KUALA LUMPUR, Jan 18 — Health director-general Tan Sri Dr Noor Hisham Abdullah today said that the detection of an early possible link to stroke from the Pfizer bivalent Covid-19 vaccine was merely a notification of a safety signal.
All safety signals must be investigated and evaluated prior to confirmation, he said in a statement this afternoon.
“However, so far no ischemic stroke safety signal has been detected through other safety monitoring systems in the United States (for example Vaccine Adverse Event Reporting System ― VAERS), which is the follow-up to the use of the Comirnaty Bivalent Covid-19 vaccine,” he noted.
Further monitoring did not confirm the safety signal and neither did safety monitoring of the Covid-19 vaccine in other reference countries detect the issue, he said.
Dr Noor Hisham explained that the information from the United States Food and Drug Administration (US FDA) dan US Centers for Disease Control and Prevention (CDC) was a notification regarding a safety signal that was detected by a safety monitoring database called the Vaccine Safety Datalink (VSD).
He assured that the National Pharmaceutical Regulatory Agency (NPRA) will continue its close monitoring of the Covid-19 vaccines in use in Malaysia.
The vaccine has not yet been used in Malaysia and was only given its conditional registration approval on December 13 during the Health Ministry’s Drug Control Authority (DCA) meeting, he said.
Because of that, Pfizer (M) Sdn Bhd must submit its latest safety data for post-vaccination, he explained.
Dr Noor Hisham was referring to a Reuters article titled “US FDA, CDC see early signal of possible Pfizer bivalent Covid shot link to stroke“ published on January 15.
The article stated that a CDC vaccine database had detected a possible safety issue for those aged 65 and above, who were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent vaccine.
