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RSS FeedPosted by Michael Wonder on 04 Mar 2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
Posted by Michael Wonder on 02 Mar 2021
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...
Posted by Michael Wonder on 01 Mar 2021
EMA accepts Pfizer's marketing authorisation application for its investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age or older
26 February 2021 - If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive ...
Posted by Michael Wonder on 25 Feb 2021
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
Posted by Michael Wonder on 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 21 Feb 2021
von der Leyen admits to COVID-19 vaccine failures
20 February 2021 - EU Commission President Ursula von der Leyen's comments come after much scrutiny of the EU vaccination ...
Posted by Michael Wonder on 20 Feb 2021
Dynavax announces European Commission marketing authorization for Heplisav B, a two dose adult hepatitis B adjuvanted vaccine
19 February 2021 - Approval based on safety and immunogenicity results from three Phase 3 clinical trials. ...
Posted by Michael Wonder on 20 Feb 2021
Confusion over Russia's EU vaccine approval bid could be result of misdirected application
20 February 2021 - Russia’s submission of its Sputnik V vaccine for approval by the European Union’s medicines regulator appears ...
Posted by Michael Wonder on 18 Feb 2021
Pfizer and BioNTech to supply the European Union with 200 million additional doses of Cominarty
17 February 2021 - New agreement brings total supply to the European Union to 500 million doses, with delivery expected by ...
Posted by Michael Wonder on 16 Feb 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
16 February 2021 - EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by Janssen-Cilag. ...
Posted by Michael Wonder on 12 Feb 2021
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
12 February 2021 - EMA’s human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID‑19 vaccine being ...
Posted by Michael Wonder on 10 Feb 2021
European Union admits errors in coronavirus vaccine rollout, 'deeply regrets' decision on export curbs
10 February 2021 - European Commission President Ursula von der Leyen has acknowledged failings in the EU's approval and rollout ...
Posted by Michael Wonder on 10 Feb 2021
EMA expected to approve Johnson & Johnson vaccine by March
10 February 2021 - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by ...
Posted by Michael Wonder on 10 Feb 2021
Clarification on Sputnik V vaccine in the EU approval process
10 February 2021 - The EMA has to date not received an application for a rolling review or a marketing ...
Posted by Michael Wonder on 10 Feb 2021
EMA preparing guidance to tackle COVID-19 variants
10 February 2021 - EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new ...