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American biotechnology company Novavax, based in Gaithersburg, Maryland, is looking to have its new COVID-19 vaccine approved by the Food and Drug Administration (FDA) this upcoming September. Novavax has developed something called the recombinant NVX-CoV2373 vaccine using a fragmented spike of the coronavirus pathogen in order to create the vaccine. Below, learn all about the new Novavax vaccine.
What does the data say?
Recent trial results show the Novavax vaccine to have 93 percent efficiency, strongly protecting subjects against the predominant SARS-CoV-2 variants in the trial population in the U.S. and Mexico. Out of almost 3,000 total subjects, the pathogens behind the 77 cases of COVID-19 among the participants were sequenced. This amount of sequencing is relatively high.
The sequencing showed that two cases were caused by the COVID beta variant, while another 35 cases were caused by the alpha variant. The remaining causes are undisclosed.
An independent organization is overseeing further studies via a Phase III clinical trial, called PREVENT-19, to ensure the safe and ethical conduct of the study.
Will Novavax be used widely in the U.S?
Previously, Novavax failed to get FDA approval by its prior goal of June. Last month, Novavax announced it would not seek approval until late September, and if approved, the Novavax vaccine will function as an alternative to the Pfizer vaccine. The Novavax vaccine is more readily stored and potentially less expensive than today’s mRNA options. Novavax’s first vaccines will be brought to a market more accessible to lower-income countries.
Where will Novavax be used?
Last year, the U.S. bet big on Novavax, which has yet to bring a vaccine to the market. Novavax won a $1.6 billion federal grant in exchange for 100 million doses of the shot. But now, these vaccines are likely destined for overseas.
The vaccine has been proving highly effective in clinical trials. The shot has shown 90.4 percent efficacy overall and 100 percent success in preventing moderate or severe disease. However, the trials haven’t yet tested the vaccine in areas with high levels of the Delta variant, which has been growing in prevalence in many countries worldwide.
When will the Novavax vaccine be formally approved?
The logistics of manufacturing the Novavax vaccine has proven to be a more daunting task for than expected. Novavax has yet to file for approval of the shot in the United States and is falling behind its expected timetable.
The delays will impact the vaccine’s uptake in the U.S., where demand has been met primarily by Pfizer, Moderna, and Johnson & Johnson.
In April, despite production delays, analysts predicted a total of $33.3 billion in vaccine sales for Novavax from 2021 to 2027. These predictions included $1.8 billion this year, growing to a peak of $7.2 billion in 2027. That forecast might have to be adjusted, but there’s still plenty of potential and a large market to serve.