FDA Restricts COVID-19 Vaccines to Seniors and High-Risk Individuals

The Food and Drug Administration (FDA) has implemented a new policy that restricts access to COVID-19 vaccines to seniors aged 65 and above, as well as individuals with specific medical conditions that heighten their risk of severe disease. This change means that many Americans without underlying health issues may not have access to updated COVID-19 vaccine shots this fall. The new policy mandates that vaccine manufacturers conduct extensive new clinical trials before approving shots for broader use, including randomized, placebo-controlled trials for individuals between the ages of 6 months and 64 years old.

Dr. Vinay Prasad, the FDA's new top vaccines official, and FDA Commissioner Dr. Martin Makary detailed this new regulatory framework in an article published in The New England Journal of Medicine. They criticized the previous "one-size-fits-all" regulatory approach, which granted broad authorization for past COVID-19 vaccine boosters. According to them, this approach led to poor uptake of past annual COVID-19 booster shots and did not account for the varying levels of risk among different age groups and health conditions. They also noted that other developed countries have already limited annual COVID-19 vaccine boosters to only older adults and those with underlying conditions that increase their risk of severe disease.

Under the new policy, vaccine manufacturers will only be able to get their routine COVID-19 vaccine updates approved for seniors and people with underlying medical conditions, such as pregnancy or diabetes. The range of diseases considered high risk includes conditions like obesity and mental health issues such as depression. The FDA is also encouraging new trials in children under 5 and adults between the ages of 50 and 64, where the balance of benefits and risks is uncertain.

Prasad emphasized that the new policy aims to strike a balance between ensuring rapid access for vulnerable populations and requiring evidence for those at average or low risk. "I think we have a really good balance between vulnerable people, that people still at high risk will still have a rapid path to access, but people at average risk and low risk, they need evidence," Prasad said. The new policy comes ahead of a key meeting of the agency's outside vaccine advisers to decide on how to update the strain used in next season's shots.

The FDA's new leadership under Health and Human Services Secretary Robert F. Kennedy Jr. has laid out a different standard for COVID-19 shots, citing differences in how the virus mutates and the immunity offered by vaccines and previous infection. They believe that requiring brand new randomized trials of the vaccines tested against a placebo to show it prevents symptomatic disease is necessary. This process is usually only required for new shots when there is no currently approved immunization available.

Pfizer, one of the leading vaccine manufacturers, stated that it is evaluating the details shared by the FDA and is in ongoing talks with the agency. The company emphasized its commitment to the science behind the Pfizer-BioNTech COVID-19 vaccine and its belief in the importance of broad vaccination programs. Moderna also expressed its commitment to working with the FDA to provide the necessary data to ensure access for Americans. Novavax, which recently earned a narrow FDA approval for its COVID-19 vaccine, declined to comment on the new policy.

The new policy may affect access and limit insurance coverage for vaccinations, as U.S. health care providers are usually allowed to administer vaccines with FDA approval "off-label" outside the limits laid out by the agency. The Centers for Disease Control and Prevention (CDC) has also been weighing narrowed recommendations for the shots, which directly impact which vaccinations health insurers are required to cover under the law.