FDA, CDC: More Americans must get vaccinated; too soon for boosters

Vaccine booster?

Pfizer is seeking U.S. authorization for a third dose of its COVID-19 vaccine. But the CDC and the FDA said fully vaccinated Americans don't need a booster yet.

Just hours after Pfizer announced it would seek U.S. authorization for a third dose of its COVID-19 vaccine, saying that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant, U.S. health officials issued a statement saying fully vaccinated Americans don't need a booster yet.

Instead, the FDA and CDC, in a joint statement, said that several parts of the country need to focus on getting more Americans vaccinated in the first place.

"People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta. People who are not vaccinated remain at risk," the FDA and CDC said in the statement. "Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community."

Fully vaccinated people don’t need COVID-19 booster at this time, FDA, CDC say

Dr. Rochelle Walensky, the CDC director, said that some parts of the U.S. have far lower immunization rates than others. That is leading to "two truths," she said: highly immunized swaths of America are getting back to normal while hospitalizations are rising in other places.

"This rapid rise is troubling," Walensky said: A few weeks ago the delta variant accounted for just over a quarter of new U.S. cases, but it now accounts for just over 50% — and in some places, such as parts of the Midwest, as much as 80%.

Research from multiple countries shows the Pfizer shot and other widely used COVID-19 vaccines offer strong protection against the highly contagious delta variant, which is spreading rapidly around the world and now accounts for most new U.S. infections.

CDC guidelines for schools

The CDC says fully vaccinated children and teachers don't need to wear masks indoors in schools. But schools can still set their own rules.

Fully vaccinated teachers and students don't need masks, CDC says

"Let me emphasize, if you were vaccinated, you have a very high degree of protection," Dr. Anthony Fauci, the U.S. government's top infectious disease expert, said Thursday.

"There's no evidence of waning immunity out there, and that’s the big take home," Dr. Eric Cioe-Peña of Northwell Health told FOX 5 NY. "In the absence of data that shows immunity is waning, it doesn’t make sense to give a booster, even if Pfizer would love to sell us all one."

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Antibodies naturally wane over time, so studies are underway to tell if and when boosters might be needed. Pfizer's Dr. Mikael Dolsten told The Associated Press that early data from the company's booster study suggests people's antibody levels jump five- to 10-fold after a third dose, compared to their second dose months earlier.

"FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary," CDC and FDA said in their statement. "This process takes into account laboratory data, clinical trial data, and cohort data — which can include data from specific pharmaceutical companies, but does not rely on those data exclusively."

Also, the CDC has updated its guidance on how schools should function as the pandemic wanes. The agency is suggesting people keep washing their hands, get tested for COVID, and wear a mask indoors if you're not vaccinated. But teachers and students who have gotten the vaccine can safely take off their masks.

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Joint CDC and FDA Statement on Vaccine Boosters (full text)

The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta. People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community.

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.

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