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Pfizer Says Its COVID Vaccine Safe For Children 5 to 11 In Lower Doses

"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 FDA and other regulators with urgency," said Pfizer CEO Albert Bourla.

Pfizer Inc.  (PFE) - Get Pfizer Inc. Report said Monday that data from a late-stage trial involving young children showed a "favorable safety profile and robust neutralizing antibody responses" even with smaller doses of its coronavirus vaccine.

A 10 µg dose given to children between the ages of 5 and 11 -- around a third of that given to older children and young adults in similar testing -- produced comparable results in generating antibodies that can protect against the deadly virus, Pfizer said. 

The drugmaker hopes to submit the trial data to the U.S. Food & Drug Administration, as well as the European Medicines Agency, "as soon as possible', adding data from trials involving children under the age of 5 will be available later this year.

“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine," said CEO Albert Bourla. "We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.” 

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“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination," he added. "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 FDA and other regulators with urgency."

Pfizer shares were marked 1.3% lower in pre-market trading Monday to indicate an opening bell price of $43.33 each. U.S. listed shares of its vaccine development partner, BioNtech  (BNTX) - Get BioNTech SE Sponsored ADR Report, were marked 4% lower at $344.70 each.

Late last week, an FDA advisory panel recommended a third dose of Pfizer's coronavirus vaccine for Americans over the age of 65, as well as for front-line healthcare workers and those at high risk of occupational exposure, but declined -- by a vote of 16 to 2 -- to make the same recommendation for the broader public, citing a lack of data.