July 22, 2020, Pfizer struck a $1.95 billion deal with the U.S. Department of Health and Human Services and the Department of Defense to provide Americans with 100 million doses of its COVID-19 vaccine, for free, with an option for 500 million additional doses.1 The agreement is part of Operation Warp Speed.
Pfizer/BioNTech have also inked a deal with the U.K. government for 30 million initial doses.2 The vaccine, currently known only as BNT162, developed in partnership with the German company BioNTech, requires two doses, which means the initial batch for the U.S. would cover 50 million people. The deal hinges on the vaccine clearing Phase 3 human trials.
According to a July 22, 2020, press release,3 Phase 2b/3 safety and efficacy trials were expected to begin at the end of July. The company expects seeking a regulatory review by the U.S. Food and Drug Administration in October 2020, which would allow them to manufacture the 100 million doses by the end of the year.
The FDA has stated a COVID-19 vaccine must be at least 50% effective to qualify for approval.4 In other words, the standards aren’t particularly high, despite the concern COVID-19 supposedly poses.
The BNT162 vaccine is based on BioNTech’s proprietary mRNA technology. BioNTech is the market authorization holder for the mRNA technology worldwide, and will own all the trademarks for the vaccine.5 According to Pfizer’s press release:6
“The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. On July 1st, Pfizer and BioNTech announced preliminary data7 from BNT162b1, the most advanced of the four mRNA formulations.
The data demonstrates that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19 … Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported.”
Former FDA Commissioner Is Now on Pfizer Board of Directors
Interestingly enough, Dr. Scott Gottlieb, who served as commissioner of the FDA from May 2017 to April 2019,8 just so happened to be elected to Pfizer’s board of directors at the end of June 2019. At the time, Ian Read, executive chairman of Pfizer’s board of directors stated:9
“We are fortunate to have Dr. Gottlieb join Pfizer’s Board of Directors. Scott’s expertise in health care, public policy and the industry will be an asset to our company and enable our shareholders to continue to benefit from a Board representing a balance of experience, competencies and perspectives.”
Well, there can be little doubt that a former FDA commissioner on your board might be an asset when you’re trying to secure a nearly $2 billion contract with the U.S. government for a novel vaccine that has never been approved by the FDA for human use.
As discussed in “Why Most Health Commissioners End Up in Bed With Big Pharma,” Gottlieb is far from alone in having walked through that revolving door. After leaving the top leadership position at the FDA, nine of the last 10 commissioners have gone on to work for pharmaceutical companies.
While none of these moves of past FDA commissioners to pharmaceutical companies is illegal, the pattern creates the suspicion there might be an unstated agreement between the pharmaceutical industry and those who are charged with regulating the approval of their products.
Another egregious example was Julie Gerberding, who served as the director of the CDC from 2002 to 2009. Immediately after leaving the CDC, she became president of Merck’s vaccine division, for which she received tens of millions of dollars a year — far more than her CDC salary.
mRNA Vaccines May Produce Serious Side Effects
As detailed in the preliminary study10 results, posted on the preprint server medRxiv July 20, 2020, BNT162b1 is a lipid nanoparticle (LNP) formulated nucleoside-modified mRNA that encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein.
mRNA vaccines have never before been licensed for use in humans. Inside your cells, mRNA activate DNA instructions, and act as a template to build a specific protein.
The theory behind mRNA vaccines is that when you inject the mRNA (encapsulated within lipid nanoparticles), the mRNA will stimulate your cells to manufacture their own viral proteins.11 In this case, those proteins would mimic the proteins found in SARS-CoV-2.
Conventional vaccines train your body to recognize and respond to the proteins of a particular virus by injecting a small amount of the actual viral protein into your body, thereby triggering an immune response and the development of antibodies.
No previous vaccines have had your own cells produce the viral proteins responsible for producing immunity. mRNA vaccines are designed to make your body produce its own viral protein, which your immune system would then mount a response to. If you suspect a whole lot could go wrong here, you’d probably be right. As reported by The Vaccine Reaction:12
“According to researchers at University of Pennsylvania and Duke University, mRNA vaccines have potential safety issues, including local and systemic inflammation and stimulation of auto-reactive antibodies and autoimmunity, as well as development of edema (swelling) and blood clots.”13
Systemic inflammation, auto-reactive antibodies and autoimmune problems are no small matters. In fact, these are in large part why previous attempts to create a coronavirus vaccine have failed.
As explained by Robert F. Kennedy, Jr., in my interview with him, coronavirus vaccines are notorious for creating paradoxical immune enhancement. Even though the vaccines create a robust antibody response, the subjects end up sicker than normal when they’re exposed to the wild virus. In one ferret study, all the vaccinated animals died.
Time will tell just how hazardous the COVID-19 vaccines turn out to be. Since they work on the genetic level, there could be long-term, perhaps even generational, issues that won’t be readily apparent anytime soon, as these vaccines could be integrated into your DNA.
Be Wary of the PR Propaganda Spin
A July 21, 2020, Wired article urges researchers and media to be upfront and transparent about the vaccines’ side effects right now, “before it ends up as fodder for the skeptics”:14
“Neither the mainstream media nor the medical press has given much attention to the two vaccines’ potential downsides — in particular, their risk of nasty adverse effects, even if they’re not life-threatening. This sort of puffery doesn’t only help to build a false impression; it may also dry the tinder for the future spread of vaccine fearmongering.”
Wired points out that some trials are not using an inert placebo but rather injected meningococcal vaccine, which might hide certain symptoms or harms. Another example: The University of Oxford added study arms in which subjects are given acetaminophen every six hours for the first 24 hours after inoculation.
Is the pain and fever reducer given to mask and downplay certain symptoms and side effects, such as pain, fever, headache or general malaise? It very well could be. Wired notes:15
“The press release for … results from the Oxford vaccine trials described an increased frequency of ‘minor side effects’ among participants. A look at the actual paper, though, reveals this to be a marketing spin …
Yes, mild reactions were far more common than worse ones. But moderate or severe harms — defined as being bad enough to interfere with daily life or needing medical care — were common too.
Around one-third of people vaccinated with the COVID-19 vaccine without acetaminophen experienced moderate or severe chills, fatigue, headache, malaise, and/or feverishness.
Close to 10 percent had a fever of at least 100.4 degrees, and just over one-fourth developed moderate or severe muscle aches. That’s a lot, in a young and healthy group of people — and the acetaminophen didn’t help much for most of those problems.”
Experts Worry Vaccine Uptake May Be Low
Indeed, medical experts have already expressed concerns that COVID-19 vaccine uptake might end up being low. As reported by Newsday June 21, 2020:16
“A recent national Washington Post/ABC poll, and a poll of Long Islanders and New York City residents by Mount Sinai South Nassau hospital in Oceanside, each found that only 45% or fewer of respondents said they would get a coronavirus vaccine if one is developed. About a quarter in each poll said they would not, and the rest said they weren’t sure or wouldn’t answer.”
That Newsday article also inadvertently provides clues as to why most states are now, months into the pandemic, which has long since been “flattened,” issuing mandatory mask mandates, even though the science clearly tell us masks cannot protect against or prevent the spread of viruses.
I believe the forced mask wearing is a way to manipulate us into taking the vaccine, once it becomes available, and that is exactly what Noel Brewer alludes to in the Newsday article:17
“A return to pre-COVID-19 life could be possible if significantly more than half of Americans — the percentage is unknown — get a vaccine, the number of new infections is low and those who already contracted the virus are immune from getting sick again …
That enticement of normal life could lead some who now are leery about a coronavirus vaccine to get one once it is available, said Noel Brewer, a professor of health behavior at the University of North Carolina who sits on World Health Organization committees on vaccine behavior and safety.
‘If a vaccine allows you to no longer wear a mask at work, or to visit your grandmother in a nursing home, or to shake hands with business colleagues, that could be very motivating,’ he said.”