Johnson & Johnson files for COVID-19 vaccine approval from EU

Johnson & Johnson anunced on Tuesday that it filed an application with European Medicines ncy (EMA) seeking authorization for its investigational single-dose vaccine candidate. In a release, pharmaceutical company informed that it submitted a conditional Marketing Authorisation Application (cMAA) with Interim Analysis of clinal trials that show 85 percent efficacy for its Janssen COVID-19 vaccine. Furrmore, it said, that Janssen vaccine candidate can prevent ‘moderate’ to ‘severe’ COVID-19 infection, 28 days after dose was administered. efficacy data of vaccine, according to company, was based on 43,783 participants accruing 468 symptomatic cases of COVID-19. 

In a statement, firm stated that Phase 3 ENSEMBLE study of its vaccine candidate evaluated “efficacy and safety of product in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination.” It furr claimed that those infected with emerging viral variants, such as UK, Brazil, or South Africa’s mutant, Janssen’s COVID-19 vaccine candidate was found to be 66 percent effective, overall. “ onset of protection was observed as early as day 14,” company anunced. If approved,  J&J would be fourth vaccine to be approved for use across 27-nation EU bloc. 

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EMA to issue report by March 

Hailing news of application for J&J vaccine approval, European Commission chief Ursula von der Leyen said Brussels "will be ready to grant authorization as soon as EMA delivers a positive scientific opinion.” "More safe and effective vaccines are on ir way," she added. Meanwhile, in a statement, Amsterdam-based European Medicines ncy (EMA.) said: ‘ EMA has received an application for conditional marketing authorization for a Covid-19 vaccine developed by Janssen-Cilag International.” It added, that regulators might “issue an opinion by middle of March 2021, provided company's data on vaccine's efficacy, safety and quality are sufficiently comprehensive and robust."

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