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Moderna gets full FDA approval for kids COVID-19 vaccine
The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.
Moderna gets full US approval for COVID shot in at-risk children 6 months and older
The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, the company said on Thursday.
COVID-19 vaccination approved for older adults and high-risk, younger children
The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one underlying condition that puts them at high risk for severe outcomes from the disease.
In era of skepticism, FDA clears Moderna COVID vaccination for some kids up to 11 years old
Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and safety of COVID-19 vaccines for young children.
Moderna COVID shot for kids cleared in face of RFK Jr. criticism
US regulators approved Moderna Inc.’s COVID-19 vaccine for children, but for a narrower group than before, continuing Robert F. Kennedy Jr.’s controversial policy that restricts access to the shots for some kids.
Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U.S. and other countries
FDA approves Moderna's COVID vaccine for children as young as 6 months old
The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The vaccine was previously only available to children through emergency use authorization after approval in Jan. 2022. Approval was expanded to people 12 years and older last year.
Top FDA vaccine official rejected broad use of Covid-19 shots, documents show
The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two COVID-19 vaccines.
Moderna gets full US approval for COVID vaccine in children 6 months and older
The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, the company said on Thursday.
Moderna COVID vaccine gets FDA green light for kids 6 months to 11 years
Moderna expects to make its updated vaccine available for eligible U.S. population for the 2025-26 respiratory virus season. Health secretary Robert F. Kennedy Jr. had in May said the U.S. has stopped recommending routine COVID-19 vaccinations for healthy children and healthy pregnant women.
Clinical Advisor4h
FDA Fully Approves Moderna’s COVID Vaccine for Some Young Kids
The FDA action comes weeks after US Health Secretary Robert F. Kennedy Jr said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.
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Food and Drug Administration - The New York Times
News about Food and Drug Administration, including commentary and archival articles published in The New York Times.