Pfizer Covid-19 vaccine gets conditional approval as booster dose - Health DG

KUALA LUMPUR (Oct 8): The Health Ministry has granted conditional approval for the Comirnaty vaccine to be used as a booster shot at least six months after the second dose for those aged 18 and above.

Health director-general Tan Sri Dr Noor Hisham Abdullah said the matter was decided during the 365th Drug Control Authority (DCA) meeting today.

"The Comirnaty vaccine produced by Pfizer Manufacturing Belgium NV (Belgium) and BioNTech Manufacturing GmbH, Germany was earlier approved for conditional registration on June 15 for individuals aged 12 and above.

"This is the first Covid-19 vaccine approved as a booster dose in the country,” he said in a statement.

Dr Noor Hisham said the approval of the conditional registration required information on the quality, safety and effectiveness of the vaccine to be monitored and evaluated based on the latest data from time to time to ensure that the benefit over risk comparison remained positive.

"The ministry is always committed in improving access to COVID-19 vaccine products in Malaysia by ensuring that they have been evaluated in terms of quality, safety and effectiveness by the National Pharmaceutical Regulatory Agency (NPRA) and approved by DCA,” he added.

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