New FDA seasonal COVID-19 shot guidance seeks ‘evidence based’ approach

Dr. Michael Osterholm reflects on COVID-19 pandemic

Dr. Michael Osterholm is a world-renowned epidemiologist, Regents professor at the University of Minnesota School of Public Health and director of the Center for Infectious Disease Research and Policy at the University of Minnesota. He sounded the warning alarms in January 2020 about the dangers of COVID-19 and says he was met with some opposition from colleagues.

(FOX 9) - Writing that more evidence is needed to weigh their effectiveness on the entire general population, officials with the Food and Drug Administration (FDA) are arguing for increased testing of seasonal COVID-19 shots, while also limiting their availability to seniors and those in high-risk categories.

Seasonal COVID-19 vaccines

What we know:

FDA officials say the agency will continue to approve vaccines for adults more than 65 years old, as well as children and younger adults with at least one high-risk health problem – a common practice since their availability in 2021.

However, a recently published article in the New England Journal of Medicine by Dr. Vinay Prasad argues that the U.S. has "adopted a one-size-fits-all regulatory framework" towards COVID-19 vaccine recommendations that "has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations," the paper says, before saying it rejected those current recommendations.

COVID-19: 5 years later with Dr. Michael Osterholm

Dr. Michael Osterholm is a world-renowned epidemiologist, Regents professor at the University of Minnesota School of Public Health, and director of the Center for Infectious Disease Research and Policy at the University of Minnesota. In January 2020, he sounded the warning alarms about the dangers of COVID-19 and says he was met with some opposition from colleagues.

Dig deeper:

Most Americans have come to expect annual updates to COVID-19 vaccines similar to the annual flu shot, as long as they show as much immune protection as the previous year’s version, officials have said.

However, the new guidance could be the end of that approach, according to Prasad and FDA Commissioner Marty Makary – who co-authored the paper.

The FDA says the new approach is said to balance "timely approval to a broad population," while also weighing "the need for evidence" for a "policy [that] will compel much-needed evidence generation."

The Associated Press reports that the new FDA approach is the culmination of a series of recent steps under Health Secretary Robert F. Kennedy Jr. that have scrutinized the use of COVID shots and raised questions about vaccine availability in the process.

New requirements

How it works:

Under the new FDA guidance, Prasad said the agency will ask all manufacturers to do a new clinical trial in people 50 to 64 years old who are otherwise healthy – randomly assigning them to get a vaccine or a placebo, and tracking outcomes.

"We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose," the paper argues.

According to estimates provided in the guidance, 100 million to 200 million Americans will still have access to vaccines in this manner.

What's next:

In June, a panel of advisers to the Centers for Disease Control and Prevention (CDC) is set to debate which vaccines could be recommended next.