The news: The FDA will limit access to COVID-19 booster shots to high-risk groups, including people over age 65 and those who have underlying medical conditions.

Vaccine-makers that want their COVID-19 shots to be approved for younger and healthy people will need to conduct new clinical trials proving their benefit for these populations. Previously, pharma companies only had to show that their COVID-19 boosters generated strong enough antibody responses.

Behind the FDA’s new policy: The agency said it rejects the view that Americans are not sophisticated enough to understand age- and risk-based health recommendations, and that all other wealthy countries have narrowed vaccine recommendations to older adults or those at high risk for getting severe COVID-19.

The FDA also cited CDC data that fewer people in the US are getting COVID-19 booster shots each year, with just 23% receiving the most recent one. The regulator estimates that between 100 million and 200 million Americans will still have access to new COVID-19 vaccines based on the CDC’s criteria for who is at high risk of serious infection.

Yes, and: The FDA’s updated guidance aligns with its recent decision to approve Novavax’s COVID-19 vaccine only for adults ages 65+ and younger patients who have a disease such as obesity or diabetes.