Australia approves Moderna’s “next-generation bivalent COVID-19 vaccine”

ON Tuesday, August 30, Australia became among the first countries in the world to approve the use of Moderna’s next-generation bivalent COVID-19 vaccine.

Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines that recently sued Pfizer and BioNTech over copyright infringement of the Covid vaccine, announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional approval for its Omicron-containing bivalent booster vaccine.

The approval was for the company’s Omicron-containing bivalent vaccine, mRNA-1273.214, which Moderna says has “demonstrated significantly higher antibody titers against all tested variants, including Omicron BA.1 and BA.4/5 subvariants.”

Australia’s TGA provisionally approved the mRNA-1273.214 (Spikevax Bivalent Original/Omicron) as a booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Spikevax Bivalent Original/Omicron is a next-generation bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant of concern (BA.1).

Arpa Garay, Chief Commercial Officer at Moderna, said: “We are delighted to receive provisional approval from the TGA for our next-generation bivalent vaccine, mRNA-1273.214. Australia becomes one of the first countries in the world to approve an Omicron-containing vaccine, highlighting its continued stewardship in the fight against COVID-19.

“This is a vital step in helping to keep the Australian people safe from the ongoing threat that COVID-19 represents to global public health.”

Moderna expects to supply mRNA-1273.214 to Australia in September.

The company said: “The decision from the TGA is based on clinical trial data from a phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralising antibody response against Omicron (BA.1) when compared to a 50 µg booster dose of mRNA-1273 in previously uninfected participants.”

It added: “A booster dose of mRNA-1273.214 increased neutralising geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorised booster (mRNA-1273) regardless of prior infection status or age.

“mRNA-1273.214’s reactogenicity and safety profile is consistent with the currently authorized Spikevax (mRNA-1273) booster.”

Michael Azrak, General Manager of Moderna for Australia and New Zealand, said: “I am incredibly proud to see our nation reach this critical step in providing access to this new vaccine.

“mRNA-1273.214 has demonstrated a superior neutralising antibody response against Omicron (BA.1) and subvariants (BA.4/BA.5) as compared to mRNA-1273, in addition to having the potential for superior durability of protection.

Moderna said it will “continue to work with the Commonwealth of Australia on the implementation of this important vaccine for Australians with the aim of supplying product in September.”

It added that the company has received approval for mRNA-1273.214 in the UK and Switzerland and has completed regulatory submissions for the next-generation vaccine worldwide.

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