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FDA Allows Extra Doses of Bivalent COVID Vax for Immunocompromised Tots

The FDA has authorized additional doses of Pfizer/BioNTech’s bivalent COVID-19 vaccine for young immunocompromised children, the agency announced on Friday. In kids ages 6 months to 4 years with certain types of immunocompromising conditions (i.e., solid-organ transplant recipients, or those considered to have a similar level of immunocompromise), and who previously received three primary 0.2-mL […]

COVID Toddler Vax Clears Major Hurdle

An advisory committee recommended that the FDA give emergency use authorization (EUA) to both Moderna and Pfizer/BioNTech’s mRNA COVID-19 vaccines for infants, toddlers, and preschool kids. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0 in favor of expanded access to each vaccine, in another unanimous decision that the benefits of the vaccines […]

COVID mRNA Vaccines Safe, Effective for Babies and Toddlers, Says FDA Staff

Moderna and Pfizer/BioNTech’s COVID-19 vaccines proved safe and effective for kids under 5 years of age, paving the way for immunization of the only age group still awaiting access, according to FDA briefing documents released ahead of 2 days of advisory meetings. On Tuesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet […]

Younger Kids ‘Should’ Get COVID Booster, Says CDC Panel

Similar to their older peers, children ages 5 to 11 should get a third dose of Pfizer/BioNTech’s COVID-19 vaccine (Comirnaty), the CDC’s Advisory Committee on Immunization Practices (ACIP) said on Thursday. In an 11-1 vote, with one abstention, the committee agreed that children ages 5 to 11 should receive an additional dose of the mRNA […]

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