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CDC advisers to review data on Pfizer-BioNTech COVID-19 vaccine

(Reuters) - A U.S. Centers for Disease Control and Prevention (CDC) advisory panel will meet on Friday to review data on the COVID-19 vaccine developed by Pfizer Inc and BioNTech SE, with a vote here expected on Sunday on specific recommendations to doctors on how it should be used.

FILE PHOTO: Robert Redfield, director, United States Centers for Disease Control and Prevention, testifies during a U.S. Senate Senate Health, Education, Labor, and Pensions Committee Hearing to examine COVID-19, focusing on an update on the federal response at the U.S. Capitol in Washington, D.C., U.S., September 23, 2020. Alex Edelman/Pool via REUTERS/File Photo

The CDC panel meeting will follow Thursday’s meeting of an independent advisory panel to the U.S. Food and Drug Administration that will discuss Pfizer’s vaccine data and recommend whether it should be authorized for emergency use. The FDA will have the final say.

Dr. William Schaffner, an infectious disease expert and non-voting member of the CDC’s Advisory Committee on Immunization Practices (ACIP), said the gap between the two ACIP meetings will allow the FDA time to draft and issue an emergency use authorization (EUA) before the ACIP vote.

That schedule could change, however, if FDA advisers have questions or request more data, he said.

Pfizer last month said its vaccine’s two-dose regimen was 95% effective at preventing illness from COVID-19 and had no major safety issues. The drugmaker is set to present its data to ACIP on Friday.

The FDA released documents on Tuesday in preparation for Thursday’s advisory committee meeting, saying the Pfizer vaccine’s efficacy and safety data met its expectations for the authorization.

The ACIP panel will have to make recommendations about several groups, including whether the vaccine should be used in adolescents aged 16 to 18, and whether it should be used in pregnant women, who were excluded from Pfizer’s late-stage trial.

Schaffner, who represents the National Foundation for Infectious Diseases on the ACIP panel, said more than 300,000 healthcare workers are women who are pregnant or lactating. Frontline healthcare workers have been prioritized to get the first vaccines in the United States.

“This is not trivial,” Schaffner said. “The question will immediately come up at every medical center: ‘Do you offer those persons the vaccine? And if so, under what circumstance?’”

So far, ACIP discussions have been leaning toward allowing these women to take the vaccine after having received full information on its safety and efficacy, he said, but they have yet to vote on the matter.

The CDC sets U.S. adult and childhood immunization schedules based on ACIP recommendations.

The committee last week voted for healthcare workers and residents of long-term care facilities to receive the first doses of a COVID-19 vaccine in the United States.

A meeting of advisers to the FDA is scheduled for Dec. 17 to discuss Moderna Inc’s vaccine, which is also being reviewed for emergency use in the United States.

Reporting by Manojna Maddipatla in Bengaluru and Julie Steenhuysen in Chicago; Editing by Shinjini Ganguli and Bill Berkrot

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