J&J COVID-19 vaccine could be available in Europe in April: source18 Jan, 2021
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.