Novavax announced a delay in plans to file for U.S. FDA authorization for its vaccine last week. The company said it intends to file emergency approval in the fourth quarter.
Novavax also announced it asked regulators to permit emergency use of its COVID - 19 vaccine to several poor countries before rich ones with ample supplies. The company partnered with the Serum Institute of India to apply for the three projects.
Preliminary company findings suggest a single booster dose administered six months after the initial two-dose regimen resulted in an increase of antibody levels with an over 6 fold increase in antibodies 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, where participants in a 5-microgram dose group received the booster shot some 189 days after initial vaccine schedule. The shot was described as generally well-tolerated with the vast majority of side effects reported after the third shot described as mild-to-medium.
Novavax also expects to publish 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.
Novavax shots are easier to transport and store than some other options, and have long been expected to play an important role in increasing supply in poor countries desperate for more vaccines.
In mid-June, the company announced its was found to be over 90% effective overall and provides 100% protection against moderate and severe disease in a Phase 3 clinical trial. The Phase 3 PURE 19 trial enrolled nearly 30,000 participants ages 18 and older in the U.S. and Mexico. Data reflected 63 COVID - 19 cases reported among the vaccine group and 14 in placebo group. All cases diagnosed in the placebo group were classified as mild, while 10 cases in the vaccine group were moderate and four were severe.