FDA OKs Pfizer, Moderna booster shot in vulnerable Americans

Aug. 13 (UPI) -- The Food and Drug Administration on Thursday authorized the administration of booster doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines for people with compromised immune systems.

The FDA said in a statement that it changed emergency use authorizations for the vaccines to allow for a third shot for solid organ transplant recipients and those who have been diagnosed with conditions that put them at increased risk.

"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," Acting FDA Commissioner Janet Woodcock said.

"After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines."

Woodcock said the third shoot will give medical professionals a way to boost immunity in compromised patients who need more protection.

Weekly caseloads in the United States have risen from 83,400 in mid-June to more than 760,000 at the start of this week, according to Johns Hopkins University.

"Estimates show the Delta variant caused nearly 95% of recent COVID-19 cases in the United States," the CDC tweeted Thursday. "Help protect yourself against Delta & other variants by getting vaccinated."

The CDC forecasted as many as 33,000 new COVID-19-related hospitalizations, 12,600 new deaths and up to 2.34 million new COVID-19 cases by Sept. 4.

The FDA noted that persons who are not at increased risk and have fully functioning immune systems do not need a booster.

"Other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time," Woodcock added. "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."

The Pfizer-BioNTech vaccine has been approved for use in those over 12 and the Moderna vaccine for people over 18. Both are two-dose regimens.

According to the CDC, the United States, which has seen more than 36 million cases and 619,000 deaths since the start of the pandemic, has administered more than 411 million doses of coronavirus vaccines. More than 167 million are fully vaccinated.