Fully Vaccinated Americans 'Do Not Need' a COVID Booster Shot Now, FDA and CDC Say

"People who are fully vaccinated are protected from severe disease and death," the joint statement between the two health agencies said

teen vaccine
A child getting vaccinated. Photo: Getty

Fully vaccinated Americans "do not need" a COVID-19 booster shot despite new variants, according to a joint statement from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

On Thursday, the two organizations said that "Americans who have been fully vaccinated do not need a booster shot at this time."

The agencies added that the "United States is fortunate to have highly effective vaccines that are widely available."

"People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta," the statement noted. "People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated."

The statement added, however, that the "FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary." If needed, the organizations said they would base future judgments on "account laboratory data, clinical trial data, and cohort data."

Covid vaccine
COVID vaccine. Getty

The new statement comes shortly after Pfizer and its partner BioNTech said that they plan to seek FDA authorization for a booster dose of their COVID-19 vaccine.

Pfizer and BioNTech announced on Thursday that the companies are developing a specially formulated COVID-19 booster shot to fight against the highly contagious Delta variant. The companies estimate that a third dose of the Pfizer vaccine will be needed 12 months after the first two doses.

In a statement, the companies said the third dose of their existing COVID-19 vaccine would be helpful against the Delta strain, also known as B.1.617.2. However, Pfizer and BioNTech "are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant."

"The first batch of the mRNA for the trial has already been manufactured at BioNTech's facility in Mainz, Germany," the companies said, adding it is anticipated that "the clinical studies to begin in August, subject to regulatory approvals."

RELATED VIDEO: Nurse Whose Husband Died of COVID Is on a Door-to-Door Vaccine Crusade: 'I Can Help Save Others'

On Friday, Dr. Vin Gupta stopped by the Today show for a virtual appearance, and said that those who are immunocompromised will need to receive a booster shot, but fully vaccinated Americans will not need one in near future.

"Whatever booster shot's being developed by Pfizer, that's great for that 4% of America that's gonna need it," he explained. "However, for the rest of us, the science just isn't there yet."

"Two doses, if you're fully vaccinated with Pfizer [or] Moderna, [is enough]," he continued. "With Johnson & Johnson, we're having that debate about getting them that second dose. Two doses seem like they're critical to giving you full protection from the hospital in light of the Delta variant."

As information about the coronavirus pandemic rapidly changes, PEOPLE is committed to providing the most recent data in our coverage. Some of the information in this story may have changed after publication. For the latest on COVID-19, readers are encouraged to use online resources from the CDC, WHO and local public health departments. PEOPLE has partnered with GoFundMe to raise money for the COVID-19 Relief Fund, a GoFundMe.org fundraiser to support everything from frontline responders to families in need, as well as organizations helping communities. For more information or to donate, click here.

Related Articles