Moderna’s Pediatric COVID Vaccine Packaging Spurs Confusion Concerns From CDC Panel
Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.
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FDA’s Doran Fink and CDC’s ACIP members say vaccine manufacturers could conduct a study to determine whether longer intervals between doses would provide greater effectiveness and longer durability. Right now, they are relying on international data.
US FDA Leaves Pfizer’s Efficacy Data Out Of Under 5 EUA Due To ‘Data Maturity,’ Lack of ‘Confidence’
Moderna’s ‘more mature’ vaccine efficacy data in children under 6 get agency highlight due to what Peter Marks called a ‘confidence’ difference in the numbers, the but CBER chief also said differences between Moderna’s and Pfizer’s vaccines are ‘subtle’ in this age group.
Moderna’s COVID-19 Vaccine Packaging Poses Booster Tracking, Safety Surveillance Challenges, Experts Say
Since company is using same vial and NDC code for primary series and booster dose, which is half the amount, immunization registries will not be able to capture how much Moderna vaccine an individual actually gets for their third dose.