Medical experts welcome TGA approval of Pfizer-BioNTech COVID-19 vaccine

Pharma News: The Therapeutic Goods Administration (TGA) announced its approval of the first COVID-19 vaccine in Australia – the Pfizer-BioNTech vaccine.

Dr Abrar Chughtai, lecturer and the director of the Master of Infectious Diseases Intelligence (MIDI) program in the School of Public Health and Community Medicine at UNSW Sydney, said “This is definitely good news and I think we need to move quickly and approve other vaccines as well, particularly the Oxford/AstraZeneca vaccine. We are already way behind other countries. Israel has already vaccinated more than 40% of the population and UAE has vaccinated around 25% of the population. More than 20 million people (6% of the population) in the US and 6 million (10% of the population) in the UK have received the first dose of a vaccine.

“According to available evidence, these vaccines are safe and reasonably effective. There have been some concerns about the Pfizer vaccine, but recent evidence suggests that adverse effects were not related to the vaccine.

“The Australian Government has secured more than 50 million doses of the Oxford/AstraZeneca vaccine, so this vaccine should also be approved quickly to start a mass vaccination program. There have also been some concerns about low efficacy of the Oxford/AstraZeneca vaccine, i.e. around 70%, but in a sub-group who were given a lower dose regime, the efficacy rose to 90%. As I have commented before, we should go ahead with the Oxford/AstraZeneca vaccine at this stage, keep monitoring safety and efficacy data and consider all other options for the future.

“We also need to keep an eye on the new COVID variant in the UK, which is more transmissible and, according to some recent data, more deadly as well. It is still not clear whether current vaccines will be effective against the new strain or not. Current studies are small (fewer than 50 cases) and have generated mixed results. Most likely these vaccines (in current form or after some modifications) will work against the new strain as well, but more data are needed to confirm this.

“As notified by the TGA, the Pfizer vaccine approval is provisional (valid for two years), subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment. This is a good strategy for public reassurance,” he concluded.

Dr Diego Silva from Sydney Health Ethics in the University of Sydney School of Public Health, commented “As a first step, the provisional approval of the Pfizer vaccine for COVID-19 by the TGA is great news. The next critical step will be for the Commonwealth and States to clearly and transparently articulate the plan for the distribution of the vaccines.

“The priority groups for the vaccine, as articulated by PM Morrison, are explicit and ethically defensible. Critically, their equitable and effective distribution will depend on the plans of the various states for the vaccine’s role out. As we have seen in other countries, this is easier said than done, hence the importance of being able to articulate to the public the plans for vaccine distribution. 

“In order to engender the public’s trust in the Pfizer and subsequent vaccines, including the trust of healthcare workers, it will be critical for the TGA to describe the pharmacovigilance system they’ll deploy to catch and analyse the negative side-effects that will occur as part of Australia’s rollout.

“As we saw last week with Norway and the deaths of those over the age of 80 who received the vaccine, the ability to quickly collate and analyse adverse events is critical for ensuring confidence in both the vaccine, as well as the policy and programmatic processes necessary to deliver the vaccine,” he added.

Professor Adrian Esterman, Chair of Biostatistics at the University of South Australia, said “The full approval for Comirnaty, the Pfizer-BioNTech vaccine by the Therapeutic Goods Administration (TGA) is welcome news. Although other regulating bodies including those in the UK, EU, Canada and Switzerland have already given full approval for the vaccine, the TGA is known for its thoroughness and rigour with respect to drug and vaccine approval. This means that the public can be reassured that the vaccine is both safe and effective.

“The vaccine is not recommended for those under 16. Those who have severe allergy problems, frail elderly, patients with impaired immune systems and pregnant and breastfeeding women will be assessed on a case-by-case basis by clinicians.

“The only potential challenge now is whether Pfizer can supply the purchased 10 million doses on time. Supplies are already being delayed in Europe, with scheduled supplies being halved in some European countries,” he concluded.