FDA committee recommends Covid-19 vaccine


Seventeen members of the Vaccines and Related Biologics Advisory Committee voted yes, four voted no and one abstained.

“The question is never when you know everything. It’s when you know enough and I think we know enough now to say that it seems like our way out of this horrible mess, ”Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a committee member, CNN’s Wolf Blitzer said after the vote.

Dr James Hildreth, president and CEO of Meharry Medical College, said he would have hoped more minorities signed up for clinical trials of the vaccine.

“I just think we need this vaccine and the benefits outweigh the risks,” Hildreth, a temporary voting member of the committee, told CNN.
Several committee members expressed concern over reports of allergic reactions in two people vaccinated in Britain, which cleared Pfizer’s vaccine before the United States.

FDA staff have said that, as with any vaccine, paperwork would accompany the Pfizer vaccine warning against its administration to anyone with a history of serious allergic reactions to vaccines or allergies to any of the ingredients in the vaccine. vaccine.

An EUA is running out of full approval. Pfizer is expected to file a separate application for full FDA approval for its vaccine. Also, Thursday’s vote doesn’t mean the vaccine will be cleared immediately.

The FDA will now decide whether or not to accept the recommendation, but has indicated it will issue the EUA for the vaccine.

“It is important to note that the final decision on whether or not to authorize the vaccine for emergency use will be made by career officials at the FDA,” the agency said in a statement after the vote.

“In this time of great urgency, FDA staff feel responsible for moving through the review process as quickly as possible. However, he knows he must fulfill his mandate to protect public health and ensure that any authorized vaccine meets our standards for safety and efficacy to which Americans are accustomed, ”said the commissioner of the FDA, Dr. Stephen Hahn.

When can I get the coronavirus vaccine?

“The entire FDA – including myself – remains committed to keeping the public informed of the data evaluation of a potential COVID-19 vaccine, so that once available, Americans can have confidence in receiving the vaccine for their families and themselves. ”

Next, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is to meet to decide whether it recommends that the vaccine be deployed for use.

ACIP has a meeting scheduled for Friday and plans to vote at a meeting scheduled for Sunday.

Operation Warp Speed ​​officials say they will begin shipping the vaccine within 24 hours of FDA clearance.

President-elect Joe Biden intervened. “We are grateful to the scientists and researchers who developed this vaccine. And we are grateful to the scientists and public health experts who evaluated the safety and effectiveness of this vaccine without political influence. The integrity of science has got us to this point, ”Biden said in a statement.

The process begins again next week. The VRPBAC is scheduled to meet again on December 17th to discuss Moderna’s EUA application.

CNN’s Jen Christensen, Brian Rokus and Shelby Lin Erdman contributed to this story


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