Alleged Increased Risk of Stroke for Older People who have Received Pfizer-Biontech COVID-19 Bivalent Vaccine

2 Ms Joan Pereira asked the Minister for Health whether the Ministry is studying the preliminary safety concerns flagged by the United States Centers for Disease Control and Prevention vaccine safety surveillance system on an alleged increased risk of stroke for people aged 65 and older who have received the Pfizer-BioNTech COVID-19 bivalent vaccine.

The Senior Minister of State for Health (Dr Janil Puthucheary) (for the Minister for Health): After more than two years of COVID-19 vaccinations, there is now a well-developed and transparent safety monitoring system, where regulators around the world will highlight observations once they detected it, even if not fully investigated. Such is the nature of the recent preliminary signal reported by one of the vaccine monitoring centres in the US about strokes in individuals aged 65 and above who have had the said vaccine.

Upon further investigations, the US Centers for Disease Control (CDC) and Food and Drug Administration (FDA) assessed that this was very unlikely to reflect a true risk. The signal of a possible risk was neither observed nor validated in other US safety systems or analyses, or by other countries.

Similarly, our local data accrued for the bivalent vaccines so far also do not show any increased risk of ischaemic stroke after receiving either the bivalent Moderna/Spikevax or the Pfizer-BioNTech/Comirnaty vaccine. In fact, HSA’s latest safety report showed that the incidence rate of severe adverse event after taking bivalent vaccines, at about one in 100,000, is lower than that of the original vaccines, at around seven in 100,000.

The US CDC and FDA are not making any changes to the vaccination practice in US and will continue to monitor the safety of the COVID-19 vaccines. Similarly, the Expert Committee on COVID-19 Vaccination (EC19V) and Health Sciences Authority (HSA) maintain that the benefit of both the bivalent Moderna and Pfizer COVID-19 vaccines continue to outweigh the risks, especially for vulnerable individuals.

Mr Speaker: Mr Yip Hon Weng.

Mr Yip Hon Weng (Yio Chu Kang): I thank the Senior Minister of State for his reply. I have senior residents in Yio Chu Kang who have raised similar concerns about bivalent vaccines having higher risk of stroke. Hence, some are reluctant to take the bivalent vaccine. How will the Ministry work towards allaying some of these concerns and thereby, improving the take-up rate of the bivalent vaccine among our seniors?

Dr Janil Puthucheary: Sir, I thank the Member for the question. Allaying such concerns will require a multi-channel, multi-stakeholder approach, as we have been doing for any issues and concerns around the vaccines and the vaccination programme from the start. The transparency of our processes, the information available from experts, academics and the professionals, the honest and complete discussion about risks and benefits – not that there are no risks, but the benefits significantly outweigh the risks – as well as that last-mile communication. I hope Members in this House can assist in that process of last-mile communication, taking the information provided by the Ministry of Health (MOH), by HSA, by the EC19V, by colleagues and replies in this House, and helping to convey to their residents as well.

Mr Speaker: Ms Joan Pereira.

Ms Joan Pereira (Tanjong Pagar): Thank you, Speaker. I have one supplementary question for the Senior Minister of State. MOH had recently published figures on the number of individuals who have received payments under the Vaccination Injury Financial Assistance Programme (VIFAP). Of these individuals, may I know how many of them had suffered from an ischemic stroke after receiving the bivalent vaccine?

Dr Janil Puthucheary: Sir, I thank the Member Ms Joan Pereira for her question. Among the subset of patients having received the vaccine who then subsequently received the VIFAP that she referred to, the data has been released, there were no cases of acute ischemic stroke. So, the short answer to her question is zero.

But we do not monitor the VIFAP applicants or recipients only. We monitor and look for safety signals across the entire population of people who receive the vaccines, who come to our clinics or centres, who receive medical care at our hospitals. And we are looking for that safety signal that this type of adverse event has increased. And it has not. That is the clear message that we want to send.