Covid Novavax (NVAX) Q1 2022 earnings.

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Novavax Monday recorded its profitable first quarter when its Covid vaccine was launched in several countries around the world, though the company still missed its earnings and revenue expectations.

Novavax stock fell more than 8% in after hours trading.

Novavax reported net income of $ 203 million in the first quarter, compared with a net loss of $ 222.7 million in the same period last year. The company reiterated its $ 4 billion to $ 5 billion revenue drive for 2022.

Here’s how the company performed compared to what Wall Street predicted, based on analyst average estimates compiled by Refinitiv:

  • Adjusted earnings: $ 2.56 per share, versus $ 2.69 expected
  • income: $ 704 million, versus an expected $ 845 million

Novavax’s two-dose Covid vaccine for adults 18 years of age and older could receive authorization in the United States as early as this summer. The Food and Drug Administration’s committee of independent consultants will meet on June 7 to review the injection data and make a recommendation on whether or not to use it.

Novavax was one of the first participants in Operation Warp Speed, the U.S. government-backed race to develop a Covid vaccine in 2020. Pfizer, Moderna, and Johnson & Johnson ultimately beat the company on time as it struggled to increase its production capacity. Novavax asked the FDA to clear the shooting four months ago in January, but officials said the review process is complicated.

“This is an incredibly complex review process that involves reviewing not only the clinical data, but also the manufacturing data that will be needed to make an emergency use authorization decision,” said Dr. Doran Fink, deputy director of clinical review at the FDA’s vaccines division, told the Center for Disease Control and Prevention’s independent vaccine consultants committee last month.

Novavax has received several authorizations for its two-dose Covid vaccine outside the United States since it released clinical trial data late last year. Australia, Canada, the European Union, Japan and the United Kingdom, among others, have approved the vaccine for adults aged 18 and over.

Novavax’s clinical trial in the United States and Mexico found that the protein-based vaccine was 90% effective in preventing mild disease and 100% effective in preventing severe disease. However, the study was conducted from December 2020 to April 2021, well before the delta and omicron variants emerged and weakened the ability of Covid vaccines to block infections.

Novavax published the results of a laboratory study in December that showed the vaccine triggered an immune response against omicron, although not as strong as the response against the original strain of the virus. A third dose potentiated the immune response against omicron to levels similar to the US and Mexican clinical trial, suggesting a high level of protection with a booster.

If cleared by the FDA, Novavax shots would offer an alternative for people who don’t want to take the Pfizer and Moderna vaccines. Novavax uses more traditional protein-based technology, while shots from Pfizer and Moderna use messenger RNA for the first time. Although Moderna and Pfizer’s shots have been shown to be safe and effective against serious illness, some people may prefer the technology that has a longer track record.

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