Novavax (NVAX) is awaiting the FDA’s decision on its COVID-19 vaccine booster and whether or not the agency will accept the original formula in lieu of a new variant-specific formula.
However, the company expects the FDA to also approve the booster shot as an option for those who received other vaccines for their primary or previous booster shots. So says Chief Commercial Officer John Trizzino.
While Novamax has already received booster approvals in other countries, the US remains a slow market for the company. Trizzino said he expects things to pick up as the U.S. market commercializes when the public health emergency is declared over sometime next year.
“Honestly, we’re looking forward to it because I think it gives us more flexibility to communicate and educate about why this is a good vaccine,” Trizzino told Yahoo Finance at the World Vaccine Congress Europe in Barcelona.
With physicians making the decisions and not the US government, Novavax has a greater chance of increasing the use of its vaccine. To support this, the company is establishing regional commercial teams and has grown to a total global presence of more than 2,000 employees.
“We’re now licensed in over 43 countries … that doesn’t even include emergency lists,” Trizzino said.
The U.S. Department of Health and Human Services (HHS) just renewed the emergency and indicated that it will submit 60 days notice when it is ready to end the declaration.
Despite the growth and stability the company has achieved over the past year, Trizzino believes the investor community is still wary of the company.
“The investment community doesn’t see some of those elements,” Trizzino said. “And we need to make sure they understand that we’re going to have a significant percentage of the market share. Estimates range from $15 billion of the total COVID market to $30 billion.”
Beyond COVID-19 vaccines, the company is already exploring expanding its portfolio. A highly anticipated COVID-19/flu combination vaccine is scheduled to begin Phase 2 trials in early 2024, Trizzino said.
If investors expect a quick timeline, they need to scale back expectations.
“They’re back in a normal process, so it’s probably going to take a couple of years,” Trizzino said. “I think as we go through this normal cycle, you need to do some kind of efficacy trial.”
Because the severity of the flu is unpredictable from year to year, the timing of conducting the study will be key to the results the company can expect, Trizzino added.
Besides respiratory, Novavax is now poised to explore other options, including acquiring early-stage companies.
“We are reviewing other pipeline candidates that have yet to be disclosed that we believe would be a good fit with our technology platform,” he said. “Certainly we’re looking for an opportunity to bring in other assets. So we’re looking at earlier-stage companies with other interesting technologies.”
Early doubts about the company’s purity levels in manufacturing the vaccine and the struggle to expand capacity are a thing of the past, Trizzino said.
“Anyone who has worked in biotechnology knows that you probably learn more from your mistakes than you do from your successes,” he said. “We learned a lot. We have invested over 10 years in our multi-pathogen platform technology. We are better off today and know more than five years ago.”
Manufacturing capacity was nil on day one of the Covid vaccine development processes as the company had just sold manufacturing facilities following a failed RSV trial. Now the company has learned from its success with Covid vaccines.
“Remember that our failed RSV phase 3 trial in older adults was a single dose without adjuvant. With the benefit of hindsight and also in view of the Covid pandemic … the adjuvant will be crucial,” said Trizzino.
Novavax faces competition there as major traditional vaccine providers pursue the same thing. Now that the company has rebuilt production capacity and trained partners on the technology, things are looking more optimistic.
“I always cringe a bit when people say, ‘Well, what caused the delay?’ I don’t know if delay is the right word, unlike some of these things that took a little longer than we thought,” Trizzino said. “We have reached the finish line, and successfully. It’s not like we have a halfway good vaccine. We have a great vaccine.”
And with eight facilities in seven countries that have already successfully manufactured the vaccine, Trizzino believes the company will no longer face supply issues for all components of the vaccine.
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