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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.
What's next?
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.