The U.S. Food and Drug Administration (FDA) has authorized COVID-19 vaccine booster shots for people with weakened immune systems.
The FDA decision is intended to protect the most vulnerable people from the highly contagious Delta variant of COVID-19.
The agency said organ transplant recipients and people who are similarly immunocompromised can now receive a third dose of the Pfizer-BioNTech (NYSE:PFE) (NASDAQ:BNTX) or Moderna (NASDAQ:MRNA) vaccines. The FDA also emphasized that other fully vaccinated people are “adequately protected” and currently do not need an extra inoculation.
The FDA approval is not the final approval, however. The Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee has scheduled a meeting for today (August 13) to consider vaccines for immunocompromised Americans. If they issue a recommendation and it is approved by the CDC, third shots could begin immediately.
White House chief medical advisor Dr. Anthony Fauci said last week that federal health officials were speeding regulatory efforts to clear third doses for vulnerable people, including cancer and HIV patients or those who have had organ transplants.
Such people represent only about 2.7% of the U.S. adult population but make up about 44% of hospitalized COVID breakthrough cases, which is when a fully vaccinated individual becomes infected, according to recent data from a CDC advisory group.
Studies suggest that a third vaccine shot might help patients whose immune systems don’t respond as well to a first or second dose. With the Delta variant surging in the U.S., doctors fear leaving such groups unprotected against the virus could lead to even more dangerous variants.