Monday, May 23, 2022

Conditional approval granted for Pfizer jab on kids 5 and above

The health ministry says the Comirnaty 10mcg concentrate has a lower dosage strength than that given to those 12 and above.

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The health ministry today announced that conditional registration approval has been granted for the use of Pfizer’s Covid-19 vaccine on children aged five to 11.

In a statement, it said the decision was made at a meeting of the Drug Control Authority today.

It said the Comirnaty 10mcg concentrate for dispersion for injection has a lower dosage strength than that given to those aged 12 and above.

Health Minister Khairy Jamaluddin said in October last year that Malaysia would proceed with the procurement of the Pfizer Covid-19 vaccine for children, with other options like Sinovac to be taken into consideration as well.

This came after a medical panel of US government advisers endorsed the Pfizer jab for children aged five to 11, saying the known benefits of the shots outweigh the risks.

Pfizer had earlier said that its vaccine was more than 90% effective in preventing symptomatic disease among children aged five to 11.

Malaysia began vaccinating teenagers 12 and above on Sept 8 last year in what Khairy called one of the fastest adolescent Covid-19 vaccination rollouts in the world.

In its statement today, the health ministry said the Comirnaty (tris/sucrose) 30mcg solution for injection which has a longer shelf life of 10 weeks compared to one month for the existing formulation had also been granted conditional registration approval.

It said this solution is for the inoculation of those aged 12 and above.

The registration holder for the two Comirnaty vaccines is Pfizer (Malaysia) Sdn Bhd with manufacturing by BioNTech Manufacturing GmbH, Germany.

Conditional approval has also been given for the use of CanSino’s Convidecia vaccine as a booster for individuals aged 18 and above at an interval of three to six months after receipt of the first dose.

The registration holder for this vaccine is Solution Biologics Sdn Bhd, and it is manufactured by CanSino Biologics Inc, China.

Health director-general Dr Noor Hisham Abdullah said approval for the conditional registration of these vaccines still requires information on the quality, safety and effectiveness of the products in question.

He said these factors would be monitored and evaluated on an ongoing basis by the National Pharmaceutical Regulatory Division to ensure that the comparison of benefit over risk for these vaccines remains positive.

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