KUALA LUMPUR, Feb 23 — The National Pharmaceutical Regulatory Agency (NPRA) today revealed that since the rollout of Covid-19 booster shots in the country, 44 cases involving suspected deaths from adverse events following Covid-19 immunisation (AEFI) have been reported.
NPRA director Dr Roshayati Mohammad Sani during a media briefing session today said that of the 44 cases reported until February 18, 22 have been ruled out by the Health Ministry’s pharmacovigilance committee (JFK) as having anything to do with Covid-19 vaccines.
“The remaining 22 cases are still under investigation and the process of being completed before it can be presented for evaluation to JFK,” she said.
Dr Roshayati said a total of 13,768,697 booster shots had been administered as of Feb 18.
Dr Roshayati said 65 million doses of Covid-19 vaccines have been administered nationwide since the national immunisation programme started on February 24 last year,
“From that number a total of 25,211 AEFI reports have been received by the NPRA including 1,186 AEFIs from booster doses,” she said during the press briefing conducted online.
She said that 93 per cent of overall AEFI reports or 23,453 cases were categorised as not serious while 1,758 AEFI reports were classified as serious.
“Non-serious AEFIs are usually resolved within a day or two. Examples of non-serious AEFIs include fever, headache, muscle ache and fatigue.
“While serious AEFIs were classified as cases with effects requiring hospitalisation, prolonged stays in the ward, life-threatening symptoms and those suspected to have resulted in death,” she said.
Dr Roshayati added that the NPRA is constantly monitoring other safety issues related to Covid-19 vaccine which is identified globally as Adverse Events of Special Interest (AESI).
“Among the AESI being monitored closely by NPRA is inflammation of the heart muscle/lining of the heart [myocarditis/pericarditis] and venous thromboembolism with thrombocytopenia [venous blood clotting with platelet count low].
“Myocarditis/pericarditis has been identified to occur globally among individuals who had received the mRNA-type Covid-19 vaccine including Comirnaty, but it is extremely rare,” she added.