Novavax Says Trials Show Its Covid Vaccine To Be Safe And 90% Effective
The vaccine manufacturer plans to apply for FDA clearance in the third quarter of this year. If authorized, it would be the fourth vaccine available in the U.S. And another coronavirus shot option would help boost global vaccination efforts.
CNBC:
Novavax Says Its Covid Vaccine Is 90% Effective, Plans FDA Submission In Q3
Biotech firm Novavax said Monday its Covid-19 vaccine was shown to be safe and 90.4% effective overall in a phase three clinical trial of nearly 30,000 participants across the United States and Mexico. Additionally, it said the two-dose vaccine was found to be 100% effective in preventing moderate and severe disease and 93% effective against some variants. The company said it plans to file for authorization with the Food and Drug Administration in the third quarter. (Lovelace Jr., 6/14)
AP:
Novavax: Large Study Finds COVID-19 Shot About 90% Effective
While demand for COVID-19 shots in the U.S. has dropped off dramatically, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies in the developing world. That help is still months away, however. The company says it plans to seek authorization for the shots in the U.S., Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then. (Johnson, 6/14)
NPR:
Novavax Says Its COVID Vaccine Is Extremely Effective
In addition to efficacy, the PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19) trial showed the Novavax vaccine was safe for users. Like other COVID-19 vaccines, it caused headaches, chills and muscle aches after injection, but few of these side effects were considered serious or severe. The study involved 29,960 volunteers in the United States and Mexico. In the study, two-thirds of the volunteers received two shots of the vaccine and one-third received two shots of a placebo. (Palca, 6/14)