Pfizer OKs shot for children 5-11

Drugmaker says vaccine safe for young kids in lower doses,

Pfizer Inc. said Monday that data from a late-stage trial involving young children showed a “favourable safety profile and robust neutralizing antibody responses” even with smaller doses of its coronavirus vaccine.

A 10g dose given to children between the ages of five 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 five 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.”

“Since July, pediatric cases of COVID-19 have risen by about 240 per cent 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 five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

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.