Blog
RSS FeedPosted by Michael Wonder on 08 Jan 2021
Extra dose from vials of Comirnaty COVID-19 vaccine
8 January 2021 - EMA’s human medicines committee (CHMP) has recommended updating the Product Information for Comirnaty to clarify that ...
Posted by Michael Wonder on 06 Jan 2021
EMA recommends Moderna COVID-19 vaccine for authorisation in the EU
6 January 2021 - EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent coronavirus disease ...
Posted by Michael Wonder on 30 Dec 2020
Update on rolling review of AstraZeneca’s COVID-19 vaccine
30 December 2020 - EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing ...
Posted by Michael Wonder on 22 Dec 2020
EMA organises a second public meeting about the new COVID-19 vaccines
22 December 2020 - EMA will organise a second public meeting on 8 January 2021 to inform European citizens about ...
Posted by Michael Wonder on 21 Dec 2020
EMA recommends first COVID-19 vaccine for authorisation in the EU
21 December 2020 - EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, ...
Posted by Michael Wonder on 17 Dec 2020
Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
17 December 2020 - Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation ...
Posted by Michael Wonder on 16 Dec 2020
Pressure mounts on EU drug regulator to approve Pfizer COVID-19 vaccine
15 December 2020 - Europe’s drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine developed by U.S. giant ...
Posted by Michael Wonder on 15 Dec 2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
15 December 2020 - EMA’s CHMP and its experts have been working intensively over the past weeks to evaluate data ...
Posted by Michael Wonder on 10 Dec 2020
Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say
10 December 2020 - U.S. drug maker Pfizer and its German partner BioNTech said on Wednesday that documents related to development ...
Posted by Michael Wonder on 01 Dec 2020
EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
1 December 2020 - EMA’s CHMP has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag. ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
1 December 2020 - EMA has received an application for conditional marketing authorisation for BNT162b2, a COVID‑19 mRNA vaccine developed by ...
Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
1 December 2020 - EMA has received an application for conditional marketing authorisation for a COVID-19 mRNA vaccine by Moderna Biotech. ...
Posted by Michael Wonder on 27 Nov 2020
Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
27 November 2020 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all stakeholders, ...
Posted by Michael Wonder on 26 Nov 2020
Moderna signs deal with EU for 160 million COVID-19 vaccine doses
26 November 2020 - The European Commission has signed a supply deal with Moderna which will see it secure an ...
Posted by Michael Wonder on 25 Nov 2020
EU drug regulator could rule on COVID-19 vaccines by year end
24 November 2020 - The EMA could produce a scientific opinion on COVID-19 vaccines seeking regulatory approval by the end ...