Novavax COVID vaccine granted interim authorisation by Singapore's HSA

Medical syringes in the mini shopping trolley are seen in front of the Novavax logo displayed on a screen. (PHOTO: Artur Widak/NurPhoto via Getty Images)
Medical syringes in the mini shopping trolley are seen in front of the Novavax logo displayed on a screen. (PHOTO: Artur Widak/NurPhoto via Getty Images)

SINGAPORE – The Health Sciences Authority (HSA) has granted interim authorisation under the Pandemic Special Access Route for the Novavax COVID-19 vaccine to be used in Singapore.

In a press release on 14 February (Monday), HSA said that Novavax's Nuvaxovid COVID-19 vaccine (Nuvaxovid) – a protein-based, non-mRNA vaccine – can be given to individuals aged 18 years and above from 3 February.

The vaccination regimen comprises two five-microgram doses of Nuvaxovid to be administered three weeks apart, HSA said. The first batch of Nuvaxovid is expected to arrive in Singapore in the next few months.

Clinical review

The HSA said that through its review, together with consultation with experts from its Medicines Advisory Committee and Panel of Infectious Diseases Experts, the vaccine has been assessed to meet the quality, safety and efficacy standards, and that "the benefits outweigh the risks for the Singapore population".

HSA’s clinical review was based on two Phase 3 clinical studies conducted in the US, Mexico and the UK, comprising more than 40,000 clinical trial participants aged between 18 and 95 years old.

The results showed that Nuvaxovid demonstrated a vaccine efficacy of approximately 90 per cent against symptomatic COVID-19 and 100 per cent in preventing severe COVID-19. It showed consistent efficacy against the Alpha variant, but there was no data on the Delta and Omicron variants as these variants were not prevalent at the time of Novavax's clinical trials.

Vaccine recipients may experience common side effects such as injection site pain and/or tenderness, fatigue, headache and muscle pain. The side effects usually resolve on their own within a few days, HSA said.

A small proportion of recipients may experience severe allergic reactions upon vaccination. They include those with a history of anaphylaxis. In such cases, immediate medical attention should be sought, HSA said. Those who develop anaphylaxis to the first dose of Nuvaxovid should not be given the second dose.

To obtain full registration for the vaccine, Novavax will need to submit the complete dataset based on prevailing international standards, HSA said.

The Novavax vaccine has been granted the World Health Organization Emergency Use Listing status.

Expert Committee of COVID-19 Vaccination's response

Considering its safety, efficacy and tolerability, the Expert Committee on COVID-19 Vaccination recommends Nuvaxovid as an acceptable alternative to the mRNA vaccines in individuals aged 18 years and above. However, the mRNA vaccines are still the preferred vaccines due to their higher efficacy and the stronger immune response they generate, the Committee said.

Persons who receive Nuvaxovid for their primary vaccination series are recommended to receive two doses of the vaccine taken 21 days apart. 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 five months after the last dose of the primary series vaccination.

"In view of the lower efficacy of the Sinovac-CoronaVac vaccine, Nuvaxovid is preferred to Sinovac-Coronavac for persons medically ineligible to receive the mRNA vaccines. Sinovac-CoronaVac vaccine should only be used by persons who are medically ineligible for the mRNA vaccines and Nuvaxovid," the Committee said.

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