FDA moves to speed along convoluted approval process for COVID booster shots

AP Photo/Matt Rourke

Some states have not waited for federal regulators to finish their convoluted approval processes. It really isn’t any wonder why so much of the general public is skeptical of the FDA, CDC, etc. (and thus become vulnerable to anti-vaxxer propaganda) when these agencies have been so inept throughout the course of the pandemic - 

WASHINGTON (AP) — U.S. regulators on Friday moved to open up COVID-19 booster shots to all adults, expanding the government’s effort to get ahead of rising coronavirus cases that experts fear could snowball into a winter surge as millions of Americans travel for the holidays. 

The Food and Drug Administration’s decision stands to simplify what has been a confusing list of who’s eligible by allowing anyone 18 or older to choose either a Pfizer or Moderna booster six months after their last dose — regardless of which vaccine they had first. The move came after about a dozen states had started offering boosters to all adults. 

“We heard loud and clear that people needed something simpler — and this, I think, is simple,” FDA vaccine chief Dr. Peter Marks told The Associated Press. 

There’s one more step before the approach becomes official: The Centers for Disease Control and Prevention must agree to expand Pfizer and Moderna boosters to even healthy young adults. Its scientific advisers were set to debate it later Friday. 

If the CDC agrees, tens of millions more Americans could have three doses of protection before the new year. Anyone who got the one-dose Johnson & Johnson vaccine can already get a booster. 

All three COVID-19 vaccines used in the U.S. offer strong protection against severe illness including hospitalization and death without boosters, but protection against infection can wane with time. Previously, the government had cleared boosters of Pfizer’s vaccine, as well as the similar Moderna vaccine, only for vulnerable groups including older Americans and people with chronic health problems. 

But Pfizer last week asked the FDA to expand that decision to everyone, citing new data from a study of 10,000 people. Ultimately, the FDA decided there was enough evidence, from studies and real-world use of boosters, to back the expansion for both Pfizer and Moderna. 

The move comes as new COVID-19 cases have climbed steadily over the last two weeks, especially in states where colder weather is driving people indoors. Some states didn’t wait for federal officials to act and opened boosters to all adults. 

Marks said he understood why some governors got out ahead of the FDA. 

“We’re going into a cold season, cases going up, high travel season, people indoors sharing good holiday times together,” he said. “They probably saw the specter of what could happen here, and were trying — well intentioned — to do something.” 

Boosters for everyone was the Biden administration’s original goal. But in September, a panel of FDA advisers voted overwhelmingly against that idea based on the vaccines’ continued effectiveness in most age groups. Instead, they endorsed an extra Pfizer dose only for the most vulnerable. (Read more)

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