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A few days ago, allegations were made against North Korean hackers for cyberattacking COVID-19 vaccine frontrunner AstraZeneca. Turns out, the British pharma wasn’t alone on Pyeongyang’s hunting list...North Korean hackers have also tried to steal information from U.S. COVID vaccine developers Johnson & Johnson and Novavax...The totalitarian state also made attempts at three South Korean drugmakers working on COVID-19 vaccines or therapeutics: Celltrion, Genexine and Shin Poong Pharmaceutical...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

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

More than 40 years since setting up shop in a rented warehouse as the modern world’s first biotech company, Roche’s Genentech is now up for a major expansion at its South San Francisco home in California...the local city council approved Genentech’s expansion proposal, which aims to almost double its headquarters’ building space to 9 million square feet from the current 4.7 million square feet...That extra buildout, all within the boundary of its existing 207-acre campus, allows the Roche unit to add as many as 12,550 employees at the HQ on top of the 10,000 or so who are there right now, according to the master plan...READ MORE

Pharma giant expects to ship half the doses it had originally planned after finding raw materials in early production didn’t meet its standards...When Pfizer Inc. said last month it expects to ship half the Covid-19 vaccines it had originally planned for this year, the decision highlighted the challenges drug makers face in rapidly building supply chains to meet the high demand...“Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”...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

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

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

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