Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment



European Medicines Agency
News & Press Releases
News: AstraZeneca’s COVID-19 vaccine: benefits and risks in context (new)
CHMP, Last updated: 23/04/2021
Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause severe disease and death. The disease can also have long-term consequences in people of all ages, including in otherwise healthy people.
The benefits of Vaxzevria outweigh its risks in adults of all age groups; however, very rare cases of blood clots with low blood platelets1 have occurred following vaccination.
To support national authorities making decisions on how to best use the vaccine in their territories, EMA’s human medicines committee (CHMP) has further analysed available data to put the risk of these very rare blood clots in the context of the vaccine’s benefits for different age groups and different rates of infection.
The analysis will inform national decisions on the roll out of the vaccine, taking into account the pandemic situation as it evolves and other factors, such as vaccine availability. The analysis could change as new data become available.
The Committee also considered available data on the use of the second dose…


News: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna (new)
CHMP, Last updated: 23/04/2021
EMA’s human medicines committee (CHMP) has adopted two important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.



News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021 (new)
CHMP, Last updated: 23/04/2021



News: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets (new)
PRAC, Last updated: 20/04/2021
At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine.
In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed…



European Commission
Statement 23 April 2021
Statement by Commissioner Kyriakides on the review by the European Medicines Agency of the AstraZeneca COVID-19 vaccine
Following a  formal request by the European Commission, the European Medicines Agency has reviewed additional vaccination and epidemiological data submitted by Member States in relation to the AstraZeneca vaccine.

Press release 20 April 2021
EU launches €100 million humanitarian initiative to support COVID-19 vaccination campaigns in Africa
Today, Commissioner for Crisis Management, Janez Lenarčič, will visit the Africa Centres for Disease control and Prevention (Africa CDC) in Addis Ababa. This visit marks the start of the implementation of the EU’s new €100 million humanitarian initiative in support of the COVID-19 vaccination campaigns in Africa. As announced by the President of the European Commission, Ursula von der Leyen, at the G7 meeting in February 2021, this €100 million initiative is part of the European Commission’s efforts to ensure equitable and fair access to safe and effective vaccines to all. By joining forces with the Africa CDC and other international partners, the European Commission aims to support a fast and safe rollout of Covid-19 vaccines in Africa…