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RSS FeedPosted 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 20 Dec 2021
CHMP issues positive opinion for Pfizer’s 20 valent pneumococcal conjugate vaccine for the prevention of vaccine type pneumococcal pneumonia in adults
17 December 2021 - Pfizer announced today that the CHMP of the EMA has issued a positive opinion to recommend the ...
Posted by Michael Wonder on 15 Dec 2021
COVID-19 Vaccine Janssen: EMA recommendation on booster dose
15 December 2021 - EMA’s CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at ...
Posted by Michael Wonder on 10 Dec 2021
International regulators stress continued need for COVID-19 therapeutics
11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...
Posted by Michael Wonder on 08 Dec 2021
Novavax COVID-19 vaccine could be approved very soon, says EMA chief
8 December 2021 - The head of the EMA on Tuesday said that it could soon approve the COVID-19 vaccine ...
Posted by Michael Wonder on 07 Dec 2021
EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
7 December 2021 - ‘Mix-and-match’ approach can be used for both initial courses and boosters. ...
Posted by Michael Wonder on 02 Dec 2021
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
2 December 2021 - The EMA’s CHMP has started a rolling review of VLA2001, a COVID-19 vaccine being developed by ...
Posted by Michael Wonder on 25 Nov 2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
25 November 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 22 Nov 2021
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
22 November 2021 - EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine ...
Posted by Michael Wonder on 17 Nov 2021
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
17 November 2021 - EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known ...
Posted by Michael Wonder on 11 Nov 2021
Valneva receives EU deal for COVID jab, and seeks apology from UK
11 November 2021 - French vaccine manufacturer, Valneva, has announced that it has won EU approval to supply up to 60 ...
Posted by Michael Wonder on 10 Nov 2021
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...
Posted by Michael Wonder on 09 Nov 2021
Moderna files to expand the conditional marketing authorisation for its COVID-19 vaccine in the European Union to include children ages 6-11 years
9 November 2021 - Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11. ...
Posted by Michael Wonder on 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...
Posted by Michael Wonder on 25 Oct 2021
Spikevax: EMA recommendation on booster
25 October 2021 - The EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) ...