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The U.S. Food and Drug Administration said it authorized the use of Pfizer Inc’s COVID-19 vaccine on Friday, with the first inoculations expected within days...The FDA granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95% effective in preventing the disease in a late-stage trial. It said the vaccine can be given to people aged 16 and older...READ MORE

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

After President Donald Trump issued a range of executive orders targeting high U.S. drug prices in recent months, America's neighbors to the north are responding...Following warnings that mass exports could cause domestic drug shortages, Canadian officials blocked the shipment of meds to the U.S. if the exports would “cause or worsen” a shortage...The Canadian restriction went into effect on Friday, before the United States’ own rule to allow cheaper imports from its neighbor country as a way to lower prices...Moving forward, companies in Canada will be “required to provide information to assess existing or potential shortages, when requested, and within 24 hours if there is a serious or imminent health risk,” Health Minister Patty Hajdu said...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

It's no secret that the drug industry isn't thrilled with the Trump administration's last-ditch push to bring down drug prices, including an order allowing drug imports from Canada. Now, PhRMA is taking its objections to court...After the administration unveiled its importation executive order in final form in September, PhRMA and other groups sued the Department of Health and Human Services last month arguing the measure violates the Food, Drug, and Cosmetic Act...The lawsuit claims HHS’ importation effort increases risks for the U.S. drug supply chain and forces companies to disclose trade secrets...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

Vaccine developers Pfizer Inc and Moderna Inc on Monday rejected U.S. President Donald Trump’s invitation to attend a White House “Vaccine Summit”...The meeting, scheduled for Tuesday, comes ahead of the U.S. Food and Drug Administration’s review of Moderna and Pfizer-BioNTech’s vaccine candidates. It will be attended by Trump, Vice President Mike Pence and private-sector executives...Invitees at the meeting include drug distributors, pharmacies and logistics companies such as McKesson Corp, Walgreens Boots Alliance Inc, CVS Health Corp, United Parcel Service Inc and FedEx Corp...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