EMA has began evaluating an utility to increase using Moderna’s COVID-19 vaccine, Spikevax, to youngsters aged 6 to 11.
Spikevax is a vaccine for stopping COVID-19, presently authorised to be used in folks aged 12 years and older. It comprises a molecule known as messenger RNA (mRNA) with directions for producing a protein, referred to as the spike protein, which is of course current in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by getting ready the physique to defend itself towards SARS-CoV-2.
EMA’s human medicines committee (CHMP) will evaluation the info on the vaccine, together with outcomes from an ongoing scientific examine involving youngsters aged 6 to 11, with the intention to determine whether or not to advocate extending its use. The timeline of any analysis at all times will depend on the info which might be submitted. The present timeline for analysis foresees an opinion in roughly 2 months, until supplementary data or evaluation is required. This can be a shortened timetable in comparison with related forms of critiques outdoors of a pandemic.
EMA will talk on the end result of its analysis. The CHMP’s opinion will then be forwarded to the European Fee, which is able to problem a closing resolution.
Spikevax was first authorised within the EU in January 2021. Extra details about the vaccine is accessible on the EMA web site.