J&J Likely to Seek EU Approval for COVID-19 Vaccine in February

BRUSSELS (Reuters) -
Vials for a single-dose of the COVID-19 vaccine being developed by Johnson & Johnson. (Cheryl Gerber/Johnson & Johnson via AP)

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 center-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 authorization, but we of course hope that an application could be submitted in the coming weeks.”

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

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 authorize 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.