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(Adds J&J comment)
By Francesco Guarascio
BRUSSELS, Jan 13 (Reuters) - 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."
Asked about the timeline described by the EU source and the
lawmaker, which appeared to be slightly behind expectations for
the vaccine in the United States, a J&J spokesman said talks
with regulators were underway, but it was premature to get into
the specifics of supply plans at this stage.
J&J Chief Scientific Officer Dr. Paul Stoffels told Reuters
the drugmaker expects to have clear data on how effective its
vaccine is by the end of this month or early February and was on
track for a U.S. rollout in March.
The EU drugs regulator had said in December it expected the
J&J to apply in the first quarter of this year.
It took EMA 20 days to approve the vaccine developed by
BioNTech SE and Pfizer Inc, and just over a
month to authorise the Moderna Inc shot after their
applications were submitted in early December. The two vaccines
are so far the only ones approved in the EU, while AstraZeneca
submitted its application on Tuesday.
"If all goes well, we will already have the fourth corona
vaccine available in a few weeks," Liese added.
The EU has booked 200 million doses of the J&J vaccine and
has an option to order another 200 million shots. The J&J
vaccine is administered as a single shot, while those from
Moderna and Pfizer/BioNTech require two doses three or four
weeks apart for full protection.
The EU has invested about 360 million euros ($438 million)
to secure the J&J vaccine with a downpayment that would need to
be complemented with payments by EU governments willing to buy
the vaccine after approval.
The U.S. government secured 100 million doses from the
company for $1 billion in an August agreement, with an option to
buy an additional 200 million doses.
($1 = 0.8216 euros)
(Reporting by Francesco Guarascio; Additional reporting by
Julie Steenhuysen in Chicago; Editing by Jason Neely, Louise
Heavens and Bill Berkrot)
