97% of vaccine side effect cases among children non-serious, says drugs authority

The National Pharmaceutical Regulatory Agency (NPRA) today said that 97% of the 207 reports it had received on adverse events following immunisation (AEFI) involving children aged five to 11 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 cases requiring admission for treatment and further monitoring.

All six have since been discharged.

One brought-in-dead (BID) case was also recorded and remains under investigation, she said in a statement.

Roshayati said a total of 1,239,194 vaccine doses had 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.

This was on par with the AEFI reporting rate for the same age group in other countries such as Canada (0.15 reports per 1,000 doses) and Australia (0.6 reports per 1,000 doses), she added.

“The common adverse effects reported are headaches, fatigue, pain, redness and swelling at injection site.”

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 vaccines for this age group,” she said.