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Federal health officials on Wednesday expressed confidence that every state will have access to at least some doses of a COVID-19 vaccine for distribution within 24 hours after authorization. "Every jurisdiction will have access immediately upon the initial push of the vaccine," Gen. Gustave Perna, chief operating officer of the Trump administration's Operation Warp Speed, said during a call with reporters. (Weixel, 11/18)

Lonza Group AG made its first commercial batch of the main ingredient in Moderna Inc.’s Covid-19 vaccine candidate in the U.S. last week and plans to start European production by the end of the month, Chairman Albert Baehny said. The company is ramping up and fine-tuning its production lines, a process that may stretch into next year.“We have access to the raw materials; we have access to the people,” Baehny said in an interview. The main challenge is “to optimize as much as possible.” (Kresge, 11/19)

Freezers required to store Covid-19 vaccines are in place at health systems that are preparing to administer the initial doses once the two leading candidates for shots receive a green light from regulators, U.S. health officials said Wednesday. The federal government will have 40 million doses—enough to vaccinate 20 million—ready to distribute by the end of December should vaccines developed by Pfizer Inc. and its partner BioNTech SE, and Moderna Inc. receive emergency-use authorizations, said Moncef Slaoui, chief scientific adviser of the joint-effort led by the Department of Health and Human Services and Defense Department to expedite the development and distribution of coronavirus vaccines, dubbed Operation Warp Speed. (Griffin and Baumann, 11/18)

A report released yesterday by the US Government Accountability Office (GAO) says supply chain issues could interfere with a smooth rollout of a COVID-19 vaccine and that the Food and Drug Administration (FDA) should disclose scientific review of vaccine and drug efficacy and safety data when issuing emergency use authorizations (EUAs). The report states that Operation Warp Speed, an effort of the Department of Health and Human Services, the Department of Defense, and private industry to dramatically accelerate development of COVID-19 vaccines and therapeutics, has condensed the timeline by directing more than $10 billion to vaccine manufacturers. But, it adds, the FDA needs to address public concerns that the process has been rushed, casting doubt on vaccine and drug effectiveness and safety. (Van Beusekom, 11/18)

As leading COVID-19 vaccines post positive phase 3 data and near FDA submissions, the agency official in charge of reviewing vaccines is emphasizing transparency and patience during the high-stakes process. Americans should expect reviews to take weeks rather than days, Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, told Business Insider. While the dire COVID-19 pandemic naturally creates urgency, Marks and his team "have to take the amount of time that we need to take," he said. The FDA is said to be discussing potential committee meetings for December 8 to 10, CNBC's Meg Tirrell reports. (Sagonowsky, 11/18)

Pfizer said Wednesday that its experimental COVID-19 vaccine appeared to be 95 percent effective in warding off the illness that’s surging around the world, a remarkable showing for the first set of complete results from a late-stage clinical trial. The pharmaceutical giant, which has a large presence in Massachusetts, said it expects to apply to the Food and Drug Administration for the first emergency use authorization of a coronavirus vaccine “within days.” (Saltzman, 11/18)

As Dolly Parton tells it, her first-ever car accident in October 2013 was minor, but left her bruised and sore enough to seek medical advice at Vanderbilt University Medical Center. That’s where she met Naji Abumrad, a physician and professor of surgery. Abumrad knew next to nothing about the beloved megastar with big, blond hair, but he soon befriended her because he deeply enjoyed their talks about current events and science. Their bond of nearly seven years received worldwide attention Tuesday after it was revealed that Parton’s $1 million donation to Vanderbilt for coronavirus research, made in honor of Abumrad, partially funded the biotechnology firm Moderna’s experimental vaccine, which a preliminary analysis released this week found is nearly 95 percent effective at preventing the illness. (Bella, 11/18)

As Pfizer and Moderna dominate headlines with positive interim readouts for their COVID-19 vaccine candidates, other mRNA players are taking note. Germany's CureVac, hot on the heels of an EU supply deal—is boosting its manufacturing network to produce "pandemic-scale volumes" of its mRNA shot across the bloc. CureVac aims to produce 300 million doses of its vaccine, dubbed CVnCoV, in 2021 and up to 600 million doses in 2022, to meet what it expects to be greater demand given the early success of other mRNA vaccines, the company said Tuesday. (Kansteiner, 11/17)