Last Updated on November 21, 2021 8:53 am by Editor
At the end of Part 1 we suggested that Dr. George, Barbados’ CMO, is implying that he is satisfied with the evidence presented by the CDC with respect to vaccines for the 5 – 11 age group. However, he apparently “needs” the weight of PAHO/WHO approval to seal Barbados’ approval. So what is that evidence with which he is apparently “satisfied”?
We suggest you read it and take careful note of the following points we make afterwards.
- The study consists of approximately 4,700 children 5 through 11 years of age. It is being conducted in the U.S., Finland, Poland and Spain.
- Only 3,100 children received the vaccine; some 1,538 children did not receive the vaccine (these are referred to as the placebo or comparison group).
- “The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age”
- The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age.
- No disclosure is made about the nature of the FDA’s model.
So much for the CDC and FDA. What are the other “multiple sources to examine” that the CMO is speaking about? He has not said.
One of the sources we consulted was the EMA (European Medicines Agency), the European equivalent of the FDA. We find it much more insightful than the CDC’s. Here is a summary of what it says about vaccine efficacy and safety:
- EMA has not set a minimum level of efficacy for approval…In spite of this, medicine developers should design studies to demonstrate a rate of efficacy of at least 50%.
- Regulators need at least one main efficacy study in many thousands of participants (over 30,000) to rapidly detect a sufficient number of cases of disease that allows concluding on how much protection a vaccine can provide.
- The efficacy studies may continue for two years or more, to allow the company to collect information on long-term protection and safety.
Please note the high number of persons required for an efficacy (effectiveness) study – 30,000. Pfizer is basing theirs on 4,700 persons, a mere 16% of the base recommended by the EMA.
Turning to another section of the EMA website, we note that the Pfizer Vaccine, whose trade name is Comirnaty has been given “Marketing Authorization” by this body.
Marketing Authorization, to all intents and purposes, is the equivalent of the EUA issued by the FDA in America.
Take note, however, that the company actually producing this vaccine in the EU is not Pfizer in America; in other words, the vaccine being authorized by the EMA is not for a batch of imports from America.
We stress this point because there have been reports of improprieties with the testing of the Pfizer in America as the British Medical Journal (BMJ) article indicates. These concerns have been reflected in some sections of the American media
No Inherent Problem
There is no inherent problem with vaccines. It is quite obvious that vaccines have done the world much good in terms of wiping out diphtheria, polio and tuberculosis to name a few diseases.
Operation Warp Speed, initiated by Donald Trump, has been a success in that it has led to the development of covid-19 vaccines in record time. However, as any of the manufacturers should admit, the full regimen of testing has not been undertaken with these vaccines.
Successful vaccines have been offered to the public after many years of trial and testing. Typically it takes about 5 years from development to roll out for most vaccines.
ALL of the covid-19 vaccines have been on the market for less than two years and therefore, have not gone through the usual long term testing. Therefore, those who object to being vaccinated on this ground have reasonable cause.
Logically, therefore, no one can vouchsafe the long-term performance of the current vaccines. This level of performance can only be assessed by long-term studies as the EMA is suggesting by its sundry statements; there can be no definitive assessment of the long-term effect and safety of vaccines without longitudinal studies.
Longitudinal studies are a type of scientific experiment where the effect of some treatment is observed on a group of people over a relatively long period of time. Longitudinal studies can take different configurations but the technical details do not negate the point.
When health officials utter the words “These vaccines are safe” they are only telling a half the truth. What they really mean is that, all other things being equal, you will not fall down dead on taking them.
But to argue that vaccines are safe and effective in any definitive, long-term sense cannot be supported by the short-term evidence available. Let’s put this another way. If the efficacy and safety of vaccines are usually assessed on the basis of long-term trials (circa 5 years) then one cannot use short-term evidence to support long-term efficacy and safety. This is a contradiction in terms. It is really that simple.
Those physicians and scientists who are promoting the use of drugs such as ivermectin and hydroxychloroquine (HCQ) which have been around for many years have a point. Why use an uncertain and untested vaccine when one can use a treatment that has been proven to work? Of course, not only will the vaccine manufacturers never agree but, as we have seen, will actively oppose this idea!
Half a Loaf
Notwithstanding all that we have said, we can understand the argument by health and medical professionals that, given the deadliness of the disease, “half a loaf is better than no loaf”.
However, those who decide to take the vaccine must understand the risk so that they can give “informed consent”. The issue with vaccine mandates therefore, is that by definition, they seek to by-pass informed consent.
People in Barbados must be careful about blindly following the covid-19 policies being implemented in America. Unless you are blind and deaf, you should have observed that America is “not itself”, so to speak.
If you are cynical enough to believe that it was bad at other times, it is worse now. You do not need to make reference to purloined elections or anything of the sort. Just look at the policies being pursued by the government.
Those policies are decidedly far left because the country is in the grip of a socialist/communist government. Using the mainstream media will not help you understand that because it is clear that a segment of the media – CNN for example – is in cahoots with government’s leftist policies.
Who is Liable?
Finally, what also needs to be understood is that some vaccine manufacturers, Pfizer in particular, have arranged to market its products without any liability to the company itself, especially here in the Caribbean and Latin America.
What that means is that if you get ill one, two, three years down the road and AND the illness can be traced to the ircovid-19 vaccine, Pfizer cannot be held liable for any death or damage.
As you have no doubt heard in the local mainstream media, insurance companies are distancing themselves from any liability arising from covid-19. So who will hold the liability bag? The government that mandated the vaccines? Your guess is as good as ours.