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The Health Sciences Authority (HSA) in Singapore has granted an interim authorisation for Nuvaxovid Covid-19 vaccine by Novavax to be used here under the Pandemic Special Access Route (PSAR).

Individuals aged 18 years and above can take the Novavax shot, which is a non-mRNA vaccine.

The go-ahead was issued on Feb. 3, 2022, HSA said it its Feb. 14 press release.

The vaccination regimen comprises two 5-microgram doses of Nuvaxovid to be administered three weeks apart.

The first batch of Nuvaxovid is expected to arrive in Singapore in the next few months.

HSA said it has reviewed that the vaccine meets the quality, safety and efficacy standards, and that the benefits outweigh the risks for the Singapore population.

Two groups of experts from HSA’s medicines advisory committee and panel of infectious diseases experts were also consulted and agreed with HSA’s recommendation for PSAR authorisation.

The vaccines approved under Singapore's Covid-19 vaccination programme include mRNA vaccines, Pfizer-BioNTech and Moderna, and non-mRNA vaccine Sinovac-CoronaVac.

Evaluation of available safety and efficacy data

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

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.

No data on Delta and Omicron variants

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 Novavax conducted the clinical trials.

Side effects

The safety profile of Nuvaxovid was generally consistent with other registered vaccines in Singapore.

Some common side effects that vaccine recipients may experience include injection site pain and/ or tenderness, fatigue, headache and muscle pain.

These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response to build immunity against Covid-19.

These side effects usually resolve on their own within a few days.

Allergic reactions possible

A small proportion of susceptible persons may experience severe allergic reactions upon vaccination.

They include those with a history of anaphylaxis, which is a rapid onset of severe allergic reactions.

In such cases, immediate medical attention should be sought.

Persons who develop anaphylaxis to the first dose of Nuvaxovid should not be given the second dose.

Safety and efficacy data in severely immunocompromised persons and those under the age of 18 are not available yet.

No recommendation can be made for the use of the vaccine in these individuals.

Novavax required to monitor long-term efficacy

As a condition for the interim authorisation under PSAR, Novavax is required to monitor the longer-term efficacy of Nuvaxovid to determine the duration of protection against Covid-19.

Novavax is also required to follow up on the safety of the vaccine over a longer period to determine its overall safety profile, including in special populations such as immunocompromised persons, pregnant women and children.

HSA said it will actively review evolving vaccine effectiveness and safety data to ensure that the benefits of the vaccine continue to outweigh the known risks.

PSAR interim authorisation may be terminated at any time, for example, if new data suggests that the benefits no longer outweigh the risks.

Novavax will need to submit the complete dataset based on prevailing international standards to obtain full registration.

Top photo via Unsplash

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