FDA, CDC Say Fully Vaccinated Do Not Need Booster Shots. Yet.

“We are prepared for booster doses if and when the science demonstrates that they are needed," the federal agencies said.
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Americans who are fully vaccinated against COVID-19 do not need a booster shot at this point, the Food and Drug Administration and the Centers for Disease Control and Prevention said in a joint statement Thursday.

The news comes just hours after reports that Pfizer plans to file for authorization to give people a third shot of its coronavirus vaccine amid the rise in more transmissible coronavirus variants around the country. The company, alongside vaccine co-developer BioNTech, said a third injection could significantly “boost” the antibodies that protect vaccinated people against COVID-19.

The FDA and CDC, however, said those who are fully vaccinated are, so far, well protected against COVID-19 and its variants. All of the vaccines available in the U.S. provide significant protection against the coronavirus, including the emerging delta strain.

“People who are fully vaccinated are protected from severe diseases and death, including from the variants currently circulating in the country such as Delta,” the agencies said in a joint statement. “People who are not vaccinated remain at risk. Virtually all COVID-19 deaths are among those who are unvaccinated.”

“Americans who have been fully vaccinated do not need a booster shot at this time,” they continued, adding that researchers are testing if a booster may be necessary in the future.

“We are prepared for booster doses if and when the science demonstrates that they are needed.”

Pfizer and BioNTech also said Thursday they will begin developing a version of a COVID-19 vaccine that targets the delta variant and that they expect to launch clinical trials of it next month.

Public health officials have continued to urge Americans to get vaccinated against COVID-19, particularly since the delta strain of the coronavirus is now estimated to be the dominant variant in the U.S. Concern is particularly focused on states with lower vaccination rates, which have seen increasing numbers of new infections due to the high transmissibility of the delta variant.

“What keeps me awake at night? Knowing preliminary data from some U.S. states suggests 99.5% of #COVID19 deaths were in unvaccinated ppl,” Dr. Rochelle Waleknsky, the director of the CDC, wrote Thursday on Twitter. “Unnecessary death, unneeded suffering from being unvaccinated. Those deaths, that pain, are preventable. Get vaccinated.”

Other variants of interest have already been seen in the United States, including reports of the gamma strain in Washington state, as well as the lambda strain, which has spread widely in South America.


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