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The U.K. became the first Western nation to grant emergency-use authorization for a COVID-19 vaccine, clearing a shot developed by Pfizer and BioNTech SE to be distributed in limited numbers within days. The two-shot vaccine is also being reviewed by FDA in the United States, where a similar authorization could come later this month and a rollout before the end of the year. The decision has stirred up a global debate about how to weigh the desperate need for a vaccine with the imperative of assuring people that it is safe. “Help is on its way with this vaccine—and we can now say that with certainty, rather than with all the caveats,” the British health secretary, Matt Hancock...READ MORE

Pfizer, alone among its peers, has faced fever-pitch scrutiny over the stringent cold storage requirements for its COVID-19 vaccine—and the logistical challenges that could pose. Looking to ease the doubters' concerns, Pfizer has now shipped its first doses by air to the U.S., and distributors are watching closely...Late last week, United Airlines started ferrying Pfizer’s COVID-19 vaccine hopeful from the Brussels International Airport in Belgium to Chicago O'Hare...marking the first “mass air shipment” of a coronavirus vaccine...READ MORE

On November 9, Pfizer announced that its COVID-19 vaccine candidate demonstrated efficacy of over 90% based on the mix of 94 cases between the placebo and vaccine groups in its Phase 3 clinical trial...Some of us had wondered about the timing of the announcement, given that the results far exceeded the primary efficacy endpoint of only 50% (with appropriate statistical confidence intervals) set by the FDA for a successful vaccine, and Dr. Fauci's concurrence that 50% would be acceptable...READ MORE

As a tide of late-stage data rolls in on COVID-19 vaccines from Pfizer, Moderna and AstraZeneca, the U.S. is gearing up for reviews that could see a vaccine authorized and deployed before the year is out. On Saturday, the chief of the White House's Operation Warp Speed effort laid out a definitive timeline, setting expectations for when the public could expect at least two shots to become available...Moderna will file for an emergency nod for its mRNA-based vaccine candidate before the month is out, Moncef Slaoui, Ph.D., head of "Warp Speed" and former vaccine chief at GlaxoSmithKline, said...That submission will segue straight into a Dec .17 data review, with the aim to ship vaccines to distributors within 24 hours of approval and potentially start vaccinations two days after the advisory panel makes its call, Slaoui said...READ MORE

The drugmaker Moderna said...it would soon begin testing its coronavirus vaccine in children ages 12 through 17. The study, listed...on the website clinicaltrials.gov, is to include 3,000 children, with half receiving two shots of vaccine four weeks apart, and half getting placebo shots of salt water...Moderna announced on Monday that data from its study in 30,000 adults had found its vaccine to be 94.1 percent effective, and that it had applied to the Food and Drug Administration for emergency authorization to begin vaccinating adults. If approval is granted, certain groups of high-risk adults, including people in nursing homes, could receive shots late in December...READ MORE

Days after grabbing headlines with its COVID-19 “vaccine for the world”, AstraZeneca is facing tricky questions about its success rate that some experts say could hinder its chances of getting speedy U.S. and EU regulatory approval...Several scientists have raised doubts about the robustness of results showing the shot was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose...“All we have to go on is a limited data release,” said Peter Openshaw, a professor of experimental medicine at Imperial College London. “We have to wait for the full data and to see how the regulators view the results,” he said, adding that U.S. and European regulators “might possibly take a different view” from each other...READ MORE

Indian Prime Minister Narendra Modi has urged states that are witnessing a surge in coronavirus cases to establish cold storage facilities for COVID-19 vaccines...India is home to some of the world’s biggest vaccine makers and there are five vaccine candidates under different phases of trial here. But the state-run cold chain facilities used to keep some vaccines consistently refrigerated would be inadequate for the enormous challenge of rolling out a COVID-19 vaccine...READ MORE

Supermarket pharmacies are gearing up to become major providers of COVID-19 vaccinations. Grocery stores say they are well-positioned to provide the vaccines because a large share of the population lives near one of their stores, and their pharmacies regularly offer vaccinations for other illnesses. The stores are now racing to secure the necessary equipment to administer COVID-19 vaccines, once they become available; train staff; and establishing online appointment scheduling services. HHS has signed on numerous grocery and pharmacy chains—including Kroger, Albertsons, and CVS Health—to provide COVID-19 vaccinations once the vaccines are approved by FDA...READ MORE

What will it take to distribute the first 6.4 million doses of Pfizer’s COVID-19 mRNA vaccine, if all goes according to plan and they ship in mid-December?...Alex Azar, secretary of health and human services, acknowledged...that the logistics—which include the need for ultra-cold storage—will be far from easy...To pull off the ambitious plan, Warp Speed has enlisted Pfizer, which has been running “dry rehearsals” at more than 50 vaccine distribution sites across the country, said Gen. Gustave Perna, who is leading the effort...The company is running the sites through the process of receiving the vaccines, opening them, and administering them, even going so far as to create YouTube videos for staffers to consult along the way...READ MORE

AstraZeneca is the latest player to unveil early COVID-19 vaccine data, and results seem to show an efficacy gap between at least one of its vaccine regimens and those of its two mRNA-based peers. But while investors may be less than enthused with the data, the vaccine does sport a major advantage in logistics given its much warmer storage needs...AstraZeneca's COVID-19 vaccine candidate, dubbed AZD1222, can be stored and transported at normal refrigerated temps of 2 degrees to 8 degrees Celsius (36 degrees to 46 degrees Fahrenheit) for at least six months and can be administered in "existing healthcare settings," giving the shot a major logistics leg up over a leading mRNA-based competitor that requires ultra-cold storage...READ MORE