1. The Expert Committee on COVID-19 Vaccination (EC19V) is updating its recommendations to:
a. Recommend the Moderna/Spikevax COVID-19 vaccine for the primary vaccination series, for children aged 6 months to 5 years.
b. Recommend the Bivalent Moderna/Spikevax COVID-19 vaccine for the primary vaccination series and for booster vaccination, for persons aged 18 years and above.
c. Offer the Bivalent Moderna/Spikevax vaccine to all persons who had completed their booster vaccination, including persons who had earlier been recommended and had received the second booster from around 5 months after their last booster dose.
COVID-19 Vaccination for Children Aged 6 Months and Above
2. The Health Sciences Authority has authorised the Moderna/Spikevax vaccine for young children aged 6 months to 5 years under the Pandemic Special Access Route. After studying the data, the Expert Committee on COVID-19 Vaccination recommends the Moderna/Spikevax vaccine for the primary vaccination of children aged 6 months to 5 years. All children aged 6 months and above should now be vaccinated as soon as the vaccine becomes available to them.
3. While the risk of severe COVID-19 in young children is generally low, they have had a higher risk of hospitalisation compared to older children who have been able to get vaccinated. Severe disease can still occur in young children, including pneumonia MIS-C (Multisystem Inflammatory Syndrome in Children), and even death. Vaccination is important to reduce risk of severe disease and death in young children.
4.Children aged 6 months to 5 years are thus recommended to receive two 25-microgram doses of the Moderna/Spikevax vaccine, given 8 weeks apart. This dosage is a quarter of that used in the primary vaccination series for adults.
5. Studies have shown that two doses of the Moderna/Spikevax vaccine in children aged 6 months to 5 years result in antibody levels comparable to that achieved in young adults vaccinated with the adult dosage.This immune response is expected to provide a high level of protection against severe disease and a moderate level of protection against infection. Vaccine efficacy against symptomatic infection with the Omicron variant was 36.8% (ages 2-5 years) and 50.6% (ages 6-23 months), which is similar to that observed in adults vaccinated with the adult dosage of the same vaccine. Local data in ages 5-11 years has also shown that primary vaccination reduces hospitalisation due to the Omicron variant by more than 80% – this high level of protection against severe COVID-19 is also expected in the younger age groups.
6. Vaccination for children aged 6 months to 5 years with the Moderna/ Spikevax vaccine is safe. The common side effects (such as fever, injection site pain and swelling) were observed less commonly than in adults, and are similar with side effects for other childhood vaccines. Serious adverse events were rare, with no cases of anaphylaxis or pericarditis/myocarditis observed in the clinical trial. The risks of pericarditis/myocarditis are expected to be very low in this age group.
7. Primary vaccination for COVID-19 has already been recommended for children aged under 5 years in several other countries, including Australia, Canada, Israel, and the United States of America (US). To date, over 1 million children aged under 5 years have received at least one dose of COVID-19 vaccines in the US as recommended by the US Centers for Disease Control and Prevention.
8. The Expert Committee encourages parents to vaccinate their children as soon as the COVID-19 vaccine is made available for them.
Bivalent Moderna/Spikevax COVID-19 Vaccine for Ages 18 Years and Above
9. HSA has also authorised the Bivalent Moderna/Spikevax COVID-19 vaccine for use in persons aged 18 years and above under the Pandemic Special Access Route. This updated vaccine contains the spike protein from both the original and Omicron variants of the virus. After studying the data, the committee recommends a switch to the Bivalent Moderna/Spikevax vaccine for all booster vaccinations in those aged 18 years and above. This updated vaccine is preferred over the original COVID-19 vaccines, and as such the primary vaccination series for those yet to be vaccinated should also be switched to the new bivalent vaccine where possible.
10. This updated vaccine is expected to result in high protection against severe disease across variants and may confer better protection against future variants than the original vaccine. Persons who had completed their booster vaccination, including persons who had earlier been recommended and had received their second booster with the original vaccine, may be better protected through the bivalent vaccine, and should be offered a booster dose of this updated vaccine around 5 months after their last booster dose if they choose to do so when this updated vaccine is available for them.
Vaccine Protection and Safety
11. In human clinical trials, the updated vaccine generated a stronger immune response against the Omicron BA.1 variant compared to the original Moderna vaccine, while enhancing the immune response against the original strain too. In addition, it resulted in substantial antibody responses against the Omicron BA.4/5 variant and other previously circulating SARS-CoV-2 variants (e.g. Alpha, Beta, Delta, Gamma). The updated vaccine is expected to result in high protection against severe disease across these variants and may confer better protection against future variants than the original vaccine by broadening the body’s immune response.
12. The safety profile of the updated vaccine was consistent with that of the original Moderna/Spikevax vaccine. The adverse events were mostly mild-to-moderate and self-resolved within days.
Use of Updated Vaccine for Primary Series Vaccination and Booster Vaccination
13. Given broader protection conferred by the updated Bivalent Moderna/Spikevax b vaccine and a similar safety profile, the EC19V recommends the use of the Bivalent Moderna/Spikevax for the primary vaccination series (50-microgram dose) and for booster vaccination (50-microgram dose) instead of the original Moderna/Spikevax vaccine for ages 18 years and above.
14. Other vaccines available locally under the National Vaccination Programme, such as the Pfizer-BioNTech/Comirnaty and Novavax/Nuvaxovid vaccines, target the original SARS-CoV-2 virus. The updated Moderna/Spikevax vaccine is preferentially recommended over them, but the Pfizer-BioNTech and Novavax/Nuvaxovid vaccines will continue to be made available for the time being for those who prefer it.
15. The Bivalent Moderna/Spikevax vaccine is not available for persons under 18 years as it has not been trialed in this age group. Persons under 18 years should proceed with their primary vaccination series and/or booster vaccination with the original COVID-19 vaccines available as soon as they are offered, as timely vaccination protection with these original vaccines is still better than no protection.
16. The EC19V will continue to assess the suitability of bivalent or variant-adjusted vaccines for persons aged under 18 years, and as and when necessary, make the appropriate recommendations on their use.
Additional Booster Dose with Updated Vaccine for Ages 18 Years and Above
17. As the Bivalent Moderna/Spikevax vaccine will broaden protection against prevailing variants and potentially future ones, the EC19V recommends that it be offered to all persons 18 years and above, even those who had already completed their booster vaccinations previously, as an additional booster dose. This would include persons who had already received the second booster. However, persons who are more vulnerable to severe disease, such as persons in the older age groups, should still be prioritised to receive the bivalent vaccine.
18. Based on local data, vaccine effectiveness against severe disease from the first booster has been sustained for at least one year thus far, particularly in those 59 years and under. Persons interested in taking the updated vaccine as an additional booster dose should thus do so at around five months to one year after their last booster dose. This period will be subjected to review as further data emerges or if the COVID-19 situation changes.
Sinovac-CoronaVac as a Booster Dose
19. Previously, Sinovac-CoronaVac was offered for booster vaccinations only for persons who were medically ineligible to receive the mRNA and Novavax/Nuvaxovid vaccines. Moving forward, individuals yet to be boosted should be offered the Sinovac-CoronaVac as a booster dose, even if they do not meet criteria for being medically ineligible for other vaccines. This is to ensure that they at least get a minimal level of booster protection.
20. Nevertheless, the Expert Committee will still recommend such individuals to preferentially consider receiving the Moderna/Spikevax, Pfizer-BioNTech/Comirnaty or Novavax/Nuvaxovid vaccines for their booster vaccination, because these confer better protection than Sinovac-CoronaVac.
Recommendations Will Continue to Be Reviewed as Updated Vaccines Become Available
21. Vaccines updated with SARS-CoV-2 variants will broaden protection against existing variants and potentially against future ones. More such vaccines will become available progressively. The EC19V will continue to monitor the development of updated COVID-19 vaccines and update the national recommendations as they become available, so as to achieve safe and effective vaccination protection for the population.
EXPERT COMMITTEE ON COVID-19 VACCINATION
7 OCTOBER 2022