European Medicines Agency |

09/09/2021 COVID-19

Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer

EMA’s human medicines committee (CHMP) has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. One site, located in Frankfurt am Main, Germany, is operated by Sanofi-Aventis...

06/09/2021 COVID-19

EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people (i.e. people who have completed their...

03/09/2021 COVID-19

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021

COVID-19 vaccines: EMA reviewing cases of multisystem inflammatory syndrome EMA’s safety committee (PRAC) is assessing whether there is a risk of multisystem inflammatory syndrome (MIS) with COVID-19 vaccines following a report of MIS with Comirnaty...

02/09/2021 COVID-19

ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued yesterday by the European Centre for Disease...

24/08/2021 COVID-19

Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna

EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Additional manufacturing site and scaled-up process for Comirnaty CHMP has approved an additional...

16/08/2021 COVID-19

EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19

EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra...

COVID-19 pandemic

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Increase in manufacturing capacity of Comirnaty

Increase in manufacturing capacity of Comirnaty

Monthly safety updates for COVID-19 vaccines

Monthly safety updates for COVID-19 vaccines

EMA evaluating data on booster dose of Comirnaty

EMA evaluating data on booster dose of Comirnaty

Annual report 2020

Annual report 2020

Latest news

Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer

EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021

ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna

EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19

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