Johnson & Johnson vaccine, second dose: Ema decision, when it arrives

The European Medicines Agency EMA has begun evaluating Johnson & Johnson’s application for the use of a booster dose of its Covid vaccine developed by the Janssen pharmaceutical division. The booster should be given at least 2 months after the first dose to people aged 18 and over. The EU regulatory body explains that “the CHMP Committee for Medicinal Products for Human Use will carry out an accelerated evaluation of the data presented by the company”. These data include “results on over 14,000 adults who received a second dose of Covid Janssen vaccine or a placebo 2 months after the initial dose.” The pool of experts will consider whether updates to the product information are appropriate. The outcome of this assessment, the EMA informs, is expected within weeks, unless additional information is required. The J&J vaccine, an adenoviral vector, is currently authorized for use in over 18s in a ‘single-dose’ version, i.e. with primary vaccination consisting of a single injection. Finally, the EMA specifies that “the implementation of vaccination campaigns in the EU, including the use of boosters, remains the prerogative of the national technical advisory groups on immunization (Nitag) that lead the campaigns in each Member State. These bodies are in the best position to take into account local conditions, including the spread of the virus (particularly any variant of concern), the availability of vaccines and the capacities of national health systems. “