MDA told to evaluate COVID-19 self-test kits - Khairy

PUTRAJAYA: The Medical Device Authority (MDA) has been instructed to call all suppliers of COVID-19 self-test kits in the country following complaints received that they were showing dubious results, Health Minister Khairy Jamaluddin said.

"I have also asked the agency (MDA) to request suppliers to obtain quality assurance information from their principal factories," he told a media conference on COVID-19 developments here today.

He said an assessment would also be made on dubious test kits in the market to determine that there was no drop in quality from the time they were approved till now.

"This is now being implemented and what transpires from MDA's follow-up action will be communicated to the public later," Khairy said.

Based on data sourced from the Health Ministry (MOH), up to Oct 27 last year, 49 COVID-19 self-test kits had been given conditional approval by the MDA.

Meanwhile, on standard operating procedures (SOP) for the Johor state election, Khairy said the Election Commission (EC) will be announcing the details.

"The MOH has made its recommendations and proposals, we have agreed with everything that was presented. I am confident that if the SOP is adhered to then they will be sufficient to prevent a drastic surge (in cases)," he said.

The EC has fixed March 12 as polling day for the state election, with nominations on Feb 26 and early voting on March 8.

In another development, National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said a detailed investigation by the Pharmacovigilance Committee on the 22 of the 42 deaths linked to booster shots were unrelated to the COVID-19 vaccine.

Dr Roshayati was referring to a news report yesterday based on an NRPA statement indicating 42 reported deaths linked to the booster vaccine.

She said each adverse events following immunisation (AEFI)-related death will be thoroughly investigated by a team comprising experts from the facility reporting the death.

"The results of the investigation including clinical information will be carefully evaluated by the Pharmacovigilance Committee comprising experts from various fields, which in turn will determine whether there is direct causality with the deaths and vaccines received," she said.

-- BERNAMA