Premarket trading of Novavax was halted Tuesday morning ahead of a Food and Drug Administration advisory panel meeting that will determine whether the firm's Covid-19 vaccine could become the fourth FDA-approved vaccine.
There are three potential vaccines in a tray.
The FDA's Vaccines and Related Biological Products Advisory Committee is reviewing the safety and effectiveness of the vaccine from the company's clinical trial data released in January.
The experts will vote on the drug.
The FDA issued a document on Friday that raised concerns about a risk of heart inflammation in people who received the vaccine, but Novavax's shares were up six percent at market close on Monday.
The company faced a number of problems in the race to develop Covid-19 vaccines, including struggling to meet the FDA's quality standards.
More than $1 billion. The U.S. government invested more in Novavax in 2020 than any vaccine company at the time.
Some experts are hoping the new shot will help Americans overcome vaccine hesitancy, as it is not made with new technology like Pfizer-bioNTech and Moderna's shots. The vaccine is similar to the ones used to protect against the flu and contains an ingredient that helps boost the immune system.
The two-dose primary vaccine was found to be effective at preventing mild, moderate or severe Covid infections. The company got a huge boost in funding from the Trump Administration in July of 2020 but faced a number of hurdles in getting regulatory approval because of not meeting quality standards. Indonesia, the Philippines, South Korea, Australia and the United Kingdom have authorized the vaccine. The FDA advisory meeting comes days after the agency warned of a possible risk of heart inflammation as a result of the vaccine, after some cases of myocarditis were found within 20 days of receiving the shot in the vaccine's clinical trial. The FDA asked Novavax to list two types of heart inflammation, myocarditis and pericarditis as risk factors for the vaccine, because of the incidents. After receiving Pfizer and Moderna's Covid vaccines, there have been cases of myocarditis and pericarditis. In a statement on Friday, Novavax said there wasn't enough evidence to show a correlation between the vaccine and heart inflammation.
If the vaccine is approved, will it be widely used? According to data from the Centers for Disease Control, the United States threw out more than 81 million Covid vaccine doses from December 2020 to May 2020. The Department of Health and Human Services is working to get a limited quantity of vaccine if the shot is approved.
Novavax is a latecomer in the vaccine race. The New York Times is a daily newspaper in the United States.
Novavax says the US will stop funding production of its vaccine.
There is a risk of heart inflammation after the vaccine.
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