World News – CA – Johnson & Johnson begins ongoing review of COVID-19 vaccine in Europe

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By Rachel Arthur
Contact

01. December 2020
– Last updated on
01. December 2020 at 16:32 GMT

Related tags:
Ema, Johnson & Johnson, COVID-19 vaccine

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The company has also started discussions with other regulatory agencies around the world about the candidate for a recombinant viral vector.

In Europe, the EMA’s On-Line Review enables the evaluation of vaccines during a public health emergency to be expedited, with the Agency starting to review data as it becomes available from pre-clinical and ongoing studies, as well as information about ingredients and production.

The Janssen COVID-19 vaccine candidate Ad26. COV2. S (also known as JNJ-78436735) is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells. It leverages the company’s AdVac vaccine platform, which was used to develop and manufacture Janssen’s Ebola vaccine regimen, approved by the European Commission in July this year, and to develop its vaccine candidates for Zika, RSV and HIV.

The vaccine is estimated to be stable for two years at -20 ° C and at least three months at 2-8 ° C. This would make the vaccine candidate compatible with standard vaccine distribution channels, says J&J.

The company has an agreement with the European Union to deliver up to 400 million doses of the vaccine if approved.

The EMA application is single-dose: it differs from most of the other front runners in COVID-19 vaccine development. The vaccine is currently in phase 3 studies (“ensemble”) with up to 60 people. 000 people aged 18 and over in the USA, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

However,

J&J has also begun exploring the vaccine’s potential as a two-dose regimen in a second Phase 3 study that began in Ensemble 2 this month.

The EMA is already reviewing three more COVID-19 vaccines. Pfizer / BioNTech and Moderna completed their ongoing review this week with the filing of a conditional marketing authorization application. AstraZeneca’s vaccine candidate is undergoing an ongoing review.

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Related topics:
Markets & regulations,
COVID-19

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Vaccine, Johnson & Johnson, Janssen Pharmaceutica, European Medicines Agency