PEOPLE FOR SAFE VAXX'S .ORG

The Project: https://www.peopleforsafevaccines.org/
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.

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.

WHAT IS THE FAST-TRACK APPROVAL PROCESS?

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 (TGA) has used what is referred to as the ‘provisional approval pathway’ to fast-track the supply of the three candidates: AstraZeneca, Janssen-Cilag (Johnson & Johnson) and Biocelect Pty Ltd (on behalf of Novavax). supply of COVID-19 vaccines to the Australian public.

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.
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).

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

Claims made by the government, manufacturers and suppliers that the experimental COVID-19 vaccines are sufficiently safe and effective to distribute across the entire
nation are highly questionable.

We are concerned by the limitations of the studies quoted above and the numerous adverse events reported as a result of the roll out of the vaccines overseas.