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 rather than a new variant-specific formula.
However, the company is expecting the FDA to green-light the booster as an option even for those who received other vaccines for their primary or previous booster doses. That's according to chief commercial officer John Trizzino.
While Novamax already received booster approval in other countries, the U.S. remains a slow market for the company. Trizzino said he expects things to pick up when the U.S. market goes commercial, if the public health emergency is declared over sometime next year.
"Frankly, we're looking forward to that, because I think that'll give 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 doctors making the choices rather than the U.S. government, Novavax has a greater chance of seeing increased administration of its vaccine. To support that, the company is building out regional commercial teams and has grown to a global overall presence of more than 2,000 employees.
"We're now approved in over 43 countries...that doesn't even include emergency listings," Trizzino said.
The U.S. Health and Human Services Department (HHS) just renewed the emergency, indicating it would provide a 60-day notice when it is ready to end the declaration.
Despite the growth and stability the company achieved in the past year, Trizzino believes the investment community is still wary of the company.
"The investment community is not seeing some of these elements," Trizzino said. "And we need to make sure that 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 the COVID-19 vaccines, the company is already looking at broadening its portfolio. A highly anticipated COVID-19 and flu combination vaccine is set to begin Phase 2 trials at the start of 2023, Trizzino said.
If investors are expecting a quick timeline, they will have to lower expectations.
"You're back to a normal process, so it's probably going to take a few years," Trizzino said. "I think as we go through that normal cycle, you're going to have to do an efficacy trial of some sort."
Because the flu severity is unpredictable year to year when the trial is conducted will be key to what kind of results the company can expect, Trizzino added.
Beyond respiratory diseases, Novavax is now ready to look at other options, including acquiring early-stage companies.
"We're looking at other pipeline candidates that have yet to be disclosed that we think would fit well with our technology platform," he said. "Certainly looking at an opportunity to bring in other assets. So, looking at earlier stage companies with other interesting technology."
The early clouds of doubt over the company's purity levels when manufacturing the vaccine, and the struggle to expand capacity, are all in the past, Trizzino said.
"Anyone who's been in biotech knows that you probably learn more from your mistakes than your successes," he said. "We've learned a lot. We've got over 10 years invested in our platform technology across multiple pathogens. We're better off and more knowledgeable today than we were five years ago,"
Manufacturing capability was zero on day one of the Covid vaccine development processes, as the company had just sold off manufacturing assets, after a failed RSV trial. Now, the company has learned from its Covid vaccine success.
"Remember, our failed RSV Phase 3 trial in older adults was a single dose that wasn't adjuvanted. With the benefit of hindsight, and also the benefit of the Covid pandemic...adjuvant is going to be critical," Trizzino said.
Novavax faces competition there as large traditional vaccine players are pursuing the same. Now that the company has built back manufacturing capacity, and trained partners on the technology, things are looking more optimistic.
"I always cringe a little bit when people say, 'Well, what caused the delay?' I don't know that delay is the right word, as opposed to some of these things took a little bit longer than we had thought," Trizzino said. "We did reach the finish line, and successfully. It's not like we have a marginally okay vaccine. We've got a great vaccine."
And with eight facilities in seven countries that have already successfully produced the vaccine, Trizzino believes the company will no longer have supply issues for all components of the vaccine.
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