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-BionNTech/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.
Dr Janil Puthucheary: 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 years of age 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 years old, 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 years 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 years, 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 years 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 years 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 years 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 Gerald Giam Yean Song (Aljunied): 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?
Dr Janil Puthucheary: 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 is 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.
Ministry of Health
15 February 2022
https://sprs.parl.gov.sg/search/sprs3topic?reportid=oral-answer-2690
Office of the Leader of the Opposition 