Morning Briefing
Summaries of health policy coverage from major news organizations
Moderna Will Apply To FDA For Covid Vaccine Use In Kids Under 6
Stat: Moderna To Ask FDA To Authorize Covid Vaccine In Kids 6 Months To 6 Years
Moderna announced Wednesday that it will ask the Food and Drug Administration to authorize its Covid-19 vaccine for emergency use in children aged 6 months to 6 years, a group for which there are currently no authorized Covid vaccines. The company’s announcement came as it released interim data from two clinical trials of its vaccine in children under 6 years of age. Moderna said the studies — in children aged 6 months to 23 months and 2 years to 6 years — showed the vaccine generated similar immune responses as those seen in adults aged 18 to 25 who received two doses of Moderna’s adult Covid vaccine. (Branswell and Herper, 3/23)
NBC News: Moderna Says Covid Vaccine For Children, 6 Months To Age 6, Protects Against Severe Omicron
Moderna said Wednesday its Covid-19 vaccine generated a strong immune response and was generally well-tolerated in kids ages 6 months up to 6 years. The drugmaker said two 25-microgram doses of the vaccine, a quarter of the dose given to those 18 and older, produced an antibody response similar to what was seen in a clinical trial of adults. For the approximately 6,900 children in the trials, the majority of side effects were "mild or moderate," and no cases of a rare heart condition called myocarditis were reported, the company said. (Lovelace Jr., 3/23)
AP: Moderna Says Its Low-Dose COVID Shots Work For Kids Under 6
Moderna’s COVID-19 vaccine works in babies, toddlers and preschoolers, the company announced Wednesday — a development that could pave the way for the littlest kids to be vaccinated by summer if regulators agree. Moderna said that in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6. The company also is seeking to have larger doses cleared for older children and teens in the U.S. (Neergaard, 3/23)
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NBC Chicago: When Could COVID Shots Begin For Children Under 5 And Which Vaccine Is Best?
Parents may find it confusing that Moderna is seeking to vaccinate the youngest children before it's cleared to vaccinate teens. While other countries already have allowed Moderna’s shots to be used in children as young as 6, the U.S. has limited its vaccine to adults. The FDA hasn't ruled on Moderna's earlier request to expand its shots to 12- to 17-year-olds because of concern about a very rare side effect. Heart inflammation sometimes occurs in teens and young adults, mostly males, after receiving either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny because its shots are a far higher dose than Pfizer’s. (3/23)
