No cases of stroke reported for Comirnaty Bivalent COVID-19 vaccine in clinical studies

KUALA LUMPUR: No cases of stroke 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 Tan Sri Dr Noor Hisham Abdullah said so far there were no safety signals of ischaemic stroke were detected through other safety monitoring systems in the United State 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 here today.

He said this in response to a Reuters report titled "U.S. FDA, CDC see early signal of possible Pfizer bivalent COVID shot link to stroke" published on Jan 15.

Dr Noor Hisham said information from the United States Food and Drug Administration (US FDA) and the US Centers for Disease Control and Prevention (CDC) was about a safety signal that was detected from one of its safety monitoring databases, the Vaccine Safety Datalink (VSD).

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

Further analysis also did not confirm the safety signal. Safety monitoring of the (Pfizer COVID-19 bivalent) vaccine in other reference countries also did not detect this issue, he added.

-- BERNAMA