FDA authorizes third COVID vaccine dose for people with weak immune systems

The Food and Drug Administration has authorized an additional dose of vaccine for people with weakened immune systems caused by disease, medical treatments, and organ transplants.

The federal panel approved the immunization boosts late Thursday.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” says Acting FDA Commissioner Dr. Janet Woodcock.

The FDA’s action only applies to those with certain immune deficiencies, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have a similar level of immunocompromise. The CDC estimates the population to be less than three percent of adults.

“As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,” Woodcock says.

“The science and resulting data in this pandemic are moving extremely rapidly. The U.S. government, in turn, is moving swiftly to analyze the science and make the recommendations most appropriate to protect Americans,” said Centers for Disease Control and Prevention Director Dr. Rochelle Walensky during a White House briefing on Thursday. “We know our vaccines are safe and effective. And if you have not gotten a vaccine yet, please do so today.”

The CDC’s Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals.

Some countries have already started administering an additional dose to seniors based on studies showing a decline in immunity over time, GPB News reports. The committee is not scheduled to take any action on the broader question of boosters for the general population.

The Pfizer-BioNTech COVID-19 Vaccine is currently authorized for emergency use in individuals ages 12 and older, and the Moderna COVID-19 Vaccine is authorized for emergency use in individuals ages 18 and older. Both vaccines are administered as a series of two shots.