FDA's Surprising COVID Vaccine Change Impacts Millions—What You Need to Know

Yahoo

28-05-2025

The FDA has updated COVID-19 vaccine regulations.
Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots.
FDA officials are asking for more data around the vaccine's effectiveness for people who are otherwise healthy.
The U.S. Food and Drug Administration made a surprising move last week, announcing that the agency will limit the use of the COVID-19 vaccine to certain groups. The changes are expected to go into effect in the fall. Just this week, the Centers for Disease Control and Prevention (CDC) will no longer recommend that pregnant people and healthy children get the COVID-19 vaccine (note: The CDC still lists pregnant people as high-risk for COVID-19 complications—more on this below).
The new regulations were laid out in an article published in The New England Journal of Medicine titled, 'An Evidence-Based Approach to Covid-19 Vaccination.' In the article, FDA vaccine division chief Vinay Prasad, M.D., and FDA commissioner Martin Makary, M.D., wrote that the American policy with COVID-19 booster shots is the 'most aggressive' compared with policies in European nations.
'The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,' the article reads. 'We reject this view.'
The FDA usually authorizes or approves vaccines for use, while the Centers for Disease Control and Prevention (CDC) specifies recommendations on how they should be used under the guidance of the Advisory Committee on Immunization Practices (ACIP). The FDA dictating how vaccines should be used is a different approach, points out William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine.
Meet the experts: Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York, William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine; infectious disease specialist Amesh Adalja, M.D., senior scholar at Johns Hopkins University Center for Health Security
The change seems to be political, given that there is a new administration in place and no new data has been released on side effects, safety, or effectiveness of these vaccines.
But what are the new FDA COVID vaccine regulations, and what does this mean for the future of COVID care? Here's the deal.
Until now, government health agencies have recommended that everyone over the age of 6 months get an annual COVID-19 vaccine. The vaccine is tweaked each year to try to match up with circulating strains of the virus and to provide the most protection.
But the new regulations will limit the use of the vaccine to people aged 65 and up, along with people over the age of 6 months who have certain medical conditions. The list of qualifying medical conditions is long, and includes more obvious things like asthma, cancer, pregnancy, and chronic lung diseases. But it also includes things like physical inactivity and mood disorders, opening the vaccine up to a wide range of people.
The FDA may now require more studies before approving COVID-19 vaccines for healthy Americans under the age of 65, according to the paper.
The article makes the argument that these changes are more in line with what the rest of the world is doing. 'All other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19,' the FDA officials write. 'The United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months.'
'The strategy in the paper aligns with what other countries have done with updated COVID vaccines in the current context of a heavily immune population,' says infectious disease specialist Amesh Adalja, M.D., senior scholar at Johns Hopkins University Center for Health Security. 'It importantly demarcates high-risk from low-risk individuals when it comes to how to think about the value of COVID vaccines and what types of studies are most likely to answer questions about that value in these populations.'
Other than those over 65 years of age, the FDA specifically flagged these groups and conditions, among others not listed, as qualifying for the COVID-19 vaccine in the future:
Asthma
Cancer
Cerebrovascular disease
Chronic kidney disease
Chronic lung disease
Chronic liver disease
Cystic fibrosis
Diabetes (type 1 and type 2)
Gestational diabetes
Disabilities, including Down syndrome
Heart conditions
HIV
Mental health conditions
Dementia
Parkinson's disease
Obesity
Physical inactivity
Pregnancy and recent pregnancy
Primary immunodeficiency
Smoking, current and former
Solid organ or blood stem-cell transplantation
Tuberculosis
Use of corticosteroids or other immunosuppressive medications
Note: While the CDC still specifies pregnancy as a condition that puts people at high risk for COVID complications, the CDC will no longer recommend routine COVID shots for pregnant women and healthy children, Health and Human Services Secretary Robert F. Kennedy Jr. recently announced on X.
Yes, the COVID vaccines are still considered safe. This paper did not conduct or call out any new research around these vaccines.
'This vaccine is extremely safe,' says Thomas Russo, M.D., professor and chief of infectious disease at the University at Buffalo in New York.
According to the CDC, the most common side effects of both Pfizer and Moderna vaccines include pain at the injection site, fatigue, headache, muscle and joint pain, and fever. 'During the COVID-19 pandemic, COVID-19 vaccines underwent the most intensive safety analysis in U.S. history,' the CDC's website reads. 'COVID-19 vaccines continue to be monitored for safety, even after FDA approval, to make sure they continue to meet FDA's standards for safety and effectiveness.'
There hasn't been recent data on the effectiveness of the COVID-19 vaccines, but data from clinical trials when the vaccines were first released (which now dates back five years) showed that the Pfizer vaccine was 95% effective at preventing COVID-19, while the Moderna vaccine was 94.1% effective. Studies conducted on the Novavax vaccine found that it was 90% effective at preventing people from developing the virus and 100% effective at protecting people from severe disease.
There is a mixed reaction, although doctors as a whole don't seem shocked. 'We have to look at the reality: In 2024-2025, only a very small portion of the population availed themselves of the vaccine,' Dr. Schaffner says. As a result, he says that changing the requirements to get the vaccine is unlikely to have a big impact on the population.
'If the goal is to prevent severe disease, targeting vaccines to high-risk individuals is the optimal strategy,' Dr. Adalja says. 'For lower risk individuals, the goal has always been less clear as protection against infection is transient and as they don't have a risk for severe disease, the cost-effectiveness of a vaccine that, at this stage, chiefly protects against severe disease doesn't apply.'
But Dr. Adalja says that the initial COVID-19 vaccine series 'should be part of routine childhood immunization.' He also points out that it's 'unclear' if new clinical trials will be needed to show that there's value for young children to receive the vaccine.
Dr. Russo has concerns that the new regulations seem to have a 'double standard that's not based in science' for the COVID-19 and influenza vaccines, both of which target viruses that change seasonally. 'Interestingly, this does nothing for the influenza vaccination, and we get annual boosters for that to target the circulating strains,' he says. 'They seem to think it's fine for influenza but, when you compare it to influenza, COVID remains a more severe disease.'
It's not clear at this point if the FDA plans to alter regulations around other vaccines in the future.
If you want to get the COVID-19 vaccine in the future but you don't fall into a vulnerable group, doctors say you probably still can. 'It will likely be the case, as it is for other vaccines, that they can be administered off-label to those who want them—with an out-of-pocket charge,' Dr. Adalja says.
Dr. Russo points out that the criteria for getting the vaccine is 'fairly liberal,' though. 'The way this is phrased, most Americans can make claims to this vaccine if they really want it,' he says.
Again, this is an unusual approach to recommendations around vaccination in the U.S. But the next meeting of the ACIP is in late June, and will likely address next steps on how the COVID vaccine will be used. 'We just have to wait until June,' Dr. Schaffner says.
As of this second, though, the CDC still recommends that everyone over the age of 6 months get vaccinated against COVID-19.
This article is accurate as of press time. However, as guidelines evolve, some of the information may have changed since it was last updated. While we aim to keep all of our stories up to date, please visit online resources provided by the CDC, WHO, and your local public health department to stay informed. Always talk to your doctor for professional medical advice.
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