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Moderna seeks FDA authorization for 4th dose of COVID shot

Moderna wants federal regulators to approve a fourth dose for all adults, not just seniors.
A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore., on Dec. 27, 2021. U.S. regulators have granted full approval to Moderna’s COVID-19 vaccine after reviewing additional data on its safety and effectiveness. Now the company is seeking authorization for a fourth dose as a booster for adults.
A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore., on Dec. 27, 2021. U.S. regulators have granted full approval to Moderna’s COVID-19 vaccine after reviewing additional data on its safety and effectiveness. Now the company is seeking authorization for a fourth dose as a booster for adults. [ JENNY KANE | AP ]
Published Mar. 18, 2022

WASHINGTON — Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults.

The request is broader than rival pharmaceutical company Pfizer’s request earlier this week for the regulator to approve a booster shot for all seniors.

In a press release, the company said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose of the mRNA vaccine, “including for those at higher risk of COVID-19 due to age or comorbidities.”

U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines’ protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to “urgently” approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations.

U.S. health officials currently recommend a primary series of two doses of the Moderna vaccine and a booster dose months later.

Moderna said its request for an additional dose was based on “recently published data generated in the United States and Israel following the emergence of Omicron.”

On Tuesday, Pfizer and its partner BioNTech asked U.S. regulators to authorize an additional booster dose of their COVID-19 vaccine for seniors, saying data from Israel suggests older adults would benefit.

By Associated Press Writer Zeke Miller

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How to get tested

Tampa Bay: The Times can help you find the free, public COVID-19 testing sites in Citrus, Hernando, Hillsborough, Manatee, Pasco, Pinellas, Polk and Sarasota counties.

Florida: The Department of Health has a website that lists testing sites in the state. Some information may be out of date.

The U.S.: The Department of Health and Human Services has a website that can help you find a testing site.

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How to get vaccinated

The COVID-19 vaccine for ages 5 and up and booster shots for eligible recipients are being administered at doctors’ offices, clinics, pharmacies, grocery stores and public vaccination sites. Many allow appointments to be booked online. Here’s how to find a site near you:

Find a site: Visit vaccines.gov to find vaccination sites in your ZIP code.

More help: Call the National COVID-19 Vaccination Assistance Hotline.

Phone: 800-232-0233. Help is available in English, Spanish and other languages.

TTY: 888-720-7489

Disability Information and Access Line: Call 888-677-1199 or email DIAL@n4a.org.

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More coronavirus coverage

OMICRON VARIANT: Omicron changed what we know about COVID. Here’s the latest on how the infectious COVID-19 variant affects masks, vaccines, boosters and quarantining.

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