FDA race to approve COVID-19 booster this week would skip input from advisory panel

Federal agencies could authorize COVID-19 booster shots for all adults before the weekend, a fast turnaround that bypasses a key advisory committee.

The Food and Drug Administration is not expected to consult with an outside advisory group that pumped the brakes on President Biden’s push for widespread boosters about two months ago.

“I’m disappointed that our committee didn’t get a chance to review this recommendation,” Dr. Paul Offit, a pediatrics professor at the University of Pennsylvania and member of the advisory panel, told The Washington Times. “I think it would have been valuable to the public to be able to hear our deliberations on this. Will be curious to hear the ACIP discussion on Friday.”

Members of the group have generally supported boosters for older persons and the medically frail but have taken a harder line on boosters for young people, saying the shots appear to be holding up on preventing hospitalization and death, and they need to analyze the risk of myocarditis, or inflammation of the heart muscle, that sometimes occurs after vaccination — particularly in teenage or young adult males.

The short-cut approval process comes a little more than a week after Pfizer and BioNTech submitted their request to the Food and Drug Administration.- READ MORE

Related Articles

(PREMIUM) PAINE IN THE MORNING: What you need to know this Monday – January 16, 2023

Here’s what you need to know today, Monday – January 16, 2023. Penn Biden Center Where Classified Documents Were Found Is a ‘Dark Money Nightmare’ – When Joe Biden rode off into the sunset at the end of his two terms as vice president, he needed something to occupy his time when he wasn’t playing on…

To access this post, you must purchase The Hot Wire, The Hot Wire (DG), Monthly Supporter​ or Monthly Supporter​ (DG).

(PREMIUM) PAINE IN THE MORNING: What you need to know this Wednesday – January 11, 2023

Here’s what you need to know today, Wednesday – January 11, 2023. This Censorious Pfizer Board Member Was A Major Influence On Lockdowns – The latest of the Twitter Files is reported by Alex Berenson, who was granted access to messaging systems from the times before Elon Musk took over. His first round of reporting concerns…

To access this post, you must purchase The Hot Wire, The Hot Wire (DG), Monthly Supporter​ or Monthly Supporter​ (DG).

Responses