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FDA to Approve COVID-19 Booster Shots for the Immunocompromised

Booster shots
A third booster shot of the COVID vaccine will be approved for the immunocompromised fighting the Delta Variant. Credit: US Secretary of Defense, CC BY 2.0

The US Food and Drug Administration is expected to announce that they will be authorizing COVID-19 booster shots for the immunocompromised. The announcement is anticipated for some time within the next 48 hours. The shot is a follow up to the two-dose vaccines by Pfizer and Moderna.

An FDA spokesperson speaking to CNN said that “The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals, the agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future.”

The news comes as a huge relief to vaccinated immunocompromised Americans, who Johns Hopkins researchers recently found to be 485 times more susceptible to serious illness and even death from COVID compared to able-bodied people who had been vaccinated. The CDC estimates that there are roughly 9 million immunocompromised people in the United States.

The CDC and a group of its vaccine advisers will meet this coming Friday to consider booster shots for immunocompromised people. The team’s meeting agenda was released by the agency on Monday.

Inside the race to approve booster shots for the immunocompromised

The three COVID-19 vaccines– Pfizer, Moderna, and Johnson&Johnson–are in use in the United States through an emergency authorization provided by the FDA. Full approval is currently pending for Pfizer’s vaccine. After vaccines are authorized by the FDA, the CDC can consider new ways to use the vaccine, such as third doses/booster shots.

US Surgeon General Dr. Vivek Murthy said that the FDA has been paying close attention to the urgency of this issue, and that their plan to protect the immunocompromised will arrive “very soon.”

“We’ve been concerned about these individuals. We’ve been following them closely, and I think most of us believe that we’ve got to do more to protect these individuals,” Murthy said in an exchange with Wolf Blitzer on CNN’s “The Situation Room.”

“The FDA has been working hard to basically do the evaluation around safety and make sure that we have everything we need to make these additional doses available to people.” said Murthy. “The CDC is also looking into making sure the guidance is clear and available for immunocompromised individuals.”

An internal CDC document warns that the Delta variant of COVID-19 appears to spread as easily as chickenpox; not only that, but it also causes a more severe infection in those who contract it.

The slide presentation out of the CDC summarizes previously unpublished data that shows that those who are fully vaccinated might even spread the Delta variant of the COVID-19 at the same rate as those who are unvaccinated.

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