Novavax delays COVID vaccine filings until Q3

Novavax has finally provided some clarity about when its long-awaited COVID-19 vaccine will be ready, saying regulatory filings in the US, UK and Europe are due in the third quarter.

The vaccine could play an important role in the next stage of the pandemic as phase 3 trials have shown encouraging safety and efficacy data.

Importantly the vaccine can be stored in a fridge, unlike the rivals from Pfizer/BioNTech and Moderna, which require storage at ultra-cool temperatures to maintain their delicate RNA structure.

That’s because Novavax has made its vaccine from a protein sub-unit that mimics the “spike” found on the surface of the coronavirus, a construct that is more stable than its RNA-based rivals.

It’s also a different approach from the viral vector vaccines from AstraZeneca and Johnson & Johnson, which have both been associated with very rare but serious safety issues caused by blood clots.

Novavax CEO Stanley Erck told CNN that filings have been delayed while the company puts together the manufacturing data that regulators require for approval.

He told CNN: “The hard part of the regulatory filings for us right now is getting all the manufacturing data put together, getting all the very complex biologic assays that we have to do developed — they have to be qualified and then validated, which are two sequential processes, and it’s just taking us longer than we wanted.

“I don’t believe we’re going to be able to make it by the end of June. Therefore we have to push off the guidance until third quarter.”

Erck’s comments follow an announcement in its Q1 results briefing, confirming that filings with the FDA, the UK’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency are due in Q3.

Rolling reviews have already begun in Canada, Australia, New Zealand, the UK and Europe, allowing regulators to review data as it emerges and make faster decisions.

The company’s partner SK bioscience has begun a regulatory review in South Korea.

The UK has ordered 60 million doses and a further 1.1 billion doses are due to go to the COVAX programme, which distributes vaccines to poorer countries.

Results from a phase 3 trial in the UK and a phase 2b trial show 100% protection against severe disease, 96% efficacy against the original strain and 86% efficacy against the UK variant.

Results from a US-based phase 3 trial are due in a few weeks, Erck told CNN.

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