Moderna booster shot receives provisional approval from TGA

The Therapeutic Goods Administration (TGA) has today provisionally approved the use of Moderna’s COVID-19 vaccine called SPIKEVAX for individuals 18 years and older in Australia.

The decision means those eligible may receive Moderna’s shot as a booster (third dose) at least six months after their second jab as long as the Australian Technical Advisory Group on Immunisation (ATAGI) also gives it the green light.

According to the TGA, the first two vaccines received can be any of the other COVID-19 vaccines registered for use in Australia, noting the data on the use of SPIKEVAX as a booster with other brands like Pfizer or AstraZeneca is more limited.

The TGA also advises that severely immunocompromised people aged 12 years and over can received their third primary dose of a COVID-19 vaccine at least 28 days after the second dose.

“TGA provisionally approved the booster dose following careful evaluation of the available data supporting safety and efficacy,” says the TGA.

“The TGA's decision was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with scientific, clinical and consumer representation.”

Federal Minister for Health Greg Hunt noted the significance of the announcement, acknowledging ATAGI is yet to make its decision.

“In addition to the Pfizer booster, subject to final approval - a second green-light by ATAGI…Australians will have two options for boosters very shortly,” Hunt said.

“I think this is another important step. Every day we’re making new strides and new progress with the vaccine program.”

Pfizer provisionally approved for kids

Today's announcement from the TGA comes three days after the Administration provisionally approved the use of Pfizer's COVID-19 vaccine called COMIRANTY in children aged 5 years and older.

Like other age groups, the TGA says the use of this vaccine in children aged 5-11 years should be given in two doses at least three weeks apart. However, a lower dose (10 micrograms) will be given to children aged 5-11 years, compared to that used for individuals 12 years of age and older (30 micrograms).

The provisional approval was made following consideration of data from clinical trials conducted in the United States, Finland, Poland and Spain, which demonstrated effectiveness by showing that the immune response to the vaccine in children was similar to that seen in older people.

Clinical trials also showed that the safety profile in children is similar to that seen in adults with the observed side effects being mild. The most frequent adverse events seen in clinical trials in children aged 5-11 years were injection site pain, fatigue, headache, injection site redness and swelling, muscle pain and chills.

Further advice on the rollout of COMIRNATY to this age group will be provided to Government by ATAGI.

Updated at 3.48pm AEDT on 8 December 2021.