Johnson & Johnson COVID-19 vaccine despatched for EU regulatory approval


The European Union’s regulatory physique on Tuesday introduced it obtained an utility from Johnson & Johnson for advertising and marketing authorization of its vaccine candidate. Final approval from the European Commission would mark the fourth vaccine within the EU’s arsenal towards the novel virus.

“EMA’s [the European Medicines Agency] human medicines committee (CHMP) will assess the vaccine, often known as COVID-19 Vaccine Janssen, underneath an accelerated timetable,” the regulator mentioned in a assertion posted Tuesday.  “The Committee might concern an opinion by the center of March 2021, supplied the corporate’s knowledge on the vaccine’s efficacy, security and high quality are sufficiently complete and sturdy.”

JOHNSON & JOHNSON COVID-19 VACCINE 66% EFFECTIVE IN GLOBAL TRIAL, COMPANY SAYS

The company mentioned a fast turn-around for a regulatory advice was tied to the rolling evaluation of knowledge already underway, assessing how effectively the vaccine triggers an immune response, and security data from laboratory knowledge.

If an extra evaluation of security and efficacy knowledge finds the vaccine’s profit outweighs dangers, it might end in a conditional advertising and marketing authorization. The closing nod will come from the European Commission, which might then resolve on approval for all EU and EEA member states “inside days,” EMA mentioned in an announcement. 

Head of the European Commision, Ursula von der Leyen, took to Twitter Tuesday to embrace information of the regulatory request.

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Johnson & Johnson’s vaccine would mark the fourth candidate authorized within the EU, following earlier authorizations for merchandise developed by Moderna, Pfizer-BioNTech and AstraZeneca.

The firm’s vaccine can also be pending U.S. Food and Drug Administration approval, introduced on Feb. 4. The FDA will convene an impartial panel of consultants on Feb. 26 to weigh approval for the vaccine.



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