Sinovac seeks amendment of EUA in PHL so vaccine could be used for children 3 to 17 years old

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Vaccine experts currently studying data on effectivity and safety of Sinovac vaccines for kids

Screenshot of PCOO video during President Rodrigo Duterte’s “Talk to the People” on Tuesday, July 6, 2021.   Food and Drug Administration Director-General Eric Domingo said Sinovac is applying for an amendment of its Emergency Use Authorization (EUA) so its vaccine could be used for children aged 3 years and above in the Philippines. (Courtesy PCOO)

 

(Eagle News) – Sinovac has applied to amend its Emergency Use Authorization (EUA) with the Philippine Food and Drug Administration so that the vaccine could be administered to children – from 3 to 17 years old.

This was revealed by FDA Director-General Undersecretary Eric Domingo during President Rodrigo Duterte’s “Talk to the People” on July 6.

If the application is approved, there would be two vaccine brands which could be used for children. But Pfizer’s amended EUA covers only children aged 12 years and above.

Domingo said Sinovac “applied for an amendment of their EUA to include children” on Tuesday afternoon, July 6.

“And in this case, children from three to 17 years old. So this is another potential vaccine that can be used po for the pediatric age group,” the FDA chief said.

He said that the country’s vaccine experts are now studying Sinovac’s application, and getting more information on the safety and efficacy of Sinovac for children.

“Our vaccine experts are now taking a look at the data, and of course, asking questions sa proponents and getting more information. So ito po inaaral natin siguro within the month to see ‘no if we will be able to allow the use of Sinovac in children,” Domingo said.

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A health worker holds up a vial of China’s Sinovac COVID-19 vaccine during the first phase of vaccinations for health workers at a hospital in Manila on March 1, 2021. – (Photo by Ted ALJIBE / AFP)

-Emergency use approval for Sinovac vaccine for children in China –

In a recent article that appeared in The Lancet Infectious Diseases journal, the researchers who conducted the study on Sinovac’s CoronaVac for children showed signs that it was safe, tolerable and could provoke an immune response.

“Children younger than 12 years are the next population who need a safe and efficient COVID-19 vaccine. In The Lancet Infectious Diseases, Bihua Han and colleagues reported the results of a double-blind, randomised, controlled, phase 1/2 clinical trial, which showed that the inactivated COVID-19 vaccine (CoronaVac) had good safety, tolerability, and immunogenicity in youths aged 3–17 years,” the article in Lancet posted on June 28 said.

“This promising result should inspire the ongoing trial of other COVID-19 vaccines in children younger than 12 years,” it said.

China in early June approved the emergency use of Sinovac vaccine for those as young as three, making it the first country to offer jabs to young children.

 

(Eagle News Service)