Sinopharm, J&J vaccines get conditional approval
KUALA LUMPUR: The Drug Control Authority (DCA) has approved the conditional registration of Sinopharm and Johnson & Johnson Covid-19 vaccines for use during disasters.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the approval for conditional registration was made during the DCA’s 361st meeting yesterday.
“The Covilo Suspension for Injection Covid-19 Vaccine (Vero Cell), Inactivated, was developed by China National Biotec Group Co Ltd, Sinopharm, which is also known as the Sinopharm Covid19 vaccine,” he said yesterday.
“The vaccine was manufactured by Beijing Institute of Biological Products Co Ltd, China, and Duopharma (M) Sdn Bhd is the registration holder in Malaysia.
“The second vaccine, Janssen Covid-19 Vaccine Suspension for Injection, was manufactured by Janssen Pharmaceutica NV, Belgium, and the registration holder in Malaysia is Johnson & Johnson Sdn Bhd.”
He said the conditional registration approval required 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.
This, he said, was to ensure that the comparison of benefit over risk for the vaccine products remained positive.
“The Health Ministry will always improve the level of public health in combating the spread of Covid-19 through the procurement of vaccine supplies that have been evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Division and approved by the DCA.
“The government is committed to ensuring that the Malaysian adult population achieves herd immunity in line with the targets of the Covid-19 National Immunisation Programme.”