Hello and welcome to the Osterholm Update, a podcast on COVID-19 and other infectious diseases with Dr. Michael Osterholm.

Dr. Ostrome is an internationally recognized medical detective and director of the Center for Infectious Disease Research and Policy, or CIDRAP, at the University of Minnesota. In this podcast, Dr. O. Strom

draws on nearly 50 years of experience investigating infectious disease outbreaks to provide

straight talk on the latest infectious disease and public health threats. I'm Chris Dahl,

reporter for CidWap News, and I'm your host for these conversations.

Welcome back, everyone, to another episode of the Ostromo Update podcast.

Early last week, leadership at the Food and Drug Administration laid out what they

called an evidence-based approach

to COVID-19 vaccination in an article in the New England Journal of Medicine.

In the piece, FDA Commissioner, Dr. Marty McCari, an FDA Center for Biologics

Evaluation and Research Director, Dr. Vinay Prasad, said that moving forward, the agency will

limit access to COVID-19 vaccines to people 65 and older

and those who have certain conditions that put them at high risk of becoming severely ill if infected.

For all other groups, vaccine manufacturers will be required to conduct randomized clinical trials

to prove safety and efficacy.

The new framework is a significant departure from the

policy that has governed COVID-19 vaccination policy in the U.S. Under that policy, updated

COVID shots have been introduced on a yearly basis and have been recommended for everyone

ages six months and older. Quote, the FDA's new COVID-19 philosophy represents a balance of regulatory

flexibility and a commitment to gold standard science, Makari and Prasad wrote. The FDA will

approve vaccines for high-risk persons and, at the same time, demand robust gold-standard data

on persons at low risk. The new COVID vaccine framework, and what it

...