KUALA LUMPUR: No cases of stroke were reported in clinic studies for the Comirnaty bivalent Covid-19 vaccine, according to data submitted by product registration holder Pfizer Sdn Bhd to the National Pharmaceutical Regulatory Agency (NPRA).
Health director-general Tan Sri Dr Noor Hisham Abdullah (pic) said so far there were also no safety signals of ischaemic stroke detected through other safety monitoring systems in the United States following the use of the Pfizer bivalent vaccine.
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"Since the vaccine was granted conditional approval in Malaysia by the Drug Control Authority on Dec 13, Pfizer Sdn Bhd must submit the latest post-vaccination safety signals in stages.
"As everyone knows, the vaccine has yet to be used in Malaysia. The NPRA will keep tabs on the data and analysis 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 on Wednesday (Jan 18).
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He was commenting on a Reuters report titled "US 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 US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) was about a safety signal detected from one of its safety monitoring databases, the Vaccine Safety Datalink (VSD).
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He said all safety signals detected need to be investigated and evaluated before being confirmed.
Further analysis also did not confirm the safety signal. Safety monitoring of the bivalent vaccine in other reference countries also did not detect this issue, he added. – Bernama
