COVID-19 vaccines

rfk-jr.-drags-feet-on-covid-19-vaccine-recommendations,-delaying-shots-for-kids

RFK Jr. drags feet on COVID-19 vaccine recommendations, delaying shots for kids

Previously, the FDA narrowed the shots’ labels to include only people age 65 and older, and those 6 months and older at higher risk. But the ACIP recommended that all people age 6 months and older could get the shot based on shared decision-making with a health care provider. Although the shared decision-making adds a new requirement for getting the vaccine, that decision-making does not require a prescription and can be done not only with doctors, but also with nurses and pharmacists. Most people in the US get their seasonal COVID-19 vaccines at their local pharmacy.

Ars Technica reached out to the HHS on Thursday about whether there was a determination on the COVID-19 vaccine recommendations and, if not, when that is expected to happen and why there is a delay. The HHS responded, confirming that no determination had been made yet, but did not answer any of the other questions and did not provide a comment for the record.

In past years, ACIP recommendations and CDC sign-offs have happened earlier in the year to provide adequate time for a rollout. In 2024, ACIP voted on COVID-19 vaccinations in June, for instance, and then-CDC Director Mandy Cohen signed off that day. Now that we’re into October, it remains unclear when or even if the CDC will sign off on the recommendation and then, if the recommendation is adopted by the CDC, how much longer after that it would take for states to roll out the vaccines to children in the VFC program.

“Children who depend on this program, including children with chronic conditions, are still waiting unprotected. The delay in adopting COVID-19 vaccine recommendations puts their health at risk, reduces access and choice for families, and puts a strain on providers who want to deliver the best care for their youngest patients,” Susan Kansagra, the chief medical officer of the Association of State and Territorial Health Officials, said in a statement to Stat.

For now, children and adults with private insurance have access to the shots without the final sign-off, and health insurance companies have said that they will continue to maintain coverage for the vaccines without the final federal approval.

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RFK Jr. adds more anti-vaccine members to CDC vaccine advisory panel

Kirk Milhoan, a pediatric cardiologist who is a senior fellow at the Independent Medical Alliance (formerly Front Line COVID-19 Critical Care Alliance), which promotes misinformation about COVID-19 vaccines and touts unproven and dubious COVID-19 treatments. Those include the malaria drug hydroxychloroquine, the de-worming drug ivermectin, and various concoctions of vitamins and other drugs. Milhoan has stated that mRNA COVID-19 vaccines should be removed from the market, telling KFF in March: “We should stop it and test it more before we move forward.”

Evelyn Griffin, an obstetrician and gynecologist in Louisiana who reportedly lost her job for refusing to get a COVID-19 vaccine. In a speech at a Louisiana Health Freedom Day in May 2024, Griffin claimed that doctors “blindly believed” that mRNA COVID-19 vaccines were safe. She has also claimed that the vaccines cause “bizarre and rare conditions,” according to the Post.

Hillary Blackburn, a pharmacist in St. Louis. Reuters reports that she is the daughter-in-law of Sen. Marsha Blackburn (R-Tenn.), who has opposed vaccine mandates.

Raymond Pollak, a semi-retired transplant surgeon who filed a whistleblower lawsuit against the University of Illinois Hospital in 1999, alleging the hospital manipulated patient data to increase their chances of receiving livers. The hospital settled the suit, paying $2.5 million, while denying wrongdoing.

ACIP is scheduled to meet at the end of this week, on September 18 and September 19. According to an agenda recently posted online, the committee will vote on recommendations for a measles, mumps, rubella, and varicella (MMRV) combination vaccine, the Hepatitis B vaccine, and this year’s updated COVID-19 vaccines. Vaccine experts widely fear that the committee will rescind recommendations and restrict access to those vaccines. Such moves will likely create new, potentially insurmountable barriers for people, including children, to get vaccines.

ACIP-recommended vaccines are required to be covered by private health insurance plans and the Vaccines for Children program for Medicaid-eligible and under- or uninsured kids, which covers about half of American children. Without ACIP recommendations for a vaccine, insurance coverage would be an open question, and vulnerable children would simply lose access entirely.

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

“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.”

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RFK Jr. barred registered Democrats from being vaccine advisors, lawsuit says

The lawsuit was filed by the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), the Infectious Diseases Society of America (IDSA), the Massachusetts Public Health Alliance, the Society for Maternal-Fetal Medicine, and a Jane Doe, who is a pregnant physician.

The group’s lawsuit aims to overturn Kennedy’s unilateral decision to drop the CDC’s recommendations that healthy children and pregnant people get COVID-19 vaccines. The medical groups argue that Kennedy’s decision—announced in a video on social media on May 27—violates the Administrative Procedure Act for being arbitrary and capricious.

Specifically, Kennedy made the decision unilaterally, without consulting the CDC or anyone on ACIP, entirely bypassing the decadeslong evidence-based process ACIP uses for developing vaccine recommendations that set standards and legal requirements around the country. Further, the changes are not supported by scientific evidence; in fact, the data is quite clear that pregnancy puts people at high risk of severe COVID-19, and vaccination protects against dire outcomes for pregnant people and newborns. Kennedy has not explained what prompted the decision and has not pointed to any new information or recommendations to support the move.

“Existential threat”

The medical groups say the decision has caused harms. Pregnant patients are being denied COVID-19 vaccines. Patients are confused about the changes, requiring clinicians to spend more time explaining the prior evidence-based recommendation. The conflict between Kennedy’s decision and the scientific evidence is damaging trust between some patients and doctors. It’s also making it difficult for doctors to stock and administer the vaccines and creating uncertainty among patients about how much they may have to pay for them.

In making the claims, the medical groups offer a sweeping review of all of the damaging decisions Kennedy has made since taking office—from canceling a flu shot awareness campaign, spreading misinformation about measles vaccines amid a record-breaking outbreak, and clawing back $11 billion in critical public health funds to wreaking havoc on ACIP.

The lead lawyer representing the groups, Richard Hughes IV, a partner at Epstein Becker Green, did not immediately respond to Ars’ request for comment.

But in a statement Monday, Hughes said that “this administration is an existential threat to vaccination in America, and those in charge are only just getting started. If left unchecked, Secretary Kennedy will accomplish his goal of ridding the United States of vaccines, which would unleash a wave of preventable harm on our nation’s children.”

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