There’s a chance that Pfizer’s Covid vaccine for young children may not get renewed by the US Food and Drug Administration (FDA) this fall, which could leave a significant gap in supply. This information comes from an email obtained by the Guardian.
If the FDA does indeed not renew, it would effectively remove the only Covid vaccine still accessible for children under five.
Currently, Moderna’s vaccine is approved only for kids who have existing health issues, and the Novavax vaccine for children is restricted to those aged 12 and older with health conditions.
Georges Benjamin, the executive director of the American Public Health Association, mentioned, “It certainly would create a hole in the availability of vaccines. And to do this so late in the season – I think it’s clearly inappropriate.”
An email from the National Center for Immunization and Respiratory Diseases (NCIRD) outlined that Pfizer was notified by the FDA that the emergency use authorization for its pediatric Covid vaccine might not be renewed for the upcoming 2025 respiratory season.
This email was distributed to state and local vaccination grantees last Friday.
Pfizer’s vaccine is for children aged six months to four years. Interestingly, Pfizer anticipates that its vaccine for children aged five to eleven will receive full licensing this fall, as stated in the correspondence.
Moreover, the Centers for Disease Control and Prevention (CDC) is currently talking with Moderna regarding the possibility of increasing its Covid vaccine supply for young ones. They’re evaluating various factors, including volume and timing, to address potential supply gaps.
Chris Ridley, a spokesperson for Moderna, remarked, “We are working to ensure there will be sufficient supply.”
As of now, the CDC, the US Department of Health and Human Services (HHS), and Pfizer have not responded to media questions before publication.
In July, the FDA approved Moderna’s Covid vaccine for pediatric use, but only for children facing significant health risks. This limited approval might restrict access for many.
Benjamin expressed concern regarding the current vaccination rate, stating, “We already have a low number of people using the vaccines to begin with. There hasn’t been enough promotion of vaccinations for kids, and then you have Mr. Robert F. Kennedy Jr.’s unscientific statements about vaccine safety, particularly for pregnant women and children. It has muddied the waters regarding vaccine efficacy and safety.”
The vaccine is highly effective, especially in preventing hospitalization and death, yet only 5.6% of children between six months and four years are vaccinated. For those aged five to 17, the vaccination rate is about 15%, according to the CDC.
While older adults face the highest hospitalization and death rates, children still show hospitalization rates from Covid similar to those observed in 2020 and 2021.
There are ongoing concerns about Covid infection’s impact on children. “We don’t yet know the long-term repercussions for kids who have contracted Covid. We do know it can lead to a multi-system inflammatory process in several children, which can be quite severe, and the long-term implications of long Covid in kids remain unknown,” Benjamin remarked.
As Covid cases continue to rise in various regions of the US, there are also proposals and implementations of other vaccine restrictions by health officials.
