Pfizer has applied for the emergency use authorization (EUA) of its COVID-19 vaccine for children aged 5 to 11, the Food and Drug Administration (FDA) said Sunday.
“This is now being evaluated by our vaccine experts,” said FDA Director General Eric Domingo, speaking in Filipino to radio dzBB.
Domingo said it was possible that an EUA would be issued to the company before the end of the year.
At the same time, Domingo said only those given two specific brands of COVID-19 vaccines—Janssen and Sputnik Light–will be allowed to get booster shots three months after their primary vaccination. Those vaccinated with other brands must wait six months before getting their booster shots.
Domingo said this is because studies have shown so far that it is only after six months that the efficacy of these vaccines starts to wane.
He was reacting to a statement by Health Secretary Francisco Duque III that the country is considering lowering the interval between the last vaccination shot and a booster shot to three months.
Duque said they will submit such a proposal to the vaccine expert panel.
The government is aiming to expand the pediatric vaccination against COVID-19 to this younger group by January 2022.
The other US pharmaceutical company, Moderna, has not yet applied for an EUA for its vaccine for use on children aged 5 to 11.
Pfizer's COVID-19 vaccine has already been approved for use on children aged 5 to 1 in the US, Canada, Europe, and Australia.
The fact that it is already used in these countries will enable the FDA to see real-world data outside clinical trials and thus better gauge the safety and efficacy of the vaccines, Domingo said.
So far, he added, the data suggests that the Pfizer vaccine has not led to serious adverse effects among young children.
“So far, the results are good,” he said. “In fact, the vaccine is given at a lower dose on young children because they are smaller…. I'm quite confident that once they submit all data, our experts will be satisfied,” Domingo said.
He said experts will determine if the vaccine will be given in one dose or two doses for young children.
Sinovac earlier submitted an application for an EUA for its vaccine to be used on children aged 3 to 17, but experts have asked for more data, Domingo said.
The FDA chief said the vaccine expert panel is set to discuss booster shots for teens, aged 16 to 17.
Last week, the US FDA expanded the authorization of the Pfizer-BioNTech COVID-19 booster to include 16- and 17-year-olds. (See full story online at manilastandard.net)
The Philippines began the inoculation of health care workers with booster shots on Nov. 17 while seniors and immunocompromised individuals started receiving booster shots on Nov. 22.
Starting Dec. 3, the government started administering booster shots to all fully vaccinated adults.
The Department of Health (DOH) assured the public it has enough syringes to last until the end of the year.
Meanwhile, the National Task Force against COVID-19 (NTF) said the Philippines is set to receive 7.5 million doses of the Janssen COVID-19 vaccine this week.
The NTF said the Dutch government donated 7,538,400 doses of the Janssen vaccine, which will arrive from Dec. 13 to 15.