A medical expert prepares a dose of the Novavax vaccine because the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.
Patrick Van Katwijk | Getty Images
Americans can finally get their hands on Novavax‘s newest Covid vaccine after U.S. regulators greenlighted the shot this week.
The vaccine’s arrival comes nearly three weeks after recent jabs from Pfizer and Moderna reached the general public, and after greater than 4 million patients rolled up their sleeves to get a shot in September. But Wall Street analysts aren’t frightened about that delay.
They said Novavax appears well positioned to catch up and compete this fall with the opposite firms within the U.S. Covid vaccine market, particularly after logistical issues hampered the rollout of the opposite shots and a Food and Drug Administration label that permits for wide accessibility to Novavax’s jab, amongst other aspects.
“I’m really not concerned concerning the timeline or lag relative to the opposite shots,” B. Riley Securities analyst Mayank Mamtani told CNBC. He added that regulators cleared Novavax’s recent shot only barely later than what the corporate had estimated, which was late within the third quarter.
That is excellent news for Novavax, which is working to strengthen its financial position after raising doubts about its ability to remain in business at first of the 12 months. The biotech company is banking on sales of its updated Covid vaccine — its only commercially available product — and a broad cost-cutting push to assist it stay afloat.
Public health officials see Novavax’s vaccine as a beneficial alternative for individuals who don’t need to take messenger RNA shots from Pfizer and Moderna, which teach cells tips on how to make proteins that trigger an immune response against Covid. Novavax’s shot fends off the virus with protein-based technology, a decades-old method utilized in routine vaccinations against hepatitis B and shingles.
Silvia Taylor, Novavax’s chief corporate affairs and advocacy officer, told CNBC that the corporate has collected data showing that 25% to 30% of individuals prefer a protein-based vaccine.
“We stay up for meeting this demand and more within the wake of recent variants and rising COVID cases,” Taylor said in an announcement.
Shares of Novavax jumped greater than 10% on Tuesday after the FDA cleared its recent shot. But the corporate’s stock remains to be down greater than 25% 12 months so far after shedding greater than 90% of its value last 12 months.
Novavax’s shot has a broad authorization label
The FDA authorized Novavax’s updated vaccine — which targets the omicron subvariant XBB.1.5 — for emergency use in people ages 12 and older. Patients previously vaccinated with an older Covid vaccine are eligible to receive one dose of Novavax’s recent jab, while unvaccinated people can receive two doses, based on the authorization.
The FDA similarly approved the brand new shots from Pfizer and Moderna for people ages 12 and older, however the agency also authorized those vaccines for emergency use in children ages 6 months through 11 years old.
Still, Mamtani said the authorization label for Novavax’s recent vaccine is “broad and with none notable restrictions for the primary time,” which is able to likely make the shot as widely accessible to teens and adults as the brand new mRNA jabs. That puts Novavax on more of a level playing field with Pfizer and Moderna this fall, at the same time as a late entrant to the sport.
The label for Novavax’s last Covid booster was much more restrictive. Last 12 months, the FDA authorized it as a primary booster dose for people ages 18 and older who couldn’t receive a recent mRNA shot for accessibility or clinical reasons. That “mainly disqualified plenty of people” from getting it last fall, based on Mamtani.
A health-care employee administers a dose of the Novavax Covid-19 vaccine at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.
Hannah Beier | Bloomberg | Getty Images
“Finally, after three years, Novavax has a label that puts its vaccine at parity with the mRNA shots,” Mamtani said. “I believe essentially the most powerful words on that label was that individuals can get it no matter their previous Covid vaccination history.”
Logistical issues slowed down Pfizer, Moderna
Novavax’s vaccine is entering the market after Pfizer and Moderna had a bumpy begin to the rollout of their shots. Insurance and supply-related issues left many Americans unable to seek out or access the brand new mRNA vaccines without spending a dime, which can give Novavax a possibility to catch up and get more people to take its shot.
“We all know that plenty of people have tried to get an mRNA vaccine, but they are not capable of due to logistical challenges of access and distribution,” Jefferies analyst Roger Song told CNBC. “So, that is one reason why the 2 or three weeks delay won’t necessarily be a hurdle for Novavax.”
There isn’t any way of knowing whether the rollout of Novavax’s recent shot will see similar logistical snags or if it should have a smoother launch. The federal government shifted Covid vaccine distribution and coverage to the private marketplace for the primary time this fall. That has proved to be a difficult transition for the U.S. health-care system.
An indication advertises COVID-19 (coronavirus) vaccine shots at a Walgreens Pharmacy in Somerville, Massachusetts, August 14, 2023.
Brian Snyder | Reuters
Nonetheless, health-care providers and pharmacies have signaled that they’re ironing out logistical issues and can be higher equipped to handle them in the longer term.
Last week, a bunch of insurers told the Biden administration they were “largely, if not completely,” done with fixing delays in insurance coverage for the brand new Covid shots. Those delays had resulted in some patients getting charged as much as $190 for a shot at pharmacies.
“Should further issues arise, we stand able to swiftly implement system improvements,” the insurers said in a letter.
Some pharmacies, like Walgreens, also look like resolving supply disruptions, which left many stores with none recent Covid shots for patients to receive.
Covid vaccinations could peak later this fall
What’s more, Novavax’s recent shot might actually be arriving at just the fitting time: a month before Covid vaccine demand is predicted to peak within the U.S. this fall and winter.
Jefferies’ Song said the height could follow an identical pattern as last season when most Covid boosters were administered in November. That is partly because there’s “less urgency” amongst Americans in the case of Covid shots in comparison with early on within the pandemic, which could cause them to get vaccinated later reasonably than earlier.
“Through the first season of Covid, everyone rushed to get vaccinations since it was really an emergency state. But now people have a mindset where they’re saying, ‘OK, I’ll wait and see how bad Covid really gets,'” Song said.
By November, Novavax’s recent shot will likely be as widely available as shots from Pfizer and Moderna at pharmacies, doctor’s offices and other vaccine distribution sites.
But the most important uncertainty this fall for all three firms is what number of Americans will resolve to get one other Covid vaccine, Song said.
Last 12 months’s uptake was already feeble: Only about 17% of the U.S. population — around 56 million people — received last 12 months’s boosters, based on the Centers for Disease Control and Prevention.
“We do not understand how big the general pie can be because we have never been in a business marketplace for Covid vaccines,” he told CNBC. “This fall will set a recent benchmark for all the Covid vaccine space.”