Pfizer Expects To Seek US Approval For COVID-19 Vaccine For Children Aged 6 Months To 5 Years In November

Pfizer Inc PFE expects to apply for U.S. authorization of its COVID-19 vaccine for children aged six months and five years in November, the Financial Times reported.

What Happened: Pfizer Chief Financial Officer Frank D’Amelio told an industry conference organized by Morgan Stanley that the pharmaceutical giant hoped to “go file” in November, as per FT. 

“We would expect to have . . . data for children between the ages of six months and five years old that we would file with the FDA,” said D’Amelio.

“I’ll call it in the weeks shortly thereafter the filing of the data for the five- to 11-year-olds.”

The timeline given out by the Pfizer CFO assumes that “all of the data is positive.”

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Separately, former U.S. Food and Drugs Administration commissioner and Pfizer director Scott Gottlieb said at a Financial Times conference Tuesday that the regulatory authorization for the coronavirus vaccine made by Pfizer and its partner BioNTech SE BNTX could come in “late 2021” or “early 2022.”

Why It Matters: In clinical trials, children aged between six months and five years are given a 3 microgram dose of the Pfizer-BioNTech vaccine, while children aged five to 11 are administered 10 micrograms. Adults are given 30 micrograms, noted FT.

As per U.S. Centers for Disease Control and Prevention data the rate of hospitalization for children aged four or younger was merely 2.2 per 100,000. 

Even so, in the week ending Aug. 14, the COVID hospitalization rate among this cohort rose 10 fold compared with the week ending June 26. 

The Pfizer-BioNTech vaccine is authorized for children up to 12 years old. The European Medicines Agency and CDC have backed the use of the vaccine for the 12-15 age group.

In July, the FDA asked both Pfizer and Moderna Inc MRNA to expand COVID-19 trials in children.

Price Action: On Tuesday, Pfizer shares closed nearly 0.3% higher at $44.71 in the regular session. On the same day, BioNTech shares closed 2.37% higher at $334.88 in the regular session and rose another 1.23% to $339 in the after-hours session.

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