PUTRAJAYA: Ninety-seven per cent of the 207 adverse events following immunisation (AEFI) reports involving children aged five to 11 received by the National Pharmaceutical Regulatory Agency (NPRA) were non-serious cases.
NPRA director Dr Roshayati Mohamad Sani said seven of the 207 AEFI reports received as of March 18 were serious, with six of them requiring admission to the ward for treatment and further monitoring, but all of them had now been discharged.
One brought-in-dead (BID) case was recorded and it was still under further investigation, she said in a statement.
Dr Roshayati said a total of 1,239,194 doses of vaccine have been administered under the Covid-19 immunisation programme for children aged five to 11, as of March 18, involving Comirnaty 10mcg Concentrate for Dispersion for Injection (Pfizer-BioNTech) and CoronaVac Suspension for Injection Covid-19 Vaccine (Vero Cell) Inactivated.
She said the AEFI reporting rate for children aged five to 11 in Malaysia was 0.2 reports per 1,000 doses.
It was on par with the AEFI reporting rate for the same age group in other countries such as Canada which stood at 0.15 reports per 1,000 doses and Australia (0.6 reports per 1,000 doses), she added.
“The common adverse effects reported are headache, fatigue, pain, redness and swelling at injection site,” said Dr Roshayati.
She said overall, the trend of AEFI reporting among children aged five to 11 received by the NPRA was not much different from what was reported by other regulatory reference countries.
“No safety issues were detected locally and globally following the use of Covid-19 vaccine for this age group,” she said. – Bernama