PUTRAJAYA: Pfizer-BioNTech’s Comirnaty vaccine has been approved by the Health Ministry for Malaysia’s booster dose programme.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the Drug Control Authority (DCA) granted the conditional approval in a meeting yesterday.
He said the 365th meeting of the DCA gave conditional approval to the “Concentrate for Dispersion for Injection” (Comirnaty ) vaccine produced by Pfizer Manufacturing Belgium NV and BioNTech Manufacturing GmbH, Germany, to be given as booster doses to those aged 18 and above.
The booster doses are to be given at least six months after their second dose.
“This conditional approval requires information on the quality, safety and effectiveness of this vaccine to be monitored and evaluated based on the latest data from time to time.
“It is to ensure that the comparison of benefits over risk for the vaccine remains positive.
“The ministry is also always committed to 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 and approved by the DCA,” Dr Noor Hisham said in a statement.
The ministry has agreed to give booster shots to groups deemed to be high-risk – such as the elderly, immunocompromised or healthcare workers.
The initiative will kick off in Sarawak this month.