FDA approves administering 3rd Pfizer, Moderna shot to immunocompromised people

The Food and Drug Administration said those who are not immunocompromised and fully vaccinated do not require a third shot at this time. Photo by Kevin Dietsch/UPI

Aug. 13 (UPI) — The Food and Drug Administration on Thursday authorized the administration of third doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines to immunocompromised individuals.

The FDA said in a statement that it had to amend its to previous emergency use authorizations for the vaccines to allow the third shot to be administered to solid organ transplant recipients or those who have been diagnosed with conditions considered to have an equivalent level of immunocompromise.

“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 arm medical professionals with a way to boost immunity in immunocompromised patients who need further protection against COVID-19 as it experiences a surge in the United States.

According to a live tracker of the pandemic by Baltimore-based Johns Hopkins University, weekly caseloads have been escalating from a low of 83,400 in mid-June to more than 760,000 in the week ending on Sunday.

“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 Thursday that there will be between 9,600 and 33,000 new COVID-19-related hospitalizations, 3,300 and 12,6000 new COVID-19 deaths and 550,000 and 2.34 million new COVID-19 cases by Sept. 4

The FDA said the third shot has been authorized for those who have a reduced ability to fight infections, such as COVID-19, and other diseases, as it found that it may increase their protection.

“Other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,” Woodcock said. “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 was approved for emergency use to be administered to those ages 12 and above and the Moderna vaccine for those 18 and above. Both are two-dose regimens.

According to the CDC, the United States, which is the sickest country to the pandemic with more than 36.3 million infections including 619,000 deaths, has administered more than 411 million doses of vaccine, fully vaccinating more than 167 million people.


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