Drug authority approves Pfizer vaccine for children, CanSino booster

 

The Drug Control Authority (DCA) has granted conditional approval a low-concentration version of Pfizer’s Covid-19 vaccine for children aged five to 11 years old, said Health Ministry director-general Dr Noor Hisham Abdullah.

The formulation uses 10 micrograms of the vaccine active ingredient per dose, compared to the 30 micrograms per dose previously approved for those aged 12 and above.

At a press conference later, Health Minister Khairy Jamaluddin said his deputy Dr Noor Azmi Ghazali - who previously headed the vaccination programme for adolescents - will also lead the vaccine rollout to children.

“We will announce (the details) later. I am still in discussion with Pfizer regarding the delivery schedule […]

“We will do it in schools just as we have done for vaccinating (adolescents),” he said.

Meanwhile, Noor Hisham said the DCA has also granted conditional approval for another formulation of the Pfizer vaccine, as well as for the CanSino Biologics vaccine to be used as a booster dose.

Unlike the existing formulation, the Comirnaty (Tris/sucrose) formulation does not need to be diluted with a saline solution before use. Once thawed from ultra-cold storage, it can be kept in normal refrigeration temperatures for up to 10 weeks compared to four weeks for the old formulation.

The new formulation is only approved for those aged 12 years and above.

As for recipients of the CanSino Biologic’s Convidecia vaccine, the same vaccine is now approved to be used as a booster dose for those aged 18 years and above. It should be administered three to six months after the first dose.

Unlike most other Covid-19 vaccines used in Malaysia, Convidecia only needs a single dose to complete its primary vaccination.

DCA’s approval for the two Pfizer formulations and the Convidecia booster is conditional on product registration holders providing continuous updates to the National Pharmaceutical Regulatory Agency regarding their products’ quality, safety, and efficacy.

“This is to ensure the benefit-over-risk comparison of these vaccines is always favourable,” Noor Hisham said.

The approved Pfizer formulations are manufactured by BioNTech Manufacturing GmhH in Germany, while Pfizer (Malaysia) Sdn Bhd is the local registration holder.

Convidecia is manufactured by CanSino Biologics Inc in China, while the local registration holder is Solutions Biologics Sdn Bhd. - Mkini