In a late-stage trial in the United Kingdom, Novavax's COVID-19 vaccine was over 96% effective against the original COVID-19 strain, potentially bringing another inoculation to market soon in the global battle against the coronavirus.
The vaccine also proved 86% effective against the variant first discovered in the United Kingdom, a promising sign as variants continue to spread worldwide.
In a smaller trial in South Africa, where volunteers were exposed primarily to a newer, more contagious variant first identified in the country, the vaccine was 55% effective among HIV-negative participants – but in both trials, the vaccine was 100% effective in preventing serious illness and death.
"We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials. Importantly, both studies confirmed efficacy against the variant strains," Stanley C. Erck, President and CEO of the Maryland-based Novavax, said in a statement released Thursday, the one-year anniversary of the WHO declaring COVID-19 a pandemic.
"With this data in hand, we are even more motivated to advance our vaccine as a potential weapon in the fight to end the suffering caused by COVID-19," Erck continued.
Novavax's regimen of two doses spread over a month is similar to those by Pfizer and Moderna.
It is not clear when Novavax will seek authorization from the United States, and the company is awaiting data from a 30,000-person trial in the U.S. and Mexico by April, but the company is expecting to submit for regulatory approval in the U.K. in the second quarter of 2021. U.S. regulators could decide that the U.K. trial's data is enough to make a decision, but it remains to be seen whether the United States will decide to do so.
"Ultimately, they have to decide whether the data we can bring to the table is adequate or whether they would prefer to wait on data from our U.S. study," Novavax Chief Medical Officer Filip Dubovsky told Reuters Thursday.