Novavax confident Covid vaccine will receive FDA authorization 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 will meet on June 7 to review Novavax’s submission. An approval from the commission, which is made up of independent experts, would mean that the drug regulatory agency will almost certainly soon approve 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 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 fully expect based on our submission, based on all the back and forth questions that have been raised and answered, based on the inspection in Serum, to come out of that meeting with a recommendation for emergency use authorization,” Trizzino said. . at Bank of America’s virtual healthcare conference on Wednesday night.

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

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

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

The vaccine would hit the US market at a time when 76% of adults have already been fully vaccinated. Trizzino said on Wednesday that Novavax’s injections would provide a choice for the rest of the adult population who would rather not receive an mRNA vaccine. Novavax’s vaccine uses more conventional protein technology, while Pfizer’s and Moderna’s use messenger RNA platforms that were first approved during the coronavirus pandemic. Trizzino said the injections could also play an important role as a booster dose and in teens ages 12 to 17.

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

The vaccine’s FDA authorization would be fine as the drug regulatory agency considers redesigning Covid shots this fall to address 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 2019 in Wuhan, China. As the virus has progressed, the injections have become less effective at blocking infections.

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 earnings call. Trizzino said during the Bank of America interview that the goal is to have the shots ready for a fall vaccination campaign by October, should the FDA decide to continue updating the shots.

“We think in the fall, we should be ready to do what our customer wants,” Trizzino said, referring to the US government. “We plan to have the clinical data, the package that has been submitted for that, and then be able to deploy in the October time frame.”

It’s unclear how many injections the US government would order if the vaccine is approved. Erck said Novavax is now in talks with the US about how the company can meet demand. Novavax has received $1.8 billion from the US government under Operation Warp Speed ​​to deliver 100 million doses, though the government will decide how many injections it wants after FDA approval.

Novavax shares are down 13% this week on uncertain demand for the shots and after the company missed Wall Street’s first-quarter earnings and revenue forecast. Although Novavax maintained its sales forecast of $4 billion to $5 billion for 2022, CFO Jim Kelly said the company has not yet received an order from COVAX, the international alliance that obtains shots for poorer countries. It’s unclear how much COVAX may 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 said it has the capacity to produce 2 billion doses by 2022. However, the global rollout of Novavax’s vaccine has started. a difficult start this year.

Novavax delivered 42 million doses in the first quarter to markets where the vaccine has already been approved, including the European Union, Canada, South Korea, Australia, New Zealand and Indonesia. However, the company expects shipments and revenues to pick up in the second quarter as it fulfills 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 injections. The Pfizer and Moderna vaccines deliver mRNA to the body’s 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’s completely synthesizes the copies of the spike protein outside the human body. The company inserts the genetic code for spike into a baculovirus that then infects cells for a particular type of moth. Novavax then harvests the peak from those cells and purifies them for recording. The vaccine also uses what is known as 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 trial was conducted long before the emergence of the omicron variant, which has undermined the vaccine’s effectiveness against infection.

Novavax released results of a lab study in December that showed the vaccine still elicited an immune response against omicron. The study found that a third increased the immune response to levels comparable to the clinical trial in the US and Mexico, suggesting a high level of protection with a third injection.

Leave a Comment

Your email address will not be published.