Moderna Seeks FDA Vaccine Clearance For Kids From 12 To 17
The application for emergency use approval follows a study of more than 3,700 adolescents in which no covid cases were observed among those who received Moderna's two-dose regimen. Four cases occurred in the placebo group. Separately, FDA vaccine advisers meet to debate vaccine protocols for kids.
NBC News:
Moderna Files For FDA Authorization For Covid Vaccine In Younger Teens, Adolescents
Moderna on Thursday filed for emergency use authorization from the Food and Drug Administration to use its Covid-19 vaccine in adolescents ages 12 to 17. If cleared by the FDA, it will become the second Covid-19 vaccine available in the United States for teens under 18 along with Pfizer-BioNTech's vaccine, which was authorized for adolescents ages 12 to 15 in May. Moderna said in May that results from its clinical trial among children ages 12 to 17 showed its two-dose mRNA vaccine to be safe and highly effective. The trial included more than 3,700 participants. (Weaver, 6/10)
Fox News:
Moderna Seeks COVID-19 Vaccine Authorization For Teens
The request follows promising data from a Phase 2 /3 TeenCOVE study involving 3,732 teens ages 12 to 18 that found the vaccine produced immune responses similar to those observed in adults. Additionally, Moderna said that no cases of COVID-19 were observed in participants who had received two doses of the jab. (Hein, 6/10)
The Washington Post:
FDA Advisers Debate Standards On A Coronavirus Vaccine For Young Children
With coronavirus vaccines available to adolescents and adults, regulators are now turning their attention to younger children and the level of proof needed before authorizing shots for children as young as 6 months. On Thursday, many members of a panel that advises the Food and Drug Administration on vaccines argued that faster authorization should be an option because of uncertainties about virus variants and a potential fall surge in cases. (Johnson, 6/10)
Politico:
Kid Covid-19 Vaccines: 3 Takeaways From The FDA's Big Meeting
With Covid-19 vaccines authorized for adults and teens, shotmakers and regulators are turning their attention to ensuring that the vaccines are safe and effective for younger children. The FDA’s independent vaccine advisory committee grappled Thursday with how to ensure the safety of Covid shots in children as disease caseloads continue to dwindle in the U.S. (Gardner and Foley, 6/10)
In other youth vaccination news —
Los Angeles Times:
Kaiser Launches COVID-19 Vaccine Trial For Children 5 To 11
Luci is one of 75 children expected to be enrolled in the study, which is also being conducted at Kaiser sites in Oakland and Santa Clara. It’s part of a nationwide effort involving about 4,600 children to evaluate a vaccine being developed by Pfizer-BioNTech, sponsors of the trial. A few weeks ago, Kaiser’s Los Angeles Medical Center kicked off a trial evaluating a Moderna vaccine for children 6 months to 11 years old, a Kaiser spokesperson said. So far, it has enrolled participants as young as 6. (Seidman, 6/10)
The Wall Street Journal:
Can Schools Mandate Covid-19 Vaccines For Children? What We Know
Many education officials, public-health officials and parents believe that vaccinating children against Covid-19 will play a key role in resuming normal life in time for in-person learning in the fall. That stance has led some parents to wonder: Will K-12 students be mandated to receive the vaccine to be allowed on campus this fall? (Koh, 6/11)
