US FDA Restricts COVID-19 Vaccine Access for Under-65s

The US Food and Drug Administration (FDA) has revised its COVID-19 vaccine eligibility criteria, allowing access to updated vaccines exclusively for individuals aged 65 and older and restricting access for those under 65 to only those with specific health risks. This decision, announced on August 27, 2023, marks a significant shift in vaccine distribution compared to previous years, when broader eligibility was in place for much of the population.

Three updated vaccines received approval: those manufactured by Pfizer in collaboration with BioNTech, Moderna, and Novavax with Sanofi. A spokesperson from the US Department of Health and Human Services (HHS) emphasized that the decision does not limit access for those who still wish to consult with their healthcare providers regarding vaccination.

Children’s Access Limited

In a notable change, Pfizer has had its emergency use authorization for its COVID-19 vaccine for children under five rescinded, potentially restricting access for pediatric healthcare providers. Meanwhile, the FDA has approved Moderna’s updated Spikevax vaccine for individuals aged six months and older, provided they have at least one underlying health condition. Similarly, the updated Comirnaty vaccine from Pfizer and BioNTech has been cleared for those aged 5 to 64 with high-risk conditions. The Novavax vaccine has also gained approval under the same criteria for individuals aged 12 to 64. Importantly, all three vaccines remain available without restrictions for those aged 65 and older.

Concerns Over Access and Coverage

The narrowing of eligibility has raised concerns regarding insurance coverage and public access to vaccines. Former FDA chief scientist Jesse Goodman highlighted potential issues, stating, “Will insurance cover it? Will access be complicated and difficult? If people have to pay for it or are worried they have to pay for it, that will certainly decrease use.”

This policy shift occurs under the direction of Robert F. Kennedy Jr., the US Health Secretary and a long-time vaccine skeptic. Kennedy announced the approvals via a post on the social media platform X and has made significant changes to US health policy, including the dismissal of all 17 members of the expert panel at the Centers for Disease Control and Prevention (CDC) that advises on vaccine usage. In a move that has raised eyebrows, he also withdrew USD 500 million in funding for messenger RNA vaccines, advocating instead for “safer, broader vaccine platforms.”

The implications of these changes are yet to be fully understood, particularly regarding the impact on public health and vaccination rates in a country where COVID-19 continues to pose a health challenge. As the updated vaccines become available, many will be looking closely at how these new guidelines will affect access and public willingness to receive vaccination.