KUALA LUMPUR, March 2 — The National Pharmaceutical Regulatory Agency (NPRA) has given conditional registration for emergency use of the AstraZeneca and Sinovac Covid-19 vaccines in Malaysia.
Health director-general Dr Noor Hisham Abdullah said this decision was made during a meeting today by the Drug Control Authority (DCA), which is under the NPRA.
“This conditional registration requires the registration holding company to submit an analysis of additional and up-to-date data by rolling submission to be evaluated by the NPRA,” Dr Noor Hisham said.
“It is to ensure the effectiveness and safety of the vaccine is always updated and the comparison of the benefits over risk of this vaccine remains positive.”
So far, three coronavirus vaccines have been given conditional registration by NPRA: Pfizer-BioNTech, AstraZeneca-Oxford University, and China’s Sinovac.
The Malaysian government has procured 12 million doses of the Chinese Sinovac vaccine, in which the wholesale form of 300,000 doses arrived last Saturday. The Sinovac vaccine still has to undergo the fill-and-finish process, which is the final critical stage of manufacturing.
Pharmaniaga LifeScience Bhd has been selected to complete the fill-and-finish process of the Sinovac vaccine, but NPRA is still evaluating Pharmaniaga’s fill-and-finish facility and has yet to give the company approval to undergo the process.
Meanwhile, 12.8 million doses of the AstraZeneca vaccine — which has an efficacy rate of between 62 and 90 per cent — have been procured by the government through direct procurement as well as through the global COVAX facility.
Dr Noor Hisham also said that NPRA is currently evaluating the Covid-19 vaccine, Sputnik V, from the Russian Gamaleya National Research Centre for Epidemiology and Microbiology.
The government has procured 6.4 million doses of the Sputnik V vaccine, which has an efficacy rate of 91.6 per cent.
The National Covid-19 Immunisation Programme started in Malaysia on February 24, vaccinating 43,881 individuals with the first dose of the Pfizer-BioNTech vaccine as of 2pm today.