COVID-19

all-childhood-vaccines-in-question-after-first-meeting-of-rfk-jr.’s-vaccine-panel

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

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night, it came to light that one of the eight new appointees—Michael Ross, an obstetrics and gynecology physician—had withdrawn from the committee during a financial holdings review that ACIP members are required to complete before beginning work on the panel.

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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.”

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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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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 »

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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 »

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Trump admin picks COVID critic to be top FDA vaccine regulator

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

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 »

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“Lab leak” marketing page replaces federal hub for COVID resources

After obliterating the federal office on long COVID and clawing back billions in COVID funding from state health departments, the Trump administration has now entirely erased the online hub for federal COVID-19 resources. In its place now stands a site promoting the unproven idea that the pandemic virus SARS-CoV-2 was generated in and leaked from a lab in China, sparking the global health crisis.

Navigating to COVID.gov brings up a slick site with rich content that lays out arguments and allegations supporting a lab-based origin of the pandemic and subsequent cover-up by US health officials and Democrats.

Previously, the site provided unembellished quick references to COVID-19 resources, including links to information on vaccines, testing, treatments, and long COVID. It also provided a link to resources for addressing COVID-19 vaccine misconceptions and confronting misinformation. That all appears to be gone now, though some of the same information still remains on a separate COVID-19 page hosted by the Centers for Disease Control and Prevention.

While there remains no definitive answer on how the COVID-19 pandemic began, the scientific data available on the topic points to a spillover event from a live wild animal market in Wuhan, China. The scientific community largely sees this as the most likely scenario, given the data so far and knowledge of how previous outbreak viruses originated, including SARS-CoV-1. By contrast, the lab origin hypothesis largely relies on the proximity of a research lab to the first cases, conjecture, and distrust of the Chinese government, which has not been forthcoming with information on the early days of the health crisis. Overall, the question of SARS-CoV-2’s origin has become extremely politicized, as have most other aspects of the pandemic.

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RFK Jr. claws back $11.4B in CDC funding amid wave of top-level departures

Those departures follow Kevin Griffis, head of the CDC’s office of communications, who left last week; Robin Bailey, the agency’s chief operating officer, left late last month; and Nirav Shah, a former CDC principal deputy director.

Pulled funding

Meanwhile, NBC News reported this afternoon that the Department of Health and Human Services (HHS) is pulling back $11.4 billion in funding from the agency, which it allocated to state and local health departments as well as partners.

NBC reported that the funds were largely used for COVID-19 testing and vaccination, and to support community health workers and initiatives that address pandemic health disparities among high-risk and underserved populations, such as rural communities and minority populations. The funds also supported global COVID-19 projects.

“The COVID-19 pandemic is over, and HHS will no longer waste billions of taxpayer dollars responding to a non-existent pandemic that Americans moved on from years ago,” HHS Director of Communications Andrew Nixon said in a statement. “HHS is prioritizing funding projects that will deliver on President Trump’s mandate to address our chronic disease epidemic and Make America Healthy Again.”

State health departments told NBC News that they’re still evaluating the impact of the withdrawn funding. On Monday, some grantees received notices that read: “Now that the pandemic is over, the grants and cooperative agreements are no longer necessary as their limited purpose has run out.”

Since the public health emergency for COVID-19 was declared over in the US on May 11, 2023, over 92,000 Americans died from the pandemic virus, according to CDC data. In total, the pandemic killed over 1.2 million in the US.

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covid-shots-protect-kids-from-long-covid—and-don’t-cause-sudden-death

COVID shots protect kids from long COVID—and don’t cause sudden death

Benefits and a non-existent risk

Using an adjusted odds ratio, the researchers found that vaccination reduced the likelihood of developing long COVID with one or more symptoms by 57 percent, and reduced the likelihood of developing long COVID with two or more symptoms by 73 percent. Vaccination prior to infection was also linked to a 75 percent reduction in risk of developing long COVID that impacted day-to-day functioning. The authors note that the estimates of protection are likely underestimates because the calculations do not account for the fact that vaccination prevented some children from getting infected in the first place.

“Our findings suggest that children should stay up to date with current COVID-19 vaccination recommendations as vaccination not only protects against severe COVID-19 illness but also protects against [long Covid],” the authors conclude.

In a second short report in JAMA Network Open, researchers helped dispel concern that the vaccines could cause sudden cardiac arrest or sudden cardiac death in young athletes. This is an unproven claim that was fueled by anti-vaccine advocates amid the pandemic, including the new US Health Secretary and long-time anti-vaccine advocate Robert F. Kennedy Jr.

While previous analyses have failed to find a link between COVID-19 vaccines and sudden cardiac deaths, the new study took a broader approach. The study, led by researchers at the University of Washington, looked at whether the number of sudden cardiac arrests (SCA) and sudden cardiac deaths (SCD) among young athletes changed at all during the pandemic (2020–2022) compared with prior years (2017–2019). The researchers drew records from the National Center for Catastrophic Sports Injury Research. They also collected medical records and autopsy reports on cases among competitive athletes from the youth, middle school, high school, club, college, or professional levels who experienced sudden cardiac arrest or death at any time.

In all, there were 387 cases, with no statistically significant difference in the number of cases in the years prior to the pandemic (203) compared with those during the pandemic (184).

“This cohort study found no increase in SCA/SCD in young competitive athletes in the US during the COVID-19 pandemic, suggesting that reports asserting otherwise were overestimating the cardiovascular risk of COVID-19 infection, vaccination, and myocarditis,” the authors conclude.

COVID shots protect kids from long COVID—and don’t cause sudden death Read More »

louisiana-officially-ends-mass-vaccinations-as-rfk-jr.-comes-to-power

Louisiana officially ends mass vaccinations as RFK Jr. comes to power

“Rather than instructing individuals to receive any and all vaccines, LDH staff should communicate data regarding the reduced risk of disease, hospitalization, and death associated with a vaccine and encourage individuals to discuss considerations for vaccination with their healthcare provider,” he wrote.

“Ripped in half”

Susan Hassig, an infectious disease epidemiologist and professor emerita at Tulane University’s School of Public Health, told the Times-Picayune that this is problematic advice. Many people don’t have primary care providers. “They go to an urgent care or a clinic,” Hassig said. “In Louisiana, they go to the emergency room.”

The memo lands amid widespread fear that Kennedy’s appointment will lead to further erosion of America’s trust in vaccination and its vaccination rates. Already, rates of routine childhood vaccination in kindergartners across the nation have slipped into the range of 92 percent, woefully below the 95 percent threshold to prevent onward disease spread. Exemptions from school vaccination requirements are at an all-time high.

Further, the country is also in the midst of the worst flu season in 15 years. The percent of doctor’s visits for influenza-like illnesses (a standard metric for flu season) hit 7.8 percent this week, a high not seen since the 2009–2010 season amid the emergence of the H1N1 swine flu. The Centers for Disease Control and Prevention estimates that there have been at least 29 million illnesses, 370,000 hospitalizations, and 16,000 deaths from flu so far this season. This week, 11 children died of flu, bringing the 2024–2025 pediatric death toll to 68.

Among the recent deaths was a healthy 9-year-old girl in North Carolina, who died from flu complications on January 29. “I literally feel like my heart has been ripped in half,” her mother told WRAL News.

Seasonal flu shots significantly reduce the risk of death, particularly in children.

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protection-from-covid-reinfections-plummeted-from-80%-to-5%-with-omicron

Protection from COVID reinfections plummeted from 80% to 5% with omicron

“The short-lived immunity leads to repeated waves of infection, mirroring patterns observed with common cold coronaviruses and influenza,” Hiam Chemaitelly, first author of the study and assistant professor of population health sciences at Weill Cornell Medicine-Qatar, said in a statement. “This virus is here to stay and will continue to reinfect us, much like other common cold coronaviruses. Regular vaccine updates are critical for renewing immunity and protecting vulnerable populations, particularly the elderly and those with underlying health conditions.”

Chemaitelly and colleagues speculate that the shift in the pandemic came from shifts in evolutionary pressures that the virus faced. In early stages of the global crisis, the virus evolved and spread by increasing its transmissibility. Then, as the virus lapped the globe and populations began building up immunity, the virus faced pressure to evade that immunity.

However, the fact that researchers did not find such diminished protection against severe, deadly COVID-19 suggests that the evasion is likely targeting only certain components of our immune system. Generally, neutralizing antibodies, which can block viral entry into cells, are the primary protection against non-severe infection. On the other hand, immunity against severe disease is through cellular mechanisms, such as memory T cells, which appear unaffected by the pandemic shift, the researchers write.

Overall, the study “highlights the dynamic interplay between viral evolution and host immunity, necessitating continued monitoring of the virus and its evolution, as well as periodic updates of SARS-CoV-2 vaccines to restore immunity and counter continuing viral immune evasion,” Chemaitelly and colleagues conclude.

In the US, the future of annual vaccine updates may be in question, however. Prominent anti-vaccine advocate and conspiracy theorist Robert F. Kennedy Jr. is poised to become the country’s top health official, pending Senate confirmation next week. In 2021, as omicron was rampaging through the country for the first time, Kennedy filed a petition with the Food and Drug Administration to revoke access and block approval of all current and future COVID-19 vaccines.

Protection from COVID reinfections plummeted from 80% to 5% with omicron Read More »