Novavax sets back COVID-19 vaccine FDA authorization request to fourth quarter

Novavax previously disclosed plans to file for FDA authorization in the third quarter

Maryland-based biotech Novavax announced a delay in plans to file for U.S. FDA authorization of its COVID-19 vaccine last week. The company said it intends to file for emergency approval in the fourth quarter. 

Novavax also announced it asked regulators in India, Indonesia and the Philippines to allow emergency use of its COVID-19 vaccine -- offering its shot to some low-income countries before rich ones with ample supplies. The company partnered with the Serum Institute of India to apply in the three countries.


Preliminary company findings suggested a single booster dose administered six months after the initial two-dose regimen resulted in a 4.6-fold increase in antibody levels, with an over 6-fold increase in antibodies acting against the delta variant. The company intends to submit the findings to a peer reviewed publication.

Results stemmed a Phase 2 trial underway in the U.S. and Australia, in which participants in a 5-microgram dose group received the booster shot some 189 days after the initial vaccine schedule. The shot was reported as "generally well-tolerated" with the vast majority of side effects following the third shot described as mild-to-moderate.


Novavax also expects to file its COVID-19 vaccine for an emergency use listing at the World Health Organization in August, and subject to approval, the global health agency’s COVAX initiative would export the vaccine to numerous participating countries, the company said.

The Novavax shots are easier to store and transport than some other options, and have long been expected to play an important role in increasing supplies in poor countries desperate for more vaccine.

In mid-June, the company announced its COVID-19 vaccine was found to be over 90% effective overall, and offered 100% protection against moderate and severe disease in a Phase 3 clinical trial. The Phase 3 PREVENT-19 trial had enrolled nearly 30,000 participants ages 18 and older in the U.S. and Mexico. Data reflected 63 COVID-19 cases reported among the placebo group and 14 in the vaccine group. All cases identified in the vaccine group were classified as mild, while 10 cases in the placebo group were moderate and four were severe. 

The Associated Press and Fox News’ Alexandria Hein contributed to this report.