COVID-19 vaccine safety report (23 September 2022)

23 September 2022 - To 18 September 2022, the TGA has received 712 reports which have been assessed as likely to ...

Read more →

Pfizer applies to Swissmedic for authorisation of another COVID-19 vaccine

22 September 2022 - Pfizer said on Thursday it had submitted an application to Swissmedic for authorisation of a further ...

Read more →

TGA provisionally approves Pfizer's COVID-19 vaccine, Comirnaty (tozinameran), for use as a booster dose in individuals 5 years and older

21 September 2022 - On 20 September 2022, the TGA provisionally approved Pfizer's COVID-19 vaccine, Comirnaty (tozinameran) for use as ...

Read more →

EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines

16 September 2022 - The EMA’s CHMP has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s ...

Read more →

Take whatever COVID booster you can get, says head of EU drugs watchdog

14 September 2022 - People in Europe should take whatever COVID-19 booster is available to them in the coming months, ...

Read more →

Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in infants and children

16 February 2022 - Merck announced today that the EMA’s CHMP has recommended the approval of Vaxneuvance (pneumococcal 15 valent conjugate ...

Read more →

ATAGI update following COVID-19 meeting (7 September 2022)

14 September 2022 - An update from the Australian Technical Advisory Group on Immunisation following their meeting on 7 September 2022.  ...

Read more →

Novavax Nuvaxovid COVID-19 vaccine granted expanded conditional marketing authorisation in the European Union for use as a booster for adults aged 18 and older

12 September 2022 - Nuvaxovid is now authorised in the EU for use in adults aged 18 and older as ...

Read more →

Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval

12 September 2022 - The EMA’s CHMP has recommended authorising an adapted bivalent vaccine targeting the Omicron sub-variants BA.4 and ...

Read more →

ATAGI statement on use of the Moderna bivalent original/Omicron vaccine

12 September 2022 - A statement from the Australian Technical Advisory Group on Immunisation regarding COVID-19 Moderna Spikevax Bivalent Original/Omicron BA.1 ...

Read more →

Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5

9 September 2022 - Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5. ...

Read more →

COVID-19 vaccine safety report (8 August 2022)

8 September 2022 - To 4 September 2022, the TGA has received 699 reports which have been assessed as likely to ...

Read more →

Statement by President Biden on FDA and CDC authorising updated COVID-⁠19 vaccines

6 September 2022 - This week, we begin a new phase in our COVID-19 response. We are launching a new ...

Read more →

FDA grants breakthrough therapy designation to Pfizer’s Group B Streptococcus vaccine candidate to help prevent infection in infants via immunisation of pregnant women

7 September 2022 - Pfizer today announced that its investigational Group B Streptococcus vaccine candidate, GBS6 or PF-06760805, received breakthrough ...

Read more →

EMA refused rolling review of SK Bioscience's COVID-19 vaccine

7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...

Read more →