Singapore's Vaccine Safety and Efficacy Validation Process, and Submission for Moderna’s mRNA Influenza Vaccine

2 Mr Yip Hon Weng asked the Coordinating Minister for Social Policies and Minister for Health (a) whether the Health Sciences Authority (HSA) has received a recent submission for Moderna’s mRNA influenza vaccine; and (b) to what extent Singapore’s safety and efficacy validation process remains independent of the US and European standards.

The Senior Minister of State for Health (Dr Koh Poh Koon) (for the Coordinating Minister for Social Policies and Minister for Health): Sir, the Health Sciences Authority (HSA) has not received any regulatory submission for Moderna’s mRNA seasonal influenza vaccine.

HSA always exercises its regulatory authority independently. That said, in the healthcare regulatory world, there are many collaborations and partnerships; highly regarded regulatory bodies become references for others; just as Singapore is a reference for others and we also reference other highly reputable jurisdictions.

Mr Speaker: Mr Yip.

Mr Yip Hon Weng (Yio Chu Kang): Thank you, Mr Speaker. I thank the Senior Minister of State for his reply. The recent United States (US) Food and Drug Administration's (FDA's) hesitation over Moderna’s mRNA flu vaccine suggests that regulators around the world can have differing views on assessments. So, can the Senior Minister of State explain how HSA ensures its decisions are not simply aligned to some of these US or United Kingdom (UK) regulators? This matters because Singaporeans must have confidence that approvals are based on what is best and safest for our population.

Dr Koh Poh Koon: Sir, as I said in my reply, HSA takes an independent review of all submissions for regulatory approval. We have our methodology that is based on science done by a panel of experts who are well versed in this area. So, we look at comprehensive data that is being submitted by any manufacturer who seeks to license their products here, and this includes parameters looking at quality safety efficacy, including data from Phase 3 randomised controlled trials, where we will also assess the methodology and whether the sample size is adequate for the type of products that are seeking to be registered.

We also look at whether there are adequate follow-up periods after the product has hit the market, typically at least more than six months, to make sure that in the post-launch period the product has not surfaced any unknown side effects that were previously not detected in the randomised controlled trial.

And of course, the manufacturer also must show evidence of compliance with good manufacturing practice (GMP standards), so that things like detailed manufacturing processes, quality control data with testing methods and acceptance criteria, will allow us to assess whether every batch of product that comes through this manufacturer has a consistency that meets quality standards. And also, we look at the stability data demonstrating that any vaccine or any medical product maintains effectiveness and safety throughout its storage period.

So, I just want to assure the Member that we have a robust system and we will continue to do so.