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RSS FeedPosted by Michael Wonder on 08 Feb 2023
ATAGI recommendations on use of the Pfizer bivalent (Original/Omicron BA.4/5) COVID-19 vaccine
8 February 2023 - On 20 January 2023, the TGA provisionally approved the Pfizer (Comirnaty) Bivalent Original/Omicron BA.4/5 vaccine for use ...
Posted by Michael Wonder on 08 Feb 2023
ATAGI 2023 booster advice
8 February 2023 - Recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) regarding COVID-19 boosters in 2023. ...
Posted by Michael Wonder on 30 Jan 2023
Moderna granted FDA breakthrough therapy designation for mRNA-1345, an investigational respiratory syncytial virus vaccine candidate
30 January 2023 - Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated ...
Posted by Michael Wonder on 29 Jan 2023
COVID-19 vaccine safety report (27 January 2023)
27 January 2023 - Since the beginning of the vaccine rollout to 22 January 2023, almost 65 million doses of COVID-19 ...
Posted by Michael Wonder on 23 Jan 2023
TGA grants provisional approval to Pfizer’s COVID-19 bivalent (Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine
23 January 2023 - On 20 January 2023, the TGA granted provisional approval to Pfizer’s bivalent COVID-19 vaccine: tozinameran and famtozinameran ...
Posted by Michael Wonder on 23 Jan 2023
TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for potential transition to full registration
20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...
Posted by Michael Wonder on 13 Jan 2023
COVID-19 vaccine safety report (12 January 2023)
12 January 2023 - Since the beginning of the vaccine rollout to 8 January 2023, almost 65 million doses of COVID-19 ...
Posted by Michael Wonder on 10 Jan 2023
Moderna considers price of $110-$130 for COVID-19 vaccine
9 January 2023 - Commercial price is similar to Pfizer’s plans for after government contracting ends. ...
Posted by Michael Wonder on 07 Jan 2023
US FDA accepts for priority review the supplemental biologics license application for Pfizer’s 20 valent pneumococcal conjugate vaccine in infants and children
6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...
Posted by Michael Wonder on 06 Jan 2023
Vaxcyte’s VAX-24 granted FDA breakthrough therapy designation for the prevention of invasive pneumococcal disease in adults
5 January 2023 - Breakthrough therapy designation for 24 valent investigational pneumococcal conjugate vaccine candidate based on positive topline proof of ...
Posted by Michael Wonder on 29 Dec 2022
US FDA accepts for review the biologics license application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents
28 December 2022 - Pfizer today announced that the US FDA accepted for review a biologics license application for its investigational ...
Posted by Michael Wonder on 24 Dec 2022
Valneva completes BLA submission to US FDA for its single shot chikungunya vaccine candidate
23 December 2022 - Valneva today announces that it has completed rolling submission of the biologics license application to the ...
Posted by Michael Wonder on 22 Dec 2022
COVID-19 vaccine safety report (22 December 2022)
22 December 2022 - This is an abbreviated version of the COVID-19 vaccine safety report. ...
Posted by Michael Wonder on 20 Dec 2022
COVID-19 vaccine safety report (15 December 2022)
15 December 2022 - To 11 December 2022, the TGA has received 706 reports which have been assessed as likely to ...
Posted by Michael Wonder on 13 Dec 2022
PharmaJet Partner Immunomic Therapeutics receives FDA fast track designation for pDNA vaccine for skin cancer
13 December 2022 - Vaccine exclusively delivered with the PharmaJet Stratis needle-free injection system. ...