rsv vaccine failure

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Navigating Novel RSV Vaccines Amid A Complex History

In mid-2023, the Centers for Disease Con­trol and Prevention (CDC) began hyping the imminent startup of the respiratory syncytial virus (RSV) “season,” at the same time con­veniently introducing two new RSV vaccines and one new RSV “immunization.” The agency now recommends nearly cradle-to-grave RSV biologics: for babies and some toddlers, pregnant women (during weeks thirty-two to thirty-six of pregnancy) and adults over age sixty.¹

According to mainstream virus narratives, the symptoms labeled as “RSV” are common, seasonal (starting in the fall and peaking in the winter in the U.S.) and experienced by “almost all children” by their second birthday.² For the most part, CDC asserts, RSV manifests as mild, cold-like symptoms such as a runny nose, re­duced appetite, coughing, sneezing, fever and/ or wheezing.³ Medical experts admit that these self-limiting symptoms are “clinically indistin­guishable from those of other viral respiratory infections.”⁴ In fact, the American Academy of Pediatrics discourages routine lab testing for RSV “because treatment is supportive only, and diagnosis does not change the management of disease for most patients.”⁴ Notably, when clinicians do decide to test for “RSV,” they use the very same “pointless,” “useless” and “meaningless” methodologies—polymerase chain reaction (PCR) and rapid antigen testing (RAT)—deployed to “diagnose” other imagi­nary viruses.⁵

The push for RSV vaccination derives its stated rationale from the claim that RSV poses greater risks to certain vulnerable groups (pre­mature infants, young children, older adults and the immunocompromised), in whom it report­edly can segue into more serious bronchiolitis or pneumonia.^4,6 Studies claim that RSV is the leading cause of hospitalization among infants under one year of age⁷; in children under age five, CDC blames RSV for over two million outpatient visits every year and fifty-eight to eighty thousand annual hospitalizations.⁸ CDC also attributes one hundred to three hundred yearly under-five deaths to RSV, but a study published in 2021 by the agency’s own research­ers showed that for the 2005–2016 period, in which approximately four million babies were born annually, RSV was listed as the “primary underlying cause of death” on death certificates for, on average, only twenty-three children un­der age five annually, and an annual tally of just seventeen infants under age one.⁹

As for older adults in the senior age group (age sixty-five and up), the CDC’s very rough estimate is that each year RSV is responsible for anywhere from sixty to one hundred sixty thousand hospitalizations and six to ten thou­sand deaths (the agency admits that these “wide ranges” reveal “substantial uncertainty” about the true burden of disease attributable to RSV).^1,10 To heighten the drama, public health officials warn seniors that if they have under­lying conditions like cardiovascular disease, diabetes, chronic obstructive pulmonary disease (COPD), asthma or immunodeficiencies, they will be more likely to experience severe RSV complications and poor outcomes.^10-12

A BANNER YEAR FOR RSV VACCINES

Until 2023, the history of attempts to de­velop RSV vaccines had been marked by six decades of failures. In the first go-round of tri­als, in 1967, two infants died and the majority of other young study participants landed in the hospital after receiving vaccines “inactivated” with formalin (an aqueous solution containing roughly 40 percent formaldehyde).¹³ The toxic effects of injected formaldehyde and formalin have been well known since at least 1905, when a Chicago pathologist observed that a “definite reaction is obtained” even with “very dilute” formulin; the author then enumerated a variety of disturbing effects depending on the locus of injection, including “intense exudation” with subcutaneous injection and myositis (inflamed muscles) with intramuscular injection.¹⁴ The pathologist also observed that “Pneumonia and bronchitis are found in all animals after the injection of formalin.” Ignoring this body of knowledge, researchers have persisted in blaming the 1967 trials’ disastrous outcomes on the dubious and unproven concept of “antibody-dependent enhancement,”¹⁵ which hypothesizes a skewed immune response in vaccinated in­dividuals that supposedly predisposes them to more severe illness when they encounter the putative germ later on.¹⁶ (In 2020, vaccine proponent Peter Hotez resurrected the antibody-dependent enhancement bogeyman with respect to the Covid injections.¹⁷)

In light of this historical context, 2023 represented a banner year for would-be manu­facturers of RSV injections. In May, the Food and Drug Administration (FDA) began by ap­proving two different RSV shots for adults sixty years of age and older—GlaxoSmithKline’s (GSK’s) Arexvy and Pfizer’s Abrysvo—mak­ing them the first RSV vaccines ever to make it through the regulatory gauntlet in the U.S.^18,19 Both adult RSV vaccines derive their antigen by culturing “genetically engineered Chinese Hamster Ovary cells.”^20,21 Additionally, GSK’s vaccine incorporates a proprietary two-pronged “adjuvant system” (AS01), which includes two “immunostimulants”: monophosphoryl lipid A (MPL) (a detoxified form of the endotoxin lipopolysaccharide) and a saponin/surfactant called QS-21, derived from Quillaja saponaria Molina (commonly referred to as soapbark tree).^22,23 GSK first deployed AS01 in its Shingrix shingles vaccine. Vaccine scientists acknowledge that while they are unclear on precisely “how immunostimulants function in combination,” the adjuvant system approach “results in complex patterns of innate immune activation.”²⁴ In fact, in 2019, a research group funded by GSK approvingly reported “systemic reactogenicity” (assessed via measurement of inflammatory cytokines) in individuals who received an AS01-adjuvanted hepatitis B vaccine, even exceeding the reactogenicity induced by aluminum-adjuvanted vaccines.²⁵

In July, the CDC followed up the FDA approvals with its recom­mendation that older adults get one of the new RSV vaccines, while couching its statements with the modest caveat that individuals should “talk to their healthcare provider about whether RSV vaccination is ap­propriate for them.”¹

MONOCLONAL ANTIBODIES FOR THE KIDS

Back in 2004, the FDA approved a “monoclonal antibody” called palivizumab (brand name Synagis) “for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease,” okaying the product (made by AstraZeneca subsidiary MedIm­mune) for monthly administration “throughout the RSV season.”²⁶ FDA defines monoclonal antibodies, which it classifies as “biologics” rather than drugs or vaccines,²⁷ as “laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.”²⁸

In July 2023, hot on the heels of its Arexvy and Abrysvo approvals, FDA approved a new RSV monoclonal antibody product for infants and young children that does not require monthly dosing.²⁹ The product—generic name nirse­vimab, brand name Beyfortus—is a joint effort by AstraZeneca and Sanofi.²⁸ The CDC im­mediately recommended that all infants under eight months of age get a dose of nirsevimab if born during or entering “their first. . . RSV season,” also advising one dose for infants and children between eight and nineteen months of age “at increased risk for severe RSV disease and entering their second RSV season.”³⁰

Enthusiastic headlines surrounding nirse­vimab’s approval neglected to mention that As­traZeneca’s clinical trials killed twelve infants in the group that received the biologic, while demonstrating a paltry 48 percent “efficacy.”^31,32 In fact, monoclonal antibody injections are known to come with inherent risks, including an association with severe allergic reactions and other hypersensitivity responses.³¹ Other potential complications, described as “infusion-related reactions,” include “flushing, fever/ chills, back or abdominal pain, nausea/vomit­ing, pruritus, or skin rashes.”³³ Brian Hooker, PhD, senior director of science and research at Children’s Health Defense, flagged as “odd” and disturbing the fact that four of the twelve infant deaths in the trials were due to cardiac arrest, with another two deaths attributed to sudden infant death syndrome (SIDS).³¹

THE PRENATAL PILE-UP

Rounding out the year’s RSV innovations, FDA, in August, extended the indications for use of Pfizer’s Abrysvo to pregnant women.³⁴ The CDC’s Advisory Committee on Immuniza­tion Practices (ACIP) followed up in September with an eleven-to-one vote in favor of the RSV vaccine for expectant mothers.¹ The ostensible rationale cited by ACIP was that administering an RSV vaccine to pregnant women enables mothers to transmit protective antibodies to their unborn children, safeguarding them against RSV from birth through the first six months of life.³⁵ However, even as CDC direc­tor Mandy Cohen praised FDA for approving Pfizer’s vaccine, other experts questioned the decision. Cardiologist Peter McCullough com­mented, “Vaccination of the mother for passive immunization of the infant is an unnecessary and risky strategy that will undoubtedly lead to fetal loss or premature deliveries when deployed on a large scale.”³⁶

Both GSK and Pfizer had embarked on the development of a prenatal RSV vaccine. The two companies’ neck-and-neck efforts and formula­tions shared remarkably similar designs—and both were associated with heightened rates of premature births and infant mortality. The alarming surge in preterm and neonatal fatali­ties during phase 3 trials forced GSK to halt its trials. Trial data revealed a 6.8 percent incidence of preterm birth in the vaccine group (238/3496) compared to 4.9 percent (86/1739) in the pla­cebo group—or approximately one additional preterm birth for every fifty-four vaccinated mothers—as well as thirteen versus three neo­natal deaths in the vaccine versus placebo arms of the study.³⁷

Pfizer, while producing similar results, continued with its trials. In May 2023, The BMJ published a news story describing experts’ concerns about Pfizer’s maternal RSV vaccine candidate, pointing out that some researchers were urging a thorough examination of Pfizer’s trial data and rigorous post-approval surveil­lance.³⁷ Even though adverse event tables from Pfizer’s phase 2 study, published in October 2022, reported a preterm birth rate of 5.3 percent in the Abrysvo group (6/114) versus 2.6 percent (3/116) in the placebo group, Pfizer informed The BMJ that they had observed “no imbalance of neonatal deaths” in their phase 3 trial.³⁷ The FDA’s approval of Abrysvo for pregnant women implies that the regulatory agency chose to take Pfizer at its word.

In its presentation to ACIP, Pfizer reported that among the three thousand six hundred eighty-two pregnant women in the Abrysvo arm of their “placebo-controlled” clinical trial, 14 percent experienced an adverse event within a month of vaccination.³⁵ Of these, 4.2 percent of vaccinated participants experienced a “serious” adverse event, 1.7 percent had a “severe” adverse event, and 0.5 percent had an adverse event categorized as “life-threatening.”³⁵ The alarm­ing inventory of adverse events included “fetal growth restriction, fetal tachycardia, gestational diabetes, nonreassuring fetal heart rate pat­tern, premature labor, premature separation of placenta, vaginal hemorrhage and thrombocy­topenia.”³⁸ The authors of another Pfizer-backed study focused on older adults, published in the New England Journal of Medicine in April, cau­tioned that Guillain-Barré syndrome was also a potential adverse effect of Abrysvo.³⁹ In the GSK trials for Arexvy, vaccine recipients had a heightened incidence of atrial fibrillation, a severe heart condition associated with complica­tions like stroke, heart attack and heart failure.⁴⁰

In the Pfizer trials, none of these types of events were recorded among the 13 percent of “placebo” participants reported to have also experienced an adverse event.³⁸ However, it should be noted that rather than use a proper inert placebo, Pfizer’s investigators fudged the comparison, us­ing a “placebo” consisting of “excipients matched to those used in the. . . vaccine formulation, minus the active ingredients.”⁴¹

Among the infants born to Abrysvo-vaccinated mothers, Pfizer’s data revealed that 37.1 percent experienced adverse events within the first month after birth: 15.5 percent “serious,” 4.5 percent “severe” and 1 percent “life-threatening.”³⁵ Adverse events for infants included “acute respiratory failure, bronchiolitis, cardiac murmur, chordee (bent penis), conjunctival hemorrhage, hypoglycemia, jaundice, low birth weight, neonatal hypoxia, neonatal respiratory failure, seizure, sepsis, upper respiratory tract infection and vascular malformation.”³⁸ Pfizer produced no data to assess the effects of Abrysvo vaccination on the breastfed infant or on milk production or excretion, nor did the manufacturer evaluate the vaccine for carcinogenicity, genotoxicity or impairment of male fertility.⁴²

SAY NO TO THE PIPELINE

There are growing concerns about the number of vaccines given to children, many of which are mandated. The U.S. vaccine schedule for children and adolescents currently amounts to as many as six dozen doses by age eighteen, including up to twenty-seven doses of ten vaccines within the first fifteen months of life.⁴³ Additionally, children routinely receive one to two annual flu shots. Often, multiple vaccines are administered simultaneously. Package inserts warn of almost four hundred different types of possible adverse events.⁴⁴ Under the federal Vaccine Injury Com­pensation Program (VICP), vaccine manufacturers have a comprehensive liability shield when their vaccines result in injury or death.⁴⁵

Illnesses labeled as “RSV” in infants are generally an easily man­ageable condition. Dr. McCullough notes the effectiveness of nebu­lizer therapy, whether administered at home or in a clinical setting, and observes that when hospitalization occurs, it is “usually a product of inadequate home treatment”; in that event, the supportive hospital care required is typically “brief.”³⁶ Considering these factors, why risk an experimental vaccine?

The same question can be asked where pregnant women are con­cerned. With the addition of prenatal RSV vaccination, the CDC now advises a minimum of four maternal vaccines—influenza, Tdap (tetanus, diphtheria and acellular pertussis), Covid and RSV—against six appar ent disease threats.⁴⁶ Depending on individual circumstances, hepatitis B and hepatitis A vaccines, as well as travel vaccines, also may be recommended for some pregnant women.⁴⁷ No clinical trial has ever assessed the potential for synergistic adverse events resulting from administration of multiple maternal vaccines during a single pregnancy. Fortunately, fewer and fewer women are complying with the CDC’s recommendations regarding vaccination during pregnancy; a maternal-fetal medicine special­ist lamented, “We are meeting more resistance than I ever remember. We didn’t get this kind of pushback on this scale before the pandemic. Now all vaccines are lumped together as bad.”⁴⁸

With the global RSV vaccine market projected to reach ten billion dollars by 2030, Pfizer and AstraZeneca may soon face increased competition.⁴⁹ The National Institutes of Health (NIH) has identified up to thirty RSV vaccine candidates in the pipeline using different vac­cine formats, ranging from live-attenuated vaccines to vectored, subunit and particle-based vaccines.⁵⁰ FDA has also granted Moderna a fast-track designation for the company’s ex­perimental mRNA vaccine targeting RSV.⁵¹ Currently, the expedited FDA review applies solely to older adults, but it’s worth noting that Moderna’s phase 1 trials also included children as young as one year old.

It is crucial to avoid becoming ensnared in a cycle of fear about yet another scary virus. The media are only too glad to function as PR agents for vaccine makers and complicit regula­tors, warning of a potential “tripledemic” (RSV, influenza and Covid). During Covid, the media’s influence on thoughts, emotions and behaviors led people to obey authority figures and con­form to unprecedented and dysfunctional social norms, resulting in severe economic and health consequences. Then, the media began to inform us of a surge in RSV-related pediatric hospital­izations and ER visits. . . just as RSV-related products were receiving market approval. With FDA and CDC continuing to endorse vaccines and drugs subjected to scant or farcical safety testing, it is a good time to remember that mild illnesses can play a vital role in the body’s de­toxification and regeneration processes.

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SIDEBAR

A FAILURE IN THEIR OWN TERMS

CDC claims that Pfizer’s Abrysvo vaccine demonstrated an 80 percent reduction in RSV hospitalizations and health care visits for infants within their first six months. However, closer examination of the data reveals that Pfizer’s clinical trial failed to yield “statistically significant results regarding the prevention of infant medical visits caused by RSV, including for non-severe cases.”38 Moreover, data presented to ACIP in February revealed uncertainty about the efficacy of the Pfizer and GSK vaccines beyond the six- to seven-month clinical trial follow-up period.⁵²

Additionally, the CDC admitted that the sample sizes used to study the two vaccines were insufficient to reliably estimate whether the vaccines could have had any positive impact on outcomes like hospitalization and death.⁵³ The clinical trials also only included participants who were healthy and had low-risk pregnancies.⁵⁴

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REFERENCES

1. Update on RSV and new vaccine recommendation. CDC, Sep. 22, 2023.
2. Respiratory syncytial virus (RSV) preventive antibody: immunization information statement (IIS). CDC, Sep. 25, 2023.
3. Symptoms and care. CDC, reviewed Sep. 6, 2023. https://www.cdc.gov/rsv/about/symptoms.html
4. Shakir SM. Respiratory syncytial virus – RSV. ARUP Laboratories, updated September 2023.
5. Bailey M. Rapid antigen tests – Making “viruses” real again. Dr. Sam Bailey, Mar. 24, 2022.
6. https://www.cdc.gov/rsv/index.html
7. Suh M, Movva N, Jiang X, et al. Respiratory syncytial virus burden and healthcare utilization in United States infants < 1 year of age: study of nationally representa­tive databases, 2011–2019. J Infect Dis. 2022;226(Suppl 2):S184-S194.
8. RSV surveillance & research: RSV burden estimates. CDC, reviewed Jul. 17, 2023.
9. Prill MM, Langley GE, Winn A, et al. Respiratory syncytial virus-associated deaths in the United States according to death certificate data, 2005 to 2016. Health Sci Rep. 2021;4(4):e428.
10. Melgar M. Evidence to recommendations framework: respiratory syncytial virus (RSV) in adults. CDC, Adult RSV ACIP Work Group, Feb. 23, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-23/RSV-Adults-04-Melgar-508.pdf
11. Respiratory syncytial virus (RSV). Mayo Clinic, Oct. 4, 2023.
12. RSV in older adults and adults with chronic medical conditions. CDC, reviewed Nov. 7, 2023.
13. Acosta PL, Caballero MT, Polack FP. Brief history and characterization of enhanced respiratory syncytial virus disease. Clin Vaccine Immunol. 2016;23(3):189-195.
14. Fischer MH. The toxic effects of formaldehyde and formalin. J Exp Med. 1905;6(4-6):487-518.
15. Zeck A. HFfH: Diving deep on terrain theory with Dr. Andrew Kaufman and Dr. Tom Cowan. The Way Forward with Alec Zeck, Oct. 22, 2021.
16. Sanders B, Koldijk M, Schuitemaker H. Inactivated viral vaccines. Vaccine Analysis: Strategies, Principles, and Control. 2014 Nov 28:45-80.
17. Hotez PJ, Corry DB, Bottazzi ME. COVID-19 vaccine design: the Janus face of immune enhancement. Nat Rev Immunol. 2020;20(6):347-348.
18. FDA approves first respiratory syncytial virus (RSV) vaccine. FDA, May 3, 2023.
19. U.S. FDA approves ABRYSVO™, Pfizer’s vaccine for the prevention of respiratory syncytial virus (RSV) in older adults. Pfizer, May 31, 2023.
20. www.fda.gov/vaccines-blood-biologics/arexvy
21. www.fda.gov/vaccines-blood-biologics/abrysvo
22. Children’s Health Defense Team. New adjuvants in the pipeline = more profits, questionable safety. CHD, Mar. 10, 2020.

23. King A. Soapbark branches out to fill essential role in vaccine recipes. Chemistry World, Jun. 21, 2022.
24. Coccia M, Collignon C, Hervé C, et al. Cellular and molecular synergy in AS01-adjuvanted vaccines results in an early IFNγ response promoting vaccine immuno­genicity. NPJ Vaccines. 2017;2:25.
25. Burny W, Marchant A, Hervé C, et al. Inflammatory parameters associated with systemic reactogenicity fol­lowing vaccination with adjuvanted hepatitis B vaccines in humans. Vaccine. 2019;37(14):2004-15.
26. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf
27. Pham-Huy A, Top KA, Constantinescu C, et al. The use and impact of monoclonal antibody biologics during pregnancy. CMAJ. 2021;193(29):E1129-E1136.
28. FDA approves new drug to prevent RSV in babies and toddlers. FDA, Jul. 17, 2023.
29. Kimball S. FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV. CNBC, Jun. 8, 2023.
30. RSV immunization for children 19 months and younger. CDC, reviewed Sep. 28, 2023.
31. Nevradakis M. “Reckless in the extreme”: FDA panel recommends new RSV shot for use in healthy infants. The Defender, Jun. 9, 2023.
32. Nevradakis M. Despite 12 deaths during clinical tri­als, CDC signs off on RSV shots for newborns. The Defender, Aug. 4, 2023.
33. Brobst B, Borger J. Benefits and risks of administering monoclonal antibody therapy for coronavirus (CO­VID-19). Treasure Island, FL: StatPearls Publishing, 2023 Jan-.
34. FDA approves first vaccine for pregnant individuals to prevent RSV in infants. FDA, Aug. 21, 2023.
35. Munjal I. Safety and efficacy of bivalent RSV prefusion F vaccine in vaccinated mothers and their infants. CDC, Feb. 22, 2023 (Pfizer presentation to ACIP). https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-23/RSV-Pediatric-06-Mun­jal-508.pdf
36. Nevradakis M. “Risky strategy”: CDC signs off on Pfizer RSV vaccine for pregnant women to protect newborns. The Defender, Sep. 25, 2023.
37. Boytchev H. Maternal RSV vaccine: further analysis is urged on preterm births. BMJ. 2023;381:p1021.
38. Nevradakis M. First RSV emergency declared as Pfizer and GSK race to get vaccines approved. The Defender, Nov. 8, 2022.
39. Walsh EE, Marc GP, Zareba AM, et al. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med. 2023;388(16):1465-1477.
40. GlaxoSmithKline Biologicals. FDA briefing document: Respiratory syncytial virus vaccine recombinant, adjuvanted (proposed trade name: Arexvy). VRBPAC Meeting, Mar. 1, 2023. https://www.fda.gov/media/165622/download
41. https://www.nejm.org/doi/suppl/10.1056/NEJMoa2216480/suppl_file/nejmoa2216480_protocol.pdf
42. www.fda.gov/media/168889/download?attachment
43. www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html
44. Children’s Health Defense Team. Read the fine print, part two—nearly 400 adverse reactions listed in vaccine package inserts. CHD, Aug. 14, 2020.
45. https://www.govinfo.gov/content/pkg/USCODE-2016-title42/html/USCODE-2016-ti­tle42-chap6A-subchapXIX-part2-subparta-sec300aa-11.htm
46. Guidelines for vaccinating pregnant women. CDC, reviewed Jul. 13, 2022.
47. Vaccines during and after pregnancy. CDC, reviewed Sep. 29, 2023.
48. Parpia R. CDC recommends SIX vaccines during pregnancy but fewer women are complying. The Vaccine Reaction, Oct. 22, 2023.
49. GSK’s RSV vaccine first to get EU regulator’s nod. Reuters, Apr. 26, 2023.
50. Rossey I, Saelens X. Vaccines against human respiratory syncytial virus in clinical trials, where are we now? Expert Rev Vaccines. 2019;18(10):1053-1067.
51. Moderna announces mRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine, has met primary efficacy endpoints in phase 3 trial in older adults. Moderna, Jan. 17, 2023.
52. Ortega-Sanchez IR. Economics of vaccinating U.S. adults >60 years-old against re­spiratory syncytial virus. A summary report comparing models from: GSK, Pfizer and University of Michigan-CDC. ACIP meeting, Feb. 23, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-23/RSV-Adults-03-Ortega-Sanchez-508.pdf
53. Melgar M. ACIP Adult RSV Work Group considerations. Centers for Disease Control and Prevention, National Center for Immunization & Respiratory Diseases, 2022. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-10-19-20/04-RSV-Adults-Melgar-508.pdf
54. Wrangham T. ACIP recommends RSV vaccinaton for pregnant women. National Vaccine Informaton Center, Sep. 28, 2023.

This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Winter 2023

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