US EditionFDA may pull authorization of Pfizer’s Covid vaccine for children under 5, company says
The FDA's move follows broader policy shifts under HHS Secretary Robert F. Kennedy Jr. and could leave young children with limited vaccine options despite high hospitalization rates, CDC data shows.
- The Food and Drug Administration is considering revoking authorization of Pfizer's Covid-19 vaccine for healthy children under 5, as confirmed by the drugmaker to CNBC.
- Pfizer seeks to keep the authorization for the fall and winter season and is currently in discussions with the agency about potential paths forward.
- Fatima Khan, co-founder of Protect Their Future, stated that taking a proven, safe, and effective vaccine away from vulnerable children is unconscionable.
- Covid-19 levels are rising in the U.S., with transmission increasing in at least 45 states, according to the CDC.
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40 Articles
FDA signals it may revoke approval of Pfizer's pediatric COVID vaccine, leaving kids fewer options
The U.S. Food and Drug Administration may not renew its authorization for Pfizer's COVID-19 vaccine approved for children under the age of 5 ahead of the peak season, according to multiple outlets.Pfizer's vaccine is the only shot approved for all children Moderna's vaccine is approved for children with certain health conditions and Novavax's shot is approved for children ages 12 and older.The Guardian reported Tuesday that it had obtained an em…
FDA could make it harder to get young kids a COVID shot
(The Hill) - The Food and Drug Administration (FDA) is considering revoking the authorization of Pfizer’s COVID-19 vaccine for healthy children younger than 5 years old, a move that would add another barrier for parents who want to vaccinate healthy children ahead of the respiratory virus season. Pfizer's three-dose shot for children between 6 months and 5 years old has long been available under an emergency use authorization (EUA). But accordi…
Pfizer spokeswoman said FDA decisions are not related to vaccine safety or efficacy
FDA may pull authorization for Pfizer COVID shot for kids under 5
The Food and Drug Administration (FDA) is considering revoking the authorization of Pfizer’s COVID-19 vaccine for healthy children under 5 years old, the company confirmed Wednesday. The move would add another barrier for parents who want to vaccinate healthy children, as shots from Moderna and Novavax were approved for more limited populations. In May, Health and Human Services Secretary Robert F. Kennedy Jr. said the Centers for Disease Con…
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