Malaysia authorises 10mcg Pfizer vaccine shots for children aged 5-11

File photo for illustration only. Photo credit: Pixabay

By Karen Bong

KUCHING, Jan 6: The Ministry of Health (MOH) has approved Covid-19 shot for children between five to 11 years old with 10mcg of Pfizer-BioNTech “Comirnaty” vaccine.

Health Director-General Tan Sri Dr Noor Hisham Abdullah, in a statement, said the decision was made following a meeting held by the Drug Control Authority (DCA) today.


“The dosage (10mcg concentrated for dispersion for injection) prepared is lower compared to Comirnaty vaccine given to individuals aged 12 and above.

“The DCA has also given conditional approval for 30mcg of Comirnaty solution for injection which is a new formula that does not require dilution before inoculation for those aged 12 and above.

“This new formulation has a longer shelf life of 10 weeks compared with the existing formulation (one month) when stored at 2ºC to 8ºC after thawing,” he explained.

For those who have received CanSino Biologic’s single-dose Convidecia vaccine may also receive their booster shots three to six months after the first dose of the same vaccine.

“Approval has also been given for CanSino vaccine to be given as booster shots to individuals aged 18 and above,” he said.

Dr Noor Hisham emphasised that the approval of this conditional registration will still require information on the quality, safety and efficacy of the vaccine that will be evaluated and monitored by the National Pharmaceutical Regulatory Division (NPRA), based on latest data from time to time.

“This is to ensure that the benefit over risk for this vaccine remains positive,” he added.

Meanwhile, Health Minister Khairy Jamaluddin also assured that the NPRA will continue to monitor the safety risks of all registered vaccines used in Malaysia, including the Covid-19 vaccines through the Adverse Effect Follow-up Immunisation (AEFI) report.

“AEFI surveillance continued to be conducted during the National Covid-19 Immunisation Programme for Booster (PICK-B).

“Since the start of PICK until Dec 31, 2021, a total of 57,119,777 doses of Covid-19 vaccines have been administered, including 5,719,456 booster doses,” he said during a press conference in Putrajaya today.

In total, he pointed out that the NPRA AEFI Reporting System received 24,042 AEFI reports, including 812 reports on booster doses of Covid-19 vaccines.

“The AEFI reporting rate for booster doses was 0.14 per 1,000 doses, compared to the overall AEFI reporting rate of 0.42 per 1,000 doses.

“Fever, injection site pain, headache, and fatigue were among the most commonly reported adverse effects among vaccine recipients,” he said.

Of the total AEFI reports received for this booster dose, Khairy said that only 38 reports (or 4.91 per cent) were classified as serious which was equivalent to a reporting rate of 0.007 per 1,000 doses.— DayakDaily