J&J COVID-19 vaccine could be available in Europe in April: source

18 Jan, 2021
Johnson & Johnson could deliver the first doses of its COVID-19 vaccine to Europe in April, an EU official told Reuters on Wednesday after a top lawmaker said the U.S. healthcare company was likely to seek EU regulatory approval in February.

Clinical data on the vaccine has been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval.

A senior EU official, who is involved in negotiations with vaccine makers and spoke on condition of anonymity, said the J&J shot could be available from April 1 in Europe.

Earlier on Wednesday, an EU lawmaker said J&J could seek EU approval for its one-shot vaccine in February.

“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who speaks on health matters for the EU’s centre-right group, the assembly’s largest.

Following Liese’s comments, a spokesman for Kyriakides said: “We cannot give any precise indications regarding an application for conditional marketing authorisation, but we of course hope that an application could be submitted in the coming weeks.”

EMA, in a statement, said “a date for submission of a marketing authorisation application has not yet been confirmed.”


For reading full text click the link.