CDC panel endorses full FDA approval of Pfizer’s COVID-19 vaccine

The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices met on Monday and voted to endorse the FDA’s full approval of Pfizer’s COVID-19 vaccine for Americans age 16 and older. 

The endorsement shortly follows the approval by the U.S. Food and Drug Administration on Aug. 23 of Pfizer’s two-dose vaccine as the U.S. faces a resurgence of virus cases and hospitalizations. 

Pfizer is also moving to seek federal approval for booster shots of its vaccine in order to extend protection. Last week, Pfizer-BioNTech announced it is also seeking approval from the FDA for a third dose of its COVID-19 vaccine.

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Following the federal approval, Pfizer-BioNTech began marketing its vaccine as Comirnaty. Brand Institute, a pharmaceutical naming company, worked with Pfizer-BioNTech to come up with the new name. 

According to a news release from the Brand Institute, the name is a mash-up representing "a combination of the terms COVID-19, mRNA, community, and immunity."

More than 200 million Pfizer doses have been administered in the U.S. under emergency provisions — and hundreds of millions more worldwide — since December. In going a step further and granting full approval, the Food and Drug Administration cited months of real-world evidence that serious side effects are extremely rare.

Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA had so much evidence to judge a shot’s safety.

Meanwhile, The delta variant has sent cases, deaths and hospitalizations soaring in recent weeks in the U.S., erasing months of progress. Deaths are running at about 1,000 a day on average for the first time since mid-March, and new cases are averaging 147,000 a day, a level last seen at the end of January.

As for effectiveness, six months into Pfizer’s original study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.

Those findings came before the delta variant began spreading, but other data from the CDC shows the vaccine is still doing a good job preventing severe disease.

This story was reported from Los Angeles. Chris Williams contributed.