FDA Chief: Changes to dosing schedules “premature”

Boston Statehouse

Food and Drug Administration building is shown Thursday, Dec. 10, 2020 in Silver Spring, Md. A U.S. government advisory panel convened on Thursday to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans. (AP Photo/Manuel Balce Ceneta)

BOSTON (SHNS) – The FDA earlier this week batted away the idea of giving half a dose of Moderna’s COVID-19 vaccine to people between the ages of 18 and 55.

Saying the agency would make any ultimate decision, Dr. Moncef Slaoui, the chief adviser to Operation Warp Speed, said Sunday that giving half of the two-dose Moderna vaccine regimen to that population “means exactly achieving the objective of immunizing double the number of people with the doses we have.”

Slaoui said a half dose, or 50 microgram dose, for that population “induces identical immune response to the hundred microgram dose.”

In a statement, FDA Commissioner Stephen Hahn said he was following discussions and news reports about “reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19.”

Hahn concluded: “These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence.

Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.”

He added: “The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose.”

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