Additional factory approved to supply AstraZeneca vaccine to Malaysia

 

Malaysia’s Drug Control Authority (DCA) has granted conditional approval for a second source of the Covid-19 vaccine co-developed by AstraZeneca and the University of Oxford, bringing the vaccine a step closer towards its use in the country’s ongoing vaccination campaign.

In a statement today, Health Ministry director-general Dr Noor Hisham Abdullah said the DCA agreed to register AstraZeneca’s contract manufacturer SK Bioscience Co Ltd in South Korea, during a meeting today.

“The conditional approval requires the National Pharmaceutical Regulatory Agency (NPRA) to monitor and evaluate additional and latest data on the vaccine from time to time, and ensure its safety and efficacy profile is always up to date and provides greater benefits over risk.

“The Health Ministry will constantly improve public health in combatting the Covid-19 pandemic through procurement of vaccines that have been evaluated for quality, safety and efficacy by the NPRA and subsequently approved by the DCA,” Noor Hisham said in a statement today.

The DCA had previously granted conditional approval for AstraZeneca-Oxford’s ChAdOx1-S vaccine manufactured by Medimmune Pharma BV in the Netherlands, but that factory will not be supplying vaccines to Malaysia.

Instead, Malaysia’s order for 12.8 million doses of the vaccine will come from two other sources.

Half the order is being procured through the Covid-19 Vaccines Global Access Facility (Covax), which will be produced by SK Bioscience. The global health partnership Gavi, which co-leads the Covax facility, said around 1.6 million doses will be shipped to Malaysia by July.

Dr Noor Hisham Abdullah

The other half is ordered directedly through AstraZeneca and will be supplied by its contract manufacturer in Thailand.

The first 600,000 doses for this order will arrive in June, but the NPRA has yet to grant approval for this factory.

The ChAdOx1-S vaccine requires two doses for each recipient, meaning the two orders would be sufficient to cover 20 percent of Malaysia’s population of 32 million.

Yesterday, however, the B.1.351 Covid-19 variant is reported to be circulating locally in Malaysia. Limited studies have found that the AstraZeneca-Oxford vaccine had an efficacy of just 10.4 percent against the variant.

So far, the variant appears to be confined to the Kuala Langat district in Selangor, where only nine cases have been identified so far.

In South Africa where the variant was first detected, is circulating widely. The government there has suspended the rollout of the vaccine in favour of Johnson & Johnson’s Covid-19 vaccine that provided 57 percent efficacy in trials in the country. - Mkini