Novavax delays COVID-19 vaccine regulatory submissions—again

Novavax will not file for approval of its COVID-19 vaccine until July at the earliest, thanks to manufacturing issues related to an assay needed to show regulators that its vaccine manufacturing process is consistent across different sites. 

“We know that we are delayed from where we thought we would be at this point. Now we’re giving guidance that nearly all of the major challenges have been overcome,” said Novavax CEO Stanley Erck Monday afternoon during the company’s first-quarter earnings call. 

Having previously targeted the second quarter for regulatory filings, the company now aims to submit the vaccine to regulators in the U.K., U.S. and European Union in the third quarter, Erck said. The Washington Post first reported the delays earlier on Monday, quoting several unnamed sources familiar with the company’s plans. 

Besides delays with the assay, the company has also run into shortages of raw materials, such as 2,000-liter plastic bags used to grow cells for vaccine production. This has cut the company’s expected production numbers by about half. 

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Novavax had expected to produce between 70 million and 80 million doses per month at its manufacturing sites, excluding the Serum Institute of India, Erck said on the call. The company has 30 million to 40 million doses on its shelves and is making more every week, he said. 

The company is confident manufacturing will hit full capacity of 150 million doses per month, but not until the fourth quarter, a little later than a previous target of the third quarter. 

It will be “a somewhat slower rollout on product approval, but not dramatically,” Erck said. 

“Although demand in the US has clearly been met by the mRNA vaccines, demand outside the U.S. remains very high and the company remains in communications with governments that want vaccine now and for 2022,” wrote Jefferies analyst Kelechi Chikere in a note to investors Monday night. 

The company has collected $772 million in payments under advance purchase agreements, according to a first-quarter earnings statement. 

RELATED: COVID-flu combo vaccine from Novavax sparks immune response to both viruses in animals 

In January, Novavax reported the vaccine was about 90% effective in a phase 3 study involving 15,000 patients in the U.K. More data shared in May showed it was far less effective against the South African variant of SARS-CoV-2, better known as B.1.351. It was 51% effective in people who were HIV negative and 43% in people who were HIV positive—though the latter result wasn’t unexpected given the nature of the disease and its impact on the immune system. 

Last fall, Novavax delayed the start of a phase 3 study in the U.S. and Mexico to November. Interim data in the event-driven trial were expected in the first quarter, meaning data would be reported when the trial participants recorded a certain number of COVID-19 cases. 

Now, the company has changed up the trial and started crossing patients over, giving doses of the vaccine to people who had initially received placebo. After this modification, the company expects top-line data by the end of the second quarter. 

"Management noted that due to the widespread availability of EUA authorized vaccines and the real chance they could see dropouts in the Phase III, the company 1) initiated the crossover portion of the Phase III study and 2) amended the final analysis plan in the Phase III to a 'time based analysis' vs prior ‘event-based analysis,'" Chikere wrote. "We also note this move removes the interim analysis at 72 events and allocates all the statistical powering to the final analysis and increases the safety database."