Vinay Prasad Explains FDA’s Revocation of Pfizer’s Covid Vaccine EUA for Children
The FDA recently revoked the emergency use authorization (EUA) for Pfizer's COVID-19 vaccine for healthy children under 5, meaning there is no longer an authorized COVID vaccine option for this group135.
Vinay Prasad, head of the FDA’s office regulating vaccines, has been pivotal in narrowing vaccine access for healthy children, emphasizing skepticism about the benefits of COVID-19 shots in children without high-risk conditions24.
Prasad stated that 'we do not have substantial certainty benefits outweigh risks for healthy children based on the totality of data,' highlighting very low rates of severe outcomes in this age group24.
The revoked EUA resulting from these arguments means updated mRNA COVID vaccines are limited to children with significant underlying health conditions, not healthy children13.
Supporting evidence cited by Prasad includes:
lack of demonstration in trials of reduction in severe COVID-19, hospitalization, ICU stays, or death in healthy children, and very low rates of such events among young kids4.
With the revocation of EUA, parents wishing to vaccinate healthy children would generally face the full out-of-pocket cost, as insurance typically only covers federally recommended vaccines1.
Organizations such as the American Academy of Pediatrics have criticized the decision, arguing it creates barriers and potential vulnerabilities for children during respiratory illness season1.
Sources:
1. https://www.cbsnews.com/news/covid-vaccine-fda-revokes-pfizer-emergency-authorization/
2. https://www.biopharmadive.com/news/vinay-prasad-fda-moderna-covid-vaccine-review-children/753183/
3. https://abcnews.go.com/Health/wireStory/fda-approves-updated-pfizer-covid-shots-limits-access-125032054
4. https://www.biospace.com/fda/vinay-prasad-overruled-reviewers-on-modernas-covid-19-shot-for-kids
5. https://www.fiercepharma.com/pharma/pfizer-biontech-pick-fda-approval-years-updated-mrna-covid-shot