There is a concerted push by drug companies and governments worldwide to develop, manufacture and roll out COVID-19 vaccines.

In Australia, the federal government has granted fast-tracked approval to four drug companies to develop their experimental vaccines, which allow them to defer many steps key to ensuring vaccine safety and efficacy. Numerous medical experts are warning about unorthodox and biased trials, unreleased results data, unknown long-term effects, and the distinct possibility of death and serious injury from these new vaccines, in their current stage of development. 

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Many people are concerned about the speed with which these vaccines are being brought to market. In the government’s rush to roll out and potentially mandate the experimental vaccines, many people have been motivated to take action to bring about honesty, transparency and accountability with this vaccine program. It is from this background that we were inspired to form People for Safe Vaccines Ltd, to address these issues head-on.

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WHAT IS THE FAST-TRACK APPROVAL PROCESS?

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Unlike the normal approval processes for new medicines, which take time and involve thorough safety and efficacy testing, the Australian government, through the Therapeutics Goods Administration, has used what is referred to as the ‘provisional approval pathway’ to fast-track the supply of COVID-19 vaccines to the Australian public.  Currently, there are 3 candidates in the developmental stage: AstraZeneca, Janssen-Cilag (Johnson & Johnson) and Biocelect Pty Ltd (on behalf of Novavax).

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Under this fast-track process, the sponsor/company need only present documentary evidence of the existence of a clinical plan to submit comprehensive data on safety and efficacy within 6 years after registration.  This raises real concerns as to the safety and efficacy of any COVID-19 ‘fast track’ vaccine and the enthusiasm with which a minimally-tested and potentially harmful product is being promoted.

On 25 January 2021, the TGA announced approval for the supply of the Pfizer experimental vaccine. The TGA highlighted some of the issues due to fast track release of the Pfizer vaccine at p.34 of its Australian Public Assessment Report as follows.

"Data limitations

In addition to the unknown longer term safety and unknown duration of vaccine protection, there are other limitations with the submitted data. The following questions have not yet been addressed:

•   Vaccine efficacy against asymptomatic infection and viral transmission.

•   The concomitant use of this vaccine with other vaccines.

•   Vaccine data in pregnant women and lactating mothers.

•   Vaccine efficacy and safety in immunocompromised individuals.

•   Vaccine efficacy and safety in paediatric subjects (< 16 years old).

•   A correlate of protection has yet to be established. The vaccine immunogenicity cannot be considered and used as the surrogate for vaccine protective efficacy at this stage.

Although the vaccine efficacies against certain outcomes have been demonstrated in the pivotal study, the real world vaccine effectiveness when this vaccine is rolled out to a larger and more diverse population is not known. The vaccine efficacy in the Aboriginal and Torres Strait Islander population has not been studied. The sponsor has planned to conduct at least one post-authorisation effectiveness study, a non-interventional study (test negative design) of individuals presenting to the hospital or emergency room with symptoms of potential COVID-19 illness in a real world setting (Study C4591014).

The proposed post-market studies will help to address the limitation of the current information. Although no Australian specific studies have been planned, the data from the studies planned to be conducted overseas are considered applicable to the Australian population."

WHAT ISSUES WILL WE ADDRESS?

We are encouraged by the government’s recent assurances that inoculation will be voluntary, and pressure will not be applied through withholding of certain financial benefits. Our members have been lobbying since the P.M.’s August 2020 announcement that the government would make the vaccines "as mandatory as possible".

However, the following are still live issues:

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Implications for the public due to safety and efficacy of the vaccines