June 14, 2021 – Novavax’s COVID-19 vaccine is highly effective and protects against variants of the coronavirus, the company said on Monday.
The bidose vaccine is globally effective at 90.4%, The Associated Press reported, which is similar to the efficacy rates of the Pfizer and Moderna COVID-19 vaccines.
“Today, Novavax takes one more step towards meeting the critical and persistent global public health need for additional COVID-19 vaccines,” said Stanley Erck, Chairman and CEO of Novavax. in a report.
“Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine… to a world that is still in dire need of vaccines,” he said.
The clinical trial recruited 29,960 participants from 119 locations in the United States and Mexico to assess the efficacy and safety of the vaccine, as well as the type of immune response it provides. Two-thirds of people in the study received two doses of the vaccine, spaced 21 days apart.
There were 77 cases of COVID-19 among the participants, including 14 in the vaccine group, all of whom had only mild symptoms. Of the 63 cases in the placebo group, 10 were moderate COVID-19, while four had severe COVID-19.
Novavax’s vaccine provided 100% protection against moderate and severe COVID-19, as well as 93% efficacy against major variants of concern and 91% efficacy in high-risk groups such as adults of over 65, the company said.
Side effects were mostly mild, with pain at the injection site, fatigue, headache, and muscle pain being the most common. There have been no reports of blood clots or unusual heart problems, Erck told the AP.
Novavax intends to file for clearance with the FDA and European agencies in September and plans to produce 100 million doses per month by then, the statement said. Other analyzes will be submitted to peer-reviewed journals for publication. The company is also starting to test the vaccine in 12-18 year olds.
The vaccine, which can be stored in regular refrigerators and is easy to transport, is expected to play a major role in the world’s vaccine supply, the AP reported. More than half of the American population has received at least one dose of the vaccine, but less than 1% of people in developing countries have received a vaccine. Novavax has pledged to deliver 110 million doses to the United States over the next year and 1.1 billion doses to developing countries.