Johnson & Johnson Requests European Medicines Agency for Covid-19 Vaccine Approval
Published On Feb 17, 2021 12:00 AM By Yamini Sharma
According to latest reports, Johnson & Johnson has filed an application with the European Medicines Agency (EMA) for authorization for its investigational single-dose vaccine candidate.
As per a release, Johnson & Johnson informed that it submitted a conditional Marketing Authorisation Application (cMAA). The application included Interim Analysis of clinical trials that depict 85% efficacy for Janssen Covid-19 vaccine. Moreover, the release stated that the Janssen vaccine candidate can prevent the ‘moderate’ to ‘severe’ novel coronavirus infection, 28 days after administration. According to the company, the efficacy data of the vaccine was on the basis of 43,783 participants accruing 468 symptomatic cases of coronavirus.
In a statement, the firm informed that the Phase 3 ENSEMBLE study of its novel coronavirus vaccine candidate analysed the efficacy and safety of the vaccine in protecting moderate to severe Covid-19 with 14 days and 28 days as co-primary endpoints after vaccination. In addition, it was found that those infected with the UK, Brazil, or South African variant mutant, Janssen’s vaccine candidate showcased efficacy of 66% overall. As per the company’s announcement, the onset of protection was observed as early as day 14.
It must be noted that if approved, the Johnson & Johnson’s would be the fourth vaccine to receive approval for use across the 27-nation EU bloc.
Highlighting the vaccine’s approval, Ursula von der Leyen, European Commission Chief informed that Brussels will be ready to grant authorization as soon as EMA delivers a positive scientific opinion. She also stated that more safe and effective coronavirus vaccines are on their way.
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Disclaimer: This article is issued in the general public interest and meant for general information purposes only. Readers are advised not to rely on the contents of the article as conclusive in nature and should research further or consult an expert in this regard.