There’s a new vaccine about to be mass-produced.
Covid-19 vaccine maker Novavax is extremely confident its Covid-19 vaccine will receive an endorsement from the FDA early this summer.
On June 7th the FDA’s committee will gather together to evaluate whether or not Novavax is safe for the public’s use (we all know how that will go).
Chief Commercial Officer John Trizzino stated that it looks like the FDA will approve Novavax as a EUA (Emergency Use Authorization) vaccine.
The only problem with that is, there’s no emergency!
Novavax confident Covid vaccine will receive FDA authorization in June after delays https://t.co/cp07aeAazU
— CNBC International (@CNBCi) May 13, 2022
NEW: Novavax announced the submission of a request for emergency use authorization to Taiwan’s Food and Drug Administration for its #COVID19 vaccine. Learn more: https://t.co/7P9KTyCJUH pic.twitter.com/rQ28fCPcxh
— Novavax (@Novavax) May 13, 2022
CNBC shared these details:
Novavax is confident its Covid-19 vaccine will receive the endorsement of the 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.
— Phil De Carolis (@PhilDeCarolis) May 13, 2022
Richmond got the scoop too:
Something puzzling or even suspicious appears to be transpiring at the Food and Drug Administration. The long-anticipated Novavax vaccine, an alternative to current messenger RNA vaccines against COVID-19, submitted for emergency use authorization to the FDA at the end of January. Without much explanation, the FDA has shown little sign of action and it only recently scheduled a tentative June vaccine advisory committee meeting for discussion.
Novavax is protein-based vaccine that uses a similar technique to existing influenza and HPV vaccines to produce viral proteins. Novavax utilizes small proteins (nanoparticles) based on the COVID-19 spike protein and a separate immune boosting compound to produce an immune response. Thus, the technology is distinct from mRNA-based Pfizer and Moderna vaccines.
In a phase three randomized trial of more than 29,000 participants, Novavax demonstrated 90.4% efficacy in preventing infection and 100% efficacy against moderate to severe disease. It also tested well against subsequent COVID-19 variants.