THE detection of an early possible link to stroke from the Pfizer bivalent Covid-19 vaccine was merely a notification of a safety signal, Dr Noor Hisham Abdullah said. 

The health director-general said all safety signals must be properly investigated and evaluated before being confirmed.

“However, so far no ischaemic stroke safety signal has been detected through other safety monitoring systems in the United States (for example Vaccine Adverse Event Reporting System), which is the follow-up to the use of the Comirnaty Bivalent Covid-19 vaccine,” he said in a statement today.

Further analysis also did not confirm the safety signal, he added. 

Noor Hisham said safety monitoring of the Covid-19 vaccine in other reference countries also did not detect this safety issue.

The health director-general clarified that the information from the United States Food and Drug Administration (FDA) and US Centers for Disease Control and Prevention (CDC) was a notification regarding a safety signal that was detected by a safety monitoring database known as the Vaccine Safety Datalink.

The vaccine was given its conditional registration approval on December 13 during the Health Ministry’s Drug Control Authority meeting. 

However, the vaccine has yet to be used. 

Noor Hisham said that Pfizer (M) Sdn Bhd must submit its latest safety data for post-vaccination. 

He said that the National Pharmaceutical Regulatory Agency will continue its close monitoring of the Covid-19 vaccines in use in Malaysia.

Noor Hisham’s explanation on the vaccine comes after Reuters published an article on January 15, titled “US FDA, CDC see early signal of possible Pfizer bivalent Covid shot link to stroke”. 

In the article, it was 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 ischaemic stroke 21 days after receiving the Pfizer-BioNTech bivalent vaccine. – January 18, 2023.