FDA Approves Updated Covid-19 Vaccines for Higher Risk Groups; Limited Access for Children and Infants
The US Food and Drug Administration (FDA) has authorized updated COVID-19 vaccines for a specific demographic, primarily adults aged 65 and above, as well as individuals with underlying health conditions who are at higher risk from the virus.
On Wednesday, US Health and Human Services Secretary Robert F. Kennedy Jr. announced that Moderna (for individuals aged 6 months and older), Pfizer (for those aged 5 years and above), and Novavax (for patients aged 12 and up) vaccines are now approved for use in these high-risk groups.
The updated vaccines aim to combat the latest strains of COVID-19 that have been circulating more frequently.
Secretary Kennedy, who had previously pledged to maintain vaccine availability for vulnerable individuals, acknowledged that the narrower approval may impact accessibility to COVID-19 vaccinations for those who had previously easily obtained them.
While infants and young children remain highly susceptible to severe illness from COVID-19, securing vaccines for this age group may prove challenging. During the last respiratory virus season, there were approximately 48 hospitalizations per 100,000 children under five – a rate nearly seven times higher than older children and more than double that of adults under 50.
Following Wednesday’s announcement, Emergency Use Authorizations (EUA) for COVID-19 vaccines have been revoked, meaning Pfizer’s Comirnaty vaccine is no longer authorized for use in children under 5 years old. Moderna’s Spikevax vaccine is approved for those as young as 6 months, but only if they have an underlying condition that increases their risk. The FDA has already approved Novavax’s COVID-19 vaccine – the sole protein-based, non-mRNA vaccine available in the US – but only for individuals aged 65 and older and those 12 years and above with at least one underlying health condition that heightens their risk of severe illness.
Critics argue that these new FDA decisions compromise science-driven policy and limit vaccine access, potentially posing a threat to millions of Americans’ health. Fatima Khan, co-founder of the nonprofit grassroots group Protect Their Future, expressed concern over the restricted availability of safe, evidence-based vaccines for children.
FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, have previously stated that there is insufficient evidence to support the clinical benefits of regular COVID-19 shots for healthy children and adults. They urged further placebo-controlled trials, particularly in adults aged 50 to 64, before recommending the vaccines for broader use.
An FDA spokesperson clarified that the decision does not affect access to these vaccines, assuring they remain available to those who choose them after consulting with their healthcare provider.
According to the Centers for Disease Control and Prevention (CDC), several health conditions elevate the risk associated with COVID-19, including lung, heart, and kidney conditions; obesity; cancer; HIV; and pregnancy.
While vaccines may be accessible off-label for healthy younger individuals, Dr. Tina Tan, president of the Infectious Diseases Society of America, stated that the new FDA decision contradicts the existing evidence base, undermines trust in science-driven policy, and restricts vaccine access, potentially putting millions of Americans at increased risk of severe COVID-19 outcomes.
The American Academy of Pediatrics has expressed concern over the FDA’s recent actions, as they may pose a barrier to vaccination for parents seeking to protect their children. Dr. Susan Kressly, president of the organization, emphasized that shared decision-making between parents and pediatricians is essential to ensure children’s long-term health.
Prior to this announcement, the CDC had stopped recommending COVID-19 vaccines for healthy children or pregnant women, and the immunization schedule was updated accordingly. However, last week, the American Academy of Pediatrics broke from the CDC to recommend COVID-19 shots for infants and young children. The American College of Obstetricians and Gynecologists also reaffirmed support for COVID-19 vaccination during pregnancy.
COVID-19 transmission has been on the rise in the US, with most states reporting increased cases according to CDC data. Preliminary wastewater surveillance suggests that virus levels are currently approximately half of what they were during last summer’s peak, matching the peak from the summer of 2023. However, epidemiologist Caitlin Rivers noted that there are no signs of a slowdown, indicating that activity will likely continue to increase in the weeks ahead.
During the first week of August, there were approximately 1.7 COVID-19 hospitalizations per 100,000 people, with the highest rates among seniors and children under five.