The American Academy of Pediatrics called the decision to limit children’s access to COVID-19 vaccines “deeply troubling.”
The FDA has approved updated COVID-19 vaccines from Pfizer, Moderna and Novavax, but with key limitations: The shots can only be used in adults 65 years and older and younger people who are at elevated risk of severe outcomes.
There are some minor differences across the three Wednesday approvals, particularly as it pertains to use in the at-risk younger population.
Novavax’s protein-based vaccine can only be given to individuals aged 12 through 64 years, while Pfizer and BioNTech’s ’s mRNA-based Comirnaty can be given to children as young as 5 years. (This is the first time that Comirnaty will receive full approval for children, for whom the vaccine was only previously under emergency use authorization). Two of Moderna’s updated vaccines were approved on Wednesday. The first, mNEXSPIKE, is indicated for those 12 through 64 years, while the second, Spikevax, has a broader coverage of 6 months through 64 years.
In a statement on Wednesday, American Academy of Pediatrics president Susan Kressly blasted the decisions, noting that limiting children’s access to vaccines is “deeply troubling.”
“As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families,” she said. The AAP continues to recommend COVID-19 immunization for “all children ages 6 months through 23 months.” Parents who want their children immunized should also have that option and access to the vaccine, Kressly said.
In a note to investors on Wednesday evening, investment analysts at William Blair noted that “Despite rhetoric that [Health Secretary Robert F. Kennedy Jr.'s] HHS could consider terminating COVID-19 vaccine use,” Wednesday’s approvals are largely consistent with previous guidance issued by the FDA in May focused on seniors and high-risk populations. These approvals signal that FDA is “maintaining autonomy” and continuing to uphold “data-driven science decisions on vaccine approvability.” This, the analysts continued, is “important for industry integrity as a whole, regardless of any negative political sentiment.”
Wednesday’s approvals are the latest in a spate of vaccine policy changes enacted by Kennedy. In May, for instance, the Secretary removed routine COVID-19 vaccination for healthy children and healthy pregnant women from CDC recommendations. Kennedy’s moves have also engendered controversy within the CDC. Late Wednesday evening, CDC director Susan Monarez was fired by the White House at Kennedy’s urging, in part because she refused to support rescinding certain approvals for COVID-19 vaccines without first consulting her advisors.
It is unclear when the previous formulations of these vaccines will be phased out, and at which point these newly updated shots will become unavailable to those who fall outside the CDC’s guidelines. There also remain uncertainties over payer coverage for these vaccines, and whether doctors will be able—or willing—to prescribe these shots off-label to people who want them.
Wednesday’s approvals will now go to the CDC’s Advisory Committee on Immunization Practices, which, according to William Blair, will convene by the end of September to discuss recommendations for COVID-19 vaccination. Kennedy in June purged all 17 members of the committee and replaced them days later with just eight panelists, some of whom have documented histories of vaccine criticism.
