FDA Grants FULL Approval (BLA) to first COVID-19 Vaccine, but no BLA product will be available

In the fastest time in history and before the clinical trials are complete, On August 23, 2021, the US FDA granted BLA approval of Pfizer/ BioNTech COVID-19 vaccine called COMIRNATY for 16 years and older, even though their own data shows higher all-cause deaths amongst the vaccinated group in the clinical trial. [5] On the same day, the FDA publishes another letter addressed to Pfizer which burried in the fine print confirmed that EUA product is "legally distinct" from COMIRNATY. [6, 7] Dr Robert Malone shares that he doesn’t believe these are legally the same products, but FDA documents state licensed and EUA formulations are the same, and can be used "interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns". Pfizer appear to be intentionally not marketing their newly approved product labelled COMIRNATY, which is unusual. "...the FDA approval does not change the fact that we don't have long-term safety data with the vaccine." stated Dr Jay Bhattacharya Granting approval is suspicious in light of 9,024 reported deaths in US following the Pfizer COVID-19 vaccine, which could be as many as 200,000 deaths, for a product with no solid long-term safety data, because the Pfizer placebo..> READ MORE

Transmission phenomenon experienced in the unvaccinated

In May 2021 a new phenomenon occurred in unvaccinated women who spent time around the COVID-19 vaccinated, and afterwards experienced unusual bleeding symptoms, including very young children. [2] Pfizer clinical trial documented warned about “occupational exposure“, [1] and it appears that the US research institutes were aware of the potential for "shedding" since 2015. As these vaccines are brand new technology, there are still many unknowns that need investigating.

TGA adds Black Triangle Scheme for drug and vaccine adverse event reporting

On October 12, 2017 the Therapeutic Goods Administration (TGA) added the Black Triangle Scheme (BTS) to their safety monitoring system. [1, 2].  "A similar Black Triangle Scheme currently operates throughout the member states of the European Union, including the UK." Five months before Provisional Registration which is added to the Therapeutics Goods Act in March 2018.  All new and Provisionally Registered (PR) products fall under the BTS to help monitor for early safety signals.  Product Inserts (PI) and Consumer Medicines Information (CMI) are indicated with a black triangle symbol [2, 3] which will appear for a period of not less than five years from start of PR.  Sponsors are responsible to supply information for PI and CMI documents. An adverse event is definded as “any unfavourable and unintended sign, symptom or disease associated with the use of ” the provisionally registered product and all “should be reported” by either consumers but most importantly health professionals, although the TGA don’t openly share this advice for COVID-19 vaccine products. All 2021 COVID-19 vaccines were only Provisionally Registratered, which is distinctly different to Registered. [4] United Kingdom's drug regulator MHRA also has a Black Triangle Scheme, for continued monitoring of medicines, which appears..> READ MORE

Pfizer submit EUA for COVID-19 vaccine in under 5 year olds

Pfizer and BioNTech, at the "request from US FDA" initiate rolling submission for Emergency Use Authorization (EUA) of their COVID-19 vaccine in children under 5 years old (6 Months to 4 years of age).  The request is for "the first two doses of a planned three-dose" vaccine regimen. The clinical trials for Pfizer, in 1300 children, failed in this age group, prompting a booster shot in the trials. In trials with older children, participants such as Maddy Garay were severely injured, yet Pfizer reported her injury as a stomach ache. The vaccine was approved regardless! [3] An urgent "call to action" went out to stop this under 5 yr EUA, a prelude to a forever "liability shield". [2] On February 11, 2022, the FDA announced it would "delay it's decision" for EUA, and Pfizer announced it's intent to "extend the rolling submission", yet it was reported they "withdrew" their application. [1]

1986 Act: US government makes vaccine makers 100% Liability Free

Following a 1977 Immunization Conference which called for a "no-fault" compensation system, on the back of manufactures facing increasing lawsuits, California's Democrat Representative Henry Waxman introduced (for the second time) a bill to congress, which on October 14, 1986 was passed, and the National Childhood Vaccine Injury Act (NCVIA), HR5546, was then signed into law "with mixed feelings", [6] by President Ronald Reagan, "as part of a larger health bill on November 14, 1986" [1, 4, 5] Vaccine manufacture Wyeth (now Pfizer) allegedly told President Reagan that vaccines are "unavoidably unsafe" and that phrase is written in the preamble of the VICP statute, this phrase was reiterated in 2011 Supreme Court ruling. [9, 10] The National Childhood Vaccine Injury Act of 1986 (PL 99-660) established the [13]: National Vaccine Program (NVP) Office in 1986 - to coordinate R&D Vaccine Injury Compensation Program (VICP) - est 1988. The law established a Vaccine Injury Table [12] Noteworthy, in 1988 the Center for Biologics Evaluation and Research (CBER) was created within the FDA to regulate vaccines National Vaccine Advisory Committee (NVAC) Vaccine Adverse Events Reporting System (VAERS) Mandated a 6-month supply of vaccines The Department of Health and Human Services (HHS) then established the..> READ MORE