fda

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

botulism, ByHeart, CDC, fda, Formula, health, outbreak, recall / 9u50fv / November 12, 2025

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.

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

fda, food inspections, health, syndication / Shannon Garcia / November 6, 2025

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

drug approvals, fda, health, Reviews / Mike M. / October 22, 2025

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.

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

CDC, COVID-19, fda, health, kennedy, mRNA, vaccines / Shannon Garcia / September 13, 2025

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.”

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

ACIP, CDC, COVID-19, fda, health, mRNA, pharmacists, robert f kennedy jr, vaccines / Mike M. / September 6, 2025

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.

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 »

Senate confirms CDC director as top FDA official resigns under political pressure

CDC, fda, health, Monarez, Prasad / DJ Henderson / July 31, 2025

As of yesterday, Susan Monarez is in and Vinay Prasad is out among top federal health officials.

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and Prevention. She is the first nominee for CDC director to be required to get Senate confirmation, following a 2022 law requiring it. She is also the first person to serve in the role without a medical degree since 1953.

Monarez has a PhD in microbiology and immunology and previously served as the deputy director for the Advanced Research Projects Agency for Health (ARPA-H) under the Biden administration. Monarez quietly helmed the CDC as acting director from January to March of this year but stepped down as required when Donald Trump nominated her for the permanent role. Before that, Trump had nominated Dave Weldon, but the nomination was abandoned over concerns that his anti-vaccine views would torpedo his Senate confirmation.

In contrast, Monarez aligns with the evidence-based public health community and has support from health experts. Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health, told NPR that she has known Monarez professionally for more than a decade. “She’s a loyal, hardworking civil servant who leads with evidence and pragmatism and has been dedicated to improving the health of Americans for the entirety of her career,” Nuzzo said of Monarez.

Similarly, Georges Benjamin, executive director of the American Public Health Association, told the outlet that Monarez “values science, is a solid researcher, and has a history of being a good manager. We’re looking forward to working with her.”

It remains to be seen how Monarez will balance evidence-based public health guidance with the ideologically driven choices of health secretary and fervent anti-vaccine advocate Robert F. Kennedy Jr.

Senate confirms CDC director as top FDA official resigns under political pressure Read More »

All 17 fired vaccine advisors unite to blast RFK Jr.’s “destabilizing decisions”

ACIP, anti-vaccine, CDC, COVID-19, fda, health, rfk jr, robert f kennedy jr, vaccines / DJ Henderson / June 18, 2025

The members highlighted their medical and scientific expertise, lengthy vetting, transparent processes, and evidence-based approach to helping set federal immunization programs, which affect insurance coverage. They also lamented the institutional knowledge lost by the removal of the entire committee and its executive secretary, as well as cuts to the CDC broadly. Together they “have left the US vaccine program critically weakened,” the experts write.

“In this age of government efficiency, the US public needs to know that the routine vaccination of approximately 117 million children from 1994–2023 likely prevented around 508 million lifetime cases of illness, 32 million hospitalizations, and 1,129,000 deaths, at a net savings of $540 billion in direct costs and $2.7 trillion in societal costs,” they write.

They also took direct aim at Kennedy, who unilaterally changed the COVID-19 vaccination policy, announcing the changes on social media. This “bypassed the standard, transparent, and evidence-based review process,” they write. “Such actions reflect a troubling disregard for the scientific integrity that has historically guided US immunization strategy.”

Since Kennedy has taken over the US health department, many other vaccine experts have been pushed out or left voluntarily. Peter Marks, the former top vaccine regulator at the Food and Drug Administration, was reportedly given the choice to resign or be fired. In his resignation letter, he wrote: “it has become clear that truth and transparency are not desired by the Secretary [Kennedy], but rather he wishes subservient confirmation of his misinformation and lies.”

All 17 fired vaccine advisors unite to blast RFK Jr.’s “destabilizing decisions” Read More »

False claims that ivermectin treats cancer, COVID lead states to pass OTC laws

cancer, fda, health, ivermectin, Social Media / Kelly Newman / June 11, 2025

Doctors told the Times that they have already seen some cases where patients with treatable, early-stage cancers have delayed effective treatments to try ivermectin, only to see no effect and return to their doctor’s office with cancers that have advanced.

Risky business

Nevertheless, the malignant misinformation on social media has made its way into state legislatures. According to an investigation by NBC News published Monday, 16 states have proposed or passed legislation that would make ivermectin available over the counter. The intention is to make it much easier for people to get ivermectin and use it for any ailment they believe it can cure.

Idaho, Arkansas, and Tennessee have passed laws to make ivermectin available over the counter. On Monday, Louisiana’s state legislature passed a bill to do the same, and it now awaits signing by the governor. The other states that have considered or are considering such bills include: Alabama, Georgia, Kentucky, Maine, Minnesota, Mississippi, New Hampshire, North Carolina, North Dakota, Pennsylvania, South Carolina, and West Virginia.

State laws don’t mean the dewormer would be readily available, however; ivermectin is still regulated by the Food and Drug Administration, and it has not been approved for over-the-counter use yet. NBC News called 15 independent pharmacies in the three states that have laws on the books allowing ivermectin to be sold over the counter (Idaho, Arkansas, and Tennessee) and couldn’t find a single pharmacist who would sell it without a prescription. Pharmacists pointed to the federal regulations.

Likewise, CVS Health said its pharmacies are not currently selling ivermectin over the counter in any state. Walgreens declined to comment.

Some states, such as Alabama, have considered legislation that would protect pharmacists from any possible disciplinary action for dispensing ivermectin without a prescription. However, one pharmacist in Idaho, who spoke with NBC News, said that such protection would still not be enough. As a prescription-only drug, ivermectin is not packaged for retail sale. If it were, it would include over-the-counter directions and safety statements written specifically for consumers.

“If you dispense something that doesn’t have directions or safety precautions on it, who’s ultimately liable if that causes harm?” the pharmacist said. “I don’t know that I would want to assume that risk.”

It’s a risk people on social media don’t seem to be concerned with.

False claims that ivermectin treats cancer, COVID lead states to pass OTC laws Read More »

FDA rushed out agency-wide AI tool—it’s not going well

AI, fda, health / 9u50fv / June 5, 2025

FDA staffers who spoke with Stat news, meanwhile, called the tool “rushed” and said its capabilities were overinflated by officials, including Makary and those at the Department of Government Efficiency (DOGE), which was headed by controversial billionaire Elon Musk. In its current form, it should only be used for administrative tasks, not scientific ones, the staffers said.

“Makary and DOGE think AI can replace staff and cut review times, but it decidedly cannot,” one employee said. The staffer also said that the FDA has failed to set up guardrails for the tool’s use. “I’m not sure in their rush to get it out that anyone is thinking through policy and use,” the FDA employee said.

According to Stat, Elsa is based on Anthropic’s Claude LLM and is being developed by consulting firm Deloitte. Since 2020, Deloitte has been paid $13.8 million to develop the original database of FDA documents that Elsa’s training data is derived from. In April, the firm was awarded a $14.7 million contract to scale the tech across the agency. The FDA said that Elsa was built within a high-security GovCloud environment and offers a “secure platform for FDA employees to access internal documents while ensuring all information remains within the agency.”

Previously, each center within the FDA was working on its own AI pilot. However, after cost-cutting in May, the AI pilot originally developed by the FDA’s Center for Drug Evaluation and Research, called CDER-GPT, was selected to be scaled up to an FDA-wide version and rebranded as Elsa.

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn’t connected to the Internet or the FDA’s internal system, and has problems uploading documents and allowing users to submit questions.

FDA rushed out agency-wide AI tool—it’s not going well Read More »

Uncertainty loomed as FDA advisors met to discuss this year’s COVID shot

annual shots, COVID-19, fda, health, seasonal shots, vaccines / Shannon Garcia / May 23, 2025

Calling it a “practical question,” he asked, “If we were to change strains, can we assume that age-specific licensure won’t change for any of these [vaccine] products?” Currently, COVID-19 boosters are accessible to those aged 6 months and up.

Weir reiterated that there was no answer. Another FDA official, David Kaslow, chimed in to say only, “Rest assured that we’re engaging with the manufacturers on this topic.”

As a follow-up to that exchange, VRBPAC member and infectious disease expert Eric Rubin of Harvard, shot down the FDA’s plan to use randomized placebo-controlled trials for licensure for healthy children and adults. The plethora of observational data—aka real-world data—on the boosters shows clear efficacy, Rubin pointed out. That suggests that requiring people in a trial to take placebos despite the availability of a clearly effective treatment could be unethical.

It suggests “that a randomized controlled trial (RCT) has no equipoise right now, and that you cannot do one,” Rubin said. “I don’t think the RCT is feasible,” he added.

The selection

While the pushback and the questions lingered, the committee still had to select a strain. For now, omicron still reigns, and variants in the JN.1 lineage are still dominant. That is largely unchanged from last year, when vaccine makers were advised to target their seasonal shots against the JN.1 lineage generally, or KP.2, the leading variant in the JN.1 lineage at the time, specifically.

This year, advisors unanimously voted to stick with vaccines that target the JN.1 lineage, in line with recommendations from the World Health Organization. The question of targeting the JN.1 lineage was the only voting question the FDA tasked them with. But there was open discussion on a more specific recommendation. Given the regulatory uncertainty, advisors were divided on whether to stick with the JN.1 and KP.2 formulations from last year or recommend switching to the latest leading variant in the JN.1 family, LP.8.1.

Shortly after the meeting, the FDA announced that it would essentially leave it up to manufacturers; they could stick with JN.1 or KP.2 but, if feasible, switch to LP.8.1.

“The COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025–2026 Formula), preferentially using the LP.8.1 strain,” it said.

Uncertainty loomed as FDA advisors met to discuss this year’s COVID shot Read More »

From birth to gene-edited in 6 months: Custom therapy breaks speed limits

clinical trial, CRISPR, fda, gene therapy, health, mutation, Science / Beth Washington / May 17, 2025

In the boy’s fourth month, researchers were meeting with the Food and Drug Administration to discuss regulatory approval for a clinical trial—a trial where KJ would be the only participant. They were also working with the institutional review board (IRB) at Children’s Hospital of Philadelphia to go over the clinical protocol, safety, and ethical aspects of the treatment. The researchers described the unprecedented speed of the oversight steps as being “through alternative procedures.”

In month five, they started toxicology testing in mice. In the mice, the experimental therapy corrected KJ’s mutation, replacing the errant A-T base pair with the correct G-C pair in the animals’ cells. The first dose provided a 42 percent whole-liver corrective rate in the animals. At the start of KJ’s sixth month, the researchers had results from safety testing in monkeys: Their customized base-editing therapy, delivered as mRNA via a lipid nanoparticle, did not produce any toxic effects in the monkeys.

A clinical-grade batch of the treatment was readied. In month seven, further testing of the treatment found acceptably low-levels of off-target genetic changes. The researchers submitted the FDA paperwork for approval of an “investigational new drug,” or IND, for KJ. The FDA approved it in a week. The researchers then started KJ on an immune-suppressing treatment to make sure his immune system wouldn’t react to the gene-editing therapy. Then, when KJ was still just 6 months old, he got a first low dose of his custom gene-editing therapy.

“Transformational”

After the treatment, he was able to start eating more protein, which would have otherwise caused his ammonia levels to skyrocket. But he couldn’t be weaned off of the drug treatment used to keep his ammonia levels down (nitrogen scavenging medication). With no safety concerns seen after the first dose, KJ has since gotten two more doses of the gene therapy and is now on reduced nitrogen scavenging medication. With more protein in his diet, he has moved from the 9^th percentile in weight to 35^th or 40^th percentile. He’s now about 9 and a half months old, and his doctors are preparing to allow him to go home from the hospital for the first time. Though he will have to be closely monitored and may still at some point need a liver transplant, his family and doctors are celebrating the improvements so far.

From birth to gene-edited in 6 months: Custom therapy breaks speed limits Read More »

Trump admin picks COVID critic to be top FDA vaccine regulator

COVID-19, fda, health, nazis, pandemic, vinay prasad / Kelly Newman / May 7, 2025

Oncologist Vinay Prasad, a divisive critic of COVID-19 responses, will be the next top vaccine regulator at the Food and Drug Administration, agency Commissioner Martin Makary announced on social media Tuesday.

Prasad will head the FDA’s Center for Biologics Evaluation and Research (CBER), which is in charge of approving and regulating vaccines and other biologics products, such as gene therapies and blood products.

“Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward,” Makary wrote on social media.

Prasad, a professor in the department of epidemiology and biostatistics at the University of California, San Francisco, is perhaps best known for his combative social media postings and criticism of the mainstream medical community. He gained notoriety amid the COVID-19 pandemic for assailing public health responses, such as masking and vaccine mandates.

In an October 2021 newsletter, titled “How Democracy Ends,” Prasad compared the country’s pandemic responses to the rise of Adolf Hitler’s Third Reich. The post led New York University bioethicist Arthur Caplan to rebuke Prasad, writing in The Cancer Letter that the comparison is “ludicrous, dangerous, and offensive,” before adding “imbecilic.”

Prasad has also criticized the FDA for approving COVID-19 booster vaccines. Last year, he accused his predecessor as the head of the CBER, Peter Marks, of being “either incompetent or corrupt” for allowing the approvals.

“Absurd”

More recently, Prasad has heaped praise on new FDA Commissioner Makary, while continuing to criticize Marks. In early March, Prasad called Makary “smart, thoughtful, and disciplined” and “exactly what we need at the FDA.” Later in the month, he continued to take shots at Marks, writing: “You could replace Peter Marks with a bobblehead doll that just stamps approval and you would have the same outcome at FDA with lower administrative fees. Maybe something DOGE should consider.”

Trump admin picks COVID critic to be top FDA vaccine regulator Read More »