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Not so fast: FDA warns of 'premature' changes to COVID-19 vaccine dosing in clash with Slaoui


Amid concerns over limited COVID-19 vaccine supplies, some have proposed tweaking the shots’ dosing to immunize more people. One suggestion came from none other than U.S. vaccine czar Moncef Slaoui, Ph.D. But the FDA’s stepping forward to dismiss the idea—at least for now. Any changes to currently authorized vaccine dosing regimens pose a “significant risk of placing public health at risk” and undermine “the historic vaccination efforts to protect the population from COVID-19,” FDA Commissioner Stephen Hahn, M.D., and Peter Marks, M.D., Ph.D., head of the agency’s biologics department, said in a statement Monday. The comment came on the heels of Operation Warp Speed chief Slaoui saying the vaccine task force is working with the FDA and Moderna to potentially reduce the company’s mRNA-1273 dose in half to stretch the supply.

Fierce Pharma - January 5, 2021

View the full story here: https://www.fiercepharma.com/pharma/not-so-fast-fda-warns-premature-changes-to-covid-19-vaccine-dosing-clash-slaoui