KUALA LUMPUR, Feb 23 – The National Pharmaceutical Regulatory Agency (NPRA) today reported that 22 of 44 deaths of Covid-19 booster vaccine recipients recorded as of February 18 were not linked to their jab.
NPRA director Dr Roshayati Mohamad Sani said in a statement today that the Covid-19 Vaccine Pharmacovigilance Special Committee is awaiting the completion of reports of the remaining 22 cases before initiating investigations.
The NPRA received 1,186 reports of adverse events following immunisation (AEFI) in the coronavirus booster vaccination programme as of February 18, or 86 vaccine side-effect reports for every one million doses, lower than the rate of 383 AEFI reports for every one million doses in the overall Covid-19 inoculation programme.
Of the 1,186 AEFI reports among booster vaccine recipients, 87 are serious AEFI cases (7.34 per cent), or 6.3 serious AEFI reports for every one million doses in the booster rollout.
“As a conclusion, based on the AEFI reports that NPRA has received to date, the AEFI reporting trend involving booster doses does not show a significant increase than what was seen with primer doses.
“Similar reporting trends were also observed in other countries that have rolled out Covid-19 booster vaccination programmes,” said Dr Roshayati.
According to slides presented at NPRA’s media briefing today, the medical regulator received 1,758 reports of serious AEFI in the overall Covid-19 vaccination programme as of February 18, or 27 reports for every one million doses.
As of February 18, a total of 65,777,392 Covid-19 vaccine doses have been administered, comprising shots from Pfizer-BioNTech, AstraZeneca-Oxford, Sinovac, CanSino, and Sinopharm.
“Serious AEFI effects are effects that require admission to hospital, extension of time in the ward, a threat to life, or suspected of causing death,” said the slide.
However, NPRA did not state how many of the 1,758 serious AEFI reports involved deaths.
