1. The Expert Committee on COVID-19 Vaccination (EC19V) recommends:
- switching to the bivalent Pfizer-BioNTech/Comirnaty COVID-19 vaccine for the primary vaccination series and for booster vaccination, instead of the monovalent Pfizer-BioNTech/Comirnaty COVID-19 vaccine, for persons aged 12 years and above; and
- the Pfizer-BioNTech/Comirnaty COVID-19 vaccine for children aged 6 months to 4 years, which comprises 3 doses, may be used for primary vaccination series for children aged 6 months to 4 years.
Bivalent Pfizer-BioNTech/Comirnaty COVID-19 Vaccine for Ages 12 Years and Above
2. EC19V notes that HSA has authorised the bivalent Pfizer-BioNTech/Comirnaty COVID-19 vaccine for use in persons aged 12 years and above under the Pandemic Special Access Route. This updated vaccine targets the spike proteins from both the original and the Omicron BA.4/5 variants of the virus.
3. After studying the data, EC19V recommends a switch from the monovalent Pfizer-BioNTech/Comirnaty vaccine to the bivalent vaccine for the primary vaccination series and for booster vaccination for persons aged 12 years and above. In general, the updated bivalent vaccines are preferred over the original monovalent COVID-19 vaccines. Either the bivalent Moderna/Spikevax vaccine or the bivalent Pfizer-BioNTech/Comirnaty vaccine can be chosen for the primary vaccination series or for booster vaccination.
Vaccine Protection and Safety
4. Studies of the bivalent Pfizer-BioNTech/Comirnaty vaccine have shown that it generates a stronger immune response against the Omicron variant compared to the original monovalent Pfizer-BioNTech/Comirnaty vaccine, while retaining the response against the original strain. A high level of protection against severe disease across variants is expected, and may also confer better protection against future variants compared to the original vaccine. The assessment of the bivalent vaccine targeting the Omicron BA.4/5 variant took into account the available data on the original and adapted versions of the Pfizer-BioNTech/Comirnaty vaccine, including the bivalent vaccine that target the closely related Omicron BA.1 subvariant. EC19V’s assessment of the data is in agreement with that published by HSA on 25 October 2022.
5. Safety data of the bivalent Pfizer-BioNTech/Comirnaty vaccine was consistent with that of the original monovalent Pfizer-BioNTech/Comirnaty vaccine. Adverse events were mostly mild-to-moderate and resolved within days.
Recommend Use of the Updated Bivalent Vaccine for Primary Vaccination Series and Booster Vaccination
6. Given similar safety profiles of the updated bivalent Pfizer-BioNTech/Comirnaty vaccine and the enhanced protection against COVID-19, as compared to the original monovalent Pfizer-BioNTech/Comirnaty vaccine, EC19V recommends the use of the bivalent Pfizer-BioNTech/Comirnaty vaccine instead of the original monovalent Pfizer-BioNTech/Comirnaty vaccine for both the primary vaccination series and for booster vaccination in ages 12 years and above. The dosage of the updated vaccine is the same as the original vaccine (30-micrograms).
7. Persons aged 12 years and above who had completed their booster vaccination with the original vaccine should be offered a booster dose of a bivalent vaccine around 5 months after their last booster dose.
8. Both the bivalent Moderna/Spikevax and bivalent Pfizer-BioNTech/Comirnaty vaccines enhance protection against Omicron variants. There is currently no evidence that either vaccine is better than the other in terms of protection against future variants. As such, i) either can be chosen for booster vaccination, and ii) persons who have already completed booster vaccinations with the bivalent Moderna/Spikevax vaccine do not need to receive an additional bivalent Pfizer-BioNTech/Comirnaty vaccine dose, or vice versa.
9. EC19V urges all eligible persons to receive their recommended vaccinations with the vaccines available when they are due, and not to delay to wait for specific vaccines to become available. This is to ensure that they continue to be sufficiently protected against COVID-19. Bivalent vaccines are not available for children under 12 years at this time, and these children should proceed with their primary vaccination series and/or booster vaccination with the original monovalent COVID-19 vaccines for their age group, as soon as they are offered.
10. EC19V will continue to monitor developments of updates to COVID-19 vaccines and update the national recommendations accordingly, to achieve safe and effective vaccine protection for our population.
Pfizer-BioNTech/Comirnaty COVID-19 Vaccine for Children Aged 6 Months to 4 Years
11. EC19V notes that the Health Sciences Authority (HSA) has approved the Pfizer-BioNTech/Comirnaty vaccine for children aged 6 months to 4 years. After studying the data on its safety and efficacy, the Expert Committee on COVID-19 Vaccination recommends that the Pfizer-BioNTech/Comirnaty vaccine may also be used for the primary vaccination series for children aged 6 months to 4 years, as an alternative to the Moderna/Spikevax vaccine for this age group.
12. The Pfizer-BioNTech/Comirnaty primary vaccination series in this age group (children aged 6 months to 4 years) consists of three doses of 3-micrograms, each given 8 weeks apart.
13. The trial of the Pfizer-BioNTech/Comirnaty vaccine in children aged 6 months to 4 years has shown that three doses generate antibody levels comparable to that achieved in young adults vaccinated with two doses of the adult dosage. This is expected to provide a high level of protection against severe disease and reduce the risk of hospitalisation from COVID-19.
14. Vaccination for children aged 6 months to 4 years with the Pfizer-BioNTech/Comirnaty vaccine is safe, and side effects were comparable or less common than that observed in older persons vaccinated with the vaccine. The risks of pericarditis/myocarditis are also expected to be very low in this age group.
15. EC19V had previously recommended that children aged 6 months to 4 years be vaccinated with two doses of the Moderna/Spikevax vaccine for their age group. With this latest recommendation, parents also have the option of letting their children aged 6 months to 4 years receive the Pfizer-BioNTech/Comirnaty vaccine instead. Parents should note that this option requires 3 doses taken over 16 weeks, compared to 2 doses taken over 8 weeks for the Moderna/Spikevax vaccine, and therefore more vaccination visits and a longer period to achieve optimal protection.
16. While the risk of severe COVID-19 in young children is low, severe disease can still occur and they have had a higher risk of hospitalisation compared to older children who have been able to get vaccinated. Hence, young children should be vaccinated as soon as they can with the vaccines available currently in order to achieve timely protection against COVID-19. Parents should not delay their young children’s vaccination or wait for specific vaccines to become available in the future.
EXPERT COMMITTEE ON COVID-19 VACCINATION
6 DECEMBER 2022