Polis chides FDA for lag on COVID-19 vaccine boosters, messaging


DENVER | Colorado Gov. Jared Polis on Monday goaded the Food and Drug Administration to quickly authorize booster shots for the Pfizer COVID-19 vaccine as well as vaccinations for children ages 5 to 11, saying the state is prepared to launch its own booster shot program.

“The FDA needs to get out of their ivory tower and realize there is a real-life pandemic,” and should expedite booster-shot approvals for the Pfizer and Moderna vaccines, the Democratic governor told a news conference. A booster dose raises the levels of antibodies to protect against COVID.

In August, Pfizer said it had started the application process for a third dose of its vaccine for everyone ages 16 and older. The White House has begun planning for boosters later this month, if both the FDA and the Centers for Disease Control and Prevention agree. Advisers to the FDA will weigh evidence about an extra Pfizer shot Friday. The U.S. already offers an extra dose of the Pfizer or Moderna vaccines to people with severely weakened immune systems.

Polis credited the Donald Trump administration’s Operation Warp Speed for dispensing with bureaucracy to quickly incentivize vaccine development. He said it’s time the Joe Biden administration did the same for booster shots and young children’s vaccines as the nation’s schools have reopened with the delta variant raging.

“This is a moment where similar leadership is needed by the Biden administration to make sure that the FDA does not succeed in using ivory tower circular reasoning to further delay the life-saving booster,” Polis said.

Polis said Monday that Colorado is ready to formally launch a booster-shot program as soon as Sept. 20, beginning with residents and staff of senior residential facilities and frontline workers, pending FDA and CDC approval. Some Colorado residents with weakened immune systems have already gotten the booster shot.

As for COVID-19 vaccines for children, those 12 and over are eligible. But with schools reopening and the delta variant causing more infections among kids, many parents are anxiously wondering when younger children can get the shots.

The FDA’s vaccine chief, Dr. Peter Marks, told The Associated Press Friday the agency will rapidly evaluate COVID-19 vaccinations for younger children as soon as it gets the needed data. Pfizer is expected to turn over its study results by the end of September. Marks said he was “very, very hopeful” that vaccinations for 5- to 11-year-olds will be underway by year’s end.

The American Academy of Pediatrics has cited delta’s growing threat to children in urging a faster decision.