FDA Panel Endorses Pfizer-BioNTech Coronavirus Vaccine, Authorization Expected Soon; Operation Warp Speed Trying To Help Obtain More Raw Materials For Vaccine Production
AP: U.S. panel endorses widespread use of Pfizer COVID-19 vaccine
“A U.S. government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine Thursday, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans. Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation…” (Neergaard/Perrone, 12/10).
Financial Times: U.S. offers to help increase production of Pfizer/BioNTech Covid vaccine
“The U.S. government is offering to help increase production of the Pfizer/BioNTech Covid-19 vaccine, as it tries to secure another 100m doses of the jab that regulators are reviewing. Operation Warp Speed, the government program to accelerate the development of a vaccine, is trying to double its pre-order of doses, after soaring demand has led to a shortage, according to people familiar with the matter. Operation Warp Speed is trying to help Pfizer obtain more raw materials and equipment under the Defense Production Act to ensure it can produce the extra doses by June 2021, according to one of the people…” (Kuchler et al., 12/11).
POLITICO: U.S. health officials say authorization is imminent for Pfizer coronavirus vaccine
“…An independent FDA advisory committee on Thursday voted to recommend use of the Pfizer vaccine for people aged 16 and older. The panel’s recommendation is nonbinding, but the agency’s top vaccine official, Peter Marks, has stated that the FDA could grant its blessing in a matter of days. Marks issued a statement with FDA Commissioner Stephen Hahn on Friday morning confirming Azar’s announcement, and saying that the agency ‘will rapidly work toward finalization and issuance of an emergency use authorization.’ The two officials added that they have also notified the Centers for Disease Control and Prevention and the Trump administration’s Operation Warp Speed, so that it can gear up for the distribution effort…” (Niedzwiadek, 12/11).
STAT: The timeline for Covid-19 vaccine distribution keeps slipping. Experts say it will change again
“…The shifting timelines are already apparent with Covid-19 vaccine distribution in the U.S. — even before the rollout starts in the coming days. The Trump administration declared in May that 300 million vaccine doses would be available by January 2021, with the first distributed in October of this year. By October, that had shifted to 100 million doses by the end of the year, according to Health and Human Services Secretary Alex Azar. Currently, the plan is for 40 million doses to be distributed in December, though some in health care are skeptical of even that prediction…” (Goldhill, 12/11).
Additional coverage of the FDA advisory panel’s recommendation and speculation regarding the distribution of a new coronavirus vaccine in the U.S. is available from The Atlantic, Financial Times, The Hill, New York Times, NPR, POLITICO, Science, STAT, and Washington Post.