COVID-19 Vaccine Dosing Interval Studies Advocated By US FDA, ACIP
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.
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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.
Calling Moderna’s and Pfizer’s vaccines ‘options’ for young children downplays the risks to the population, some CDC advisory committee members argue as they urge a strong message for vaccination given the more than 200 COVID-19 deaths in children six months to five years.
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.