Novavax in talks with FDA over quick approval for COVID-19 shot

The SARS-CoV-2 coronavirus

Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks.

The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

Following an upbeat Q4 results announcement CEO Stanley Erck told CNBC that discussions with the FDA are ongoing but the hope is that the regulator will accept the phase 3 data from the UK showing 96% efficacy against the original COVID-19 variant.

The vaccine also offers some protection against the newer UK and South African variants and is also much easier to distribute and handle than the delicate mRNA vaccines from Moderna and Pfizer/BioNTech, which require ultra-cool storage temperatures.

Novavax’s vaccine is a sequence of protein engineered from the genetic sequence of the SARS-CoV-2 virus that mimics the “Spike” protein found on the pathogen’s surface.

It cannot replicate or cause the disease but does produce a strong immune response that neutralises the virus in the event of an infection.

Novavax’s phase 3 trial in the US is still ongoing with 30,000 participants, but the company hope data already reported from the UK trial will be enough to convince the FDA to approve.

Three regulators – the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency and Health Canada – started rolling reviews of the vaccine at the beginning of February.

This allows them to review trial data as it breaks, vastly speeding up the approval process.

This sets up a potential approval in the UK next month followed by a US filing in May, although the timeline could be pushed by up to two months if the FDA decides to wait for data from the US trial.

Novavax has agreements in place for up to 300 million doses including the UK government, which has 60 million doses of the vaccine on order if approved.

The US biotech will make some of the vaccine at a UK factory in Billingham, Stockton-on-Tees.

Up to 1.1 billion doses could be supplied in a tie-up with the Serum Institute of India to the COVAX scheme aimed at providing access in poorer countries.

There are three COVID-19 vaccines approved in the US, from Moderna, Pfizer/BioNTech and Johnson & Johnson, which was granted an Emergency Use Authorization at the end of last week.

Feature image courtesy of Rocky Mountain Laboratories/NIH