14th Feb 2022
1. The Expert Committee on COVID-19 Vaccination notes the interim authorisation of the Novavax Nuvaxovid COVID-19 vaccine ("Nuvaxovid") by the Health Sciences Authority (HSA) under the Pandemic Special Access Route (PSAR), for use in Singapore in individuals aged 18 years and above to prevent COVID-19.
2. The Expert Committee has independently reviewed the Nuvaxovid vaccine's safety and efficacy data, and has been briefed by HSA on its full range of considerations in granting interim authorisation.
3. Nuvaxovid is a protein subunit vaccine. In its key Phase III clinical trial study, two doses of Nuvaxovid demonstrated a vaccine efficacy of 90% against symptomatic infection and 100% against severe disease with the wildtype SARS-CoV-2 and the Alpha variant. There is no data available on its efficacy with the Delta or Omicron variants.
4. There have been no significant safety concerns identified with Nuvaxovid. Most side effects were mild to moderate in severity and resolved in one to three days. These included injection site pain, fatigue, headache and muscle aches.
5. In addition, the COV-Boost vaccine trial, a multicentre, randomised, controlled, phase 2 trial in the UK with more than 2,800 participants, which studied various vaccines for booster vaccination showed that Nuvaxovid as a booster vaccine resulted in a substantial rise in antibody level and cellular response, although this was to a lower extent when compared to boosting with mRNA vaccines.
6. Considering its safety, efficacy and tolerability, the Expert Committee recommends Nuvaxovid as an acceptable alternative to the mRNA vaccines in individuals aged 18 years and above, although the mRNA vaccines still remain the preferred vaccines due to their higher efficacy and the stronger immune response they generate. Persons who receive Nuvaxovid for their primary vaccination series are recommended to receive two doses of the vaccine taken 21 days apart.
7. Nuvaxovid is also recommended as an acceptable alternative to the mRNA vaccines for booster vaccination for persons 18 years and above. One dose of the Nuvaxovid vaccine is recommended as a booster dose about 5 months after the last dose of the primary series vaccination.
8. In view of the lower efficacy of the Sinovac-CoronaVac vaccine, Nuvaxovid is preferred to Sinovac-Coronavac for persons medically ineligible1 to receive the mRNA vaccines. Sinovac-CoronaVac vaccine should only be used by persons who are medically ineligible for the mRNA vaccines and Nuvaxovid.
9. The availability of Nuvaxovid will offer persons medically ineligible for the mRNA vaccines a good alternative to achieve vaccine protection against COVID-19. The committee encourages all eligible persons to be vaccinated and boosted at the earliest opportunity.
EXPERT COMMITTEE ON COVID-19 VACCINATION
14 FEBRUARY 2022
[1] Individuals who are medically ineligible for mRNA COVID-19 vaccines include those who developed anaphylaxis/severe allergic reactions or myocarditis/pericarditis to a previous dose of any mRNA vaccine.