Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2022
Vaccine approval before Phase 3 trial results: a consequence of vaccine access inequity
2 March 2022 - The final Phase 3 clinical data for CanSino Biologics' adenovirus type 5 vector vaccine show that Ad5-nCoV ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
24 February 2022 - EMA’s CHMP has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends approval of Spikevax for children aged 6 to 11
24 February 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use ...
Posted by Michael Wonder on 09 Feb 2022
Novavax underdelivers on COVID vaccine promises
9 February 2022 - Novavax has delivered just a small fraction of the 2 billion COVID-19 shots it plans to ...
Posted by Michael Wonder on 08 Feb 2022
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
8 February 2022 - EMA has started evaluating an application for the use of a booster dose of Comirnaty (BioNTech/Pfizer’s vaccine) ...
Posted by Michael Wonder on 04 Feb 2022
EU watchdog says supports fast development of Omicron only vaccine
3 February 2022 - The European Union's drug regulator said on Thursday it would support a filing for approval of ...
Posted by Michael Wonder on 27 Jan 2022
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...
Posted by Michael Wonder on 21 Jan 2022
International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
21 January 2022 - International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 16 Jan 2022
Global regulators discuss path towards regulatory alignment on response to Omicron variant
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
Posted by Michael Wonder on 11 Jan 2022
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
Posted by Michael Wonder on 10 Jan 2022
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...
Posted by Michael Wonder on 26 Dec 2021
Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA
23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...
Posted by Michael Wonder on 20 Dec 2021
EMA recommends Nuvaxovid for authorisation in the EU
20 December 2021 - EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as ...
Posted by Michael Wonder on 16 Dec 2021
EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
16 December 2021 - Rolling review starts in parallel ...