Novavax to apply to FDA for US authorization of its COVID vaccine as soon as this month, company says

Novavax, the fifth company to receive federal funding for its COVID-19 vaccine, plans to apply for authorization in the U.S., maybe as soon as this month, its president and CEO Stanley Erck said Monday.

“I’m not putting a date down, but it’s in a few weeks,” he said in a interview with USA TODAY.

While the company has shown strong safety and effectiveness data from trials in the U.K. and South Africa, it has not yet released data from a study led largely in the U.S. That data will be released by the end of June, according to the company’s quarterly statement, made public Monday.

Three of the COVID-19 vaccines whose development or manufacturing was backed by billion-dollar federal investments are available to the public: from Moderna, Pfizer-BioNTech and Johnson & Johnson. AstraZeneca, which developed a vaccine in connection with Oxford University has released data from a large-scale trial and begun making shots, but hasn’t yet applied for a use permit in the U.S.

For Novavax, which received $1.6 billion in federal funds, the hang-up remains smoothing out the manufacturing process, so the company can make millions and eventually billions of doses safely and quickly at its own and its partners’ facilities around the world.

“All of the questions about ‘whether’ or ‘if’ are behind us now. I think we’ve solved those problems,” Erck said. “It’s a matter of time to get there.”

The challenge for the last year has been “can you take a process that we developed a year ago at the 10-liter stage and develop that process and make it at 2,000 or 6,000 liters,” he said.

A potential COVID-19 vaccine at Novavax labs on March 20, 2020, in Gaithersburg, Maryland.

Now, at all of its plants, Novavax has achieved that leap in scale, though it is still working to produce doses at a faster pace.

“We can make it. A lot of confidence. Now, it’s just a race to the finish line,” he said, adding, “Of course, for us, the finish line is just the starting line.”

Erck said he hopes to have manufacturing and supply issues resolved by the fourth quarter of this year and expects Novavax to produce as many as 3 billion doses worldwide next year along with its partner, the Serum Institute of India.

Most people who want to be vaccinated will have gotten their shots by the time Novavax makes it to market. But Erck said he expects his company’s vaccine will be very useful around the world in the later part of this year, and to provide booster shots in the U.S. and abroad in the future.

“We have countries calling us all the time,” he said. “This isn’t going to go away from a commercial point of view anytime in the future.”

Novavax has promised to deliver 350 million doses to COVAX, which provides shots to low- and middle-income countries, beginning in the third quarter of the year and 1.1. billion doses over time.

The company began a trial in the U.S. and Mexico on Dec. 27, 2020 and more than 30,000 people volunteered within five weeks. The company had planned to release interim data from that trial last month but decided to wait until there were more cases of COVID-19, particularly serious cases and hospitalizations, Erck said.

On Monday, the company said it began a “blind crossover” of the trial in April, providing active vaccine to those who had received a placebo and visa versa to protect the trial at a time when other vaccines were widely available in the United States. Final results will be released before the end of next month.

Erck said he expects booster shots of the original shot and/or vaccines tailored to specific strains will eventually be needed to keep COVID-19 in check.

Novavax recently completed testing a combination flu and COVID-19 vaccine in animals and expect to begin human testing later this year.

“Our vaccine is likely to be ideal for a booster shot,” he said.

The animal studies have shown that vaccines for the two types of viruses don’t undermine each other and provide good protection against both diseases, Erck said.

The combination vaccine would target four flu strains and up to two COVID-19 strains simultaneously, he said, and might even include protection against Respiratory Syncytial Virus, which can cause serious disease in infants and older adults.

“Both our commercial analysis and our product data that we published today says that’s going to be the best way to go: a one-shot seasonal respiratory vaccine,” he said. “As we get past his emergency period with COVID, we can start thinking about expanding and having the seasonal respiratory vaccine.”

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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