Third dose of Modern vaccine, ok Ema for over 18 recall

A third dose of Moderna’s Covid vaccine “may be considered in people aged 18 and over.” The booster dose consists of half the dose used in the primary vaccination cycle, specifies the EMA in the note. The recommendation of the European Medicines Agency EMA’s CHMP Committee for Medicinal Products for Human Use is based on data showing that a third dose of the Spikevax vaccine, “administered 6 to 8 months after the second, led to increased levels of antibodies “in adults where these levels were decreasing. The EU agency also takes stock of the side effects of the booster. And he explains that “the current data indicate that the pattern of adverse effects after the booster is similar to what occurs after the second dose. The risk of inflammatory heart conditions or other very rare side effects is closely monitored” after the booster. As with all medicines, “Ema will continue to review all data on the safety and efficacy of Spikevax.” At national level, the EMA continues, “public health bodies can issue official recommendations on the use of booster doses, taking into account the local epidemiological situation, as well as emerging efficacy data and limited safety data for the dose. booster “.” At the beginning of this month – recalls the regulatory body – the CHMP concluded that a booster dose of Comirnaty * (the other authorized mRna vaccine, that of BioNTech / Pfizer, ed) can be taken considered at least 6 months after the second dose for people aged 18. In addition, it is recommended that an extra dose of Comirnaty and Spikevax be given to people with severely weakened immune systems, at least 28 days after the second dose. ” More information on the recall recommendation for Spikevax will be available in the updated information on the product, informs the EMA which specifies once again as “the implementation of the campaigns of vaccination in the EU “remains” the prerogative of the National Immunization Technical Advisory Groups (NITAG) that lead vaccination campaigns in each EU Member State. These organisms are best placed to account for local conditions, including the spread of the virus (particularly any variants of concern), the availability of vaccines and the capabilities of national health systems. EMA will continue to work closely with national authorities and the European Center for Disease Prevention and Control (ECDC) to evaluate the available data and provide recommendations to protect people during the ongoing pandemic. “