TRUMP ADMIN UNVEILS PHARMACY PLAN FOR COVID VAX — The federal government will work with several major retail pharmacy chains to distribute and administer future coronavirus vaccines to the public, HHS said Thursday. The details: Albertsons, Costco, CVS, Publix, Walgreens, Walmart and Kroger are among the 19 companies that are part of the program, which HHS said is aimed at increasing access to a future vaccine in underserved areas of the country. Pharmacists, and interns and technicians they supervise, will help administer vaccines, David Lim reports. More than 60 percent of pharmacies nationwide are covered by the partnership. How it'll work: An HHS spokesperson told POLITICO only half of available doses of two-dose vaccines will be initially sent to pharmacies to ensure more can be sent 21 or 28 days later, when the first recipients will need their second shots. "This prevents administration sites from having to manage and store second doses," the spokesperson said. "Sites will also be provided vaccination reminder cards to provide every person, and administration sites are leveraging existing systems to text and email reminders." HHS says the government has set up the pharmacy partnerships in anticipation a vaccine will be ready for use by the end of 2020. LABS SOUND ALARM ON COVID TESTING CAPACITY — Clinical laboratories on Thursday warned they could soon face delays processing coronavirus tests as infections surge to record numbers across the country, similar to slowdowns during this summer's outbreaks. The nation's testing capacity has increased, but not fast enough to keep pace with the swarm of new cases, David writes. Over the past week the U.S. conducted nearly 10 million coronavirus tests, an increase of 12.5 percent from the previous week, while cases rose 40.8 percent to over 875,000 over the same period. "The surge in demand for testing will mean that some members could reach or exceed their current testing capacities in the coming days," said Julie Khani, the president of the American Clinical Laboratory Association, which represents private labs including LabCorp and Quest. HHS testing czar Brett Giroir told POLITICO the mean turnaround time for commercial laboratories currently stands at 1.6 days. Lab-based testing is a significant portion of overall testing capacity; however, 50 million to 60 million point-of-care tests are available this month, according to HHS. EXCLUSIVE: BIO QUESTIONS STATE VACCINE REVIEWS — BIO is taking issue with the "unintended consequences" of state-level vaccine safety and efficacy reviews, the industry group said in a letter sent Thursday to Gov. Andrew Cuomo of New York and Arkansas Gov. Asa Hutchinson. "Our greatest concern is the delay in access to FDA-approved COVID-19 vaccines," BIO president and CEO Michelle McMurry-Heath wrote. States including New York, California, Michigan, West Virginia, and potentially others are conducting their own reviews in addition to the FDA's reviews after raising concerns about politics interfering with the approval process. TRUMP USES VAX NEWS TO RAISE CASH FOR ELECTION CHALLENGES — President Donald Trump sent a fundraising email late Wednesday that claimed a Biden administration would slow a potential vaccine, and falsely implied the FDA had already approved a coronavirus vaccine. "The truth is, if Joe Biden were President, you wouldn't have the vaccine for another four years, nor would the U.S. Food and Drug Administration have ever approved it so quickly," the email says. The campaign team's email, which seeks to raise funds for his legal challenge to the election, also called out Pfizer, claiming it "didn't have the courage" to announce its positive results prior to the election. The announcement of Pfizer's positive results came early Monday, and Pfizer CEO Albert Bourla has said the independent data safety monitoring board reviewed the early vaccine data the day before. OPERATION WARP SPEED WILL WAIT TO BUY MORE PFIZER VACCINE — The Trump administration's coronavirus vaccine accelerator, Operation Warp Speed, has yet to exercise its option to purchase an additional 500 million doses of Pfizer's vaccine, Zachary Brennan reports. The first 100 million doses of the vaccine, which Warp Speed agreed to buy for almost $2 billion in July, will be delivered by March, according to Pfizer. The company said this week that the vaccine was more than 90 percent effective in early data from its Phase III trial. An HHS spokesperson told Prescription PULSE the U.S. government is not obligated to purchase the doses and may wait to do so until after the FDA grants the vaccine an emergency authorization or full approval. WOODCOCK DEFENDS DOSAGE OF LILLY ANTIBODY — Operation Warp Speed's therapeutics lead Janet Woodcock rejected criticism of the FDA's decision this week to authorize a low dose of Eli Lilly's coronavirus antibody drug, Zachary writes. Experts have raised concerns that FDA green-lit a dose — 700 milligrams — that did not appear to be the most effective in published trial results. According to results published in the New England Journal of Medicine late last month, only the 2800 mg dose of the antibody drug "appeared to accelerate the natural decline in viral load over time." "The authorized dose is a single infusion of 700mg. I don't think people will be able to give more than that. This seems to be an issue," tweeted Walid Gellad, Director of the Center for Pharmaceutical Policy & Prescribing at the University of Pittsburgh. But Woodcock told reporters Tuesday that the 700 mg dose does reduce viral load in people with Covid-19. She also noted that an even lower dose could have been authorized, although she did not offer further explanation of why that would be the case. | 
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