Novavax applies to Singapore's HSA for approval to use its COVID vaccine

SINGAPORE — US biotechnology company Novavax on Wednesday (24 November) announced that it has filed for interim authorisation with Singapore's Health Sciences Authority (HSA) for use of its COVID-19 vaccine under the pandemic special access route.

The submission includes clinical data from two "pivotal" Phase 3 clinical trials for its protein-based vaccine, or NVX-CoV2373, said the company in a press release.

One trial, titled PREVENT-19, involved 30,000 participants in the US and Mexico which demonstrated 100 per cent protection against moderate and severe disease and 90.4 per cent efficacy.

The other involved 15,000 participants in the UK that demonstrated the efficacy of 96.4 per cent against the original virus strain, 86.3 per cent against the alpha variant, or B117, and 89.7 per cent efficacy overall.

In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile, said the company.

Its president and chief executive officer Stanley C Erck added that the filing in Singapore reinforces an ongoing commitment to deliver its COVID-19 vaccine to help end the pandemic.

"Each additional market submission marks further progress in delivering our vaccine to the world, which we believe may help address major obstacles to global vaccination, including global distribution challenges and vaccine hesitancy," he said.

On the number of doses to be delivered to Singapore if approval for the vaccine goes through, a company spokesperson said that the information is "not publicly available".

Review may vary from 'several weeks to months'

In response to queries from Yahoo News Singapore, the HSA confirmed that the company submitted its data for the application of its vaccine under the pandemic special access route on Monday.

"The HSA has commenced a careful and thorough rolling review of the data to ensure that the vaccine meets the requirements for quality, safety, and efficacy for interim authorisation before it is approved for use in Singapore," added the authority.

The HSA also noted that the time taken for the review would depend on the completeness of the data submitted for evaluation and the time taken by the company to respond to its queries on issues that may surface during the regulatory evaluation.

This may "vary from several weeks, if the data is complete and meets the stipulated standards, to months, if there are data gaps and inconsistencies in the dossiers", the authority said, adding that it would provide an update once a regulatory decision is made.

Singapore's Health Minister Ong Ye Kung in late June announced that Singapore had signed an advance purchase agreement for the Novavax vaccine.

The vaccine had then been projected to arrive in Singapore before the end of this year – subject to supply and regulatory approval – to be included as part of the city-state's national vaccination programme.

Additional non-mRNA option under national drive, if approved

Once approved, the Novavax vaccine would be one of two non-mRNA shots approved for use under the national drive, alongside the inactivated CoronaVac developed by Chinese vaccine maker Sinovac.

The two-dose vaccine is made with lab-grown copies of the spike protein that coats the coronavirus.

It is developed differently from the messenger ribonucleic acid (mRNA) vaccines produced by Pfizer-BioNTech and Moderna – the other two vaccines used under Singapore's national vaccination drive – which deliver genetic instructions for the body to make its own spike protein.

Indonesia was the first country to grant emergency use authorisation for the Novavax vaccine on 1 November, followed by the Philippines on 17 November. The former is slated to receive 20 million doses of the protein-based vaccine this year, according to its government.

Among those that the company has also filed for authorisation of its vaccine are the UK, European Union, Canada, Australia, India, New Zealand.

Novavax has also completed the submission process for emergency use listing of its vaccine candidate with the World Health Organization and expects to file for US approval by end of the year.

As of Monday, 94 per cent of Singapore's eligible population – aged 12 and above – have received two doses of COVID-19 vaccines or completed their full regimen.

Among the total population, 85 per cent have received two doses, 86 per cent have received at least one dose, and 24 per cent have received their booster shots.

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