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RSS FeedPosted by Michael Wonder on 11 Mar 2023
COVID-19 vaccine safety report (9 March 2023)
9 March 2023 - To 5 March 2023, over 44 million doses have been administered in Australia, as well as about ...
Posted by Michael Wonder on 09 Mar 2023
Swissmedic issues unlimited authorisation for booster dose of Moderna's bivalent COVID-19 Original/Omicron BA.4-5 vaccine
8 March 2023 - Spikevax bivalent Original/Omicron BA.4-5 mRNA vaccine authorised for people aged 18 and over. ...
Posted by Michael Wonder on 06 Mar 2023
US FDA approves intramuscular administration for Merck’s MMRV family of vaccines: M-M-RII (measles, mumps and rubella virus vaccine live), Varivax (varicella virus vaccine live) and ProQuad (measles, mumps, rubella and varicella virus vaccine live)
6 March 2023 - With this additional route of administration, the MMRV family now joins other routinely recommended vaccines that ...
Posted by Michael Wonder on 01 Mar 2023
Pfizer and BioNTech submit for US emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 booster in children under 5 years
1 March 2023 - Pfizer and BioNTech today submitted an application to the US FDA for emergency use authorisation of ...
Posted by Michael Wonder on 01 Mar 2023
Release of the Australian Government's response to the Review of COVID-19 Vaccine and Treatment Purchasing and Procurement
28 February 2023 - The Australian Government has responded to the Halton review into COVID-19 vaccine and treatment procurement. ...
Posted by Michael Wonder on 28 Feb 2023
Supplies secured of latest Moderna COVID-19 vaccine as recommended by Halton Review
28 February 2023 - The Australian Government has secured an additional 3 million doses of the latest Moderna Omicron-specific COVID-19 vaccine ...
Posted by Michael Wonder on 27 Feb 2023
Pfizer and BioNTech submit supplemental biologics license application for US FDA approval of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine for ages 12 years and older as primary series or booster
24 February 2023 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the US ...
Posted by Michael Wonder on 23 Feb 2023
Moderna and Merck announce mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with pembrolizumab, was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection
22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. ...
Posted by Michael Wonder on 23 Feb 2023
COVID-19 vaccine safety report (23 February 2023)
23 February 2023 - To 19 February 2023, over 44 million doses have been administered in Australia, as well as ...
Posted by Michael Wonder on 21 Feb 2023
Icosavax granted FDA fast track designation for IVX-A12
21 February 2023 - Icosavax today announced the US FDA has granted fast track designation for IVX-A12, a bivalent respiratory syncytial ...
Posted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 20 Feb 2023
FDA accepts Valneva’s chikungunya vaccine license application for priority review
20 February 2023 - Valneva today announced that the US FDA has completed a filing review of its biologics license ...
Posted by Michael Wonder on 20 Feb 2023
TGA grants provisional approval to Moderna’s COVID-19 bivalent (Spikevax Bivalent Original/Omicron BA.4-5) booster dose vaccine
20 February 2023 - On 17 February, 2023, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine: elasomeran and ...
Posted by Michael Wonder on 19 Feb 2023
Health Canada authorises Moderna's Omicron targeting bivalent COVID-19 vaccine in children & adolescents (6-17 years)
17 February 2023 - The recommendation is based on clinical data for Moderna's bivalent Omicron targeting COVID-19 vaccine, mRNA.1273.214. ...
Posted by Michael Wonder on 09 Feb 2023
COVID-19 vaccine safety report (09 February 2023)
9 February 2023 - To 5 February 2023, over 44 million doses of Comirnaty have been administered in Australia, as well ...