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Novavax (NVAX) announced Thursday that it is expected to postpone its application for emergency use of the COVID-19 vaccine with the FDA by about a month, again, this time due to quality concerns Manufacturing.
CEO Stanely Erck told Yahoo Finance that Novavax itself had not delayed the filing. Instead, he said, the outside companies the company was asked to work with by Operation Warp Speed - the old government program launched under the Trump administration to fund six vaccine candidates – are blame.
“We are going to take more time to file than we hoped, several weeks, because we are in the process of validating the tests, and because we do not have control of all the deadlines with the external companies that we have to use to do that, we decided that September was not the most likely date and that it would have to be around October or around that date, ”Erck said.
The US government asked Novavax to work with Fujifilm Diosynth Biotechnologies, which has factories in Texas and North Carolina.
The Texas facility “has been shut down due to quality issues. They have been working to bring their quality system up to our standards and government standards,” Erck said.
The inspections are ongoing and as soon as they are completed and a subsequent FDA review is completed, the plant will be able to resume operations, he said.
Novavax has received approximately $ 1.75 billion in federal funding for the development and manufacture of a COVID-19 vaccine. He was one of six recipients of such funding as part of Operation Warp Speed.
In a filing with the SEC on Thursday, Novavax said the government “recently asked the company to prioritize alignment with the (FDA)….”
The break in funding only applies to the manufacturing part, and other components, such as clinical trials, are still funded, according to the filing.
A recent announcement shows that Fujifilm is investing heavily in expanding capacity, with an investment of $ 850 million in US and UK factories.
“The expansions will double production of cell cultures for recombinant vaccines in the United States,” the June statement said.
The manufacturer could not be reached for comment on Friday.
Optimism for global markets
But the company is more optimistic about its role in the global response, announcing that it has filed for emergency use in India, the Philippines and Indonesia. Erck previously told Yahoo Finance that his vaccines would be of great use in middle- and low-income countries.
“We made our first regulatory filings in three different countries, which is a major step forward for our business,” said Erck. “And we crossed a major hurdle to get there,” he added.
The company’s vaccine has shown high efficacy, around 90%, which puts it on par with Moderna (MRNA) and Pfizer (PFE) / BioNTech (BNTX). A recall test also shows strong protection against variants, Erck said.
Like the other companies, Novavax also predicts that boosters will be needed. But questions remain as to exactly when they will be needed. The European Union said so on Friday, even as France and Germany push ahead with their stimulus packages next month.
“This is classical immunology; this is what happens in pediatric vaccines,” Erck added, noting that boosters play a role in it as well. That’s why the company is targeting 2022 for boosters, globally.
“We are very happy with the direction we are taking on this issue,” said Erck.
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