CDC's Covid shot shift for pregnant women slammed
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Driving The Day
COVID VAX PUSHBACK — The Trump administration's decision to pull the Covid-19 vaccine from the CDC's list of recommended shots for healthy pregnant women was immediately questioned by public health groups that say the immunization is a critical tool to protect mothers and newborn infants.
HHS Secretary Robert F. Kennedy Jr. also said the CDC would no longer recommend the shots for healthy children — a position that drew less criticism — but opened questions about whether access to the shots could erode.
'We're now one step closer to realizing President Trump's promise to make America healthy again,' Kennedy said in a video posted on social platform X, standing beside FDA Commissioner Marty Makary and NIH Director Jay Bhattacharya.
It also bucks the recommendations of several European countries, ranging from Denmark to France, and the World Health Organization.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the group is concerned and extremely disappointed by the decision. He pointed to data showing that newborns can benefit from maternal antibodies from the vaccine for protection from Covid.
'In fact, growing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalized infants less than 6 months of age — those who are not yet eligible for vaccination — born to unvaccinated mothers,' Fleischman said.
The Society for Maternal-Fetal Medicine said it will continue to recommend that pregnant patients take the Covid vaccine because surveillance data 'clearly demonstrates the safety and efficacy of mRNA vaccines in pregnancy.'
'Maternal immunization is proven to protect patients and their infants against severe illness and death from infectious diseases,' the group, a medical professional society for obstetricians, said in a press release.
Insurance companies typically align their coverage decisions with the recommendations from the CDC and its outside panel of vaccine advisers. But the Advisory Committee on Immunization Practices did not vote on the change announced by Kennedy on Monday.
AHIP spokesperson Tina Stow said the insurer trade group is 'reviewing today's announcement closely' when asked whether any insurers it represents plan to alter coverage of the Covid vaccine.
On Capitol Hill, the decision was also questioned by a top Democrat.
'This reckless decision by the Trump Admin will make it harder for people to access the vaccine, but not impossible or illegal,' Rep. Frank Pallone (D-N.J.), ranking member of the Energy and Commerce Committee, posted on X. 'Please talk to your doctor and health care providers about your options.'
IT'S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Do you have insight into how the decision to alter the CDC's vaccination schedule was made?
Send your tips to David Lim (dlim@politico.com, @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@politico.com, @Gardner_LM or gardnerlm.01 on Signal).
Eye on the FDA
MAKARY LAUNCHES PHARMA TOUR — The Trump administration hasn't endeared itself to the pharmaceutical industry — but FDA Commissioner Marty Makary and other top agency officials are kicking off a national tour to meet with drugmaker executives next week at the agency's headquarters.
The series of meetings will be held in major biotech cities across the U.S. — think Boston, New York, San Diego and San Francisco — in the coming weeks.
The goal? Meeting with the executives to get input on 'how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.'
The FDA is collecting registrations from firms with at least one investigational new drug, new drug application or a biologics license application actively on file.
Makary is bringing his number two, FDA Principal Deputy Commissioner Sara Brenner, and top vaccine regulator Vinay Prasad to the meetings.
AI ON THE MIND — The FDA has brought on Dr. Shantanu Nundy, former chief medical officer for care navigator Accolade Health, to lead its artificial intelligence policy work, Ruth reports.
Nundy is the latest addition to the agency's growing roster of AI leadership.
The FDA has already hired senior adviser Jeremy Walsh, formerly of government contractor Booz Allen Hamilton, to lead the FDA's broader AI efforts. It also rehired Sri Mantha, former director of the Center for Drug Evaluation and Research's Office of Strategic Programs, after he was cut as part of President Donald Trump's reduction in force. Now, Nundy has joined as a contractor to lead development of FDA's AI-related guidance and regulations.
Nundy, a primary care physician who studied medicine at Johns Hopkins University, has known Makary for some 20 years. The two wrote an op-ed in 2021, arguing that the CDC was not adequately guiding businesses on how to safely bring staff back to work. Separately, Nundy has advocated for making data from the CDC's vaccine-safety reporting platform V-safe, public to help combat vaccine hesitancy.
He has spent much of his career in startups trying to bring the health care industry into the digital age. Before Accolade, he was director of the nonprofit arm of the Human Diagnosis Project, an Andreessen Horowitz-backed platform where doctors can consult one another on medical diagnoses and treatments.
Research Corner
KENNEDY BASHES MEDICAL JOURNALS — HHS Secretary Kennedy has threatened to stop government scientists from publishing their work in major medical journals as part of his escalating war on institutions he says are influenced by pharmaceutical companies.
Speaking on the 'Ultimate Human' podcast Tuesday, Kennedy said The New England Journal of Medicine, JAMA and The Lancet, three of the most influential medical journals in the world, were 'corrupt' and publish studies funded and approved by pharmaceutical companies.
The remarks come after FDA Commissioner Makary chose to publish a framework for how his agency will review Covid vaccines moving forward in NEJM last week. It also comes after JAMA and NEJM received letters from the Department of Justice probing them for partisanship.
A JAMA spokesperson said the journal had nothing to add when asked about Kennedy's remarks, while NEJM and The Lancet did not respond to requests for comment. HHS also did not respond to requests for comment.
WHAT WE'RE READING
Young scientists are reconsidering their career opportunities and abandoning research amid drastic cuts to NIH grants, The Boston Globe's Chris Serres and STAT's J. Emory Parker report.
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