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

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Novavax is confident that its vaccine against Covid-19 will receive approval from the advisory committee of the Office of Food and Drug Administration earlier this summer, executives said this week.

The FDA committee is scheduled to meet on June 7 to consider Novavax’s submission. Approval by a committee of independent experts will mean that the drug regulator will almost certainly soon allow a two-dose vaccine for use in the United States

This week, CEO Stanley Erk said Novavax’s manufacturing partner in India, the Indian Serum Institute, has successfully completed an FDA audit. Erk told analysts during a call about the company’s earnings in the first quarter that he fully expects the committee to allow the adult vaccine.

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

“We fully expect that based on our submission, based on all the feedback that has been asked and answered, based on the inspection in Serum, will come out of this meeting with a recommendation for permission for emergency use,” said Trizino. during Bank of America’s virtual health conference on Wednesday night.

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

“It’s an incredibly complex review process that involves reviewing not only the clinical data, but also the production data that will be needed to make an emergency decision,” said Dr. Doran Fink, Deputy Director of Clinical Review in the Vaccine Division. The FDA said last month a committee of independent consultants on the Vaccine Centers for Disease Control and Prevention.

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

The vaccine will hit the U.S. market at a time when 76% of adults are already fully vaccinated. Trizino said Wednesday that Novavax injections will give a choice to the rest of the adult population, who prefer not to receive the mRNA vaccine. The Novavax vaccine uses more conventional protein technology, while Pfizer and Moderna use information RNA platforms that were first allowed during coronavirus pandemic. Trizino said injections may also play an important role as booster doses and in adolescents aged 12 to 17 years.

Novavax has passed its data from teenagers to the FDA and is also providing data on booster doses, Chief Physician Philip Dubowski said during a call about the company’s earnings. It is unclear, however, if the FDA may view vaccination campaigns for teens and as booster doses.

The FDA’s authorization for the vaccine will work properly, as the drug regulator is considering recycling Covid injections this fall to target mutations that the virus has evolved over the past two years. All modern vaccines, including Novavax, target the adhesion protein of the original strain of the virus, which appeared in Wuhan, China, in 2019. As the virus developed, injections became less effective in blocking infections.

Novavax plans to begin clinical trials this month on a version of the vaccine aimed at omicron mutations, Erk said during a campaign call about profits. Trizino in an interview with the Bank of America said the goal is to get vaccines ready by October for the fall vaccination campaign when the FDA decides to move forward with the vaccine update.

“Our opinion of the fall, we must be ready to do what our client wants,” said Trizino, referring to the US government. “We intend to obtain clinical data, a package that is submitted for this, and then be able to deploy in October.”

It is unclear how many injections the U.S. government will order if the vaccine is approved. Erk said Novavax is now in discussions with the U.S. about how the company can support demand. Novavax received $ 1.8 billion from the U.S. government as part of Operation Warp Speed ​​to deliver 100 million doses, although the government will decide how many injections it wants after FDA approval.

Shares of Novavax fell 13% this week due to uncertain demand for filming and after the company missed the stock on Wall Street. earnings and earnings for the first quarter expectations. Although Novavax has kept its sales forecast for 2022 at $ 4 billion to $ 5 billion, CFO Jim Kelly said the company has not yet received an order from COVAX, an international alliance that buys drugs for poor countries. It’s unclear how much COVAX can order, Kelly said it could put downward pressure on sales management.

Last year, Novavax signed a memorandum of understanding to make 1.1 billion doses of its vaccine available to COVAX, and earlier the company said it had the potential to produce 2 billion doses in 2022. However, the spread of the Novavax vaccine around the world began sluggishly earlier this year.

Novavax delivered 42 million doses in the first quarter to markets where the vaccine is already allowed, including the European Union, Canada, South Korea, Australia, New Zealand and Indonesia. However, the company expects supplies and revenues to increase in the second quarter as it fulfills an order of 42 million doses from the EU, Trizino told analysts during a call about earnings.

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

Novavax completely synthesizes copies of adhesion protein outside the human body. The company inserts the genetic code of the thorn into the baculovirus, which then infects the cells of a certain type of moth. Novavax then collects the spike from these cells and cleans them for a shot. To boost the immune response, the vaccine also uses what is known as an adjuvant, peeled from the bark of the South American tree.

A Novavax clinical study in the United States and Mexico found that its vaccine was 90% effective in preventing lung disease and 100% effective in preventing serious disease. However, the study was conducted long before the omicron variant appeared, which undermined the effectiveness of the vaccine against the infection.

Novavax published the results of a laboratory study in December that showed that its vaccine still elicits an immune response against omicron. The study found that the third boosts the immune response to levels similar to clinical trials in the U.S. and Mexico, indicating a high level of protection with the third injection.

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