A draft copy of the Make America Healthy Again Commission’s latest report, obtained by Politico, focuses on vaccine-related injuries and expediting access to investigational medicines for children—even though the FDA has recently rejected several of them.
Health Secretary Robert F. Kennedy Jr.’s latest Make America Healthy Again strategy homes in on creating a new vaccine framework—with an emphasis on addressing vaccine-related injuries—and streamlining access to investigational drugs, specifically for children. This is according to a draft copy of the report obtained by Politico.
The Make America Healthy Again Commission—created by President Donald Trump in February with a mission to overhaul the country’s food supply and chronic health outcomes—was expected to deliver its strategy to the president on Aug. 12, per executive order, according to Politico.
The latest report is being delayed to ensure it’s not “f---ed up” like the last one, according to one source who spoke with Politico’s Playbook. Speaking with Politico, White House spokesperson Kush Desai countered that the report, which is focused on “making children healthy again,” is delayed due to additional time needed to “coordinate officials’ schedules.”
In May, the MAHA Commission released a 73-page report that blamed chronic childhood diseases on poor diet, environmental chemicals, a lack of physical activity, stress and over-medication. It was quickly revealed by the nonprofit news organization NOTUS that the report was riddled with errors, including the citing of at least seven nonexistent studies. Ivan Oransky, co-founder of the watchdog site Retraction Watch, noted in comments to The New York Times that the report’s errors were characteristic of those produced through use of generative AI.
The May report took aim at pharma lobbying and the growing use of GLP-1 drugs to treat obesity in children, as well as the vaccine schedule. While the leaked draft strategy touches on pharma lobbying and so-called “conflicts of interest on advisory committees, such as those run by the FDA,” the primary emphasis from a pharmaceutical standpoint appears to be on vaccines.
The draft strategy lays out a vaccine framework focused on five key points:
- Ensuring America has the best childhood vaccine schedule
- Addressing vaccine injuries
- Modernizing American vaccines with transparent, gold-standard science
- Correcting conflicts of interest and misaligned incentives
- Ensuring scientific and medical freedom.
Additionally, a new vaccine injury research program at the NIH Clinical Center “will investigate vaccine injuries with improved data collection and analysis.”
The MAHA report’s focus on vaccines is in lockstep with Kennedy’s actions since taking office—removing the CDC’s COVID-19 vaccine recommendation for healthy children and pregnant women, overhauling the CDC’s ACIP and pulling $500 million in funding from mRNA vaccine research. Most recently, the Department of Health and Human Services revived the long-dormant Task Force on Safer Childhood Vaccines after last month vowing to “fix” the country’s Vaccine Injury Compensation Program.
The report’s emphasis on “bringing transformative treatments to patients” also aligns with comments from Kennedy and FDA Commissioner Marty Makary. Since taking office in April, Makary has repeatedly said that pushing innovative therapies to market more quickly is a priority.
In an interview with former Fox News journalist Megyn Kelly weeks into his tenure, Makary introduced a new regulatory pathway based on what he called a “plausible mechanism,” focusing mainly on rare or incurable diseases that affect “a small number of people.” Since then Makary—along with Kennedy and Center for Biologics Evaluation and Research head Vinay Prasad—have continued to advocate for streamlined access to cutting-edge medicines.
At the same time, the FDA has issued a handful of unexpected rejections. In July alone, the agency turned away novel therapies for two rare diseases primarily affecting children: Capricor Therapeutics’ deramiocel for Duchenne muscular dystrophy and Ultragenyx’s UX111 for Sanfilippo syndrome type A, with both companies expressing their surprise and disappointment.
In the draft strategy, the MAHA commission promises to “[streamline] the use of certain investigational drugs for Phase I clinical trials through targeted and risk-based exemptions to speed the access of investigational drugs to patients.”
