NovavaxAccording to executives, Covid-19 is expected to be approved early in summer by the Food and Drug Administration’s advisory panel.

Novavax will be submitted to the FDA for review on June 7, when it is expected to meet with members of its committee. A recommendation from this committee of experts would almost guarantee that Novavax will be approved by the FDA to use the two dose vaccine in the United States.

Stanley Erck, the CEO of Novavax, said this week, that Serum Institute of India (Novavax’s manufacturing partners in India) has completed an FDA inspection. Erck stated to analysts in the company’s quarterly earnings call, that he expects the FDA committee to approve the vaccine for adults.

John Trizzino (Chairman Commercial Officer) stated in an interview that all indicators point to a positive recommendation of the committee next week.

Trizzino stated that, “Based upon our submission and all the back-and forth questions, which have been answered, and based on the inspection at Serum,” he expected to leave that meeting with an emergency use authorization recommendation.” Trizzino spoke during the Bank of America’s Virtual Health-Care Conference.

Novavax has been submitted to the FDA for several months. Although Novavax’s vaccine maker requested that the regulator approve the vaccine in January of this year, federal officials stated that the application was too complex.

“This is an extraordinarily complex review process that includes review of both clinical and manufacturing data required for emergency use authorization determinations,” Dr. Doran Fink from the FDA’s vaccine department, said to the Centers for Disease Control and Prevention’s independent advisory committee.

Novavax’s vaccine will become the first to be approved by FDA if it is successful in reaching the U.S. market within a period of more than one year. Pfizer, Moderna Johnson & Johnson are the three vaccines currently used in the U.S., and the FDA last week limited the use of J&J’s shots.

It would be available for purchase in the U.S. at a moment when 76% of Americans are fully vaccinated. Trizzino indicated Wednesday that Novavax’s vaccines would be available to those adults who prefer to not receive an mRNA vaccination. Novavax’s vaccine employs more conventional technology for protein, while Moderna’s uses messenger RNA platforms which were approved by Pfizer. the coronavirus pandemic. Trizzino suggested that the shots might also serve as booster doses for teenagers between 12 and 17.

Novavax’s data has been submitted to FDA from teens. It is also filing booster dose data, Philip Dubovsky, chief medical officer of the company said in the earnings call. However, it is not clear when Novavax’s data from teenagers will be considered by the FDA for booster doses and shots for teens.

FDA approval of the vaccine comes at a time when the drug regulator is looking into redesigning Covid shots in the fall to address mutations that the virus has evolved over the last two years. Novavax is the only vaccine that targets the original virus strain, which emerged in Wuhan (China) in 2019. The effectiveness of the vaccines has decreased as the virus evolves.

Novavax intends to start a clinical trial on its vaccine against omicron mutants this month, Erck announced during the earnings call. Trizzino said during the Bank of America interview that Novavax aims to have vaccines ready for October in case the FDA updates the shots.

Trizzino, speaking of the U.S. Government, stated, “Our thinking in the fall. We need to be prepared to do what our customers want.” We expect to receive the clinical data and the complete package by October.

If the vaccine is approved, it’s not clear how many shots would be ordered by the U.S. government. Erck stated that Novavax was in talks with the U.S. about how it can meet demand. Novavax received $1.8B from the U.S. under Operation Warp Speed. It is expected to ship 100 million doses. However, the FDA will determine how many shots Novavax wants.

Novavax shares fell 13% last week because of uncertain demand and Wall Street’s rejection. first-quarter earnings and revenue expectations. Novavax’s 2022 sales forecast of $4 billion-$5 billion was maintained, but Jim Kelly, Novavax’s CFO, stated that the company had not received an order yet from COVAX. This international alliance procures shots to poorer countries. Kelly indicated that the COVAX order amount could be lower than expected, but it’s not known how large.

Novavax and COVAX signed last year a memorandum to agree to provide 1.1 billion doses to COVAX. The company had previously stated that it can produce 2 billion doses by 2022. Novavax has had a slow start to its global vaccine rollout.

Novavax distributed 42 million doses of the vaccine in its first quarter to all countries that have approved it, which included the European Union, Canada and South Korea. Trizzino, a Trizzino analyst, stated that Novavax expects to see an increase in shipments and revenues as it fulfills an order for 42 million doses of the EU.

Novavax uses a different vaccine technology from Moderna and Pfizer. Moderna and Pfizer vaccines deliver mRNA into the cells of the body. The virus spike protein then produces harmless copies which in turn trigger an immune response to fight Covid. This is how the virus invades human cells using spike protein.

Novavax fully synthesizes spike proteins outside of the human body. This company infects cells with a virus that contains the genetic code of spike. Novavax takes the spike out of those cells, and then purifies it for use in the shot. To boost immune responses, the vaccine uses adjuvant. It is a substance that’s extracted from South American trees.

Novavax’s clinical trials in Mexico and the U.S. found its vaccine to be 90% effective against mild illnesses and 100% for severe disease prevention. The trial took place before the Omicron variant was developed, so it has weakened vaccine effectiveness.

Novavax published December lab results that showed the vaccine still triggers an immune reaction against omicron. According to the study, a third of vaccines boosted immune responses to similar levels to those in Mexico’s clinical trial. It suggests that third shots can provide high protection.