Novavax (NVAX) finally passed all four necessary steps for its COVID-19 vaccine to be available for adults in the U.S. next week, with the final green light coming from the CDC.
3.2 million doses purchased by the U.S. government as part of contracts with the Trump administration’s Operation Warp Speed and U.S. Department of Defense have been released to the government’s distribution sites. They are slated to arrive Friday, according to Novavax senior vice president Silvia Taylor.
It’s a milestone the company has pursued despite several setbacks over the past two years, and CEO Stanley Erck said this approval is just the beginning.
“Our hope is that the demand for this [vaccine] will encourage the CDC and the U.S. government to continue to buy more batches,” Erck told Yahoo FInance Live (video above). “And we are talking to them about the next batch right now, and that’s before we get to the fall season. I think there’s going to be a fairly large demand in the fall.”
Novavax’s COVID-19 vaccine is the biotechnology company’s first commercial product, and it has given the company leverage to pursue a flu vaccine and combination flu/COVID vaccine. Experts believe that annual boosters to protect against COVID could be necessary for the foreseeable future.
Unlike its competitors, the price per dose has not yet been revealed for Novavax’s two-dose recombinant protein vaccine.
“The pricing is not transparent because it’s part of a very large, billion-dollar-plus contract,” Erck said. “We haven’t decided and haven’t published what the pricing will be. But my guess is it will be in the range of what other vaccines are charging, which has recently been in the $30 range.”
The Pfizer/BioNTech (PFE/BNTX) vaccine was just under $20 per shot in its initial deals. Meanwhile, Johnson & Johnson (JNJ) sold its original single-shot vaccine at a nonprofit price of about $10 per dose. And the Serum Institute of India, which is currently producing Novavax’s vaccine, previously produced AstraZeneca (AZN)/Oxford’s doses and sold them to the Indian government for under $3 each.
Novavax now has its sights set on making its vaccine eligible for younger age groups and is working with the FDA toward booster authorization after submitting data from its Phase 3 trial.
“The FDA has data now that shows that our booster works, and it works well,” Erck said.”They may require additional data. We are filing with them over the coming weeks” with hopes of a decision by the end of summer, at the earliest.
The company’s vaccine is already in use in other countries both as a booster as well as for younger age groups.
“There’s precedent for getting authorized in other markets with boosting,” Taylor told Yahoo Finance in a separate interview. “I think it’s kind of understood that that’s the next step.”
Novavax hopes to have the booster authorization in hand in time for an anticipated fall coronavirus surge. It is also working on a variant-specific booster that the FDA anticipates will be necessary later this year.
Manufacturing and quality woes delayed the company’s vaccine, which won a contract for use within the Department of Defense, for more than a year.
With more momentum behind it, Novavax aims to build a local clinical production site in the U.S. However, the company anticipates overseas contract manufacturers like Serum and SK Bioscience will be central to production for the foreseeable future.
“Now we just get into a routine cadence in the plant in India,” Erck said, adding that the capacity of all its manufacturing partners overseas is enough to supply global demand.
Though the company hasn’t terminated its relationships with the previous manufacturers, there isn’t a need for that capacity at this time. Taylor said that could change “depending on our needs. We may add additional manufacturing sites.”
Now that the company is in talks with the U.S. government about fall vaccine needs, Erck said Novavax will keep its eyes open on expanding in the U.S., but “that’s a longer-term decision to be making.”
“It feels really good to be able to say, we’re authorized in 40-plus countries,” Taylor said. “We do have a little bit more headspace and a bigger organization than we did a couple of years ago.”
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