This Week at FDA: HHS to require placebo studies for vaccines, Makary says no planned FDA reorg, 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 Department of Health and Human Services (HHS) is reportedly planning to require placebo-controlled trials for new vaccines, which would be a significant departure from current practice for diseases for which there are already approved vaccines on the market.

The Washington Post reported that Kennedy plans to require all vaccines to undergo safety testing in placebo-controlled trials before being licensed. Medical experts have raised concerns that the plan could limit access and undermine public trust in vaccines. The move would also raise ethical questions for studying new vaccines for diseases such as measles or polio, as study participants who receive a placebo would be deprived of a proven intervention and be placed at greater risk of disease.

Axios reported that some experts are concerned the policy change could impose unnecessary burdens on vaccine makers and make vaccines more scarce, as such a requirement would slow vaccine development.

The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) announced the National Institute of Allergy and Infectious Diseases (NIAID) is launching Generation Gold Standard, a universal vaccine platform using a beta-propiolactone (BPL)-inactivated, whole-virus platform. The agency said the initiative will use the approach to induce B and T cell immune responses that it argues offers long-lasting protection across diverse viral families.

In a Q&A with Jeremy Faust in Inside Medicine, FDA Commissioner Martin Makary made several interesting comments, including stating there are no plans for further reorganization at the agency, distancing himself from the recent mass layoffs, questioning the need for COVID-19 boosters considering there is "broad population immunity" against the disease, and asserting that regardless of Kennedy's views, the decisions at FDA are ultimately his.

After requiring a new clinical study for Novavax’s COVID-19 vaccine, in a post on the social media platform X, Makary called the vaccine a new product that is different from the one the company was developing in 2021 and has been available under an emergency use authorization (EUA) since 2022.

Novavax was slated to get a decision for approval of its vaccine on 1 April, but FDA notified the company that it wanted a postmarketing commitment (PMC) to generate additional clinical data. While it was confident in the phase III trial data it provided to the agency, last week Novavax said it would continue talking to regulators to address the PMC request.

More broadly, Makary told CBS News that the FDA is examining whether it will still approve COVID-19 vaccines for the winter season, arguing that there is a lack of data on booster shots. "I think there's a void of data. And I think rather than allow that void to be filled with opinions, I'd like to see some good data," he said.

CNN reported that Kennedy has asked the Centers for Disease Control and Prevention (CDC) to "activate a scientific process" to develop treatments for measles and other conditions with medications and alternative therapies, such as vitamins, beyond vaccines. While HHS recommends vaccination as the most effective means of preventing measles, the department notes that some people may choose not to use vaccines and wants to give them alternative ways to address diseases like measles.

Reuters reported that Kennedy has reprised various misleading claims about vaccines during media interviews this week, including claiming that measles vaccines contain cells from aborted fetuses on News Nation, and the combination in the mumps vaccine has not been safety tested during a town hall event with TV host Dr. Phil on his YouTube channel.

During his talk with Dr. Phil, Kennedy also made false claims that external FDA advisory committees approve new drugs, and that the pharmaceutical industry controls the panels. Pharmaceutical industry representatives have traditionally been on the panels as non-voting members to give their input, but ultimately, the decision to approve medical products is made by FDA reviewers with recommendations from the panels.

CBS News also reported that some scientists and inspection staff at the FDA have been told that their firing will be reversed after the recent mass layoffs as part of the Trump administration's reduction-in-force (RIF) initiative caused serious disruptions to the agency's operations.

The White House published its proposed budget for fiscal year 2026 that would slash funding by $163 billion or 23%. There isn't much detail on how the budget would affect FDA, but it would make massive cuts to HHS broadly while adding $500 million in funding for Kennedy's Make America Health Again (MAHA) initiative.

The Senate Finance Committee announced it will hold a confirmation hearing for James “Jim” O'Neill for deputy HHS secretary and Gary Andres as HHS assistant secretary on 6 May. Andres is a Republican staff director on the House Budget Committee and previously worked for the biotechnology lobby group, the Biotechnology Innovation Organization (BIO).

O'Neill is the former CEO of the Thiel Foundation and a close associate of billionaire Peter Thiel and in the past has argued that FDA should approve products based on safety rather than safety and effectiveness. He was also considered for the FDA commissioner position in the first Trump administration.

NIH announced that it is launching a new initiative to prioritize human-based research technologies while reducing the use of animals in research. "By integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application," said NIH Director Jay Bhattacharya. "This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments."

Drugs & Biologics

As part of the Generic Drug User Fee Amendment (GDUFA III), the Center for Drug Evaluation and Research (CDER) reported that FDA awarded seven new grants and six new contracts in the last fiscal year for generic drugs extramural research projects and conducted more than 70 research projects internally in its FY2024 GDUFA Science and Research Report. The agency also reported issuing 206 new and revised product-specific guidances (PSG) on generic drug development.

While most guidance development has been frozen since President Donald Trump came to office and issued an executive order requiring 10 regulations, rules, and guidances be removed for each one issued, FDA published two draft guidances this week. One of the guidances addresses ways to reduce the risk of transmission of Mycobacterium tuberculosis (Mtb) by human cells, tissues, and cellular and tissue-based products (HCT/P), and the other provides details on reducing the risk of transmission of disease agents associated with sepsis from HCT/Ps.

This Week at FDA: HHS to require placebo studies for vaccines, Makary says no planned FDA reorg, and more

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