Johnson & Johnson seeks vaccine approval from European Union

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THE HAGUE: US pharmaceutical giant Johnson & Johnson has utilized for authorisation for its coronavirus vaccine within the EU with a choice attainable by the center of March, Europe’s medication regulator mentioned Tuesday.

The single-shot vaccine can be the fourth jab to be authorized to be used throughout the 27-nation European Union if it will get the inexperienced gentle from the Amsterdam-based European Medicines Agency.

has obtained an software for conditional advertising and marketing authorisation for a Covid-19 vaccine developed by Janssen-Cilag International”, J&J’s European subsidiary, the watchdog mentioned.

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.”

With delays to deliveries of three already-authorised vaccines by AstraZeneca, Pfizer/BioNTech and Moderna, the EMA is beneath strain from European capitals to hurry extra into service.

European Commission chief Ursula von der Leyen hailed the information and mentioned Brussels “will be ready to grant authorisation as soon as EMA delivers a positive scientific opinion.”

“More safe and effective vaccines are on their way,” she added.

J&J’s vaccine has been beneath a “rolling review” by the EMA since December 1.

Two different vaccines are beneath rolling evaluation with the EMA: by German agency CureVac and US biotech agency Novavax.

The European Commission has ordered 200 million doses of the Johnson & Johnson vaccine with an choice for 200 million extra. It says 100 million doses ought to be delivered by June whether it is authorized.

Johnson & Johnson has requested US regulators for emergency authorisation for the United States.

The vaccine presents logistical benefits as a result of it doesn’t require two doses and the deep-freeze storage wanted for some already-approved pictures.

J&J introduced in late January that medical trials confirmed the vaccine was general 66 % efficient and 85 % efficient in stopping extreme types of the illness.

But it didn’t shield as effectively in opposition to a extremely transmissible virus variant first recognized in South Africa, which is spreading quickly world wide

The J&J shot makes use of a common-cold inflicting adenovirus, modified so it can’t replicate, as a “vector” to shuttle genetic directions into human cells, telling them to create a protein of the coronavirus.

This trains the immune system to be prepared for the stay coronavirus.



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