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Novavax (NVAX) announced Thursday it would have to push back its COVID-19 vaccine emergency use authorization (EAU) filing with the FDA by about one month, once again, this time due to manufacturing quality concerns.

CEO Stanely Erck told Yahoo Finance Novavax itself did not delay the filing. Instead, he said, outside firms that the company was directed to work with by Operation Warp Speed — the former government program launched under the Trump administration to fund six vaccine candidates — are to blame.

“We are going to take longer to file than we hoped, by several weeks, because we are in the process of validating assays, and because we don’t have control over all the timelines with the outside firms we have to use to do that, we decided that September is not the most likely date, and it would have to be around October or some time around then,” Erck said.

The U.S. government directed Novavax to work with Fujifilm Diosynth Biotechnologies, which has plants in Texas and North Carolina.

The Texas facility “has been stopped because of quality problems. They’ve been working on bringing their quality system up to our standards and the government standards,” Erck said.

Inspections are ongoing and as soon as those are complete, and a subsequent FDA review is completed, the plant can resume operation, he said.

Novavax received about $1.75 billion in federal funding for the development and manufacturing of a COVID-19 vaccine. It was one of six recipients of such funding under Operation Warp Speed.

In an SEC filing Thursday, Novavax said the government had “recently instructed the company to prioritize alignment with the (FDA) … before conducting additional manufacturing and further indicated that the U.S. government will not fund additional U.S. manufacturing until such agreement has been made.”

The pause in funding only applies to the manufacturing portion, and other components, such as the clinical trials, are still being funded, according to the filing.

A recent announcement shows Fujifilm is investing heavily in expanding its capacity, with a $850 million investment in U.S. and U.K. plants.

“The expansions will double cell culture production for recombinant vaccines in the United States,” according to the statement in June.

The manufacturer could not be reached for comment Friday.

Optimism for global markets

But the company is more optimistic about its role in the global response, announcing it filed for emergency use in India, the Philippines and Indonesia. Erck previously told Yahoo Finance its vaccines would largely be useful in middle- and low-income countries.

“We’ve made our first regulatory filings in three different countries, which is a major advance forward for our company,” Erck said. “And we’ve gone over a major hurdle to get to that point,” he added.

The company’s vaccine showed high efficacy, in the 90% range, which puts it on par with Moderna (MRNA) and Pfizer (PFE)/ BioNTech (BNTX). A booster trial also shows strong protection against variants, Erck said.

Like the other companies, Novavax also predicts boosters will be needed. But questions remain about exactly when they will be required. The European Union said as much Friday, even as France and Germany are moving ahead with their booster plans next month.

“That’s classic immunology; that’s what happens in pediatric vaccines,” Erck added, noting boosters play a role there as well. It’s why the company is targeting 2022 for boosters, globally.

“We’re very happy with where we’re going on this,” Erck said.

Quelle: (finance.yahoo)