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FDA poised to authorize 3rd vaccine dose for immune-compromised people: Sources


(WASHINGTON) — The Food and Drug Administration is planning to authorize a third shot for the immune-compromised on Thursday, two sources familiar with the plans confirmed to ABC News.

If the FDA green-lights the additional shots — first reported by NBC News — it’s up to the Advisory Committee on Immunization Practices, the Centers for Disease Control’s expert advisory panel, to make its own recommendation on who should get the shot and what factors they might want to consider. Those recommendations are typically adopted by the CDC as nationwide public health guidance. The ACIP is scheduled to meet on Friday, though it is not currently scheduled to vote.

Many immunocompromised Americans have not had high immune responses to the vaccines, leaving them vulnerable to the virus even after getting a shot. Response has been low particularly in transplant recipients, cancer patients or people on medications that suppress their immune response.

About 2.7% of U.S. adults are considered immunocompromised.

Asked to comment on the plans, the FDA said its “closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals.”

“The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future,” the FDA said in a statement.

At a July meeting, members of ACIP were largely supportive of giving immunocompromised people a third dose to boost their immunity and they called on the FDA to move on the issue.

ABC News’ Anne Flaherty contributed to this report.

This is a developing news story. Please check back for updates.

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