完整标题：EMA starts evaluating use of COVID-19 vaccine Comirnaty in young peopl
e aged 12 to 15
发稿单位：欧洲药物管理局
发稿时间：2021/5/3
原文连结：https://bit.ly/3elD77s
EMA has started evaluating an application to extend the use of the COVID-19 vacc
ine Comirnaty to include young people aged 12 to 15.
Comirnaty is a vaccine for preventing COVID-19. It is currently authorised for u
se in people aged 16 and older. It contains a molecule called messenger RNA (mRN
A) with instructions for producing a protein, known as the spike protein, natura
lly present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by
preparing the body to defend itself against SARS-CoV-2.
EMA’s human medicines committee (CHMP) will carry out an accelerated assessment
of data submitted by the company that markets Comirnaty, including results from
a large ongoing clinical study involving adolescents from 12 years of age, in o
rder to decide whether to recommend the extension of indication. The CHMP’s opi
nion will then be forwarded to the European Commission, which will issue a final
legally binding decision applicable in all EU Member States.
EMA will communicate on the outcome of its evaluation, which is expected in June
unless supplementary information is needed.
Comirnaty was first authorised in the EU in December 2020. More information abou
t the vaccine is available.