Novavax files for non-mRNA Covid-19 vaccine to be approved for use in Singapore

• American biotech company Novavax has applied to the authorities here for interim authorisation of its Covid-19 vaccine 
• Its vaccine is produced by cloning Covid-19 spike proteins that is then injected into the body to stimulate an immune response
• HSA said it could take several weeks to months before the vaccine is approved for use here

SINGAPORE — A new non-messenger ribonucleic acid (mRNA) Covid-19 vaccine may soon be offered as an option here, with American biotech company Novavax announcing on Wednesday (Nov 24) that it had applied to the Singapore authorities for interim authorisation of its vaccine under the Pandemic Special Access Route.

If approved, it will join three other vaccines that have been approved under this route, which facilitates early access to critical new vaccines and medicines during a pandemic. 

The other vaccines are Pfizer BioNTech and Moderna vaccines, which use mRNA technology, and Sinovac, which uses inactivated virus technology. 

Novavax said in response to TODAY’s queries that its initial filing is for the primary vaccination, which is a two-dose regime, and that it intends to submit more information regarding the vaccine’s use for booster jabs.

Under the Pandemic Special Access Route, companies can only apply to the Health Sciences Authority for designated products that the Government of Singapore requires during a pandemic.

In response to queries from TODAY, HSA said that Novavax had submitted data on its vaccine on Monday.

It has begun “a careful and thorough rolling review of the data” to ensure that the vaccine meets requirements for interim authorisation, before it is approved for use in Singapore, it added.

It also said that it could take “several weeks... to months” for the review to be completed. 

The time taken for the review would depend on the completeness of the data submitted by Novavax for evaluation, the time taken by Novavax to respond to HSA’s queries as well as whether there are data gaps or inconsistencies in the submission.

HSA said that it will provide an update once a decision is made.

Dr Janil Puthucheary, Senior Minister of State for Health, said in Parliament in August that the Novavax vaccine was expected to arrive in Singapore by the end of the year.

HOW IT WORKS

Novavax uses a “sub-unit vaccine approach”, where moth cells are used to clone the coronavirus' spike protein. A spike protein is the part of a virus that it uses to penetrate human cells and cause infection.

The cloned spike protein is then extracted and combined with a substance to enhance the body’s immune response.

When the vaccine is injected into a person’s body, the spike protein reacts with the body’s immune system, stimulating the production of antibodies against the Sars-CoV-2 coronavirus that causes Covid-19.

Novavax said in its statement that the protein does not cause Covid-19.

Its approach differs from Moderna and Pfizer-BioNTech, which rely on genetic material called mRNA to direct human cells to create the spike protein and trigger the body’s immune response.

EFFICACY

In its statement, Novavax said that it had submitted clinical data from two of its clinical trials. 

The first involved 30,000 participants in the United States and Mexico and it demonstrated 90.4 per cent efficacy against the coronavirus. 

The second involved a trial of 15,000 participants in the United Kingdom that demonstrated an efficacy of 96.4 per cent against the original virus strain of Covid-19, 86.3 per cent against the Alpha variant and 89.7 per cent efficacy overall. 

Both trials demonstrated “a reassuring safety and tolerability profile” of the vaccine, Novavax said. 

Novavax's vaccine is now approved for emergency use in Indonesia and the Philippines. It has also filed an application to be authorised for emergency use in India.

It has filed an application in Australia, Canada, the European Union, New Zealand and the United Kingdom, and with the World Health Organization, for approval of the vaccine.