New Straits Times

Sinopharm, J&J vaccines get conditiona­l approval

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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.”

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