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TGA statement on UK government emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech

2 December 2020

The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.

The UK emergency use authorisation is temporary and only relates to a limited number of specific batches of the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech, in response to the increased spread of COVID-19 and loss of life.

This emergency approval is not a market authorisation, therefore there is no general authorisation to place this vaccine on the market in the UK.

This emergency authorisation is in response to the very high disease load in the UK at present, noting that sadly the UK has had over 13,400 new COVID cases in the last 24 hours (Dec 1 2020) and has had over 59,000 deaths.

It allows the UK Government to deploy the vaccine as quickly as possible to specific groups of patients such as frontline healthcare workers, people over 80 and aged care residents. It is understood that under the Emergency Use Authorisation the vaccine will not be generally available to the wider UK population.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) will continue conducting its rolling review of the Pfizer/BioNTech vaccine for conditional or full market authorisation.

The TGA, continues to assess and receive ongoing vaccine efficacy and safety data from Pfizer as part of the Australian assessment process. The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines, including the Pfizer vaccine.

In addition to this emergency use determination, the TGA is actively monitoring COVID-19 vaccine development that is occurring both in Australia and around the world, and is part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines and the establishment of systems for monitoring the efficacy and safety of COVID-19 vaccines once they have reached the market.

The ability to access early data and planned collaboration with international regulators will assist the TGA to expedite the evaluation of any new vaccines without compromising on our strict requirements for safety, quality and effectiveness of products.

Further details relating COVID-19 vaccines under evaluation.