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Eu­ro­pean Eval­u­a­tion Pro­ce­dure for Boost­er Vac­ci­na­tion with Janssen COVID-19 Vac­cine Start­ed

On 22 November 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) started its review of the variation application for COVID-19 Vaccine Janssen (Johnson & Johnson). The subject of the variation is the authorisation of a booster dose of COVID-19 vaccine Janssen at least two months after the first dose of COVID-19 Vaccine Janssen in people aged 18 years and older.

COVID-19 Vaccine Janssen (Source: pcruciatti/shutterstock.com)

The CHMP at the EMA will conduct an accelerated assessment of the data submitted. The results include data from more than 14,000 adults who were homologously vaccinated with Janssen's COVID-19 vaccine or placebo two months after the first dose.

Booster vaccines are given to fully vaccinated people (i.e. people who have completed their basic immunisation) in order to maintain or restore immune protection after it has worn off.

After reviewing the data, the CHMP will issue a recommendation on whether the variation and the corresponding amendment to the product information should be authorised by the European Commission. The outcome of this assessment is expected in the coming weeks.

Updated: 23.11.2021