Booster dose AEFI: Only 7.34 per cent of 1,186 reported cases classified as serious

PUTRAJAYA: A total of 87 cases or 7.34 per cent of 1,186 reports of adverse events following immunisation (AEFI) for the COVID-19 vaccine booster dose received as of Feb 18 have been classified as serious, says National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani.

She said this was equivalent to 86 reports per million doses.

"From the monitoring of AEFI reports received by NPRA so far, the trend and rate of AEFI reporting involving booster doses did not show any increase from what was seen during the administration of primer doses.

"The reporting trend is similar to those of other countries that have conducted immunisation programmes for COVID-19 vaccine booster doses," she said during a virtual briefing with the media today.

Dr Roshayati said, on the whole, NPRA had received a total of 25,211 AEFI reports, of which 93 per cent or 23,453 cases were non-serious, while 1,758 were categorised as serious.

Of the 1,758 serious cases, she said 1,069 involved the Pfizer-BioNTech COVID-19 vaccine, 544 (Sinovac); 142 (AstraZeneca); and three cases involving the Convidecia (CanSino) vaccine.

Dr Roshayati said fever, pain at the injection site, headache, muscle aches and fatigue were among the most common adverse effects reported by vaccine recipients while serious effects were those which required hospitalisation, were life-threatening, or suspected to have caused death.

She said a total of 38 AEFI reports involving vaccine recipients among children aged five to 11 were received as of Feb 18, of which 37 were non-serious, while one serious case which involved hospitalisation had recovered.

"The AEFI data received is important to ensure that the benefit-over-risk comparison of vaccine products remains positive in preventing the transmission of COVID-19," she said.

On the issue of a woman who claimed to have lost the sense of touch on her two fingers following a COVID-19 vaccine booster shot and may have to undergo an amputation, Dr Roshayati said the NPRA had received a report on the case and were currently investigating it.

"However, there is another test that has not been completed and needs to be done. The NPRA will later determine whether it is directly related to the COVID-19 vaccine. Once the test results are received, it will be discussed at the Pharmacovigilance Committee level," she said.

-- BERNAMA