Pfizer and BioNTech have begun seeking FDA approval for emergency use authorization of their COVID-19 vaccine in children under age 5.
And such a vaccine would benefit everyone, says the Santa Barbara County Public Health Department.
“We welcome Pfizer’s application for EUA for the COVID-19 vaccine 6 months to 5 years,” Dr. Henning Ansorg, the county public health officer, told the News-Press Wednesday in an email.
“Having a COVID-19 vaccine for all age groups will help to protect the whole population,” Dr. Ansorg said.
The main target age for the new vaccine would be children between the ages of 2-4.
The under-5 age group is the only one not yet eligible for COVID-19 vaccines. Both Pfizer and BioNTech SE began the approval process Tuesday. A decision from the Food and Drug Administration is expected sometime this month.
“Having a safe and effective vaccine available for children in this age group is a priority,” acting FDA Commissioner Janet Woodcock said in a report by Reuters. The application process for approval comes after the winter surge caused by the omicron variant.
“Sadly, we are seeing the rates of hospitalizations increasing for children 0 to 4 — children who are not yet currently eligible for COVID-19 vaccination,” said Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, according to the New York Times.
The FDA said that on Feb. 15, an outside committee of expert advisers would meet to discuss the authorization. If the FDA supports the vaccine, the next step would be for the CDC to sign off on how the vaccines would be implemented.
The sign-off would come following a meeting of the CDC’s own advisers. These meetings tend to take place within about a week of FDA meetings.
“Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech, in a Pfizer press release. “If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children six months through 4 years of age from COVID-19 and the potentially severe consequences of infection.”
The companies expect to complete their application for the first two doses or what is projected to be a three-dose regiment in the coming days with data for a third dose is soon to come.
“If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” said Albert Bourla, the Pfizer chief executive.
A three-microgram dose is being tested for the under-5 age group, which is comparable to the 10 microgram dose used in the 5-11 age range and the 30 microgram dose in the 12-and-over age group. Data submissions for the first two doses are expected to be completed in the days to come, with data on the third dose soon to follow.
Mr. Bourla said a third dose will ultimately be needed for the best protection against omicron and any future variants. But if the first two doses are approved, kids can start getting vaccinated while the final dose is in the approval process.