The Ministry of Health (MOH) announced on Jan. 14 that local data "at this time do not show an increased risk of ischaemic stroke after receiving either the Moderna or the Pfizer-BioNTech/Comirnaty Bivalent vaccine".
MOH's statement comes after an announcement by the U.S. Centers for Disease Control and Prevention (CDC).
The CDC announcement said its Vaccine Safety Datalink (VSD), a near real-time surveillance system, had identified a need for additional investigation into whether there was a safety concern for ischaemic stroke for people ages 65 and older, who received the Pfizer-BioNTech Covid-19 bivalent vaccine.
An ischaemic stroke occurs when the blood supply is blocked or reduced to part of the brain, preventing brain tissue from getting oxygen and nutrients. This would lead to brain cells beginning to die in minutes.
"Very unlikely to reflect a true risk"
A joint report by CDC and Food and Drug Administration (FDA) said that this is "very unlikely to reflect a true risk" as it was seen in one vaccine safety monitoring system, but not observed and validated in other U.S. safety systems or analyses, nor by other countries.
The U.S. has not changed its prevailing recommendations for persons to be boosted with the bivalent mRNA vaccines.
Pfizer and BioNTech also compared this to published incidence rates of ischaemic stroke in this older population and observed a lower number of reported ischaemic strokes following vaccination with the bivalent vaccine, MOH said in their statement.
Currently, local data does not show an increased risk of ischaemic stroke after receiving either the Moderna or the Pfizer-BioNTech/Comirnaty bivalent Covid-19 vaccines, MOH said in a statement on Jan. 14, in response to media queries on the joint statement by the U.S. CDC and FDA.
They added: "The safety profile of the bivalent mRNA vaccines has been observed to be similar to that of their monovalent versions."
In addition, there have been multiple international studies which show 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," MOH urged.
Benefits outweigh risks
The Health Sciences Authority 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, said MOH.
The EC19V continues to recommend that individuals receive their bivalent booster doses to maintain a high level of protection against severe disease.
Top image by Mufid Majnun via Unsplash.