The Janssen Covid-19 Vaccine from Johnson & Johnson is among the two new vaccine variants given conditional approval by Malaysia. – AFP file photo
KUALA LUMPUR (June 15): Malaysia has given conditional approval for two new vaccine variants which need only one dose to be administered, Health director-general Tan Sri Dr Noor Hisham Abdullah announced today.
The vaccines are the Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), produced by CanSino Biologics Inc, China, and the Janssen Covid-19 Vaccine from Johnson & Johnson.
Dr Noor Hisham announced that the Comirnaty vaccine produced by Pfizer-BioNTech has also been approved for use in those aged 12 and above.
He said that the decision was reached at the 359th Drug Control Authority (PKBD) meeting.
“The meeting agreed to grant conditional registration approval for use during a disaster for two vaccine products requiring only one dose of immunisation, namely Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), produced by CanSino Biologics Inc, China (registration holder products: Solution Biologics Sdn Bhd) and Johnson & Johnson’s Janssen Covid-19 Vaccine which has been granted Emergency Use Listing (EUL) approval by the World Health Organisation (WHO).
“The registration of the Janssen Covid-19 vaccine obtained by the Malaysian government through the Covax facility is implemented through a recognition mechanism on WHO EUL approval,” he said, adding that the PBKD also approved the use of Pfizer’s Comirnaty vaccine to those aged 12 and above.
Comirnaty was previously approved conditional registration on January 8, 2021, for use on individuals who are 18 years of age and above.
Dr Noor Hisham said that despite today’s approved additional indications, the Health Ministry (MoH) is still of the view that vaccination priority should be given to high-risk groups in line with the existing policy set under the National Covid-19 Immunisation Programme (NIP).
“MoH would like to announce that approval of this conditional registration 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. It is to ensure that the comparison of benefit over risk for the vaccine products remains positive,” he added. — Malay Mail