CDC recommends reformulated Pfizer, Moderna COVID boosters for all Americans over 12

New booster doses of COVID-19 vaccine should be available soon to anyone 12 and older who wants one. 

A federal advisory panel voted 13-1 Thursday to recommend the boosters after members spent more than six hours reviewing data on the current state of the pandemic and the new shots. The director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, signed off on the panel's recommendation a few hours later.

“This recommendation followed a comprehensive scientific evaluation and robust scientific discussion," Walensky said in a statement. "If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it."

The new boosters from Pfizer-BioNTech and Moderna target both the original virus and the most recent variants, called BA.4 and BA.5, which now dominate both the U.S. and the world. Pfizer-BioNTech shots will be available to anyone 12 and older, while Moderna's will be for adults.

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Although data on effectiveness remains incomplete, officials expect the more targeted booster will increase protection against severe disease and prevent milder infections for some period of time, as well as long COVID, which leads to lingering symptoms such as profound fatigue and brain fog. 

Officials predict that COVID-19 infections will rise again this fall and winter when children are back in school and people spend more time indoors and in close contact with each other. In fall 2021, the dangerous delta variant dominated, to be replaced later that year by omicron, which caused the highest caseload and number of deaths of the pandemic. 

BA.5 now accounts for 88% of the COVID-19 infections in the United States, with BA.4 making up most of the rest. Currently, more than 5,000 Americans per day are hospitalized with COVID-19 and about 400 die.

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Side effects are expected to be about the same as with previous COVID-19 vaccines.

Only about one-third of Americans have gotten a single booster after their initial two-dose series. Evidence suggests that a third dose is more protective against the omicron variants than two because of its differences from the original virus.

Also, protection wanes over time, so experts suggest that most people get a booster six months after their last shot or infection. Most Americans over age 5 received a vaccine more than six months ago, data suggests.

People who are immunocompromised may want to get boosters more often.

The new boosters are identical to previous shots except that some of the original vaccine has been replaced with vaccine targeting the new variants. The original vaccines, with Pfizer-BioNTech's known as Comirnaty and Moderna's as SPIKEVAX, will still be available as primary shots.

CDC said doses should be available within the next few days. Pfizer has already shipped more than 100,000 doses to 62 locations across the United States and expects to have 3 million doses available at more than 3,300 sites by Tuesday, the end of the Labor Day holiday weekend. 

Moderna also promises to make its new booster available this month.

The U.S. government has bought about 171 million bivalent mRNA booster doses for the fall and beyond.

If vaccination rates continue through March of next year, CDC officials expect that they could prevent at least 100,000 deaths, 1 million hospitalizations, 25 million infections and $62 million in medical costs. 

People who are old enough can get either vaccine, regardless of which company's vaccine they received earlier. 

The new shots are authorized to be give at least two months after a previous dose, but some members said people should wait at least 3 months after a vaccination or infection before getting another shot.

The booster can also be given at the same time as an annual flu shot.

People who are immunocompromised should be offered Evusheld, a monoclonal antibody that protects against COVID-19 for six months, CDC officials said.

Several committee members said they were uncomfortable authorizing a vaccine without a completed clinical trial. The only member to vote no, Dr. Pablo Sanchez, a professor of pediatrics at The Ohio State University and a pediatric infectious disease specialist at Nationwide Children’s Hospital in Columbus, said he felt the vote was "a bit premature."

Others said they were comfortable voting yes, noting that annual flu vaccines are approved without additional human trials, because, as in this case, the changes are not expected to affect safety.

Delaying authorization of a booster until later this fall could cost more than 9,000 lives and lead to more than 100,000 hospitalizations, the CDC projected.

"It would be better to have more information," said committee chairwoman Dr. Grace Lee, associate chief medical officer at Lucile Packard Children’s Hospital and a professor of pediatrics at Stanford University School of Medicine. "But we again have this situation in front of us where we anticipate there will be a tough winter season ahead both with flu and with COVID-19. I feel our job is to do our best to protect public health."

Contact Weintraub at kweintraub@usatoday.com 

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