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FDA Grants Full Approval to Pfizer COVID-19 Vaccine in People 16+

PROVIDENCE, RI – With the announcement from the U.S. Food and Drug Administration (FDA) today that the Pfizer COVID-19 vaccine has full approval for use in people 16 and older, Governor Dan McKee and the Rhode Island Department of Health are urging all eligible Rhode Islanders who have not been vaccinated yet to get vaccinated today.

Full authorization for Moderna's COVID-19 vaccine is expected in the coming weeks. (Moderna submitted their request for full approval several weeks after Pfizer.) Both vaccines have been authorized on an emergency-use basis since December.

"To anyone who was on the fence, the science is crystal clear. These vaccines are safe, and they are very effective at keeping people healthy," said Governor Dan McKee. "It is time. It is time to protect yourself. It is time to protect your family. It is time to get vaccinated. We have vaccination opportunities available in communities across Rhode Island. If you have not gotten your shot, get vaccinated today."

Full FDA approval is a rigorous, months-long process focused on safety and effectiveness. To receive full FDA approval, Pfizer needed to submit hundreds of pages of clinical data, information on manufacturing processes, safety reports, and data and background in many other areas. Of the more than 170 million people in the United States fully vaccinated against COVID-19, more than 92 million received the Pfizer vaccine.

"The FDA did an extremely thorough review of this vaccine and reaffirmed that it absolutely was safe," said Director of Health Nicole Alexander-Scott, MD, MPH. "It is undeniable that the COVID-19 vaccines save lives. If you are eligible, get vaccinated today to protect you and your family. It's easier than it has ever been before."

COVID-19 vaccine is available in variety of settings in Rhode Island, including retail pharmacies, pop-up and community clinics, the State-run site at Sockanosset Cross Road, and hospitals. To find a clinic near you, visit C19vaccineRI.org. In addition, the State is coordinating more than 100 back-to-school clinics in communities throughout Rhode Island. For a full list of back-to-school clinics, visit www.back2schoolri.com.

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