The following information is from Children’s Health Defense.
The US 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.
An email from the Centers for Disease Control and Prevention (CDC) to state and local health departments, as reported by those outlets, said the shot for children 5-11 years old — also still under EUA — is expected to be fully approved this fall.
HHS spokesperson Andrew Nixon said:
“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 possible move and told The New York Times it is “currently in discussions with the agency on potential paths forward.” According to Fierce Pharma, Pfizer asked the FDA to extend the EUA through the 2025–2026 season, saying the potential decision was “not related to the safety and efficacy of the vaccine.”
Pediatrician Dr. Michelle Perro, CEO of GMOScience 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 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.”
The possible move comes after the CDC changed its recommendations in May, removing its universal recommendation for all children ages 6 months and older to receive COVID-19 shots. US Health Secretary Robert F. Kennedy Jr. announced that the CDC would no longer recommend the vaccines for healthy children, instead advising “shared clinical decision-making” between parents and providers.
If the Pfizer EUA is rescinded, there will be no COVID-19 vaccine approved or authorized for healthy children under age 5, though doctors could prescribe Moderna’s shot “off label” if requested by parents.
CDC data show only 5.6% of children ages 6 months through 5 years have received the COVID-19 vaccine, and about 15% of children ages 5–17. Critics of the shots point to risks for children, including myocarditis, pericarditis, autoimmune disease, and altered immune system response.
For more information, read the full article here.
