Novavax is confident the Covid vaccine will receive FDA approval in June after the delay

Novavax Executives said this week they are confident their Covid-19 vaccine will receive the endorsement of the Food and Drug Administration’s advisory committee earlier this summer.

The FDA committee is scheduled to meet June 7 to review Novavax’s submission. Confirmation from the committee, which includes independent experts, means that the drug regulator will almost certainly soon authorize the use of the two-dose vaccine in the United States.

This week, Novavax’s manufacturing partner in India, the Serum Institute of India, has successfully completed the FDA inspection, CEO Stanley Erck said. Erck told analysts during the company’s first-quarter earnings call that he fully expects the commission to license the vaccine for adults.

Chief Commercial Officer John Trizzino, in an interview with Bank of America, said all signs point towards a positive recommendation from the committee next month.

“We fully expect based on our submission, based on all the back-and-forth questions asked and answered, based on the test at Serum, to come out of that meeting with a recommendation. recommend emergency use,” Trizzino said during Bank of America’s virtual healthcare conference Wednesday night.

The FDA has been reviewing Novavax’s filings for several months. The vaccine maker asked the drug regulator for permission to use the vaccine in January, but federal health officials say the application is complicated.

“This is an extremely complex review process, including consideration of not only clinical data but also manufacturing data that will be needed to make an urgent use authorization decision,” said Dr. Doran Fink, associate director of clinical evaluation at the FDA’s vaccine division, told the Centers for Disease Control and Prevention’s committee of independent vaccine advisors last month.

If Novavax’s vaccine is approved by the FDA, it will be the first new shot to hit the US market in more than a year. Pfizer, Moderna and Johnson & Johnson are three vaccines currently in use in the US, and the FDA last week restricted the use of J&J shots.

This vaccine will enter the US market by the time 76% of adults are fully immunized. Trizzino said Wednesday that Novavax’s shots will provide an option for the rest of the adult population who don’t want the mRNA vaccine. Novavax’s vaccine uses more conventional protein technology, while Pfizer and Moderna use a messenger RNA platform authorized for the first time in coronavirus pandemic. These injections can also play an important role as booster doses, Trizzino said, in adolescents aged 12 to 17 years.

Novavax has submitted data from its teens to the FDA and is also submitting data on booster doses, Chief Medical Officer Philip Dubovsky said on the company’s earnings call. However, it is still unclear when the FDA might consider the company’s injections intended for adolescents and as a booster dose.

FDA approval for a vaccine will come as the drug regulator is considering redesigning Covid shots this fall to target the mutations the virus has evolved in. past two years. All current vaccines, including Novavax, target the mutant protein of the virus strain that originally emerged in Wuhan, China, in 2019. As the virus evolved, the shots become less effective at preventing infection.

Novavax plans to launch clinical trials this month on a version of the vaccine that targets the omicron mutation, Erck said during the company’s earnings press conference. Trizzino, in the Bank of America interview, said the goal is to have the shots by October for the fall vaccination campaign if the FDA decides to keep updating the shots.

“Our thinking is at a failing stage, we need to be ready to do what the customer wants,” Trizzino said, referring to the US government. “We plan to have clinical data, the package is filed for that, and then maybe roll it out in the October timeframe.”

It is not clear how many shots the US government will prescribe if the vaccine is licensed. Erck said Novavax is currently in discussions with the US on how the company can support demand. Novavax received $1.8 billion from the US government in Operation Warp Speed ​​to deliver 100 million doses, though the government will decide how many injections after FDA approval.

Novavax shares have fallen 13% this week on uncertain demand for hits and after the company missed Wall Street first quarter earnings and revenue expected. Although Novavax maintains 2022 sales of $4 billion to $5 billion, Chief Financial Officer Jim Kelly said the company has yet to receive orders from COVAX, the international alliance that supplies products for poorer countries. Kelly said it remains unclear how much COVAX can order, which could put downward pressure on sales guidance.

Last year, Novavax signed a memorandum of understanding to supply 1.1 billion doses of its vaccine to COVAX and the company previously said it has the capacity to produce 2 billion doses by 2022. Novavax’s vaccine rollout worldwide has gotten off to a slow start this year.

Novavax distributed 42 million doses in the first quarter to markets where the vaccine was licensed, including the European Union, Canada, South Korea, Australia, New Zealand and Indonesia. However, the company expects shipments and revenue to increase in the second quarter as it completes an order of 42 million doses from the EU, Trizzino told analysts during the earnings call.

Novavax’s vaccine uses a different technology from that of Pfizer and Moderna. The Pfizer and Moderna vaccines deliver mRNA to the body’s cells, which then make harmless copies of the virus’s mutant protein, triggering an immune response against Covid. The spike protein is the tool the virus uses to get into human cells.

Novavax’s synthesizes full copies of the mutant protein outside the human body. The company inserts the genetic code for the mutation of a baculovirus that will then infect the cells of a certain type of caterpillar. Novavax then harvests twigs from those cells and refines them for spinning. The vaccine also uses a substance called an adjuvant, which is purified from the bark of a South American tree, to boost the immune response.

Novavax’s clinical trials in the United States and Mexico have shown their vaccine to be 90% effective at preventing mild illness and 100% effective at preventing severe disease. However, testing was well underway before the omicron variant appeared, which weakened the vaccine’s effectiveness against infection.

Novavax published results from a laboratory study in December showing that its vaccine still triggers an immune response against omicrons. The study found that the third dose enhanced the immune response to the same extent as clinical trials in the US and Mexico, showing a high degree of protection with the third dose.