Novavax Announces Start Of Rolling Review Process For Authorization Of COVID-19 Vaccine
GAITHERSBURG, Md. (WJZ) -- Novavax announced Thursday the start of the rolling review process for authorization of its COVID-19 vaccine, by multiple regulatory agencies.
The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom and the United States and through initial authorization for emergency use granted under country-specific regulations, the biotech company said.
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"The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide," Gregory M. Glenn, MD, President of Research and Development, Novavax, said. "We appreciate the agencies' confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination."
To date, Novavax has begun the rolling review process with several regulatory agencies worldwide, including the EMA, FDA, MHRA and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.
Novavax' vaccine candidate is currently in Phase 3 clinical development in both the U.K. and U.S. for the prevention of COVID-19.
It was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa.
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