In the interest of “transparency”, Pfizer CEO Dr. Albert Bourlas released a statement on Friday outlining the timeline for when its experimental COVID-19 vaccine might be ready for approval for regular, non-emergency use. Much to Trump’s chagrin, CEO Dr. Albert Bourla said the earlier the company expects to apply for an emergency-use approval from the FDA would be the third week of November, after the election has come and gone.
While JNJ executives insisted their vaccine candidate likely wasn’t the cause, they brought in investigators and are now working to get the trial going again as quickly as possible. If what happened with the AstraZeneca-Oxford vaccine is any guide, it could be weeks before US regulators sign off on allowing the trial to resume. AstraZeneca-Oxford trial in the US has been paused for more than a month.
Back in September, AstraZeneca briefly halted global studies after UK regulators investigated a pair of patients who came down with symptoms of a rare illness which scientists worried might be connected with the vaccine. Trials in the UK and elsewhere restarted days later, but in the US, regulators have refused to allow the trials to resume.
Already, the time lost by JNJ and AstraZeneca-Oxford has pushed them out of the lead in the race to apply for an emergency use authorization from the FDA. Vaccine candidates being developed by Moderna and Pfizer-BioNTech have taken the lead.
But as Bloomberg pointed out in a piece published Saturday morning, both the AZ and JNJ vaccines relied on the same technique: the so-called adenovirus vector which was also used by the Gameleya Institute’s vaccine (aka Sputnik 5) and at least one of the leading Chinese vaccines.
And this year, with Covid-19 vaccines entering strongly into the politics of the hour, transparency and trust are key to fighting a virus that’s hit more than 39 million people globally and hamstrung economies. If concerns about side effects in experimental vaccines in trials using adenoviruses are validated, it could boost skepticism in the general public and raise questions for other drugmakers.
It would also amount to a considerable setback to adenovirus vector vaccines.
As Bloomberg explains, the adenovirus vaccine vector is nothing new to medicine. They are well studied and versatile, according to Bloomberg. Humans have been shown to easily tolerate them, which is what initially attracted scientists to experiment with this method for COVID-19. A J&J vaccine based partially on the method was recently approved to guard against Ebola.
However, the technique already has a couple of conspicuous blemishes on its safety record. Here’s one example: An AIDS vaccine based on the technique was abandoned after the virus was potentially tied to increased infections among those who received it.
In other experiments, though, there were disappointing results. In 2008, a vaccine using an adenovirus developed by Merck & Co. to prevent HIV was tied to increased infections among some who received it in a trial. Merck abandoned the shot, and several similar programs fell by the wayside.
Virtually every chronic disease has grown to epidemic proportions in our children. ADHD, allergies, autism, cancer, autoimmune conditions, diabetes, epilepsy, and the list goes on. With the dramatic rise of these chronic diseases happening over an infinitely small timeline in terms of evolution, the notion that the rise has been driven by genetics falls flat.
One in six children has a developmental disability indicating that something is affecting the neurological health of our children. Autoimmune conditions, ranging from eczema to arthritis tells us that something is causing our children’s immune systems to act out of order and inappropriately causing it to attack friendly cells inside the body. The prevailing medical dogma is that this rise in disease must be environmental and yet the majority of the industry refuses to look at one of the most obvious culprits – vaccination.
Following the 1986, Vaccine Injury Compensation Act, which provided vaccine manufacturers legal immunity for damage and death caused by vaccines, the vaccine schedule has more than tripled. In parallel to the rise of the number of vaccinations we’ve witnessed the greatest fall in children’s health in history.
In Canada, all types of allergies in children have increased six times since 1980. For more than a century, science has understood that repeatedly injecting foreign proteins (vaccination) reliably causes allergies.
In 1903, the French immunologist Nicolas Maurice Arthus published an eye-opening experiment (8): after the fourth subcutaneous injection of horse serum in rabbits, a local oedematous reaction occurred; after the fifth, it became purulent; and after the seventh gangrenous. In other words, an increased specific sensitivity followed repeated injections of a foreign protein that was primarily nontoxic.
This fact underscores the importance of thorough, long-term safety studies for vaccinations. Not all adverse reactions will happen immediately but can appear over time especially in the case of autoimmune conditions. Informed Consent Network Canada demands that proper studies be conducted to prove vaccine safety. Until we stem the tide of chronic disease in children no stone, including vaccines, should be left unturned.
When the medical system is so clearly failing the health of our children, the fact that proper studies are not conducted on the vaccines we inject into children becomes much more distressing.
Governments, the pharmaceutical industry, and our health officials repeatedly claim that vaccines are the first pharmaceutical drug that is universally safe. We’re consistently told that the “science is settled” and that time for debate is over. But is science really settled?
Arguably, vaccines have the least settled science in all of medicine. They have the least rigorous study, for the shortest periods of follow-up of any drug. Vaccine safety is far from being established. In the United States, as many as 50,000 adverse events are reported to their national Vaccine Adverse Event Reporting System (VAERS). A study funded by the US Dept. Of Health and Human Services found that just 1% of all adverse events are actually reported to the VAERS system which means the true number of adverse events could be in the millions every year.
Worse yet, vaccines are not as effective as they are reported to be. In fact, “effective” is not even used in the literal sense for vaccines, but rather the theoretical sense. Throughout history and up until today outbreaks consistently occur in vaccinated populations highlighting the common issue of vaccine failure.
With the effectiveness of vaccines in question, and the safety of vaccines having never been established – to suggest that the science is settled defies rationality.