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Pfizer Shot Gets FDA Advisers’ Nod as Agency Decision Nears

Pfizer is about to win the U.S. Covid-19 vaccine race.
(LookerStudio)
(LookerStudio)
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Pfizer and BioNTech’s Covid-19 vaccine is expected to receive emergency-use authorization from the FDA after a panel of government advisors gave its blessing Thursday, Bloomberg reports.

Why It Matters: It marks a light at the end of this pandemic-darkened tunnel. A widespread vaccine expedites the world’s population path to herd immunity. It will take months, possibly years, to inoculate the population. Still, it’s an important milestone that will likely save many lives in the process.

Let Me Hit You With Some Details:

  1. The committee of experts reviewing the vaccine voted 17 to 4, with one abstention, that “the benefits of the vaccine from Pfizer Inc. and BioNTech SE outweigh the risks for use in people ages 16 and older.” (The FDA doesn’t have to follow the panel’s advice, but usually does.)
  2. Emergency-use approval from the FDA could be days away. Then, the U.S. begins a massive vaccine distribution undertaking with long-term care facility residents and health-care workers up to receive the two-part shot first. (States get the final call on who gets it first.)
  3. Two months of late-stage trial data showed the side effects of the vaccine were “were mild and developed more frequently in those age 55 and younger, with no signs of serious safety concerns.”
  4. The government plans to engage a safety monitoring system as soon as people start getting immunized. Though, Pfizer didn’t see any severe allergic reactions in trials.

The Takeaway: William Gruber, Pfizer’s SVP of Vaccine Clinical Research and Development, said the company plans to apply for full approval in April. Until then, it’s an experimental drug and cannot be marketed to the public.

  • Bonus: Moderna’s Covid-19 vaccine, which uses the same mRNA technology as Pfizer’s, is expected to trail close behind for FDA emergency-use. It could be an essential stop-gap to getting the American population enough doses if the U.S. government can’t reach an expanded deal with Pfizer.

Update: Business Insider reported the FDA said Friday it would “rapidly work toward” giving Pfizer’s vaccine emergency-use approval.

Justin Oh:

From Morning Cents 12/8: “The real challenge will be distributing these vaccines to the masses. My hypothesis is still that this will be a gradual distribution over the course of 2021.”
Apple CEO Tim Cook also just said most staff won’t return to the office until June.

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