FDA official explains decision on 'simplified' booster shots

WASHINGTON (AP) — The U.S. government's booster campaign got a lot simpler Friday after Food and Drug Administration officials authorized the Pfizer and Moderna COVID-19 vaccines for all adults.

It replaces a complicated system in which eligibility was based on age, health conditions and other factors.

“It’s simplified things, I think significantly over the situation that we had in place previously,” FDA's vaccine chief Dr. Peter Marks told The Associated Press.

The FDA action comes after months of debate among experts over whether everyone 18 and older should get an extra shot for protection.

Just two months ago the FDA's own advisers soundly rejected the idea, based on the vaccines' continued strong performance. But the White House continued pressing for broader use to head off another potential surge. And in the last week nearly a dozen states jumped ahead of FDA to make booster shots available to millions of Americans.

“I think we are at a point in this pandemic that everyone, including state governors, are getting a little bit desperate,” said Marks.

The FDA ultimately ruled that the extra booster protection outweighed risks of rare vaccine side effects, including cases of heart inflammation, called myocarditis, that mostly occurs in young men. That's a different approach than several European countries, which limited use of Moderna's vaccine due to signs it carries a slightly higher heart risk than other shots.

Marks spoke with the AP Friday about how the agency made the decision on boosters. The conversation has been edited for clarity and length.

Q: The FDA reviewed data submitted by the companies but also trends in how the virus is spreading across the U.S. How did that factor into this decision?

A: If you look at the numbers for COVID-19, the seven-day...