Articles

Covid-19 Injections

FDA Alert (June 23, 2021): Covid-19 injections can cause heart inflammation.

Informed Consent

Everything in the medical field is about informed consent. It is the process by which a patient learns about and understands the purpose, benefits, and potential risks, and then either agrees to receive the treatment or not. This is also referred to as a “benefit-risk assessment.”

The science is never settled and scientist will be studying these injections for many years to come.

The co-founder of BioNTech designed the coronavirus vaccine it made with Pfizer in just a few hours over a single day and Moderna spent less than a weekend on their design.

Pfizer Fact Sheet
The Pfizer-BioNTech Covid-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older.

Moderna Fact Sheet
The Moderna Covid-19 vaccine is an unapproved vaccine that may prevent Covid-19. There is no FDA-approved vaccine to prevent Covid-19. The FDA has authorized the emergency use of the Moderna Covid-19 Vaccine to prevent Covid-19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA). The significant known and potential risks and benefits of the Moderna Covid19 Vaccine, and the extent to which such risks and benefits are unknown.

Janssen (Johnson & Johnson) Fact Sheet

AstraZeneca Fact Sheet

Learn the Risks

Fundamental to informed consent is understanding the risk versus the benefits. Patients have the right to receive ample information and ask as many questions as needed in order to make an informed decision. Even with the safest of vaccines, there is a risk for having an adverse reaction. 

Currently all of the Covid-19 injections are not FDA approved and only have  Emergency Use Authorization (EUA). Trial studies will likely continue until at least 2023.

Pfizer’s website: “The approval status of the Pfizer‑BioNTech COVID‑19 Vaccine varies worldwide. In countries where the vaccine has not been approved by the relevant regulatory authority, it is an investigational drug, and its safety and efficacy have not been established.”

Animal Studies

Texas Senate Hearing on May 6, 2021: Minute 44

Mr. Hall: “And as what I’ve read, they actually started the animal tests and because the animals were dying, they stopped the tests. Folks, I think that’s important to understand there that what we’re talking about is American people are now the guinea pigs. This is the test program, that’s going on.
They didn’t do the human testing and they stopped the animal test because the animals were dying. And then they turned it out for the pubic.”

** Disclaimer** Mr. Hall may be referring to prior animal studies and not the current ones. The current animal studies do not appear to be available for public viewing.

Most vaccine trial studies take 15-20 years and regulators require safety testing in animals, prior to experimenting with humans. However, do to the urgency of finding a Covid-19 vaccine, manufacturers were allowed to mostly skip over animal studies. Pfizer and Moderna were authorized to simultaneously test their Covid-19 injections on animals, while conducting Phase 1 trials on humans.

Moderna and Pfizer were originally going to submit for FDA approval around 2023, however Pfizer is now hoping to do so by June 2021.

CDC Vaccine Trials

 

Risk of Antibody Dependent Enhancement After Covid-19 Injections

Antibody Dependent Enhancement (ADE), is when anti-covid antibodies, created by a vaccine, instead of protecting the person, cause a more severe or lethal disease when the person is later exposed to Covid-19 in the wild. It amplifies the infection rather than preventing damage. Dengue and RSV vaccines are two good examples of how this can occur.

While ADE has been well documented in vitro for a number of viruses, including Human Immunodeficiency Virus (HIV), Ebola, Influenza and Flaviviruses (positive strand RNA viruses), the relevance of in vitro ADE for human coronaviruses remains less clear. Post vaccination animal challenge studies will be critical for assessing the risk for ADE. 

Due to this risk, the FDA will be monitoring for Enhanced Respiratory Disease in Phase III clinical trials and has also advised for additional monitoring for at least two more years. 

Mortality Risk from Covid-19 Infection

Everyone has a different risk for Covid-19 mortality and any subsequent long-term effects resulting from it. Increased age is one of the biggest risk factors for mortality and 40% of all Covid-19 deaths have been linked to nursing homes. Per the CDC, 80% of all deaths have occurred in those aged 65 and older.

Some studies indicate that low Vitamin D levels increase the risk for mortality. Other vitamins like Vitamin C, Zinc, and Quercetin may also play a vital role in decreasing the severity of Covid-19 symptoms. Research studies also show that mortality is higher in those with obesity, high blood pressure, diabetes, and heart failure, whereas exercising decreases the mortality risk.  

We will likely never know the exact death toll from Covid-19. As of now, the CDC estimates 377,883 Covid-19 related deaths for the year 2020 in the United States, however excess mortality rates is estimated to be greater than 500,000. At the start of 2020, the United States had approximately 331 million people. So if you go by excess mortality rates, that would make the Covid-19 mortality rate around 0.15% for the United States population.

To view other mortality rates, click on the following links: Countries, United States, New York City, Ohio, and Palm Beach County, Florida.

New York City (NYC) has had more deaths than any other city in the United States. Per the current numbers in NYC, my personal mortality risk is less than 0.06%. If I still lived in my Florida, my risk for mortality would be less than 0.03%

What About Herd Immunity?

Herd immunity is defined as “the resistance of a group of people to an attack by a disease to which a large proportion of the members of the group are immune” (p. 27). In other words, if enough people build up immunity to Covid-19, then the remaining will be protected because of herd immunity.

Herd immunity thresholds vary between viruses. For example, prior research shows that herd immunity requires vaccination against measles for 93-95% of the population, 92% for mumps, and 90-95% for diphtheria. It is speculated that herd immunity for Covid-19 will be reached once 60% of the population has achieved immunity, but per other research it may take up to 80%. As variants continue to change, these estimates could also go up.

Covid-19 is a new virus, and there are still many unanswered questions: At what point is herd immunity reached? How do we identify immunity against reinfection? How do we identify mutations and how do mutations impact the degree of protection from reinfection? How long does immunity last and how can that be assessed?

Covid-19 immunity from the infection could last years. A recent study found showed protection for at least 12 months after initial infection. Another study reports that you will probably produce antibodies for a lifetime, after a Covid-19 infection.

Scientist are currently predicting that reaching herd immunity to Covid-19 in the United States is unlikely. Like many coronaviruses (e.g., the common cold), Covid-19 variants may mutate and spread too quickly for vaccines to have any chance of keeping up. Both Moderna and Pfizer are working on booster injections for the new variants. Even if everyone in the United States were to be vaccinated, what happens when people travel in and out of the country? The United States is a hub for global travel and new variants will continue to circulate, which may also increase the chance of vaccine escape.

CDC Guidelines for Covid-19 Injections

The CDC requires all sites to have 3 doses of Epinephrine on hand at any given time. This policy is in place, in the advent that someone has an anaphylactic reaction. As of June 4, 2021 there have been 1,459 reported cases of anaphylaxis.

The CDC requires a checklist of questions to be answered prior to injection. Some of the questions asked include: history of allergic reaction, allergy to polyethylene glycol (PEG) or polysorbate, history of Covid-19 infection, history of antibody therapy for Covid-19, weakened immune system, bleeding disorder, breastfeeding/pregnant, and history of dermal fillers.

The CDC advises all health care providers to report all adverse reactions or deaths, following any Covid-19 injection, to the Vaccine Adverse Event Reporting System (VAERS). As of May 28, 2021 there have been 5,165 deaths reported to VAERS.

The CDC advises the public to seek medical attention if they develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after injection. I would also like to add in: blurred vision, difficulty with speech, weakness, drowsiness, seizures, chest pain, and/or a rash that looks like small bruises under the skin (called a petechiae rash).  These symptoms may indicate a blood clot and require immediate evaluation in the Emergency Room.

Vaccine Safety Monitoring

There are many different agencies who are monitoring the new Covid-19 injections. The World Health Organization is currently monitoring adverse reactions for Africa, Americas, Asia, Europe, and Oceania. Type “comirnaty” into their search box. Comirnaty contains the active ingredient for the Pfizer and Moderna Covid-19 injections. The stats are always changing, but the vast majority of adverse reactions occur in females aged 18-64.
* COMIRNATY® (Pfizer-BioNTech Covid-19 injection) has been granted conditional marketing authorization by the European Medicines Agency to prevent coronavirus disease 2019 (Covid-19) in people from 16 years of age

V-Safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you have received a Covid-19 injection. In order to register, you will need to have a smartphone. V-Safe was set up to help the CDC monitor for any adverse reactions to the Covid-19 injections.

The CDC has an Advisory Committee on Immunization Practices (ACIP) for Covid-19 Vaccine Safety Technical (VaST). The last public meeting was held on May 17, 2021, which included several presentations on myocarditis following mRNA vaccines, from the Department of Defense (DoD), the Vaccine Adverse Event Reporting System (VAERS), and Vaccine Safety Datalink (VSD).

The Vaccine Adverse Event Reporting System (VAERS) monitors for adverse reactions to vaccines in the United States. Anyone can report a reaction to this site, however I highly recommend having your health care provider do it for you. Historically reactions to vaccines have been under-reported. It is estimated that less than 1% of vaccine reactions ever get reported.
* VAERS is a passive surveillance system in the United States that captures adverse events following vaccination, but is unable to prove causation (i.e., that the injection caused the adverse event or possible side effect).

Viewing adverse reports from the VAERS website is far from user friendly and I recommend using one of these sites instead: National Vaccine Information Center and OpenVAERS. VAERS is updated every Friday, but cannot prove that the injection is responsible for the alleged injury. Covid19VaccineReactions.com has also been documenting adverse reactions.

Image from OpenVAERS.com

Directions for Accessing VAERS

1.Go to https://vaers.hhs.gov/data.html. Scroll to the bottom.
2. There are two ways to view. Select the first box.
3. Agree to the terms and click “Search CDC Wonder.”
4. Scroll to the bottom and click “I agree”
5. Click “Request Form”
6. Scroll to the Second Box & select “all symptoms”
7. Scroll to the Third Box & select Covid-19
8. Scroll down and select the manufacture (Moderna, Pfizer or Janssen)
9. Select to see “All doses”
10. Scroll down to the Fourth Box and select “The United States”
11. Scroll down to the bottom and select “send”

The United Kingdom also has their own monitoring system for adverse reactions. It is called the Yellow Card Scheme. Just like VAERS, reported events are not always proven to be real side effects.

Europe’s Monitoring System: to view reports on Covid-19 injections, scroll to “C” and click on the appropriate link. Updated online every Monday.

Canadian Adverse Events Following Immunization Surveillance System (CAEFISS). Weekly reports for Covid-19 injections are updated each Friday.  Report a vaccine side effect.

If you have an adverse reaction to Pfizer, please submit a report to their reporting website in addition to VAERS. If you have a reaction to Moderna, please call 1-866-MODERNA (1-866-663-3762) or email ModernaPV@modernatx.com to file a report and still file a report to VAERS.

FDA Alert: Covid-19 injections can cause Heart Inflammation
European Medical Agency (EMA) is reviewing reports of heart inflammation and nerve disorder after Pfizer and AstraZeneca Covid-19 injections. Israel is also investigating reports of heart inflammation in men 30 and younger.

 

If you have a reaction who pay’s the bills?

You cannot sue for a vaccine reaction and pharmaceutical companies have zero liability. I learned this hard way when I had an adverse reaction to the original Gardasil Vaccine. Not only did I have chest pain and palpitations for a year, I was also stuck paying for my Emergency Room visit and Cardiology workup. Please always make an informed decision, prior to any medical procedure and weigh out the risk versus the benefits of the treatment.

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

 

All Deaths Reported to VAERS by year.

 

 

Possible Benefits of Covid-19 Injections

Per the CDC “there is some evidence that vaccination may make illness less severe,” but let’s look at the statistics. Vaccine efficacy is generally reported as a relative risk reduction. It is a ratio comparing the risk of infection in people who got vaccinated versus the people who did not (the control group). An absolute risk reduction is the size of your own risk and looks at the percentage points your own risk goes down, if you take the Covid-19 injection. Both Pfizer and Moderna only advertise the relative risk reduction, which can lead to an over-estimation of the efficacy of the Covid-19 injections.

Based on the data for Pfizer’s Covid-19 injection the appraisal shows a relative risk reduction of 95.1% and an absolute risk reduction of only 0.7%. For Moderna’s Covid-19 injection the appraisal shows a relative risk reduction of 94.1% and an absolute risk reduction of only 1.1%. So a Covid-19 injection with a 95% effectiveness, does not mean 95% of recipients are protected from the disease and 5% are not. Instead it means that you are 95% less likely to contract the infection, compared to someone who did not get the injection. An absolute risk reduction helps to clarify your actual risk reduction, from getting the injection. The absolute risk reduction changes, depending on your actual risk for a Covid-19 infection.

Image from PubMed
Image from PubMed

There is a concern that the injections are less effective in people who are 65 and older and may be less effective in those with autoimmune disease. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Covid-19 Injections.

Clinical trials are not finished, thus more data will be needed and real world circumstances are still being evaluated. A very small study has found some potentially hopeful news. They found the Pfizer/Moderna injections to be 94% effective against Covid-19 hospitalizations, however the study sample included only one patient who was fully vaccinated and 19 others who had received only one injection. Another promising study was just recently published that showed only one Pfizer injection could decrease the risk of spread to others in the household by up to half. This study was much larger and included 1.5 million adults.

From Moderna’s website: Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Moderna COVID19 Vaccine may be effective for the prevention of Covid19 in individuals as specified in the Full EUA Prescribing Information. The Moderna Covid-19 vaccine may not protect all vaccine recipients.

Do they prevent transmission?

Per the World Health Organization, they do not know. They have also stated that they do not approve of vaccine passports because they “are not certain at this stage that the vaccine prevents transmission.

Doctors in India are warning that some vaccinated people could become silent carriers and could unknowingly spread the virus to others. Clinical trial specialist, Santanu Tripathi, cautioned that “the vaccine is not meant to stop transmission. It is meant to boost a person’s immunity against the virus and reduce the severity of the infection.”

Researches have warned that it may be possible to transmit the virus even after natural immunity. As of May 4, 2021, the CDC has stated that they are still learning how well vaccines prevent you from spreading the virus to others, even if you do not have symptoms.

Take a look at flu shots: Evidence does not support vaccinating healthcare workers against seasonal influenza to protect patients. No reliable published evidence shows that healthcare workers’ vaccination has substantial benefit to their patients.

How long does protection last?

The CDC states “we are still learning” but, “there will be a small percentage of people who are fully vaccinated who still get sick, are hospitalized, or die from Covid-19.” There have been over 9,000 breakthrough cases, but due to under-reporting, that number is likely much higher. Starting on May 14, 2021 the CDC will only report on breakthrough cases that result in hospitalization or death

June 17, 2021: More than 350 doctors and medical workers have caught Covid-19 in Indonesia despite being fully vaccinated and dozens have been hospitalized, officials said, as concerns grow about the efficacy of some vaccines against more infectious variants

The head of China’s Center for Disease Prevention and Control went on record stating that none of the current Covid-19 injections offer a very high protection rate and that changes might be needed to dosage, interval, or number of doses.

Many of the new variants appear to reduce the effectiveness of the Covid-19 injections. There is also a concern that Covid-19 injections may actually create new variants. Viruses produce slight variations when they multiply, and if any of these variants evade a person’s immune system, those variants are more likely to survive and possibly spread to others. This is similar to antibiotic resistance, which is when bacteria evolve to the point where antibiotics are no longer effective. Some think it may be far fetched to reach herd immunity through vaccines alone, and argue that we need to learn how we can live with the virus.

Even if immunity lasts for 3-6 months, vaccine escape is a potential issue. Vaccine escape is where new variants may “escape” the immunity from the injection. Covid-19 injections may not offer protection for mutated variants and per the CDC, early data shows that vaccines may work against some variants but could be less effective against others. The variant from India has now been discovered in the United States and the California variant may be able to evade fully vaccinated people.

A real-world data study in Israel – not yet peer-reviewed – found some people who had been fully vaccinated against Covid-19 still caught the South Africa variant.

Due to these reasons, Pfizer is already working on an antiviral pill to treat Covid-19 patients in an outpatient setting. 

Covid-19 Variants

There are numerous different Covid-19 variants and both the World Health Organization (WHO) and the Centers for Disease Control (CDC) are monitoring them.

Terminology Used by the CDC/WHO:

  • A variant of concern (VOC) has been proven through scientific research to be more contagious or to cause more severe disease. It may also reduce the effectiveness of therapeutics and vaccines. People who have previously had Covid-19 may become re-infected by the new strain.
  • A variant of interest (VOI) has caused discrete clusters of infections in the United States or in other Countries and has gene changes that suggest it might be more contagious or may be able to escape immunity. Treatments and tests may not work as well against it.
  • A variant of high consequence causes more severe disease and greater numbers of hospitalizations. It has also been shown to defeat medical countermeasures, such as vaccines, antiviral drugs, and monoclonal antibodies. So far, none of the variants meets this definition.
  • The FDA has alerted the medical field that some genetic variants of Covid-19 may lead to false negatives on Molecular PCR testing. France has also put out a similar warning, that some variants may not show up on a PCR test.
  • PATH has been actively compiling available data on target proteins and genes for the Covid-19 antigen and molecular diagnostics, and the manufacturer claims regarding a test’s ability to detect emerging strains of Covid-19. Check these two links out: Implication of variants on Covid-19 antigen test detection (rapid testing) and Implications of variants on Covid-19 molecular test detection (PCR testing).

Vaccine Performance against Variants of Concern (VOC)

Can you still contract the virus after the injection?

Yes. The CDC’s current guidelines state that a small percentage of people will still develop Covid-19 symptoms after injection. These are called “breakthrough” cases. This phenomena is still being studied, to see how common this is. The CDC further clarifies that a small percentage of people may still become hospitalized or die from Covid-19 even after both injections. It is also possible for some to have the infection, but not have symptoms (asymptomatic infections).

From January 1, 2021 to April, 30, 2021 the CDC reported over 10,000 breakthrough cases. As of May, 1, 2021 the CDC will no longer be reporting on breakthrough cases and will only be focusing on hospitalized or fatal cases. No vaccine is 100% effective and it is also being reported that the Covid-19 injections will likely not protect those with weakened immune systems. Autoimmune diseases and certain cancers can disrupt immune cells. Immune suppressant medications like methotrexate may also interfere with immunity.

The World Health Organization stated that they do not approve of vaccine passports because they “are not certain at this stage that the vaccine prevents transmission.”

The Health Minister of Australia (Greg Hunt) recently stated that even if the entire population is fully vaccinated against Covid-19, the borders would likely stay closed. “Vaccination alone is no guarantee that you can open up,” Mr Hunt said. He further clarified by stating “we still have to look at a series of different factors: transmission, longevity [of vaccine protection] and the global impact – and those are factors which the world is learning about.”

 

Do you need the injection if you have already had the virus?

Not a single published study has demonstrated that patients with prior infection benefit from Covid-19 injections.

Latest study from Cleveland Clinic evaluated 52,238 employees and concluded: Individuals who have had SARS-CoV-2 infection are unlikely to benefit from Covid-19 injections, and should be safely prioritized to those who have not been infected before. Another study found people who recover from mild Covid-19 have bone-marrow cells that can churn out antibodies for decades.

Per the CDC, population immunity means that enough people in a community are protected from getting a disease because they’ve already had the disease or because they have been vaccinated.

Reinfection after a Covid-19 infection appears to be a rarity and prior infection has been shown to be highly protective against reinfection and symptomatic disease. Covid-19 immunity from the infection could last years. A recent study found showed protection for at least 12 months after initial infection. Even mild infections induces long lasting antibody protection.

A professor at John Hopkins said that half of Americans have natural immunity for Covid-19 due to prior infection.

A study published in Science Immunology suggest that only one Covid-19 injection may be needed (for those with prior infection) to produce a sufficient antibody response.

 

If you have a history of Covid-19 infection, is there an increased risk for a reaction?

Side effects are up to three times more common in those who have had the virus and experts are questioning whether those with prior immunity need the second dose. Even after antibodies decline, T-cell immunity remains. T-cell immunity also appears to be effective against new Covid-19 variants.

Dr. Noorchashm echos these concerns. In his letter to the FDA, he warns that those who have had a prior Covid-19 infection, could be at an increased risk for having an adverse reaction. Dr. Noorchashm fully believes in the Covid-19 injections, and is fully vaccinated himself. He is however advocating for delayed Covid-19 injections, after natural infection. In addition, he is also advising for patients to be screened for Covid-19 prior to injection.

Dr. J. Patrick Whelan has also issued a public statement to the FDA: “I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein (including the mRNA vaccines of Moderna and Pfizer) have the potential to cause microvascular injury to the brain, heart, liver, and kidneys in a way that does not currently appear to be assessed in safety trials of these potential drugs.”

Anaphylactic Reactions

Anaphylaxis is a sever, life-threatening allergic reaction. It has been hypothesized that two of the ingredients in the Covid-19 injections may be responsible. As of June 4, 2021 there have been 1,459 reported cases of anaphylactic reactions. 

Polyethylene glycol (PEG) is used in the Pfizer and Moderna injections as a protective coating for messenger RNA or mRNA. Polysorbate 80, which is found in the Johnson & Johnson and AstraZenca injections, may be another culprit for some of the anaphylactic reactions. One study concluded that Polysorbate 80 can cause severe non-immunologic anaphylactoid reactions.

Should you get tested for these allergies? You can but some feel it may be a waste of time and money, because these allergies are a rarity.

Are there any possible fertility risks?

This has not been been fully studied. Please remember that these injections are new and will be in clinical trials until at least 2023 and will require several years of monitoring even after FDA approval. Covid-19 guidelines have changed many times. Please check out the latest guidelines from the American College of Obstetricians and Gynecologists (ACOG), The Society for Maternal Fetal Medicine and the CDC.
 
Originally, women were told not to have the injection if they were pregnant or planned to be pregnant, within 3 months of the first dose. Current guidelines now advise that pregnant women should be offered Covid-19 injections. They also now say there is no reason to delay pregnancy after the injection.

Pfizer statement: available data on Pfizer-BioNTech Covid-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
Moderna statement: available data on Moderna Covid19 Vaccine administered to pregnant women are insufficient to inform vaccineassociated risks in pregnancy.

Menstrual Cycles & Vaginal Bleeding
There are currently little to no research on how injections could affect periods, and menstrual cycles were not monitored in trial studies. After thousands of women reported abnormal periods after having the Covid-19 injection and or after being around others who recently had the Covid-19 injection, a study has been launched to investigate it. Some women who are reporting vaginal bleeding, are postmenopausal. There is no research on this next one, but unvaccinated women are reporting miscarriages after interactions with vaccinated people. Correlation does not mean causation, however there have been no studies performed to fully assess this.

An independent group is studying changes in women’s cycles due to the Covid-19 injections. If you were affected, please click here to file a report.

To find out whether the Covid-19 injection truly disrupts the menstrual cycle, experts say there would need to be a controlled study with a placebo group. Currently, clinical trials omit tracking menstrual cycles, so there is no evidence to put the women’s reports into context. Long-term studies have also been hindered by the elimination of the placebo group in trial studies.

Vaccine Induced Immune Thrombotic Thrombocytopenia (low platelets) could be a potential cause for vaginal bleeding, after Covid-19 injections. Platelets are responsible for helping the body to clot, and having low platelets can cause unusual bleeding to occur. It is plausible then that vaccine-induced thrombocytopenia could be the cause of abnormal menstrual bleeding.

Data from the Centers for Disease Control and Prevention (CDC) shows that many more women than men are experiencing side effects after getting the Covid-19 injection.

Pregnancy & Miscarriages

As of June 11, 2021, 2,283 pregnant women have reported adverse events related to Covid-19 injections, including 707 reports of miscarriage or premature birth. Dr. Robert Malone, inventor of mRNA technology, found alarmingly high concentrations of the lipid nanoparticles in the ovaries. Instead of staying at the injection site, the spike protein (from the lipid nanoparticles) leave and accumulate in organs and tissues.

On December 1, 2020, the ex-Pfizer head of respiratory research Dr. Yeadon and former head of public health department Dr. Wodarg filed a petition to the European CDC, for the immediate suspension of all Covid-19 vaccine studies. In section XI, they warn of the possibility of the Covid-19 injections preventing the formation of the placenta during pregnancy.

Out of 827 pregnant women enrolled in the V-Safe pregnancy registry, close to 14% lost their baby. In the v-safe pregnancy registry, there were 104 miscarriages, 92.3% of which occurred before 13 weeks of gestation. There were also 46 miscarriages reported to the VAERS, which the researchers wrote was the most frequently reported pregnancy-related adverse event in the database. Interesting to note that the CDC is monitoring pregnancies with confirmed Covid-19 infections, and as of May 4, 2021, 92.4% have had live births. Two other studies may show that Covid-19 injections are safe and effective for pregnant women, however these are short-term studies and not long-term.

Many are concerned for the risk of infertility. In a public statement to the CDC, molecular biologist and toxicologist Dr. Janci Chunn Lindsay, Ph.D., advised for halting Covid-19 injections, citing fertility, blood-clotting concerns, and vaccine escape. “First, there is a credible reason to believe that the Covid vaccines will cross-react with the syncytin and reproductive proteins in sperm, ova, and placenta, leading to impaired fertility and impaired reproductive and gestational outcomes.

There is an ongoing clinical trial being done in Israel to study the affects of the Covid-19 injections on ovaries. In a recently leaked Pfizer document, animal studies show high toxicology rates in female ovaries (p.17).

Pfizer’s Statement on Infertility: There are no data to suggest that the Pfizer-BioNTech Covid-19 injection causes infertility. It has been incorrectly suggested that Covid-19 vaccines will cause infertility because of a very short amino acid sequence in the spike protein of SARS-CoV-2 that is partly shared with a protein in the placenta called syncytin-1. From a scientific perspective, the differences between the two sequences are quite significant, making it very unlikely our vaccine could generate a response that would harm the placenta.

Men
There was a study that found Covid-19 to be present in testicles for up to six months following infection. Due to this, researchers are now investigating the fertility risk in men from Covid-19 injections.

One ingredient for potential fertility concern is Polysorbate 80, which is found in the Johnson & Johnson and AstraZenca injections. Many are concerned that Polysorbate 80 can cause infertility. I will continue to research this part, but I did come across a very old study on female rats, which showed infertility issues after being exposed to Polysorbate 80. Another study I found showed that Polysorbate 80 can cause non-immunologic anaphylactoid reactions.

Are there any concerns with breastfeeding?

Current guidelines state that it is okay to have the injections while breastfeeding, however both Pfizer and Moderna state: data are not available to assess the effects of Covid19 Vaccine on the breastfed infant or on milk production/excretion.

The department of health for the United Kingdom, put out a toxicology report for Pfizer’s Covid-19 injection and stated “women who are breastfeeding should also not be vaccinated” (p.21).

In a small observational study of 116 Covid-19 positive mothers, who breastfed their newborns, all newborns tested negative for Covid-19 and were asymptomatic. A study conducted by Columbia University Irving Medical Center found mother-to-infant Covid-19 transmission to be unlikely  and it is safe for newborns to room with their mothers, regardless of the mother’s exposure history.

While there are no studies to confirm the safety of Covid-19 injected moms to breastfeed their babies, VAERS (ID 1166062-1) recently reported a 5-month-old who developed a rash and died after breastfeeding from a Covid-19 injected mom.

The VAERS report states that a female patient received her second dose of Pfizer on March 17th and on March 18th her 5-month-old breastfed infant developed a rash. Within 24 hours her baby was inconsolable, refused to eat, and developed a fever. The patient brought her baby to the local ER and her baby was diagnosed with Thrombotic Thromocytopenic Purpura. He baby subsequently died two days later. Correlation does not mean causation, but it is interesting to note that the infant died from low platelets, especially since 1,392 adults have now experienced this after Covid-19 injections. It is being speculated that Covid-19 injections could be causing an autoimmune response against platelets that may cause thrombocytopenia, hemorrhage, and blood clots.

Can Covid-19 injections be mandated?

Organizations Fighting Mandates:
June 16, 2021: Arizona Governor Doug Ducey issued an executive order prohibiting Universities from mandating Covid-19 injections (June 16, 2021).
June 22, 2021: Houston Methodist Hospital terminated 153 employees for not accepting the Covid-19 injection.
New York State Nurses Association opposes medical mandates for Covid-19 injections. 
June 23, 2021: The Union for New York Presbyterian Hospital (Massachusetts, New Jersey, Maryland, Florida and Washington, D.C.) are fighting the medical mandate for Covid-19 injections.
June 23, 2021: Students at Indian University sue school over Covid-19 injection mandates.

Per the World Health Organization (WHO) vaccines have to be proven to be safe and effective and a mandate would not be ethical if the risks were greater than the benefits. The WHO further clarifies that it is unethical to mandate vaccines in children, due to the uncertainty regarding herd immunity, new variants, and limited evidence of Covid-19 injections.

Mandating vaccines in the United States is not clear cut. Federal law  21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III) requires that the person to whom an Emergency Use Authorization (EUA) vaccine is administered be advised, ‘of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

The following is an excerpt from The Defender: “This right of refusal stems from the fact that Emergency Use Authorization products are, by definition, experimental and forced participation in a medical experiment could result in injury. Under the Nuremberg Code, no one may be coerced to participate in a medical experiment. Consent of the individual is ‘absolutely essential. If a vaccine has been issued EUA by the FDA, it is not fully licensed and must be voluntary. A private party, such as an employer, school or hospital cannot circumvent the EUA law, which prohibits mandates. Indeed, the EUA law preventing mandates is so explicit that there is only one precedent case regarding an attempt to mandate an EUA vaccine. Private colleges are not required to grant religious exemptions under federal law, though some states have the Religious Freedom Restoration Acts (RFRAs), which may be interpreted to require public colleges and universities to provide religious exemptions.”

Per OSHA guidelines, in the event that an employer does mandate a vaccine, as a condition of employment, then any adverse reaction to the injection is considered work-related. In order for an injection to be truly voluntary, you cannot fear of any repercussions for not getting it. UPDATE: OSHA reversed their guidelines and employers will NOT be held liable for any adverse reactions that may result from the Covid-19 injections.

The PREP Act shields pharmaceutical companies from liability, however it does NOT shield employers, should they mandate the experimental injection. “Pursuant to an EUA, each person has a right to decline a medication/biologic that is not fully licensed” (p.27). Covid-19 injections have only been given Emergency Use Authorization, and are not FDA approved. The FDA is still monitoring the effectiveness against asymptomatic infection, death, and transmission of the virus.

Healthcare workers in Houston, Texas are suing their hospital over forced Covid-19 injections. This is the first time in history, where a place of employment has mandated an experimental injection as a requirement for employment.

For additional information, please check out America’s Frontline Doctors, Children’s Health Defense, Physicians for Informed Consent, Informed Consent Action Network (ICAN), National Vaccine Information Center (NVIC), The Healthy American, and Millions Against Medical Mandates.

Covid-19 Employee Rights Form
Covid-19 Students Rights Form 

 

Other Concerns

Booster Shots
How often will they be needed? As of now they are predicting that they will be needed by September, 2021.

Antibody-Dependent Enhancement
Participants should be given informed consent of the risk. The “viral vector, DNA or RNA and irrespective of delivery method, may worsen Covid-19 disease via antibody-dependent enhancement (ADE).” 

Can the Covid-19 Injections cause Autoimmune Disease?
Young females, who are already predisposed to autoimmune disorders, the administration of a nucleic acid vaccine (e.g., mRNA) may put them at risk of unwanted and unprecedented immunological side-effects. In the last decade, reports have accumulated on various autoimmune disorders, such as idiopathic thrombocytopenia purpura, myopericarditis, primary ovarian failure, and systemic lupus erythematosus (SLE), following vaccination. The FDA advises for clinical trials to evaluate for the risk of Enhanced Respiratory Disease after Covid-19 injections and Pfizer has a list of possible immune system issues after injection, including severe allergic reactions, anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema).

To pick up autoimmune issues, a 2 to 3 year follow-up period in phase 3 patients would be required to monitor for potential autoimmune consequences from vaccines — but that monitoring didn’t happen with the Pfizer and Moderna vaccines.

Lymphedema
It appears that lymph node swelling is a fairly common side effect for both the Moderna and Pfizer injections. As a result, women are being advised to either have their mammogram prior to Covd-19 injections, or at least four weeks afterwards. Breast cancer survivors are being advised to have the injection on the unaffected side and individuals who have had lymph node removal on both sides, may opt to have the injection in the thigh. Due to an increase in false positives, the Mayo Clinic in Rochester, Minnesota also recommends holding off on PET scans for at least  3-4 weeks.

Thrombocytopenia & Blood Clots
As of June 11, 2021 there have been 6,352 reports of blood clots, of that 24 occurred in those aged 12-17 years old.

There have been reports of hemorrhage, blood clots and thrombocytopenia following administration of all EUA Covid-19 injections. People with thromboyctopenia have low platelet levels. Platelets aid in blood clotting, which helps to stop bleeding. When platelets are low, there is an increased risk for bruising and bleeding. Signs of low platelets: red, purple, or brown bruises (called purpua), a rash with small red or purple dots (called petechiae), nosebleeds, bleeding gums, heavy menstrual bleeding, rectal bleeding, blood in stool and blood in urine. Thromboyctopenia can cause a bleed to the brain. It is likely that RNA viruses can directly infect platelets and mRNA translation within platelets is a possible explanation for the autoimmune response against platelets instead of previously proposed molecular mimicry theory.

A new biodistribution study found the Spike Protein in the Covid-19 injections to be the likely cause of clotting issues. “We made a big mistake. We didn’t realize it until now,” said Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario. “We thought the spike protein was a great target antigen, we never knew the spike protein itself was a toxin and was a pathogenic protein. So by vaccinating people we are inadvertently inoculating them with a toxin.”

The adverse events reported for the mRNA Covid-19 injections have raised concerns over the safety of genetic vaccines for mass immunization on a global scale.

Both AstraZeneca and Janssen (Johnson & Johnson) use an adenovirus vector, and have reported blood clots after injection. Brain hemorrhages are also being reported to VAERS. This raises the question of whether or not people should be screened for the risk of thromboyctopenia. As of June 11, 2021 there have been 1,671 reports of thromboyctopenia. Large vessel strokes have been linked to AstraZeneca injections. June 21, 2021: Israeli researchers discovered a link between the Pfizer injection and thrombotic thrombocytopenia purpura (TTP).

Heart Attacks
As of June 11, 2021 there have been 2,232 reported cases of heart attacks to VAERS.

Myocarditis/Pericarditis (Inflammation to the heart)
FDA Alert (June 23, 2021): Covid-19 Injections can cause heart inflammation.
Israel (June 6, 2021): found a likely connection between Covid-19 injections and myocarditis.
United Kingdom (June 15, 2021): Ministers will be advised against the mass rollout of Covid-19 injections to children until scientists obtain more data on the risks, The Telegraph understands.

As of June 11, 2021 there have been 1,342 reported cases  of Myocarditis/Pericarditis to VAERS. Of that 109 cases occurred in children age 17 and younger

April 23, 2021: Israel is probing the link to Pfizer injection and heart problems in men under 30.
May 22, 2021:
The CDC is investigating dozens of reports of heart inflammation in teenagers and young adults that occurred four days after their second dose of Moderna or Pfizer injections.
The June 1, 201:  Report by a work group of the CDC’s Advisory Committee on Immunization Practices states that within 30 days of receiving the second dose of either Pfizer or Moderna vaccines, “there was a higher number of observed than expected myocarditis/pericarditis cases in 16-24-year-olds.
June 1, 2021: Myocarditis has also been found in some athletes post Covid-19 infection.
June 4, 2021: Seven teenage boys in the U.S. developed myocarditis after a second dose of Covid-19 injection.
UPDATE (June 10, 2021): CDC plans emergency meeting to discuss heart inflammation following Covid-19 injections.
UPDATE from FDA (June 10, 2021): Date thru May 31, 2021 there were 48 serious adverse events (life threatening) for children 12-15 years old and 656 serious adverse events for those aged 16-25. 

Erectile Dysfunction 
Some men are reporting erectile dysfunction (ED) after Covid-19 injections. ED has also been reported after having the Covid-19 infection.

Tinnitus (Ringing in the Ears)
A vaccinologist the CDC and FDA to investigate this, after he and at least 2,250 people who reported developing the condition following the Covid-19 injections.

Herpes
Some people are reporting herpes/shingle outbreaks after Covid-19 injections.

Narcolepsy
Narcolepsy is a central nervous system disorder characterized by excessive daytime sleepiness and abnormal manifestations of rapid eye movement sleep. An increased risk of narcolepsy was found following vaccination with Pandemrix, 2009 H1N1 influenza vaccine that was used during the H1N1 influenza pandemic. The FDA has also listed narcolepsy as a potential risk with the Covid-19 injections (p.17).

Bells Palsy
As of June 11, 2021 there have been 1,868 reported cases to VAERS.

Disability
As of June 11, 2021 there have been 4,874 reported cases to VAERS.

Allergic Reactions
The current Covid-19 injection trial studies did not test people with severe allergies, however allergic reactions are estimated to be 10 times more common than in flu vaccines. This is the CDC’s protocol for lab testing after allergic reactions.

As of June 11, 2021, there have been 974 reported case of anaphylaxis in children aged 12-17 years old.

Botox & Facial Fillers
Covid-19 injections may cause facial swelling and inflammation in patients who have cosmetic fillers.

Lipid Nanoparticle and Cationic Lipids
Injections based on mRNA-containing lipid nanoparticles (LNPs) are a new type of platform used by both Pfizer and Moderna, for their Covid-19 injections. A study conducted on mice, found the lipid nanoparticles in the mRNA Covid-19 injections to be highly inflammatory. The authors speculate that the lipid nanoparticles could be responsible for some of the side effects being reported in humans. Cationic Lipids (coating of mRNA Covid-19 injections) may potentially be toxic: possible lung damage, possible liver damage, immune & nervous system issues

Can Covid-19 Injections Shed?
Brazil rejected Russia’s Covid-19 Injection called Sputnik due to concerns of shedding. Brazil is concerned the vaccine could contain active adenovirus particles, responsible for the common cold, which could make recipients sick. Some people in the medical community are speculating whether or not the mRNA injections are shedding as well. It has been reported that saliva samples from healthcare workers vaccinated with mRNA vaccines were positive with spike protein antibodies. In an open letter to the World Health Organization (WHO), a Virologist wrote that  “we are currently turning vaccinees into asymptomatic carriers shedding infectious variants.” Another potential concern is the phenomenon called imprinting. Click here to read more about that. 

For anyone interested, there is talk about self-spreading vaccines. Article from 2015: Self-disseminating vaccines for emerging infectious disease. One from 2020: We now have the technology to develop vaccines that spread themselves.

Red Cross: You cannot donate convalescent plasma after Covid-19 injections
One blood bank reports that “right now, one in every four patients hospitalized with Covid-19 requires a convalescent plasma transfusion. But in order to keep that going, donations have to keep up. Once people are vaccinated, they cannot donate plasma. The reason why is because the vaccine causes spike antibodies, and for convalescent plasma, they need nucleocapsid antibodies.” The FDA says that convalescent plasma should not be collected from individuals who received an investigational Covid-19 vaccine in a clinical trial or who received an authorized or licensed Covid-19 vaccine, unless they meet specific criteria detailed in the guidance.

The Red Cross is experiencing a critical shortage in donations. In comparison to 2019, hospitals have seen a 10% increase in hemorrhages (bleeding), which is more than five times the growth of other facilities that provide transfusions.

Vaccine Trial Studies
They are set up to succeed and they do not tell us if they stop the transmission of the virus. They also did not test for drug interactions. Long-term safety studies will likely be impossible, because the placebo group has been eliminated.

Companies History
J&J knowingly sold cancer laced baby powder for years. Denmark has permanently banned the J&J injection. J&J had to toss out 15 million doses due to a “mix-up” at the plant and the FDA examination found substandard conditions at the J&J production site. A batch of J&J was contaminated with AstraZeneca at the Emergent BioSolutions plant. Due to the risk of blood clots, an expert panel in Norway is advising not to use vaccines by J&J or AstraZenca. 

AstraZeneca has been suspended or partially suspended by many European countries, due to severe and lethal adverse reactions like blood clots. Brazil suspended AstraZenca, after a pregnant woman died from a hemorrhagic stroke.  European Medical Agency (EMA) is reviewing reports of heart inflammation and nerve disorder after Pfizer and AstraZeneca Covid-19 injections. India declined authorizing use of Pfizer, citing safety concerns and lack of data to support immunity. 

Moderna has never had an FDA approved medication or vaccine, despite fielding several vaccine candidates, none of which made it through phase III clinical trials. In January it was reported that Moderna gave “bad batches” of injections to participants.

In 2007 Nigeria sued Pfizer $7 billion for illegal tests on children. Pfizer allegedly carried out illegal trials of an anti-meningitis drug that killed or disabled children. In 2009 Pfizer paid a $2.3 billion settlement for illegal marketing practices. Starting in 2012 there have been lawsuits filed against Pfizer’s drug Zoloft, for allegedly causing birth defects. In 2013 Pfizer was sued $300 million for its Chantix product, after reports of suicide were filed. In 2016, Pfizer also paid a $486 million settlement for safety risks associated with its Celebrex and Bextra pain-relieving drugs. Shareholders accused Pfizer of having concealed tests that began in 1998 and which suggested health risks associated with Celebrex and Bextra. Months after that, Pfizer paid $67.5 million in settlements for its drug Pristiq. In 2019, 44 Attorney Generals filed antitrust lawsuit against Pfizer, Teva for allegedly fixing prices on generic drugs. Pfizer expects the global sales of its coronavirus injections to reach $26 billion in 2021. Both the European Medical Agency and Israel are reviewing reports of heart inflammation from Pfizer’s Covid-19 injection.

Just a reminder, you CANNOT sue for any adverse reactions from vaccines in the United States.

Health Officials for the United States
Dr. Facui, Dr. Rochelle Walensky, and Dr. Peter Marks testified to the Senate committee on May 11, 2021, that 40-50% of their staff had not received the Covid-19 injections.

Conclusion

The virus is not likely going away any time soon and more focus needs to put into treatment options like outpatient antivirals. Phase III vaccine trial studies were not designed to see how well they prevented infections, particularly asymptomatic infection, or their efficacy at reducing viral shedding and the risk of transmission. This is why it is unknown if Covid-19 injections reduces the need for masks or social distancing.

Accepting any medical treatment is a personal choice and should always remain a personal freedom. Please do your own research and make an informed decision. A risk-benefit analysis is an important factor and vaccine companies have zero liability for any reactions. “The implication is that the risks of a Covid-19 injections may outweigh the benefits for certain low-risk populations, such as children, young adults and people who have recovered from Covid-19 infection.” This is especially true in regions with low levels of community spread, since the likelihood of illness depends on exposure riskThe science is always changing and is never settled, however there are things you can do to boost up your immune system: good nutrition, good sleep, vitamins, and reduce your stress.

Study shows hydroxychloroquine and zinc treatments increased coronavirus survival rate by almost three times (June, 2021).

For anyone who is interested, this is great link for Eastern Virginia’s Medical School Covid-19 treatment protocol.

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