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Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
European Medicines Agency
News & Press Releases
News: Additional manufacturing site for COVID-19 Vaccine Janssen (new)
CHMP, Last updated: 25/06/2021
… The site, located in Anagni, Italy, is operated by Catalent Anagni SRL. The site will perform finished product manufacturing.
The site is expected to support the continued supply of COVID-19 Vaccine Janssen in the European Union.
This recommendation does not require a European Commission decision and the site can become operational immediately.
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021 (new)
CHMP, Last updated: 25/06/2021
News: Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine (new)
CHMP, Last updated: 22/06/2021
… One site, located in Reinbek, Germany, is operated by Allergopharma GmbH & Co. KG. The other in Stein, Switzerland, is operated by Novartis Pharma. The sites will perform finished product manufacturing steps at different stages of the process.
The two new sites are expected to support the continued supply of Comirnaty in the European Union.
This recommendation does not require a European Commission decision and the sites can become operational immediately.
European Centre for Disease Prevention and Control
ECDC statement on the SARS-CoV-2 Delta variant in the EU/EEA
23 Jun 2021
ECDC publishes a threat assessment brief on the implications of the spread of the Delta variant of concern for the EU/EEA.
Dr. Andrea Ammon, ECDC Director:
Variants of SARS-CoV-2 are emerging at a significant rate worldwide. ECDC is constantly analysing the characteristics of these variants to rapidly inform public health authorities in the European Union. Some variants can put our efforts to control the pandemic at risk and require immediate actions.
Based on available scientific evidence, the Delta variant is more transmissible than other circulating variants and we estimate that by the end of August it will represent 90% of all SARS-CoV-2 viruses circulating in the European Union.
Unfortunately, preliminary data shows that it can also infect individuals that have received only one dose of the currently available vaccines. It is very likely that the Delta variant will circulate extensively during the summer, particularly among younger individuals that are not targeted for vaccination. This could cause a risk for the more vulnerable individuals to be infected and experience severe illness and death if they are not fully vaccinated.
The good news is that having received two doses of any of the currently available vaccines provides high protection against this variant and its consequences. However, about 30% of individuals older than 80 years and about 40% of individuals older than 60 years have not yet received a full vaccination course in the European Union.
There are still too many individuals at risk of severe COVID-19 infection whom we need to protect as soon as possible. Until most of the vulnerable individuals are protected, we need to keep the circulation of the Delta virus low by strictly adhering to public health measures, which worked for controlling the impact of other variants.
It is very important to progress with the vaccine roll-out at a very high pace. At this stage it becomes crucial that the second vaccination dose is administered within the minimum authorised interval from the first dose, to speed up the rate at which vulnerable individuals become protected. I am aware that it requires a significant effort from public health authorities and the society at large to achieve this goal. But now is the time to walk the extra mile. We have several safe and effective vaccines available and every single infection prevented now through our compliance with public health measures, is a life that can be saved by vaccination.
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