Novavax (NVAX) is awaiting the FDA’s decision on its COVID-19 vaccine booster and whether the agency will accept the original formulation rather than the new variant-specific formulation.
However, the company expects the FDA to approve boosters as an option for people who have received other vaccines in the initial or previous booster doses as well. This is from Chief Commercial Officer John Trizzino.
Novamax has already received booster approvals in other countries, but the US remains a slow market for the company. He said he expects the situation to improve when the
“Frankly, we’re looking forward to it because I think it gives us the flexibility to tell and educate why this is a good vaccine,” said Trizzino at the conference in Barcelona. told Yahoo Finance at the World Vaccine Congress Europe.
Because doctors, not the US government, make the choice, Novavax is more likely to receive increased doses of the vaccine. To support it, the company has built regional commercial teams and collectively he has grown to a global presence of over 2,000 employees.
“It is now approved in over 43 countries…not including emergency lists,” said Trizzino.
The U.S. Department of Health and Human Services (HHS) just updated its state of emergency, indicating it will give 60 days’ notice when it’s ready to end the declaration.
Despite the growth and stability the company has achieved over the past year, Trizzino believes the investment community remains wary of the company.
“The investment community is unaware of some of these factors,” said Trizzino. “And we need them to understand that they are going to have a significant percentage of the market share. Estimates range from $15 billion to $30 billion for the overall COVID market.”
Beyond the COVID-19 vaccine, the company is already looking to expand its portfolio. The long-awaited combination COVID-19 and flu vaccine is set to begin Phase II trials in early 2024, he said, Trizzino said.
If investors expect a quick timeline, they should lower their expectations.
“It’s going back to the normal process, so it’s probably going to take a few years,” said Trizzino.
Trizzino added that because the severity of influenza is unpredictable from year to year, the key is what companies can expect when the tests are conducted.
Beyond respiratory diseases, Novavax is ready to explore other options, including acquiring early-stage companies.
“We are considering other pipeline candidates that have not yet been disclosed that we believe fit well with our technology platform,” he said. “Certainly we are looking for opportunities to bring in other assets, so we are looking at early stage companies with other interesting technologies.”
Trizzino said early doubts about the company’s purity levels when manufacturing the vaccine and the struggle to expand production capacity are all past.
“Anyone who has worked in biotechnology knows that we probably learn more from our mistakes than from our successes.” We are richer and more knowledgeable today than we were five years ago.”
The company had just sold its manufacturing assets after the RSV trial failed, so it had zero manufacturing capacity on the first day of the Covid vaccine development process. Now the company has learned from the success of his Covid vaccine.
“Recall that the failed RSV Phase 3 trial in the elderly was a single dose without adjuvant. Let’s go,” said Trizzino.
Novavax faces competition there as big traditional vaccine companies pursue the same. Things look more optimistic now that the company has rebuilt its manufacturing capacity and trained its partners on the technology.
“‘What caused the delay? We’ve reached the finish line, we’ve done it. There’s not just a vaccine that’s just okay, there’s a vaccine that’s great.”
And with eight facilities in seven countries already successfully manufacturing the vaccine, Trizzino believes the company won’t have problems supplying all the vaccine ingredients.
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