FDA pushes back on suggestion to alter COVID-19 vaccine dosing

FDA pushes back on suggestion to alter COVID-19 vaccine dosing

January 5, 2021

The Food and Drug Administration (FDA) on January 4 responded to suggestions that coronavirus vaccine doses could be altered to speed up the distribution process, saying that these actions would be "premature" and "not rooted solidly in the available evidence."

During an appearance on CBS's "Face the Nation" on January 3, Moncef Slaoui, the chief science adviser for Operation Warp Speed, said there is evidence that giving people between the ages of 18 and 55 two half-doses instead of the two full ones now required would lead to "identical immune response" to the normal dosage.

However, FDA Commissioner Stephen Hahn and Peter Marks, director of the agency's Center for Biologics Evaluation and Research, wrote in a statement the following day that "the available data continue to support the use of two specified doses of each authorized vaccine at specified intervals."

"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," their statement continued. "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."

Of the coronavirus vaccines authorized for emergency use, the Pfizer-BioNTech inoculation requires two doses administered 21 days apart, while there must be 28 days between the first and second dose of the Moderna vaccine.

Final trial data on both vaccines showed them to have a roughly 95% efficacy rate at preventing COVID-19, although Moderna's vaccine has an 86% efficacy rate for those older than 65 years.

As of January 4, approximately 15.4 million doses of the coronavirus vaccine had been distributed across the U.S., with more than 4.5 million people receiving their first dose, according to tracking data from the Centers for Disease Control and Prevention.

The Trump administration did not come close to its goal of vaccinating 20 million people by the end of 2020, with much of the efforts to distribute vaccines falling on local health departments.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, on Monday challenged notions that the second vaccine dose could be delayed to speed up the number of those inoculated.

"We don't have any idea what the level of protection is and what the durability of protection is," Fauci said, according to The Washington Post. "It's fraught with some danger when you're making a decision about the regimen you're going to use when you don't really have a considerable amount of data."

Read more: https://www.msn.com/en-us/news/politics/fda-it-would-be-premature-to-cha...

Read the FDA statement: https://www.fda.gov/news-events/press-announcements/fda-statement-follow...