The Novavax COVID vaccine is going to a U.S. FDA advisory committee.
(Reuters) – On Tuesday, advisers to the U.S. Food and Drug Administration will decide whether to recommend Novavax Inc.’s COVID-19 vaccine for adults. The drugmaker hopes that some Americans who are sceptical about vaccines will choose this shot over others.
Novavax’s shot is a more traditional type of vaccine that uses technology that has been used for decades to fight diseases like hepatitis B and influenza.
The company wants to reach the less than one-quarter of U.S. adults who haven’t been vaccinated yet, especially those who don’t want to get a vaccine like the ones made by Pfizer/BioNTech or Moderna (NASDAQ: MRNA) Inc., which are based on new messenger RNA (mRNA) technology.
John Trizzino, the Chief Commercial Officer of Novavax, told reporters at the end of last month that there are still a lot of people who haven’t been vaccinated. “I think people who have been hesitant to get a vaccine or who prefer something other than the mRNA vaccine will get it.”
This demand hasn’t shown up in Europe, where Novavax also said it could get people who aren’t sure about getting vaccinated to do so.
Around 12.6 million doses of Novavax’s vaccine have been given out in the European Union, but only about 220,000 doses of the two-shot inoculation have been given out there since it came out in December.
The Department of Health and Human Services says that in the near future, there may not be many Novavax shots available in the United States (HHS).
An HHS spokesperson said Monday that the agency is working with Novavax “to receive a limited amount of vaccine and will make that vaccine available to the American public” if the shot is approved by the FDA and recommended by the Centers for Disease Control and Prevention.
Novavax filed for U.S. approval at the end of January, almost a year later than it had planned. This was because of problems with development and production. The Serum Institute of India is also making the vaccine.
Novavax said that about 41 million doses were given out in 41 different countries in the first three months.
In documents for the meeting that were made public on Friday, the FDA said that data showed it could lower the risk of mild to severe disease. It also made people worry that the vaccine could cause an inflammation of the heart called myocarditis, which has been seen after mRNA vaccinations, mostly in young men.
Novavax thought that its sales would be between $4 billion and $5 billion this year. Refinitiv says that analysts expect sales to be at the low end of that range.
Stewart Glickman, an analyst at CFRA, said, “Their pace has to really improve just to get to the low end of the range.” He also said that the company’s forecast is based on risky sales to low-income countries, where orders may be delayed or cut.