TGA approves Pfizer COVID-19 booster vaccine for Aus adults
The Therapeutic Goods Administration (TGA) has provisionally approved a booster dose of Pfizer and BioNTech’s COVID-19 vaccine, COMIRNATY, for individuals 18 years and older. The provisional approval means that Australian adults may receive a booster (third dose), at least six months after the completion of a COVID-19 vaccine primary course of two doses, providing additional protection and peace of mind.
The primary series can be of any of the COVID-19 vaccines registered for use in Australia, although data on the use of COMIRNATY as a booster with other COVID-19 vaccines is limited. Individuals who have received one dose of COMIRNATY should preferably receive a second dose of COMIRNATY to complete the primary vaccination course and for any additional doses, the TGA noted.
Final advice on the rollout of boosters will be provided to the government by the Australian Technical Advisory Group on Immunisation (ATAGI). Subject to final ATAGI advice, it is expected that a general population booster program will commence no later than 8 November, with original priority groups — including people in aged care and disability care settings — to be offered the option to receive a booster as a priority. Booster shots are already available for severely immunocompromised people aged 12 years and over, at least 28 days after the second dose, in order to address the risk of suboptimal or non-response to the standard two-dose schedule.
The TGA approval coincides with the news that a panel of independent advisers to the US Food and Drug Administration (FDA) has recommended that the agency issue an emergency use authorisation (EDA) for the Pfizer–BioNTech vaccine in children aged 5–11 years old, claiming the benefits of the vaccine outweigh the risks.
Pfizer and BioNTech are seeking clearance for a 10 µg dose of the vaccine in children, versus 30 µg for those aged 12 and older. Their application follows a clinical trial in which the vaccine was found to be 90.7% effective at preventing COVID-19 infection in children aged 5–11.
If the FDA authorises the vaccine for this age group, an advisory panel to the US Centers for Disease Control and Prevention (CDC) will meet next week to make a recommendation on the administration of the vaccine. TGA Deputy Secretary John Skerritt expects Pfizer and BioNTech to make a similar application for Australian children in the coming weeks, suggesting that, should no issues arise, Australian approval could be issued by the end of November.
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