J&J likely to seek EU approval for COVID-19 vaccine in February - lawmaker

By Francesco Guarascio BRUSSELS (Reuters) - U.S. firm Johnson & Johnson is likely to apply for EU approval for its COVID-19 vaccine candidate in February, a top lawmaker said on Wednesday.

Reuters January 14, 2021 00:07:00 IST
J&J likely to seek EU approval for COVID-19 vaccine in February - lawmaker

COVID-19 vaccine in February - lawmaker" src="https://images.firstpost.com/wp-content/uploads/reuters/01-2021/14/2021-01-13T120748Z_1_LYNXMPEH0C0UL_RTROPTP_2_HEALTH-CORONAVIRUS-VACCINE-USA.jpg" alt="JJ likely to seek EU approval for COVID19 vaccine in February lawmaker" width="300" height="225" />

By Francesco Guarascio

BRUSSELS (Reuters) - U.S. firm Johnson & Johnson is likely to apply for EU approval for its COVID-19 vaccine candidate in February, a top lawmaker said on Wednesday.

Clinical data of the vaccine, which Johnson & Johnson is developing through its subsidiary Janssen, have been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval.

"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 represents health matters for the EU's centre-right group, the assembly's largest.

A spokesman for Kyriakides said later on Wednesday: "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."

"A date for submission of a marketing authorisation application has not yet been confirmed," EMA said later on Wednesday.

Johnson & Johnson did not immediately respond to a request for comment.

The possible approval timeline in the EU appears to be slightly slower than that expected in the United States.

Moncef Slaoui, chief advisor to the U.S. government's Operation Warp Speed, said at a media briefing on Tuesday that he expected Johnson & Johnson to apply for U.S. emergency authorization by the end of January, which could lead to approval by mid-February.

The EU drugs regulator had said in December it expected the company to apply in the first quarter of this year.

It took EMA 20 days to approve the vaccine developed by BioNTech and Pfizer, and just over a month to authorise the Moderna shot after their applications in early December. The two shots 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 jab is single dose, unlike other vaccines approved so far in the EU and which require two doses 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 @fraguarascio; additional reporting by Rebecca Spalding; editing by Jason Neely, Louise Heavens and Bernadette Baum)

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