KUALA LUMPUR: A total of 24,490 adverse events following immunisation (AEFI) have been reported to the National Pharmaceutical Regulatory Agency (NPRA) as of Feb 11.
The agency had also received 976,019 responses through MySejahtera feedback, at 15,086 per million doses reported.
NPRA director Dr Roshayati Mohamad Sani said the total include 1,104 reports involving Covid-19 booster shots and eight for vaccine recipients aged five to 12.
She said the agency's AEFI reporting system recorded 386 AEFI cases in every one million vaccine doses administered.
"However, 93 per cent of the AEFI cases reported are not serious. Mostly fever, pain at the injection site, headache, muscle aches and fatigue as among the most frequently reported effects.
"These effects would usually heal within one to two days.
"From the total AEFI reports received, only 1,747 cases were reported as AEFI serious, which equates to 27 cases per million vaccine doses," she said in a statement, today.
Dr Roshayati described serious adverse effects including those requiring hospitalisation, prolonged-period in the ward, life-threatening or possible fatalities.
She said the agency was also monitoring rare occurences identified as Adverse Event of Special Interest (AESI) among vaccine recipients in the country.
"This includes anaphylaxis (all vaccines), acute facial paralysis (all vaccines), myocarditis/ pericarditis (Comirnaty) and venous thromboembolism with thrombocytopenia (AstraZeneca).
"For anaphylaxis, 0.9 to 1.8 reports received for each one million doses, acute facial paralysis (2.0-3.3 per million doses), myocarditis/ pericarditis (Comirnaty: 1.2 per million doses) and venous thromboembolism with thrombocytopenia (AstraZeneca: 0.6 per million two).
"We found that these effects are extremely rare and consistent with trends reported globally," she said.
She said 64,697,725 Covid-19 vaccine doses consisting of Cominarty (Pfizer), CoronaVac (Sinovac), AstraZeneca (AZ), Convidecia (CanSino) and COVILO (Sinopharm) had been administered since Feb 24 last year till Feb 11 recently.
She said the agency had also received reports of death among vaccine recipients were 9.2 deaths per one million vaccines dose administered.
"The agency received reports of death among Sinovac vaccine recipients to be the highest, which is 11.7 per million doses, followed by Pfizer (8.2), AZ (6.2), CanSino (4.8) and zero death reported among Sinopharm vaccine recipients."
Meanwhile, 13,000,984 Covid-19 booster shots and 79,393 vaccine doses to five to 12-years-old recipients had been administered as of Feb 11.
On Covid-19 booster shots, she said the agency received 1,104 AEFI reports, equating to 85 reports per million doses administered, which she deemed lower than the overall AEFI reporting rate.
"Of the total AEFI reports received for booster shots, only 80 reports are classified as serious, which equates to six reports per million doses.
"From the AEFI monitoring reports received by NPRA so far, we can conclude that the trends and AEFI cases involving booster doses do not show any improvement from what is currently seen from primary dose administration.
"The same reporting trend was also reported by other countries that have run immunisation programs for booster doses vaccine Covid-19," she said.
She said the death rate reported among booster shot recipients were three in every one million shots administered.
On AEFI cases among vaccine recipients aged five to 12 years old, she said only eight non-serious AEFI were received or equivalent to 0.1 per 1,000 vaccine doses administered.
"Skin reactions, vomiting and pain in the abdomen are the most adverse effects that have been reported".