No stroke cases reported for Pfizer bivalent vaccine in clinical studies, says health DG

No stroke cases were reported for the Comirnaty bivalent Covid-19 vaccine in the clinical studies conducted, according to the data submitted by the product registration holder, Pfizer Sdn Bhd, to the National Pharmaceutical Regulatory Agency (NPRA).

Health director-general Dr Noor Hisham Abdullah said there were so far no safety signals of ischaemic stroke detected through other safety monitoring systems in the US following the use of the Pfizer bivalent vaccine.

"Since the vaccine was granted conditional approval in Malaysia by the Drug Control Authority on Dec 13, 2022, Pfizer Sdn Bhd must submit in stages the latest post-vaccination safety signals.

"As everyone knows, the vaccine has yet to be used in Malaysia. The NPRA will keep tabs on the data and analysis regarding the use of the bivalent vaccine in reference countries and will continue to monitor the safety level of all Covid-19 vaccines used in Malaysia," he said in a statement.

He was responding to a Reuters report titled "US FDA, CDC see early signal of possible Pfizer bivalent Covid shot link to stroke" published on Jan 15.

Noor Hisham said the information from the US Food and Drug Administration and the US Centers for Disease Control and Prevention was about a safety signal detected from one of its safety monitoring databases, the Vaccine Safety Datalink.

He said all safety signals that are detected need to be investigated and evaluated before being confirmed.

Further analysis did not confirm the safety signal while the safety monitoring of the Pfizer Covid-19 bivalent vaccine in other reference countries did not detect the issue, he added.