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 →

Actemra IV (tocilizumab for injection) receives authorisation for additional indication from Health Canada for the treatment of COVID-19

28 October 2022 - Actemra is shown to improve outcomes including mortality in patients hospitalised with COVID-19 requiring supplemental oxygen. ...

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 →

Calls for TGA to withdraw Covid drug approval

17 October 2022 - The medicines regulator is facing calls to withdraw its provisional approval for the antiviral drug molnupiravir ...

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 →

Swiss drugs regulator approves one of Pfizer's COVID-19 booster shots

10 October 2022 - Swiss drugs regulator Swissmedic said on Monday it had temporarily approved Pfizer's COVID-19 booster shot targeting ...

Read more →

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

7 October 2022 - Today, Health Canada authorised a second bivalent COVID-19 vaccine booster.  ...

Read more →

COVID-19 vaccine safety report (6 October 2022)

6 October 2022 - To 2 October 2022, the TGA has received 703 reports which have been assessed as likely to ...

Read more →