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RSS FeedPosted by Michael Wonder on 10 Dec 2022
Health Canada authorises the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent adapted COVID-19 booster for children 5 to 11 years of age
9 December 2022 - Today, Health Canada authorised the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent adapted booster for use in children 5 ...
Posted by Michael Wonder on 10 Dec 2022
VBI Vaccines announces Health Canada approval for PreHevbrio for the prevention of hepatitis B in adults
8 December 2022 - VBI Vaccines today announced that Health Canada has approved PreHevbrio [3 antigen hepatitis B vaccine (recombinant)] for ...
Posted by Michael Wonder on 10 Dec 2022
Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza
9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...
Posted by Michael Wonder on 08 Dec 2022
FDA authorises updated (bivalent) COVID-19 vaccines for children down to 6 months of age
8 December 2022 - Today, the US FDA amended the emergency use authorisations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 ...
Posted by Michael Wonder on 08 Dec 2022
Takeda’s Qdenga (dengue tetravalent vaccine [live, attenuated]) approved for use in European Union
8 December 2022 - Qdenga becomes the only dengue vaccine approved in the EU for use in individuals regardless of previous ...
Posted by Michael Wonder on 07 Dec 2022
US backs delay to decision on COVID patent waiver extension
6 December 2022 - The United States on Tuesday urged delaying a decision on whether to waive patent protection for ...
Posted by Michael Wonder on 07 Dec 2022
Novavax Nuvaxovid COVID-19 vaccine approved in Canada for use as a primary series in adolescents
7 December 2022 - Novavax today announced that Health Canada has approved a supplement to a new drug submission for Nuvaxovid ...
Posted by Michael Wonder on 07 Dec 2022
US FDA accepts for priority review the biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate for the prevention of RSV disease in older adults
7 December 2022 - If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years ...
Posted by Michael Wonder on 07 Dec 2022
ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary vaccination
6 December 2022 - EMA’s Emergency Task Force considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron ...
Posted by Michael Wonder on 06 Dec 2022
Pfizer and BioNTech submit application to US FDA for emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine in children under 5 years
5 December 2022 - Pfizer andBioNTech today announced that the companies have submitted an application to the US FDA for ...
Posted by Michael Wonder on 03 Dec 2022
COVID-19 vaccine safety report (1 December 2022)
1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...
Posted by Michael Wonder on 26 Nov 2022
GSK Canada submits respiratory syncytial virus vaccine candidate for regulatory review
25 November 2022 - Application includes important pivotal Phase 3 data evaluating the efficacy and safety of our vaccine candidate against ...
Posted by Michael Wonder on 23 Nov 2022
Takeda’s biologics license application for Dengue vaccine candidate (TAK-003) granted priority review by US FDA
23 November 2022 - TAK-003 is being evaluated for the prevention of Dengue disease caused by any Dengue virus serotype ...
Posted by Michael Wonder on 21 Nov 2022
Moderna applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine
18 November 2022 - Application submitted for Spikevax Bivalent Original / Omicron BA.4-5 (mRNA-1273.222) ...
Posted by Michael Wonder on 19 Nov 2022
COVID-19 vaccine safety report (17 November 2022)
17 November 2022 - To 13 November 2022, the TGA has received 706 reports which have been assessed as likely to ...