U.S. FDA approves COVID-19 boosters for some high-risk people as CDC mulls guidance

The FDA authorized booster doses for Americans who are 65 and older, younger people with underlying health conditions and those in jobs that put them at high-risk for COVID-19.

The U.S. moved a step closer Wednesday to offering booster doses of Pfizer’s COVID-19 vaccine to senior citizens and others at high risk from the virus as the Food and Drug Administration signed off on the targeted use of the extra shots.

The FDA authorized booster doses for Americans who are 65 and older, younger people with underlying health conditions and those in jobs that put them at high-risk for COVID-19. The ruling represents a drastically scaled back version of the Biden administration’s sweeping plan to give third doses to nearly all American adults to shore up their protection amid the spread of the highly contagious delta variant.

However, more regulatory hurdles lie ahead before the dispensing of boosters can begin.

Advisers to the Centers for Disease Control and Prevention opened a two-day meeting Wednesday to make their own, more specific recommendations about who should get the extra shots and when. And in their first day of discussions, some experts were so perplexed by the questions surrounding the rationale for boosters that they suggested putting off a decision for a month in hopes of more evidence.

The uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month.

The FDA decision Wednesday was expected after the agency’s own panel of advisers last week overwhelmingly rejected the Biden plan. The panel instead recommended boosters only for those most vulnerable to severe cases of COVID-19.

The timing of the FDA decision was highly unusual given that the agency typically takes action before the CDC convenes its own experts.

The CDC panelists heard a series of presentations Wednesday outlining the knotty state of science on boosters. On one hand, the COVID-19 vaccines continue to offer strong protection against severe illness, hospitalization and death. On the other hand, there are signs of more low-grade infections among the vaccinated as immunity wanes.