On 29 September 2022, the Therapeutic Goods Administration (TGA) provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged 6 months to less than 5 years. As seen with older age groups, it is expected that vaccines for younger children will provide protection from the most severe COVID-19 outcomes, such as hospitalisation and death.

This decision follows provisional approval for the use of COMIRNATY for immunisation as a primary course to prevent COVID-19 in individuals 5 years and older on 3 December 2021, and as a booster dose in individuals 5 years and older on 20 September 2022. This paediatric vaccine is made in the same way as the vaccines for older persons, however, it contains a lower amount of active ingredient (3 micrograms).

In making this regulatory decision, the TGA carefully considered data from an ongoing clinical study conducted in the United States. The study, which included over 4500 participants aged 6 months to 5 years, demonstrated that the immune response to the vaccine was similar to that seen in children aged 5 to 12 years. The study also showed that the safety profile in children was similar to that seen in adults with observed side effects being mild.

The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation. The Australian Public Assessment Report for this decision will be published in the coming days.

As with all COVID-19 vaccines, the Government’s decision on the use of this vaccine in this age group will be informed by advice from the Australian Technical Advisory Group on Immunisation (ATAGI).

End of Empire.

Rep. Andrew Clyde: “Can biological men become pregnant and give birth?”

Planned Parenthood Dr. Bhavik Kumar: “Men can have pregnancies, especially trans men.” pic.twitter.com/7k2mHBqDx6

— Breaking911 (@Breaking911) September 29, 2022

KAMALA HARRIS: "The United States shares a very important relationship, which is an alliance with the Republic of North Korea." pic.twitter.com/H2dI5UYOlo

— RNC Research (@RNCResearch) September 29, 2022

Might create some bother on Middle East routes.

Daniel Keneally (Kristina Keneally's son), to be charged for making a false statement that caused a man to be wrongfully imprisoned.https://t.co/OJ32D08Rtu

— Peter Wallace (@PeterWallaceAU) September 29, 2022

UPDATE - and this from 2021, thanks to G Sahathevan:

We can’t give a free pass to our PM cosying up to a nationalist authoritarian government.

Modi’s administration has made India a more dangerous place for minorities. This has had serious impacts for the diaspora in Aus as well. It has to be called out.https://t.co/dBXVWY1pV9

— Mehreen Faruqi (@MehreenFaruqi) December 2, 2021