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This Vaccine Adviser to RFK Jr. Has Some Choice Words for His Critics
“Reckless” and “dangerous” were just two of the broadsides American medical groups lobbed at Robert F. Kennedy Jr.’s vaccine advisers after they recommended ending universal vaccination at birth for hepatitis B, the virus that causes liver failure and cancer.
Retsef Levi, one of the advisers, has some choice words for the critics: They’re conflicted. They’re misleading the public. They’re party to gross, even criminal negligence, he says. The war of words — and a new directive from President Donald Trump — suggests the Advisory Committee on Immunization Practices on which Levi sits will soon launch a much broader review of the childhood vaccine schedule. That could have far-reaching consequences both for public health and for vaccine uptake.
States rely on federal guidance in determining which shots to require for daycare and school attendance. Levi was among the eight panel members to vote earlier this month to recommend the Centers for Disease Control and Prevention end the universal birth dose of the hep B shot. The American public health establishment credits that dose, given within 24 hours of birth, with nearly wiping out infections in children who otherwise can catch the virus from their mothers. The committee would still encourage vaccination of children born to mothers who test positive for hepatitis B or whose infection status is unknown.
RFK Jr. And Dr. Oz to Announce Moves to Ban Gender-Affirming Care for Young People
The Trump administration is expected to announce several moves Thursday that will have the effect of essentially banning gender-affirming care for transgender young people, even in states where it is still legal. The U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. will be announcing the measures in a press conference at 11 a.m. at the headquarters HHS.
Dr. Mehmet Oz, who leads the Centers for Medicare and Medicaid, Dr. Marty Makary, who leads the U.S. Food and Drug Administration, and Dr. Jay Bhattacharya, who leads the National Institutes of Health, will all be at the press conference. In October, NPR exclusively reported on two new proposed rules for hospitals that Oz is expected to announce Thursday.
The first would prohibit doctors and hospitals from receiving federal Medicaid reimbursement for medical care provided to transgender patients younger than age 18. The second would block all Medicaid and Medicare funding for any services at hospitals that provide pediatric gender-affirming care. Medicaid provides health care coverage to low-income children and adults in the U.S. Medicare is the health program for Americans over 65 and disabled people.
Virtually every hospital in the country takes Medicare and relies on it, so the rule would have a wide-ranging effect. Makary and Bhattacharya are also expected to make announcements about health care that transgender young people receive.
CDC Awards $1.6 Million for Hepatitis B Vaccine Study by Controversial Danish Researchers
The Centers for Disease Control and Prevention (CDC) has awarded an unsolicited $1.6 million grant for vaccine research to Danish researchers whose studies have been challenged by mainstream scientists but championed by anti-vaccine activists, including the U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
According to a notice in the Federal Register posted yesterday, the CDC is paying the University of Southern Denmark to conduct a single-blind clinical trial of the hepatitis B vaccine in newborns in Guinea-Bissau, a small country in West Africa with exceptionally high rates of maternal and infant mortality, where nearly one in five people are infected with the hepatitis B virus.
The CDC is an agency within HHS. The study aims to assess the optimal timing and delivery of hepatitis B vaccinations, according to the notice. Although the federal announcement did not include the names of the researchers, the Danish university’s Bandim Health Project, which has conducted vaccine research in the developing African country for decades, has acknowledged being awarded the CDC grant. The Bandim project leaders have claimed to find “non-specific effects” from vaccines — some good and some bad — that they say should change how vaccine safety studies are conducted.
Moderna Receives $54.3M Investment for Bird Flu Vaccine, Covering Axed Federal mRNA Contracts
Moderna announced Thursday it will receive up to $54.3 million from a global vaccine partnership to fund its ongoing research into a potential bird flu mRNA vaccine, helping to recover some of the funding that was cut off when the federal government canceled hundreds of millions of dollars in contracts.
The Coalition for Epidemic Preparedness Innovations (CEPI), a public-private partnership of governments and philanthropic groups developing new vaccines to prevent future epidemics, will be making the investment to help Moderna get its bird flu vaccine candidate to licensure.
“We are proud to have the support of CEPI to advance our pandemic influenza vaccine candidate, research that is critical to our commitment to pandemic preparedness. mRNA technology can play a vital role in addressing emerging health threats quickly and effectively, and we look forward to continuing our partnership with CEPI as we advance our health security portfolio, and in parallel, further the 100 Days Mission,” Moderna CEO Stéphane Bancel said in a statement.
A contract with Moderna worth $590 million was announced in January by the Biden administration, to help develop a vaccine effective against bird flu. There are currently no vaccines specifically indicated for the virus. But in May, the Department of Health and Human Services announced it was canceling this contract.
3 Key Takeaways From the Fda’s New Animal Testing Guidance
Pharma has long taken small steps toward phasing out animal testing by using new approach methodologies, such as organ-on-a-chip or AI modeling, instead. Earlier this year, the U.S. Food and Drug Administration (FDA) reinforced that approach by releasing a roadmap to cut down on animal testing in preclinical safety studies for monoclonal antibodies. The NIH soon followed suit with an initiative to adopt “innovative, human-based science” that limits the use of animals in studies.
Earlier this month, the FDA released draft guidance outlining how drug developers can reduce or eliminate six-month non-human primate toxicity testing in certain monoclonal antibody studies.
In what Nahle described as an “extraordinary” statement, FDA Commissioner Dr. Marty Makary then told the news program “Full Measure” a few days later that the agency is “seeing drug applications come in now where they have an outline for animal testing, and we’re telling them, we don’t want you to do this animal testing. We don’t think it’s going to inform us about drug safety. Use computational modeling and other technology instead.” The draft guidance paired with statements from Makary, should signal to drug developers that “this is not a fluke,” Nahle said.
