FDA May Not Renew Pfizer's Authorization For Covid Shots In Younger Children, Moderna Prepares To Boost Supply
Pfizer Inc.'s (NYSE:PFE) COVID-19 vaccine for children under five may lose U.S. Food and Drug Administration authorization this fall, raising the possibility of supply shortages and prompting Moderna Inc. (NASDAQ:MRNA) to step in to help fill potential gaps.
"We are working to ensure there will be sufficient supply," said Chris Ridley, a Moderna spokesperson.
See what PFE stock is doing here.
According to an email from the National Center for Immunization and Respiratory Diseases obtained by The Guardian, the FDA recently told Pfizer it may not renew the emergency use authorization for its pediatric COVID-19 vaccine for the 2025 respiratory season.
The move could remove the only COVID-19 vaccine available to all children under five from the market. The vaccine is currently authorized for children between six months and four years old.
Pfizer expects its COVID-19 vaccine for children aged 5 to 11 to receive full FDA approval this fall.
However, options would be limited without authorization for the youngest age group.
Moderna's pediatric vaccine, approved by the FDA in July, is only available for children with certain health conditions that make them more vulnerable to COVID-19.
Novavax Inc.'s (NASDAQ:NVAX) pediatric shot is available only for children 12 and older with similar health conditions.
The Centers for Disease Control and Prevention (CDC) said it is in talks with Moderna to quickly increase vaccine supply for young children in anticipation of possible gaps.
Health experts are concerned that narrowing vaccine access could further depress low uptake rates.
CDC data show that only 5.6% of children aged six months to four years have received a COVID-19 vaccine, and only 15% of children between the ages of 5 and 17 are vaccinated.
Despite low usage, the vaccines remain highly effective, particularly in preventing hospitalization and death.
In May, the U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the U.S. Centers for Disease Control and Prevention's immunization schedule.
In 2021, Kennedy filed a citizen petition requesting the FDA to revoke Emergency Use Authorizations for existing COVID-19 vaccines and refrain from approving and licensing them.
The update follows the FDA's changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults.
In July, an alliance of medical and public health organizations filed a lawsuit against Kennedy.
The plaintiffs contend that Kennedy has launched an "assault on science, public health, and evidence-based medicine" through unilateral and arbitrary changes to COVID-19 vaccine recommendations for children and pregnant individuals.
PFE Price Action: Pfizer stock is up 0.10% at $24.61, and MRNA stock is down 2.79% at $25.39 at publication on Monday.
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