vaccines

all-17-fired-vaccine-advisors-unite-to-blast-rfk-jr.’s-“destabilizing-decisions”

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

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

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 »

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RFK Jr. announces 8 appointees to CDC vaccine panel—they’re not good

Anti-vaccine advocate and current Health Secretary Robert F. Kennedy Jr. took to social media Wednesday to announce the names of eight people he is appointing to a critical federal vaccine advisory committee—which is currently empty after Kennedy abruptly fired all 17 previous members Monday.

In the past, the vetting process for appointing new members to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) could take years. But Kennedy has taken just two days.

The panel, typically stocked with vaccine, infectious disease, and public health experts, carefully and publicly reviews, analyzes, and debates vaccine data and offers recommendations to the CDC via votes. The CDC typically adopts the recommendations, which set clinical practices nationwide and determine insurance coverage for vaccinations.

Yesterday, Kennedy pledged that none of the new ACIP members would be “ideological anti-vaxxers.” However, the list of today’s appointees includes Robert Malone, who falsely claims to have invented mRNA vaccines and has spent the past several years spreading misinformation and conspiracy theories about them.

Speaking at an anti-vaccine rally in 2022, Malone spread dangerous falsehoods about mRNA COVID-19 vaccines: “These genetic vaccines can damage your children. They may damage their brains, their heart, their immune system and their ability to have children in the future. Many of these damages cannot be repaired.”

Troubling list

Malone aligned with the anti-vaccine crowd during the pandemic and has become a mainstay in conspiratorial circles and an ally to Kennedy. He has claimed that vaccines cause a “form of AIDS,” amid other nonsense. He has also meddled with responses to the measles outbreak that erupted in West Texas in January. In April, Malone was the first to publicize news that a second child had died from the highly infectious and serious infection, but he did so to falsely claim that measles wasn’t the cause and spread other dangerous misinformation.

RFK Jr. announces 8 appointees to CDC vaccine panel—they’re not good Read More »

anti-vaccine-advocate-rfk-jr.-fires-entire-cdc-panel-of-vaccine-advisors

Anti-vaccine advocate RFK Jr. fires entire CDC panel of vaccine advisors

“Most likely aim to serve the public interest as they understand it,” he wrote. “The problem is their immersion in a system of industry-aligned incentives and paradigms that enforce a narrow pro-industry orthodoxy.”

Kennedy, who is currently trying to shift the national attention to his idea of clean living and higher-quality foods, has a long history of advocating against vaccines, spreading misinformation and disinformation about the lifesaving shots. However, a clearer explanation of Kennedy’s war on vaccines can be found in his rejection of germ theory. In his 2021 book that vilifies infectious disease expert Anthony Fauci, he bemoaned germ theory as “the pharmaceutical paradigm that emphasized targeting particular germs with specific drugs rather than fortifying the immune system through healthy living, clean water, and good nutrition.”

As such, he rails against the “$1 trillion pharmaceutical industry pushing patented pills, powders, pricks, potions, and poisons.”

In Kennedy’s op-ed, he indicates that new ACIP members will be appointed who “won’t directly work for the vaccine industry. … will exercise independent judgment, refuse to serve as a rubber stamp, and foster a culture of critical inquiry.”

It’s unclear how the new members will be vetted and appointed and when the new committee will be assembled.

In a statement, the president of the American Medical Association, Bruce Scott, rebuked Kennedy’s firings, saying that ACIP “has been a trusted national source of science- and data-driven advice and guidance on the use of vaccines to prevent and control disease.” Today’s removal “undermines that trust and upends a transparent process that has saved countless lives,” he continued. “With an ongoing measles outbreak and routine child vaccination rates declining, this move will further fuel the spread of vaccine-preventable illnesses.”

This post has been updated to include a statement from the AMA. This story is breaking and may be updated further.

Anti-vaccine advocate RFK Jr. fires entire CDC panel of vaccine advisors Read More »

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

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 »

cdc-updates-covid-vaccine-recommendations,-but-not-how-rfk-jr.-wanted

CDC updates COVID vaccine recommendations, but not how RFK Jr. wanted

In practice, it is unclear how this change will affect access to the vaccines. Health insurers are required to cover vaccines on the CDC schedules. But, it’s yet to be seen if children will only be able to get vaccinated at their doctor’s office (rather than a pharmacy or vaccine clinic) or if additional consent forms would be required, etc. Uncertainty about the changes and requirements alone may lead to fewer children getting vaccinated.

In the adult immunization schedule, when viewed “by medical condition or other indication” (table 2), the COVID-19 vaccination recommendation for pregnancy is now shaded gray, meaning “no guidance/not applicable.” Hovering a cursor over the box brings up the recommendation to “Delay vaccination until after pregnancy if vaccine is indicated.” Previously, COVID-19 vaccines were recommended during pregnancy. The change makes it less likely that health insurers will cover the cost of vaccination during pregnancy.

The change is at odds with Trump’s Food and Drug Administration, which just last week confirmed that pregnancy puts people at increased risk of severe COVID-19 and, therefore, vaccination is recommended. Medical experts have decried the loss of the recommendation, which is also at odds with clear data showing the risks of COVID-19 during pregnancy and the benefits of vaccination.

The President of the American College of Obstetricians and Gynecologists (ACOG) put out a statement shortly after the Tuesday video, saying that the organization was “extremely disappointed” with Kennedy’s announcement.

“It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families,” ACOG President Steven Fleischman said.

CDC updates COVID vaccine recommendations, but not how RFK Jr. wanted Read More »

uncertainty-loomed-as-fda-advisors-met-to-discuss-this-year’s-covid-shot

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

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 »

seasonal-covid-shots-may-no-longer-be-possible-under-trump-admin

Seasonal COVID shots may no longer be possible under Trump admin

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.

Seasonal COVID shots may no longer be possible under Trump admin Read More »

measles-quickly-spreading-in-kansas-counties-with-alarmingly-low-vaccination

Measles quickly spreading in Kansas counties with alarmingly low vaccination

The cases in Kansas are likely part of the mushrooming outbreak that began in West Texas in late January. On March 13, Kansas reported a single measles case, the first the state had seen since 2018. The nine cases reported last week had ties to that original case.

Spreading infections and misinformation

On Wednesday, KDHE Communications Director Jill Bronaugh told Ars Technica over email that the department has found a genetic link between the first Kansas case and the cases in West Texas, which has similarly spread swiftly in under-vaccinated communities and also spilled over to New Mexico and Oklahoma.

“While genetic sequencing of the first Kansas case reported is consistent with an epidemiological link to the Texas and New Mexico outbreaks, the source of exposure is still unknown,” Bronaugh told Ars.

Bronaugh added that KDHE, along with local health departments, is continuing to work to track down people who may have been exposed to measles in affected counties.

In Texas, meanwhile, the latest outbreak count has hit 327 across 15 counties, mostly children and almost entirely unvaccinated. Forty cases have been hospitalized, and one death has been reported—a 6-year-old unvaccinated girl who had no underlying health conditions.

On Tuesday, The New York Times reported that as measles continues to spread, parents have continued to eschew vaccines and instead embraced “alternative” treatments, including vitamin A, which has been touted by anti-vaccine advocate and current US Health Secretary Robert F. Kennedy Jr. Vitamin A accumulates in the body and can be toxic with large doses or extended use. Texas doctors told the Times that they’ve now treated a handful of unvaccinated children who had been given so much vitamin A that they had signs of liver damage.

“I had a patient that was only sick a couple of days, four or five days, but had been taking it for like three weeks,” one doctor told the Times.

In New Mexico, cases are up to 43, with two hospitalizations and one death in an unvaccinated adult who did not seek medical care. In Oklahoma, officials have identified nine cases, with no hospitalizations or deaths so far.

Measles quickly spreading in Kansas counties with alarmingly low vaccination Read More »

rfk-jr.-promptly-cancels-vaccine-advisory-meeting,-pulls-flu-shot-campaign

RFK Jr. promptly cancels vaccine advisory meeting, pulls flu shot campaign

Indefinite changes

Stat asked the HHS specifically about the Wild to Mild campaign as well as promotional campaigns for other vaccines, but an HHS spokesperson puzzlingly responded with a statement saying: “No, the CDC was not told to take down the flu vaccination campaign webpage,” which wasn’t what the outlet had asked about.

The statement went on to say: “Unfortunately, officials inside the CDC who are averse to Secretary Kennedy and President Trump’s agenda seem to be intentionally falsifying and misrepresenting guidance they receive.” NPR received the same statement.

Meanwhile on Thursday, The Washington Post reported that the HHS told the CDC to indefinitely postpone a meeting of its vaccine advisory committee (the Advisory Committee on Immunization Practices, or ACIP), which Kennedy has criticized. ACIP, comprised of independent experts, meets regularly to review and discuss vaccine safety and efficacy data and vote on recommendations.

ACIP was previously scheduled to meet February 26 to 28 to discuss a large number of vaccines, including those against meningitis, influenza, RSV, chikungunya, HPV, mpox, pneumococcal infections, Lyme disease, COVID-19, and CMV. An HHS spokesperson told the Post that the meeting was “postponed to accommodate public comment in advance of the meeting,” but there is no rescheduled date.

Leading medical experts and organizations, such as the American Medical Association, quickly sent a joint letter urging Kennedy to preserve the meeting. “Each ACIP meeting holds tremendous weight and relevance,” the letter states. ‘Infectious diseases are constantly evolving opponents; vaccines are among the best tools for constantly adapting and responding to the latest public health threats. … Making America healthy requires healthy discussion and timely, evidence-based decisions. This meeting should be no different.”

But, also on Thursday, Politico reported that Kennedy is preparing to remove ACIP members. And, the AP noted earlier that during a speech to HHS employees on Tuesday, Kennedy vowed to investigate the CDC’s childhood vaccine schedule, despite assuring senators prior to his confirmation that he would not make changes to it.

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Nine unvaccinated people hospitalized as Texas measles outbreak doubles

In an interview with Ars Technica last week, Zach Holbrooks, the executive director of the South Plains Public Health District (SPPHD), which includes Gaines, said that the area has a large religious community that has expressed vaccine hesitancy.

Additional cases likely

Pockets of the county have yet lower vaccination rates than the county-wide averages suggest. For instance, one independent public school district in Loop, in the northeast corner of Gaines, had a vaccination rate of 46 percent in the 2023–2024 school year.

Measles is one of the most infectious diseases known. The measles virus spreads through the air and can linger in the airspace of a room for up to two hours after an infected person has left. Ninety percent of unvaccinated people who are exposed will fall ill with the disease, which is marked by a very high fever and a telltale rash. Typically, 1 in 5 unvaccinated people with measles in the US end up hospitalized, and 1 in 20 develop pneumonia. Between 1 to 3 in 1,000 die of the infection. In rare cases, it can cause a fatal disease of the central nervous system called Subacute sclerosing panencephalitis later in life. Measles can also wipe out immune responses to other infections (a phenomenon known as immune amnesia), making people vulnerable to other infectious diseases.

“Due to the highly contagious nature of this disease, additional cases are likely to occur in Gaines County and the surrounding communities,” the state health department said.

While Gaines is remarkable for its low vaccination rate, vaccination coverage nationwide has slipped in recent years as vaccine misinformation and hesitancy have taken root. Overall, vaccination rates among US kindergartners have fallen from 95 percent in the 2019–2020 school year into the 92 percent range in the 2023–2024 school year. Vaccine exemptions, meanwhile, have hit an all-time high. Health experts expect to see more vaccine-preventable outbreaks, like the one in Gaines, as the trend continues.

Nine unvaccinated people hospitalized as Texas measles outbreak doubles Read More »

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Dead babies, critically ill kids: Pediatricians make moving plea for vaccines

As federal lawmakers prepare to decide whether anti-vaccine advocate Robert F. Kennedy Jr. should be the next secretary of the Department of Health and Human Services, pediatricians from around the country are making emotional pleas to protect and support lifesaving immunizations.

The American Academy of Pediatrics (AAP) has assembled nearly 200 stories and dozens of testimonials on the horrors of vaccine-preventable deaths and illnesses that pediatricians have encountered over their careers. The testimonials have been shared with two Senate committees that will hold hearings later this week: the Senate Committee on Finance and the Senate Committee on Health, Education, Labor, and Pensions (HELP).

“I remember that baby’s face to this day”

In a statement on Monday, AAP President Susan Kressly noted that the stories come from a wide range of pediatricians—from rural to urban and from small practices to large institutions. Some have recalled stories of patients who became ill with devastating diseases before vaccines were available to prevent them, while others shared more recent experiences as vaccine misinformation spread and vaccination rates slipped.

In one, a pediatrician from Raleigh, North Carolina, spoke of a baby in the 1990s with Streptococcus pneumoniae meningitis, a life-threatening disease. “I remember holding a baby dying of complications of pneumococcal meningitis at that time. I remember that baby’s face to this day—but, thanks to pneumococcal vaccination, have never had to relive that experience since,” the doctor said. The first pneumococcal vaccine for infants was licensed in the US in 2000.

A doctor in Portland, Maine, meanwhile, faced the same disease in a patient who was unvaccinated despite the availability of the vaccine. “As a resident, I cared for a young, unvaccinated child admitted to the pediatric intensive care unit with life-threatening Streptococcus pneumoniae meningitis. This devastating illness, once common, has become rare thanks to the widespread use of pneumococcal conjugate vaccines. However, this child was left vulnerable…and [their parents] now faced the anguish of watching their child fight for their life on a ventilator.”

Kressly emphasizes that “One unifying theme of these stories: vaccines allow children to grow up healthy and thrive. As senators consider nominees for federal healthcare agencies, we hope these testimonies will help paint a picture of just how important vaccinations are to children’s long-term health and wellbeing.”

Dead babies, critically ill kids: Pediatricians make moving plea for vaccines Read More »