COVID-19

Bonkers CDC vaccine meeting ends with vote to keep COVID shot access

ACIP, COVID-19, health, vaccines / Shannon Garcia / September 20, 2025

At one point, Hillary Blackburn, a pharmacist and daughter-in-law of Sen. Marsha Blackburn (R-Tenn.), noted that her mother developed lung cancer two years after getting a COVID-19 vaccine, suggesting, without any evidence, that there could be a link. Evelyn Griffin, an obstetrician and gynecologist in Louisiana who reportedly lost her job for refusing to get a COVID-19 vaccine, meanwhile, did her own research and tried to suggest that the mRNA in mRNA vaccines could be turned into DNA inside human cells and integrate into our genetic material. She made this assertion to a scientist at Pfizer (a maker of an mRNA COVID-19 vaccine), asking him to respond.

With admirable composure, the Pfizer scientist explained that it was not biologically plausible: “RNA cannot reverse transcribe to DNA and transport from the cytoplasm to the nucleus and then integrate. That requires a set of molecules and enzymes that don’t exist in humans and are largely reserved for retroviruses.”

At the very start of the meeting, liaisons from mainstream medical organizations pressed that the ACIP committee needs to ditch such anecdotal nonsense and unvetted data, and return to the high-quality framework for evidence-based decision-making that ACIP has used in the past, which involves comprehensive, methodical evaluations.

Retsef Levi, who works on operations management and has publicly said that COVID-19 vaccines should be removed from the market, responded by falsely claiming that there are no high-quality clinical trials to show vaccine safety, so calls to return to methodological rigor for policy making are hypocritical. “With all due respect, I just encourage all of us to be a little bit more humble,” Levi, who was the head of the ACIP’s COVID-19 working group, said.

During his response, a hot mic picked up someone saying, “You’re an idiot.” It’s unclear who the speaker was—or how many other people they were speaking for.

This post was updated to include the adoption of the recommendation by the CDC.

Bonkers CDC vaccine meeting ends with vote to keep COVID shot access Read More »

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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Ousted CDC director to testify before Senate after RFK Jr. called her a liar

ACIP, CDC, COVID-19, health, robert f kennedy jr, Senate, vaccines / 9u50fv / September 11, 2025

Kennedy is reportedly vetting seven additional members for ACIP, who may be added before the next meeting. They include additional anti-vaccine voices and fringe members of the medical community, such as Kirk Milhoan, who promoted the de-worming drug ivermectin to treat COVID-19, despite several clinical trials finding it is not effective. There is also Joseph Fraiman, who has repeatedly called for COVID-19 vaccines to be pulled from the market.

Also on the list is Catherine Stein, who, The Washington Post noted, has advocated against vaccine mandates and wrote a 2021 article arguing that people should not be afraid of contracting COVID-19 because: “Our Lord has given us a mission to share the gospel. If we live in fear of death, that weakens our testimony. Remember, the Lord Jesus did not fear lepers, and leprosy was (and continues to be) a highly contagious infectious disease.”

Leprosy, or Hansen’s disease, is, in fact, not a highly contagious disease. It does not spread easily from person to person, is not spread through casual contact, and about 95 percent of people are immune to it naturally. COVID-19, meanwhile, is estimated to have caused more than 7 million deaths worldwide since the start of the pandemic.

Regardless of whether these candidates are added to the roster, Cassidy has called for the ACIP meeting scheduled for September 18 and 19 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.”

After Monarez and Houry testify before the HELP committee, Cassidy said that Senators are planning to invite current health officials to respond in a subsequent hearing.

Ousted CDC director to testify before Senate after RFK Jr. called her a liar Read More »

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 »

OTC nasal spray seemed to cut COVID infections by 67% in mid-sized trial

allergies, COVID-19, health, nasal spray, respiratory infections, robert f kennedy jr / Shannon Garcia / September 3, 2025

COVID context

Like all trials, there are limitations. As mentioned, the number of infections here is small—the impressive efficacy numbers could potentially vanish in a larger trial with more infections. And, while the trial had a high-quality design, it was undertaken in just one location in Germany and mostly involved healthy white women between the ages of 20 and 46, so the findings are not generalizable. The study was also funded by a pharmaceutical company that makes an azelastine nasal spray (though not the one that is sold over the counter in the US).

Still, with the previous studies, the trial offers some hope that this accessible nasal spray could be used as a viral prophylactic for respiratory seasons in the future. And the results land at a time when access to COVID-19 vaccines—which have firmly proven to be safe and highly effective—has been severely restricted in the US by health secretary and anti-vaccine activist Robert F. Kennedy Jr.

As it stands now, it appears that only people ages 65 and over, and those at higher risk of COVID-19 will have access to the shots this year, though some aspects of that access are murky, including how people will prove they’re at high risk. For healthy children, teens, and adults under 65, there may be no access or extremely limited access. That includes groups that medical experts recommend get vaccinated, namely healthy pregnant people and children ages 6 months to 23 months, both of which are considered at high risk from COVID-19 by medical experts, but not federal guidance under Kennedy. Experts also recommend access for healthy people who have contact with vulnerable people, such as cancer doctors, people who live with immunocompromised family members, and people who work in nursing homes.

With limited vaccine access and the normal slew of respiratory viruses on the horizon, a simple nasal spray is an appealing addition to the defenses. The main side effects are fairly minor, including bitter taste in the mouth, nosebleeds, and tiredness.

OTC nasal spray seemed to cut COVID infections by 67% in mid-sized trial Read More »

Top pediatricians buck RFK Jr.’s anti-vaccine meddling on COVID shot guidance

aap, american academy of pediatrics, anti-vaccine, CDC, childhood vaccines, COVID-19, COVID-19 vaccines, health, kennedy, robert f kennedy jr, vaccines / Shannon Garcia / August 20, 2025

“It’s clear that we’re in a different place in the pandemic than we were four or five years ago in terms of risks to healthy older kids,” Sean O’Leary, chair of the AAP Committee on Infectious Diseases (COID), said in a statement. However, “the risk of hospitalization for young children and those with high-risk conditions remains pretty high.”

According to CDC data, the rate of COVID-19 hospitalization in children under 2 is the highest among any pediatric group. Further, the rate of hospitalization among children 6 months to 23 months is comparable to that of adults ages 50 to 64. Critically, more than half of children ages 6 months to 23 months who are hospitalized for COVID-19 have no underlying medical condition that puts them at high risk for severe infection.

For children 2 to 18, the AAP recommends COVID-19 shots for children who have a medical condition that puts them at high risk, are residents of care facilities, have never been vaccinated, or have household contacts who are at high risk of severe COVID-19. All other children and teens should also have access to updated seasonal shots if they desire them, the AAP says.

“The AAP will continue to provide recommendations for immunizations that are rooted in science and are in the best interest of the health of infants, children, and adolescents,” Kressly said. “Pediatricians know how important routine childhood immunizations are in keeping children, families, and their communities healthy and thriving.”

Coverage questions

With school starting, COVID-19 cases ticking up around the country, and cold-weather respiratory virus season looming, the question now is how the conflicting recommendations will be interpreted by insurance companies. Insurers are required to cover vaccines recommended by the CDC. But there is no such obligation for recommendations from medical groups.

AAP has been holding meetings with insurers to press for continued coverage of evidence-based vaccine recommendations.

O’Leary told The Washington Post that insurers are “signaling that they are committed to covering our recommendations.” The Post also noted that AHIP, the major insurance lobby, released a statement in June saying its members are committed to “ongoing coverage of vaccines to ensure access and affordability for this respiratory virus season.”

Top pediatricians buck RFK Jr.’s anti-vaccine meddling on COVID shot guidance Read More »

All childhood vaccines in question after first meeting of RFK Jr.’s vaccine panel

ACIP, anti-vaccine, CDC, COVID-19, health, influenza, measles, Robert F Kenned Jr., vaccination / Shannon Garcia / June 26, 2025

A federal vaccine panel entirely hand-selected by health secretary and anti-vaccine activist Robert F. Kennedy Jr. gathered for its first meeting Wednesday—and immediately announced that it would re-evaluate the entire childhood vaccination schedule, as well as the one for adults.

The meeting overall was packed with anti-vaccine talking points and arguments from the new panel members, confirming public health experts’ fears that the once-revered panel is now critically corrupted and that Kennedy’s controversial picks will only work to fulfill his long-standing anti-vaccine agenda.

Controversial committee

An hour before the meeting began, the American Academy of Pediatrics came out swinging against the new panel, saying that the panel’s work is “no longer a credible process.” The organization shunned the meeting, refusing to send a liaison to the panel’s meeting, which it has done for decades.

“We won’t lend our name or our expertise to a system that is being politicized at the expense of children’s health,” AAP President Susan Kressly said in a video posted on social media.

The panel in question, the Advisory Committee on Immunization Practices (ACIP), has for more than 60 years provided rigorous public scientific review, discussion, and trusted recommendations to the Centers for Disease Control and Prevention on how vaccines should be used in the US after they’ve earned approval from the Food and Drug Administration. The CDC typically adopts ACIP’s recommendations, and once that happens, insurance providers are required to cover the cost of the recommended shots.

The system is highly regarded globally. But, on June 9, Kennedy unilaterally and summarily fired all 17 esteemed ACIP members and, two days later, replaced them with eight new people. Some have clear anti-vaccine views, others have controversial and contrarian public health views, and several have little to no expertise in the fields relevant to vaccines.

Last night, it came to light that one of the eight new appointees—Michael Ross, an obstetrics and gynecology physician—had withdrawn from the committee during a financial holdings review that ACIP members are required to complete before beginning work on the panel.

All childhood vaccines in question after first meeting of RFK Jr.’s vaccine panel 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 »

New COVID variant swiftly gains ground in US; concern looms for summer wave

CDC, COVID-19, ECDC, Europe, health, NB.1.8.1, omicron, SARS-CoV-2, vaccines, variant, WHO / 9u50fv / June 17, 2025

While COVID-19 transmission remains low in the US, health experts are anxious about the potential for a big summer wave as two factors seem set for a collision course: a lull in infection activity that suggests protective responses have likely waned in the population, and a new SARS-CoV-2 variant with an infectious advantage over other variants.

The new variant is dubbed NB.1.8.1. Like all the other currently circulating variants, it’s a descendant of omicron. Specifically, NB.1.8.1 is derived from the recombinant variant XDV.1.5.1. Compared to the reigning omicron variants JN.1 and LP.8.1, the new variant has a few mutations that could help it bind to human cells more easily and evade some protective immune responses.

On May 23, the World Health Organization designated NB.1.8.1 a “variant under monitoring,” meaning that early signals indicate it has an advantage over other variants, but its impact on populations is not yet clear. In recent weeks, parts of Asia, including China, Hong Kong, Singapore, and Taiwan, have experienced increases in infections and hospitalizations linked to NB.1.8.1’s spread. Fortunately, the variant does not appear to cause more severe disease, and current vaccines are expected to remain effective against it.

Still, it appears to be swiftly gaining ground in the US, fueling worries that it could cause a surge here as well. In the latest tracking data from the Centers for Disease Control and Prevention, NB.1.8.1 is estimated to account for 37 percent of cases in the US. That’s up from 15 percent two weeks ago. NB.1.8.1 is now poised to overtake LP.8.1, which is estimated to make up 38 percent of cases.

It’s important to note that those estimates are based on limited data, so the CDC cautions that there are large possible ranges for the variants’ actual proportions. For NB.1.81, the potential percentage of cases ranges from 13 percent to 68 percent, while LP.8.1’s is 23 percent to 57 percent.

New COVID variant swiftly gains ground in US; concern looms for summer wave Read More »

Top CDC COVID vaccine expert resigns after RFK Jr. unilaterally restricts access

anti-vaccine, CDC, COVID-19, health, robert f kennedy jr, vaccines / DJ Henderson / June 4, 2025

A top expert at the Centers for Disease Control and Prevention who was overseeing the process to update COVID-19 vaccine recommendations resigned on Tuesday.

The resignation, first reported by The Associated Press and confirmed by CBS News, comes just a week after health secretary and anti-vaccine advocate Robert F. Kennedy Jr. unilaterally revoked and altered some of the CDC’s recommendations for COVID-19 vaccines, restricting access to children and pregnant people. The resignation also comes three weeks before CDC’s experts and advisors are scheduled to meet to publicly evaluate data and discuss the recommendations for this season—a long-established process that was disrupted by Kennedy’s announcement.

The departing CDC official, Lakshmi Panagiotakopoulos, a pediatric infectious disease expert, was a co-leader of a working group on COVID-19 vaccines who advised experts on the CDC’s Advisory Committee on Immunization Practices (ACIP). She informed her ACIP colleagues of her resignation in an email on Tuesday.

“My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role,” Panagiotakopoulos wrote.

Unilateral changes

Previously, the CDC and ACIP recommended COVID-19 vaccines for everyone ages 6 months and up. Experts have emphasized that pregnant people in particular should get vaccinated, as pregnancy suppresses the immune system and puts pregnant people at high risk of severe COVID-19 and death. The American College of Obstetricians and Gynecologists states that “COVID-19 infection during pregnancy can be catastrophic.” Further, dozens of studies have found that the vaccines are safe and effective at protecting the pregnant person, the pregnancy, and newborns.

Top CDC COVID vaccine expert resigns after RFK Jr. unilaterally restricts access 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.

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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.”

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