Why The FDA Is Likely To Sign Off On Covid Boosters — With Some Caveats

Booster shots could expand the opportunity for Covid vaccine stocks like Pfizer (PFE) and Moderna (MRNA) 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 Administration’s vaccines advisory committee. The panel of independent experts will discuss offering a third dose of the Pfizer-BioNTech (BNTX) 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, it’s still possible the FDA’s 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 aren’t vaccinated don’t 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. On the stock market today, BioNTech stock jumped 4.9% to 372.65. Moderna stock rose 1.4% to 440.65. Pfizer stock, on the other hand, dipped 0.7% to 44.47.

Pfizer’s 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. Moderna’s vaccine is only authorized for adults. Pfizer and BioNTech’s 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. It’s also likely that Johnson & Johnson (JNJ) 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 committee’s vote Friday could help both pop.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.


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