NPRA: Covid-19 Booster Side Effects Lower Rate Than Overall PICK

The Covid-19 booster vaccination programme saw 98 AEFI reports per million doses as of April 8, lower than the overall vaccination programme’s rate of 377 reports per million doses.

KUALA LUMPUR, April 13 – The National Pharmaceutical Regulatory Agency (NPRA) has received 1,552 reports of side effects from Covid-19 booster vaccines as of April 8, equal to 98 reports per million doses.

This is lower than the rate of adverse events following immunisation (AEFI) for the overall National Covid-19 Immunisation Programme (PICK) at 377 reports per million doses.

Out of the 1,552 AEFI reports from the booster vaccination programme, 137 were serious, equivalent to nine reports per million doses.

These 137 serious AEFI cases among Covid-19 booster vaccine recipients included 57 deaths, 25 of which have been concluded by regulators to be unconnected to the vaccine.

The remaining 32 death reports are still under investigation before evaluation by the Special Covid-19 vaccine pharmacovigilance committee (JFK).

“As a conclusion, based on the AEFI reports received by the NPRA thus far, the AEFI reporting rate and trend for booster doses do not show an increase from what was observed in the administration of primer doses.

“This same reporting trend has also been reported in other countries that ran Covid-19 booster vaccination programmes,” NPRA said today in its weekly report on Covid-19 vaccine AEFI.

Malaysia’s paediatric Covid-19 vaccination programme (PICKids) saw an AEFI rate of 201 reports per million doses as of April 8, about twice higher than the booster programme (98), but lower than the overall PICK rate of 377.

The majority at 94 per cent of the total 288 AEFI reports received from PICKids are not serious. Frequent side effects cited are fever, stress response to the immunisation process, skin itchiness, dizziness, and headache.

Eighteen of the 288 AEFI reports for the coronavirus inoculation programme for children aged five to 11 years are serious, including 17 who required hospital admission and one death.

Twelve of the 17 are still in recovery, while five have recovered completely. The sole fatality of the child who received a Covid-19 vaccine dose was reported as a brought-in-dead case that is still under investigation.

“Preliminary reports indicate that this child had pre-existing illnesses,” NPRA said.

Malaysia’s AEFI rate in the children’s Covid-19 vaccination programme at 0.2 reports per 1,000 doses is similar to other countries, like Canada (0.2) and Australia (0.6).

“The lower AEFI reporting rate among children aged five to 11 years compared to adult vaccine recipients was also reported in these countries,” NPRA said.

As a whole, NPRA received 26,071 AEFI reports from PICK, including the 1,552 reports from booster vaccine recipients and 288 from child vaccine recipients, leading to a rate of 377 reports per million doses.

About 93 per cent of the 26,071 reports of vaccine side effects received as of April 8 are not serious. A total of 1,831 AEFI reports are serious, equivalent to 27 reports per million doses.

Serious side effects include cases that require hospital admissions, require longer hospital stays, result in significant loss of ability, birth defects, and suspected deaths.

The serious AEFI reports included 610 fatalities, out of which 460 were concluded by the JFK to be unrelated to the Covid-19 vaccine. The remaining 150 death cases are still under investigation.

On adverse events of special interest (AESI), NPRA found these vaccine side effects to be very rare in Malaysia, consistent with global trends.

As of April 8, NPRA reported 0.9 to 4.6 reports of anaphylaxis per million doses, 2.0 to 3.2 reports of acute facial paralysis per million doses, 1.3 reports of myocarditis or pericarditis per million Pfizer doses, and 0.7 reports of venous thromboembolism with thrombocytopenia per million AstraZeneca doses.

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