FDA oks third COVID shot for the immunocompromised

Aug. 13, 2021

The U.S. FDA has amended the emergency use authorizations for both the Pfizer-BioNTech and the Moderna COVID-19 vaccines to allow an additional dose for some immunocompromised individuals.

Specifically, third doses are authorized for solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. It is estimated that around 3% of Americans — roughly 10 million people — are immunocompromised.

The amended EUAs dictate that the third dose of vaccine should be given at least 28 days after the second shot in the series.

The U.S. joins a growing list of governments, including Chile, Germany and Israel, that have decided to offer booster doses to specific populations in the face of the fast-spreading Delta variant.

A recent double-blind, randomized controlled trial of 120 individuals who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo. In the study, the third dose of mRNA-1273 was generally well tolerated.

Back in June, the U.S. government purchased an additional 200 million doses of Moderna’s vaccine, bringing the government’s confirmed order commitment to 500 million doses. Last month, the U.S. government purchased an additional 200 million doses of the Pfizer-BioNTech vaccine, earmarked for delivery from October 2021 through April 2022, bringing the total number of doses to be supplied to the U.S. to 500 million. Pfizer also plans to provide the U.S. government with 500 million doses for donation to the world’s poorest nations.