Bivalent Pfizer BioNTech COVID-19 vaccine

NOTICE PAPER NO. 1650 
NOTICE OF QUESTION FOR ORAL ANSWER
FOR THE SITTING OF PARLIAMENT ON OR AFTER 7 FEBRUARY 2023

Name and Constituency of Member of Parliament
Ms Joan Pereira
MP for Tanjong Pagar GRC

Question No. 4088

To ask 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.

Answer

After more than two years of COVID-19 vaccinations, there is  a well-developed and transparent safety monitoring system in place. Regulators around the world highlight observations once they detected it, even if not yet fully investigated. This  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 having had  the said vaccine. 

Upon further investigations, the US Center 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, Health Sciences Authority (HSA)’s latest safety report showed that the incidence rate of severe adverse event after taking bivalent vaccines, is at about 1 in 100,000, which is lower than that of the original vaccines, at about  7 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 (EC-19V), here in Singapore and our HSA maintain that the benefit of both the bivalent Moderna and Pfizer COVID-19 vaccines continue to outweigh the risks, especially for vulnerable individuals.