RFK Jr. cancels almost $500M in mRNA vaccine contracts

HHS Secretary Robert F. Kennedy Jr. announced Tuesday that BARDA is terminating 22 grants totaling nearly $500 million supporting the development of mRNA vaccines. Kennedy argued that "data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu," adding that "one mutation and the vaccine becomes ineffective" which he said encourages "new mutations and actually prolong pandemics."

Kennedy said the decision was based on a review of available science and consultation with "the experts" but didn't name the experts he consulted with.

Kennedy noted that some contracts in their final stages would be allowed to finish "to preserve prior taxpayer investment," but any new mRNA-based projects will not be funded in the future.

Unlike traditional vaccines, which often take years to develop and test, mRNA vaccines can be made in months and can be quickly altered as a virus changes. These vaccines instruct the body to produce a fragment of the targeted virus, which then sets off the body's immune response.

They were first used during the COVID-19 pandemic by Pfizer-BioNTech and Moderna and allowed for the fastest production of a vaccine in history, with creation, testing, and regulatory authorization within 11 months. The two scientists who were credited with developing the platform, Katalin Karikó and Drew Weissman, were awarded the 2023 Nobel Prize in medicine.

Kennedy's claim that mRNA vaccines become ineffective after a single mutation and encourage new mutations is incorrect. The coronavirus that causes COVID-19 accumulated a number of mutations before agencies like FDA asked vaccine manufacturers to update their COVID-19 vaccines in the summer of 2022.

Vaccine experts expressed concern at Kennedy's announcement.

"This isn't prudent oversight, it's self-inflicted vulnerability," said Rick Bright, a former director of BARDA. "We're weakening critical countermeasures at the very moment that global health risks are intensifying."

Bright added that the decision "will have severe consequences, measured in lost lives, when a rapid vaccine response is needed."

Chris Meekins, an assistant secretary for pandemic preparedness in the first Trump administration, said that ending BARDA's work on mRNA vaccines creates a "national security vulnerability."

"These tools serve as a deterrent to prevent other nations from using certain biological agents," Meekins said. "The speed of the technology to create new biodefense capabilities is a national security asset."

(Branswell, STAT+ [subscription required], 8/5; Mandavilli, New York Times, 8/6)

Trump announces development of health records system

President Donald Trump last week announced the development of a healthcare records system that he said will allow Americans to access their health information and share it with providers more easily.

"Today the dream of easily transportable, electronic medical records final becomes a reality," he said at a White House event.

The administration said it has commitments from more than 60 companies, including Amazon, Apple, Google, and OpenAI, to work in two areas: promoting an interoperability framework to more easily share information between patients and providers, and increasing the availability of personalized tools for patients.

Officials said the apps could help with diabetes and obesity management and include AI assistants to help patients check their symptoms and choose care options. They added that new digital check-in methods could reduce paper intake.

"We have the tools and information available now to empower patients to improve their outcomes and their healthcare experience," said CMS Administrator Mehmet Oz. "We stand ready for a paradigm shift in the U.S. health care system."

Patients would have to opt in to share their health data and records on the new systems and apps.

"The system will be entirely opt-in, and there will be no centralized government-run database, which everyone is always concerned about," Trump said. "People are very, very concerned about personal records. They want to keep them very quiet, and that's their choice."

Experts expressed concerns about privacy and security with the new initiative, saying the announcement didn't provide many details regarding how patients would be able to access their medical histories in a way that will keep them private. In addition, easy availability of health records can sometimes conflict with laws that protect privacy like the Health Insurance Portability and Accountability Act.

"It's not something that can be done overnight without changing existing regulations and resolving the tension with existing laws," said Peter K. Jackson, a cybersecurity and privacy lawyer at Greenberg Glusker.

(Kanno-Youngs/Abelson, New York Times, 7/30; Bettelheim, Axios, 7/30)

Trump revives the Presidential Fitness Test in public schools

President Donald Trump last week signed an executive order expanding his council on sports, fitness, and nutrition and bringing back the Presidential Fitness Test, which was first introduced by President Lyndon B. Johnson in 1966 and phased out more than a decade ago.

"From the late 1950s until 2013, graduate scholars all across our country competed against each other in the Presidential Fitness Test, and it was a big deal," Trump said. "This was a wonderful tradition, and we're bringing it back."

The test brings back the fitness challenge that presented children who received the highest scores in five activities — a one-mile run, a shuttle run, a sit-and-reach, and pullups or pushups — with presidential recognition. In 2012, President Barack Obama abandoned the test and replaced it with an assessment called the FitnessGram which was focused on improving individual health.

Trump administration proposes rule banning abortions at VA hospitals

The Trump administration on Friday proposed a rule that would roll back a Biden-era policy that allowed the Department of Veterans Affairs (VA) to counsel veterans and their eligible family members about abortion and offer the procedure to veterans in limited circumstances, even in states that banned abortion following the Supreme Court's overturning of Roe v. Wade.

At the time, VA said the bans were "creating urgent risks" to the lives of pregnant veterans and as a result, the policy change was "essential."

In its proposed rule, the Trump administration said the rule change was "inappropriate" and "legally questionable." The rule also said that, despite rolling back the 2022 policy, veterans undergoing miscarriages or ectopic pregnancies would still be able to receive care, and that veterans would be able to get abortions "when a physician certifies that the life of the mother would be endangered if the fetus were carried to term."

A spokesperson for VA said the Biden-era policy was "politically motivated" and that the new proposed rule will bring VA "back in line with historical norms."

(Somasundaram, Washington Post, 8/4; Sherman, The Guardian, 8/4)

RFK Jr. says he's 'reviewing' whether to remove USPSTF members

HHS Secretary Robert F. Kennedy Jr. on Monday said he's "reviewing" whether to remove the members of the U.S. Preventive Services Task Force (USPSTF), which determines what cancer screenings and other preventive health measures insurers must cover. A decision hasn't been made yet.

In July, people familiar with the matter told the Wall Street Journal that Kennedy plans to remove all the members of USPSTF because he views them as too "woke." David Mansdoerfer, chief strategy adviser to the Independent Medical Alliance, a group of physicians aligned with Kennedy, said he's aware of people being considered for the panel.

Both Mansdoerfer and the person who spoke to STAT said the people under consideration for the task force are likely to more closely align with the Trump administration's goals related to restoring confidence in public health.

Mansdoerfer said that currently USPSTF is "M.D. heavy" and a new version of the panel is likely to include "allied health professionals," which are healthcare providers who aren't nurses or physicians, like physical therapists or dietitians.

During a press conference regarding the Supplemental Nutrition Assistance Program, Kennedy didn't rule out removing the members of USPSTF.

"The task force has done very little over the past five years, and we want to make sure it is performing, and it is approving interventions that are actually going to prevent the health decline of the American public. And it hasn't," Kennedy said. "We're looking at the personnel and we're making the decision now, but no decision has been made."

(Weixel, The Hill, 8/4)