The FDA reportedly based its decision to authorize doses 4 and 5 on Israeli data posted on the preprint server medRxiv, February 15, 2022. What evidence was provided in this study?
- A preprint study posted April 3, 2022, reports high rates of infection with BA.1, BA.1.1 and BA.2 — variants of Omicron — among triple-jabbed health care workers. In all, the incidence rate among the triple-jabbed with one of these variants was 22%, and only 10% remained asymptomatic
- March 29, 2022, the U.S. Food and Drug Administration authorized a second booster (dose No. 4, for those taking Pfizer or Moderna) for adults over age 50, as well as a third booster (dose No. 5) for immunocompromised people aged 12 and older. The additional boosters are to be given four months after the last dose
- The U.S. Centers for Disease Control and Prevention is also recommending adults who have received two doses of Janssen’s viral vector DNA shot to get a third shot using either Pfizer or Moderna, despite there being no data on the safety or effectiveness of mixing the various shots
- FDA authorized doses 4 and 5, without input from its expert voting panel, based on data showing the Moderna shot was only 11% effective, and caused side effects in 40% of recipients, and the Pfizer shot was 30% effective and caused side effects in 80% of people
- The lead author of that paper, Dr. Gili Regev-Yochay, an infectious disease specialist at Sheba Medical Center in Tel HaShomer, Israel, has publicly stated that “Not a third dose, not a fourth dose, not a fifth dose will do anything to stop infections [long-term]”
That the mRNA-based COVID shot is not a real vaccine is evidenced by the sheer number of “boosters” required to keep COVID-19 at bay. When the injections were released at the beginning of 2021, the promises flowed.
Getting the two-dose regimen was said to be 95% effective and would keep you safe from serious infection. If everyone would just roll up their sleeves and get the jab, the pandemic would be over in no time. By mid-July 2021, just over half the adult U.S. population had received the shot. (Specifically, 56% had received one dose, and 49% were fully vaccinated with two doses.)
Well, before the year was over, reality started setting in, as effectiveness waned far more rapidly than anyone expected. What’s worse, the shot actually increased the infectivity of the Delta variant, and toward the latter part of 2021, hospitals around the world were starting to fill up with “vaccinated” COVID patients.
A preprint study, posted April 3, 2022, also reports high rates of infection with BA.1, BA.1.1 and BA.2 — variants of Omicron — among triple-jabbed health care workers. In all, the incidence rate among the triple-jabbed with one of these variants was 22%, and only 10% remained asymptomatic. As concluded by the authors:
“We report high incidence of omicron infections despite recent booster vaccination in triple vaccinated individuals. Vaccine-induced antibody titres seem to play a limited role in risk of omicron infection. High viral load and secretion of live virus for up to nine days may increase transmission in a triple vaccinated population.”
FDA Authorizes Fourth and Fifth Doses
In mid-August 2021 — just eight months into the COVID jab campaign — the U.S. Food and Drug Administration authorized the first booster (the third dose of mRNA), starting with the immunocompromised.
Then, March 29, 2022, the FDA cleared a second booster (dose No. 4, for those taking Pfizer or Moderna) for adults over age 50, as well as a third booster (dose No. 5!) for the immunocompromised aged 12 and older. The additional boosters are to be given four months after the last dose.
The U.S. Centers for Disease Control and Prevention is also recommending adults who have received two doses of Janssen’s viral vector DNA shot to get a third shot using either Pfizer or Moderna. This despite there being ZERO data on mixing the various shots.
So, in a little over one year, we’ve gone from “two mRNA jabs will ensure you won’t carry the virus or get sick or die of COVID” to “you need a booster every four months and you can still contract, transmit, get sick and die of COVID.” At this rate, we’re looking at three injections per year, and the fully-jabbed and boosted are still getting sick with COVID.
For example, we recently found out that 7 in 10 “vaccinated” CDC employees got breakthrough infections in August 2021, and Princess Cruises reported an outbreak onboard the Ruby Princess in March 2022, despite a 100% “vaccination” rate among both crew and passengers, plus proof of a negative COVID test prior to boarding. As noted by Robert F. Kennedy Jr. in the video above, “it’s time to follow the science.”
COVID Policy Has Nothing To Do With Science
Remarkably, the FDA made the decision to approve another booster without convening its expert voting committee, as is the norm. As noted by Dr. Marty Makary in a Wall Street Journal op-ed:
“The Food and Drug Administration last week authorized Americans 50 and over to get a fourth COVID vaccine dose. Some of the FDA’s own experts disagree with the decision, but the agency simply ignored them.
It will convene its advisory committee this Wednesday [April 6, 2022] to discuss future vaccine needs. That’s like having lawyers present arguments to a judge who’s already issued a verdict … Decisions like this only reinforce the perception that COVID policy is driven by groupthink and politics.”
Even Dr. Paul Offit, whose faith in vaccines is legendary, expressed surprise and dismay at the FDA’s decision to move forward without holding an open meeting to allow experts to comment on the data. He told CNBC:
“It’s just sort of fait accompli. So, is this the way it works? We talk endlessly about how we follow the science — it doesn’t seem to work out that way.”
Dr. Peter Hotez, another well-known vaccine pusher, has also expressed concern about the continued booster trend. He told CNBC that vaccine policy should not merely be based on keeping people out of the hospital, but should also seek to prevent COVID infection and “long COVID.”
He pointed out that the effectiveness of the third dose against hospitalization from Omicron infection has been shown to decline from 91% to 78% in just four months. “That gives me pause for concern that the boosters are not necessarily holding up as well as we’d like,” he said. It is really hard to believe that both of these vaccine pushers are actually waking up and beginning to question the narrative.
FDA’s Decision Based on Shockingly Bad Data
The FDA reportedly based its decision to authorize doses 4 and 5 on Israeli data posted on the preprint server medRxiv, February 15, 2022.  What evidence was provided in this as yet non-peer-reviewed study that was compelling enough to circumvent the voting committee and public comment? According to the authors:
“Breakthrough infections were common, mostly very mild, yet, with high viral loads. Vaccine efficacy against infection was 30% and 11% for BNT162b2 [Pfizer] and mRNA1273 [Moderna], respectively. Local and systemic adverse reactions were reported in 80% and 40%, respectively.”
This is worth repeating. FDA authorized doses 4 and 5 based on data showing the Moderna shot was only 11% effective, and caused side effects in 40% of recipients, and the Pfizer shot was 30% effective and caused side effects in 80% of people. I know, you are probably shaking your head, saying, “What?!” That’s beyond astounding.
The FDA is charged with confirming that medical products are safe and effective. By authorizing the fourth and fifth COVID shots with abysmal effectiveness and sky-high adverse reaction rates they make it abundantly clear that that they are a completely captured agency and have completely abrogated their responsibility for public health.
The lead author of that paper, Dr. Gili Regev-Yochay, and infectious disease specialist at Sheba Medical Center in Tel HaShomer, Israel, has even publicly stated that “Not a third dose, not a fourth dose, not a fifth dose will do anything to stop infections [long-term].”
Experts: We Cannot Boost Our Way Out of the COVID Pandemic
In an April 4, 2022, article, Forbes staff reporter Robert Hart writes:
“While a fourth dose appears to be beneficial at preventing serious illness in older or high-risk people, Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told Forbes that repeated boosting is not ‘a viable strategy’ and it’s not clear that younger groups without high-risk health conditions ‘benefit much from even third doses.’”
Professor Deepta Bhattacharya, an immunologist at the University of Arizona, agrees, saying the current strategy is “not sustainable.” Similarly, Dr. Dan Barouch, a physician and vaccine researcher at Harvard Medical School, told Hart that getting a booster shot every three to six months is impractical for wealthy countries and “simply not possible” in poorer ones.
What we really need, Barouch said, is “vaccines with better durability.” John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine also weighed in, telling Hart he doesn’t think we can “simply boost our way out of the pandemic.”
Regions With Low COVID Jab Rates Have Fared Well
Adding to suspicions that the COVID jabs aren’t doing much of anything is the fact that areas with low injection rates, such as Africa, have fared no worse than those with very high rates.
As reported by The New York Times, the Kamakwie district in Sierra Leone has registered a total of just 11 COVID cases since the beginning of the pandemic, and no deaths. Sierra Leone, in total, has had just 125 COVID deaths since the pandemic was declared. This, despite gathering for large weddings, concerts and football matches without masks.
Bill and Melinda Gates went on record early on in the pandemic stating Africa would be destroyed by COVID unless we made a concerted effort to get the COVID jab to them.
Their prediction turned out to be completely false, and while the African Union has been pushing to reach a 70% injection rate in West and Central Africa, the low incidence of COVID has sparked arguments against continuing the injection campaign this year, as health care funds are needed for other far more common ailments, such as malaria, HIV/AIDS and tuberculosis.
Importantly, Africa wasn’t spared because SARS-CoV-2 didn’t sweep through it, because it did in spades. Studies looking at blood samples reveal two-thirds of the population in sub-Saharan countries have antibodies against SARS-CoV-2 — evidence that they were exposed, recovered and developed the best protection possible — natural immunity.
Areas with more reliable death registries and other data collection, such as South Africa, do show excess deaths during 2020 and 2021, which are being attributed to COVID. But by the third quarter of 2021, only 4% of Africans had received the jab and, by and large, it seems they are far better off because of it.
As noted by Del Bigtree in a Highwire video, the shots have basically decimated the immune function of those who took them, and the FDA has no other plan or option now than to roll out a never-ending series of boosters to “top up” people’s immune defenses, even if it’s only to a slight degree. They have nothing else. The damage is done.
COVID Shots ‘Proven to Cause More Harm Than Good’
While the official narrative is that the COVID shots may be “less than perfect but still better than the alternative” (i.e., getting the infection when you’re unvaccinated), immunologist Dr. Bart Classen published a study in the August 2021 issue of Trends in Internal Medicine, disputing this claim.
The study,“U.S. COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, ‘All Cause Severe Morbidity,’” details a core problem with the Pfizer, Moderna and Janssen (Johnson & Johnson) trials.
All three employed a surrogate primary endpoint for health, namely “severe infections with COVID-19.” This, Classen says, “has been proven dangerously misleading,” and many fields of medicine have stopped using disease-specific endpoints in clinical trials and have adopted the far superior endpoint “all-cause mortality and morbidity”.
The reason for this is because if a person dies from the treatment or is severely injured by it, even if the treatment helped block the progression of the disease they’re being treated for, the end result is still a negative one. The COVID jab would fare very poorly using this metric.
The proper endpoint was calculated by adding together all severe events reported in the trials, not just COVID-19 but also all other serious adverse events. By doing this, severe COVID-19 infection gets the same weight as other adverse events of equivalent severity. According to Classen:
“Results prove that none of the vaccines provide a health benefit and all pivotal trials show a statistically significant increase in ‘all cause severe morbidity’ in the vaccinated group compared to the placebo group.
The Moderna immunized group suffered 3,042 more severe events than the control group. The Pfizer data was grossly incomplete but data provided showed the vaccination group suffered 90 more severe events than the control group, when only including ‘unsolicited’ adverse events.
The Janssen immunized group suffered 264 more severe events than the control group. These findings contrast the manufacturers’ inappropriate surrogate endpoints:
Janssen claims that their vaccine prevents 6 cases of severe COVID-19 requiring medical attention out of 19,630 immunized; Pfizer claims their vaccine prevents 8 cases of severe COVID-19 out of 21,720 immunized; Moderna claims its vaccine prevents 30 cases of severe COVID-19 out of 15,210 immunized.
Based on this data it is all but a certainty that mass COVID-19 immunization is hurting the health of the population in general. Scientific principles dictate that the mass immunization with COVID-19 vaccines must be halted immediately because we face a looming vaccine induced public health catastrophe.”
To make the above numbers more clear and obvious, here are the prevention stats in percentages:
- Pfizer 0.00036%
- Moderna 0.00125%
- Janssen 0.00030%
We also have a cost-benefit analysis by Stephanie Seneff, Ph.D., and researcher Kathy Dopp, published in March 2022, which shows the COVID jab increases children’s risk of dying from COVID infection. Children under 18 are also 51 times more likely to die from the jab than they are to die from COVID if not vaccinated.
Jamie Jenkins, former head of health and labor market analysis at the British Office for National Statistics, has also revealed that 4 million doses must be administered to children, 5 to 11 years of age, to prevent a single ICU admission in this age group.
Menstrual Problems Among Transgendered
One side effect that has made headlines in alternative media over the past year is abnormal bleeding and menstrual irregularities. For example, vaginal bleeding has been reported both in children who aren’t old enough to begin menstruation and in post-menopausal women.
Now, an online survey by researchers at Washington University in St. Louis reveals transgendered people are also reporting breakthrough menstruation, despite being on menstruation-suppressing hormones. As reported by Newswise:
“The study is the first to examine vaccine-associated breakthrough bleeding in people who take testosterone or other hormones that suppress menstruation. The research focuses on individuals with a range of gender identities such as transgender, nonbinary or gender-fluid.
Previous studies of COVID-19 vaccine related menstrual symptoms have largely focused on cisgender (cis) women, those whose gender identity matches the female gender they were assigned at birth …
Out of over 160,000 survey respondents, the researchers identified 552 people who said they used testosterone or other gender-affirming hormones and did not usually menstruate. Most of these respondents (84%) selected more than one gender category, with 460 identifying as transgender, 373 specifying man or man identified, 241 identifying as non-binary and 124 indicating they were genderqueer/gender non-conforming.
One-third of these respondents reported breakthrough bleeding after receiving a COVID-19 vaccine, 9% reported chest or breast soreness and 46% reported having other symptoms they would usually associate with a period, such as cramping and bloating.
Some respondents used the survey’s open-ended text boxes to report significant negative mental health impacts in response to their period symptoms, including anxiety, depression, gender dysphoria, panic attacks and suicidal ideation …
‘I hope that discussing these findings openly allows people to know that this could be a side effect so they can prepare appropriately,’ said [lead author Katharine] Lee.
‘This is especially important given the fact that some people described mental health outcomes like anxiety, depression and suicidal ideation as responses to unexpected breakthrough bleeding after vaccination.’”
Originally published April 12, 2022 on Mercola.com
Sources and References
- 1 USA Facts Vaccine Tracker Updated July 12, 2021
- 2 CDC MMWR August 18, 2021; 70 New COVID Cases and Hospitalizations Among Adults by Vaccination Status
- 3 CDC MMWR August 18, 2021; 70 Sustained Effectiveness of Pfizer and Moderna Vaccines Against COVID Associated Hospitalizations Among Adults
- 4 CDC MMWR August 18, 2021; 70 Effectiveness of Pfizer and Moderna Vaccines Among Nursing Home Residents
- 5 MedRxiv August 25, 2021
- 6 Evening Standard August 20, 2021
- 7 Twitter Alex Berenson July 18, 2021
- 8 Science August 16, 2021
- 9 MedRxiv April 3, 2022 DOI: 10.1101/2022.04.02.22273333
- 10 Mundo Hispanico August 14, 2021
- 11, 13, 17 CNBC March 29, 2022
- 12 The Highwire, The FDA Authorizes 4th and 5th Booster Doses
- 14 DHHS FOIA Response March 3, 2022
- 15 Epoch Times March 29, 2022
- 16 WSJ April 3, 2022
- 18 MedRxiv February 15, 2022, DOI: 10.1101/2022.02.15.22270948
- 19 NEJM Correspondence March 16, 2022 DOI: 10.1056/NEJMc2202542
- 20 NPR February 22, 2022
- 21 Forbes April 4, 2022
- 22, 24 New York Times March 23, 2022
- 23, 25 NYT republished by BDNews24.com March 23, 2022
- 26, 27, 28 Trends in Internal Medicine August 2021; 1(1): 1-6
- 29 COVID-19 and All-Cause Mortality Data Analysis by Kathy Dopp and Stephanie Seneff (PDF)
- 30 Stats Jamie
- 31 Stats Jamie February 20, 2022
- 32 Newswise March 25, 2022
Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times
Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times.