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The FDA warns against changing the dosing levels and schedules of COVID-19 vaccines by Moderna and Pfizer-BioNTech...Amid concerns over limited COVID-19 vaccine supplies, some have proposed tweaking the shots’ dosing to immunize more people. One suggestion came from none other than U.S. vaccine czar Moncef Slaoui, Ph.D...Any changes to currently authorized vaccine dosing regimens pose a “significant risk of placing public health at risk” and undermine “the historic vaccination efforts to protect the population from COVID-19,” FDA Commissioner Stephen Hahn, M.D., and Peter Marks, M.D., Ph.D., head of the agency’s biologics department, said in a statement...READ MORE

The U.K.'s drug regulator has authorized a coronavirus vaccine from AstraZeneca and the University of Oxford, the first clearance for a shot viewed as critical to global immunization efforts but whose exact effectiveness is uncertain...The Medicines and Healthcare Products Regulatory Agency based its decision on positive data from studies in the U.K., Brazil and South Africa, which showed the shot was able to prevent symptomatic COVID-19 in a majority of vaccinated participants and protect against severe disease. The authorization comes less than a year after a team of Oxford researchers adapted pre-existing work on different coronaviruses to develop a shot for SARS-CoV-2...READ MORE

Will mRNA vaccines continue to protect the public against COVID-19 as mutant strains emerge? Pfizer and Moderna have set out to answer that question...After a mutated, fast-spreading variant of COVID-19 in the U.K. disrupted global travel over the weekend, a troubling question emerged: Will the new vaccines from Pfizer and Moderna work against this scary new strain of the virus?... They’re launching new studies designed to prove their mRNA-based shots will fend off the new coronavirus strain, while simultaneously expressing confidence this new vaccine technology is ideal for protecting against rapidly mutating viruses...READ MORE

Scientists are eyeing a potential culprit causing the allergic reactions to the Pfizer Inc. and BioNTech SE Covid-19 vaccine: the compound polyethylene glycol, also known as PEG...Six severe allergic reactions to the vaccine have been reported in the U.S., according to the Centers for Disease Control and Prevention, out of 272,001 doses administered through Dec. 19. At least two cases of anaphylaxis have also occurred in the U.K. People in the U.S. began receiving Moderna Inc.’s vaccine Monday, and no allergic reactions to it have been reported so far...READ MORE (full story behind pay wall)

With more than 1 billion BD injectors called for in the global fight against COVID-19, the company is looking at ways to support vaccination efforts up close and preparing for the future delivery of pandemic prophylactics...Becton Dickinson...last month surpassed 1 billion pandemic injection device orders globally...The company recently stumped up $1.2 billion to expand its pre-filled syringe capacity, sketching plans for a new plant in Europe, plus upgrades to six of the company’s existing sites in the U.S., Mexico, Europe and Japan. Those moves are expected to boost capacity by more than 50%...The company also teamed up with BARDA on a $70 million project to expand operations and dial up capacity for traditional needle and syringe devices at its Nebraska facilities. That upgrade, set to wrap in summer 2021, will provide the feds with priority access to “hundreds of millions” of injectors for COVID-19 vaccination efforts, plus supplies for future pandemics...READ MORE

The amount of money flowing into the biopharma industry via grants and collaborations with nonprofit and government entities is a 272% increase over last year, with efforts to fight the COVID-19 pandemic accounting for 84% of the total for 2020...BioWorld has tracked 855 bio/nonprofit deals worth $14.66 billion and 630 grants awarded to the industry and valued at $12.72 billion for a combined total this year of 1,485 and $27.4 billion. Companies developing therapeutics and vaccines for the SARS-CoV-2 virus are the recipients of about $23 billion of those funds through 628 deals (42%)...READ MORE

The new brand name for Pfizer and BioNTech's COVID-19 vaccine, Comirnaty mashes up community, immunity, mRNA and COVID—pretty much everything that could fit into the moniker for the world's most high-profile product at the moment...How did those concepts become a brand? We asked the naming agency behind both Comirnaty and its non-proprietary name, tozinameran—industry heavyweight Brand Institute, which began working with BioNTech in April. Pfizer joined the effort shortly after, when the duo’s vaccine collaboration was announced...READ MORE

Authorities arrested a suburban Milwaukee pharmacist Thursday suspected of deliberately ruining hundreds of doses of coronavirus vaccine by removing them from refrigeration for two nights...Police...said the Advocate Aurora Health pharmacist was arrested on suspicion of reckless endangerment, adulterating a prescription drug and criminal damage to property, all felonies. The pharmacist has been fired and police said in a news release that he was in jail. Police did not identify the pharmacist, saying he has not yet been formally charged...His motive remains unclear. Police said that detectives believe he knew the spoiled doses would be useless and people who received them would mistakenly think they’d been vaccinated when they hadn’t...READ MORE

Novavax Inc has begun a large late-stage study of its experimental COVID-19 vaccine in the United States, the drug developer said on Monday, after delaying the trial twice due to issues in scaling up the manufacturing process...It will enroll up to 30,000 volunteers across about 115 sites in the United States and Mexico, with two-thirds of them receiving the shot 21 days apart and the rest getting placebo, the company said...READ MORE

The U.S. government has reached a deal to acquire 100 million more doses of Pfizer and BioNTech's coronavirus vaccine, giving the U.S. enough of a stockpile to vaccinate 100 million total residents. The vaccine is administered via two shots...Under the deal, Pfizer will deliver 70 million doses by the end of June and another 30 million by July 31 The U.S. also retains an option to acquire an additional 400 million doses of the vaccine. As with the original supply deal the two struck in July, Pfizer will receive $1.95 billion, suggesting a per-dose price of about $20...READ MORE