Fed’s expert outlines the risks and why we’re on the waiting list

The chairman of the federal government’s Advisory Committee for Vaccines Professor Allen Cheng has responded to commentary on Australia’s decision to wait to roll out a COVID vaccine instead of registering one based on approvals in other countries

“It’s obvious that vaccines need to be effective, safe and made to a high quality.

EFFICACY

“For COVID vaccines, the benchmark was set by WHO at

50 per cent, and most of the vaccines being considered appear to be much more effective.

SAFETY

“The phase 3 studies have generally included about 20,000-25,000 people who received the vaccine. This is sufficient to exclude moderately uncommon side effects, but not serious but rare side effects (eg those occurring in less than 1 in 10,000 people). “An example are the cases of transverse myelitis (spinal cord inflammation) that were reported in the AstraZeneca trial. “There were three cases in this study — one 14 days after the COVID vaccine, another occurred 10 days after vaccination but on further review was felt to be due to pre-existing multiple sclerosis, and the third case occurred in the control (non-COVID vaccine) group.

QUALITY

“During the manufacturing process, ‘controls’ are put in place.

“We want to know that there is the correct amount of vaccine in each dose. We want to know they are free from contamination. That there are no differences between different batches or those made in different factories. We need to know the shelf life under different conditions.

“Ultimately, the question is whether the benefit of using the vaccine outweighs the known risks and the uncertainties. Countries where there are hundreds or thousands of deaths each day are clearly willing to tolerate some uncertainty to prevent this, and this is appropriate.

“It is worth noting that other regulatory agencies have generally given ‘temporary’ approvals or ‘emergency use authorisation’ reflecting that not all the data is available yet.

“But we’re in a different position in Australia — even with the current situation in NSW and Victoria, we can afford to wait for the TGA to do its job.”