Novavax Has Started a Large Late-stage Study on its Covid Vaccine in the U.S.

Vaccine development company Novavax has begun a late-stage trial of its Covid-19 vaccine in the U.S.

The drug developer announced on Monday that its experimental vaccine started the trial in the U.S. after it was delayed twice due to issues in scaling up the manufacturing process.

The company has said that it will be enrolling up to 30,000 volunteers across about 115 sites in the United States and Mexico, with two-thirds of them receiving the shot 21 days apart and the rest getting placebo.

“With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” said Stanley C. Erck, president and chief executive officer, Novavax.

“We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the U.S. FDA and the government of Mexico on this program.”

The company has also signed supply agreements with several countries and is set to provide 60 million doses to the U.K., where a late-stage study is underway. The interim data from this trial is expected in the first quarter of 2021.

Novavax is already getting ready to deliver 100 million doses to the United States by January after it was awarded $1.6 billion for developing and testing its potential vaccine.

The company is additionally running a fully enrolled Phase 2b trial in South Africa and a Phase 1/2 continuation in the United States and Australia. Efficacy data from the trials could be available early next year.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.