Assessment of Use of Non-mRNA COVID-19 Vaccines in Wider Population

Mr Gerald Giam Yean Song asked the Minister for Health (a) what are the considerations for not making the Sinovac-CoronaVac and Sinopharm vaccines generally available to children and adolescents, except adolescents who are not medically eligible for the Pfizer-BioNTech/Comirnaty vaccine; and (b) whether the Ministry has plans to make at least one non-mRNA vaccine generally available to children under 18 in order to maximise the vaccination rate of the Singapore population.

Sir, as of 9 February 2022, there were about 1,000 individuals who completed the primary vaccine course with non-mRNA vaccines and would have their “fully-vaccinated” status expire by 14 February 2022.

Persons who are medically ineligible to receive the mRNA vaccine and aged 18 and above, can receive Sinovac-CoronaVac vaccine under the National Vaccination Programme (NVP) as a booster vaccine.

The use of the Sinovac-CoronaVac vaccine under NVP is only for persons aged 18 and above, as the vaccine manufacturer did not include children and adolescents when filing for interim authorisation of the vaccine under the Health Sciences Authority (HSA)’s Pandemic Special Access Route (PSAR). Both Sinovac-CoronaVac and the Sinopharm vaccines are also not currently recommended for routine use in persons aged below 18 by the World Health Organization.

Notwithstanding the manufacturer’s filing on the use of the vaccine, limited data from the Sinovac-CoronaVac vaccine manufacturer’s early Phase I and II trials in healthy children and adolescents aged three to 17 do not show safety concerns and we recognise the need for alternative vaccines for persons medically ineligible for the currently approved vaccine in this age group.

MOH has, therefore, also separately introduced a dedicated public health programme – Sinovac after mRNA (SAM) – outside of the NVP, to offer the Sinovac-CoronaVac vaccine to individuals aged 12 to 17 who are medically ineligible for the Pfizer-BioNTech/Comirnaty COVID-19 vaccine, to afford them some level of protection against COVID-19 while closely monitoring their safety.

SAM is, therefore, part of a research study which, under our current regulatory framework, enabled the administration of the Sinovac vaccine to an age group outside the scope of PSAR approval. In January 2022, the programme was further extended to eligible children aged five to 11, after the data from the older age group indicated that the safety profile of the vaccine was generally consistent with that of other registered vaccines used in immunisation against other diseases.

MOH is working to bring in other non-mRNA options for those who are medically ineligible. The Novavax COVID-19 vaccine has been assessed by HSA to be safe and effective for persons aged 18 and above, with two doses demonstrating a vaccine efficacy of 90% against symptomatic infection and 100% against severe disease with the wildtype SARS-CoV2 and the Alpha variant, with no significant safety concerns.

Therefore, in February 2022, HSA issued its PSAR interim authorisation letter to Novavax for its COVID-19 vaccine. Novavax recently released data that the vaccine was found to be 80% effective against COVID-19 in a late-stage trial in adolescents aged 12 to 17 in the United States when the Delta variant was the dominant strain. HSA and MOH will evaluate the data from this study and will continue to monitor for more data on its efficacy and safety in children and adolescents.

The Expert Committee for COVID-19 Vaccination (EC19V) has also reviewed data on the vaccine’s safety and efficacy and has recommended the use of the Novavax COVID-19 vaccine under the NVP for primary and booster vaccination in individuals aged 18 and older.

We hope that the initial doses of the Novavax COVID-19 vaccine will arrive in Singapore within a matter of months, provided that there are no disruptions to the shipment schedule. Meanwhile, those who are medically eligible are encouraged to take the available mRNA vaccines as they offer more optimal protection.

Mr Yip Hon Weng (Yio Chu Kang): Thank you, Mr Speaker. I thank the Senior Minister of State for his reply. I have a related supplementary question on COVID-19. How are the healthcare workers and healthcare system coping with the increased number of infected cases from the Omicron wave?

Mr Speaker, the Member asked a question not quite related to vaccines but on healthcare workers, so, I thought I might as well answer.

Right now, we are getting 10,000 or more cases on a daily basis. It is within our expectations. We had earlier said that, at its peak, we may reach 15,000 to 20,000 cases a day or even more. That is within our expectations.

Right now, the week-on-week increase is about 1.5. So, it is not increasing at three times multiples anymore. But whether cases will go up further, I think that is a possibility and we should be prepared for that.

Having said that, as we have always explained, what is important now is not so much the topline infection numbers but how that translates into disease severity and impact on our healthcare capacity. Yesterday, there were a few Written Questions on this topic, and we put out some responses to those.

By and large, our healthcare system is coping well. I will give an example – the ICU beds. At its peak, during the Delta wave, we had 171 ICU beds occupied, out of a capacity of 200-plus, close to 300. Today, even at 10,000 cases a day, as of last night, it was 23 beds occupied. The week before, at one point, it reached 30 and it actually came down and it is now 23. So, we see it hobbling between 20 and 30. So long as we maintain that, ICU is in good shape.

If you look at those who need oxygen supplementation, those who require hospitalisation, the healthcare system is coping.

But I think where we face pressure now is not on the clinical side of healthcare but on the operational side of healthcare because the number of calls from patients to our hotline is increasing. Fortunately, we have the help of many public agencies like CPF Board, and SAF stood up a fairly big team to support the operations. So, we are able to answer well over 90% of the calls without them dropping. So, that is coping well.

But the GPs are facing quite a bit of pressure. Queues are long. If you go to our community GP clinics, you can see there are queues. So, I think on that front, we have to help the GPs. GPs have given feedback to us that the patients either have mild or no symptoms. They had self-tested, got a positive result and decided, "I had better see a GP, either to get an MC or some ART kits from the doctors." Many of them also worry about travel. If they have to go through a PCR test while travelling, they like to say, "I register a positive result, but I am a recovered shedder". They want to show that, actually, they have had COVID-19, they are shedders and they have recovered.

So, for various reasons, people are visiting doctors and GPs, not because they are very sick. So, it is the operational side that is posing a challenge.

Later, MOH will be making an announcement. We are going to allow individuals to come to the Quick Test Centres (QTCs), go through a supervised ART test and, within 30 minutes, we can ingest their infection record, if they are tested positive, into their HealthHub record. From there, they can also withdraw ART kits. What they will not get is a doctor's MC because, for that, you would have to see a doctor.

So, that way, I hope we can divert many of the very mild cases away from GP clinics into the QTCs. We have about 200 QTCs now, all over, including in malls. We will start with about a quarter of them. So, by the end of today, you will be able to book an appointment with the QTCs and go through an ART test and then ingest the record, if you are positive, into your HealthHub.

I hope I have answered the question.

Sir, there remains about 3% of 12- to 19-year-olds who have yet to get vaccinated and this works out to almost 10,000 unvaccinated adolescents, not counting children aged five to 11. Given the findings that adolescents and children have a higher COVID-19 Omicron infection rate than older age groups, does the Senior Minister of State agree that it is better for them to get vaccinated with the Sinovac vaccine, than remain unvaccinated?

I recognise that it is generally better for them to get the Pfizer vaccine because it is more efficacious. However, these adolescents have chosen not to for various reasons. Anecdotally, from the residents I have met, either they or their parents have a preference for non-mRNA vaccines and are unlikely to change their stance. So, why not approve the Sinovac vaccine for adolescents so that they will get vaccinated and our population can reach closer to a full vaccination rate earlier?

Secondly, the Sinovac vaccine has already been approved in Singapore for adolescents who are medically ineligible for the Pfizer vaccine. Jurisdictions like China and Hong Kong have already approved it for those aged three and above. So, what are the residual safety concerns to it becoming generally available for children and adolescents?

Sir, as the Member will appreciate, the issue of safety when it comes to medication, vaccines, medical therapeutics, is not absolute. Nothing is completely absolutely safe or absolutely unsafe. It is about the relative risk and the relative benefit.

The individuals under the age of 17 who are getting the non-mRNA vaccines – currently, the Sinovac-CoronaVac vaccines – in those circumstances, because they are medically ineligible for the mRNA vaccines, the benefits of being vaccinated with any vaccine are, indeed, outweighed by the risks and safety concerns that currently exists for those vaccines, and weighed up against the risk of getting a Coronavirus infection. But for the others who are not medically ineligible, the safety and efficacy data are quite clear. Therefore, we would continue to recommend for them an mRNA vaccine.

Because it is not just about their risks and their immunity at this point in time, but over the next few months, as the pandemic continues to be a challenge for us and around the world, we have to think about how quickly their immunity will wane, what would be their ability to deal with the future waves or even this existing wave as it makes its way through our society. So, we continue to recommend the mRNA vaccines.

As I have explained, we are trying to bring in other options for these individuals in the near future.