FDA panel recommends use of Pfizer COVID-19 vaccine
A federal advisory panel on Thursday recommended the emergency use of Pfizer’s COVID-19 vaccine. The Food and Drug Administration is expected to approve the drug, kicking off a massive nationwide operation to get nearly 3 million doses of the vaccine to hospitals and drug stores across the country.
“We’ve been working very closely with our state and local partners to make sure they have plans in place to identify providers that are able to receive, store and use the vaccine,” said Dr. Anita Patel, deputy of the CDC’s vaccine task force.
The experts voted 17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding. Health care workers and nursing home residents will be among the first to get the vaccine.
Pfizer CEO Albert Bourla applauded the panel’s decision. “We are pleased with the strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic,” Bourla said in a statement.
The FDA, however, is not required to follow the panel’s advice. “After we receive recommendations, we will incorporate that into our decision,” Stephen Hahn, the agency’s commissioner, told “CBS This Morning,” calling the endorsement “nonbinding.”
The news comes as the virus continues surging across the country. The U.S. on Wednesday recorded the most deaths in a single day: over 3,000, and hospitals are nearing capacity in intensive care units. Nearly 300,000 Americans have died from the virus, which has sickened over 15 million people in the U.S., according to Johns Hopkins University.
Speaking to the panel Thursday, Dr. Nancy Messonnier, a senior CDC official, said “active surveillance systems” will be in place to monitor the safety of the first vaccine recipients to track any potential adverse side effects. Messonnier said the systems will provide useful information about how the vaccine is affecting different communities.
“Understand that vaccine safety and effective monitoring is a top priority for the U.S government and we’re committed to ensuring that all these systems are in place and ready to go as soon as the vaccine program is implemented,” Messonnier said.
Clinical trials showed the Pfizer vaccine was nearly 95% effective for adults 18 to 64 and was just as effective for people of all ethnicities. However, some groups — people with weak immune systems, individuals with severe allergic reactions, and pregnant women — could be restricted from getting the shot.
However, British health officials on Wednesday warned that people with a history of “significant” allergic reactions to vaccines, medicine, or food should not be given Pfizer’s vaccine.
Hahn said the FDA is working closely with its partners in the U.K. to understand what happened with the allergic reactions. “We study the data very carefully to say who should not receive the vaccine and these are the things the FDA does to ensure the safety and effectiveness” of the drug, Hahn said Thursday.
Zoe Christen Jones contributed reporting.
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