The Food and Drug Administration (FDA) is rapidly approaching a potential authorization for a third dose of Pfizer’s and Moderna’s COVID-19 vaccines among certain immunocompromised patients, within the next day, Dr. Rochelle Walensky, head of the Centers for Disease Control and Prevention (CDC) said Thursday.
“Emerging data show that certain people who are immune compromised, such as people who have had organ transplant and some cancer patients, may not have had an adequate immune response to just two doses of the COVID vaccine,” Walensky said during a White House briefing, estimating the patient group comprises less than 3% of the U.S. adult population.
“FDA is working with Pfizer and Moderna to allow boosters for these vulnerable people,” she continued. “An additional dose could help increase protection for these individuals, which is especially important as the delta variant spreads.”
Following the FDA’s decision, an independent advisory panel to the CDC plans to convene Friday to discuss the matter and offer its recommendations.
Walensky cited research published Wednesday in the New England Journal of Medicine among 120 organ-transplant recipients who received a third dose of Moderna’s vaccine, which indicated a substantial boost in neutralizing antibodies and T-cell counts, compared to a group receiving saline placebo.