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FDA Fully Approves Pfizer's COVID Vaccine

(CBS) -- The FDA gave full approval to Pfizer's two-dose COVID vaccine Monday. It's the first COVID vaccine in the United States to earn that distinction; Moderna and Johnson & Johnson's shots are currently authorized for emergency use.

That could boost vaccination efforts as many unvaccinated people say they are hesitant to get the shot before the vaccines are fully approved.

"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," said Acting FDA Commissioner Dr. Janet Woodcock in a statement. "While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

The vaccine is approved for people 16 and older. It's available for kids 12 and older under emergency use authorization. A third dose is also available under emergency use authorization for certain immunocompromised people.

The FDA said its evaluation process involved a large clinical trial, analyzing hundreds of thousands of pages of data, and inspections of vaccine manufacturing facilities.

In Massachusetts, 71% of the state's population has received at least one dose of the COVID vaccine, compared to 60% of the national population. Gov. Charlie Baker had called on the FDA to urgently approve the COVID vaccines, saying he thought it could make a "big difference."

"The Baker-Polito Administration is pleased that the Pfizer vaccine has received full approval from the Food and Drug Administration for individuals sixteen years of age and older," Baker spokesman Terry MacCormack said in a statement. "Massachusetts remains a national leader in vaccinating its residents and the Administration is hopeful this development will provide one more reason for people to get vaccinated, as the vaccines are the best way people can protect themselves and their families."

Cambridge-based Moderna has also started the process for seeking full approval from the FDA and had said it hopes to finish its submission by August. A person familiar with the FDA's plan told CBS News recently that the company has yet to complete the application.


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