Novavax pushes back COVID-19 vaccine approval plans to third quarter

Novavax disclosed Monday that it is now looking at a third-quarter filing for authorisation of its COVID-19 vaccine candidate NVX–CoV2373 in the UK, US and Europe, as it works to gather data required for submission. "It's just a long process," remarked CEO Stanley Erck, who had previously suggested the vaccine could be authorised in the US as early as May. "Our guidance had been that we'd get the project done by the second quarter and I'm now saying…we can't get it all done by the end of June, so it's going to slip into the third quarter unfortunately," he said.

The company also indicated during its quarterly earnings report on Monday that it does not expect to reach its production goal of 150 million doses per month until the fourth quarter of this year, later than its previous third-quarter target. Instead, it now anticipates producing 100 million doses per month by the end of the third quarter. Novavax shares slipped as much as 9% on the news.

Raw material shortages

"It's the volume of work," said Erck about the forecasted delay, noting that Novavax has gone from a staff of 150 to 900 over the past year. He suggested the company has struggled with accessing raw materials needed to make its vaccine, including bags, filters and cell culture media, and described as "painful" the fact that one of its plants lay dormant for three weeks due to a shortage of materials, an issue that has since been resolved. Assuming all its plants become fully operational, the CEO stated that Novavax should be able to produce 150 million doses on a monthly basis.

NVX–CoV2373 has yet to be authorised by regulators in any country, but Novavax has reported late-stage data from a UK trial of more than 15,000 participants, showing overall effectiveness of 89.7% at the final analysis. The two-dose, protein-based vaccine also exhibited efficacy rates of 96.4% and 86.3%, respectively, against the original strain of SARS-CoV-2 and the B.1.1.7 variant, and was found to provide 100% protection against severe disease as well.

While the UK trial data are complete, Novavax says it is working on collecting manufacturing data that would demonstrate the drugmaker can safely and repeatedly make the same vaccine doses. Meanwhile, its Phase III PREVENT-19 trial testing NVX-CoV2373 in about 30,000 adult volunteers in the US is expected to wrap up in the second quarter. The company recently expanded that trial to test NVX-CoV2373 in up to 3000 adolescents aged 12 to 17 years old.

While vaccine demand is declining in the US, Novavax chief commercial officer John Trizzino says "unmet demand outside of the [country] has resulted in continued demand for [our] vaccine." The company has committed to supplying 200 million doses to countries around the world, in addition to the 1.1 billion doses it has committed to the COVAX vaccine sharing programme, Trizzino added.

Combination vaccine against influenza, COVID-19

Meanwhile, Novavax disclosed Monday that it is also working on combining NVX-CoV2373 with its quadrivalent seasonal influenza vaccine candidate NanoFlu, which is separately in late-stage testing. The company said positive preclinical results for the combination, uploaded as a preprint on bioRxiv, pointed to the "development of robust responses to both influenza and COVID-19, and protection against the SARS-CoV-2 virus" in animal models. "Despite low rates during the COVID-19 pandemic, influenza remains a significant risk to global public health," noted Novavax R&D head Gregory Glenn. The company said it expects to initiate clinical testing of the NVX-CoV2373/NanoFlu combination later this year.

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