Novavax’s Covid Vaccine Begins Rolling Review Process in U.S.
(Bloomberg) -- Regulators in the U.S. have begun to review certain data required for clearance of Novavax Inc.’s Covid-19 vaccine while final-phase clinical trials are still underway, the company said in a statement.
The process, called a rolling submission, has also begun in the U.K. and Canada, Novavax said. On Wednesday, the company said European regulators were doing a similar review.
“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 Glenn, president of research and development at Novavax, said in the statement.
The Gaithersburg, Maryland-based company will submit more trial data and information about its manufacturing processes to the regulatory authorities as they become available, Novavax said.
The drugmaker is in discussions with the the Food and Drug Administration about whether it could use trial data from other countries where it will have data sooner to seek authorization in the U.S.
Novavax said last week an interim analysis of a trial in the U.K. showed its vaccine to be 89.3% effective in preventing symptomatic Covid-19 and remained effective against the B.1.1.7 strain more common there that has been found in the U.S. The vaccine would help bolster vaccine doses in the U.S. where the FDA has authorized shots from Pfizer Inc. and Moderna Inc. and will likely do the same for one from Johnson & Johnson in the coming weeks.
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