(Reuters) – An AstraZeneca Plc govt mentioned the British drugmaker would take into account not submitting its COVID-19 vaccine for approval in the US if the regulatory course of takes too lengthy, the Monetary Occasions reported on Thursday.
The corporate’s analysis and improvement head, Mene Pangalos, mentioned AstraZeneca would as an alternative concentrate on promoting the vaccine in different nations, although it would proceed talks with the U.S. Meals and Drug Administration, in line with the report.
AstraZeneca didn’t instantly reply to a Reuters request for remark.
“We need not push it in locations we aren’t wanted or wished,” Pangalos advised the Monetary Occasions.
Giving up on U.S. approval could be a contemporary setback for the vaccine which has had a tumultuous 18 months.
Final 12 months, manufacturing issues compelled the corporate to chop deliveries to the European Union, prompting the bloc to launch a authorized problem that has been settled.
Nations together with Britain, Australia and Canada have additionally restricted its use amongst sure age teams following hyperlinks to uncommon blood clots.
The shot has confronted questions since late 2020, when the drugmaker and Oxford College revealed information from its first large-scale trial with two totally different efficacy readings because of a dosing error.
In March final 12 months, U.S. well being officers criticized the drugmaker for utilizing “outdated info” to indicate how nicely its vaccine labored, a extremely uncommon public rebuke.
AstraZeneca Chief Government Officer Pascal Soriot in July final 12 months mentioned it nonetheless deliberate to hunt U.S. approval for its vaccine, licensed in some 170 nations, though the method was taking longer than anticipated.