Dr Noor Hisham: conditional approval given for Comirnaty vaccine for children under 12 years old

SHAH ALAM - The Ministry of Health (MOH) has approved the conditional registration for Pfizer's type vaccine, Comirnaty 10mcg Concentrate for Dispersion for Injection to be used for immunization of children aged five to 11 years.

Director-General of Health, Tan Sri Dr Noor Hisham Abdullah said, the prepared vaccine has a lower potency compared to another Comirnaty vaccine meant to be given to individuals above 12 years old.

He said this decision was reached during the 368th Drug Control Authority (DCA) meeting where conditional approval was also given to the Comirnaty (Tris/Sucrose) 30mcg Solution for Injection.

“It is a Corminaty vaccine with a new formulation that does not require dilution before administration and has a longer shelf life, which is 10 weeks compared to the existing formulation (1 month) when stored at 2 to 8 degrees Celsius after thawing.

"The indication of Comirnaty (Tris/Sucrose) 30mcg Solution for Injection is for Covid-19 immunization to individuals aged 12 years and above," he said in a statement today.

Dr Noor Hisham also informed that the registration holder for the two Comirnaty vaccines is Pfizer (Malaysia) Sdn Bhd and manufactured by BioNTech Manufacturing GmbH, Germany.

At the same time, Dr Noor Hisham also informed that the DCA also gave conditional approval for the use of Convidecia Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Solution for Injection as a booster dose to individuals aged 18 and above.

He said the aforementioned booster dose would be given at intervals of three to six months after the recipient received the first dose of the same vaccine.

According to Dr Noor Hisham, the registration holder for the booster vaccine is Solution Biologics Sdn Bhd and it is manufactured by CanSino Biologics