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Johnson & Johnson subsidiary applies to EMA for Covid-19 vaccine approval

The single-dose vaccine could be approved as early as next month.
Feb 16th 2021, 4:02 PM 24,329 31

THE EUROPEAN MEDICINES Agency (EMA) has announced that pharmaceutical firm Janssen has applied for conditional authorisation for its Covid-19 vaccine.

The agency said in a statement that a decision to approve the jab developed by Johnson & Johnson, the parent company of Janssen, could be made by the middle of March.

In a statement, the EMA said such approval would be conditional on data relating to the vaccine’s efficacy, safety and quality being “sufficiently comprehensive”.

The company’s application is the fourth received by the EMA for a Covid-19 vaccine since the beginning of the pandemic last year, and follows the approval of shots by BioNTech/Pfizer, Moderna and AstraZeneca.

The EMA said it has already reviewed some data from Janssen as part of the vaccine’s development, including how well it triggers the production of antibodies and immune cells and clinical safety data.

Unlike BioNTech/Pfizer and Moderna’s vaccines, which use mRNA technology, the Johnson & Johnson jab uses ‘viral vector’ technology, in which a modified version of a different virus delivers instructions to the body’s cells to create immunity.

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The vaccine only requires a single dose to be effective, in contrast to both mRNA vaccines and the AstraZeneca jab, and can be kept in a standard fridge, meaning it can be rolled out a lot more easily.

Last October, the European Union reached a deal with Johnson & Johnson to obtain 200 million doses of the vaccine for distribution among member states.

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Stephen McDermott


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