![]() ![]() The vaccine is given via two shots administered three weeks apart, so 100 million doses would be enough to vaccinate 50 million people.Īmericans will receive the vaccine for free, according to the statement from the companies and the U.S. The company expects to produce 100 million doses by the end of 2020 and as many as 1.3 billion doses through 2021. Like other companies, Pfizer is already manufacturing doses of its shot before there's evidence that it will work. Emergency authorizations, like what was granted to Gilead's COVID-19 drug remdesivir, would be considered on a case-by-case basis, the agency stated. Guidance recently issued by the regulator indicates FDA reviewers will want evidence any experimental vaccine reduces, by at least half, the risk of either coronavirus infection or developing COVID-19. Should that go well, the drugmaker said it could be in a position to ask for an emergency authorization from the FDA in October. With encouraging Phase 1 data now in hand, Pfizer plans to begin a Phase 2b/3 study as early as this month. Pfizer and AstraZeneca could be close behind, however. Moderna's candidate is likely to be the first to begin late-stage testing in the U.S., with a Phase 3 trial slated to start on July 27. government has also funded vaccine makers Moderna, Johnson & Johnson and Sanofi, although no specific supply agreement has been announced for any of those three. The firm will only get the $1.95 billion upon delivery after an emergency authorization or approval from the Food and Drug Administration. The deals with AstraZeneca and Novavax appear to include funding for Phase 3 testing, likely to involve 30,000 people in each trial, and related manufacturing scale-up costs. Taken together, the three agreements could total as much as $4.75 billion in funding for experimental vaccines. So far, the administration appears to be hedging its bets, lining up orders for some 500 million vaccine doses from AstraZeneca, Novavax and now Pfizer. It's an extraordinarily ambitious goal, particularly as there's no guarantee the experimental shots now in early studies will be proven safe and effective by large Phase 3 trials. Under a project dubbed "Operation Warp Speed," the Trump administration aims to have 300 million doses of a coronavirus vaccine ready for distribution by January 2021. ![]() should help the large drugmaker recoup its investment. But the sizable purchase order from the U.S. and, earlier this week, the U.K. Unlike other drugmakers racing to develop a coronavirus vaccine, Pfizer chose to fund clinical testing and manufacturing on its own. ![]()
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