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

Novavax is confident its Covid-19 vaccine will receive approval from 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 application. Approval from the committee, made up of independent experts, would mean the drug agency will almost certainly quickly approve the two-dose vaccine for use in the United States

CEO Stanley Erck said this week that Novavax’s manufacturing partner in India, the Serum Institute of India, has successfully completed an FDA inspection. Erck told analysts during the first-quarter earnings call that he fully expects the committee to approve the adult vaccine.

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

“We anticipate that based on our submission, based on all the questions asked and answered back and forth based on the inspection at Serum, from this meeting we will issue an Emergency Authorization Recommendation,” Trizzino said during the Bank of America virtual health conference on Wednesday night.

The FDA has been reviewing Novavax’s application for months. The vaccine maker asked the drug agency in January to approve the vaccine, but federal health officials said the application was complex.

“This is an incredibly complex review process that involves not only reviewing clinical data but also the manufacturing data needed to make an emergency use approval decision,” said Dr. Doran Fink, deputy director of clinical review at the FDA’s Vaccine Division, told the Centers for Disease Control and Prevention’s Committee of Independent Vaccine Advisors last month.

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

The vaccine would come to the US market at a time when 76% of adults are already fully vaccinated. Trizzino said Wednesday that Novavax’s vaccines would provide a choice for the rest of the adult population who would prefer not to receive an mRNA vaccine. Novavax’s vaccine uses more conventional protein technology, while those of Pfizer and Moderna use messenger RNA platforms first approved during the coronavirus pandemic. Trizzino said the shots could also play an important role as booster doses and in teenagers aged 12 to 17.

Novavax has submitted its teenage data to the FDA and is also filing data on booster doses, Chief Medical Officer Philip Dubovsky said during the company’s conference call. However, it’s unclear when the FDA will consider the company’s shots for teens and as booster doses.

FDA approval of the vaccine would come at just the right time as the drug agency considers redesigning Covid shots this fall to target mutations the virus has developed over the past two years. All current vaccines, including Novavax, target the spike protein of the original virus strain that emerged in Wuhan, China in 2019. As the virus has evolved, vaccines have become less effective in fighting off infection.

Novavax plans to start a clinical trial this month with a version of the vaccine that targets omicron mutations, Erck said during the company’s conference call. Trizzino said during the Bank of America interview that the goal is to have the recordings ready by October for a fall vaccination campaign if the FDA decides to proceed with updating the recordings.

“Our thinking is in the fall, we have to be ready to do what our customers want,” Trizzino said, referring to the US government. “We intend to have the clinical data and the package submitted for it and then be able to provide it in the October timeframe.”

It’s unclear how many shots the US government would order should the vaccine be approved. Erck said Novavax is currently in talks with the US about how the company can support demand. Novavax has been awarded $1.8 billion by the US government to deliver 100 million doses as part of Operation Warp Speed, although the government will decide how many shots it wants after FDA approval.

Novavax stock is down 13% this week on uncertain demand for the shots and after the company missed Wall Street’s earnings and revenue expectations for the first quarter. Though Novavax kept its 2022 sales guidance of $4 billion to $5 billion, CFO Jim Kelly said the company has yet to secure an order from COVAX, the international alliance that sources syringes for poorer nations. It’s unclear how much COVAX might order, Kelly said, which could put pressure on sales forecasts.

Last year, Novavax signed a letter of intent to provide 1.1 billion doses of its vaccine to COVAX, and the company previously said it has the capacity to manufacture 2 billion doses in 2022. However, global rollout of Novavax’s vaccine has gotten off to a slow start this year.

Novavax shipped 42 million doses in the first quarter to markets where the vaccine is already approved, including the European Union, Canada, South Korea, Australia, New Zealand and Indonesia. However, the company expects shipments and revenue to rise in the second quarter as it fills an order for 42 million doses from the EU, Trizzino told analysts during the earnings call.

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

Novavax synthesizes the spike protein copies entirely outside of the human body. The company inserts the genetic code for Spike into a baculovirus, which then infects cells for a specific species of moth. Novavax then harvests the spike from these cells and purifies them for the shot. The vaccine also uses something called an adjuvant, purified from the bark of a South American tree, to boost the immune response.

Novavax’s clinical trial in the US and Mexico found that the vaccine was 90% effective in preventing mild disease and 100% effective in preventing severe disease. However, the study was conducted well before the advent of the Omicron variant, which has undermined the vaccine’s effectiveness against infections.

Novavax released results of a lab study in December that found its vaccine still elicited an immune response against Omicron. The study found that one-third boosted the immune response to levels similar to the clinical trial in the US and Mexico, suggesting a high level of protection with a third vaccination.