Sinovac third phase clinical trials for children under 12 to start at the end of October


KUALA LUMPUR: Third phase vaccine clinical trials for Sinovac for children under 12 will begin in Malaysia at the end of this month, said Datuk Aaron Ago Dagang.

"Malaysia was selected as one of the locations for the clinical trials.

"The trials are expected to begin at the end of October and will be carried out at 10 research locations involving eight facilities under the Health Ministry, Universiti Malaya and UiTM," the Deputy Health Minister II said when replying to a question raised by Wong Kah Woh (PH-Ipoh Timur) in Dewan Rakyat on Tuesday (Oct 26).

Apart from Sinovac, he said that the other vaccine being studied was Novavax.

He informed the House that the ministry had also been in contact with several vaccine manufacturers to get their latest data on vaccines for those below 12.

"However, we have still yet to get the data that is needed from the companies producing the Covid-19 vaccines," he added.

So far, he noted that Pfizer-BioNTech had published its third phase clinical vaccine trial findings for children between three and five years old on Sept 20 this year.

"The vaccine was found to be safe and showed a strong neutralisation antibody reaction," he said, adding that the company submitted its findings to the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) on Oct 21.

Aaron also said that China had approved two vaccines, produced by Sinovac Biotech Ltd and Sinopharm, for emergency use for children between three and 17 years old.

He said phase I and II of clinical trials showed that the vaccines were safe and increased immunity reaction among children and adolescents.

Meanwhile, former health minister Datuk Seri Dr Dzulkefly Ahmad urged the government to take note of the US FDA's announcement on the use of Pfizer vaccines on children below 12 at 8.30pm (local time) on Tuesday (Oct 26).

"While we respect the findings of the vaccine studies, we should also take heed of what international bodies or jurisdictions have to say," he said.

Dr Dzulkefly said so far 108 children have died due to Covid-19.

He added that as of Oct 23, 198 out of 235 children with Covid-19 fell under category 3, 4 and 5 patients.

Patients under these categories required admission for medical treatment which included breathing assistance in intensive care units.

The Deputy Minister assured Dr Dzulkefly that the ministry would take note of the US FDA's announcement.

Aaron said that vaccination of adolescents had shown to reduce Covid-19 infections among youths.

He said the previous infection rate among children was between 15% and 20% but was reduced to below 12% when vaccination of youths between 12 and 17 began recently.

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