FDA is permitting Covid vaccine booster shots for people with weakened immune systems

August 16, 2021: -The Food and Drug Administration authorized Covid-19 vaccine booster shots for people with weakened immune systems, a highly anticipated move intended to shield some of the most vulnerable Americans from the highly contagious delta variant.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

The agency said organ transplant recipients, and similarly, immunocompromised people could receive a third dose of the Pfizer-BioNTech or Moderna vaccines. The FDA also emphasized that other fully vaccinated people are “adequately protected” and currently do not need an extra amount.

The FDA OK is not the final go-ahead. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a Friday meeting to consider immunocompromised Americans’ shots. If they issue a recommendation and the CDC approves it, third shots could begin immediately.

Last week, White House chief medical advisor Dr. Anthony Fauci said that federal health officials were speeding regulatory efforts to clear third doses for such people, which include cancer and HIV patients or those who have had organ transplants. He said new data suggested they don’t produce an adequate immune response after receiving two doses of a Covid vaccine.

“Immunocompromised individuals are vulnerable,” Fauci said Thursday. “We need to move to get those individuals their boosters, and we are now working on that, and we will make that be implemented as quickly as possible. It is a very high priority.”

Such people represent only about 2.7% of the U.S. adult population but makeup about 44% of hospitalized Covid breakthrough cases, which is when a fully vaccinated individual becomes infected, according to recent data from a Centers for Disease Control and Prevention advisory group.

Studies suggest that third vaccine doses might help patients whose immune systems don’t respond as well to a first or second dose.

Last month, four small studies cited by the CDC showed that 16% to 80% of people with weakened immune systems didn’t have detectable antibodies to fight Covid after two shots. According to the CDC, 33% to 50% developed an antibody response among vaccinated patients who had no detectable antibody response after receiving an additional dose.

“The hardest to vaccinate people are those who are immunosuppressed,” Dr. Dan Barouch, an immunologist at Harvard Medical School, said in late June. Data suggests at least a third of them respond well if they get a third dose, he added.