The European Medicines Agency (EMA) is fast-tracking evaluation of the Johnson&Johnson (Janssen) COVID-19 vaccine booster dose to be given two months after the first shot to people aged 18 and older.
EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets the vaccine.
The data include results from more than 14,000 adults who received a second dose of COVID-19 Vaccine Janssen or placebo (a dummy treatment) two months after the initial dose.
The CHMP will recommend whether updates to the product information are appropriate.
The outcome of this evaluation is expected within weeks unless supplementary information is needed.
The implementation of vaccination campaigns in the EU, including booster doses, remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State.
These bodies are best placed to consider the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems.