Johnson & Johnson files for EU vaccine approval
US pharmaceutical powerhouse Johnson & Johnson has applied for authorisation for its coronavirus vaccine in the EU with a decision possible by the middle of March, Europe's drugs regulator said Tuesday.
The single-shot vaccine from J&J would be the fourth treatment to be approved for use across the 27-nation European Union, if it gets the green light from the Amsterdam-based European Medicines Agency (EMA.)
"The EMA has received an application for conditional marketing authorisation for a Covid-19 vaccine developed by Janssen-Cilag International," the agency announced. Janssen-Cilag is J&J's European subsidiary.
The regulator "could issue an opinion by the middle of March 2021, provided the company's data on the vaccine's efficacy, safety and quality are sufficiently comprehensive and robust."
"More safe and effective vaccines are on their way," she added.
I welcome news of Johnson & Johnson's application to @EMA_News for its #COVID19 vaccine.— Ursula von der Leyen (@vonderleyen) February 16, 2021
The @EU_Commission will be ready to grant authorisation as soon as EMA delivers a positive scientific opinion.
More safe and effective vaccines are on their way. https://t.co/siCYHa393B
J&J's vaccine has been under a "rolling review" by the EMA since 1 December.
The European Commission has ordered 200 million doses of the Johnson & Johnson vaccine with an option for 200 million more. It says 100 million doses should be delivered by June if the treatment is approved.
Emergency Use Authorisation
Johnson & Johnson has asked US regulators for Emergency Use authorisation for the United States.
The vaccine offers logistical advantages because it does not require two doses, nor the deep-freeze storage necessary for some already-approved shots.
J&J announced in late January that clinical trials showed the vaccine was overall 66 percent effective and 85 percent effective in preventing severe forms of the disease.
But it did not protect as well against a highly transmissible virus variant first identified in South Africa, which is spreading rapidly around the world.
The J&J shot uses a common cold-causing adenovirus, modified so it cannot replicate, as a "vector" to shuttle genetic instructions into human cells, telling them to create a protein which is part of the coronavirus.
This trains the immune system to be ready for the live coronavirus.
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