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Novavax (NASDAQ:NVAX) executives remain hopeful that the company’s COVID-19 vaccine will clear U.S. regulatory hurdles and win FDA authorization as the agency plans to hold a meeting of its vaccine experts next month to discuss the company’s protein-based shot.
In late April, Novavax (NVAX) shares jumped when the FDA announced the June 07 meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to weigh the emergency use authorization (EUA) for the vaccine, branded as Nuvaxovid in Europe.
In a healthcare conference organized by Bank of America on Wednesday, Novavax (NVAX) Chief Commercial Officer John Trizzino said that all signs point to a positive recommendation from the panel.
“We’re fully expecting based upon our submission, based upon all the back and forth questions that have been asked and answered, based upon the inspection at Serum, to come out of that meeting with a recommendation for emergency use authorization,” he added.
In late June, VRBPAC is set to discuss whether the current generation of COVID-19 vaccines needs to be updated as the virus mutates and if so, which strains should be picked for Fall 2022.
Trizzino said that the company will soon advance Omicron-specific shots into clinic, targeting a potential rollout in October. “We've got Omicron and BA.1, BA.2, both of those are soon to be in the clinic,” he said.
“So the customer may want to bivalent or BA.1 or BA.2, we intend to have the clinical data, the package that's filed for that and then be able to deploy in sort of the time frame of October.”
Novavax (NVAX) has received $1.8 billion from the U.S. government to deliver 100 million COVID vaccine doses, subject to regulatory clearance.
Meanwhile, at the recent earnings call, Novavax (NVAX) Chief Executive Stanley Erck also issued positive remarks on a potential FDA nod for the vaccine after a successful conclusion of an FDA inspection at a production site of its partner, Serum Institute of India.
"….with a VRBPAC meeting now set for June 7 following the successful completion of an inspection of our manufacturing site at Serum Institute of India," he said, "our expectation with the VRBPAC meeting is authorization for primary vaccination in adults."