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

Johnson & Johnson announced on Tuesday that it filed an application with the European Medicines Agency (EMA) seeking authorization for its investigational single-dose vaccine candidate. In a release, the 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. Furthermore, it said, that the Janssen vaccine candidate can prevent the ‘moderate’ to ‘severe’ COVID-19 infection, 28 days after the dose was administered. The efficacy data of the vaccine, according to the company, was based on 43,783 participants accruing 468 symptomatic cases of COVID-19. 

In a statement, the firm stated that the Phase 3 ENSEMBLE study of its vaccine candidate evaluated the “efficacy and safety of the product in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination.” It further claimed that those infected with the 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. “The onset of protection was observed as early as day 14,” the company announced. If approved, the  J&J would be the fourth vaccine to be approved for use across the 27-nation EU bloc. 

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EMA to issue report by March 

Hailing the news of the 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 their way," she added. Meanwhile, in a statement, the Amsterdam-based European Medicines Agency (EMA.) said: ‘The EMA has received an application for conditional marketing authorization for a Covid-19 vaccine developed by Janssen-Cilag International.” It added, that the regulators might “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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