This Week at FDA: RFK’s MAHA report, VRBPAC recommends COVID-19 boosters target newer JN.1 strains

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 Department of Health and Human Services (HHS) released a report on key causes of childhood chronic diseases, and FDA’s vaccine advisory committee recommended the strain for updated COVID-19 vaccines days after agency leaders unveiled a new framework for approving such vaccines.

The Department of Health and Human Services published a report from the Presidential Commission to Make America Healthy Again (MAHA) on childhood chronic diseases in the US. The report examines key causes of these diseases, including poor diet, environmental chemicals, lack of physical activity, and “overmedicalization”. As next steps, it says FDA and NIH should conduct more research to find solutions. The report was

As STAT News noted, the report also includes a section on the childhood vaccine schedule and concerns about the role of the vaccines in the childhood chronic disease crisis. It argued that the section is a "dog whistle" promoting ideas from when HHS Secretary Robert Kennedy Jr. was a member of the Children's Health Defense. Other outlets, including the Washington Post, cited contradictions or misleading information in the report, as well as the omission of issues such as gun violence, which are a leading cause of death for children and teens.

Members of FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended that the COVID-19 vaccines for 2025-2026 target newer strains of the JN.1 variant, which accounts for 70% of infections in the US. The panel also recommended frequent reviews of the strains of SARS-COV-2 to track the dominant strain.

The recommendation follows last week's recommendation from the World Health Organization's Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) to manufacturers to develop monovalent JN.1 or KP.2 vaccines for the following year. The group also said the monovalent vaccine targeting the JN.1 descendant strain LP.8.1 is an acceptable alternative vaccine antigen.

CBS News reports that FDA has instructed Pfizer and Moderna to expand the warnings on their mRNA COVID-19 vaccines related to the rare risk of heart inflammation, primarily in young males. Previously, Pfizer’s vaccine warned of the risk of myocarditis and pericarditis in men ages 12-17, while Moderna’s called out the risk for males 18-24 years old. Now, both vaccines will warn of the risk in males ages 16-25.

In related news, Senate Republicans have released an interim report alleging that federal agencies “downplayed” the risk of myocarditis and other adverse events related to COVID-19 vaccines. The report was released in conjunction with a hearing on Wednesday that featured testimony from several vaccine skeptic doctors and a lawyer with close ties to HHS Secretary Robert F. Kennedy Jr., Politico reports.

Reuters reported that Moderna has withdrawn its biologics license application (BLA) for its combination influenza and COVID-19 vaccine to wait for results from a late-stage trial of its flu vaccine. The news comes a day after FDA announced a new COVID-19 vaccine framework that would limit the approval of COVID-19 vaccines to people 65 and older and those with certain risk factors, unless additional randomized, placebo-controlled trials are conducted.

FDA said it plans to make it easier for states and Indian tribes to import certain prescription drugs cheaply from Canada under section 804 of the Federal Food, Drug and Cosmetic Act. The agency outlined a process by which states and tribes can apply to import the drugs and said it plans to develop a tool for them to develop their drug import proposal that will also shorten review times.

FDA’s inspections office has a new acting leader following the retirement of former Associate Commissioner for Inspections and Investigations Michael Rogers. Elizabeth Miller will now fill the role after most previously serving as deputy associate commissioner for medical products and assistant commissioner for medical products and tobacco operations.

The Senate Health, Education, Labor, and Pensions Committee will hold a hearing with testimony from CDER Acting Director Jacqueline Corrigan-Curay, to review the reauthorization of the Over-the-Counter Monograph Drug User Fee Program, which is set to expire in September 2025, on 4 June 2025.

AgencyIQ reported that FDA has again deleted its diversity action plan draft guidance from its website. The guidance was removed initially after the Trump administration began targeting diversity, equity, and inclusivity (DEI) initiatives in the federal government, but the agency was forced to republish it due to a temporary court restraining order that has expired.

The US Government Accountability Office (GAO) published a report on human organ-on-a-chip (OOC) technology, which can simulate human organs and offer an alternative way to test drugs that relies less on animal testing. The report listed several challenges to the technology, including acquiring good-quality human cells, a lack of data sharing, and regulatory uncertainties.

Drugs & biologics

FDA asked for public feedback on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluoropyrimidine chemotherapy drugs such as fluorouracil and capecitabine. More specifically, the agency wants to know what challenges healthcare providers and patients may have faced using the drugs, what factors healthcare providers consider when testing patients for DPD, and what factors they consider when deciding to use fluoropyrimidine chemotherapy drugs.

FDA on Thursday approved GSK’s asthma drug Nucala (mepolizumab) to treat certain patients with chronic obstructive pulmonary disease (COPD). The treatment will be available as an add-on maintenance therapy for adults with inadequately controlled COPT and blood eosinophil count of 150 cells/μL or greater, which the company said accounts for about 70% of US patients with inadequately controlled COPD.

The Federal Trade Commission has sent warning letters to drugmakers Novartis, Amphastar, Mylan Specialty, Covis Pharma, and three Teva subsidiaries, telling the companies that more than 200 of their device patent listings in FDA’s Orange Book are improperly listed in the wake of a recent federal appeals court ruling. The FTC previously warned the companies in 2023 and 2024 over the listings, which relate to 17 branded products, including treatments for asthma, diabetes, and COPD.

This week, FDA released its latest batch of product-specific guidances (PSGs) to promote generic drug development. The batch includes 34 new and 14 revised draft guidances, including 13 that address complex products and 37 products for which there are no approved generic alternatives.

Medtech

Jayaleka Amarasinghe, a microbiologist at the Winchester Engineering and Analytical Center (WEAC), is scheduled to give a presentation hosted by FDA on cleaning biofilms from surfaces such as medical devices on 29 May. The FDA said the presentation will specifically discuss photothermal ablation using gold nanorod coatings and electrical stimulation to prevent biofilms from forming.

FDA is again warning of data integrity issues found at third-party testing labs in China. The agency said it sent general correspondence letters to two firms, Tianjin-based Mid-Link Technology Testing Co., and Sanitation & Environment Technology Institute of Soochow University in Suzhuo, after uncovering falsified or invalid data in premarket device submissions referencing testing studies conducted at their facilities. “Because the FDA could not ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted at their respective testing facilities, the agency will reject those testing facilities’ data generated for use in premarket device submissions,” FDA said. Both firms were sent warning letters for these issues in September 2024.

This Week at FDA: RFK’s MAHA report, VRBPAC recommends COVID-19 boosters target newer JN.1 strains

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