Novavax’s safe Covid vaccine will receive FDA clearance in June after delays

Novavax is confident that its Covid-19 vaccine will receive approval from the Food and Drug Administration advisory board earlier this summer, executives said this week.

The FDA committee will meet on June 7 to review the Novavax presentation. Approval by the committee, which is made up of independent experts, would mean the drug regulator is almost certain to rapidly authorize the two-dose vaccine for use in the United States.

CEO Stanley Erck said this week that Novavax India’s manufacturing partner, the 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 to authorize the vaccine for adults.

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

“We fully expect, based on our presentation, based on all the back and forth questions that have been asked and the answers, based on the inspection at Serum, to come out of that meeting with a recommendation for authorization to ’emergency use,’ Trizzino said at the Bank of America’s virtual health care conference Wednesday night.

The FDA has been reviewing the Novavax presentation for months. The vaccine manufacturer asked the drug regulator to authorize the vaccine in January, but federal health officials said the question was complex.

“This is an incredibly complex review process that involves reviewing not only the clinical data, but also the manufacturing data that will be needed to make an emergency use authorization decision,” said Dr. Doran Fink, deputy director of clinical review at the FDA’s vaccines division, told the Centers for Disease Control and Prevention’s committee of independent vaccine consultants last month.

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

The vaccine would enter the US market at a time when 76% of adults are already fully vaccinated. Trizzino said Wednesday that Novavax shots would give the rest of the adult population a choice that they would rather not receive an mRNA vaccine. Novavax’s vaccine uses more conventional protein technology, while Pfizer and Moderna’s messenger RNA platforms were first authorized during the coronavirus pandemic. Trizzino said the shots could also play an important role as booster doses and in teens ages 12 to 17.

Novavax has submitted its teen data to the FDA and is also archiving data on booster doses, Chief Medical Officer Philip Dubovsky said during the company’s earnings call. It’s unclear, however, when the FDA might consider the company’s teen shots and how booster doses.

FDA clearance for the vaccine would come just as the drug regulator is considering redesigning the Covid shots this fall to target the mutations the virus has developed over the past two years. All current vaccines, including Novavax, target the spike protein of the original strain of the virus that emerged in Wuhan, China in 2019. As the virus evolved, vaccines became less effective at blocking infections.

Novavax plans to launch a clinical trial this month on a version of the vaccine that targets omicron mutations, Erck said during the company’s earnings call. Trizzino, during the interview with Bank of America, said the goal is to have the vaccines ready by October for a fall vaccination campaign in case the FDA decides to move forward with the shot update.

“Our thinking is in the fall, we have to be ready to do what our client wants,” Trizzino said, referring to the US government. “We intend to have the clinical data, the package that was archived for that and then be able to deploy in the October timeframe.”

It is unclear how many shots the US government would order if the vaccine received clearance. Erck said Novavax is now in discussion with the US about how the company can support demand. Novavax has received $ 1.8 billion from the US government under Operation Warp Speed ​​to dispense 100 million doses, although the government will decide how many shots it wants after FDA clearance.

Novavax shares fell 13% this week due to uncertain demand for the hits and after the company missed its Wall Street stock earnings and revenues for the first quarter expectations. Although Novavax has maintained its 2022 sales lead from $ 4 billion to $ 5 billion, CFO Jim Kelly said the company has not yet received an order from COVAX, the international alliance that delivers strikes to the world’s largest nations. poor. It’s unclear how much COVAX can order, Kelly said, which could put downward pressure on sales guidance.

Last year, Novavax signed a Memorandum of Understanding to make 1.1 billion doses of its vaccine available to COVAX, and the company previously claimed it has the capacity to produce 2 billion doses in 2022. However, Novavax’s worldwide vaccine rollout has got off to a slow start this year.

Novavax delivered 42 million doses in the first quarter to markets where the vaccine is already authorized, 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 fulfills a 42 million dose order from the EU, Trizzino told analysts during the earnings call.

Novavax’s vaccine uses a different technology than Pfizer and Moderna’s. The Pfizer and Moderna vaccines deliver mRNA to the body’s cells, which then make harmless copies of the virus’s spike protein, which induces an immune response that fights Covid. The spike protein is the tool the virus uses to invade human cells.

Novavax completely synthesizes copies of the spike protein outside the human body. The company inserts the genetic code for the tip into a baculovirus which then infects the cells for a certain type of moth. Novavax then collects the tip from those cells and purifies them for the shot. The vaccine also uses what’s known as an adjuvant, purified from the bark of a South American tree, to boost the immune response.

Novavax’s clinical trial in the United States and Mexico found that its vaccine was 90% effective at preventing mild illness and 100% effective at preventing serious illness. However, the study was conducted well before the omicron variant emerged, which undermined the vaccine’s effectiveness against infections.

Novavax published the results of a laboratory study in December that found that its vaccine still triggered an immune response against omicron. The study found that a third boosted the immune response to similar levels to the clinical trial in the United States and Mexico, suggesting a high level of protection with a third shot.