NPRA looks into Sinovac's application for use on children, says MOH

After Pfizer, the National Pharmaceutical Regulatory Agency (NPRA) is now looking into Sinovac's application for the vaccine to be used on adolescents in the country.

According to the Health Ministry, the Beijing-based pharmaceutical company has submitted its dossier recently to seek the agency's approval.

"Yes, Sinovac has submitted. They (NPRA) are now looking into it.

"It is still in the process," said the ministry's Institute for Clinical Research director Dr Kalaiarasu Peariasamy during a press briefing today.

Kalaiarasu was one of the medical experts who spoke in a media engagement session that discussed the National Covid-19 Immunisation Programme for Adolescents which kicked off recently.

However, the ministry did not provide further details on the application.

To date, the health authority has only approved Pfizer's Comirnaty Covid-19 vaccine for use on teenagers aged between 12 and 17.

In May, it was reported that Pharmaniaga Berhad was waiting for approval from China’s Food and Drug Administration (FDA) for the vaccine to be used on children aged three to 17.

Pharmaniaga is the sole distributor for Sinovac in Malaysia.

"We are awaiting approval by the China FDA for the Sinovac Covid-19 vaccine for children aged three to 17 years and (to allow) manufacturing of two doses per vial before submitting it to the NPRA for the variation process.

"The production capacity is expected to increase by four million per month once the two-dose vial is approved," Pharmaniaga group managing director Zulkarnain Md Eusope said during an online press conference on May 26.

Risk of myocarditis among vaccinated teenagers very low - MOH

KJ: Adolescent vaccination important, 'herd immunity' now irrelevant

Unvaccinated students won't be stopped from returning to school - Mah

LETTER | Parenting during pandemic: Opportunities and challenges

Unvaccinated children suffering Covid-19 impact, Americas health agency warns