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FDA panel votes not to allow...

FDA panel votes not to allow Pfizer’s booster for general public at this time

By: Anne Summerhays - September 17, 2021

By a vote of 16-2,  the FDA advisory committee rejected request to add a third dose for the public, saying they still need more data for approval. 

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) held an eight hour long meeting in which they discussed Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in those 16 years and older.

By a vote of 16-2,  the FDA advisory committee rejected the request to add a third dose for the general public, saying they still need more data for approval. However, in an 18-0 vote, they endorsed the extra shots for those who are 65 or older or run a high risk of severe diseases.

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.

A CDC advisory committee will meet to discuss boosters next week, “after which the CDC will make their final recommendation,” Surgeon General Vivek Murthy said at a briefing on Friday.

In late August, the Food and Drug Administration officially gave approval for the Pfizer COVID-19 vaccine. Before this, it had been in use through emergency approval since December of 2020. The Pfizer-BioNTech vaccine is the first and only COVID-19 vaccine to receive full approval from the FDA.

The Mississippi Department of Health announced that Mississippians with qualifying health conditions can now schedule a third COVID-19 vaccination directly from county health departments. Today the MSDH is reporting 2,321 more cases of COVID-19 in Mississippi, 49 deaths, and 108 ongoing outbreaks in long-term care facilities.

 

About the Author(s)
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Anne Summerhays

Anne Summerhays is a recent graduate of Millsaps College where she majored in Political Science, with minors in Sociology and American Studies. In 2021, she joined Y’all Politics as a Capitol Correspondent. Prior to making that move, she interned for a congressional office in Washington, D.C. and a multi-state government relations and public affairs firm in Jackson, Mississippi. While at Millsaps, Summerhays received a Legislative Fellowship with the Women’s Foundation of Mississippi where she worked with an active member of the Mississippi Legislature for the length of session. She has quickly established trust in the Capitol as a fair, honest, and hardworking young reporter. Her background in political science helps her cut through the noise to find and explain the truth. Email Anne: anne@magnoliatribune.com