FDA, NIH scientists dismiss call for Pfizer, Moderna single-shot regimens

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Scientists from the FDA and the National Institutes of Health are advising against one-dose regimens for Pfizer and Moderna's COVID-19 vaccines, saying there is not available evidence to prove a single dose offers long-term protection, according to a March 6 report from The Wall Street Journal.

On March 2, seven members of Congress who are also physicians sent a letter to HHS urging the department to revise its COVID-19 vaccine emergency use authorization to be "based on all available clinical data." The lawmakers said such a revision could lead to an endorsement of single-dose regimens for Pfizer and Moderna vaccines, which could speed up the nation's COVID-19 vaccination effort.

However, government scientists have said there is not enough reliable data to justify single-dose regimens for Pfizer and Moderna vaccines. They said although single doses of these vaccines may offer short term-protection from COVID-19, they are designed to give recipients long-term protection only after two doses, according to the Journal.

"It is essential that these vaccines be used as authorized by FDA in order to prevent Covid-19 and related hospitalizations and death," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, told the Journal.

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