FDA announces plans to restrict access for COVID vaccines

Yahoo

21-05-2025

The U.S. Food and Drug Administration plans to change its recommendations for getting a COVID-19 vaccination, suggesting the vaccine for those 65 and older and for those older than 6 months of age who have health conditions that make severe COVID-19 symptoms a risk.
Those who don't fit one of the categories likely will not have access.
'For all healthy persons — those with no risk factors for severe COVID-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes" before licensing will be granted, according to an article published Tuesday in the New England Journal of Medicine.
Manufacturers who make the vaccine for the high-risk group will be encouraged to do the trials for healthy populations as part of their 'postmarketing commitment,' per the New England Journal article, written by Dr. Martin A. Makary, who heads the FDA, and Dr. Vinay Prasad, head of the Center for Biologics Evaluation and Research at the FDA. That organization approves or rejects vaccine licensing applications.
'The views expressed in this article represent the policy position of the Food and Drug Administration,' they wrote.
It's likely lots of people won't mind the new policy, given dwindling uptake of annual boosters. The two wrote that in the last two seasons, 'uptake of the annual COVID-19 booster has been poor,' citing Centers for Disease Control and Prevention statistics. Fewer than a quarter of Americans receive boosters, 'ranging from less than 10% for children younger than 12 years of age in the 2024-25 season to 50% of adults over 75 years old.'
The report notes that vaccine hesitancy has affected 'even vital immunization programs such as for measles-mumps-rubella (MMR) vaccination, which has been clearly established as safe and highly effective.'
The goal, per the FDA officials, is 'evidence-based' COVID-19 booster recommendations.
During a media briefing, Prasad said the approach aligns the U.S. with that of other high-income countries and will help improve trust in vaccines.
The list of underlying medical conditions that increases risk of severe symptoms should someone catch the novel coronavirus infection is quite long. It includes asthma, cancer, cerebrovascular disease, chronic kidney disease, chronic liver disease, chronic lung disease, cystic fibrosis, diabetes of all types (including gestational), disabilities, heart conditions, HIV, specific mental health conditions (just mood disorders including depression and schizophrenia spectrum disorders), neurological conditions (only dementia and Parkinson's disease), obesity, physical inactivity, pregnancy and recent pregnancy, primary immunodeficiencies, smoking or a history of it, organ or stem-cell transplant, tuberculosis and use of immunosuppressant medications or corticosteroids.
The report notes the need to balance competing evidence while providing access to as many as 100 to 200 million Americans.
'We simply don't know whether a healthy 52-year-old woman with a normal (body mass index) who has had COVID-19 three times and has received six previous doses of COVID-19 vaccine will benefit from a seventh dose,' the two FDA officials said, noting the change would 'compel much-needed evidence generation.'
'I find it refreshing to see the clarity in these guidelines,' Rick Bright, a former federal vaccine official, told NPR. 'The FDA is signaling a major departure from the one-size-fits-all approach that's largely defined the U.S. vaccination policy until now. Not everyone is at equal risk and public policy should reflect that reality.'
NPR noted worry by some that 'the regulatory move sends the misleading message that the vaccines have not been adequately evaluated and that it would limit the availability of the vaccines because insurers would no longer pay for the shots for everyone.' Critics also said it's an unneeded move for vaccines that are 'safe and effective.'
And some worry about long COVID, which impacts younger people as well as older people.
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told NPR the move violates U.S. Health and Human Services Secretary Robert F. Kennedy's promise not to take vaccines away from anyone. If insurers won't pay, Osterholm said, then many won't be able to afford them.
CNN reported that it's not clear if manufacturers will commit to the trials being sought, as they cost a lot and take time. The New York Times reported that an FDA spokesman said the clinical trials 'would be required, not just recommended or anticipated.'
CNN noted the change is already becoming apparent. 'Just days before the FDA's announcement, it approved the Novavax COVID-19 vaccine, which was six weeks past its planned approval deadline. The FDA restricted the use of the vaccine to people 65 and older and those 12 and up with underlying health conditions.'
Per the Associated Press, 'Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year. The virus was the underlying cause for two-thirds of those and it was a contributing factor for the rest. Among them were 231 children whose deaths were deemed COVID-related, 134 of them where the virus was the direct cause — numbers similar to yearly pediatric deaths from the flu.
Per the Times, 'Deaths from COVID have fallen each year since the start of the pandemic, but there were still roughly 1,000 deaths per week last winter, most of them in adults 75 and older. In the year ending in August, the CDC reported 150 pediatric deaths, a number comparable to deaths among children in a typical flu season.'