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As the country battles "yet another wave of the COVID-19 pandemic," the U.S. Food and Drug Administration authorized the use of an additional vaccine dose—a COVID booster shot—for "certain immunocompromised individuals," the FDA said in a statement on August 12.
The federal body advised the latest action "does not apply to people who are not immunocompromised" and that "fully vaccinated individuals do not need an additional vaccine dose right now."
Acting FDA Commissioner Janet Woodcock stated Thursday: "The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease."
Following a "thorough review" of the available data, the federal body determined "this small, vulnerable group" may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines, Woodcock said.
At a White House press briefing Thursday, the director of the U.S. Centers for Disease Control and Prevention, Rochelle Walensky, estimated the group of vulnerable people eligible for the booster shot was less than three percent of adults.
The CDC's Advisory Committee on Immunization Practices is scheduled to convene on Friday to discuss "further clinical recommendations regarding immunocompromised individuals," the FDA said.
Who Is Eligible for the COVID Booster Shot?
Certain immunocompromised people who require extra protection from COVID-19 are eligible for the booster shot.
These specifically include "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise," the FDA said Thursday.
The FDA explained: "People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19."
Following an evaluation of the current information available on the use of a third vaccine dose, the federal body determined a booster shot may increase protection among these immunocompromised individuals.
The FDA said these vulnerable people should "maintain physical precautions" to help prevent infection.
It also advised "close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection to their loved ones."
When Will the COVID Booster Be Available?
Currently it is unknown when the booster COVID dose will be available to those eligible, how it would be distributed and where it can be accessed.
Newsweek has contacted the FDA, the CDC, the White House and the U.S. Department of Health and Human Services (HHS) for comment.
Does Everyone Need a COVID Booster?
The FDA's Woodcock advised those who are "fully vaccinated are adequately protected" against COVID-19 and do not require a booster at this time.
"The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future," Woodcock said Thursday.
According to the CDC website, which was last reviewed on August 11 ahead of the FDA's latest announcement: "The need for and timing for COVID-19 booster doses have not been established. No booster doses are recommended at this time. This guidance may be updated as more information becomes available."
In a statement on July 8, the HHS said: "FDA, CDC, and NIH [National Institutes of Health] are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary."
About the writer
Soo Kim is a Newsweek reporter based in London, U.K. She covers various lifestyle stories, specializing in Read more