- Novavax’s updated coronavirus vaccine is set to arrive in the U.S. nearly three weeks after newer vaccines from Pfizer and Moderna reached Americans, but analysts are not concerned about the delay.
- The company still appears well positioned to compete with other companies in the U.S. coronavirus vaccine market this fall, especially after logistical issues hampered the rollout of other vaccines.
- That’s good news for Novavax, which is working to strengthen its financial position after casting doubt on its ability to continue operating at the beginning of the year.
A health worker prepares a dose of Novavax vaccine as the Dutch Health Service launches the Novavax vaccination program in The Hague, Netherlands, on March 21, 2022.
Patrick Van Katwijk | Patrick Van Katwijk Getty Images
This week, U.S. regulations approved Novavax’s latest coronavirus vaccine, which is finally available to Americans.
The vaccine’s arrival comes nearly three weeks after Pfizer and Moderna rolled out new vaccines to the public, and after more than 4 million patients rolled up their sleeves to get vaccinated in September. But Wall Street analysts aren’t worried about the delay.
They said Novavax appears to be well-positioned to catch up and compete with other companies in the U.S. COVID-19 vaccine market this fall, especially as logistical issues have hampered the rollout of other vaccines and a Food and Drug Administration label allows for widespread use of the Novavax vaccine. and other factors.
“I’m not really worried about the timeline or the lag relative to other shots,” B. Riley Securities analyst Mayank Mamtani told CNBC. He added that regulatory approval of Novavax’s new vaccine came only slightly later than the company had expected. , that is, the end of the third quarter.
That’s good news for Novavax, which is working to strengthen its financial position after casting doubt on its ability to continue operating at the beginning of the year. The biotech company is counting on sales of its updated COVID-19 vaccine, its only commercial product, and broad cost-cutting efforts to help it stay afloat.
Public health officials view Novavax’s vaccine as a valuable alternative for people who don’t want to receive Pfizer and Moderna’s messenger RNA shots, which teach cells how to make proteins that trigger an immune response against the coronavirus. Novavax’s vaccine protects against the virus through protein-based technology, a decades-old approach used in routine hepatitis B and shingles vaccinations.
Silvia Taylor, Novavax’s chief corporate affairs and communications officer, told CNBC that the company has collected data showing that 25% to 30% of people prefer protein-based vaccines.
“As new variants and COVID-19 cases continue to increase, we look forward to meeting this need and more,” Taylor said in a statement.
Novavax shares rose more than 10% on Tuesday after the FDA approved its new vaccine. But the company’s stock price fell more than 90% last year and is still down more than 25% so far this year.
The FDA authorized Novavax’s updated vaccine (against omicron subvariant XBB.1.5) for emergency use in people 12 years and older. Under the authorization, patients who have previously received an older version of the COVID-19 vaccine are eligible to receive one dose of Novavax’s new vaccine, while unvaccinated people can receive two doses.
The FDA also approved new vaccines from Pfizer and Moderna for people ages 12 and older, but the agency also authorized the vaccines for emergency use in children 6 months to 11 years old.
Still, Mamtani said the authorization label for Novavax’s new vaccine is “broad and for the first time does not have any apparent restrictions,” which could make it as widely available to adolescents and adults as the new mRNA vaccine. That puts Novavax on a more level playing field this fall with Pfizer and Moderna, even though it was a late entrant.
Novavax’s last Covid booster had a much more restrictive label. Last year, the FDA authorized it as the first booster dose for people 18 and older who cannot receive the new mRNA shot due to availability or clinical reasons. Mamtani said this “basically disqualified a lot of people” from being eligible last fall.
A health care worker administers a dose of the Novavax Covid-19 vaccine at a pharmacy in Schwenksville, Pennsylvania, U.S., Monday, August 1, 2022.
Hannah Bell | Bloomberg | Getty Images
“After three years, Novavax finally has a label that puts its vaccine on par with its mRNA vaccines,” Mamtani said. “I think the most powerful statement on this label is that people can get it regardless of their previous COVID vaccination history.”
Novavax’s vaccine is about to hit the market after a rocky start to the rollouts of Pfizer and Moderna’s vaccines. Insurance and supply-related issues have prevented many Americans from finding or getting the new mRNA vaccine for free, which could give Novavax a chance to catch up and get more people vaccinated.
“We know that a lot of people have tried to get an mRNA vaccine but haven’t been able to because of the logistical challenges of acquisition and distribution,” Jefferies analyst Roger Song told CNBC. “So this is That’s one of the reasons why a two- to three-week delay isn’t necessarily a roadblock for Novavax.”
There’s no way of knowing whether the rollout of Novavax’s new products will encounter similar logistical hurdles or whether it will be a smoother rollout. This fall, the federal government shifted distribution and coverage of COVID-19 vaccines to the private market for the first time. This has proven to be a complex transition for the U.S. health care system.
A sign promotes COVID-19 (coronavirus) vaccine shots at a Walgreens pharmacy on August 14, 2023 in Somerville, Massachusetts.
Brian Snyder | Reuters
However, health care providers and pharmacies have said they are working through logistical issues and will be better prepared to handle them in the future.
A group of insurance companies told the Biden administration last week that they have “largely, if not completely,” resolved delays in coverage of COVID-19 vaccines. Those delays have resulted in some patients paying as much as $190 for a shot at a pharmacy.
“We stand ready to quickly implement system improvements if further issues arise,” the insurer said in a letter.
Some pharmacies, such as Walgreens, also appear to be dealing with supply disruptions that have left many stores without any new coronavirus vaccines for patients to receive.
What’s more, Novavax’s new vaccine may actually come at just the right time: It’s still a month before U.S. coronavirus vaccine demand is expected to peak this fall and winter.
Jefferies’ Song said the peak will likely follow a similar pattern to last season, when most COVID-19 vaccine boosters were administered in November. That’s partly because Americans are “less urgent” to get vaccinated than they were early in the pandemic, which could lead them to delay rather than get vaccinated sooner.
“In the first season of COVID-19, everyone was scrambling to get vaccinated because it was really a state of emergency. But now people have a mentality where they’re like, ‘Well, I’m going to wait and see how big COVID-19 is. Seriously.'” Song said.
By November, Novavax’s new vaccine will likely be widely available in pharmacies, doctors’ offices and other vaccine distribution sites, like those from Pfizer and Moderna.
But Song said the biggest uncertainty facing the three companies this fall is how many Americans will decide to get another COVID-19 vaccine.
Last year’s vaccination rollout was already meager: Only about 17% of the U.S. population, or about 56 million people, received last year’s booster shot, according to the Centers for Disease Control and Prevention.
“We don’t know how big the overall market will be because we’ve never been in the commercial market for a COVID-19 vaccine,” he told CNBC. “This fall will set a new benchmark for the entire COVID-19 vaccine field.”