Citing AstraZeneca Plc's (NASDAQ:AZN) head of research and development, the Financial Times reported that the Company would consider not submitting its COVID-19 vaccine for approval in the U.S. if the regulatory process takes too long.
According to the report, AstraZeneca's R&D head, Mene Pangalos, said AstraZeneca would instead focus on selling the vaccine in other countries, though it will continue talks with the FDA. "We don't need to push it in places we are not needed or wanted," Pangalos told the Financial Times. If we don't end up submitting it for a BLA [biologics license application], I don't think it will have an impact around the world."
Related: AstraZeneca, GSK's COVID-19 Therapies Lose Efficacy Against Omicron's Subvariants.
The U.S. officials have expressed concern over how AstraZeneca presented data on the efficacy of its vaccine. In recent months, senior officials have stopped talking about the possibility of AstraZeneca's Covid vaccine hitting the U.S. market. "That product has fallen off my radar," one told the Financial Times.
But the U.S. is relying on the Company for the supply of its long-acting antibody treatment, Evusheld.
Read Next: White House Warns It Cannot Afford COVID-19 Related Solutions If Cases Increase: FT.
Price Action: AZN shares are down 1.08% at $62.98 during the premarket session on the last check Friday.
