Pfizer Says Low COVID Vaccine Dose Is Good For Kids 5 To 11

NEW JERSEY - Pfizer-BioNTech announced Monday that preliminary COVID vaccine trials showed positive results when children ages 5 to 11 were given a third of the dose that was given to adults.

These are the first results from the trial, said the company in this press release published Monday. In total, Pfizer is testing its COVID vaccine on 4,500 children worldwide, with 2,268 participants enrolled in the 5-11 age group.

The children in that age group were given two doses of 10 micrograms of the vaccine, in two shots given 21 days apart (anyone 12 and older is given 30-microgram doses of the vaccine).

The children demonstrated a strong immune response one month after the second dose, said Pfizer. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years old.

Pfizer said the trial results showed them that 10 µg is the "preferred dose" for children 5 to 11 years of age.

Pfizer and BioNTech said Monday they plan to share their findings with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators "as soon as possible."

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”

Last week, former FDA commissioner Dr. Scott Gottlieb predicted that the FDA could approve the Pfizer vaccine for kids 5-11 by Halloween.

"In a best-case scenario, given that timeline they've just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween," said Gottlieb, who currently sits on Pfizer's board of directors. "If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they've collected."

In total, Pfizer tested 4,500 children ages 6 months to 11 years of age in the United States, Finland, Poland and Spain for their COVID vaccine. They broke their trial up into three parts: Ages 5 to 11 years; ages 2 to 5 years; and ages 6 months to 2 years.

Study results from the infant and toddler trial are expected to come sometime in October, November or December.

"Topline readouts for the other two age cohorts from the trial — children 2-5 years of age and children 6 months to 2 years of age — are expected as soon as the fourth quarter of this year," said Pfizer.

Currently, Rutgers has 100 children ages 5 to 11 enrolled in the Pfizer-BioNTech trial. It is the only Pfizer COVID-19 clinical trial site for children in New Jersey.

Be the first to know. Sign up to get Patch emails: https://patch.com/subscribe Contact this Patch reporter: Carly.baldwin@patch.com