fda

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

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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.

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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 »

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

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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 »

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

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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 »

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

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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 »

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

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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 »

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

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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 »

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

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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 9th percentile in weight to 35th or 40th 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 »

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Trump admin picks COVID critic to be top FDA vaccine regulator

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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 »

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Seasonal COVID shots may no longer be possible under Trump admin

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Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the virus variants circulating that year, according to recent statements by Trump administration officials.

Since the acute phase of the pandemic, vaccine manufacturers have been subtly updating COVID-19 shots annually to precisely target the molecular signatures of the newest virus variants, which continually evolve to evade our immune responses. So far, the FDA has treated these tweaked vaccines the same way it treats seasonal flu shots, which have long been updated annually to match currently circulating strains of flu viruses.

The FDA does not consider seasonal flu shots brand-new vaccines. Rather, they’re just slightly altered versions of the approved vaccines. As such, the regulator does not require companies to conduct lengthy, expensive vaccine trials to prove that each slightly changed version is safe and effective. If they did, generating annual vaccines would be virtually impossible. Each year, from late February to early March, the FDA, the Centers for Disease Control and Prevention, and the World Health Organization direct flu shot makers on what tweaks they should make to shots for the upcoming flu season. That gives manufacturers just enough time to develop tweaks and start manufacturing massive supplies of doses in time for the start of the flu season.

So far, COVID-19 vaccines have been treated the exact same way, save for the fact that the vaccines that use mRNA technology do not need as much lead time for manufacturing. In recent years, the FDA decided on formulations for annual COVID shots around June, with doses rolled out in the fall alongside flu shots.

However, this process is now in question based on statements from Trump administration officials. The statements come amid a delay in a decision on whether to approve the COVID-19 vaccine made by Novavax, which uses a protein-based technology, not mRNA. The FDA was supposed to decide whether to grant the vaccine full approval by April 1. To this point, the vaccine has been used under an emergency use authorization by the agency.

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RFK Jr.‘s bloodbath at HHS: Blowback grows as losses become clearer

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Last week, Health Secretary and anti-vaccine advocate Robert F. Kennedy Jr. announced the Trump administration would hack off nearly a quarter of employees at the Department of Health and Human Services, which oversees critical agencies including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS).

The downsizing includes pushing out about 10,000 full-time employees through early retirements, deferred resignations, and other efforts. Another 10,000 will be laid off in a brutal restructuring, bringing the total HHS workforce from 82,000 to 62,000.

“This will be a painful period,” Kennedy said in a video announcement last week. Early yesterday morning, the pain began.

It begins

At the FDA—which will lose 3,500 employees, about 19 percent of staff—some employees learned they were being laid off from security guards after their badges no longer worked when they showed up to their offices, according to Stat. At CMS—which will lose 300 employees, about 4 percent—laid-off employees were instructed to file any discrimination complaints they may have with Anita Pinder, identified as the director of CMS’s Office of Equal Opportunity and Civil Rights. However, Pinder died last year, The Washington Post noted.

At the NIH—which is set to lose 1,200 employees, about 6 percent—new director Jay Bhattacharya sent an email to staff saying he would implement new policies “humanely,” while calling the layoffs a “significant reduction.” Five NIH institute directors and at least two other senior leaders have been ousted, in addition to hundreds of lower-level employees. Bhattacharya wrote that the remaining staff will have to find new ways to carry out “key NIH administrative functions, including communications, legislative affairs, procurement, and human resources.”

At CDC—which will lose 2,400 employees, about 18 percent—the cuts slashed employees working in chronic disease prevention, sexually transmitted diseases, HIV, tuberculosis, global health, environmental health, occupational safety and health, maternal and child health, birth defects, violence prevention, health equity, communications, and science policy.

Some leaders and workers at the CDC and NIH were reportedly reassigned or offered transfers to work at the Indian Health Services (IHS), an HHS division that provides medical and health services to Native American tribes. The transfers, which could require employees to move to a remote branch, are seen as another way to force workers out.

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Judge orders Trump admin. to restore CDC and FDA webpages by midnight

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“Irrational removal”

In his opinion, Bates cited the declarations from Stephanie Liou, a physician who works with low-income immigrant families and an underserved high school in Chicago, and Reshma Ramachandran, a primary care provider who relies on CDC guidance on contraceptives and sexually transmitted diseases in her practice. Both are board members of Doctors for America.

Liou testified that the removal of resources from the CDC’s website hindered her response to a chlamydia outbreak at the high school where she worked. Ramachandran, meanwhile, testified that she was left scrambling to find alternative resources for patients during time-limited appointments. Doctors for America also provided declarations from other doctors (who were not members of Doctors for America) who spoke of being “severely impacted” by the sudden loss of CDC and FDA public resources.

With those examples, Bates agreed that the removal of the information caused the doctors “irreparable harm,” in legal terms.

“As these groups attest, the lost materials are more than ‘academic references’—they are vital for real-time clinical decision-making in hospitals, clinics and emergency departments across the country,” Bates wrote. “Without them, health care providers and researchers are left ‘without up-to-date recommendations on managing infectious diseases, public health threats, essential preventive care and chronic conditions.’ … Finally, it bears emphasizing who ultimately bears the harm of defendants’ actions: everyday Americans, and most acutely, underprivileged Americans, seeking healthcare.”

Bates further noted that it would be of “minimal burden” for the Trump administration to restore the data and information, much of which has been publicly available for many years.

In a press statement after the ruling, Doctors for America and Public Citizen celebrated the restoration.

“The judge’s order today is an important victory for doctors, patients, and the public health of the whole country,” Zach Shelley, a Public Citizen Litigation Group attorney and lead counsel on the case, said in the release. “This order puts a stop, at least temporarily, to the irrational removal of vital health information from public access.”

Judge orders Trump admin. to restore CDC and FDA webpages by midnight Read More »