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Novavax Again Delays EUA Filing with FDA

12.08.2021 - As it continues to grapple with documentation issues, US biotech Novavax has again altered its timeline for seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its two-dose Covid-19 vaccine. Concurrently, the US government is curbing some of the funding awarded last year by the administration of former president Donald Trump.

After pushing back the EUA filing earlier this year initially – from May to July – CEO Stanley Erck said the Gaithersburg-Maryland-based company will now delay applying to the FDA, as well as some other regulatory authorities, until the upcoming fourth quarter.

Novavax has already filed for approval in India, Indonesia and the Philippines and has promised a substantial share of doses to the World Health Organization’s Covax distribution scheme.  In an investor conference call to discuss quarterly figures, the CEO suggested that while the company deals with FDA information requests, the shot could initially be prioritized to low- and middle-income countries, “to support critical unmet demand for primary vaccinations.”

It is unclear how the EU might be affected by the fresh filing delay, announced just days after Novavax finalized a long delayed advance purchase order with the European Commission. The order for the vaccine that has been in a rolling review with the European Medicines Agency (EMA) for several months, calls for supply of 100 million doses initially, combined with an option to take an additional 100 million by 2023.

Any delay would add to the EU’s existing constraints with Germany’s CureVac, from which the 27-member bloc has ordered 410 million doses. CureVac’s filing plans with the EMA are currently on ice due to weaker than expected efficacy results. In clinical tests, the US biotech’s shot, by contrast, has shown efficacy exceeding 90%.

The EU can draw some hope from a company statement that Novavax plans to submit a regular filing to the UK before the end of the current quarter, and “within weeks” could apply to the EMA, Australia, Canada and New Zealand.

Regarding the FDA submission, Erck told Reuters that “it is a matter of getting validation work done" to demonstrate consistency in the vaccine's manufacturing process. Late stage trials in progress in the US have now been expanded to include 2,000 volunteers between the ages of 12 and 17. The CEO said the company will submit a separate application for booster shots to the FDA once its initial EUA submission is processed.

According to Erck, Novavax remains on track to produce 100 million doses per month in the current quarter. "We appear to have got past (certain) supply issues and are now being able to produce at scale," he told Reuters, adding that the company has already manufactured “tens of millions of shots”, which are being kept frozen.

US withholds some of its Novavax funding

Any further lag in the Maryland biotech’s US filing could be costly. Novavax signed a major supply contract with Operation Warp Speed last year, and the government appears to be weary of waiting for its parameters to be met. In a quarterly filing with the US Securities and Exchange Commission (SEC), the company revealed that it was having to do without some government funding until it resolves federal regulators’ concerns. Clinical trials were not affected, however.

US press reports said Novavax apparently has been unable to demonstrate that its production process meets certain standards, in particular regarding testing and quality control. Erck said earlier he hoped that the FDA would accept data from a UK trial.

The original $1.6 billion agreement with Operation Warp Speed (later increased to $1.75 billion) covers 110 million doses. Adding to the company’s funding is also a $60 million contract with the Department of Defense covering 10 million doses. Novavax is additionally receiving $400 million from the Coalition for Epidemic Preparedness Innovations (CEPI), a global alliance backed by the Bill and Melinda Gates Foundation.

For the second quarter of 2021, the vaccine maker reported a net loss of $352 million, or $4.75 per share, considerably exceeding the net loss of $18 million posted for the same period of 2020. Its quarterly sales revenue came in at $298 million, up from $35.4 million a year earlier.

Author: Dede Williams, Freelance Journalist

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