Vaccino Moderna, the European Medicines Agency Ema has begun to evaluate the request made by the American company to authorize the administration of a third dose of the anti Covid 19 vaccine Spikevax
“at least 6 months after the second, to persons aged 12 years or older”. This was announced by the EMA, explaining that the Committee for Medicinal Products for Human Use (CHMP) will carry out “an accelerated evaluation of the data presented by the company that markets” the product, “including the results of an ongoing clinical study”.
On the basis of the review started, the CHMP will recommend any updates to the product information, continues the EMA which “will communicate the outcome of the evaluation in due course”, reads a note.
The EU regulatory body returns to the concept of ‘booster’ dose: it is the booster to be administered to people who have completed the primary vaccination, to restore the level of protection after it has reduced. It is therefore different from booster intended as an ‘additional’ dose, aimed at patients in particular immunocompromised conditions and considered a completion of the primary vaccination course.
Ema and the European Center for Disease Prevention and Control (Ecdc) – the EU agency recalls – highlighted their position regarding the need for additional doses and booster doses of the anti-Covid vaccine in a previous communication, in early September. “Although Ema and Ecdc do not consider the need for booster doses in the general population urgent – reiterates the regulatory body – Ema is evaluating this question” on the Moderna mRna vaccine, as already the one on the third dose of the mRna vaccine. Pfizer / BioNTech, “to ensure that evidence is available to support additional doses if needed. Advice on how to administer vaccinations remains the prerogative of the National Immunization Technical Advisory Groups (Nitag) that lead vaccination campaigns in each Member State of the EU “. Therefore, “while the EMA is evaluating the data – the agency repeats once again – the Member States can already consider preparatory plans for the administration of booster doses and additional doses”.