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KUALA LUMPUR, March 2 — Malaysia’s Drug Control Authority has today agreed to grant several Covid-19 vaccines conditional registration for use during disaster, Health director-general Tan Sri Dr Noor Hisham Abdullah said.
In a statement, Dr Noor Hisham, said the Covid-19 vaccines are as follows:
1. Covid-19 Vaccine AstraZeneca Solution for Injection
Registration holder: AstraZeneca Sdn. Bhd.
Manufacturer: Medimmune Pharma BV Netherland
2. CoronaVac Suspension for Injection — Sinovac
Registration holder: Pharmaniaga Lifescience Sdn. Bhd.
Manufacturer: Sinovac Life Sciences Co Ltd, China
3. Comirnaty Concentrate for Dispersion for Injection (Application for second source to Comirnaty products that have been granted conditional registration)
Registration holder: Pfizer (M) Sdn. Bhd.
Manufacturer for the first source (drug product and final release): Pfizer Manufacturing Belgium NV, Puurs, Belgium
Manufacturer for the second source (final release): BioNTech Manufacturing GmbH, Mainz, Germany
Dr Noor Hisham added that the 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 National Pharmaceutical Regulatory Agency (NPRA).
“It is to ensure the effectiveness and safety of the vaccine is always updated and the comparison of the benefits (benefits over risk) of this vaccine remains positive.
“Currently, NPRA is still evaluating two more Covid-19 vaccine products namely Gam-Covid-Vac or Sputnik V (produced by Gamaleya National Research Centre for Epidemiology and Microbiology, Russia) and CoronaVac Suspension for Injection — Sinovac (manufactured for fill and finish by Pharmaniaga LifeScience Sdn Bhd),” he said.
On Saturday, Coordinating Minister for the National Covid-19 Immunisation Programme, Khairy Jamaluddin, said China’s Sinovac Covid-19 vaccine, as received by Malaysia, must first go through a manufacturing process by the pharmaceutical company, Pharmaniaga, to be evaluated and approved by the regulatory agency.
He also said that the manufacturing process was one of the criteria that would be evaluated by the NPRA before giving recommendations to the Drug Control Authority for approval.