A health worker prepares a dose of the Novavax vaccine as 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 new jabs from Pfizer and Moderna reached the public, and after more than 4 million patients rolled up their sleeves to get a shot in September. Wall Street analysts, however, are not worried about this delay. He added that regulators cleared Novavax’s new shot only slightly later than what the company had estimated, which was late in the third quarter.
That’s good news for Novavax, which is working to strengthen its financial position after raising doubts about its ability to stay in business at the beginning of the year. The biotech firm is relying on the sales of its updated Covid product, its only commercially-available product, and a wide cost-cutting campaign to stay afloat. The Novavax shot uses a decades-old method of fighting the virus using protein-based technology. This is a technique that has been used in routine vaccinations against hepatitis B and shingles for years. Novavax’s shot fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.
Silvia Taylor, Novavax’s chief corporate affairs and advocacy officer, told CNBC that the company has collected data showing that 25% to 30% of people prefer a protein-based vaccine.
“We look forward to meeting this demand and more in the wake of new variants and rising COVID cases,” Taylor said in a statement.
Shares of Novavax jumped more than 10% on Tuesday after the FDA cleared its new shot. But the company’s stock is still down more than 25% year to date after shedding more than 90% of its value last year.
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 new jab, while unvaccinated people can receive two doses, according to the authorization.
The FDA similarly approved the new shots from Pfizer and Moderna for people ages 12 and older, but 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 new vaccine is “broad and without any notable restrictions for the first time,” which will likely make the shot as widely accessible to teens and adults as the new mRNA jabs. Novavax is now on a more level playing field this fall with Pfizer, Moderna and other late-comers. The FDA approved it last year as a booster for adults over 18 who could not receive a new mRNA injection for clinical or accessibility reasons. Mamtani said that this “basically disqualified” a lot people from receiving it last fall.
A health-care worker 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. The label’s most important message was that anyone can receive it, regardless of previous Covid vaccinations.
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. Many Americans were unable to access or find the new mRNA vaccinations because of insurance and supply issues. This may have given Novavax a chance to catch up with its competitors and encourage more people to try their shot. Roger Song, an analyst at Jefferies, told CNBC that many people had tried to obtain the mRNA vaccine but were unable to do so due to logistical issues. Novavax won’t be hindered by the delay of two to three weeks. There’s no way to know if the launch of Novavax’s new shot will be smooth or not. This fall, the federal government moved Covid’s distribution and coverage from the public to the private sector for the first. The transition has been difficult for the U.S. healthcare system.
A sign advertises COVID-19 (coronavirus) vaccine shots at a Walgreens Pharmacy in Somerville, Massachusetts, August 14, 2023.
Brian Snyder | Reuters
However, health-care providers and pharmacies have signaled that they are ironing out logistical issues and will be better equipped to handle them in the future.
Last week, a group of insurers told the Biden administration they were “largely, if not completely,” done with fixing delays in insurance coverage for the 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
, also appear to be resolving supply disruptions, which left many stores without any new Covid shots for patients to receive.
Covid vaccinations could peak later this fall
What’s more, Novavax’s new shot might actually be arriving at just the right time: a month before Covid vaccine demand is expected to peak in the U.S. this fall and winter. Song, who works at Jefferies, said that the peak may follow a pattern similar to last year’s when most Covid boosters had been administered in November. That’s partly because there is “less urgency” among Americans when it comes to Covid shots compared to early on in the pandemic, which could cause them to get vaccinated later rather than earlier.
“During the first season of Covid, everyone rushed to get vaccinations because it was really an emergency state. Song explained that people are now more hesitant to get vaccinated because they want to wait and see just how bad Covid will be. By November, Novavax will have the same shot as Pfizer, Moderna, and at other distribution sites.
But the biggest uncertainty this fall for all three companies is how many Americans will decide to get another Covid vaccine, Song said.Last year’s uptake was already feeble: Only about 17% of the U.S. population — around 56 million people — received last year’s boosters, according to the Centers for Disease Control and Prevention.“We don’t know how big the overall pie will be because we’ve never been in a commercial market for Covid vaccines,” he told CNBC. This fall will be a benchmark in the Covid vaccine market. “