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Singapore data for bivalent COVID-19 vaccines does not show increased risk of stroke: MOH

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SINGAPORE: Data in Singapore on the bivalent COVID-19 vaccines does not show an increased risk of ischemic stroke linked to either the updated Moderna or the Pfizer-BioNTech shots, said the Ministry of Health (MOH) on Saturday (Jan 14).

The Health Ministry's statement comes after US federal health authorities launched an investigation into a preliminary safety concern about a potential increased risk of stroke in seniors who received the bivalent vaccine.

"In Singapore, the local data accrued for the bivalent vaccines at this time does not show an increased risk of ischaemic stroke after receiving either the Moderna or the Pfizer-BioNTech/Comirnaty Bivalent vaccine," said MOH.

"The safety profile of the bivalent mRNA vaccines has been observed to be similar to that of their monovalent versions."

An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain.

The preliminary safety concern was detected by one of the US Centers for Disease Control and Prevention's monitoring systems.

The US CDC said in a statement on Friday that no other surveillance system has detected a similar safety concern so far.

It also noted that other countries have not observed an increased risk for ischemic stroke with the updated bivalent vaccines, adding that the matter requires more investigation.

Singapore's Health Ministry said multiple international studies have shown that receiving an updated bivalent COVID-19 vaccine reduces the risk of severe disease and death by multiple folds compared to not receiving it.

"It is important to remain up-to-date with COVID-19 vaccination to reduce one’s risk of severe COVID-19, and to protect against current and future variants," said MOH.

"The Health Sciences Authority (HSA) and Expert Committee on COVID-19 Vaccination (EC19V) assess that the benefit of both the Moderna and Pfizer-BioNTech/Comirnaty COVID-19 bivalent vaccines continue to outweigh the risks."

The committee continues to recommend that individuals receive their bivalent booster doses to maintain a high level of protection against severe disease, the ministry added, noting that the US has also not changed its prevailing recommendations for people to receive the bivalent mRNA booster shot.

The safety concern was picked up in one vaccine safety monitoring system, but not observed and validated in other US safety systems or analyses, nor by other countries, MOH said.

"Pfizer and BioNTech have also stated in a statement that compared to published incidence rates of ischaemic stroke in this older population, they have to date observed a lower number of reported ischaemic strokes following vaccination with the bivalent vaccine," it added.

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