KUALA LUMPUR – The Drug Control Authority (DCA) has granted a conditional approval for single dose Covid-19 vaccines, Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) and Janssen COVID-19 Vaccine.
The Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) is produced by CanSino Biologics Inc, China (License holder: Solution Biologics Sdn. Bhd) while Janssen COVID-19 Vaccine is manufactured by Johnson & Johnson.
According to the Director-General of Health Tan Sri Dr. Noor Hisham Abdullah, the two vaccines have been granted the approval under Emergency Use Listing (EUL) by the World Health Organization.
“The Janssen Covid-19 Vaccine is procured by the government through the COVAX facility and will be carried out through the acknowledgement mechanism on the recognition by WHO EUL.
“The decision to conditional approval for the two vaccines is made during the 359th Malaysia Drug Control Authority Meeting today,” he said in a statement today.
Besides that, the DCA also approved the usage of Comirnaty Covid-19 Vaccine by Pfizer-BioNTech for individuals aged 12 years and above.
Dr Noor Hisham said, the Comirnaty was conditionally approved on 8 January for the active immunisation of individuals aged 18 years and above.
“Although the additional indication has been approved, the MOH sees that the priority of the vaccination is still on the high-risk groups, in line with the existing policy under the National Covid-19 Immunisation Programme (PICK).
“MOH wishes to inform that the conditional approval requires information on the quality, safety and effectiveness of the vaccine product to be monitored and evaluated based on the latest data from time to time to ensure the benefit-risk comparison of the vaccines would remain positive.
“MOH will always increase the public health level in combatting the Covid-19 pandemic through the procurement of vaccine supplies after they are being evaluated from the aspects of quality, safety and efficacy by the National Pharmaceutical Regulatory Division (NPRA) and approved by the DCA.
“The government is also committed in ensuring that Malaysians will reach the herd immunity as targeted by PICK,” he said. –MalaysiaGazette