ATAGI recommendations on use of the Pfizer bivalent (Original/Omicron BA.1) COVID-19 vaccine

On 27 October 2022, the Therapeutic Goods Administration of Australia provisionally approved the Pfizer (Comirnaty) Bivalent Original/Omicron BA.1 vaccine (subsequently referred to as Pfizer bivalent) for use as a booster COVID-19 vaccine in people aged 18 years and older. The Australian Technical Advisory Group on Immunisation (ATAGI) has evaluated the immunogenicity, efficacy, and safety data on this vaccine.

Recommendations

ATAGI updates its existing recommendations regarding use of bivalent Original/Omicron BA.1 vaccines with the following:

• The Pfizer bivalent vaccine can be used as an alternative vaccine to any of the available mRNA COVID-19 vaccines (Pfizer original vaccine, Moderna bivalent vaccine or Moderna original vaccine) for any booster dose in people aged 18 years or older who are currently recommended to receive a COVID-19 booster.
• In those who are eligible for a booster dose, ATAGI does not have a preference for bivalent mRNA vaccines over original mRNA vaccines.
• Booster doses of COVID-19 vaccine should be given at least 3 months after the most recent COVID-19 vaccine dose or confirmed SARS-CoV-2 infection.
• As with other mRNA COVID-19 vaccines, the Pfizer bivalent vaccine can be co-administered with other non-COVID-19 vaccines.
• The Pfizer bivalent vaccine is not recommended for the primary course of vaccination (the first two doses in most people or first three doses in severely immunocompromised people).
• ATAGI does not currently recommend use of the Pfizer bivalent vaccine as a booster in anyone aged under 18 years as it is not registered for use in this age group.