NPRA study: Fewer Covid-19 vaccine side effects reported with children, booster recipients

KUALA LUMPUR, April 27 — A National Pharmaceutical Regulatory Agency (NPRA) study found lower rates of side effects reported among children and booster dose recipients versus the country’s overall Covid-19 vaccination programme.

For children aged five to 11, it said there were 324 adverse events following immunisation (AEFI) reported or approximately 191 cases per million doses. AEFI reporting among booster dose recipients amounted to 1,581 reports, equivalent to 99 reports per million doses.

Both compared favourably to overall AEFI rate of 374 per million doses from the 26,160 reports since the beginning of the National Covid-19 Immunisation Programme (PICK).

The report also noted that from the 324 AEFI reported among children, only 21 were categorised as serious. Of these, 20 required admission for further treatment and monitoring, including 13 that were still under observation.

However, one case involved a patient who was brought-in-dead (BID). The case is still under investigation but a preliminary report noted pre-existing illnesses.

According to the report, Malaysia’s AEFI reporting rate among children (0.2 reports per 1000 doses) was similar to Canada and lower than in Australia, which had 0.7 reports per 1000 doses.

As for the AEFI from the National Covid-19 Booster Vaccination Programme (PICK-B), the NPRA said 144 of the 1,581 reported were considered serious, including 58 that involved death.

Of the 58 deaths, investigations have found no link to vaccination while the remaining 33 were still being reviewed.

The majority of the AEFI reported were for non-serious events, primarily fever, pain at injection site, headache, and muscle aches, which typically resolve within two days.

Malaysia started The National Covid-19 Immunisation Programme (PICK) on February 24, 2021, and a total of 69,916,684 doses of Covid-19 vaccine has been administered till April 22, 2022.

The NPRA said vaccine recipients could report any AEFI encountered through the official Covid-19 tracking app MySejahtera or the Consumer Side Effect Reporting Form on its official website.