US approve EUA for Pfizer COVID-19 vaccine for 5-11 years

On October 29, 2021, the FDA grants EUA for Pfizer’s COVID-19 vaccine for children 5 to 11 years old, based on the “scientific evidence available”.  This occurred after CDC’s ACIP panel approves the jabs by ignoring vaccine risks and knowing only 2000 children were tested and followed up for only 2 month. [4] The HART group claim the FDA decision is based on a fraudulent model. Within 2 weeks of this date over 1 million US kids in this age group were jabbed, and around 100,000 adverse events were reported to VAERS, of which 82% of the reported the event immediately after the jab – a major safety signal that wasn’t detected in the premarket testing.  VAERS is a known under reported system yet it is revealing 1 in 10 children have experienced an adverse reaction following their jab. [1] Doctors and scientists have been warning not to vaccinate the kids with these novel COVID-19 vaccines because the risks outweighs any benefit for kids; the data shows they’ll survive with no treatment. [2, 3]

FDA Grants FULL Approval to First COVID-19 Vaccine, but no product will be available

In the fastest time in history and before the clinical trials are complete, On August 23, 2021, the US FDA grants approval of BioNTech COVID-19 vaccine called Comirnaty for 16 years and older even though their own data shows higher all-cause deaths amongst the trial vaccinated group. [5] On the same day, the FDA publishes another letter addressed to Pfizer granting EUA for their vaccine in 12-15 year olds. 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. 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 control group was un-blinded in December 16, 2020. Did Pfizer’s early 2020 lobbying efforts to the FDA and CDC help with this approval? Totaling $13.2 million in 2020, the most since 2009. This product approval is another example of unprecedented deviation from normal protocols; failing to adhere to the normal regulatory process with checks and balances. [1, 2, 3, 4] Pfizer appear to be intentionally not marketing their..> 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.

FDA issues first COVID-19 vaccine EUA – no data on “preventing transmission”

On December 11, 2020, the US Food and Drug Administration (FDA) granted the first Emergency Use Authorisation (EUA) for a brand new technology product, the Pfizer-BioNTech COVID-19 mRNA vaccine, just 9 months after phase I trials began, and after only 108 days of regulatory safety review. In their press release they stated: "The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA".  The FDA stated the vaccine "may be effective in preventing COVID-19", then state it is 95% effective in "preventing" COVID-19, that 95% is based on "a 2 month study of a couple hundred people.  That's it!". [3] The day before, on December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to assess the Pfizer-BioNTech COVID-19 Vaccine and prepare a Briefing Document for the FDA. [6] The FDA stated "[t]he vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group."  8 plus 162 equals 170 trial participants was all that were used to determined the relative risk of "95% effective", where as the absolute risk (of all 36,523 trial participants)..> READ MORE

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]