Health Canada authorises second bivalent COVID-19 booster targeting the Omicron BA.4/5 variants

3 November 2022 - Today, Health Canada authorised an adapted version of the Moderna Spikevax COVID-19 vaccine that targets the Omicron ...

Read more →

GSK’s respiratory syncytial virus older adult vaccine candidate granted priority review by US FDA

2 November 2022 - US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023. ...

Read more →

Vaxzevria receives full marketing authorisation in the EU for the prevention of COVID-19

1 November 2022 - AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full marketing authorisation in the European Union. ...

Read more →

GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment

28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract ...

Read more →

TGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adults

28 October 2022 - On 27 October 2022, the TGA provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron ...

Read more →

ATAGI recommendations for a booster dose of the paediatric Pfizer COVID-19 vaccine in children aged 5 to 11 years

24 October 2022 - Recommendations from the Australian Technical Advisory Group on Immunisation on Pfizer booster doses for children aged 5 ...

Read more →

Pfizer COVID vaccine price hike to boost revenue for years, rivals may follow

21 October 2022 - Pfizer's plan to as much as quadruple US prices for its COVID-19 vaccine next year is ...

Read more →

COVID-19 vaccine safety report (20 October 2022)

20 October 2022 - To 16 October 2022, the TGA has received 705 reports which have been assessed as likely to ...

Read more →

US FDA grants emergency use authorisation for Novavax COVID-19 Vaccine, adjuvanted as a booster for adults

19 October 2022 - Novavax today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorisation from the ...

Read more →

TGA provisionally approves Moderna’s COVID-19 vaccine for use as a booster dose in individuals 12 years and older

20 October 2022 - On 19 October 2022, the TGA provisionally approved Moderna's COVID-19 vaccine, Spikevax (elasomeran), for use as ...

Read more →

EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age

19 October 2022 - The EMA’s CHMP has recommended extending the use of Comirnaty and Spikevax targeting the original strain ...

Read more →

EMA recommends approval of second adapted Spikevax vaccine

19 October 2022 - The EMA’s CHMP has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 ...

Read more →

US FDA approves Menveo in a new single vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W

17 October 2022 - Single vial presentation option removes the need for reconstitution of Menveo before use in individuals 10 ...

Read more →

Takeda receives positive CHMP opinion recommending approval of Dengue vaccine candidate in EU and Dengue endemic countries

14 October 2022 - TAK-003 recommended for the prevention of Dengue disease caused by any Dengue virus serotype in individuals four ...

Read more →

FDA authorises Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups

12 October 2022 - Today, the US FDA amended the emergency use authorisations of the Moderna COVID-19 Vaccine, Bivalent and the ...

Read more →