Vaccines
SYNOPSIS
During the coronavirus disease 2019 (COVID-19) pandemic, COVID-19 vaccination-induced hyperglycemia and related complications have been reported. However, there have been few reports of type 1 diabetes triggered by COVID-19 vaccines in subjects without diabetes.
TITLE
Adult-Onset Type 1 Diabetes Development Following COVID-19 mRNA Vaccination
H. Moon, S. Suh, M. Kyoung Park
During the coronavirus disease 2019 (COVID-19) pandemic, COVID-19 vaccination-induced hyperglycemia and related complications have been reported. However, there have been few reports of type 1 diabetes triggered by COVID-19 vaccines in subjects without diabetes. Here, we report the case of a 56-year-old female patient who developed hyperglycemia after the second dose of COVID-19 mRNA-based vaccination without a prior history of diabetes. She visited our hospital with uncontrolled hyperglycemia despite administration of oral hyperglycemic agents. Her initial glycated hemoglobin level was high (11.0%), and fasting serum C-peptide level was normal. The fasting serum C-peptide level decreased to 0.269 ng/mL 5 days after admission, and the anti-glutamic acid decarboxylase antibody was positive. The patient was discharged in stable condition with insulin treatment. To our knowledge, this is the first case of the development of type 1 diabetes without diabetic ketoacidosis after mRNA-based COVID-19 vaccination, and is the oldest case of type 1 diabetes development under such circumstances.
TAGS
SYNOPSIS
Vaccines can have beneficial off-target (heterologous) effects that alter immune responses to, and protect against, unrelated infections. The heterologous effects of COVID-19 vaccines have not been investigated in children.
TITLE
BNT162b2 COVID-19 vaccination in children alters cytokine responses to heterologous pathogens and Toll-like receptor agonists
A. Noé, T. D. Dang, C. Axelrad, E. Burrell, S. Germano, S. Elia, D. Burgner, K. P. Perrett, N. Curtis, N. L. Messina
In addition to antigen-specific adaptive immunity to the target pathogen and cross-protective immunity to related microbes (e.g., protection against Mycobacterium tuberculosis and Mycobacterium leprae induced by Mycobacterium bovis-derived bacille Calmette–Guérin (BCG)) (1), vaccines have off-target (heterologous) effects that protect against unrelated pathogens (2–4).
In high-mortality settings, live-attenuated vaccines are associated with reductions in all-cause infant mortality greater than can be attributed to vaccine-specific protection alone (5–7). The reduction in all-cause mortality in high-mortality settings is proposed to be due, at least in part, to protection against infections unrelated to the vaccine target (2–4). Trained immunity, the process by which innate immune cells such as monocytes develop immunological memory through metabolic and epigenetic changes, is one proposed mechanism by which vaccines exert heterologous effects (8, 9). Understanding heterologous effects and trained immunity, and harnessing positive heterologous effects has the potential to extend vaccine-induced protection to a diverse array of pathogens.
The COVID-19 pandemic has prompted a resurgence of interest in the heterologous effects of BCG and other vaccines and compounds (10–14). Heterologous immunological effects following vaccination have been explored in several studies by assessing in vitro cytokine responses to heterologous antigens (9, 15–19). Two small studies have reported on heterologous effects of COVID-19 vaccines. One study in adults reported that following adenoviral COVID-19 (ChAdOx1) vaccination, monocyte proinflammatory cytokine and chemokine production and glycolysis is enhanced in resting states as well as in response to unrelated stimulants (20). COVID-19 mRNA-based vaccines have been reported to modulate transcriptional profiles in monocytes from adults (21). To date, the heterologous effects of COVID-19 vaccines have not been investigated in children.
In the COVID-19-Specific vaccine and heterologous Immunity in MIS BAIR (COSI BAIR) study (22), we investigated the heterologous and specific immunological effects of BNT162b2 COVID-19 vaccination in children.
TAGS
SYNOPSIS
To assess the association between cumulative aluminum exposure from vaccines before age 24 months and persistent asthma at age 24 to 59 months.
TITLE
Association Between Aluminum Exposure From Vaccines Before Age 24 Months and Persistent Asthma at Age 24 to 59 Months
CITATION
SUMMARY
In a large observational study, a positive association was found between vaccine-related aluminum exposure and persistent asthma. While recognizing the small effect sizes identified and the potential for residual confounding, additional investigation of this hypothesis appears warranted.
TAGS
SYNOPSIS
Autoimmune/inflammatory Syndrome Induced by Adjuvants (ASIA; Shoenfeld’s syndrome) comprehends a group of autoimmune conditions that flourish in genetically predisposed individuals, following an external stimulus by the so-called adjuvants. Many adjuvants were described, such as vaccines, aluminum and other metals, silicone, tattoos, among others. Here we report on a case of an 18-year-old woman who presented with extreme cachexia due to severe dysautonomia caused by the ASIA syndrome induced by the tetanus, diphtheria, and pertussis vaccine (Tdap).
TITLE
Dysautonomia following Tetanus, Diphtheria, and Pertussis vaccine (Tdap): The first case of extreme cachexia caused by autoimmune/inflammatory syndrome induced by adjuvants (ASIA syndrome) in a human 2022
CITATION
Hen, Or et al. “Dysautonomia Following Tetanus, Diphtheria, and Pertussis Vaccine (Tdap): The First Case of Extreme Cachexia Caused by Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA Syndrome) in a Human.” Medicina (Kaunas, Lithuania) vol. 57,12 1333. 6 Dec. 2021, doi.org/10.3390/medicina57121333
SUMMARY
This is a case study of an 18-year-old female who presents with severe cachexia (wasting disease). Post-vaccination she experienced headaches, dizziness, arthralgia, myalgia, extreme fatigue, orthostatic intolerance, mouth ulcers and new food and pollen allergies, that she still deals with. Cachexia has gotten progressively worse since vaccination. She was diagnosed with ASIA following the Tdap vaccination given when she was 14 years old. This is based in part on high titers of anti-tetanus antibodies present in her immune system.
TAGS
SYNOPSIS
The observed incidence of Bell’s palsy in the vaccine arms is between 3·5-times and 7-times higher than would be expected in the general population.
TITLE
Bell’s palsy and SARS-CoV-2 vaccines
CITATION
Ozonoff, A., Nanishi E., Levy, O. (2021) Bell’s palsy and SARS-CoV-2 vaccines. Lancet Infectious Disease 2021
Published Online February 24, 2021 https://doi.org/10.1016/S1473-3099(21)00076-1
SUMMARY
Media reports have stated that the incidence of Bell’s palsy among participants of the Pfizer-BioNTech and Moderna vaccine trials is comparable to that observed in the general population. The FDA briefing on the Pfizer-BioNTech trial stated “observed frequency of reported Bell’s palsy in the vaccine group is consistent with the expected background rate in the general population”, although this statement was removed from the subsequent FDA briefing on the Moderna trial. However, this reporting is based on a misconception, driven by a subtle distinction between rates and proportions, that has persisted in the lay media. The estimated incidence rate of Bell’s palsy in the general population ranges from 15 to 30 cases per 100 000 person-years. Since the 40 000 vaccine arm participants were followed for a median of 2 months, the combined safety population receiving vaccine across the two trials represents roughly 6700 person-years of observation time for an expected incidence of Bell’s palsy of one to two cases, in line with the single observed case in the combined placebo arms. Therefore, the observed incidence of Bell’s palsy in the vaccine arms is between 3·5-times and 7-times higher than would be expected in the general population. This finding signals a potential safety phenomenon and suggests inaccurate reporting of basic epidemiological context to the public.
TAGS
SYNOPSIS
The increasing rates of allergy, ear infections, and neurodevelopmental disorders (NDDs) in countries with high rates of vaccination could be related to mass vaccination and to its impact on liver function and vitamin A metabolism.
TITLE
Multiple Vaccinations and the Enigma of Vaccine Injury
CITATION
Mawson, A.R.; Croft, A.M. Multiple Vaccinations and the Enigma of Vaccine Injury. Vaccines 2020, 8, 676.
SUMMARY
Mawson and Croft have written a comprehensive review article in the journal Vaccines and have investigated the role of multiple vaccinations in long term health effects include neurodevelopmental disorders, allergies, infections and neuropsychiatric disorders. Past research on vaccine adverse events highlighted in the paper includes multiple childhood vaccines as well as multiple vaccines given to military personnel during the Gulf war. Mawson and Croft hypothesize that multiple vaccines trigger the retinoid cascade which initiates apoptotic hepatitis that releases stored vitamin A compounds into circulation in toxic concentrations. Further, the authors link vitamin A toxicity to multiple adverse events following vaccination.
This review article is a very important contribution to the science around vaccine injury, especially injuries following multiple vaccinations which given the bloated CDC infant vaccination schedule is the rule and not the exception. Mawson has previously completed his own study of vaccinated versus unvaccinated children where he found relationships between vaccination status and multiple sequelae including allergic rhinitis, eczema, otitis media, pneumonia and neurodevelopmental disorders (Mawson et al. 2017, J Transl Sci).
TAGS
SYNOPSIS
Although animal models of SARS-CoV-2 infection may elucidate mechanisms of immune protection, we need observations of enhanced disease in people receiving candidate COVID-19 vaccines to understand the risk of immune enhancement of disease. Neither principles of immunity nor preclinical studies provide a basis for prioritizing among the COVID-19 vaccine candidates with respect to safety at this time.
TITLE
Prospects for a safe COVID-19 vaccine
CITATION
Barton F. Haynes, Lawrence Corey, Prabhavathi Fernandes, Peter B. Gilbert, Peter J. Hotez, Srinivas Rao, Michael R. Santos, Hanneke Schuitemaker, Michael Watson and Ann Arvin; Science Translational Medicine 04 Nov 2020: Vol. 12, Issue 568, eabe0948 DOI: 10.1126/scitranslmed.abe0948
SUMMARY
Rapid development of an efficacious vaccine against the viral pathogen severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the cause of the coronavirus disease 2019 (COVID-19) pandemic, is essential, but rigorous studies are required to determine the safety of candidate vaccines. Here, on behalf of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Working Group, we evaluate research on the potential risk of immune enhancement of disease by vaccines and viral infections, including coronavirus infections, together with emerging data about COVID-19 disease. Vaccine-associated enhanced disease has been rarely encountered with existing vaccines or viral infections. Although animal models of SARS-CoV-2 infection may elucidate mechanisms of immune protection, we need observations of enhanced disease in people receiving candidate COVID-19 vaccines to understand the risk of immune enhancement of disease. Neither principles of immunity nor preclinical studies provide a basis for prioritizing among the COVID-19 vaccine candidates with respect to safety at this time. Rigorous clinical trial design and post-licensure surveillance should provide a reliable strategy to identify adverse events, including the potential for enhanced severity of COVID-19 disease, after vaccination.
TAGS
SYNOPSIS
There is a positive association between COVID-19 deaths and Influenza Vaccination Rate (IVR) of people ≥65 years-old.
TITLE
Positive association between COVID-19 deaths and influenza vaccination rates in elderly people worldwide
CITATION
Wehenkel C. 2020. Positive association between COVID-19 deaths and influenza vaccination rates in elderly people worldwide. PeerJ 8:e10112 https
SUMMARY
The aim of this study was therefore to analyze the association between COVID-19 related deaths and influenza vaccination rate (IVR) in elderly people worldwide. The results showed a positive association between COVID-19 deaths and IVR of people ≥65 years-old. There is a significant increase in COVID-19 deaths from eastern to western regions in the world. Further exploration is needed to explain these findings, and additional work on this line of research may lead to prevention of deaths associated with COVID-19.
TAGS
SYNOPSIS
Delay or catch-up vaccination due to COVID19 social distancing should be done judiciously if at all, to minimize aluminum toxicity.
TITLE
Impact of catch-up vaccination on aluminum exposure due to new laws and post social distancing
CITATION
Lyons-Weiler, J. G McFarland and E La Joie. 2020. Impact of catch-up vaccination on aluminum exposure due to new laws and post social distancing; Journal of Trace Elements in Medicine and Biology Volume 62, December 2020, 126649 http://sciencedirect.
SUMMARY
This study utilized the established clearance and accumulation models to calculate expected per-body-weight whole-body toxicity of aluminum from vaccines considering for children of all ages under CDC’s Catch-Up schedule from birth to ten years, assuming social distancing for 6 months. Our updated Pediatric Dose Limit (PDL) model assumes a linear improvement in renal function from birth to two years. The results indicate that due diligence in considering alternative spacing and use of non-aluminum containing vaccines when possible will reduce whole body toxicity and may reduce risk of morbidity associated with exposure to aluminum. The study concludes that careful consideration of expected aluminum exposures during regular and Catch-Up vaccination is found to be especially important for infants and children below 2 years of age. We urge caution in the mass re-starting of vaccination under CDC’s Catch-Up schedule for children under 12 months and offer alternative strategies to minimize per-day/week/month exposure to aluminum hydroxide following the COVID-19 period of isolation.
TAGS
SYNOPSIS
There is a physiological effect of thimerosal in humans that could alter dopamine receptor pathways which are associated with locomotion and more importantly, motor disorders.
TITLE
The activities of drug inactive ingredients on biological targets
CITATION
Joshua Pottel, et al.; The activities of drug inactive ingredients on biological targets;July 24, 2020; Science Vol. 369, No. 6502; DOI: 10.1126/science.aaz9906.
SUMMARY
Excipients, considered “inactive ingredients,” are a major component of formulated drugs and play key roles in their pharmacokinetics. Despite their pervasiveness, whether they are active on any targets has not been systematically explored. We computed the likelihood that approved excipients would bind to molecular targets. Testing in vitro revealed 25 excipient activities, ranging from low-nanomolar to high-micromolar concentration. Another 109 activities were identified by testing against clinical safety targets. In cellular models, five excipients had fingerprints predictive of system-level toxicity. Exposures of seven excipients were investigated, and in certain populations, two of these may reach levels of in vitro target potency, including brain and gut exposure of thimerosal and its major metabolite, which had dopamine D3 receptor dissociation constant Kd values of 320 and 210 nM, respectively. Although most excipients deserve their status as inert, many approved excipients may directly modulate physiologically relevant targets.
TAGS
SYNOPSIS
The European Medicines Agency (EMA) reports that AAHS was introduced without any prelicensure safety evaluation.
TITLE
Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe?
CITATION
Petersen SB, Gluud C; Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe? BMJ Evidence-Based Medicine Published Online First: 06 August 2020. doi: 10.1136/bmjebm-2020-111419
SUMMARY
The Merck Sharp & Dohme Corp aluminium adjuvant ‘amorphous aluminium hydroxyphosphate sulfate’ (AAHS), primarily used in the Gardasil vaccines against human papilloma virus, has been criticised for lack of evidence for its safety. Documentation from Danish authorities and answers from the European Medicines Agency (EMA) suggest that AAHS may not have been sufficiently evaluated. Documentation from the Danish Medicines Agency shows discrepancies in the trial documents of two prelicensure clinical trials with Gardasil in 2002 and 2003. For both trials, the Agency seems to have authorised potassium aluminium sulfate as the adjuvant and not AAHS. In addition, the participants in the trial launched in 2002 were informed that the comparator was saline, even though the comparator was AAHS in an expedient consisting of L-histidine, polysorbate-80, sodium borate and sodium chloride. According to the EMA, AAHS was first introduced in Europe in 2004 as the adjuvant in Procomvax, a vaccine against the hepatitis B virus and Haemophilus influenza type b. The EMA reports that AAHS was introduced without any prelicensure safety evaluation. The adjuvant is described by the company to be both physically and functionally distinct from all other previously used aluminium adjuvants. There is a need for rigorous evaluation of benefits and harms of the adjuvant AAHS.
TAGS
SYNOPSIS
Higher proportions of parents of color were vaccine hesitant, and all vaccine‐hesitant parents agreed that “toxins in vaccines” were a cause of their child’s ASD.
TITLE
Vaccine Hesitancy and Attributions for Autism among Racially and Ethnically Diverse Groups of Parents of Children with Autism Spectrum Disorder: A Pilot Study
CITATION
Little is known about how racial/ethnic differences may influence attributions for autism spectrum disorder (ASD) and subsequent vaccine hesitancy, the latter of which refers to a continuum of concerns about vaccine safety that may lead to vaccine delays and/or refusals. Two hundred and twenty‐five parents of children with ASD who were enrolled in the SPARK cohort (Simons Foundation Powering Autism Research for Knowledge) completed the Parent Attitudes about Childhood Vaccines survey and the Revised Illness Perception Questionnaire . 28.9% of respondents (n = 65) were vaccine hesitant (PACV score ≥ 50). Significant differences were observed between proportions of vaccine‐hesitant parents (VHP) in the White sample and combined samples of color (Asian, Black, Latinx, Multiracial, and Other): 22.8% of the White sample (n = 39) versus 48.1% of the samples of color (n = 26). White, non‐hesitant parents more often agreed with the child’s brain structure as a cause of their child’s ASD, while White, VHP more often agreed with the deterioration of the child’s immunity as a cause. All VHP (regardless of race) agreed more often with diet , their own decisions , and vaccines as causes. VHP of color more often agreed with accident or injury , environmental pollution , their own general stress , and their own emotional state as causes. Future work should examine this phenomenon in larger, diverse samples to further understand differences across specific racial/ethnic groups.
TAGS
SYNOPSIS
Peer-reviewed critique of Merck’s reckless and immoral marketing strategy for Gardasil.
TITLE
HPV vaccination discourses and the construction of “at-risk” girls
CITATION
Geneviève Rail, Luisa Molino, Caroline Fusco, Moss Edward Norman, LeAnne Petherick, Jessica Polzer, Fiona Moola, Mary Bryson. June 2018; Canadian Journal of Public Health (2018) 109:622–632 https://doi.org/10.17269/s41997-018-0108-8.
The objective of this study was to investigate the deployment of HPV vaccination (HPVV) discourses and their impact on Canadian girls, parents, nurses and physicians.
TAGS
SYNOPSIS
The CDC vaccine schedule results in a high degree of chronic aluminum toxicity in the first seven months of life.
TITLE
Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation
CITATION
SUMMARY
This study shows that the CDC vaccine schedule results in a high degree of chronic aluminum toxicity in the first seven months of life—a time period critically important to neurodevelopment and immune system development. The authors reached this conclusion after assessing “time spent in toxicity” (defined as “the percentage of days of each week an infant spends with a body burden that exceeds the minimum safe level”) for the CDC schedule and two other lower-aluminum schedules. Important safety considerations include aluminum adjuvant dose per vaccine, spacing of aluminum-containing vaccines, the child’s weight at the time of vaccination and genetic variants that may limit ability to clear aluminum. Changes to the vaccine schedule, including use of vaccines that do not contain aluminum, can significantly reduce “time spent in toxicity.”
TAGS
SYNOPSIS
The data indicated non-live vaccines like Tdap are immunosuppressive. It could mean each non-live vaccine administered could defeat the benefits of all previously administered vaccines. And of course, the general immunosuppressive effect means the person is more susceptible to all pathogens except the ones the vaccine is intended to protect.
TITLE
Interacting, Nonspecific, Immunological Effects of Bacille Calmette-Guérin and Tetanus-diphtheria-pertussis Inactivated Polio Vaccinations: An Explorative, Randomized Trial
CITATION
SUMMARY
Certain vaccines, such as Bacille Calmette-Guérin (BCG), have nonspecific effects, which modulate innate immune responses and lead to protection against mortality from unrelated infections (trained immunity). In contrast, in spite of the disease-specific effects, an enhanced overall mortality has been described after diphtheria-tetanus-pertussis (DTP) vaccination in females. This randomized trial aimed to investigate the nonspecific immunological effects of BCG and DTP-containing vaccines on the immune response to unrelated pathogens. The trial results showed Tdap vaccination led to short-term potentiation and long-term repression of monocyte-derived cytokine responses, and short-term as well as long-term repression of T-cell reactivity to unrelated pathogens. BCG led to short-term and long-term potentiation of monocyte-derived cytokine responses. When given together with Tdap or after Tdap, BCG abrogated the immunosuppressive effects of Tdap vaccination.
The data indicated non-live vaccines like Tdap are immunosuppressive. It could mean each non-live vaccine administered could defeat the benefits of all previously administered vaccines. And of course, the general immunosuppressive effect means the person is more susceptible to all pathogens except the ones the vaccine is intended to protect.
TAGS
SYNOPSIS
This study explores the D-4 escape measles mutant, a strain that has emerged in countries that have intense vaccination.
TITLE
Antigenic Drift Defines a New D4 Subgenotype of Measles Virus
CITATION
SUMMARY
Measles virus is a paradigmatic RNA virus, as the antigenic composition of the vaccination has not needed to be updated since its discovery. The vaccine confers protection by inducing neutralizing antibodies that interfere with the function of the hemagglutinin protein. Viral strains are indistinguishable serologically, although characteristic nucleotide sequences differentiate 24 genotypes. In this work, we describe a distant evolutionary branch within genotype D4. Designated subgenotype D4.2, this virus is distinguishable by neutralization with vaccine-induced monoclonal antibodies that target the neutralizing epitope (NE). The subgenotype D4.2 viruses have a higher predominance in countries with intermediary levels of vaccine coverage. Our studies demonstrate that subgenotype D4.2 lacks epitopes associated with half of the known antigenic sites, which significantly impacts our understanding of measles virus evolution.
TAGS
SYNOPSIS
This preliminary study provides evidence that post-vaccination abnormal autoimmunity plays an important role in the development of unique symptoms after HPV vaccination.
TITLE
Autoantibodies against Autonomic Nerve Receptors in Adolescent Japanese Girls after Immunization with Human Papillomavirus Vaccine
CITATION
SUMMARY
In Japan a significant number of adolescent girls complain of unusual symptoms after human papillomavirus (HPV) vaccination that are considered adverse effects of HPV vaccination. However, a causal link between HPV vaccination and these adverse effects has not been demonstrated. In the present study, we investigated autoantibodies against diverse G-protein coupled receptors in the serum of girls who complained of possible adverse effects after HPV vaccination. This preliminary study provides evidence that post-vaccination abnormal autoimmunity plays an important role in the development of unique symptoms after HPV vaccination.
TAGS
SYNOPSIS
Out-of-sequence vaccinations may increase child mortality.
TITLE
Out-of-sequence DTP and measles vaccinations and child mortality in Guinea-Bissau: a reanalysis.
CITATION
Thysen SM, Rodrigues A, Aaby P, et al. British Medical Journal Open 2019;9:e024893; doi:10.1136/bmjopen-2018-024893.
SUMMARY
This study’s objective was to assess whether the sequence of diphtheria-tetanus-pertussis vaccine (DTP) and measles vaccine (MV) was associated with child survival. Using a data set previously used to assess non-specific effects of vaccines with no consideration of vaccination sequence researchers found that out-of-sequence vaccinations in children were associated with higher mortality compared with children vaccinated in-sequence.
TAGS
SYNOPSIS
Researchers assert that bivalent HPV vaccination in Scotland has been “highly effective” in reducing pre-malignant cervical disease, but have failed to discuss serious adverse events following HPV vaccination or other secular trends that could provide an explanation for the declines.
TITLE
Comments in response to: “Prevalence of cervical disease at age 20 after immunisation with bivalent HPV vaccine at age 12-13 in Scotland: retrospective population study.”
CITATION
Comments by Exley C, Gervas J, Selley P, Stone J, Thomas N, Vasquez A, Miller NZ, in response to: Palmer T, Wallace L, Pollock KG, et al. Prevalence of cervical disease at age 20 after immunisation with bivalent HPV vaccine at age 12-13 in Scotland: retrospective population study. BMJ. 2019;365:l1161.
SUMMARY
This collection of published comments responds to the assertion by Scottish researchers (Palmer et al., 2019) that bivalent HPV vaccination in Scotland has been “highly effective” in lowering the prevalence of pre-malignant cervical disease. The seven commenters make the following points:
- Exley critiques the authors’ “serious omission” in failing to discuss serious adverse events following HPV vaccination; those with “privileged access to human data” should use it “to cover all aspects of both efficacy AND safety of this vaccine.”
- Gervas estimates that 4,300 women would need to receive the HPV vaccine to prevent one case of severe cervical dysplasia (the “number needed to treat”).
- Selley describes secular trends in teen sexual behavior over the study period and asks whether the falling prevalence of pre-malignant cervical disease attributed to the HPV vaccine could be related to changes in sexual behavior.
- Stone calls attention to an article (Castanon and Sasieni, 2018) that reported a “dramatic increase” in England of cervical cancers in the first generation to be targeted for HPV vaccination.
- Thomas contests the lead author’s assertion that “In Scotland, as elsewhere, no serious adverse effects have been demonstrably linked to the [HPV] vaccine,” pointing to reports of several hundred thousand adverse events assembled by the World Health Organization (including 400 deaths) and almost 13,000 reported reactions in the UK, and observes that valid informed consent is not possible without communicating information about these risks.
- Vasquez points to Scotland’s public health campaign to address endemic vitamin D deficiency implemented in “close chronologic proximity” to its launch of HPV vaccination. “Crediting the reduction in HPV-related disease solely to vaccination…is potentially invalid and misleading, especially when the authors make no account whatsoever of the national program for vitamin D supplementation which started in the same timeframe.”
- Miller points out that the Palmer et al. study only included 12- and 13-year-old girls and “did not include older teens and women who are sexually active, have been exposed to HPV prior to HPV-vaccination, and are likely to have significantly worse outcomes than unvaccinated females.”
TAGS
SYNOPSIS
This case report describes bilateral deafness following influenza vaccination.
TITLE
Bilateral deafness two days following influenza vaccination: a case report
CITATION
Kolarov C, Lobermann M, Fritsche C, Hemmer C, Mlynski R, Reisinger EC. Human Vaccines & Immunotherapeutics. 2019;15(1):107-108.
SUMMARY
This case report describes bilateral deafness following influenza vaccination in a 79-year-old woman with previously normal hearing.
TAGS
SYNOPSIS
These data suggest that specific immune outcomes may wane at different rates and highlight our currently incomplete understanding of protective immune responses to mumps and measles.
TITLE
Differential durability of immune responses to measles and mumps following MMR vaccination.
CITATION
Richard B. Kennedy Inna G. Ovsyannikova, Antonia Thomas, Beth R. Larrabee, Steven Rubin, Gregory A. Poland, Vaccine, Volume 37, Issue 13, 22 March 2019, Pages 1775-1784
SUMMARY
The development and wide-spread use of mumps vaccine resulted in a dramatic and sustained decrease in the incidence of mumps disease; however, since 2000, an increase in the size and number of mumps outbreaks in the United States and other countries has sparked renewed interest in the durability of mumps-specific immunity elicited by mumps vaccination. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity. Researchers examined changes in markers of measles and mumps immunity at two timepoints, approximately 7 and 17 years after two-dose MMR-II® vaccination, and found that the mumps IgG titers exhibited a large and significant decline during this time period. There was a similar discrepancy with measles-specific immune responses.
TAGS
SYNOPSIS
Waning levels of measles antibodies with increasing time post-vaccination suggests that measles susceptibility is potentially increasing in Korea.
TITLE
An increasing, potentially measles-susceptible population over time after vaccination in Korea
CITATION
Kang, H. J., et al. Vaccine, 35 (2017) 4126–4132.
SUMMARY
In Korea, measles occurs mainly in infants <12 months of age, who are unvaccinated. In
addition, vaccine populations, including adolescents and young adults, can become infected through importation. Thus, the question arises whether the current level of herd immunity in Korea is now insufficient for protecting against measles infection.
TAGS
SYNOPSIS
More than one in ten vaccine-related adverse events in Zimbabwe are serious (11%), and measles-containing vaccines are one of the vaccines most frequently responsible for serious and systemic reactions.
TITLE
Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase from 1997 to 2017
CITATION
SUMMARY
The authors examined passively collected reports of adverse events following immunization (AEFI) in Zimbabwe from 1997 to 2017. Given widespread underreporting to the country’s still-developing vaccine surveillance system, just 272 Individual Case Safety Reports (ICSRs) were available, of which 11% represented “serious events.” Of these, 6% were deaths and 5% were life-threatening or involved prolonged hospitalization. Measles-containing vaccines had the highest AEFI reporting rate and were also strongly associated with serious events, as was a six-component vaccine containing antigens for oral poliovirus, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and hepatitis B (OPV/DTP-Hib-HepB). The majority of AEFI were systemic (versus vaccine site reactions)—and systemic events, again, were associated with measles-containing vaccines.
TAGS
SYNOPSIS
In Israel in 2017, nine measles cases were identified in a population with high measles vaccination coverage.
TITLE
Measles Outbreak in a Highly Vaccinated Population – Israel, July-August 2017
Citation
Avramovich E, Indenbaum V, Haber M, Amitai Z, Tsifanski E, Farjun S, Sarig A, Bracha A, Castillo K, Markovich MP, Galor I. MMWR Morbidity and Mortality Weekly Report. 2018 Oct 26;67(42):1186-1188.
Summary
On August 6, 2017, the Israeli Defense Force Public Heath Branch (IDFPHB) was notified of two suspected measles cases. IDFPHB conducted an epidemiologic investigation, which identified nine measles cases in a population with high measles vaccination coverage. All measles patients had signs and symptoms consistent with modified measles (i.e., less severe disease with milder rash, fever, or both, with or without other mild typical measles symptoms). A total of 1,392 contacts were identified, and 162 received postexposure prophylaxis (PEP) with measles-mumps-rubella (MMR) vaccine; the remaining contacts were followed for 21 days (one incubation period). No tertiary cases were identified.
TAGS
SYNOPSIS
Gardasil clinical trial and post-marketing data should raise a red flag about HPV vaccine safety.
TITLE
Comment on: Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.
CITATION
Martinez-Lavin M. Comment on: Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Database of Systematic Reviews. 2018 October 1.
SUMMARY
This brief comment disputes as flawed the conclusions of a Cochrane systematic review of human papillomavirus (HPV) vaccine safety (Arbyn et al., 2018). The earlier review reported no increased risk of serious adverse events and dismissed post-HPV-vaccine deaths as a “chance occurrence.” However, other published studies show significantly more serious adverse events in (1) women who received Gardasil versus aluminum placebo and (2) women who received 9-valent Gardasil-9 versus 4-valent Gardasil. Stating that “hard statistical data must take preeminence over the expert’s opinion,” the author argues that Gardasil clinical trial and post-marketing data “should raise a red flag on HPV vaccine safety.”
TAGS
SYNOPSIS
There are statistical increases in the incidence rate of autism, mental retardation , and speech disorders after thimerosal-containing DTaP vaccines in comparison with thimerosal-free DTaP vaccines.
TITLE
Vaccination and autoimmunity-‘vaccinosis’: a dangerous liaison?
CITATION
Shoenfeld Y, Aron-Maor A. Journal of Autoimmunity. 2000 Feb;14(1):1-10.
SUMMARY
An analysis of the Vaccine Adverse Events Reporting System (VAERS) database showed statistical increases in the incidence rate of autism (relative risk [RR] = 6.0), mental retardation (RR = 6.1), and speech disorders (RR = 2.2) after thimerosal-containing diphtheria, tetanus, and acellular pertussis (DTaP) vaccines in comparison with thimerosal-free DTaP vaccines.
TAGS
SYNOPSIS
Indian study reveals birth dose of Hepatitis B vaccine is unnecessary.
TITLE
Evaluation of the Protection Provided by Hepatitis B Vaccination in India
CITATION
Puliyel, J., Naik, P., Puliyel, A. et al. Indian Journal of Pediatrics, (2018). https://doi.org/10.1007/s12098-017-2601-0.
SUMMARY
In India, Hepatitis B vaccination is recommended at 6 wk except for hospital-deliveries. The authors examined protection afforded by the birth dose and found that birth vaccination has no added protection when compared to the unvaccinated. Children who were fully vaccinated with or without birth dose of the hepatitis B vaccine had similar levels of protection against the infection.
TAGS
SYNOPSIS
Dengue vaccine increases the risk of severe dengue in unexposed children.
TITLE
Effect of Dengue Serostatus on Dengue Vaccine Safety and Efficacy
CITATION
S. Sridhar, A. Luedtke, E. Langevin, M. Zhu, et al. The New England Journal of Medicine, (2018), DOI: 10.1056/NEJMoa1800820.
SUMMARY
In efficacy trials of a tetravalent dengue vaccine, study authors found: “…in the absence of previous dengue exposure, the (Sanofi) vaccine partially mimics primary infection and increases the risk of severe dengue.” (800,000 kids were already vaccinated before they pulled the vaccine.)
TAGS
SYNOPSIS
Women vaccinated for HPV have a lower probability of conceiving.
TITLE
A lowered probability of pregnancy in females in the USA aged 25–29 who received a human papillomavirus vaccine injection
CITATION
Gayle DeLong (2018) Journal of Toxicology and Environmental Health, Part A, 81:14, 661-674, DOI: 10.1080/15287394.2018.1477640
SUMMARY
Approximately 60% of the single women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived. For married women, 75% who did not receive the shot were found to conceive, while only 50% who received the vaccine had ever been pregnant.
TAGS
SYNOPSIS
The neonatal hepatitis B vaccination induced an anti-inflammatory response lasting for 4–5 weeks.
TITLE
IL-4 mediates the delayed neurobehavioral impairments induced by neonatal hepatitis B vaccination that involves the down-regulation of the IL-4 receptor in the hippocampus
CITATION
Yang XWJ, Xing Z, Zhang H, et al. Cytokine. 2018; 110:137-149.
SUMMARY
Experiments showed that IL-4 mediates the delayed neurobehavioral impairments induced by neonatal hepatitis B vaccination, which involves the permeability of neonatal blood–brain barrier and the down-regulation of IL-4 receptor. This finding suggests that clinical events concerning neonatal IL-4 over-exposure, including neonatal hepatitis B vaccination and allergic asthma in human infants, may have adverse implications for brain development and cognition.