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

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

The FDA committee will meet on June 7 to review Novavax’s presentation. The approval of the panel of independent experts would mean that the drug regulator is almost certain that it will quickly allow a two-dose vaccine for use in the U.S.

CEO Stanley Erck said this week that Novavax’s Indian manufacturing partner, the Serum Institute of India, has successfully completed its FDA audit. Erck told analysts in the company’s first-quarter earnings call that he fully hoped the board would allow the adult vaccine.

Commercial director John Trizzino, in an interview with Bank of America, said all the signals were in line with a positive recommendation from the commission next month.

“Based on our submission, based on all the questions asked and answered, based on the Serum inspection, we hope to come out of that meeting with a recommendation for emergency permission,” Trizzino said. Wednesday evening at the Bank of America’s virtual health care conference.

The FDA has been reviewing Novavax’s shipment for months. The author of the vaccine asked the regulatory regulator to authorize the vaccine in January, but federal health officials said the request was complex.

“It’s an incredibly complex review process that reviews not only the clinical data, but also the manufacturing data that is needed to decide on the emergency use permit,” said Dr. Doran Fink, deputy director of clinical review for the FDA’s vaccine division. he told the board of independent vaccine advisors at the Centers for Disease Control and Prevention last month.

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

The vaccine would enter the U.S. market by the time 76% of adults are fully vaccinated. Trizzino said Wednesday that Novavax’s shooting would allow the rest of the adult population to prefer not to receive the mRNA vaccine. Novavax vaccine uses more conventional protein technology, with Pfizer’s and Modern’s RNA messenger platforms for the first time using platforms authorized in the coronavirus pandemic. Trizzino said shots can also play an important role in booster doses and in adolescents between the ages of 12 and 17.

Novavax has submitted data on teens to the FDA and is also submitting data on booster doses, medical director Philip Dubovsky said in the company’s profit announcement. It is unclear, however, when the FDA may consider the company as a vaccine and booster dose for teens.

The FDA’s vaccine authorization would be welcome, as drug regulators are reviewing the redesign of Covid’s shots this fall to address mutations that the virus has developed over the past two years. All current vaccines, including Novavax, target the spinal protein of the original strain of the virus that originated in Wuhan (China) in 2019. As viruses have evolved, they have become less effective at blocking infections.

Novavax plans to launch a clinical trial this month with a version of the vaccine aimed at omicron mutations, Erck said in the company’s profit announcement. Trizzino, in an interview with Bank of America, said the goal is to have the vaccines ready in October for an autumn vaccination campaign if the FDA decides to move forward with updating plans.

“Our thinking is in the fall, we need to be ready to do what our customers want,” Trizzino said, referring to the U.S. government. “Clinical data, we plan to have the package archived for this purpose and then release it in October.”

It is unclear how many shots the U.S. government would order if the vaccine were approved. Erck said Novavax is now in discussions with the US to find out how the company accepts the request. Novavax has received $ 1.8 billion from the U.S. government to provide 100 million doses under Operation Warp Speed, though the government will decide how many shots it wants after FDA approval.

Shares of Novavax were down 13% this week due to strong demand for plans and the company’s loss of first-quarter earnings and revenue expectations on Wall Street. While Novavax has maintained its $ 4 billion and $ 5 billion sales policy by 2022, CEO Jim Kelly said the company has not yet received an application from COVAX, an international alliance that offers plans for the poorest nations. It’s not clear how much COVAX can charge, 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 manufacture 2 billion doses in 2022. a slow start to this year.

Novavax delivered 42 million doses in the first quarter to markets where the vaccine is already licensed, including the European Union, Canada, South Korea, Australia, New Zealand and Indonesia. However, the company expects to increase shipments and revenues as it meets a 42 million dose order from the EU in the second quarter, Trizzino told analysts in the earnings call.

The Novavax vaccine uses a different technology compared to the Pfizer and Modern shots. Pfizer and Moderna vaccines transmit mRNA to cells in the body, which in turn produce harmful copies of the virus’s apex protein, which triggers an immune response that fights Covid. Spike protein is a tool used by viruses to invade human cells.

Novavax completely synthesizes copies of pike protein outside the human body. The company injects the genetic code of the spike into a baculovirus, which then infects the cells of a particular type of moth. Novavax then gathers the edge of these cells and purifies them for the shot. The vaccine also uses what is known as an adjuvant, purified from the bark of a South American tree to boost the immune response.

A clinical trial in Novavax in the United States and Mexico found that the vaccine was 90% effective in preventing mild illness and 100% effective in preventing serious illness. However, the test was performed long before the creation of the omicron variant, which has weakened the effectiveness of the vaccine against infection.

Novavax released the results of a laboratory study in December that found that its vaccine still causes an immune response to omicron. The study found that one-third boosted the immune response to levels similar to the U.S. and Mexican clinical trials, suggesting a high level of protection with a third shot.

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

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

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