Novavax confident Covid vaccine will receive FDA clearance in June after delays


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

The FDA committee is scheduled to meet on June 7 to review Novavax’s submission. Approval from the committee, which is made up of independent experts, would mean the drug regulator is almost certain to quickly authorize the use of the two-dose vaccine in the United States.

CEO Stanley Erck said this week that Novavax’s manufacturing partner in India, the Serum Institute of India, had successfully passed an FDA inspection. Erck told analysts on the company’s first-quarter earnings call that he fully expects the committee to clear the vaccine for adults.

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

“We expect that, based on our submission, based on all questions that have been asked and answered, based on the inspection at Serum, to come out of this meeting with a recommendation for clearance to ’emergency use,'” 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 license the vaccine in January, but federal health officials said the request was complex.

“This is an incredibly complex review process that involves reviewing not only clinical data, but also manufacturing data that will be needed to make a decision on emergency use authorization,” said Dr. Doran Fink, deputy director of clinical review in the FDA’s vaccines division, told the Centers for Disease Control and Prevention’s independent vaccine advisory committee 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, Moderna and Johnson & Johnson are the three vaccines currently used in the United States, and the FDA last week restricted the use of J&J’s vaccines.

The vaccine would enter the US market at a time when 76% of adults are already fully vaccinated. Trizino said Wednesday that Novavax injections 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 from Pfizer and Moderna use messenger RNA platforms first licensed during the coronavirus pandemic. Trizino said the injections could also play an important role as booster doses and in adolescents aged 12 to 17.

Novavax has submitted its adolescent data to the FDA and is also filing data on booster doses, Chief Medical Officer Philip Dubovsky said during the company’s earnings call. It’s unclear, however, when the FDA may consider the company’s injections for teens and as booster doses.

FDA clearance of the vaccine would come just as the drug regulator plans to redesign Covid injections 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 strain of the virus that emerged in Wuhan, China, in 2019. As the virus has evolved, injections have become less effective at blocking the infections.

Novavax plans to launch a clinical trial this month of a version of the vaccine that targets omicron mutations, Erck said during the company’s earnings call. Trizino, during the Bank of America interview, said the goal was to have the vaccines ready by October for a fall vaccination campaign if the FDA decided to go ahead with the vaccine update.

“Our thinking is in the fall, we have to be ready to do what our client wants,” Trizino said, referring to the US government. “We intend to have the clinical data, the package filed for that, and then be able to roll out by October.”

It’s unclear how many vaccines the US government would order if the vaccine received approval. Erck said Novavax is currently in discussions with the United States about how the company can support the request. Novavax received $1.8 billion from the US government under Operation Warp Speed ​​to deliver 100 million doses, although the government decides how many doses it wants after FDA clearance .

Novavax stock fell 13% this week on uncertain demand for the shots and after the company missed Wall Street expectations for first-quarter earnings and revenue. Although Novavax maintained its 2022 sales forecast of $4 billion to $5 billion, Chief Financial Officer Jim Kelly said the company has yet to receive an order from COVAX, the international alliance that provides vaccines to countries. the poorest. It’s unclear how much COVAX can order, Kelly said, which could put downward pressure on the sales forecast.

Last year, Novavax signed a memorandum of understanding to make 1.1 billion doses of its vaccine available to COVAX, and the company has previously said it has the capacity to manufacture 2 billion doses in 2022. However, Novavax’s vaccine rollout around the world got off to a sluggish start this year.

Novavax delivered 42 million doses in the first quarter in markets where the vaccine is already 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 fills an order for 42 million doses from the EU, Trizino told analysts on the earnings call.

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

Novavax synthesizes copies of the spike protein entirely outside of the human body. The company inserts the woodpecker’s genetic code into a baculovirus which then infects the cells of a certain type of moth. Novavax then harvests the tip of these cells and purifies them for firing. The vaccine also uses what is called 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 its vaccine to be 90% effective in preventing mild disease and 100% effective in preventing severe disease. However, the trial was conducted long before the emergence of the omicron variant, which compromised the effectiveness of the vaccine against the infection.

Novavax released the results of a lab study in December that found its vaccine still triggered an immune response against omicron. The study found that a 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 vaccine.


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