Putrajaya To Discuss Precautions For Sinovac Vaccine: Khairy

There is a lack of clinical data of Sinovac’s Covid-19 vaccine — which has been approved by Malaysia’s NPRA — for people aged above 60.

KUALA LUMPUR, March 22 — The Covid-19 Vaccine Supply Access Guarantee Committee (JKJAV) will determine tomorrow if precautions should be issued on Sinovac’s Covid-19 vaccine for certain groups in the absence of clinical data.

Vaccine Minister Khairy Jamaluddin noted that the coronavirus vaccine by China’s Sinovac Biotech has shown efficacy rates of between about 51 per cent and 90 per cent in Phase Three clinical trials, and that Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has given conditional approval for the Sinovac shot.

“We are confident in using the Sinovac vaccine,” Khairy told a virtual press conference today.

“We’re having a Jawatankuasa Jaminan Akses Vaksin (meeting) tomorrow to determine whether or not there’ll be precautions for certain groups for the Sinovac vaccine, due to the lack of clinical data, for instance those above 60 years old. 

“We’ll come up with an advisory based on the decision that will be made tomorrow at the Jawatankuasa Jaminan Akses Vaksin.”

The Ministry of Health’s (MOH) pharmacy regulatory division recently told CodeBlue that the NPRA gave conditional approval for the Sinovac vaccine on the basis of the Brazil trial on health care workers that showed the vaccine was 50.65 per cent effective in preventing symptomatic Covid-19, barely clearing the World Health Organization’s (WHO) minimum 50 per cent efficacy standard.

The Sinovac vaccine’s product information on NPRA’s website stated that official interim analysis of an ongoing trial in Turkey was still pending. Sinovac has yet to publish any Phase Three clinical trial data on its Covid-19 vaccine, CoronaVac, in a peer-reviewed journal. 

Turkish researchers said earlier this month that the final results of Phase Three trials showed the Sinovac vaccine was 83.5 per cent effective, down from a preliminary finding of 91.25 per cent efficacy. The vaccine reportedly gave full protection against hospitalisation and severe illness.

By today, Malaysia would have received 200,000 finished doses of the Sinovac vaccine, separate from the 12 million doses that the government is purchasing from local pharmaceutical company Pharmaniaga Berhad tasked with the fill-and-finish process of the Sinovac shot.

Khairy said all medical frontline workers in Malaysia should receive the Pfizer-BioNTech vaccine.

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