The Trump administration has just announced it will limit seasonal COVID-19 vaccine approvals to the elderly and high-risk groups, while awaiting more data on other groups. This raises the question of whether non-prioritized individuals who still wish to receive vaccines in the fall will have access.
According to the new guidelines from the FDA, vaccines will still be fast-tracked for individuals aged 65 and older, children, and adults with underlying conditions. However, for healthy individuals, the FDA requires vaccine companies to conduct large-scale and extended clinical trials before being granted market approval. This is a major change from the previous policy recommending annual COVID boosters for all individuals aged 6 months and older.
Dr. Vinay Prasad – a new vaccine expert joining the FDA – calls this a "reasonable compromise solution," allowing continued protection for high-risk groups while collecting data on real-world effectiveness in healthy individuals. He believes there is still no clear answer as to whether those who have received 6-7 COVID vaccine doses should continue to get more.
Some experts like Dr. Paul Offit raise the issue that the new guidelines may create difficulties for the public when seeking vaccinations: who will determine if they belong to a high-risk group? If the vaccine is no longer widely covered by insurance, people's choices – especially parents wanting to protect their children – may be limited.
Data from the CDC shows that last year, COVID-19 was still the cause of more than 47,000 American deaths, including 231 children. This indicates that the virus remains a significant health threat.
The FDA's new guidelines come in the context of Health Secretary Robert F. Kennedy Jr. making numerous moves to reconsider vaccine policy and tighten approval standards. Two days later, the FDA will hold a meeting with outside vaccine experts for further discussion.
Last week, the FDA approved Novavax's vaccine but with many restrictions on the target population – similar to what was just announced. Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) – the two main COVID vaccine manufacturers – stated they will continue to collaborate with the FDA to adapt to the new policy.
Previously, the public was encouraged to receive annual COVID vaccines just like seasonal flu shots. But with the new guidelines, the FDA will no longer automatically approve new vaccines solely based on their ability to generate immunity equivalent to the previous year's vaccine. Instead, companies will need to conduct trials on healthy individuals aged 50-64, monitoring effects on severe disease, hospitalization, and death. If a significant new virus variant emerges, this process may need to be repeated. Companies can still request permission to test vaccines on younger individuals or children.
Since taking office in February, Kennedy has appointed several figures critical of the government's vaccine policy to agencies like the FDA, including Prasad and FDA Director Marty Makary. These two argue that America's 'one size fits all' policy is inappropriate, suggesting a strategy similar to Europe – only booster shots for the elderly or those at risk.
However, the FDA's announcement of new policy in a medical journal rather than through the usual public comment process has sparked controversy and may violate administrative regulations.
Some experts agree that the necessity of annual COVID vaccination for everyone needs to be reconsidered. In June, the CDC advisory council will further discuss which groups should be recommended for vaccination.
Dr. Offit warns that the FDA acting before the CDC makes recommendations could disrupt the operational process. Nevertheless, he also emphasizes that studies from the CDC have shown that booster shots still provide short-term protection (4-6 months) against mild to moderate symptoms, even in healthy individuals.
