This Week: CDC partly walks back RFK’s COVID vaccine changes, fake citations found in MAHA report, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, the Centers for Disease Control and Prevention (CDC) updated its COVID-19 vaccine schedule for children and pregnant women, contradicting an earlier announcement by federal health leaders, and numerous citations in the recently released MAHA Report were found to be fake.

On Tuesday, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, FDA Commissioner Martin Makary, and National Institutes of Health Director Jay Bhattacharya announced that healthy children and pregnant women have been removed from the CDC’s COVID-19 immunization schedule. In a video posted to X, the officials claimed that there is no scientific support for giving healthy children the COVID-19 booster.

However, CBS News reported that the administration had updated COVID-19 immunization schedule late Thursday, in a shift from the policy announced by Kennedy earlier in the week. The agency now states that people 6 months to 17 years old who are not moderately or severely immunocompromised may receive the vaccine based on shared clinical decision-making with their healthcare provider. For pregnant women, the CDC has removed its previous recommendation for the vaccines and instead has changed its guidance to “no guidance/not applicable,” though the agency still hasn’t removed webpages recommending the vaccine during pregnancy.

Following the announcement about removing children and pregnant women from the vaccine schedule, several experts raised concerns about the change, which they argued wasn’t justified by data. Former FDA Commissioner Robert Califf shared a study on LinkedIn from the British Medical Journal (BMJ) that reviewed 67 studies involving 2 million women, which found that vaccines significantly benefit pregnant women. He also published a blog post detailing why he had taken the COVID-19 booster and argued that the administration’s policy change lacked transparency.

Last week, HHS self-published a report from the Presidential Commission to Make America Healthy Again (MAHA) on childhood chronic diseases in the US. The Allbritton Journalism Institute’s NOTUS, reported that some of the citations were made up, while others were misrepresented. The New York Times also reported that after discovering the fake citations, the commission republished the report without the citations, which have the hallmarks of being produced by generative artificial intelligence (AI).

Since coming to office, Kennedy, Makary, and Bhattacharya have claimed that public health agencies have not been using gold-standard science and common sense in their decision-making. Last week, President Donald Trump signed an executive order that he said is intended to restore gold-standard science in government and ensure that federally funded research is "transparent, rigorous, and impactful, and that Federal decisions are informed by the most credible, reliable, and impartial scientific evidence available." While research advocates support the order in principle, according to ScienceInsider, many are concerned that it gives political appointees the power to control what research is published and persecute government researchers who don't tow the government line.

While it's been standard practice for public health officials to publish research and commentary in various peer-reviewed journals, Kennedy is reportedly considering banning government scientists from publishing in such journals and instead create an in-house publication for their work. As reported by several news outlets, including the Washington Post, during a recent podcast he said he would "probably" stop government researchers from publishing in some of the most prestigious medical journals, including the Lancet, New England Journal of Medicine, and JAMA because he said they are "all corrupt."

Following Makary's Senate Appropriations hearing last week, where he defended the administration's mass firings of FDA staff, former FDA Commissioner Scott Gottlieb published an op-ed in STAT News criticizing the mass firings and argued that it would undo much of the progress Trump did with getting generic drugs on the market under his first presidency. Democrats on the House Energy and Commerce (E&C) also wrote a letter to Kennedy the same day, demanding answers to why the administration fired HHS staff and eliminated various programs.

Sen. Dick Durbin (D-IL) also sent Makary a letter asking about the mass firings at FDA's Office of Prescription Drug Promotion (OPDP) and raised concerns about whether the agency has the resources to regulate prescription drug advertising. Specifically, the Senate Democratic whip asked Makary who was in charge of OPDP since its top officials were fired, how many staff it employs, and how the firings will affect its ability to carry out its mission.

Politico reported that, according to anonymous sources, Shantanu Nundy, former chief medical officer for care navigator Accolade Health, has been hired by FDA to help develop its AI policies. On his LinkedIn page, Nundy states that he has taken a senior advisor role in clinical AI in May but does not name his employer.

A month after Kennedy and Makary announced they are encouraging companies to stop using certain synthetic dyes in food products, FDA published a draft guidance on how they can replace color additives. The guidance also asks that new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit information for color additive replacements in changes being effected in 30 days (CBE-30) supplement applications.

Top FDA officials, including Makary, Sara Brenner, principal deputy commissioner, and Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), are going on a nationwide listening tour throughout June and July. They will speak to CEOs of drug and biologics companies or their chief medical officers to get input on how the agency can modernize its regulatory framework.

Prasad is also expected to give the keynote address at the National Organization for Rare Disorders' (NORD) Rare Disease Scientific Symposium in Washington, DC, on 3 June. Two weeks later, Makary is slated to speak during a town hall event at the DIA 2025 Global Annual Meeting on 16 June to share his thoughts on FDA. He is expected to be joined on stage by Emer Cooke, executive director of the European Medicines Agency (EMA); Lawrence Tallon, CEO of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA); and Sudip Parikh, CEO of the American Association for the Advancement of Science (AAAS).

Drugs & Biologics

Rocket Pharmaceuticals announced this week that it had paused a Phase 2 trial of its gene therapy drug RP-A501 to treat Danon disease after FDA put a hold on the trial following an acute systemic infection. The company said it is working with FDA, the Independent Data Safety Monitoring Committee, clinical investigators, and scientific experts, to assess how it moves forward.

Reuters reported that FDA has approved Sanofi's meningococcal vaccine, MenQuadfi, as the first vaccine intended for infants as young as six weeks old. The vaccine is already approved for children as young as two years old and is meant to inoculate people against the four most common strains of meningococcal bacteria - A, C, W and Y.

FDA issued a safety communication warning the public from long-term use of the popular over-the-counter (OTC) oral allergy drugs Zyrtec (cetirizine) or Xyzal (levocetirizine) due to rare cases of severe itching. According to the agency, some cases may be serious, and it plans to ask the manufacturers to include a warning about the issue.

Medtech

FDA issued a safety warning to healthcare providers and laboratory staff that certain capillary blood collection tubes used with Magellan Diagnostics LeadCare Testing Systems may give false-positive results. The agency said the errors have been associated with use of ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes though it hasn't been able to pinpoint the root cause for the errors.

This Week: CDC partly walks back RFK’s COVID vaccine changes, fake citations found in MAHA report, and more

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