Novavax expects to apply for full approval of COVID vaccine in H2

Novavax Inc said yesterday it would pursue full approval of its COVID-19 vaccine in the second half of this year and forecast total revenue between $4 billion and $5 billion for 2022.

“We expect to gain additional authorisations where we have already filed, including in the US. We will pursue full approval of our vaccine including filing our Biologics Licence Application (BLA), in the second half of 2022,” Stanley Erck, Chief Executive Officer, Novavax, said during a post-earnings call.

Novavax late last month filed for Emergency Use Authorisation (EUA) of the shot in US adults, a much-awaited step following months of struggles with development and manufacturing problems.

The company said it has completed delivery of around nine million vaccine doses to Indonesia, six million to Australia and two million to South Korea, and expects to supply 69 million doses to Europe in the first half of this year.

The company earlier forecast to send two billion COVID-19 shots around the world in 2022.

Novavax yesterday did not disclose how many doses it expects to deliver in the first quarter, but forecast $4 billion to $5 billion in overall revenue in 2022. Analysts had forecast $4.70 billion in revenue.

A big chunk of the revenue would be through product sales, and of that, the vast majority is related to vaccine product sales, the company said.

Separately, Novavax said an extended analysis of a late-stage study conducted in the UK showed that its COVID-19 vaccine provided long-term protection against the coronavirus.

The protein-based vaccine, NVX-CoV2373, continued to provide protection and maintained overall efficacy of 82.7 per cent over a six-month period.

Novavax is working on developing an Omicron-specific vaccine and said yesterday it expects to begin manufacturing doses of the shot at a commercial scale in the first quarter.