FDA Advisers Give Go-Ahead On Covid Vaccines For Littlest Kids
All kids over 6 months old are on the verge of being able to receive a covid vaccine. A key hurdle was cleared yesterday when the Food and Drug Adminstration's Vaccine and Related Biological Products Advisory Committee recommended authorization for Moderna and Pfizer's shots.
NBC News:
Covid Vaccines For Children Under 5 Endorsed By FDA Panel
Food and Drug Administration advisers voted Wednesday to recommend authorizing both Moderna and Pfizer-BioNTech’s Covid-19 vaccines for young children, clearing one of the final hurdles to getting the youngest Americans vaccinated. The Vaccine and Related Biological Products Advisory Committee held a vote for each vaccine during its Wednesday meeting. Both recommendations were unanimous: 21-0. Moderna’s vaccine is for children ages 6 months to 5 years, while Pfizer’s is for children ages 6 months to 4 years. (Lovelace Jr., 6/15)
CIDRAP:
FDA Advisers OK COVID-19 Vaccines For Youngest Kids
The group voted separately on whether benefits outweigh the risks for the two vaccines, but results were unanimous for approval for both. Moderna's EUA applies to kids ages 6 months through 5 years, given in two 25-microgram doses, which is one fourth of the adult dose. Pfizer's EUA applies to kids ages 6 months through 4 years, given in three 3-microgram doses, one tenth of the adult dose. (Schnirring, 6/15)
Stat:
FDA Panel Backs Use Of Pfizer, Moderna Covid Shots In Young Kids
Before families can start to avail themselves of the vaccines, though, an advisory committee for the Centers for Disease Control and Prevention needs to recommend the shots, too, and CDC Director Rochelle Walensky must accept the recommendation. The group meets Friday and Saturday, when the votes will be held. (Herper and Branswell, 6/15)
USA Today:
FDA Panel Recommends COVID Vaccines For Kids As Young As 6 Months Old
Although young children have largely been spared the worst of COVID-19, they can become seriously ill, and more than 200 have died from infections, according to data presented by the FDA. Half of the young children hospitalized with COVID-19 did not have any preexisting conditions before they fell ill, the FDA said. (Weintraub, 6/15)
And Moderna will test its vaccine in babies as young as 3 months old —
The Wall Street Journal:
Moderna To Study Its Covid-19 Vaccine In Babies As Young As 3 Months
Moderna Inc. is planning to test its Covid-19 vaccine in babies 3 months to 6 months old, the youngest age group studied to date. The Cambridge, Mass., company said Wednesday it is in the final stages of planning the study, to be called BabyCove and expected to begin enrolling as many as 700 babies in September. BabyCove would be the first study of Moderna’s vaccine in infants younger than 6 months. (Loftus, 6/15)
In related news about vaccine research —
AP:
Dolly Parton Gives $1M To Infectious Disease Research, Again
Dolly Parton is donating $1 million to pediatric infectious disease research at Vanderbilt University Medical Center in Nashville, the organization announced on Wednesday. The new gift is one of several Parton has made to the center over the years, including a $1 million gift in April 2020 for COVID vaccine research. ... Parton’s new gift will support a variety of ongoing research at the medical center, including understanding how viruses and bacteria cause disease, understanding and preventing antibiotic resistance, preventing and treating infections, diagnosing and treating infections in children with cancer, and gauging the impact of childhood infections throughout the world, according to the news release. (6/15)
