“Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic ― but not until after a long, hard winter. The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study. The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon. With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision. “Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert said on the eve of Pfizer’s announcement, adding that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.” Friday’s filing sets off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans. How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart. Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.
Trump: Millions Of Americans Getting COVID-19 Is ‘Terrific’ And A ‘Powerful Vaccine’
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["President Donald Trump on Tuesday spun the high number of Americans who have been infected with COVID-19 as “terrific,” claiming falsely that all those cases serve as a “powerful vaccine.” “I think that the vaccine ...
Studies Suggest AstraZeneca COVID-19 Vaccine Safe And Effective
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["New results on a possible COVID-19 vaccine from Oxford University and AstraZeneca suggest it is safe and about 70% effective, but questions remain about how well it may help protect those over 55 — a key concern for...
U.S. Regulators Post Positive Review Of Pfizer Vaccine Data
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["WASHINGTON (AP) — Documents released by U.S. regulators Tuesday confirmed that Pfizer and BioNTech’s COVID-19 vaccine was strongly protective against COVID-19 ― offering the world’s first detailed look at the eviden...
William Shakespeare Is Second Person To Receive Vaccine As UK Begins Shots
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["An historical occasion like the rollout of a coronavirus vaccine requires an historic name, right? Enter one William Shakespeare, an 81-year-old British man who on Tuesday became the second person in the world to re...
Pfizer Declines Invitation To White House ‘Vaccine Summit’
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["Pfizer and Moderna, two pharmaceutical companies that have developed promising COVID-19 vaccines, will not participate in a “vaccine summit” Tuesday at the White House that touted the participation of private sector...
Trump Administration Declined Summer Offer To Buy More Of Pfizer’s Vaccine: Reports
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["The Trump administration declined an offer from Pfizer to buy more doses of its COVID-19 vaccine at the end of the summer, according to several reports. The New York Times first reported Monday that Pfizer offered t...
Tuesday Is ‘V-Day’ In Britain; First Citizens Will Get COVID-19 Vaccine
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["LONDON (AP) — It’s been dubbed “V-Day” in Britain ― recalling the D-Day landings in France that marked the start of the final push in World War II to defeat Nazi Germany. A week after the U.K. became the first Weste...