KUALA LUMPUR, Jan 6 — The Covid-19 Comirnaty vaccine manufactured by Pfizer has been given conditional approval for the immunisation of children aged between five and 11.
Health director-general Tan Sri Dr Noor Hisham Abdullah said the decision was made at the 368th meeting of the Drug Control Authority (DCA) today.
“The Comirnaty 10mcg Concentrate for Dispersion for Injection has been approved for Covid-19 immunisation to children aged five to 11.
“This dosage has a lower potency compared to the Comirnaty vaccine given to individuals aged 12 and above,” he said in a statement today.
Meanwhile, the meeting also approved the Comirnaty (Tris/Sucrose) 30mcg dosage with a new formulation for Covid-19 immunisation of individuals aged 12 and above.
The new formulation, he said, did not require dilution before administering and had a longer shelf life of 10 weeks compared to the existing formulation, which is one month, when stored at 2°C to 8°C after thawing.
Meanwhile, the DCA also approved the use of the Convidecia® Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (CanSino) vaccine as a booster dose for individuals aged 18 and above.
The booster shot could be taken at an interval of between three and six months after receiving the first dose of the same vaccine.
However, he said the conditional approval still required information on the quality, safety and effectiveness of the vaccine product to be monitored and evaluated continuously by the National Pharmaceutical Regulatory Agency (NPRA) based on the latest data from time to time.
“This is to ensure the comparison of benefits over risk for the vaccines remained positive,” he said. — Bernama
