Sir Mene Pangalos, PhD, AstraZeneca’s head of research and development, said the company would not seek U.S. approval if it is “banging its head against a brick wall indefinitely” with regulators.
“We don’t need to push it in places we are not needed or wanted,” he told the Financial Times. “If we don’t end up submitting it for a [biologics license application], I don’t think it will have an impact around the world.”
U.S. regulators have closely scrutinized AstraZeneca’s clinical trial data for the vaccine. The drugmaker has still not filed an approval application with the FDA, with some sources telling The Wall Street Journal last April the company was having trouble compiling the necessary data for it.
If AstraZeneca opts not to submit the vaccine for U.S. approval, the company would instead focus on selling the vaccine in other countries, Dr. Pangalos said.
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