NPRA: No Serious Side Effects Reported From Children’s Covid-19 Vaccination

Of 79,393 Covid vaccine doses administered to under-12 kids, only 8 reports of non-serious adverse effects have been received, equal to 0.1 reports per 1,000 doses.

KUALA LUMPUR, Feb 16 – Regulators have not received any reports of serious side effects resulting from Covid-19 vaccines given to under-12 children, out of 79,393 doses administered as of February 11.

The National Pharmaceutical Regulatory Agency (NPRA) said only eight reports of non-serious adverse effects from the coronavirus vaccine have been received from the children’s Covid-19 vaccination programme (PICKids) for children aged five to under 12 years.

This is equivalent to 0.1 reports for every 1,000 doses.

“Reactions on the skin, vomiting, and pain in the abdomen were among the adverse effects reported,” NPRA director Dr Roshayati Mohamad Sani said in a statement today.

As for the Covid-19 booster programme, out of 13,000,984 booster vaccine doses administered as of February 11, the NPRA has received 80 reports of serious adverse events following immunisation (AEFI). 

This is equal to six reports for every one million doses.

Overall AEFI reports among booster vaccine recipients totalled 1,104, equivalent to 85 reports for every one million doses. This is a lower rate compared to the 386 AEFI reports per million doses in the entire Covid-19 vaccination programme.

“As a conclusion, based on the AEFI reports received by NPRA thus far, the AEFI reporting trend and rate involving booster doses show no increase from what was seen during the administration of primer doses,” said Dr Roshayati.

“This same trend was observed in other countries that rolled out Covid-19 booster immunisation programmes.”

Throughout the overall Covid-19 vaccination programme in Malaysia, NPRA has received 1,747 reports of serious AEFI, or 27 reports per million doses, to date. 

A total of 64,697,715 vaccine doses have been administered nationwide since the start of the National Covid-19 Immunisation Programme (PICK) on February 24 last year, comprising shots from Pfizer, Sinovac, AstraZeneca, CanSino, and Sinopharm.

The NPRA also found that certain side effects from Covid-19 vaccination — such as anaphylaxis (severe allergic reaction) and acute facial paralysis from all coronavirus vaccines, myocarditis (inflammation of the heart) or pericarditis (inflammation of the thin tissue sac around the heart) from Pfizer’s shot, and venous thromboembolism with thrombocytopenia (unusual blood clots with low blood platelets) from AstraZeneca’s vaccine — were extremely rare in Malaysia, consistent with global trends.

In Malaysia, anaphylaxis was reported at 0.9 to 1.8 incidents per million doses, acute facial paralysis (2.0 to 3.3 per million doses), myocarditis or pericarditis (1.2 per million Pfizer doses), and venous thromboembolism with thrombocytopenia (0.6 per million AstraZeneca doses).

The NPRA did not furnish statistics on the total number of deaths among Covid-19 vaccine recipients in the overall coronavirus inoculation programme, but provided mortality rates instead. 

From the overall PICK, 9.2 deaths per million doses have been reported as of February 11, out of 64,697,715 doses administered. 

As of February 11, the NPRA has received reports of 42 deaths among individuals who received Covid-19 booster vaccines, including 14 among those who received heterologous inoculation, or a different booster shot from their primer vaccine. 

This is equivalent to three deaths per million doses out of 13,000,984 booster doses administered.

The NPRA said among all the reported deaths of coronavirus vaccine recipients, it has yet to confirm a case of a direct cause of death from the Covid-19 vaccine.

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