NPRA monitoring data after early signal links bivalent shots to stroke

 

The National Pharmaceutical Regulatory Agency (NPRA) is closely monitoring data on Pfizer's bivalent vaccine after US agencies found an early signal possibly linking it to strokes.

Health Ministry director-general Dr Noor Hisham Abdullah (above), however, noted in a statement today that thus far, no other monitoring systems in the US or other countries have detected this early signal.

Reuters had previously reported that the US Centers for Disease Control and Prevention (CDC) vaccine database had uncovered a possible safety issue in which people aged 65 and older were more likely to have an ischemic stroke 21 days after receiving the bivalent shot, compared with days 22 to 44.

An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain.

Noor Hisham repeated the CDC and the Food and Drug Administration (FDA)’s remarks that while the matter had only been flagged once, it still requires further investigation.

He added that while Pfizer itself has not reported any cases of strokes caused by the bivalent vaccine during clinical trials, the company is required to furnish up-to-date safety data.

"As is publicly known, the (bivalent) vaccine is not yet in use in Malaysia.

"The NPRA will closely monitor data and analysis from reference countries regarding the bivalent vaccine and will continue to monitor the safety of all Covid-19 vaccines in Malaysia," he said. - Mkini