The Food and Drug Administration (FDA) is contemplating withdrawing approval for Pfizer’s Covid-19 vaccine aimed at healthy children under five.
Pfizer’s three-dose vaccine for kids aged 6 months to 5 years has been available under an Emergency Use Authorization (EUA) for quite some time. However, the company indicates that the FDA is considering its approval status.
Pfizer mentioned, “We’re discussing ways to advance our options and advocating for the EUA to remain in effect for the 2025-2026 season.”
The company also emphasized that these discussions do not pertain to the safety and effectiveness of the vaccines, which they claim continue to show a positive profile.
They anticipate that the FDA will approve vaccinations for children aged 5-11 with similar restrictions that apply to Moderna and Novavax.
Recently, in July, the FDA authorized Moderna’s vaccine for children over six months, but limited it to those with specific health conditions that increase the risk of severe Covid-19. Novavax has not received approval for children under 12.
Since 2022, Pfizer has had full FDA approval for its Covid-19 vaccine for individuals 12 and older.
It is relatively common for the FDA to rescind an emergency permit for a product when a competitor secures alternative approval. Pfizer has yet to apply for full approval for the youngest age group.
Initially, all Covid-19 vaccines were distributed solely under emergency use authorizations, granted largely during times of need without approved replacements.
However, if Pfizer’s approval is withdrawn, and given the restrictions on Moderna’s shots, healthy children under five might have no official vaccination options available to them.
Fatima Khan, a co-founder advocating for vaccine access, shared, “Parents have faced access issues. Last year, some drove 2-3 hours just to get vaccines for their kids.”
Khan expressed frustration, stating, “It feels like we’re abandoning our children now. Why can’t we get this? It’s safe and easy for kids.”
The Department of Health and Human Services (HHS) stated it wouldn’t comment on these potential changes.
They noted, “The Covid-19 pandemic officially concluded with the end of the federal public health emergency in May 2023. We won’t discuss future regulatory changes unless they’re officially announced.”
In May, HHS Director Robert F. Kennedy Jr. indicated that the CDC would no longer recommend the Covid-19 vaccine for healthy children and pregnant women.
After this, the CDC updated its vaccination guidelines, suggesting that children without underlying health conditions could “receive” the Covid-19 vaccine after consulting with healthcare providers.
Kennedy expressed a personal distaste for both Moderna and Pfizer vaccines, labeling them as dangerous and unreliable. HHS has also decided to reduce funding for research, including mRNA technology used for vaccine development.
State health officials noted that Moderna plans to bolster its vaccine supply for the fall and stated they could handle demand if Pfizer’s vaccine were no longer available for younger children. Providers who previously ordered Pfizer vaccines for the next season might easily switch to Moderna.
That said, since Moderna’s vaccine is authorized only for children at risk of severe infections, pediatricians might have to administer it “off-label” to healthy kids, often without insurance coverage guarantees.
Claire Hannan, executive director of an association for state and local health officials, expressed hopes that clinical judgments would enable vaccination requests to be covered by insurance. Yet, she added, “It’s complicated.”
She noted, “There’s confusion since the FDA has stepped back from recommending the licensing process for the Moderna vaccine, and we’re waiting for the CDC for more guidance.”
Infectious disease experts referred to CDC data indicating that children under two face a risk of severe Covid-19 infections, even if they are otherwise healthy.
Ayana Bennett, director of the Department of Health in Washington D.C., suggested that healthy children deserve to thrive. She stated, “If vaccinations can prevent serious illness, it shouldn’t be a debate.”
Bennett expressed her desire for children to avoid missing school and suffering through hospital visits, emphasizing, “If we can prevent something, we should do it. This is a place where we can definitely make a difference.”
