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 instead of a new variant-specific formula.
However, the company hopes the FDA will greenlight the booster as an option even for those who received other vaccines for their primary or previous booster doses. That’s according to business director John Trizzino.
While Novamax has already received booster approval in other countries, the US remains a slow market for the company. Trizzino said he hopes things will improve when the US market trades, if the public health emergency is declared sometime next year.
“Frankly, we’re looking forward to it, because I think it will give us more flexibility to communicate and educate why this is a good vaccine,” Trizzino told Yahoo Finance at the World Vaccine Congress Europe in Barcelona.
Since doctors make the decisions instead of the US government, Novavax has a better chance of seeing more administration of its vaccine. To support that, the company is building regional business teams and has grown to have a global global presence of more than 2,000 employees.
“We are now approved in more than 43 countries…that doesn’t even include emergency listings,” Trizzino said.
The US Department of Health and Human Services (HHS) has just renewed the emergency, stating that it will provide a 60-day notice when it is ready to finalize the declaration.
Despite the growth and stability the company achieved last 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 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 looking to expand its portfolio. A long-awaited combination flu and COVID-19 vaccine is scheduled to begin phase 2 trials in early 2024, Trizzino said.
If investors are expecting a fast 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 some kind of efficacy testing.”
Because the severity of the flu is unpredictable from year to year when the trial is done, it will be key to the kind of results the company can expect, Trizzino added.
Beyond respiratory illnesses, Novavax is now ready to look at other options, including acquiring early-stage companies.
“We are looking at other pipeline candidates that have not yet been revealed that we think would be a good fit with our technology platform,” he said. “Certainly looking for an opportunity to bring in other assets. So looking at earlier-stage companies with other interesting technology.”
The first clouds of doubt about the company’s purity levels in manufacturing the vaccine and the struggle to expand capacity are 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 have learned a lot. We have invested more than 10 years in our multi-pathogen platform technology. We are better and more informed today than we were five years ago.”
Manufacturing capacity was zero on the first day of the Covid vaccine development processes, as the company had just sold manufacturing assets, after a failed RSV trial. Now the company has learned from the success of its Covid vaccine.
“Remember, our failed phase 3 RSV trial in older adults was a single dose that did not receive adjuvant. With the benefit of hindsight, and also the benefit of the COVID pandemic … the adjuvant will be critical,” Trizzino said. .
Novavax faces competition there, as the big traditional vaccine players are all after the same thing. Now that the company has regained manufacturing capacity and trained partners on the technology, things are looking more optimistic.
“I always cringe a little when people say, ‘Well, what caused the delay?’ I don’t know if delayed is the right word, unlike some of these things that took a little longer than we thought,” Trizzino said. “We made it to the finish line and we made it. It’s not like we have a marginally acceptable vaccine. We have 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 problems for all the components of the vaccine.
Follow Anjalee on Twitter @AnjKhem
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