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Coronavirus

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

Published: Updated:

A US 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 expected on Sunday on specific recommendations to doctors on how it should be used.

The CDC panel meeting will follow Thursday’s meeting of an independent advisory panel to the US 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.

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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.

ACIP 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 US.

Healthcare personnel who have been infected with the coronavirus in the three preceding months, can choose to delay vaccination to let those susceptible to infection receive the shots first, the agency said on its website https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19/clinical-considerations.html.

“Current evidence suggests reinfection is uncommon during this period after initial infection,” it said.

Pfizer last month said its vaccine’s two-dose regimen was 95 percent 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 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.

“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 US adult and childhood immunization schedules based on ACIP recommendations.

A meeting of advisers to the FDA is scheduled for Dec. 17 to discuss Moderna Inc’s COVID-19 vaccine, which is also being reviewed for emergency use in the US.

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