—then holds a completely public meeting to review, analyze, and discuss the data. They make a recommendation on a potential approval and then the FDA commissioner can decide to sign off, typically in accordance with internal experts.

Resulting FDA approvals or authorizations are usually broad, basically covering people who could safely get the vaccine. The specifics of who should get the vaccine fall to the CDC.

Once the FDA approves or authorizes a vaccine, the CDC has a similar evaluation process. Internal experts review all the data for the vaccine, plus the epidemiological and public health data to assess things like disease burden, populations at risk, resource access, etc. A committee of outsides expert advisors do the same—again in a totally transparent public meeting that is livestreamed with all documents and presentations available on the CDC’s website.

That committee, the Advisory Committee on Immunization Practices (ACIP), then makes recommendations to the CDC about how the shots should be used. These recommendations can provide nuanced clinical guidance on exactly who should receive a vaccine, when, in what scenarios, and in what time series, etc. The recommendations may also be firm or soft—e.g., some people should get a vaccine, while others may get the vaccine.

The CDC director then decides whether to adopt ACIP’s recommendations (the director usually does) and updates the federal immunization schedules accordingly. Those schedules set clinical standards for immunizations, including routine childhood vaccinations, nationwide. Once a vaccine recommendation makes it to the ACIP-guided federal immunization schedules, private health insurance companies are required to cover those recommended vaccinations at no cost to members. And—a key catch for this year—19 states tie ACIP vaccine recommendations to pharmacists’ ability to independently administer vaccines.

What actually happened

Days after Kennedy’s X announcement of COVID-19 vaccine restrictions in late May, the CDC changed the federal immunization schedules. The recommendation for a COVID-19 shot during pregnancy was removed. But, for healthy children 6 months to 17 years, the CDC diverged from Kennedy slightly. The updated schedule doesn’t revoke access outright; instead, it now says that healthy children can get the shots if there is shared decision-making with the child’s doctor, that is, if the parent/child wants to get the vaccine and the doctor approves. ACIP was not involved in any of these changes.

On August 27, the FDA followed through with its plans to change the labels on COVID-19 vaccines, limiting access to people who are 65 and older and people who have an underlying condition that puts them at high risk of severe COVID-19.

FDA’s advisory committee, VRBPAC, met in late May, just a few days after FDA officials announced their plans to restrict COVID-19 vaccine access. The committee was not allowed to discuss the proposed changes. Instead, it was limited to discussing the SARS-CoV-2 strain selection for the season, and questions about the changes were called “off topic” by an FDA official.

ACIP, meanwhile, has not met to discuss the use of the updated COVID-19 vaccines for the 2025–2026 season. Last year, ACIP met and set the 2024–2025 COVID-19 shot recommendations in June. But, instead, in June of this year, Kennedy fired all 17 members of ACIP, falsely claiming members were rife with conflicts of interest. He quickly repopulated ACIP with anti-vaccine allies who are largely unqualified and some of whom have been paid witnesses in lawsuits against vaccine makers, a clear conflict of interest. While Kennedy is reportedly working to pack more anti-vaccine activists onto ACIP, the committee is scheduled to meet and discuss the COVID-19 vaccine on September 18 and 19. The committee will also discuss other vaccines.

Outside medical and public health experts view ACIP as critically compromised and expect it will further restrict access to vaccines.

With this set of events, COVID-19 vaccine access is in disarray. Here’s what we do and don’t know about access.

Getting a vaccine

FDA vaccine criteria

Prior to Kennedy, COVID-19 vaccines were available to all people ages 6 months and up. But that is no longer the case. The current FDA approvals are as follows:

Pfizer’s mRNA COVID-19 vaccine (COMIRNATY) is only available to people:

  • 65 years of age and older, or
  • 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Moderna’s mRNA COVID-10 vaccine (SPIKEVAX) is only available to people:

  • 65 years of age and older, or
  • 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Novavax’s protein subunit COVID-19 vaccine NUVAXOVID is only available to people:

  • 65 years of age and older, or
  • 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Who can get a COVID-19 vaccine and where now depends on a person’s age, underlying conditions, and the state they reside in.

States-based restrictions

The fact that ACIP has not set recommendations for the use of 2025–2026 COVID-19 vaccines means vaccine access is a messy patchwork across the country. As mentioned above, 19 states link pharmacists’ ability to independently provide COVID-19 vaccines to ACIP recommendations. Without those recommendations, pharmacies in those states may not be able to administer the vaccines at all, or only provide them with a doctor’s prescription—even for people who fit into the FDA’s criteria.

Last week, The New York Times reported that CVS and Walgreens, the country’s largest pharmacy chains, were either not providing vaccines or requiring prescriptions in 16 states. And the list of 16 states where CVS had those restrictions was slightly different than where Walgreens had them, likely due to ambiguities in state-specific regulations.

The National Alliance of State Pharmacy Associations (NASPA) and the American Pharmacists Association (APhA) have a state-by-state overview of pharmacist vaccination authority regulations here.

For people meeting the FDA criteria

In the 31 states that allow for broader pharmacist vaccination authority, people meeting FDA’s criteria (65 years and older, and people with underlying conditions), should be able to get the vaccine at a pharmacy like usual. And once ACIP sets recommendations later this month—assuming the committee doesn’t restrict access further—people in those groups should be able to get them at pharmacies in the remaining states, too.

Proving underlying conditions

People under 65 with underlying health conditions who want to get their COVID-19 shot at a pharmacy will likely have to do something to confirm their eligibility.

Brigid Groves, APhA’s vice president of professional affairs and the organization’s expert on vaccine policy, told Ars that the most likely scenario is that people will have to fill out forms prior to vaccination, indicating the conditions they have that make them eligible, a process known as self-attestation. This is not unusual, Groves noted. Other vaccinations require such self-attestation of conditions, and for years, this has been sufficient for pharmacists to administer vaccines and for insurance policies to cover those vaccinations, she said.

“APhA is a strong supporter of that patient self-attestation, recognizing that patients have a very good grasp of their medical conditions,” Groves said.

For people who don’t meet the FDA criteria

There are a lot of reasons why healthy children and adults outside the FDA’s criteria may still want to get vaccinated: Maybe they are under the age of 2, an age that is, in fact, still at high risk of severe COVID-19; maybe they live or work with vulnerable people, such as cancer patients, the elderly, or immunocompromised; or maybe they just want to avoid a crummy respiratory illness that they could potentially pass on to someone else.

For these people, regardless of what state they are in, getting the vaccine would mean a pharmacist or doctor would have to go “off-label” to provide it.

“It’s very gray on how a pharmacist may proceed in that scenario,” Groves told Ars. Going off-label could open pharmacists up to liability concerns, she said. And even if a patient can obtain a prescription for an off-label vaccine, that still may not be enough to allow a pharmacist to administer the vaccine.

“Pharmacists have something called ‘corresponding responsibility,’ Groves explained. “So even if a physician, or a nurse practitioner, or whomever may send a prescription over for that vaccine, that pharmacist still has that responsibility to ensure this is the right medication, for the right patient, at the right time, and that they’re indicated for it,” she said. So, it would still be going outside what they’re technically authorized to do.

Doctors, on the other hand, can administer vaccines off-label, which they might do if they choose to follow guidance from medical organizations like AAP and ACOG, or if they think it’s best for their patient. They can do this without any heightened professional liability, contrary to some suggestions Kennedy has made (doctors prescribe things off-label all the time). But, people may have to schedule an appointment with their doctor and convince them to provide the shot—a situation far less convenient than strolling into a local pharmacy. Also, since pharmacies have provided the vast majority of COVID-19 vaccines so far, some doctors’ offices may not have them on hand.

Pregnancy

It’s unclear if pregnancy still falls under the FDA’s criteria for a high-risk condition. It was included in the list that FDA officials published in May. However, the agency did not make that list official when it changed the vaccine labels last month. Some experts have suggested that, in this case, the qualifying high-risk conditions default to the CDC’s existing list of high-risk conditions, which includes pregnancy. But it’s not entirely clear.

In addition, with Kennedy’s previous unilateral change to the CDC’s immunization schedule—which dropped the COVID-19 vaccine recommendation during pregnancy—pregnant people could still face barriers to getting the vaccine in the 19 states that link pharmacist authorization to ACIP recommendations. That could change if ACIP reverses Kennedy’s restriction when the committee meets later this month, but that may be unlikely.

Insurance coverage

It’s expected that insurance companies will continue to cover the full costs of COVID-19 vaccines for people who meet the FDA criteria. For off-label use, it remains unclear.

Groves noted that in June, AHIP, the trade organization for health insurance providers, put out a statement suggesting that it would continue to cover vaccines at previous levels.

“We are committed to ongoing coverage of vaccines to ensure access and affordability for this respiratory virus season. We encourage all Americans to talk to their health care provider about vaccines,” the statement reads.

However, Groves was cautious about how to interpret that. “At the end of the day, on the claims side, we’ll see how that pans out,” she said.

Rapidly evolving access

While the outcome of the ACIP meeting on September 18 and 19 could alter things, a potentially bigger source of change could be actions by states. Already, there have been rapid responses with states changing their policies to ensure pharmacists can provide vaccines, and states making alliances with other states to provide vaccine recommendations and vaccines themselves.

Photo of Beth Mole

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

Who can get a COVID vaccine—and how? It’s complicated. Read More »