Malaysian children aged 3 to 11 to join Sinovac vaccine trial

 

Health minister Khairy Jamaluddin says the government is reviewing the effectiveness and safety of the Covid-19 vaccine for children under 12.

PETALING JAYA: Malaysia has been selected as one of the locations for Sinovac’s Covid-19 vaccine trial on children, said health minister Khairy Jamaluddin.

Khairy said that the Phase 3 clinical trial will start at the end of this month and will be conducted in 10 locations, covering eight facilities under the health ministry as well as Universiti Malaya and Universiti Teknologi Mara (UiTM).

A ministry spokesman told FMT the trials will be conducted for children aged between three and 11.

Khairy was providing a parliamentary written reply to Wong Kah Woh (PH-Ipoh Timur), who asked whether the health ministry has reviewed the suitability and efficacy of Covid-19 vaccines for children 12 and below and whether it has obtained relevant information from vaccine manufacturers.

He said the ministry had held several discussions with vaccine manufacturers to obtain information on efficacy and safety regarding vaccines for children under 12.

“Although we have not received the required data from vaccine manufacturers yet, the Covid-19 vaccine candidate selection committee (JKPCV) and the ministry are reviewing the effectiveness and safety of the vaccine on the population based on scientific evidence through clinical studies or real world data,” he said.

He said several clinical studies were underway and had been conducted on the matter.

Khairy said that on Sept 20, Pfizer-BioNTech released the findings of a Phase 3 clinical trial for children aged five to 11, with the vaccine found to be safe, well tolerated and showing a strong neutralising antibody response.

The study’s data had been submitted to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), he said.

He said China had approved two Covid-19 vaccines manufactured by Sinovac Biotech Ltd. and Sinopharm for emergency use for those aged between three and 17 years, after Phase 1 and 2 clinical trials found that the vaccine was safe and able to stimulate a strong immune response in children and adolescents.

Khairy had previously lauded Malaysia’s teenager vaccination rate as among the fastest globally, after 80% of those aged 12 to 17 were given at least one dose of the Covid-19 vaccine as of last week.

He noted that this was achieved in less than two months since the rollout of the vaccine for teens began on Sept 8. - FMT