FDA nearing decision on COVID vaccine boosters for people with weakened immune systems

Immunocompromised people are at greater risk for becoming severely ill from COVID-19

The Food and Drug Administration is nearing a decision on COVID-19 vaccine booster shots for people with weakened immune systems.

The FDA has been closely monitoring data on studies about administering an extra dose for immunocompromised individuals, a spokesperson told Fox News. The agency has been working with the Centers for Disease Control and Prevention to evaluate options and will have an update soon, they said, without giving a specific timeline.

The CDC has identified immunocompromised people as being at higher risk for getting severely ill from COVID-19, more likely leading to hospitalization or death. And Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said during a White House press briefing this week that "immunocompromised individuals are vulnerable."

Examples of persons with weakened immune systems include those with HIV/AIDS; cancer and transplant patients who are taking certain immunosuppressive drugs; and those with inherited diseases that affect the immune system, the CDC explains on its website.

"The reason is that it is clear now from the observational data that was made that they do not make, in general, with some exceptions, but in general, do not make an adequate response that we felt — feel would be adequately protected," Dr. Fauci said. "So, in this regard, it is extremely important for us to move to get those individuals their boosters.

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"And we are now working on that, and we’ll make that be implemented as quickly as possible because, for us and for the individuals involved, it is a very high priority," Fauci added.

Recent data have indicated people with weakened immune systems could benefit from a booster dose of vaccine in order to bump up their antibody response against the virus. 

In the meantime, health officials have recommended that immunocompromised people continue taking precautions against the coronavirus.

FULLY VACCINATED, IMMUNOCOMPROMISED PATIENTS SHOULD KEEP MASKING UP AS EXPERTS PROBE BOOSTER SHOTS: CDC PANEL

Last month, Dr. Sara Oliver, member of the CDC’s Epidemic Intelligence Service, recommended that anyone with a weakened immune system should continue wearing a mask, social distancing from others and avoiding poorly ventilated spaces even if they’re vaccinated.

For now, health officials have said that vaccinated Americans don’t need an extra dose. 

The Food and Drug Administration is nearing a decision on COVID-19 vaccine booster shots for people with weakened immune systems. (iStock)

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However, with a changing situation with new virus stains like the highly contagious delta variant, an FDA spokesperson said the agency, along with the CDC and NIH, are still evaluating the potential of vaccine booster doses.

Officials are considering lab data, clinical trial data and cohort data from different pharmaceutical companies, the spokesperson said. 

Fox News' Kayla Rivas contributed reporting.

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