Health director-general Dr Noor Hisham Abdullah has sought to allay fears of a link between Pfizer’s bivalent vaccine and strokes in senior citizens.
Noor Hisham said a recent Reuters report was based on information from the US Food and Drug Administration and the US Centers for Disease Control and Prevention (CDC) about a safety signal that was detected from one of its safety monitoring databases.
On Friday, the agencies said CDC’s Vaccine Safety Datalink database uncovered a possible safety issue in which people 65 years and older were more likely to have an ischemic stroke 21 days after receiving the Pfizer bivalent shot compared with days 22 to 44.
An ischemic stroke is caused by blockages in arteries that carry blood to the brain.
“All safety signals that are detected need to be investigated and evaluated first before being confirmed,” said Noor Hisham in a statement today.
“So far, no ischemic stroke safety signals were detected through other safety monitoring systems in the US, such as the Vaccine Adverse Event Reporting System, following the use of the Pfizer bivalent vaccine.
“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.”
Pfizer’s bivalent vaccines were granted conditional approval in Malaysia by the Drug Control Authority on Dec 13, with the public expected to have access to them by the end of this month.
Noor Hisham said that based on data submitted to the National Pharmaceutical Regulatory Agency (NPRA) by the company that holds the product registration for Pfizer’s bivalent vaccine in Malaysia, Pfizer Sdn Bhd, there have been no reported cases of stroke in the clinical studies conducted.
He said NPRA is keeping tabs on the data and analysis regarding the use of the bivalent vaccine in other countries.
Bivalent vaccines are essentially an upgraded version of Covid-19 vaccines and are aimed at providing improved protection against new subvariants.
The early vaccines were monovalent, meaning they only contained the spike protein of the original SARS-CoV-2 virus.
The new bivalent vaccines contain the spike protein of the original strain and also those of the Omicron subvariants BA.1 and BA.4-5. – FMT