Johnson & Johnson COVID-19 vaccine sent for EU regulatory approval
A recommendation could come in mid-March, but still awaits final OK from European Commission
{{#rendered}} {{/rendered}}The European Union’s regulatory body on Tuesday announced it received an application from Johnson & Johnson for marketing authorization of its vaccine candidate. Final approval from the European Commission would mark the fourth vaccine in the EU's arsenal against the novel virus.
"EMA’s [the European Medicines Agency] human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable," the regulator said in a statement posted Tuesday. "The Committee 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."
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{{#rendered}} {{/rendered}}The agency said a quick turn-around for a regulatory recommendation was tied to the rolling review of data already underway, assessing how well the vaccine triggers an immune response, and safety information from laboratory data.
If a further review of safety and efficacy data finds the vaccine's benefit outweighs risks, it could result in a conditional marketing authorization. The final nod will come from the European Commission, which could then decide on approval for all EU and EEA member states "within days," EMA said in a statement.
Head of the European Commision, Ursula von der Leyen, took to Twitter Tuesday to embrace news of the regulatory request.
{{#rendered}} {{/rendered}}Johnson & Johnson’s vaccine would mark the fourth candidate approved in the EU, following previous authorizations for products developed by Moderna, Pfizer-BioNTech and AstraZeneca.
The company’s vaccine is also pending U.S. Food and Drug Administration approval, announced on Feb. 4. The FDA will convene an independent panel of experts on Feb. 26 to weigh approval for the vaccine.