Novavax plans to present US data on its COVID-19 vaccine as soon as this month, but manufacturing will delay deliveries

Novavax plans to release data about its COVID-19 vaccine's safety and effectiveness as soon as this month, but production issues are slowing the process, its president and CEO Stanley Erck said Monday. 

"All of the questions about 'whether' or 'if' are behind us now. I think we've solved those problems," Erck told USA TODAY. "It's a matter of time to get there."

In its quarterly report, released Monday, the company said it revised its anticipated capacity downward, to 100 million doses per month by the end of the third quarter, with 150 million doses per month predicted by the fourth quarter. 

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

The challenge for the past 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," Erck said.

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," he said. "A lot of confidence. Now, it's just a race to the finish line. Of course, for us, the finish line is just the starting line."

Getting to that starting line will also require safety and effectiveness data from large-scale clinical trials. 

While the company has shown strong data from trials in the United Kingdom 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.

"I'm not putting a date down, but it's in a few weeks,"  Erck said.

Novavax is one of five companies that received large sums of money from the federal government for developing and/or manufacturing COVID-19 vaccines. 

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 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.

Fact check:COVID-19 vaccinated people don’t ‘shed’ virus, infect others

"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 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 vice versa to protect the trial at a time when other vaccines were widely available in the U.S. Final results will be released before the end of next month.

In the U.K., the company reported that its vaccine had protected against all severe disease and was better than 96% effective against any disease from the original form of COVID-19, and 86% efficacy against the B.1.1.7 variant first seen in the U.K. The vaccine was 55% effective in a smaller trial of among HIV-negative participants in South Africa, where another variant, called B.1.351, was prevalent.

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

'Closer to returning to a sense of normalcy':FDA authorizes Pfizer-BioNTech COVID-19 vaccine for younger teens

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 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.