The US drug agency supports the efficacy of Janssen’s single-dose vaccine against Covid

The pharmaceutical antigen has shown an efficacy of 66%.

Janssen's vaccine, in a clinical trial.

The vaccine against Covid-19 that Janssen is developing -and that only needs one dose- “it is safe and effective”. This has been stated by the United States drug agency (FDA) in an opinion published this Wednesday after having analyzed the results of various clinical trials presented by the pharmaceutical company.

It will be this Friday when a panel of independent experts from the FDA decides whether to approve the antigen from Janssen for sale in the United States.

The opinion published today by the FDA paves the way for the authorization of this vaccine, although the experts are not obliged to follow the advice issued by the US regulatory agency.

According to the latest results presented by the pharmaceutical company, its vaccine has shown an effectiveness of 66% in the prevention of Covid-19 in a global trial involving almost 44,000 people.

Its effectiveness 28 days after injection ranged from 72% in the United States, to 68% in Brazil and 64% in South Africa, where a new variant has spread. In addition, according to the general data of the trial, the vaccine managed to prevent 85% of severe cases of Covid-19.

Europe

In addition to the United States, Janssen has also submitted an application for approval in the European Union. It was on February 16 when the European Medicines Agency (EMA) received the request from the pharmaceutical company.

The European regulatory body plans to issue an opinion in mid-March 2021, provided that the data on the efficacy, safety and quality of the vaccine are sufficiently complete and robust.