Novavax discusses plans for new XBB vaccine, settlement with SK manufacturer in Q2 earnings

Novavax is preparing to have its XBB.1.5 Covid-19 vaccine ready for market by the end of September, calling it its “highest priority.” However, the company is still in the middle of the filing process with the FDA.

The company said Tuesday in its second-quarter earnings report that it plans to have its updated Covid vaccine ready for the fall vaccination season.

Filip Dubovsky

“We submitted the preclinical and clinical packages, and we’re going to complete that file this month,” Novavax R&D chief Filip Dubovsky said on an investor call.

The ambitious timeline leaves a couple of weeks for Novavax to get the filing done and go through regulatory review.

“The company continues to work closely with the FDA; we have had ongoing positive engagements to ensure we are prepared for the fall season, and we are providing all supporting data that is required for the review of our updated non-mRNA XBB Covid vaccine,” a Novavax spokesperson told Endpoints News.

Their filing is weeks behind Covid vaccine competitors Moderna and Pfizer/BioNTech. The companies, which have made billions of dollars off their wildly successful mRNA vaccines, filed their updated versions of the shot with the FDA back in late June. Those filings occurred about a week after the FDA’s Vaccines and Related Biological Products Advisory Committee recommended 21-0 to go with a monovalent of XBB lineage for the newest iteration of Covid shots.

The biotech’s share price $NVAX was down about 3% in trading on Tuesday afternoon.

Novavax also said it reached a settlement with South Korea’s SK bioscience around a drug manufacturing deal first set up for an antigen component of Novavax’s then-Covid vaccine candidate in 2020.

The company has agreed to pay SK bioscience $154 million to settle $195 million in manufacturing liabilities. SK bioscience has also taken an equity investment of $85 million at $13 a share, a 59% premium, in Novavax, which described the shift from being a contract manufacturing organization to a strategic business partnership.

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