The U.S. Food and Drug Administration has announced that Novavax, Inc.’s (NASDAQ: NVAX) COVID-19 vaccine could prevent mild to severe infection. It could also protect people from the omicron strain of COVID-19. The regulator had analysed data from the company trials before omicron and delta became the main variants causing infection.
According to the FDA staff, the data from the trial leads the regulator to believe that the vaccine could reduce the risk of infection of the omicron strain, especially deadly diseases. Moreover, this could give people more choices in protecting themselves against the virus.
The vaccine carries a risk of myocarditis and pericarditis
The study involved 30,000 adult participants from Mexico and the U.S. The researchers determined that the vaccine had a 90.4% efficacy. Despite this, the GDA pointed out that the vaccine carried a risk of myocarditis and pericarditis.
Myocarditis and pericarditis are conditions caused by inflammation of the heart and surrounding tissues. It is a common side effect of rival mRNA vaccines. During Novavax’s study, five trial participants developed myocarditis twenty days after receiving their shot. Scientists suspect that the disease itself caused the fifth case. However, they have not found another explanation for the other four.
The side effect has also been seen in vaccines developed by Pfizer Inc. (NYSE: PFE), BioNTech SE (NASDAQ: BNTX), and Moderna Inc (NASDAQ: MRNA), which also make mRNA vaccines. While this adverse effect is not common, it still raises significant concerns with regulators.
The FDA will hold a meeting with its advisory board
The FDA has published their view on the Novavax vaccine. It is now awaiting a meeting with outside advisers on the shot. This meeting will help the regulator decide on authorising the vaccine for adult use. While the FDA is not bound to recommendations given by its advisory committee, it usually follows them. Following the news of the upcoming meeting, Novavax shares went down by over 16%.
Novavax stands out from other mRNA vaccines as it is developed on a more traditional vaccine platform compared to the commands produced by other companies. This fact might convince people who haven’t gotten their shots to get vaccinated. The technology that Novavax used to create its vaccine is similar to that of influenza virus shots.