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

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

 

EMA
EMA News: COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events – vaccine’s benefits currently still outweigh risks – Update
PRAC, Last updated: 11/03/2021

 

EMA News: EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU
CHMP, Last updated: 11/03/2021
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of age.
After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality. COVID-19 Vaccine Janssen is the fourth vaccine recommended in the EU for preventing COVID-19.
“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director, adding, “this is the first vaccine which can be used as a single dose”…

 

EMA News: EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesevimab for COVID-19
CHMP, Last updated: 11/03/2021

 

EMA News: COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch used in Austria
PRAC, Last updated: 10/03/2021

European Commission [to 13 Mar 2021]
http://europa.eu/rapid/search-result.htm?query=18&locale=en&page=1
Latest
Press release 11 March 2021
Commission extends transparency and authorisation mechanism for exports of COVID-19 vaccines
The Commission has today extended until end of June the transparency and authorisation mechanism for COVID-19 vaccine exports. This follows persistent delays in some of the deliveries of vaccines to the EU.
Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “The first weeks of the application of this instrument have shown that the trade disruption feared by many did not take place. Since the measure was introduced, shipments were authorised to more than 30 countries. This confirms that even during a very critical health situation, the EU has made a considerable effort to be a reliable and responsible trading partner.”
Commissioner for Health and Food Safety Stella Kyriakides said: “We expect companies with which we have signed a contract to fulfil their obligations towards EU citizens. The EU exports very significant volumes of COVID-19 vaccines, true to our commitment to global solidarity. Yet, not all companies are honouring their agreements with the EU despite having received a down payment to enable sufficient production. We will insist that compliance is ensured and we will continue to work with companies to ramp up production in Europe as quickly as possible.”
EU number one supplier of COVID-19 vaccines to the world
The EU continues to be the leading provider of vaccines around the world. Six weeks into the existence of this mechanism, 249 export requests to 31 different countries* have been granted for a total of 34,090,267 doses, as they did not threaten the contractual engagements between the EU and the vaccine producers. Only one export request was not granted. The main export destinations include the United Kingdom (with approximately 9.1 million doses), Canada (3.9 million), Mexico (3.1 million), Japan (2.7 million), Saudi Arabia (1.4 million), Hong Kong (1.3 million), Singapore (1 million), United States (1 million), Chile (0.9 million) and Malaysia (0.8 million).
The export authorisation mechanism
This export authorisation mechanism only applies to exports from companies with which the EU has concluded Advance Purchase Agreements (APAs). These APAs commit the vaccine producers to deliver to EU Member States a pre-agreed number of vaccines. The mechanism provides for authorisations of exports of COVID-19 vaccines outside the EU…

Press release 11 March 2021
European Commission authorises fourth safe and effective vaccine against COVID-19
Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVID19 vaccine developed by Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and the fourth COVID-19 vaccine authorised in the EU.

Press release 10 March 2021
Commission supports Member States in tackling coronavirus hotspots with offer of four million additional doses of BioNTech-Pfizer vaccine to be delivered this month
The European Commission has reached an agreement with BioNTech-Pfizer for the supply of four million more doses of COVID-19 vaccines for Member States in the next two weeks in order to tackle coronavirus hotspots and to facilitate free border movement.