Biotech firm Novavax says its COVID-19 vaccine has been found to be 90.4% effective in a phase three clinical trial of nearly 30,000 participants held across the United States and Mexico.
Additionally, the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants of COVID-19, Novavax said. The company plans to file for emergency use authorization with the U.S. Food and Drug Administration (FDA) in the third quarter of this year.
The analysis evaluated 77 confirmed COVID-19 infections among the trial’s 29,960 participants. Novavax said 63 cases of COVID-19 were observed in the placebo group versus 14 cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 90.4%, the company said.
The vaccine also appeared to be well-tolerated, according to the company. The most common side effects were fatigue, headache, muscle pain and pain at the injection site, which usually lasted no more than two or three days, Novavax said.
Novavax said the vaccine also appears to be effective against some coronavirus variants, including the Alpha variant, first identified in the United Kingdom.
If Novavax’s vaccine is authorized by the FDA, it would follow three other shots already approved for emergency use in the U.S. – Pfizer-BioNTech, Moderna and Johnson & Johnson.
The new data comes as federal officials say the U.S. has more than enough doses of COVID-19 vaccines to finish vaccinating the entire American population. As of Sunday, more than 173 million Americans have had at least one dose of a vaccine, according to data from the Centers for Disease Control and Prevention.
It’s possible the U.S. could end up donating doses of the Novavax vaccine. The Biden administration has committed to donating at least 20 million doses of COVID-19 vaccines to other countries.
Novavax said it remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of this year.
