KUALA LUMPUR, Jan 13 — The Malaysian government said it will not continue the procurement of the Covid-19 vaccine developed by China’s Sinovac if local regulators are not satisfied with its effectiveness or safety.
In a late-stage trial done in Brazil, the Sinovac vaccine was found to be only 50.38 per cent effective, taking into account asymptomatic and mild infections, Reuters reported. The Sinovac shot is an inactivated vaccine that can be stored at between two and eight degrees Celsius.
Responding to reports of the Brazil study, Science, Technology and Innovation Minister Khairy Jamaluddin said today that Malaysia’s Covid-19 vaccine procurement is subject to approval by the country’s pharmaceutical regulator, the National Pharmaceutical Regulatory Agency (NRPA).
“If we are not satisfied with the safety and efficacy, we will not go through with the procurement,” Khairy tweeted.
“Sinovac’s clinical data is just being released. We will review the data and decide. This is why our strategy has been a portfolio of vaccines. To ensure we have enough supply and to mitigate against regulatory and manufacturing issues.
“Buy from more than one source. Plus the fact, no manufacturer can supply all our requirements. Same for most countries.”
Malaysia’s local pharmaceutical company Pharmaniaga Bhd signed a deal with Sinovac yesterday to carry out the fill and finish process of 14 million doses of the Sinovac vaccine, a two-dose regimen. Fill and finish is a critical part of the pharmaceutical manufacturing process, whereby vials are filled with vaccine and packed for distribution.
Pharmaniaga claimed that it had the capacity to manufacture two million doses of Sinovac’s Covid-19 vaccine a month from March onwards. The company would also be investing RM3 million to retrofit its plant to enable production of the coronavirus vaccine.
Pharmaniaga said that it has started discussing with NPRA for the registration of the Sinovac vaccine and aims to distribute the vaccine to the public by the end of March this year.
So far, NPRA has only given conditional approval to the Pfizer-BioNTech vaccine to be used in Malaysia.