The pandemic has not been kind to parents, but this morning there was a sliver of good news as Pfizer and BioNTech announced today that children ages five to 11 could receive the two companies’ Covid-19 vaccination by Halloween.
The two companies plan to apply to the Food and Drug Administration (FDA) by the end of the month for authorization to use the vaccine for children in this age group. If the regulatory process proceeds as it has for older age groups, then authorization for use would be expected by the end of October.
Translation? The companies announced the Pfizer-BioNTech coronavirus vaccine (commonly referred to as just the Pfizer vaccine) has been shown to be safe and effective in young children aged 5 to 11 years old. This data must now be reviewed by the FDA before children can be inoculated, but experts are hopeful that the approval process will go smoothly and that millions of children will be eligible to receive the vaccine very soon.
Earlier this month, FDA chief Dr Peter Marks, told the Associated Press that he was “very, very hopeful” that vaccinations for 5- to 11-year-olds will be underway by the end of the year. He added that once Pfizer turned over results, his agency would evaluate the data “hopefully in a matter of weeks.”
In a statement, Albert Bourla, chairman and chief executive officer of Pfizer said: “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% in the US – underscoring the public health need for vaccination.”
In the Pfizer and BioNtech trial, elementary school aged children were given two shots of a 10-microgram dose, which is one third of an adult shot. Despite the lower dosage, the vaccine produced antibody levels comparable to those in 16-to-25-year-olds given the adult dose, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.
Dr. Gruber also revealed that after a second dose, children aged five to 11 experienced similar or fewer temporary side-effects—like sore arms, fever or aches—that teens experience.
“I think we really hit the sweet spot,” he said, adding: “I feel a great sense of urgency. There’s pent-up demand for parents to be able to have their children returned to a normal life.”
As for younger kids, Pfizer and BioNTech also said data for “the other two age cohorts from the trial – children two to five years of age and children six months to two years of age – are expected as soon as the fourth quarter of this year”.