The companies tested a two-dose regimen in children age 5 to 11. For children under age 12, Pfizer and BioNTech cut the doses by a third. Still, one month following the second dose, the antibody levels in children compared well to a test group of people age 16 to 25 who received the original vaccine.
Now, Pfizer and BioNTech say they plan to ask for authorization to vaccinate that age group. They also expect to have data from tests in children age 2 to 5 and 6 months to 2 years in the fourth quarter. Pfizer Chief Executive Albert Bourla noted the “substantial threat” the delta variant poses to children.
“Since July, pediatric cases of Covid-19 have risen by about 240% in the U.S. — underscoring the public health need for vaccination,” he said in a written statement. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the (Food and Drug Administration) and other regulators with urgency.”
But on the stock market today, several vaccine stocks fell. BioNTech stock toppled 5.6% to 339.01. Moderna (MRNA) stock lost 1.6%, ending the day at 423.33. But Pfizer stock turned around from its dip, rising a fraction to 44.20.
Vaccine Stocks Dive On Advisory Committee Vote
On Friday, a split FDA advisory committee voted down booster shots for all people age 16 and older. The experts expressed concern about safety issues. Young people are particularly susceptible to heart inflammation following the second dose of the Pfizer-BioNTech and Moderna vaccines. It’s unknown how that risk will play out following a third dose six months after the second.
But the committee supported booster shots for people age 65 and older and for individuals at high risk of developing severe Covid. Vaccine stocks fell late Friday and continued their descent on Monday. The decision isn’t set in stone. The full FDA still has to make a decision before the matter heads to the Centers for Disease Control and Prevention where a similar team of experts will weigh in.
SVB Leerink analyst Geoffrey Porges expects “boosters for all” by year-end.
“We expect Pfizer to return to the FDA with more data in the next few months to reassure the agency,” he said in a report to clients. Then, Pfizer and BioNTech will ask the FDA to fully approve the booster shots, updating from an emergency use authorization.
Porges raised his price target on vaccine stock Pfizer to 50 from 49. He also boosted his expectations for Pfizer and BioNTech’s vaccine — officially called Comirnaty — to $39.5 billion in 2021 sales. In 2022-23, he expects $9 billion and $4.7 billion in sales, respectively.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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