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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

The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use...The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27...“This is the first marketing authorization of a COVID-19 vaccine in the EU. It is valid in all 27 member states at the same time,” said EMA Executive Director Emer Cooke. “There is a firm scientific foundation for roll out,” she said...READ MORE

On Monday before the stock market opened, Pfizer announced that its COVID-19 mRNA vaccine had proven 90% effective so far in its ongoing late-stage trial, lifting the company’s shares nearly 8% through the course of the day...The same day, in a stock sale Pfizer says was planned months ago, CEO Albert Bourla offloaded 132,508 shares—more than 60% of his total holdings—for $5.6 million...Insider trading? Nope. Extraordinarily lucky? To be sure. And no doubt the size and timing of this sale, coupled with Bourla's confidence over the last few months leading to Monday's data announcement, are enough to rile up critics of executive pay packages in Big Pharma...READ MORE

...Pfizer is offering early retirement to U.S. workers ahead of layoffs early next year, it announced internally to employees…The company...employs more than 90,000, didn't say how many people it plans to cut. But it told employees…that all business units and divisions will likely lay off nonunion workers, according to materials outlining the workforce reduction program…As we prepare for growth we are creating a simpler more efficient structure which will affect some managerial roles and responsibilities. We are offering enhancements to certain benefits to lessen this effect...Overall, its workforce will shrink by "a couple percentage points,"

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

As a tide of late-stage data rolls in on COVID-19 vaccines from Pfizer, Moderna and AstraZeneca, the U.S. is gearing up for reviews that could see a vaccine authorized and deployed before the year is out. On Saturday, the chief of the White House's Operation Warp Speed effort laid out a definitive timeline, setting expectations for when the public could expect at least two shots to become available...Moderna will file for an emergency nod for its mRNA-based vaccine candidate before the month is out, Moncef Slaoui, Ph.D., head of "Warp Speed" and former vaccine chief at GlaxoSmithKline, said...That submission will segue straight into a Dec .17 data review, with the aim to ship vaccines to distributors within 24 hours of approval and potentially start vaccinations two days after the advisory panel makes its call, Slaoui said...READ MORE

Pfizer's COVID-19 vaccine strategy includes two phases, plus a broader mandate to develop more mRNA platform vaccines...With its trials and pricing set, Pfizer has pulled back the curtain on the long-range commercial strategy for its COVID-19 vaccine. During its earnings call...execs laid out two phases, pandemic and seasonal, with some combination of the two likely to play out over the next several years...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

...Pfizer and its German partner BioNTech said they plan to apply Friday to the Food and Drug Administration for an emergency use authorization for their Covid-19 vaccine, a watershed moment in the effort to curb the global pandemic...It is unclear how long the FDA will take to review the application, though the agency is expected to move swiftly. Agency officials have pledged to seek advice from an expert panel of outside experts, the Vaccines and Related Biological Products Advisory Committee...before ruling on the application. VRBPAC members have been asked to hold three days in December as potential meeting dates...READ MORE

Pharma is the fourth-largest spender on TV ads in the U.S., with $6.6 billion spent over the past year. That’s according to MediaRadar’s annual study of TV ad spending, which includes OTC drug ads in its total that push it higher than other tallies...While likely no surprise to most TV viewers, only retail ($8.7 billion), financial and real estate ($7.9 billion) and tech ($7.4 billion) serve up more TV ads than pharma. The industry edged out automakers ($6 billion), a traditional TV ad stronghold that’s been dropping media spend as car sales continue to decline...The top-spending pharma companies...Pfizer, AbbVie and GlaxoSmithKline. Pfizer spent most on brands Chantix and Eucrisa, while AbbVie spent on Humira, Orilissa and Mavyret. GSK spent more of its TV dollars on prescription product Breo Ellipta, but also on consumer brands Sensodyne and Flonase....READ MORE