CDC to fund new study on autism and vaccines

CDC is planning to award a contract to Rensselaer Polytechnic Institute (RPI) to investigate a potential link between vaccinations and autism. According to CDC, RPI "has unique ability to link children to maternal cohorts using proprietary databases and de-identified data sets, enabling advanced statistical analyses within the project's timeframe."

In a statement, an RPI spokesperson said the university "appreciates" CDC's intention to award it the grant. RPI also noted that Juergen Harn, director of the university's Center for Biotechnology and Interdisciplinary Studies, is well known for his research on autism, including risk factors for the condition.

Hahn "is renowned for the quality and rigor of his research," the university said. "If this project is awarded, he intends to publish the results of his work at the conclusion of the project."

According to Alycia Halladay, who oversees research activities and grants at the Autism Science Foundation, the funding notice raises several questions, including why RPI was specifically chosen since it does not have any special access to data on the topic and "wouldn't be the obvious choice."

Halladay also questioned why money was being spent on a study on vaccines and autism at all since there has been no evidence of increased autism rates among those who have been vaccinated compared with those who haven't.

"The question has been studied for 20 years, multiple times by researchers around the world using millions of people, and there has never been a credible association found between vaccines and autism," Halladay said.

However, despite numerous large studies disproving the link between autism and vaccines, vaccine skeptics, including HHS Secretary Robert F. Kennedy Jr., have continued to push the connection.

The funding for this study could be going to "other important research questions" on autism, including studies of genetics and environmental factors, Halladay said. "I think that's the most frustrating part."

(Weixel, The Hill, 9/12; Stobbe, Associated Press, 9/12)

CMS opens applications for $50B rural health fund

CMS has opened applications for the five-year, $50 billion Rural Health Transformation Program. Funding for the program was authorized by the One Big Beautiful Bill Act (OBBBA) to help mitigate the impact of upcoming Medicaid funding cuts on rural healthcare organizations.

The program will allocate $10 billion each year between 2026 and 2030, with half the money being equally distributed among all approved states and half being used at CMS' discretion to help strengthen rural providers and communities.

CMS has outline five strategic goals for the program, including:

• Making rural America healthy again by promoting preventive care and chronic disease management
• Improving rural providers' efficiency and sustainability
• Attracting and retaining healthcare workers for rural communities, with five-year service commitments
• Developing and implementing innovative payment models
• Improving access to digital tools, remote care, and other technologies

"We believe we can use this as an opportunity to pivot from the crisis that we are currently living in to the comeback that America expects from us," said CMS Administrator Mehmet Oz. "If we're going to be able to invest these monies wisely, we won't just have health care systems barely hanging on in rural America — they'll start to thrive."

The program allows CMS to take back funding from states depending on their performance. "If states don't perform, we have the ability to claw back some of that money and reallocate the states that are performing," Oz said. "This is not punitive. This is a very clever decision by the crafters of the law."

States have until Nov. 5 to apply for the program, and CMS will announce awardees by Dec. 31. This is the only opportunity states will have to apply for the program, and states will not be able to appeal application denials.

According to Fierce Healthcare, hospital groups have criticized the rural health fund, saying that it is insufficient to offset upcoming Medicaid cuts. Some lawmakers have also proposed increasing the fund from $50 billion to $100 billion.

In a recent analysis, the National Rural Health Association and Manatt Health estimated that the $50 billion fund would only address up to 88% of OBBBA's Medicaid cuts, but only if 100% of the funds were directed to rural hospitals and not other healthcare providers.

"Rural advocates are grateful for $50 billion," said Lisa Davis, director of the Pennsylvania Office of Rural Health. "But while $50 billion sounds like a lot of money, in looking at some of the issues that states need to address, it may not completely alleviate the situation."

(Muoio, Fierce Healthcare, 9/15; Weixel, The Hill, 9/15; Ollstein, Politico, 9/15)

FDA is also investigating the common practice of giving patients flu and COVID-19 vaccines at the same time. According to Vinay Prasad, FDA's top vaccine regulator, his team will require pharmaceutical companies conduct new clinical trials showing that coadministering multiple respiratory virus vaccines is safe and effective — something that outside experts have called unnecessary and potentially counterproductive.

Currently, studies show that there are no safety issues associated with coadministering flu and COVID-19 vaccines. In one CDC study, people who received a flu and COVID-19 vaccine at the same time were slightly more likely to have reactions, such as fatigue or headache, than people who only received a COVID-19 vaccine, but these reactions were mostly mild and quickly went away.

Although medical experts say FDA's memo doesn't prevent doctors or pharmacies from providing COVID-19 and flu vaccines at the same time, they are concerned that the increased scrutiny from top medical regulators will discourage coadministration and potentially decrease vaccination rates.

"For many, this inconvenience of having to return for a second visit just to get the other vaccine will deter them from getting that other vaccine," said L.J. Tan, chief policy officer for Immunize.org. "Access to vaccination suffers."

(Rudd, MedPage Today, 9/5; Diamond, et al., Washington Post, 9/3)

RFK Jr. appoints 5 new ACIP members ahead of meeting

On Monday, HHS Secretary Robert F. Kennedy appointed five new members to CDC's Advisory Committee on Immunization Practices (ACIP). Previously, it was reported that Kennedy was considering at least seven new ACIP members.

In June, Kennedy fired all 17 members of ACIP and replaced them with eight new appointees, several of whom had previously expressed skepticism about vaccines and their safety. Since then, one member has left. With the five newly appointed members, ACIP now has a total of 12 members.

The five new members include:

• Evelyn Griffin, an ob/gyn at Baton Rouge General Medical Center. Griffin has expressed vaccine skepticism and in 2023 testified against Louisiana's decision to add COVID-19 to the school immunization schedule.
• Catherine Stein, a professor at Case Western Reserve University who focuses on infectious disease epidemiology and population health. During the COVID-19 pandemic, Stein testified in support of bills that would allow Ohio lawmakers to vote against public health orders, as well as a "Truth in COVID Statistics" bill.
• Kirk Milhoan, a pediatric cardiologist who reportedly has ties to Children's Health Defense, an anti-vaccine group founded by Kennedy. Milhoan has advocated against COVID-19 vaccines for children and supported failed COVID-19 treatments like ivermectin and hydroxychloroquine.
• Hillary Blackburn, a pharmacist and a director of medication access and affordability at Ascension.
• Raymond Pollak, a semi-retired transplant surgeon with a background in immunology. According to HHS, Pollak has published over 120 peer-reviewed articles and been a principal investigator on NIH transplant biology grants and drug trials.

"ACIP safeguards the health of Americans by issuing objective, evidence-based vaccine recommendations," Kennedy said. "Its new members bring diverse expertise that strengthens the committee and ensures it fulfills its mission with transparency, independence, and gold-standard science."

Currently, ACIP is scheduled to meet Sept. 18 and 19, and members are expected to discuss vaccinations for measles, mumps, rubella, and varicella (MMRV), hepatitis B, and COVID-19.

(Mandavilli, New York Times, 9/15; Cirruzzo, et al., STAT, 9/15; Fiore, MedPage Today, 9/15)