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Pfizer says data supports its request for Food and Drug Administration approval of a third dose of the COVID-19 vaccine about six months after the second dose in people 16 years and older.
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The FDA announced the Pfizer vaccine is the first in the U.S. that is now fully approved. Here's what that means for vaccine mandates and convincing vaccine-hesitant people to get vaccinated.
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Pfizer and BioNTech's COVID-19 vaccine has been given full approval by the Food and Drug Administration. Along with that approval process is the companies' new brand name for the vaccine: Comirnaty.
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The approval replaces the emergency use authorizations granted last December and could make it easier for employers, the military and universities to mandate vaccination.
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Health officials have been investigating an extremely rare side-effect of vaccination with the mRNA vaccines in young people: heart inflammation that's mostly mild and temporary.
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The FDA has authorized storing the Pfizer-BioNTech COVID-19 vaccine at refrigerator temperatures for up to a month. Previously the vaccine could only be kept in a regular fridge for up to 5 days.
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Pfizer said in late March that clinical trials found "100% efficacy and robust antibody responses" to the coronavirus in 12- to 15-year-olds.
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The company said in late March that clinical trials showed the vaccine elicits "100% efficacy and robust antibody responses" in adolescents.
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Pfizer and Moderna each agreed to supply 100 million doses of COVID-19 vaccine to the U.S. by the end of March. With just under three weeks left, both companies have their work cut out for them.
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The two companies producing COVID-19 vaccines for use in the United States will have to raise production to meet contractual goals of 100 million doses each by the end of March.