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The U.S. Food and Drug Administration (FDA) is considering ending the emergency use authorization (EUA) for Pfizer’s COVID-19 shot for children under age 5, The New York Times and The Guardian reported.
Pfizer’s shot for infants and young children has been available under EUA since June 2022, but never received full approval.
Now, the FDA may end the authorization for that age group, according to an email sent by the Centers for Disease Control and Prevention (CDC) to state and local health departments, the outlets reported. However, the shot for children 5-11 years old — also still under EUA — is expected to be fully approved this fall, the email said.
Andrew Nixon, communications director for the U.S. Department of Health and Human Services (HHS), said in an email Tuesday to The Defender:
“The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023. We do not comment on potential, future regulatory changes. Unless officially announced by HHS, discussion about future agency action should be regarded as pure speculation.”
Pfizer confirmed the FDA’s possible move on Monday and said it was “currently in discussions with the agency on potential paths forward,” the Times reported.
According to Fierce Pharma, Pfizer asked the FDA to extend the EUA through the 2025-2026 season, saying the FDA’s possible decision was “not related to the safety and efficacy of the vaccine.”
Pfizer did not respond to The Defender’s request for comment as to why the FDA might deny approval for its shots.
‘Tsunami of data’ shows no benefits of COVID shot for young kids
Until recently, no COVID-19 vaccines had been fully licensed for any children under age 12 in the U.S.
Last month, the FDA fully approved Moderna’s COVID-19 shot Spikevax for children ages 6 months through 11 years, but only for those with an underlying condition that puts them at increased risk for COVID-19 disease.
Novavax, the only other COVID-19 shot available in the U.S. — and the only non-mRNA shot — is fully approved for people ages 65 and up, and for people ages 12-64 at heightened risk for COVID-19 illness.
Moderna is reportedly in discussions with the CDC about rapidly increasing its pediatric COVID-19 vaccine supply, The Guardian reported. The outlet cited concerns that the FDA’s possible EUA decision could “limit access to Covid vaccines.”
However, few children are getting the shots. CDC data show only 5.6% of children ages 6 months through 5 years are vaccinated against COVID-19, and about 15% of children ages 5-17.
Dr. Michelle Perro, a pediatrician, told The Defender she fully supported rescinding the EUA. “This is a population that faced essentially zero risk of severe illness from COVID-19, yet has been subjected to an experimental gene-modulating product with documented cardiac and neurologic harms.”
Perro, CEO of GMOScience, added:
“There is a tsunami of data showing the shots have no benefit for small children, and children have suffered irreversible myocarditis, seizures, and other adverse events. Releasing a gene-modifying drug to children who never needed it, despite clear risk signals in the clinical trials, is a blatant violation of the most fundamental principles of medical ethics.
“The only responsible actions are to remove the EUA on the Covid-19 shot and simultaneously place a moratorium on all mRNA ’therapies’ indefinitely.”
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Change would mean no COVID shots authorized for healthy kids under 5
If the FDA were to rescind the EUA for Pfizer’s shot, the move would come on the heels of the CDC’s decision in May to change the agency’s COVID-19 vaccine recommendations on the Child and Adolescent Immunization Schedule.
U.S. Health Secretary Robert F. Kennedy Jr. announced at the time that the vaccines would no longer be recommended by the CDC for healthy children.
Instead of a universal recommendation that all children ages 6 months and older receive the COVID-19 shots, the CDC now recommends “shared clinical decision-making” between parents and providers for children ages 6 months to 17 years who are not moderately immunocompromised.
That means parents and providers can decide together whether a child should take the shot based on the child’s health status and parents’ preferences.
If the Pfizer EUA is rescinded, there will be no COVID-19 vaccine approved or authorized for healthy kids under age 5. However, doctors could prescribe Moderna’s vaccine “off label” for children whose parents request it, the Times reported.
At the last meeting of the CDC’s vaccine advisory committee, CDC scientists said healthy young children were at high risk for COVID-19, citing 16 deaths nationally among children ages 2-4 between July 2024 and June 2025 related to the illness.
Yet experts on all sides of the COVID-19 vaccine debate have questioned whether healthy children need the vaccines at all. And COVID-19 vaccine critics point to proven safety risks for children, including increased rates of autoimmune disease and altered immune system response, myocarditis and pericarditis, and inflammation.
In 2022, Children’s Health Defense (CHD) sued the FDA for granting EUA for the COVID-19 shots for children and babies. The lawsuit alleged the FDA misused emergency power to push dangerous biologics on minors. CHD appealed the case to the U.S. Supreme Court, which declined to hear it.
Public health agencies authorized the COVID-19 vaccine for people ages 16 and up from the start, and expanded authorization to 12-year-olds by May 2021. The FDA authorized the drug for children ages 5 and up in October 2021, and for babies 6 months and older in June 2022.
In February 2023, the CDC added COVID-19 vaccination to its routine immunization schedules for children and adults after the agency’s vaccine advisers unanimously recommended it. At the time, the FDA had not granted full approval to any of the COVID-19 shots for children under age 12.
The CDC continued to recommend annual boosters for children until recommendations were changed earlier this year.
The schedule is the basis for vaccine recommendations made by most physicians.
In May, FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research chief, Dr. Vinay Prasad, instituted stricter requirements for future COVID-19 vaccine approval.
Related articles in The Defender
- Media, Health Officials Lash Out at RFK Jr. Over New COVID Vaccine Recommendations — CDC Was Likely to Make the Change Anyway
- Breaking: CDC Removes COVID Vaccine Recommendation for Healthy Kids, Healthy Pregnant Women
- HHS Will Stop Recommending COVID Vaccines for Kids, Teens and Pregnant Women, WSJ Reports
