Pharmacy Daily | No need to rush COVAX approval

AUSTRALIAN regulators should "hold the line [and] wait for robust data" before approving COVID-19 vaccines, former Pharmaceutical Society of Australia National President, Shane Jackson, believes.

Responding to a statement issued by Federal Health minister, Greg Hunt, welcoming Britain's move to grant emergency approval for the Pfizer vaccine. Jackson tweeted that Australia had the "luxury of time on our side", adding, "confidence in approval processes [is] paramount for vaccine uptake".

A statement from the Therapeutic Goods Administration (TGA) said, "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," the TGA said.

"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."

Meanwhile, the European Medicines Agency (EMA), which is responsible for approving potential COVID-19 vaccines in the EU, has voiced criticism of the Britain's Medicines and Healthcare Regulatory Agency (MHRA) ultra-fast emergency approval process.

The EMA started reviewing preliminary data from the BNT162b2 trials on 06 Oct, with the aim of accelerating its approval process, while the MHRA commenced its analysis on 30 Oct, using less information than the EU's regulator.

Former EMA Executive Director, Guido Rasi, said he was surprised by the British move to grant emergency approval.

"Personally, I would have expected a robust review of all available data, which the British Government has not done," Rasi said.

The EMA said it expects to be in a position to make a decision on whether or not to grant emergency approval for the vaccine on 29 Dec.