A medical examiner 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 latest 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 apprehensive about that delay.
They said Novavax appears well positioned to catch up and compete this fall with the opposite corporations 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 latest 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 stay in business originally of the yr. The biotech company is banking on sales of its updated Covid vaccine — its only commercially available product — and a broad cost-cutting push to help 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 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 glance forward to meeting this demand and more within the wake of latest variants and rising COVID cases,” Taylor said in a press release.
Shares of Novavax jumped greater than 10% on Tuesday after the FDA cleared its latest shot. But the corporate’s stock is still down greater than 25% yr to date after shedding greater than 90% of its value last yr.
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 latest jab, while unvaccinated people can receive two doses, according to 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 latest vaccine is “broad and with none notable restrictions for the primary time,” which can 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 yr, the FDA authorized it as a primary booster dose for people ages 18 and older who couldn’t receive a latest mRNA shot for accessibility or clinical reasons. That “principally disqualified a variety of people” from getting it last fall, according to 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 feel essentially the most powerful words on that label was that folks 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 start to the rollout of their shots. Insurance and supply-related issues left many Americans unable to find or access the brand new mRNA vaccines totally free, which can give Novavax a possibility to catch up and get more people to take its shot.
“We all know that a variety of people have tried to get an mRNA vaccine, but they don’t seem to be able to 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 is no way of knowing whether the rollout of Novavax’s latest shot will see similar logistical snags or if it’s going to 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 tough 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 might be higher equipped to handle them in the long run.
Last week, a gaggle 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 up to $190 for a shot at pharmacies.
“Should further issues arise, we stand ready to swiftly implement system improvements,” the insurers said in a letter.
Some pharmacies, like Walgreens, also appear to be resolving supply disruptions, which left many stores with none latest Covid shots for patients to receive.
Covid vaccinations could peak later this fall
What’s more, Novavax’s latest shot might actually be arriving at just the appropriate time: a month before Covid vaccine demand is anticipated to peak within the U.S. this fall and winter.
Jefferies’ Song said the height could follow an analogous pattern as last season when most Covid boosters were administered in November. That is partly because there’s “less urgency” amongst Americans when it comes to Covid shots compared to early on within the pandemic, which could cause them to get vaccinated later fairly 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 latest 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 corporations is what number of Americans will resolve to get one other Covid vaccine, Song said.
Last yr’s uptake was already feeble: Only about 17% of the U.S. population — around 56 million people — received last yr’s boosters, according to the Centers for Disease Control and Prevention.
“We do not understand how big the general pie might be because we have never been in a business marketplace for Covid vaccines,” he told CNBC. “This fall will set a latest benchmark for your entire Covid vaccine space.”