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"With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," the pharmaceutical giant said.
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Pfizer and BioNTech say that early trial results show their vaccine established a strong antibody response against the coronavirus. FDA review is still needed.
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Advisers to the Food and Drug Administration supported boosters of the Pfizer-BioNTech COVID-19 vaccine for a smaller group of people after they voted against recommending it for anyone 16 and older.
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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 lab has access to a high-security facility that Pfizer needed to prove its COVID-19 vaccine was working. Now the scientists there are testing the vaccine's effectiveness against viral variants.
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Onondaga County is ready for state and federal approval to vaccinate 12- to 15-year-olds against the coronavirus. County Executive Ryan McMahon suggests…
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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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The new deal effectively doubles the federal government's order from the company. Pfizer says the U.S. government has agreed to pay $1.95 billion for the additional doses.
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Hours after the EU's drug agency signed off on the vaccine, the European Commission approved its use, clearing the way for inoculations to begin across Europe.
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Pfizer is pushing back on the Trump administration's suggestion that the company is having trouble producing enough COVID-19 vaccine.