• The FDA Plans to Limit COVID-19 vaccine approvals mainly to older adults and high-risk individuals.
• Vaccine makers must conduct more rigorous trials for healthy younger groups before approval.
• The change aims to improve public trust, but raises concerns about protecting children and long-term effects.

The FDA is changing how it approves COVID-19 vaccines in the United States. From now on, the FDA Plans to Limit COVID-19 shots to older adults and people with medical conditions that increase their risk of serious illness. Healthy adults and children may no longer have access to updated vaccines under this new approach. Doctors Vinay Prasad and Marty Makary argue that current evidence does not show clear benefits for healthy children and adults from regular COVID-19 shots. They want vaccine makers to conduct more placebo-controlled trials, especially in adults aged 50 to 64, before recommending vaccines to wider groups.

Vaccine Makers Face Costly and Slow Trial Demands

The FDA wants vaccine companies like Pfizer, Moderna, and Novavax to run expensive randomized controlled trials in certain age groups. These studies take many months or even years to complete. Moderna said it supports the FDA Plans to Limit COVID-19 vaccine approvals and will provide the data needed. However, Pfizer and Novavax have not publicly commented on the new requirements. Just before this announcement, the FDA approved the Novavax vaccine, but limited its use to people 65 and older or those 12 and up with health risks. Novavax’s CEO, John Jacobs, explained that older adults and people with medical conditions are the main groups seeking COVID-19 vaccines seasonally.

FDA Questions Benefits for People Aged 50 to 65

Dr. Prasad explained the reasoning behind focusing on certain age groups. For people aged 50 to 65, the FDA is unsure if vaccines provide a clear benefit. Different countries recommend vaccines for this group at different ages—some say 40 and older, others 65 and older. Prasad said this age range is an area with global disagreement. He hopes more data will clarify whether vaccines help these people. Dr. Noel Brewer from the University of North Carolina supports the FDA’s new approach. He believes aligning U.S. policy with other countries is a positive step. Still, experts remain worried about very young children, especially those under age 2, who face higher COVID-19 hospitalization rates.

Some Experts Disagree Strongly with New Approach

Dr. Paul Offit from Children’s Hospital of Philadelphia strongly disagrees with the FDA’s new vaccine framework. He argues that the U.S. has used good evidence to recommend vaccines so far. Offit says mRNA vaccines are very safe and effective. He worries the FDA wrongly assumes we don’t already have strong data. Offit believes the current vaccine recommendations have helped protect many people safely. Meanwhile, Dr. Jodie Guest from Emory University warns that restricting vaccine access could lead to more COVID-19 variants. She also says this policy may worsen health inequalities and make vaccines harder to insure.

FDA Will Use Faster Approval for High-Risk Groups

For older adults and people with high-risk conditions, the FDA will approve COVID-19 vaccines based on immunobridging studies. These studies test whether vaccines produce enough antibodies to fight the virus. Immunobridging studies can happen quickly and in smaller groups. This method is similar to how flu vaccines get approved each year. It helps vaccine companies prepare shots in time for expected COVID-19 waves during the fall and winter. Indeed, the FDA Plans to Limit COVID-19 vaccine approvals for other groups will require strong evidence.

Stricter Evidence Needed for Vaccines in Healthy People

For everyone else, the FDA requires stronger evidence before approval. Vaccine makers must show through placebo-controlled trials that the shots reduce symptomatic COVID-19 better than no vaccine. They will also look at whether vaccines reduce severe illness, hospitalizations, and deaths. However, the FDA’s new plan does not consider long-term effects like long COVID. This decision worries some experts who point out that vaccines can lower the risk of long COVID and other serious complications such as heart attacks and strokes.

Vaccines Also Protect Vulnerable Loved Ones

Some healthy people choose to get vaccinated to protect family and friends with weaker immune systems. The FDA’s new approach does not address this benefit. Experts say this could leave many without access to vaccines, even if they want to protect vulnerable people close to them. Prasad and Makary say that the FDA Plans to Limit COVID-19 vaccine access aim to speed up vaccine approval for the most vulnerable while collecting better evidence for other groups. They also note that millions of Americans younger than 65 will still qualify for vaccines if they have certain CDC-listed health conditions.

Millions Still Eligible, But Verification May Be Tricky

The FDA estimates between 100 and 200 million Americans will qualify for COVID-19 vaccines under the new rules. But many people get vaccinated at pharmacies or other places outside doctor’s offices. It remains unclear who will verify whether someone truly has a high-risk condition. Dr. Offit questioned whether pharmacists will require proof or ask about health status. He doubts pharmacies will closely check if patients meet risk criteria before giving vaccines.

Public Trust and Vaccine Uptake Remain Challenges

Prasad and Makary want this new policy to restore trust in vaccines. They argue that broad vaccine recommendations and mandates during the pandemic may have caused some people to lose trust and avoid all vaccines. However, Offit disagrees. He believes vaccination rates dropped because many people no longer fear COVID-19. He also points to “booster fatigue” — a feeling of tiredness from repeated vaccine recommendations over the past few years. According to Offit, the drop in vaccine use has little to do with trust.