The TGA has granted provisional approval for Pfizer’s new bivalent booster dose.
On Friday 20 January 2023, the TGA announced that Pfizer’s bivalent COVID vaccine, the COMIRNATY Original/Omicron BA.4-5, had been granted provisional approval for use as a booster dose in individuals aged 12 years and older in Australia.
The new bivalent vaccine comprises 15 micrograms of famtozinameran based on the BA.4/BA.5 variant of Omicron, and 15 micrograms of tozinameran based on the original strain of SARS CoV-2.
This is the first vaccine provisionally approved by the TGA that is designed to specifically target BA.4 and BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine on 27 October 2022.
In making this regulatory decision, the TGA explained that it had carefully considered data from an ongoing Phase II/III study, which showed that the vaccine “elicited a satisfactory neutralising antibody response against both the ancestral and new Omicron BA.4/BA.5 strain one month after a booster dose.”
“The vaccine also elicited a good neutralising antibody response against several other currently circulating and emerging variants, and evidence from extensive use in the US and Europe over recent months has also shown that this booster provides clear reductions in hospitalisation and death,” the TGA said, noting that the bivalent vaccine has a similar safety profile to the original COMIRNATY booster.
“The decision to approve COMIRNATY Original/Omicron BA.4-5 COVID vaccine was informed by export advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical, and clinical fields and including consumer representation.”
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approving the bivalent vaccine as a booster nearly five months ago, on 12 September 2022, and its use was authorised across the EU.
It was granted full approval as a primary vaccination by the EMA’s Emergency Task Force on 06 December 2022.
The potential use of this vaccine in the national COVID vaccination program is still to be determined but The Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice to the Government on these matters in coming weeks.
According to the National Centre for Immunisation Research and Surveillance (NCIRS), The main difference between the BA.1 and BA.4/5 vaccines is the Omicron sub-variant that they contain, and even though the Moderna and Pfizer bivalent vaccines approved for use in Australia target the BA.1 sub-variant, they are broadly protective against multiple Omicron sub-variants, including the currently circulating BA.4/5.
However, there are no trials that directly compare the BA.1 bivalent vaccines with the BA.4/5 bivalent vaccines and it is not clear if BA.4/5 vaccines will offer greater protection than the BA.1 vaccine against currently circulating or future variants/sub-variants.
The TGA has also commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID vaccine, SPIKEVAX, from provisional status to full registration for the immunisation of individuals aged six years and over, and as a booster dose for individuals aged 12 years and older.
This is the first application received by the TGA to transition a provisionally approved COVID vaccine to full registration, however, several COVID vaccines, including SPIKEVAX already have the equivalent of full registration (market authorisation) in major overseas countries.
The TGA explained that as part of the provisional approval, sponsors are required to continue to submit longer-term evidence of safety and efficacy to the TGA, and data from these ongoing trials can support a sponsor’s application to transition their COVID vaccine to full registration status.
“The TGA will undertake a rigorous assessment of the safety, efficacy, and quality of this vaccine for use in individuals six years of age and older,” the Administration said.