No reason to doubt Covid-19 vaccine safety: NPRA on Aefi reports

KUALA LUMPUR – The public should not doubt vaccine safety as the Covid-19 vaccines remain safe to be taken, even for individuals with comorbidities, according to the National Pharmaceutical Regulatory Agency (NPRA).

NPRA’s pharmacovigilance head Dr Azuana Ramli stressed that the risk in taking the Covid-19 vaccine is much lower than the risk in being infected with the virus itself.

Speaking during the briefing session on the Adverse Effects Following Immunisation (Aefi) of Covid-19 vaccine today, she said that the Aefi reports that the NPRA has received so far do not necessarily translate to cases that have been conclusively linked to the effects of the Covid-19 vaccine.

The reports, she said, involved cases which may be either related to it or coincidental effects.

As of March 11, NPRA has received a total of 182 Aefi reports relating to PICKids and the majority (96.7%) were found to be not serious.

However, six of the cases were classified as serious, including one death.

The six cases included three with Bell’s Palsy involving a 10-year-old male, 6-year-old female and 8-year-old female.

Other cases involve a 10-year-old female with asthma and another 10-year-old female who came in with seizure and was admitted for 3 days.

Additionally, the death of a 7-year-old female four days after her vaccination is still currently under investigation.

“Her parents said she did not show any side effects on the first day but started showing symptoms which were more related to her underlying condition the day after.

“Due to the temporal relation and suspicion that the child’s death might have been related to her vaccine shot, it was advised for the parents to report their child’s case.

“However, evidence is currently pointing more towards her underlying condition and the case is still under investigation,” she said.

Meanwhile, NPRA director Dr Roshayati Mohamad Sani presented a breakdown of cases and reports that have been classified under Aefi as of March 11.

According to Roshayati, NPRA has received a total of 25,746 Aefi reports related to the Covid-19 vaccine.

It was reported that 1,411 cases were related to the booster dose with 182 cases involving children aged between 5 to 11 receiving their first dose.

From the total number of cases, 23,457 (93%) cases were identified as not serious.

The remaining 1,789 cases, she said, are categorised as serious Aefi cases according to the classification set by the World Health Organisation.

Additionally, she said that the NPRA has received a total of 54 reports involving deaths among those who received booster shots that required investigation and evaluation.

The evaluation made by the Covid-19 vaccine Pharmacovigilance Special Committee so far found that 24 of the cases were unrelated to the vaccine shot received while the other 30 reports are currently under investigation.

It was also stated that the Aefi reports received tended to be from those in the older age group as compared to children.

This was said to be most likely due to their comorbidities and other existing illnesses, and with their cause of death being mostly coincidental.

Children were also said to face a lower amount of severe effects or major issues due to the Covid-19 vaccine. – The Vibes, March 16, 2022