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RSV Roulette



Should pregnant moms get the new RSV shot?

How do we know if vaccines are safe?

We test them.

How are they tested?

First, they are tested in animals – guinea pigs, primates, mice, horses, pigs, sheep, and cattle.

Then they are tested on the intended target. In the case of a vaccine against Respiratory Syncytial Virus (RSV), the primary target is infants.

Researchers have been attempting to create a vaccine against RSV for more than 60 years, but none has ever been safe or effective. One vaccine expert, Fernando Polack of Johns Hopkins University, has been quoted in the journal Nature as saying, “There are some vaccines that came very easily, but developing a vaccine for RSV is very tricky.”[i] The creation of a safe and effective RSV vaccine has been so difficult that Dr. Robert M. Chanock, the researcher who first identified RSV in 1956 and worked for many decades on a vaccine, joked in 2001 that the public could expect one to be perfected on “March 32nd.”[ii]

But a vaccine for RSV is big business. RSV is cited as “the single most important respiratory tract pathogen for infants and children.”[iii] Why is that? It’s the leading cause of hospitalization in infants, though hospitalization is a rare occurrence, and “99% of deaths occur in resource-limited countries,” according to experts.[iv] It’s widely accepted that almost all kids get RSV before they are 2 years of age, with most severe outcomes occurring before the child is 6 months old. So the fear factor on this disease is high and the market is 100% of children. RSV is a seasonal virus (rather than occurring in occasional outbreaks), with at least one injection recommendedannually, if not boosters, as well. And if the RSV vaccine is put on the ACIP recommended childhood schedule, those who make and give the shot won’t have to worry about lawsuits because of the 1986 Act.

Unlike some other diseases, an RSV infection doesn’t guarantee a person will never get it again, though it’s widely accepted that after developing natural immunity, any subsequent infection will be milder than the first one. And RSV is usually mild in most of the population. You can bet the profits from an RSV vaccine would be tremendous. The global public health nonprofit PATH is tracking 137 trials right now (which you can download from their website).[v]

All attempts at an RSV vaccine have failed thus far, some with deadly results.

In one of the first RSV vaccine trials conducted by researchers at NIH, Pfizer, and two medical welfare organizations in Washington D.C., the researchers described: “Infants between 2 and 7 months of age who attended a Child Health Center [in Washington D.C.] were selected for administration of vaccine after parental consent was obtained. The infants lived at home and came from a population of relatively low socioeconomic status families, primarily Negro.” [vi] Children from Junior Village, a Washington D.C. facility for “homeless but otherwise normal infants and children,” who had been removed from their homes due to parental death, drug use, incarceration, or poverty (and were regularly experimented upon and abused, according to vaccine experts and news reports) were also included in the RSV vaccine experiment.[vii]

The results of the experiment on these poor children was disastrous. The experimental vaccine not only failed to prevent RSV infection; it also greatly increased the severity of the disease. Today this is known as Antibody Dependent Enhancement, but in the 1960s, the researchers declared, “These findings were entirely unexpected,” and “paradoxical,” even though similar enhancement of symptoms after experimental vaccines had already been observed in trials for four other types of diseases. Even today, with a century of vaccine research, it’s not widely known that rather than stopping a disease as the public is told, a vaccine can sometimes make the effects of a virus worse – even deadly – when it otherwise wouldn’t have been.

In that 1966 study, because of the unexpected enhancement of severity of symptoms with RSV infection after vaccine failure, two children died.[viii] Interestingly, the researchers observed the most severe illness happened in the first six months of life, “when maternally derived serum antibody is present.”

What happened when the researchers saw that the vaccine made children more sick and more susceptible to the disease they were trying to prevent? Let the record (peer-reviewed, published research) speak for itself: “On December 29, 1966, the injection of RS virus vaccine was stopped for reasons to be recounted later.”

What is the state of RSV vaccine research today?

Many expect an RSV vaccine to finally be available for the public in 2023. But the dismissive 1966 statement is eerily similar to GlaskoSmithKline’s (GSK) recent hesitation in response to stopping administration of its experimental maternal RSV vaccine. GSK has been experimenting with developing an RSV vaccine that would be injected into pregnant mothers, referred to as “maternal immunization,” (MI). After injecting the shot into over 10,000 pregnant women,[ix] the company “voluntarily paused enrollment and vaccination” after a “routine safety assessment” by the Independent Data Monitoring Committee tasked with oversight on the trial. Why? We don’t know.

“The Company will provide a further update on the RSV maternal vaccine candidate in due course.”[x]

There have been no more statements from the company since its February 2022 announcement. The FDA claimed it would take 75 years before it could release Pfizer data on the safety and efficacy of the COVID shots,[xi] while people around the world were subject to shots in arms and forced to rely on passive surveillance of VAERS and anecdotal evidence that has only increased in frequency and severity. How long does GSK want?

In the end, the ultimate testing ground for the safety of vaccines is us. You, me, and our children. It happens after shots are authorized or licensed by the FDA and released for sale to the general population, which you can read more about in Stand for Health Freedom’s article “Our kids are post-market data.” Essentially, the largest part of the experiment is done on the American people, and more so the faster the pharmaceutical is developed.

Where are we now with RSV vaccines?

After six decades of failures in hundreds of trials, researchers are now turning to the new technology of mRNA delivery systems. Pfizer, GSK, and AstraZeneca with Sanofi claim to be close to a vaccine now for the elderly, for infants, or for pregnant mothers.

The CDC’s Advisory Committee on Immunization Practices (ACIP), recently heard a summary of the safety and efficacy information available on GSK and Pfizer’s RSV vaccine for older adults, and also AstraZeneca and Sanofi’s “Nirsevimab” RSV vaccine for infants, in trials called “Medly” and “Melody.”[xii] (The presentation was made at the same October 2022 meeting where ACIP recommended the COVID shot to be put on the childhood schedule, indefinitely protecting manufacturers against lawsuits for injury or death from COVID shots before they are even licensed by the FDA.) Nirsevimab’s trials include approximately 3000 infants (including 615 preterm). The drug is intended to be administered at birth for those children born during RSV season, alongside Hep B administration (no information about administering two shots at the same time in a newborn infant was presented to the CDC). The vaccine is expected to go to ACIP vote for recommendation June 2023, provided the FDA licenses it by that time.[xiii] It is currently in Phase III of its trials.

As of January 2023, Pfizer is closest to a vaccine for pregnant mothers.[xiv]

How dangerous is RSV?

Most children have RSV infection before they are 2 years old. The most severe and potentially life-threatening cases of RSV happen in the youngest infants, before the age of 6 months, as it can obstruct or prevent an infant from breathing through their nose, and their lungs and chest are tiny. Studies show 99% of deaths in infants happen in resource-limited countries where it is harder to access emergency care. In summary, all kids acquire natural immunity with almost no issues and the most dangerous cases of RSV happen in the youngest children in the most impoverished countries. This information amounts to informed consent and should be shared by medical providers with parents deciding whether risks of the shot are worth any potential benefits.

RSV was first identified in 1956 by researcher Robert M. Chanock at Johns Hopkins University. He started his career with oral polio vaccine researcher Albert Sabin. Chanock then moved to the National Institute of Allergy and Infectious Diseases (NIAID), eventually becoming director of the Infectious Disease Laboratory in 1968. He was the first to identify RSV, which was notably similar to a virus found in monkey cell cultures used for polio research called Chimpanzee Coryza Agent (CCA).[xv] The only other species that is known to have RSV was also the species used for polio vaccine research and Chanock worked on both vaccines. Interestingly, Chanock was also involved in research with coronaviruses and, according his NIAID biography, “was responsible for the initial isolations of coronavirus.”[xvi]

Chanock was involved in the invention of the RotaShield vaccine against rotavirus that was pulled from the market after infant deaths and illnesses were reported to VAERS. He thought the CDC was wrong on their safety data.[xvii]

Recently, there’s been an uptick of reporting of RSV in infants. Some believe it’s a side effect of either the COVID shots or the isolation from lockdowns due to COVID policy. Parents are being told to fear the “triple threat” of RSV, influenza, and COVID during the winter cold season. The decision to use an experimental medical intervention will be in the hands (and hearts) of mothers and fathers.

Should pregnant mothers or new moms opt for an RSV vaccine, when available?

Parents must weigh the risks and benefits, becoming educated through medical professionals, their own research, and considerations of what’s right with their family and their faith.

There’s no vaccine for RSV yet, for any age group. The world’s best scientific minds for over 60 years of research have turned out hundreds of experimental candidates that have been unsafe and ineffective. But now, Pfizer has claimed to have created a safe and effective RSV vaccine for the absolute most sensitive and vulnerable of populations: pregnant mothers. It’s yet another new immunization milestone, led by Pfizer. Maternal vaccines are intended to vaccinate a child in the womb before they are born.

As of January 2023, the American College of Gynecologists (ACOG) recommends three shots in pregnancy (Tdap, Influenza, COVID), and is already training its doctors on the promises of two more that are still being researched: RSV and Guillain-Barré Syndrome (GBS).[xviii]

Five steps to informed consent for pregnant moms:

  1. Check out the FDA’s Lists of Pregnancy Exposure Registries for any pharmaceuticals you may be considering. https://www.fda.gov/science-research/womens-health-research/list-pregnancy-exposure-registries

  2. Know that if there is an injury or death, manufacturers and doctors do not take care of your child — you do. Learn about the Vaccine Injury Compensation Program (VICP, a.k.a. “vaccine court”).

  3. Ask your doctor what they know about the safety of the shot. How many years of data exist for safety? Ask them to explain how it’s safe (especially if there is only a year or two of data). What safety evidence do they have? Ask every question you can.

  4. Remember you can always get a shot later, but you cannot undo a shot once it is done. It’s okay to wait for more safety data to come out.

  5. What if we allow mild RSV infection as infants? Maternal antibodies through pregnancy and breastfeeding lessen the symptoms, leading to natural immunity, which works better than vaccination throughout life. And it’s far safer. We also have reports that measles infection early in life prevents cancer.

Understand how to do a risk-benefit analysis.

The best risk-benefit analysis goes beyond scoring points for “good” or “bad” outcomes. It also considers the likelihood that the good or bad will happen and the intensity of each. When a mother considers a medical intervention she should ask herself:


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Conclusion

Pregnancy is a special, sacred time. Mothers are the gatekeepers of life on earth. The decisions a mother makes in pregnancy and in the first moments of a child’s life lay the foundation for that child’s experience on the planet. Mothers face a lot of pressure to make the right decision, “following the science” so their child will be as healthy as possible. So it’s important they understand they have choices and they can ask questions.

No parent wants their child to suffer, but we can’t give in to fear when deciding what is best for our children. Mothers must ask questions. Be curious. Follow your intuition. Keep asking questions until your mind is clear and your heart is moved. Being curious and informed is the best way to keep your baby (and your body) safe.



 

References & Sources

[i] Mullard, A. Vaccine failure explained. Nature (2008). https://doi.org/10.1038/news.2008.1302

[iii] Kim, H. W., CANCHOLA, J. G., Brandt, C. D., Pyles, G., Chanock, R. M., Jensen, K., & Parrott, R. H. (1969). Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. American journal of epidemiology89(4), 422-434. Available at http://sa.uploads.ru/SU2xL.pdf, accessed January 10, 2023.

[vi] Kim, H. W., CANCHOLA, J. G., Brandt, C. D., Pyles, G., Chanock, R. M., Jensen, K., & Parrott, R. H. (1969). Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. American journal of epidemiology89(4), 422-434. Available at http://sa.uploads.ru/SU2xL.pdf, accessed January 10, 2023.

[vii] KAPIKIAN, A. Z., MITCHELL, R. H., CHANOCK, R. M., SHVEDOFF, R. A., & STEWART, C. E. (1969). An epidemiologic study of altered clinical reactivity to respiratory syncytial (RS) virus infection in children previously vaccinated with an inactivated RS virus vaccine. American journal of epidemiology89(4), 405-421. Available at http://s2.uploads.ru/MQhdS.pdf, accessed January 10, 2023.

[viii] Mullard, A. Vaccine failure explained. Nature (2008). https://doi.org/10.1038/news.2008.1302

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