The Food and Drug Administration (FDA) is a licensing agency within the U.S. Department of Health and Human Services. They are tasked with the job of assuring the quality and safety of the food supply and human and veterinary drugs and vaccines among other products.

By Patricia Harrity

Due to their Emergency Use Approval (EUA), many people have received their first and second doses of the COVID-19 vaccines. Now the additional booster shots are being rolled out in many countries, and EUA has been extended to children from age 12 and above.

Given that these vaccinations are still experimental and clinical trials have never been performed on more than two injections of any vaccine, we rely on the judgement of the FDA scientists to ensure efficacy and more importantly the safety of these vaccines.

In their field as a licencing agency, the FDA have the monopoly and without their approval, it is illegal to offer a product for sale or use among society. What this means is they have the final say regardless of whether they have made errors in their assessments and approvals. However, the FDA have seemingly approved these vaccinations and ignored not only the lack of necessity or efficacy but also their safety.

THE IGNORED WARNINGS OF CLOTS AND BLEEDING

The final say in the approval of these vaccinations have been arrived at without heeding the findings from esteemed independent scientists and researchers in the fields of immunology and microbiology since early 2021. These experts have been warning medical regulators of vaccine related blood clotting, bleeding and blood abnormalities, findings that were based on established immunological science which predated the roll out of vaccines around the world. 

WE HAVE PRE-EXISTING IMMUNITY

Through discoveries that have found that the SARS-CoV-2 virus is a member of the coronavirus family, and not totally new to our immune systems, these researchers have found that the overwhelming majority of people show a memory-type antibody profile to COVID-19 vaccines. What this means is that our immune systems have seen viruses similar to SARS-CoV-2 before.

Due to our long-lasting cross immunity from exposure to other common cold coronaviruses. our bodies have stored an immune memory of that family of viruses, enabling us to powerfully fight off the next encounter we may have with a similar virus.

The infection fatality rate for COVID-19 of 0.15 – 0.2% worldwide has shown that there is a likelihood that this is happening and that any fundamentally healthy, immunocompetent person is therefore, sufficiently protected against COVID 19. The protection we are afforded from our pre-existing immunity is better than we were told to expect when confronted with the “novel” coronavirus.

THE PFIZER EMERGENCY AUTHORISATION

Our natural immunity has been dismissed by both the vaccination manufacturers and FDA also. Focusing on just one of the available vaccinations, Pfizer and BioNTech (the sponsor) who submitted an EUA request to the FDA on November 2020, for an investigational COVID-19 vaccine (BNT162b2) intended to prevent COVID-19.

Pfizer provided data to aid FDA approval which implies that the vaccine protects from COVID more effectively than prior infection of the virus. Pfizer’s data reported 8 cases of COVID-19 among vaccinated people which amounted to an incidence of 0.044%, however, they also reported 7 cases among unvaccinated people who had initially tested positive.

This group was considerably smaller, and the 7 cases were to translate into a ninefold higher incidence (0.38%). It is common knowledge that vaccines cannot surpass the immunity to be gained from natural infection. This is shown in a recent report that found individuals who have had SARS-CoV-2 infection are, in fact, unlikely to benefit from COVID-19 vaccination. Despite studies and Pfizer’s obvious play with numbers, the FDA appeared to have ignore evidence.

PFIZER EXAGERATED THE EFFICACY OF THE VACCINATION

The FDA appears to have also overlooked, the figures that Pfizer/BioNTech touted that were simply not true, by converting the absolute efficacy of 1.4% to a relative one of 100%, see Figure 2. A fact that was picked up by lawyer Renate Holzeisen who has devised a statement which he has submitted to the European General Court together with a lawsuit to challenge the use of the mRNA vaccine on children over the age of 12.

Holzeisen states that Pfizer had also made unlikely claims and contradictions in their evidence on efficacy, which he says were reported very modestly when expressed in absolute terms, yet even this low efficacy cannot be accepted at face value, this he says is also apparent from the assessment reports prepared by the FDA. Therefore, the efficacy of the Pfizer mRNA vaccine is exaggerated at best, which is another area that the FDA has chosen to ignore.

 IS THIS GOOD NEWS?

This should be good news, but only when unvaccinated as our natural immunity, is said to aggravate the risk of the Covid-19 vaccines by inducing blood clotting and/or leaky blood vessels. The antibodies induced by the vaccines activate the “complement system” and can cause the destruction of any cell that manufactures the SARS-CoV-2 spike protein particularly in the circulation. If this were to happen on the lining on the inner surfaces of the blood vessels, then they may begin to leak and clots will form.

According to the UK Health Security Agency’s COVID-19 vaccine surveillance report (Week 40), studies have shown vaccine effectiveness and that 2 doses  offer between 65 and 95% effectiveness preventing symptomatic disease. Yet they also state that there is “some evidence of waning of protection against infection and symptomatic disease over time. This of course, is to encourage people to get the booster vaccines, which will further add to the risks.

Again, the FDA, it would appear, have not looked at these risks before granting the approval of the vaccinations and in particular to those with robust immunity already protecting them from coronaviruses.

NO PROOF THAT TRANSMISSION IS REDUCED – NO PROOF OF BENEFIT

Despite the urgent and obvious dangers of the vaccinations, there have been no clinical trials conducted to assess the effect of the vaccine in preventing the virus shedding and transmission. In their own admission the FDA offers that “additional evaluations including data from clinical trials and from vaccine use post-authorisation will be needed to assess the effect of the vaccine in preventing virus shedding and transmission.

In other words, there is no evidence that transmission is reduced, and there are no trials even designed to evaluate such an effect. In fact, the clinical trials carried out by Pfizer on all tested age groups, contain no proof of any benefits from the vaccine.

WHY WOULD THE FDA APPROVE THESE VACCINATIONS?

The Acting Director of the FDA, Janet Woodcock, has been said to refuse to convene its Drugs Advisory Committee for discussion of the Pfizer and BioNTech decisions. This denial of a public hearing may have prevented discussions about the safety of the Pfizer vaccine due to the recent figures recorded by the Government Centers for Disease Control (CDC) showing tens of thousands of adverse reactions including blood clots, heart attacks, miscarriages and  more fatalities from the Pfizer mRNA vaccine in seven months previous, than for all vaccines combined in the previous 30 years. 

Scott Gottlieb

Perhaps their conflicts of interest get in the way of rational decisions concerning the safety of the public. For instance, the previous head of the FDA Scott Gottlieb, was appointed to the board of directors of Pfizer just three months after resigning from his position.

Another member of Pfizer’s Board of Directors, Dr Susan Desmond-Hellmann, headed the Bill and Melinda Gates Foundation until 2020. A co designer of the trials for both Pfizer and Moderna mRNA for Fauci’s NIAID from her Seattle center, which is also funded by the Gates Foundation Professor Holly Janes is also a member of the FDA Vaccine Committee until 2023.

There are other links within the FDA to the Gates Foundation and conflicts of interest that as a result of what appears to be a reckless decision, must surely be considered.

If we cannot trust the Food and Drug Administration to do the job that they are tasked to do in assuring the quality and safety of these mRNA vaccines, who can we rely on to be responsible for assuring the quality of the FDA?

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