Novavax (NASDAQ:NVAX) is confident its COVID-19 vaccine will receive the endorsement of the U.S. Food and Drug Administration’s advisory committee early this summer, executives said this week.
The FDA committee is scheduled to meet on June 7 to review Novavax’s submission. An endorsement from the committee, which is made up of independent experts, would mean the drug regulator is almost certain to quickly authorize the two-dose vaccine for use in the U.S.
CEO Stanley Erck said this week that Novavax’s manufacturing partner in India, Serum Institute of India, has successfully completed an FDA inspection. Erck told analysts during the company’s first-quarter earnings call that he fully expects the committee will authorize the vaccine for adults.
Chief Commercial Officer John Trizzino, in an interview with Bank of America, said all signs point toward a positive recommendation from the committee next month.
“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,” Trizzino said during Bank of America’s virtual health-care conference on Wednesday evening.
The FDA has been reviewing Novavax’s submission for months. The vaccine maker asked the drug regulator to authorize the vaccine in January, but federal health officials said the application was complex.
NVAX shares leaped $2.67, or 5.6%, to $50.65.
