The FDA Says It Is Working “Rapidly” To Clear Pfizer & BioNTech’s COVID-19 Vaccine

Plus, Disney shares surge higher following the announcement of a new slate of content for its Disney+ streaming service, and AMC raise $100 million but is still in danger of bankruptcy.

Stocks were lower to start Friday with the Dow falling 27 points, or 0.1%. The S&P 500 slid 0.3%, while the Nasdaq dipped 0.2%.

The FDA said it is working “rapidly” toward clearing Pfizer and BioNTech’s COVID-19 vaccine for emergency use after a key panel overwhelmingly endorsed the shots late Thursday. “Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” FDA Commissioner Stephen Hahn and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement. “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.” Hahn added in a tweet that the FDA “is finalizing the necessary documents to ensure that patients and providers have the information that they need to make informed decisions and to safely administer the vaccine.” Once approved for emergency use, Health and Human Services Secretary Alex Azar said the U.S. may begin vaccination on “Monday or Tuesday of next week,” and the pace of inoculations may reach 20 million people in December, rising to 30 million in January and 50 million in February, according to FDA Assistant Secretary Brett Giroir.

In other vaccine news, AstraZeneca said it will soon start work with Russia’s Gamaleya Institute  to investigate whether their two coronavirus vaccine candidates could be successfully combined. The announcement comes shortly after the developers of the Sputnik V COVID-19 vaccine approached the company via Twitter late last month the ask whether they should try combining the two common cold virus-based vaccines to boost efficacy. “Being able to combine different COVID-19 vaccines may be helpful to improved protection and/or to improve vaccine accessibility,” AstraZeneca said in a statement. “This is why it is important to explore different vaccine combinations to help make immunisation programmes more flexible, but allowing physicians greater choice at the time of administering vaccines.” Elsewhere, Sanofi and GlaxoSmithKline are delaying testing for their COVID-19 vaccine after early phase trials showed poor efficacy in protecting those over age 49. Sanofi and GlaxoSmithKline said they are reformulating their shots to boost performance in older adults

Bipartisan talks on a new coronavirus relief bill are hung up on differences between Republicans and Democrats on shielding companies from virus-related lawsuits, raising doubts about a deal and risking dragging negotiations past next week. Senate Majority Leader Mitch McConnell is urging lawmakers to drop aid for state and local governments and liability protections, and to proceed with a smaller bill without either, while House Speaker Nancy Pelosi and other top Democrats have rejected that pitch in favor of pausing the discussion on liability lawsuits while still including $160 billion in state aid floated by a bipartisan group of negotiators. Pelosi told reporters that “We cannot leave here without having a piece of legislation” for pandemic aid, suggesting that Congress could stick around longer if it fails to strike a deal by December 18. 

Disney shares are up nearly 14% this morning following the Mouse House announcing a slew of impressive Disney+ releases, including over 100 movies and shows connected to franchises like Star Wars, Marvel, FX, and National Geographic. CEO Bob Chapek said Disney’s content strategy is about “balance” and meeting consumer demand, adding that of the around 100 projects that Disney shared, 80% will go directly to Disney+. With the content additions, Disney said it now expects to see between 230 million and 260 million subscribers to Disney+ by 2024, up from the goal of 60 million to 90 million subscriptions by 2024 set when the service debuted 13 months ago. “The enormous success of Disney+ inspired us to be envy more ambitious,” said Executive Chairman Bob Iger said. “Our pipeline is much more robust thane initially anticipated.”

And AMC just got a $100 million shot in the arm. The world’s largest theater chain said Mudrick Capital Management had agreed to invest the money to help the cash-strapped AMC survive the ongoing coronavirus pandemic. Still, AMC will still need around $750 million of additional liquidity to fund cash requirements through 2021. “Given the uncertainty regarding our ability to raise material amounts of additional liquidity and the uncertainty as to the time at which attendance levels might normalize, substantial doubt exists about the company’s ability to continue as a going concern for a reasonable period of time,” AMC said in a regulatory filing. “A significant spike in coronavirus cases, together with delays of major movie releases or the direct or simultaneous release of movie titles to the home video or streaming markets in lieu of theatre exhibition, have led to theatre closures, prevented the opening of theaters in major markets and have had, and are expected to continue to have in the future, a material adverse impact on theatre attendance levels and our business.”

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Datadog Inc (NASDAQ: DDOG): Datadog announced yesterday the Datadog Vulnerability analysis GitHub Action, the company’s first action listed on the GitHub Marketplace. The new Datadog action continuously monitors dependency and version information of code being deployed. “Maintaining strong security posture is critical for modern applications, but with traditional vulnerability analysis it can be difficult to distinguish the signal from the noise,” said Ilan Rabinovitch, Vice President, Product and Community at Datadog. “Integrating the Continuous Profiler with the vulnerability database highlights meaningful security vulnerabilities, while utilizing the GitHub Action automates this process by bringing security directly into application development.”

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