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The FDA Is Likely To Sign Off On Covid Boosters With Some Caveats For Pfizer, Moderna16-Sep-2021:13:29:00, The FDA Is Likely To Sign Off On Covid Boosters With Some Caveats For Pfizer, Moderna Booster shots could expand the opportunity for Covid vaccine stocks like Pfizer and Moderna by $3 billion to $4 billion in the U.S. alone, according to one estimate. The estimate from investment bank SVB Leerink comes a day ahead of a key meeting by the Food and Drug Administrations vaccines advisory committee. The panel of independent experts will discuss offering a third dose of the Pfizer-BioNTech shot at six months following the second. Their recommendation could ensure booster shots begin this month. The question of booster shots is "not if, but when," they said. However, its still possible the FDAs advisors could recommend limiting boosters to specific populations, like the elderly and a broader group of immunocompromised people. Further, before boosters can launch, a Centers for Disease Control and Prevention advisory committee will also have a say on the data. Still, recent arguments against boosting in the U.S. while many people in the U.S. and abroad still arent vaccinated dont hold water with Leerink. "While these are thoughtful arguments in principle, the obligation of the White House, FDA and CDC is to protect American lives, first and foremost," they said in another report. Current studies are likely enough to gain FDA and CDC support "by the end of the month." Vaccine Stocks: Huge Booster Opportunity Vaccine stocks BioNTech and Moderna climbed Thursday. In midday trading on the stock market today, BioNTech stock jumped 2.7% near 364.90. Moderna stock rose 1.6% near 441.60. Pfizer stock, on the other hand, dipped 1.2% near 44.20. Pfizers data appear to support its case for boosting at six months, Leerink analysts said. Immunity seems to wane at five to six months following the second dose. A third shot returns neutralizing antibodies close to the level they were following the second jab. "With more than 177 million people now fully vaccinated in the U.S., the booster market is likely to add another $3 billion to $4 billion in revenue potential in the U.S. alone for the existing vaccines, and considerably more value from markets outside the U.S. when they catch up and follow the lead of Israel, the U.K. and likely imminently the U.S. with boosting recommendations," they said. Investors in vaccine stocks are already baking in the likelihood of boosters for Moderna, Pfizer and BioNTech, they said. The impact for is particularly important for Moderna stock. Modernas vaccine is only authorized for adults. Pfizer and BioNTechs shot is authorized for ages 12-15 and fully approved for people ages 16 and up. Meeting For Pfizer-BioNTech Only The review Friday will consider only boosters for recipients of the Pfizer-BioNTech vaccine. But in the future, a similar process will take place for Moderna, Leerink analysts said. Its also likely that Johnson & Johnson recipients could ultimately be authorized for boosters. Vaccine stocks Moderna and BioNTech hit high points in August, but pulled back and have mostly trended sideways this month. The FDA advisory committees vote Friday could help both pop. Follow Allison Gatlin on Twitter at @IBD_AGatlin. |
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