See the below research on the efficacy of the vaccine:
IMPORTANT 2022 WHO STUDY (Risks of Adverse Events from the vaccine greater than any benefits) – Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239
VERY IMPORTANT (Leaky vaccines) – Evidence of leaky protection following COVID-19 vaccination and SARS-CoV-2 infection in an incarcerated population https://www.nature.com/articles/s41467-023-40750-8
During both the Delta and Omicron periods, we found that neither prior infection, nor vaccination, nor hybrid immunity provided significant levels of protection against SARS-CoV-2 infection following cell exposure events and that the levels of protection were significantly smaller following cell exposure events than following events without documented exposures. Further, despite having a limited sample during the period of Delta predominance, we observed similar gradients in the level of protection offered by prior infection, vaccination, and hybrid immunity against symptomatic infection. These findings provide empirical evidence that, while accounting for factors thought to be associated with vaccine acceptance and infection, the protection offered by prior infection, vaccination, and hybrid immunity, appears to be leaky. They suggest that there may be an additional mechanism, based on the intensity of the infectious exposure, which may explain observed, partial levels of immunity conferred by infection and vaccination, in addition to factors such as variant-specific immune escape, waning immunity and reduced effectiveness in specific subpopulations, such as older people28,29,30.
IMPORTANT VARIANT DRIVER – Imperfect Vaccination Can Enhance the Transmission of Highly Virulent Pathogens https://journals.plos.org/plosbiology/article?id=10.1371%2Fjournal.pbio.1002198
IMPORTANT – Vaccination shapes evolutionary trajectories of SARS-CoV-2 https://www.biorxiv.org/content/10.1101/2022.07.19.500637v1
VERY IMPORTANT (Bias in observational vaccine efficacy research) – Sources of bias in observational studies of covid-19 vaccine effectiveness https://onlinelibrary.wiley.com/doi/10.1111/jep.13839
VERY IMPORTANT (UK JCVI group on latest vaccine efficacy – 2023) – JCVI statement on the COVID-19 vaccination programme for 2023: 8 November 2022 https://www.gov.uk/government/publications/covid-19-vaccination-programme-for-2023-jcvi-interim-advice-8-november-2022/jcvi-statement-on-the-covid-19-vaccination-programme-for-2023-8-november-2022 Appendix 1 NNV values (number of patients needed to be vaccinated in order to prevent 1 single case https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1131409/appendix-1-of-jcvi-statement-on-2023-covid-19-vaccination-programme-8-november-2022.pdf
IMPORTANT (Comparison for children, jabbed and unjabbed, during Delta and Omicron, showed ARR much more effective being unjabbed) – Real-world Effectiveness of BNT162b2 Against Infection and Severe Diseases in Children and Adolescents https://www.medrxiv.org/content/10.1101/2023.06.16.23291515v3.full-text
VERY IMPORTANT (Scottish Covid-19 inquiry findings) – Report for the Scottish COVID-19 Inquiry – Dr Ashley Croft MA (Oxon) MBBS MSc PhD DTM&H DMCC FFPHM Consultant Public Health Physician / Medical Epidemiologist https://www.covid19inquiry.scot/sites/default/files/2023-07/Dr-Croft-epidemiology-report.pdf
Further comment. By the time of the September 2021 follow-up study Thomas 2021 (and as occurred also with the other vaccine follow-up studies), there were multiple drop-outs from the original ‘pivotal’ Pfizer study; the study in effect had shrunk in size. The follow-up study found that vaccine efficacy declined at “an average… of 6% every 2 months”. The lack of transparency in the data presented by Pfizer in their follow-up study was strongly criticised in an online editorial in the British Medical Journal Doshi 2021 .
Aside from fatal events, analysis by the MHRA of two consecutive years of Yellow Card reports suggests that COVID-19 vaccination may cause an increased risk of the following serious adverse events MHRA 2022 :
- Anaphylaxis (i.e. immediate-onset, life-threatening allergic reaction) [number of
reports to MHRA – 990 in total, most (90%) with AstraZeneca]; - Bells’ palsy (i.e. unilateral facial nerve paralysis) [number of reports to MHRA – not
disclosed (but “continuously reviewed”)]; - Guillain-Barré syndrome (i.e. ascending paralysis of the lower limbs) [number of
Part Four – vaccines used against COVID-19 …71
reports to MHRA – not disclosed]; - immune thrombocytopaenia [number of reports to MHRA – not disclosed];
- major thrombo-embolic events (i.e. life-threatening blood clots) [number of reports
to MHRA – 486 in total, most (91%) with AstraZeneca]; - menstrual disorders and vaginal bleeding [number of reports to MHRA – 51,695 in
total (“mostly transient [and] MHRA will continue to review”)]; - myocarditis [number of reports to MHRA – 1241 in total, 15 with a fatal outcome
(“reports… are being monitored closely”]; - pericarditis [number of reports to MHRA – 954 in total];
- transverse myelitis (i.e. spinal cord inflammation) [number of reports to MHRA – 179
in total, most (72%) with AstraZeneca (“the product information has been updated”)];
Vaccines against COVID-19
- Vaccines against COVID-19 became available to the UK general public in December
2020; initially only the high-risk groups (the very old, the very sick) were targeted. - All the COVID-19 vaccines procured by the UK government during 2020 and 2021
were nucleic acid vaccines using novel gene technology. - As additional vaccine supplies became available, vaccination was extended to
young, middle-aged and elderly adults, and to children. - Vaccination against COVID-19 became a prerequisite of travel to many countries,
and some UK employers made it obligatory for their workforce. - It remains unclear as to whether or not COVID-19 vaccination has resulted in fewer
deaths from COVID-19. - COVID-19 vaccines have been shown in randomised controlled trials to be effective,
or probably effective, in reducing the number of people acquiring COVID-19 or
severe COVID-19; however vaccine-induced protection against COVID-19 is short-
lived. - Because of the antigenic variability of all coronaviruses, including SARS-CoV-2, it
was foreseeable that COVID-19 vaccines would only provide short-term protection
against COVID-19 (as is the case also with current vaccines against seasonal
IMPORTANT (Elderly vaccination no discernable benefit from hospital outcomes) – Hospital Outcomes of Community-Acquired SARS-CoV-2 Omicron Variant Infection Compared With Influenza Infection in Switzerland https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2801464
IMPORTANT (Reduced effectiveness of repeated influenza injection) – Reduced effectiveness of repeat influenza vaccination: distinguishing among within-season waning, recent clinical infection, and subclinical infection https://www.medrxiv.org/content/10.1101/2023.03.12.23287173v2
Studies have reported that prior-season influenza vaccination is associated with higher risk of clinical influenza infection among vaccinees. This effect might arise from incomplete consideration of within-season waning and recent infection. Using data from the US Flu Vaccine Effectiveness (VE) Network (2011-2012 to 2018-2019 seasons), we found that repeat vaccinees were vaccinated earlier in a season by one week. After accounting for waning VE, repeat vaccinees were still more likely to test positive for A(H3N2) (OR=1.11, 95%CI:1.02-1.21) but not for influenza B or A(H1N1). We found that clinical infection influences individuals’ decision to vaccinate in the following season while protecting against clinical infection of the same (sub)type. However, adjusting for recent clinical infections did not strongly influence the estimated effect of prior-season vaccination. In contrast, we found that adjusting for subclinical infection could theoretically attenuate this effect. Additional investigation is needed to determine the impact of subclinical infections on VE.
IMPORTANT (Disease severity for unvaccinated had reduced hospitalisations and death) – Disease severity of unvaccinated SARS-CoV-2 positive adults less than 65 years old without comorbidity, in the Omicron period and pre-Omicron periods https://www.medrxiv.org/content/10.1101/2023.02.02.23285377v1
Authors found:
Conclusion In the Omicron period, compared to pre-Omicron periods, unvaccinated SARS-CoV-2 positive adults <65 years old without comorbidity had reduced proportions of hospitalization and death overall, but similar proportion of severe illness among patients hospitalized for COVID-19. These results support continuous efforts to prevent hospitalizations for COVID-19.
IMPORTANT (VE Pfizer / AstraZeneca negative efficacy) Published Oct 22 – Waning of first- and second-dose ChAdOx1 and BNT162b2 COVID-19 vaccinations: a pooled target trial study of 12.9 million individuals in England, Northern Ireland, Scotland and Wales https://pubmed.ncbi.nlm.nih.gov/36272418/
Study authors found: Results: For Doses 1 and 2 of ChAdOx1 and Dose 1 of BNT162b2, VE/rVE reached zero by approximately Days 60-80 and then went negative. By Day 70, VE/rVE was -25% (95% CI: -80 to 14) and 10% (95% CI: -32 to 39) for Doses 1 and 2 of ChAdOx1, respectively, and 42% (95% CI: 9 to 64) and 53% (95% CI: 26 to 70) for Doses 1 and 2 of BNT162b2, respectively. rVE for Dose 2 of BNT162b2 remained above zero throughout and reached 46% (95% CI: 13 to 67) after 98 days of follow-up.
IMPORTANT (Infection rate rises with vacination – Iceland study) Published 03 August 2022 – Rate of SARS-CoV-2 Reinfection During an Omicron Wave in Iceland https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2794886
Authors found: The probability of reinfection increased with time from the initial infection (odds ratio of 18 months vs 3 months, 1.56; 95% CI, 1.18-2.08) (Figure) and was higher among persons who had received 2 or more doses compared with 1 dose or less of vaccine (odds ratio, 1.42; 95% CI, 1.13-1.78). Defining reinfection after 30 or more days or 90 or more days did not qualitatively change the results.
VERY IMPORTANT (Risk of Covid-19 infection increases with each prior vaccination) – Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine https://www.medrxiv.org/content/10.1101/2022.12.17.22283625v1 Updated https://www.medrxiv.org/content/10.1101/2022.12.17.22283625v5 Published Open Forum Infectious Diseases https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofad209/7131292?login=false
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“The association of increased risk of COVID-19 with higher numbers of prior vaccine doses in our study, was unexpected. A simplistic explanation might be that those who received more doses were more likely to be individuals at higher risk of COVID-19. A small proportion of individuals may have fit this description. However, the majority of subjects in this study were generally young individuals and all were eligible to have received at least 3 doses of vaccine by the study start date, and which they had every opportunity to do.”
“Therefore, those who received fewer than 3 doses (>45% of individuals in the study) were not those ineligible to receive the vaccine, but those who chose not to follow the CDC’s recommendations on remaining updated with COVID-19 vaccination, and one could reasonably expect these individuals to have been more likely to have exhibited higher risk-taking behavior.”
“Despite this, their risk of acquiring COVID-19 was lower than those who received a larger number of prior vaccine doses. This is not the only study to find a possible association with more prior vaccine doses and higher risk of COVID-19. A large study found that those who had an Omicron variant infection after previously receiving three doses of vaccine had a higher risk of reinfection than those who had an Omicron variant infection after previously receiving two doses of vaccine [21]. Another study found that receipt of two or three doses of a mRNA vaccine following prior COVID-19 was associated with a higher risk of reinfection than receipt of a single dose [7]”
VERY IMPORTANT (Risk of Covid-19 infection increases with each prior vaccination) Second Cleveland Study analysis – Risk of Coronavirus Disease 2019 (COVID-19) among Those Up-to-Date and Not Up-to-Date on COVID-19 Vaccination https://www.medrxiv.org/content/10.1101/2023.06.09.23290893v1 Published https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0293449
Risk of COVID-19 Based on Vaccination Status and Prior Infection
The risk of COVID-19 was lower in the “not up-to-date” state than in the “up-to-date” state, with respect to COVID-19 vaccination (Figure 1). When stratified by tertiles of propensity to get tested for COVID-19, the “not up-to-date” state was not associated with a higher risk of COVID-19 than the “up-to-date” state in any tertile (Figure 2).
DISCUSSION
This study found that not being “up-to-date” on COVID-19 vaccination, using the current CDC definition, was associated with a lower risk of COVID-19 than being “up-to-date”, while the XBB lineages were the dominant circulating strains of SARS-CoV-2.
There are two reasons why not being “up-to-date” on COVID-19 vaccination by the CDC definition was associated with a lower risk of COVID-19. The first is that the bivalent vaccine was somewhat effective against strains that were more similar to the strains on the basis of which the bivalent vaccine was developed, but is not effective against the XBB lineages of the Omicron variant [2]. The second is that the CDC definition does not consider the protective effect of immunity acquired from prior infection. Because the COVID-19 bivalent vaccine provided some protection against the BA.4/BA.5 and BQ lineages [2], those “not-up-to-date” were more likely than those “up-to-date” to have acquired a BA.4/BA.5 or BQ lineage infection when those lineages were the dominant circulating strains. It is now well-known that SARS-CoV-2 infection provides more robust protection than vaccination [4,11,12]. Therefore it is not surprising that not being “up-to-date” according to the CDC definition was associated with a higher risk of prior BA.4/BA.5 or BQ lineage infection, and therefore a lower risk of COVID-19, than being “up-to-date”, while the XBB lineages were dominant.
The strengths of our study include its large sample size, and its conduct in a healthcare system that devoted resources to have an accurate accounting of who had COVID-19, when COVID-19 was diagnosed, who received a COVID-19 vaccine, and when. The study methodology, treating vaccination status as a time-dependent covariate, allowed for determining vaccine effectiveness in real time. Adjusting for the propensity to get tested for COVID-19 should have mitigated against concern that individuals who bothered to remain up-to-date on COVID-19 vaccination may have been more likely to get tested for COVID-19 when they had symptoms.
IMPORTANT (Meta-analysis of natural immunity versus vaccine) – Past SARS-CoV-2 infection protection against re-infection: a systematic review and meta-analysis https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02465-5/fulltext
IMPORTANT (Past infection protection) – Past SARS-CoV-2 infection protection against re-infection: a systematic review and meta-analysis https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02465-5/fulltext
We identified a total of 65 studies from 19 different countries. Our meta-analyses showed that protection from past infection and any symptomatic disease was high for ancestral, alpha, beta, and delta variants, but was substantially lower for the omicron BA.1 variant. Pooled effectiveness against re-infection by the omicron BA.1 variant was 45·3% (95% uncertainty interval [UI] 17·3–76·1) and 44·0% (26·5–65·0) against omicron BA.1 symptomatic disease. Mean pooled effectiveness was greater than 78% against severe disease (hospitalisation and death) for all variants, including omicron BA.1. Protection from re-infection from ancestral, alpha, and delta variants declined over time but remained at 78·6% (49·8–93·6) at 40 weeks. Protection against re-infection by the omicron BA.1 variant declined more rapidly and was estimated at 36·1% (24·4–51·3) at 40 weeks. On the other hand, protection against severe disease remained high for all variants, with 90·2% (69·7–97·5) for ancestral, alpha, and delta variants, and 88·9% (84·7–90·9) for omicron BA.1 at 40 weeks.
Interpretation
Protection from past infection against re-infection from pre-omicron variants was very high and remained high even after 40 weeks. Protection was substantially lower for the omicron BA.1 variant and declined more rapidly over time than protection against previous variants. Protection from severe disease was high for all variants. The immunity conferred by past infection should be weighed alongside protection from vaccination when assessing future disease burden from COVID-19, providing guidance on when individuals should be vaccinated, and designing policies that mandate vaccination for workers or restrict access, on the basis of immune status, to settings where the risk of transmission is high, such as travel and high-occupancy indoor settings.
IMPORTANT (Childrens immunity wanes quickly post injection) – Effects of Vaccination and Previous Infection on Omicron Infections in Children https://www.nejm.org/doi/full/10.1056/NEJMc2209371
IMPORTANT (Booster negative efficacy) – Long-term COVID-19 booster effectiveness by infection history and clinical vulnerability and immune imprinting: a retrospective population-based cohort study https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00058-0/fulltext
IMPORTANT (Booster ineffective against death and minimal impact on the virus) – Effectiveness of a fourth SARS-CoV-2 vaccine dose in previously infected individuals from Austria https://onlinelibrary.wiley.com/doi/full/10.1111/eci.14136
For infections, rVE rapidly declined with time elapsed after the fourth vaccination (Table 3). Individuals with repeated previous infections had reduced re-infection risk (Table S4). Analyses on infection rates according to year of the last prior infection showed significantly waning immunity with time elapsed since last infection (Table S5).
Evidence of peak effectiveness about 3–5 weeks after receiving the fourth vaccine dose, but then decreasing effectiveness towards no remaining effect beyond 15 weeks was previously reported and fits well to our findings.5, 25 The public health significance of this transient risk reduction in SARS-CoV-2 infections lasting for several weeks after receiving the fourth vaccine dose remains unclear. Although this reduced infection risk did not translate into prevention of COVID-19 deaths according to our data, we cannot exclude other benefits related to non-fatal adverse health outcomes following SARS-CoV-2 infections. While rapidly waning vaccine protection is observed for laboratory confirmed SARS-CoV-2 infections, previous studies documented that vaccine effectiveness seems to be long lasting for protection against severe and lethal COVID-19.5, 17 Similarly, data from Qatar suggest that natural immunity confers a very strong protection against severe COVID-19 with no evidence of waning immunity, a conclusion that is supported by a systematic review and meta-analyses.14, 16
IMPORTANT (Bivalent efficacy against XBB variant – 21% with wide confidence intervals) – Bivalent mRNA-1273.214 vaccine effectiveness against SARS-CoV-2 omicron XBB* infections https://www.medrxiv.org/content/10.1101/2023.04.15.23288612v2.full-text
The adjusted hazard ratio comparing incidence of infection in the bivalent cohort to that in the no-recent-vaccination cohort was 0.75 (95% CI: 0.57-0.97; Table S2). Bivalent vaccine effectiveness against infection was 25.2% (95% CI: 2.6-42.6%; Figure 1B). Effectiveness was 21.5% (95% CI: -8.2-43.5%) among persons with no prior infection and 33.3% (95% CI: -4.6- 57.6%) among persons with prior infection. In absence of severe COVID-19 cases, effectiveness against severe COVID-19 could not be estimated. Further results and limitations are in Section S2.
mRNA-1273.214 reduced incidence of SARS-CoV-2 infection, but the protection was modest at only 25%, consistent with a modest protection for the bivalent vaccines based on SARS-CoV-2 ancestral and omicron BA.1 or BA.4/BA.5 strains.4–6 The modest protection may have risen because of XBB* immune evasion or immune imprinting effects,2,7,8 or combination of both.
IMPORTANT (Efficacy zero after a few months) – Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity: A Systematic Review and Meta-analysis https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2804451
IMPORTANT (Antibodies showed a 16 day half life) – Durability of humoral and cellular immunity six months after the BNT162b2 bivalent booster https://pubmed.ncbi.nlm.nih.gov/38185981/
Neutralizing antibodies against either the D614G strain, the delta variant, the BA.5 variant, or the XBB.1.5 subvariant were measured. The cellular response was assessed by measurement of the release of interferon gamma from T cells in response to an in vitro SARS-CoV-2 stimulation. A substantial waning of neutralizing antibodies was observed after 6 months (23.1-fold decrease), especially considering the XBB.1.5 subvariant. The estimated T1/2 of neutralizing antibodies was 16.1 days (95% CI = 10.2-38.4 days). Although most participants still present a robust cellular response after 6 months (i.e., 95%), a significant decrease was also observed compared to the peak response (0.95 vs. 0.41 UI/L, p = 0.0083). A significant waning of the humoral and cellular response was observed after 6 months.
IMPORTANT (Immune reducing effects of booster efficacy) – Effectiveness of second booster compared to first booster and protection conferred by previous SARS CoV-2 infection against symptomatic Omicron BA.2 and BA.4/5 in France https://www.medrxiv.org/content/10.1101/2023.01.11.23284137v1 Published https://www.sciencedirect.com/science/article/pii/S0264410X23003158
IMPORTANT (Efficacy of boosters) – Durability of Bivalent Boosters against Omicron Subvariants https://www.nejm.org/doi/full/10.1056/NEJMc2302462
IMPORTANT (Waning effectiveness – 3 doses to 46% after 3 months) – Waning of vaccine effectiveness against moderate and severe covid-19 among adults in the US from the VISION network: test negative, case-control study https://www.bmj.com/content/379/bmj-2022-072141
Main outcome measures The main outcome was waning of vaccine effectiveness with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine during the omicron and delta periods, and the period before delta was dominant using logistic regression conditioned on calendar week and geographic area while adjusting for age, race, ethnicity, local virus circulation, immunocompromised status, and likelihood of being vaccinated.
Results 45 903 people admitted to hospital with covid-19 (cases) were compared with 213 103 people with covid-like illness who tested negative for SARS-CoV-2 (controls), and 103 287 people admitted to emergency department or urgent care with covid-19 (cases) were compared with 531 168 people with covid-like illness who tested negative for SARS-CoV-2. In the omicron period, vaccine effectiveness against covid-19 requiring admission to hospital was 89% (95% confidence interval 88% to 90%) within two months after dose 3 but waned to 66% (63% to 68%) by four to five months. Vaccine effectiveness of three doses against emergency department or urgent care visits was 83% (82% to 84%) initially but waned to 46% (44% to 49%) by four to five months. Waning was evident in all subgroups, including young adults and individuals who were not immunocompromised; although waning was morein people who were immunocompromised. Vaccine effectiveness increased among most groups after a fourth dose in whom this booster was recommended.
Conclusions Effectiveness of mRNA vaccines against moderate and severe covid-19 waned with time after vaccination. The findings support recommendations for a booster dose after a primary series and consideration of additional booster doses.
IMPORTANT (Prisons study showing more incidences in vaccinated cohort) – COVID-19 Infection Rates in Vaccinated and Unvaccinated Inmates: A Retrospective Cohort Study https://www.cureus.com/articles/179946-covid-19-infection-rates-in-vaccinated-and-unvaccinated-inmates-a-retrospective-cohort-study#!/
Results
Our results indicate that the infection rates in the bivalent-vaccinated and entirely unvaccinated groups are 3.24% (95% confidence interval (CI): 3.06-3.42%) and 2.72% (CI: 2.50-2.94%), respectively, with an absolute risk difference of only 0.52%. When the data were filtered for those aged 50 and above, the infection rates were 4.07% (CI: 3.77-4.37%) and 3.1% (CI: 2.46-3.74%), respectively, revealing a mere 0.97% absolute risk difference. Among those aged 65 and above, the infection rates were 6.45% (CI: 5.74-7.16%) and 4.5% (CI: 2.57-6.43%), respectively, with an absolute risk difference of 1.95%.
Conclusion
We note low infection rates in both the vaccinated and unvaccinated groups, with a small absolute difference between the two across age groups. A combination of monovalent and bivalent vaccines and natural infections likely contributed to immunity and a lower level of infection rates compared to the height of the pandemic. It is possible that a degree of ‘herd immunity’ has been achieved. Yet, using p<0.05 as the threshold for statistical significance, the bivalent-vaccinated group had a slightly but statistically significantly higher infection rate than the unvaccinated group in the statewide category and the age ≥50 years category. However, in the older age category (≥65 years), there was no significant difference in infection rates between the two groups. This suggests that while the bivalent vaccine might offer protection against severe outcomes, it may not significantly reduce the risk of infections entirely. Further research is needed to understand the reasons behind these findings and to consider other factors, such as underlying health conditions. This study underscores the importance of developing vaccines that target residual COVID-19 infections, especially in regard to evolving COVID-19 variants.
IMPORTANT (Vaccination increases risk of infection) – SARS-CoV-2 Infection, Hospitalization, and Death in Vaccinated and Infected Individuals by Age Groups in Indiana, 2021‒2022 https://ajph.aphapublications.org/doi/10.2105/AJPH.2022.307112
Authors estimated the incidence of COVID-19 was higher among the vaccinated when compared with the unvaccinated but naturally immune. Six months after the index date—30 days after an initial infection or 30 days after a vaccination—the cumulative infection rate was 6.7 percent among the vaccinated and just 2.9 percent among the previously infected. The rate remained higher among the vaccinated in all age groups when the results were stratified by age.
“Interestingly, at least in the study population and at [the] time of this analysis, natural immunity appears more effective in preventing new infections, a finding that is also reported in an earlier observational study,” the researchers said, pointing to an April paper from Israeli researchers. They theorized that vaccinated people may be more likely to get tested for COVID-19, which would lead to vaccine effectiveness being underestimated.
IMPORTANT (Negative efficacy) – Long-term COVID-19 booster effectiveness by infection history and clinical vulnerability and immune imprinting https://www.medrxiv.org/content/10.1101/2022.11.14.22282103v1.full
IMPORTANT (Negative efficacy after 18 weeks) – Effectiveness of COVID-19 Vaccines Over 13 Months Covering the Period of the Emergence of the Omicron Variant in the Swedish Population https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9782222/
VE after Two Doses before and after the Emergence of Omicron
The more fast-waning VE observed for the entire follow-up than in other earlier published data appeared to be related to the emergence of Omicron. It is, therefore, important to analyze the pre-Omicron and Omicron periods separately. There was a large difference in VE against infection before and after the emergence of Omicron. VE was above 85% before Omicron in most time intervals (Figure 3a, Table S8), whereas VE was lower and decreased rapidly during the Omicron period and two doses of the vaccine showed no protection against infection by week 14
VERY IMPORTANT (Negative effectiveness; Kaiser Permanente health care network) – Effectiveness of mRNA-1273 against infection and COVID-19 hospitalization with SARS-CoV-2 Omicron subvariants: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5 https://www.medrxiv.org/content/10.1101/2022.09.30.22280573v1
As the study authors note, against these subvariants, vaccine effectiveness against infection “waned rapidly” after receipt of the primary two-dose series plus a booster shot.
After two booster shots, vaccine effectiveness peaked at a statistically non-significant 75.7 percent against BA.4 and only 36.7 percent against BA.5, “disappearing beyond 90 days for all subvariants.”
The authors note that prior studies had found that the two-dose regimen of mRNA COVID‑19 vaccines resulted in effectiveness against hospitalization with the original Omicron variant (BA.1) that was “modest and waned quickly”; and while effectiveness after a booster shot “was initially higher, it also waned.”
The authors looked only at cases where SARS‑CoV‑2, the coronavirus that causes COVID‑19, was successfully genome sequenced, ruling out false positive results of PCR testing and enabling them to identify specific variants. Consequently, this study focuses on cases “that tended to have a higher viral load and were more likely symptomatic.” They also took care to confirm hospitalization for severe COVID‑19, “rather than hospitalization that was coincident with COVID‑19.”
Since the data show loss of significant protection against infection within several months with “still unknown” durability against hospitalization, the authors conclude that the “monovalent Wuhan strain formulated mRNA vaccine would be inadequate in controlling a potential BA.5 surge during the winter season.” Their interpretation of the data is that “Omicron-specific boosters are likely needed to maintain protection against Omicron subvariants and minimize waning effectiveness.”
IMPORTANT (Negative efficacy on hospitalisations) – Effectiveness of Vaccination and Previous Infection Against Omicron Infection and Severe Outcomes in Children Under 12 Years of Age https://www.medrxiv.org/content/10.1101/2023.01.18.23284739v1
IMPORTANT (Negative efficacy after 8 months – protection no better than unvaccinated) – Risk of infection, hospitalisation, and death up to 9 months after a second dose of COVID-19 vaccine: a retrospective, total population cohort study in Sweden https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8816388/
IMPORTANT (VE <50%) – Effect of mRNA Vaccine Boosters against SARS-CoV-2 Omicron Infection in Qatar https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8929389/
IMPORTANT (VE 46.4% of relative 5th booster efficacy compared to previous injections. Everyone was jabbed in the study, controls were jabbed but didn’t have PCR confirmed SARS-CoV-2) – Relative vaccine effectiveness (rVE) of mRNA COVID-19 boosters in the UK vaccination programme, during the Spring-Summer (monovalent vaccine) and Autumn-Winter 2022 (bivalent vaccine) booster campaigns: a prospective test negative case-control study https://www.medrxiv.org/content/10.1101/2023.03.16.23287360v1.full-text
IMPORTANT (VE 8% of new boosters) – Protection against symptomatic SARS-CoV-2 BA.5 infection conferred by the Pfizer-BioNTech Original/BA.4-5 bivalent vaccine compared to the mRNA Original (ancestral) monovalent vaccines – a matched cohort study in France https://www.medrxiv.org/content/10.1101/2023.03.17.23287411v2
A total of 136,852 individuals were included and followed for a median period of 77 days. The bivalent vaccine conferred an additional protection of 8% [95% CI: 0% – 16%, p=0.045] against symptomatic SARS-CoV-2 infection compared to the monovalent vaccines.
IMPORTANT (Waning immunity against newer XBB.1.5 variant) – Waning Immunity Against XBB.1.5 Following Bivalent mRNA Boosters https://www.biorxiv.org/content/10.1101/2023.01.22.525079v1
Authors found:
We assessed humoral and cellular immune responses in 30 participants who received the bivalent mRNA boosters and performed assays at baseline prior to boosting, at week 3 after boosting, and at month 3 after boosting. Our data demonstrate that XBB.1.5 substantially escapes NAb responses but not T cell responses after bivalent mRNA boosting. NAb titers to XBB.1 and XBB.1.5 were similar, suggesting that the F486P mutation confers greater transmissibility but not increased immune escape. By month 3, NAb titers to XBB.1 and XBB.1.5 declined essentially to baseline levels prior to boosting, while NAb titers to other variants declined less strikingly.
IMPORTANT (Safety) – Comparative Safety of BNT162b2 and mRNA-1273 Vaccines in a Nationwide Cohort of US Veterans https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2793236
Findings In this cohort study of 433 672 US veterans during 38 weeks of follow-up, recipients of the BNT162b2 vaccine, compared with recipients of the mRNA-1273 vaccine, had an excess per 10 000 persons of 10.9 ischemic stroke events, 14.8 myocardial infarction events, 11.3 other thromboembolic events, and 17.1 kidney injury events. Small-magnitude differences between the 2 vaccines were seen within 42 days of the first dose, and few differences were seen within 14 days of the first dose.
IMPORTANT (VE 36% 2 to 5 year olds and 50% for 6 to 23 months) – Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age https://www.nejm.org/doi/full/10.1056/NEJMoa2209367?query=TOC&cid=NEJM%20eToc,%20November%203,%202022%20DM1623929_NEJM_Non_Subscriber&bid=1242467044
IMPORTANT (VE 46% 5 to 7 year olds, 16% 8 to 11 year olds, 30% against infection) – Covid-19 Vaccine Protection among Children and Adolescents in Qatar https://www.nejm.org/doi/full/10.1056/NEJMoa2210058?query=TOC&cid=NEJM%20eToc,%20November%203,%202022%20DM1623929_NEJM_Non_Subscriber&bid=1242467044
Authors found: “Among children, the overall effectiveness of the 10-μg primary vaccine series against infection with the omicron variant was 25.7% (95% confidence interval [CI], 10.0 to 38.6). Effectiveness was highest (49.6%; 95% CI, 28.5 to 64.5) right after receipt of the second dose but waned rapidly thereafter and was negligible after 3 months. Effectiveness was 46.3% (95% CI, 21.5 to 63.3) among children 5 to 7 years of age and 16.6% (95% CI, −4.2 to 33.2) among those 8 to 11 years of age.”
IMPORTANT (VE against Omicron in Japan. BA2 61% second dose & 86% third dose. BA5 37% second dose & 63% third dose) – Estimation of mRNA COVID-19 Vaccination Effectiveness in Tokyo for Omicron Variants BA.2 and BA.5 -Effect of Social Behavior https://www.medrxiv.org/content/10.1101/2022.09.15.22280010v1
IMPORTANT (Negative VE) – Effectiveness of COVID-19 vaccines against Omicron or Delta symptomatic infection and severe outcomes https://www.medrxiv.org/content/10.1101/2021.12.30.21268565v2 published https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2796615
IMPORTANT (Pfizer 52% and Moderna 36% against Omicron – turning negative) – Vaccine effectiveness against SARS-CoV-2 infection with the Omicron or Delta variants following a two-dose or booster BNT162b2 or mRNA-1273 vaccination series: A Danish cohort study https://www.medrxiv.org/content/10.1101/2021.12.20.21267966v3
IMPORTANT (Showing possible ADE after 12 months – Protection drops below 0 for hospitalisation and death) – Effectiveness of COVID-19 Vaccines Over 13 Months Covering the Period of the Emergence of the Omicron Variant in the Swedish Population https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4224504
IMPORTANT (VE of Moderna against Delta and Omicron) – Effectiveness of mRNA-1273 against SARS-CoV-2 omicron and delta variants https://www.medrxiv.org/content/10.1101/2022.01.07.22268919v3
Protection against omicron infection wanes within 3 months after dose 2, suggesting that a shorter interval between second and booster doses may be beneficial. Lack of protection against omicron infection in the immunocompromised population underscores the importance of monitoring the effectiveness of the recommended fourth dose (booster) for this population. Continued monitoring of VE against omicron infection and hospitalization in immunocompetent and immunocompromised individuals and surveillance for the emergence of newer SARS-CoV-2 variants are warranted to inform future vaccination strategies.
IMPORTANT (Bivalent booster) – Bivalent booster effectiveness against severe COVID-19 outcomes in Finland, September 2022 — January 2023 https://www.medrxiv.org/content/10.1101/2023.03.02.23286561v1
Authors found:
Among elderly aged 65–120 years, bivalent vaccination reduced the risk of hospitalisation and death due to COVID-19. Among the elderly the hazard ratios comparing exposed and unexposed ranged from 0.36 to 0.43 during the first 14–30 days since bivalent vaccination but signs of waning were observed as soon as two months after vaccination. Among the chronically ill aged 18–64 years bivalent vaccination did not reduce the risk of severe COVID-19 outcomes. These results are crucial for further developing COVID-19 vaccination programme worldwide.
VERY IMPORTANT (PASC reinfection) – Acute and postacute sequelae associated with SARS-CoV-2 reinfection https://www.nature.com/articles/s41591-022-02051-3
IMPORTANT – Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar https://www.medrxiv.org/content/10.1101/2022.03.13.22272308v1
IMPORTANT – Higher risk of SARS-CoV-2 Omicron BA.4/5 infection than of BA.2 infection after previous BA.1 infection, the Netherlands, 2 May to 24 July 2022 https://www.medrxiv.org/content/10.1101/2022.09.21.22280189v1
IMPORTANT – Healthcare system overstretch and in-hospital mortality of intubated COVID-19 patients in Greece: an updated analysis, September 2020 to April 2022 https://www.medrxiv.org/content/10.1101/2022.09.25.22280326v1
IMPORTANT (VE from natural to vaccinal comparison) – Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Naturally Acquired Immunity versus Vaccine-induced Immunity, Reinfections versus Breakthrough Infections: A Retrospective Cohort Study https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9047157/
IMPORTANT – Published June 09 2022 – Protection and Waning of Natural and Hybrid Immunity to SARS-CoV-2 https://www.nejm.org/doi/full/10.1056/NEJMoa2118946
IMPORTANT – Use of whole genome sequencing to estimate the contribution of immune evasion and waning immunity to decreasing COVID-19 vaccine effectiveness during alpha and delta variant waves https://www.medrxiv.org/content/10.1101/2022.08.25.22278443v1
Breakthrough infection research:-
IMPORTANT ARTICLE (Breakthroughs in 2021 – U.S. officials knew of more than 5 million COVID-19 cases in the vaccinated) – EXCLUSIVE: Millions of Breakthrough COVID-19 Cases in 2021, Files Show https://www.theepochtimes.com/health/exclusive-millions-of-breakthrough-covid-19-cases-in-2021-files-show-5523013
One million vaccinated people tested positive for COVID-19 by September 2021, and another four million tested positive by the end of the year, according to the internal files.
While so-called breakthrough cases are already a known phenomenon—starting within days of the first shots being rolled out—the files, obtained from the U.S. Centers for Disease Control and Prevention (CDC), show the amount of vaccine failure was much higher than previously known.
The new files show that many of the breakthrough cases happened among the “fully vaccinated,” or people who tested positive at least 14 days after completing a primary series. Approximately 4.5 million cases came among that population, including more than half a million in September 2021 alone.
The CDC quietly posted the data online in October 2022. The CDC says data come from 32 jurisdictions, including Arkansas, California, and New York City. Another 883,222 cases were identified among the “partially vaccinated,” or people who received at least one shot but did not meet the definition of fully vaccinated.The cases among the partially vaccinated were never posted online.
IMPORTANT (Breakthrough infection in individuals) – Vaccine Breakthrough Infections with SARS-CoV-2 Variants https://www.nejm.org/doi/full/10.1056/NEJMoa2105000
In a cohort of 417 persons who had received the second dose of BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) vaccine at least 2 weeks previously, we identified 2 women with vaccine breakthrough infection. Despite evidence of vaccine efficacy in both women, symptoms of coronavirus disease 2019 developed, and they tested positive for SARS-CoV-2 by polymerase-chain-reaction testing. Viral sequencing revealed variants of likely clinical importance, including E484K in 1 woman and three mutations (T95I, del142–144, and D614G) in both. These observations indicate a potential risk of illness after successful vaccination and subsequent infection with variant virus, and they provide support for continued efforts to prevent and diagnose infection and to characterize variants in vaccinated persons.
IMPORTANT (India healthcare breakthrough infections) – Breakthrough COVID19 infections after vaccinations in healthcare and other workers in a chronic care medical facility in New Delhi, India https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091733/
Out of 123 employees, 113 were vaccinated (Covaxin, 28, Covishield, 85). Second dose was completed in 107 (94.7%) and first dose in 6 persons (5.3%). Symptomatic COVD19 infections occurred in 19 persons (16.9%) post any dose of vaccine. Symptomatic breakthrough infections > 14 days after second dose occurred in 15 persons (13.3%). Except one (required hospitalization), all 14 had mild COVID19 disease.
IMPORTANT (Breakthroughs low to high) – COVID-19 vaccine breakthrough infections https://www.science.org/doi/10.1126/science.abl8487
In the early months after vaccinations at scale began, around January 2021, post-vaccination infections (or breakthrough infections) were rare, accounting for <1% of COVID-19 cases, and only ∼0.1% resulted in hospitalization or death in high-income countries (1, 2). However, by 5 to 6 months after vaccinations began, this pattern changed. Even before vaccine introduction, it was anticipated that a third, booster dose would be necessary to preserve efficacy, but when that would be needed was uncertain.
Worldwide Bayesian Causal Impact Analysis of Vaccine Administration on Deaths and Cases Associated with COVID-19: A BigData Analysis of 145 Countries https://vector-news.github.io/editorials/CausalAnalysisReport_html.html
Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8481107/
Vaccine effectiveness against SARS-CoV-2 infection with the Omicron or Delta variants
following a two-dose or booster BNT162b2 or mRNA-1273 vaccination series: A Danish cohort
study https://www.medrxiv.org/content/10.1101/2021.12.20.21267966v3.full.pdf
Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00648-4/fulltext
Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, Vietnam https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3897733
IMPORTANT – Infection-enhancing anti-SARS-CoV-2 antibodies recognize both the original Wuhan/D614G strain and Delta variants. A potential risk for mass vaccination? https://www.journalofinfection.com/article/S0163-4453(21)00392-3/fulltext
Hospitalisation among vaccine breakthrough COVID-19 infections https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00558-2/fulltext
Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1.full
Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795
Antibody-dependent SARS coronavirus infection is mediated by antibodies against spike proteins https://pubmed.ncbi.nlm.nih.gov/25073113/
Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance — VISION Network, 10 States, August 2021–January 2022 https://www.cdc.gov/mmwr/volumes/71/wr/mm7107e2.htm?s_cid=mm7107e2_w
Waning immune responses against SARS-CoV-2 variants of concern among vaccinees in Hong Kong https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(22)00088-3/fulltext
Variation in the COVID-19 infection–fatality ratio by age, time, and geography during the pre-vaccine era: a systematic analysis https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02867-1/fulltext
A log-odds system for waning and boosting of COVID-19 vaccine effectiveness https://www.medrxiv.org/content/10.1101/2022.03.16.22272519v1
Effect of vaccination rates on the prevalence and mortality of COVID-19 https://www.medrxiv.org/content/10.1101/2022.03.31.22273274v1
Protection by a Fourth Dose of BNT162b2 against Omicron in Israel https://www.nejm.org/doi/full/10.1056/NEJMoa2201570
The Kinetics of COVID-19 Vaccine Response in a Community-Vaccinated Population https://www.jimmunol.org/content/208/4/819?cct=2512
EARLY OUTPATIENT TREATMENT OF COVID-19: A RETROSPECTIVE ANALYSIS OF 392 CASES IN ITALY https://www.medrxiv.org/content/10.1101/2022.04.04.22273356v1
Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19 https://ijvtpr.com/index.php/IJVTPR/article/view/23
Vaccine-Induced Covid-19 Mimicry Syndrome https://elifesciences.org/download/aHR0cHM6Ly9jZG4uZWxpZmVzY2llbmNlcy5vcmcvYXJ0aWNsZXMvNzQ5NzQvZWxpZmUtNzQ5NzQtdjEucGRmP2Nhbm9uaWNhbFVyaT1odHRwczovL2VsaWZlc2NpZW5jZXMub3JnL2FydGljbGVzLzc0OTc0/elife-74974-v1.pdf?_hash=M3tV3CBURMPDusQ7NrIaPAEaUUWS4VA%2B3MLUB9khIOw%3D
On COVID vaccines: why they cannot work, and irrefutable evidence of their causative role in deaths after vaccination https://doctors4covidethics.org/wp-content/uploads/2021/12/end-covax.pdf
Reduced neutralisation of SARS-COV-2 Omicron-B.1.1.529 variant by post-immunisation serum https://www.medrxiv.org/content/10.1101/2021.12.10.21267534v1
Waning Immunity after the BNT162b2 Vaccine in Israel https://www.nejm.org/doi/full/10.1056/NEJMoa2114228?query=featured_coronavirus
4th Dose COVID mRNA Vaccines’ Immunogenicity & Efficacy Against Omicron VOC https://www.medrxiv.org/content/10.1101/2022.02.15.22270948v1
Waning Immune Humoral Response to BNT162b2 Covid-19 Vaccine over 6 Months https://www.nejm.org/doi/full/10.1056/NEJMoa2114583
Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity:
reinfections versus breakthrough infections https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1.full.pdf
1) Gazit et al. out of Israel showed that “SARS-CoV-2-naïve vaccinees had a 13-fold (95% CI, 8-21) increased risk for breakthrough infection with the Delta variant compared to those previously infected.” When adjusting for the time of disease/vaccine, there was a 27-fold increased risk (95% CI, 13-57).
2) Ignoring the risk of infection, given that someone was infected, Acharya et al. found “no significant difference in cycle threshold values between vaccinated and unvaccinated, asymptomatic and symptomatic groups infected with SARS-CoV-2 Delta.”
3) Riemersma et al. found “no difference in viral loads when comparing unvaccinated individuals to those who have vaccine “breakthrough” infections. Furthermore, individuals with vaccine breakthrough infections frequently test positive with viral loads consistent with the ability to shed infectious viruses.” Results indicate that “if vaccinated individuals become infected with the delta variant, they may be sources of SARS-CoV-2 transmission to others.” They reported “low Ct values (<25) in 212 of 310 fully vaccinated (68%) and 246 of 389 (63%) unvaccinated individuals. Testing a subset of these low-Ct samples revealed infectious SARS-CoV-2 in 15 of 17 specimens (88%) from unvaccinated individuals and 37 of 39 (95%) from vaccinated people.”
4) In a study from Qatar, Chemaitelly et al. reported vaccine efficacy (Pfizer) against severe and fatal disease, with efficacy in the 85-95% range at least until 24 weeks after the second dose. As a contrast, the efficacy against infection waned down to around 30% at 15-19 weeks after the second dose.
5) From Wisconsin, Riemersma et al. reported that vaccinated individuals who get infected with the Delta variant can transmit SARS-CoV-2 to others. They found an elevated viral load in the unvaccinated and vaccinated symptomatic persons (68% and 69% respectively, 158/232 and 156/225). Moreover, in the asymptomatic persons, they uncovered elevated viral loads (29% and 82% respectively) in the unvaccinated and the vaccinated respectively. This suggests that the vaccinated can be infected, harbor, cultivate, and transmit the virus readily and unknowingly.
6) Subramanian reported that “at the country-level, there appears to be no discernable relationship between percentage of population fully vaccinated and new COVID-19 cases.” When comparing 2947 counties in the United States, there were slightly less cases in more vaccinated locations. In other words, there is no clear discernable relationship .
7) Chau et al. looked at transmission of SARS-CoV-2 Delta variant among vaccinated healthcare workers in Vietnams. Of 69 healthcare workers that tested positive for SARS-CoV-2, 62 participated in the clinical study, all of whom recovered. For 23 of them, complete-genome sequences were obtained, and all belonged to the Delta variant. “Viral loads of breakthrough Delta variant infection cases were 251 times higher than those of cases infected with old strains detected between March-April 2020”.
8) In Barnstable, Massachusetts, Brown et al found that among 469 cases of COVID-19, 74% were fully vaccinated, and that “the vaccinated had on average more virus in their nose than the unvaccinated who were infected.”
9) Reporting on a nosocomial hospital outbreak in Finland, Hetemäli et al. observed that “both symptomatic and asymptomatic infections were found among vaccinated health care workers, and secondary transmission occurred from those with symptomatic infections despite use of personal protective equipment.”
10) In a hospital outbreak investigation in Israel, Shitrit et al. observed “high transmissibility of the SARS-CoV-2 Delta variant among twice vaccinated and masked individuals.” They added that “this suggests some waning of immunity, albeit still providing protection for individuals without comorbidities.”
11) In the UK COVID-19 vaccine Surveillance Report for week #42, it was noted that there is “waning of the N antibody response over time” and “that N antibody levels appear to be lower in individuals who acquire infection following 2 doses of vaccination.” The same report (Table 2, page 13), shows the in the older age groups above 30, the double vaccinated persons have greater infection risk than the unvaccinated, presumably because the latter group include more people with stronger natural immunity from prior Covid disease. As a contrast, the vaccinated people had a lower risk of death than the unvaccinated, across all age groups, indicating that vaccines provide more protection against death than against infection. See also UK PHE reports 43, 44, 45, 46 for similar data.
12) In Israel, Levin et al. “conducted a 6-month longitudinal prospective study involving vaccinated health care workers who were tested monthly for the presence of anti-spike IgG and neutralizing antibodies”. They found that “six months after receipt of the second dose of the BNT162b2 vaccine, humoral response was substantially decreased, especially among men, among persons 65 years of age or older, and among persons with immunosuppression.”
13) In a study from New York State, Rosenberg et al. reported that “During May 3–July 25, 2021, the overall age-adjusted vaccine effectiveness against hospitalization in New York was relatively stable 89.5%–95.1%). The overall age-adjusted vaccine effectiveness against infection for all New York adults declined from 91.8% to 75.0%.”
14) Suthar et al. noted that “Our data demonstrate a substantial waning of antibody responses and T cell immunity to SARS-CoV-2 and its variants, at 6 months following the second immunization with the BNT162b2 vaccine.”
15) In a study from Umeå University in Sweden, Nordström et al. observed that “vaccine effectiveness of BNT162b2 against infection waned progressively from 92% (95% CI, 92-93, P<0·001) at day 15-30 to 47% (95% CI, 39-55, P<0·001) at day 121-180, and from day 211 and onwards no effectiveness could be detected (23%; 95% CI, -2-41, P=0·07).”
16) Yahi et al. have reported that “in the case of the Delta variant, neutralizing antibodies have a decreased affinity for the spike protein, whereas facilitating antibodies display a strikingly increased affinity. Thus, antibody dependent enhancement may be a concern for people receiving vaccines based on the original Wuhan strain spike sequence.”
17) Goldberg et al. (BNT162b2 Vaccine in Israel) reported that “immunity against the delta variant of SARS-CoV-2 waned in all age groups a few months after receipt of the second dose of vaccine.”
18) Singanayagam et al. examined the transmission and viral load kinetics in vaccinated and unvaccinated individuals with mild delta variant infection in the community. They found that (in 602 community contacts (identified via the UK contract-tracing system) of 471 UK COVID-19 index cases were recruited to the Assessment of Transmission and Contagiousness of COVID-19 in Contacts cohort study and contributed 8145 upper respiratory tract samples from daily sampling for up to 20 days) “vaccination reduces the risk of delta variant infection and accelerates viral clearance. Nonetheless, fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts.”
19) Keehner et al. in NEJM, has recently reported on the resurgence of SARS-CoV-2 infection in a highly vaccinated health system workforce. Vaccination with mRNA vaccines began in mid-December 2020; by March, 76% of the workforce had been fully vaccinated, and by July, the percentage had risen to 87%. Infections had decreased dramatically by early February 2021…”coincident with the end of California’s mask mandate on June 15 and the rapid dominance of the B.1.617.2 (delta) variant that first emerged in mid-April and accounted for over 95% of UCSDH isolates by the end of July, infections increased rapidly, including cases among fully vaccinated persons…researchers reported that the “dramatic change in vaccine effectiveness from June to July is likely to be due to both the emergence of the delta variant and waning immunity over time.”
20) Juthani et al. sought to describe the impact of vaccination on admission to hospital in patients with confirmed SARS-CoV-2 infection using real-world data collected by the Yale New Haven Health System. “Patients were considered fully vaccinated if the final dose (either second dose of BNT162b2 or mRNA-1273, or first dose of Ad.26.COV2.S) was administered at least 14 days before symptom onset or a positive PCR test for SARS-CoV-2. In total, we identified 969 patients who were admitted to a Yale New Haven Health System hospital with a confirmed positive PCR test for SARS-CoV-2”…Researchers reported “a higher number of patients with severe or critical illness in those who received the BNT162b2 vaccine than in those who received mRNA-1273 or Ad.26.COV2.S…”
21) A very recent study published by the CDC reported that a majority (53%) of patients who were hospitalized with Covid-19-like illnesses were already fully vaccinated with two-dose RNA shots. Table 1 reveals that among the 20,101 immunocompromised adults hospitalized with Covid-19, 10,564 (53%) were fully-vaccinated with the Pfizer or Moderna vaccine (Vaccination was defined as having received exactly 2 doses of an mRNA-based COVID-19 vaccine ≥14 days before the hospitalization index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before the hospitalization or the hospitalization date if testing only occurred after the admission). This highlights the ongoing challenges faced with Delta breakthrough when vaccinated.
22) Eyre, 2021 looked at The impact of SARS-CoV-2 vaccination on Alpha & Delta variant transmission. They reported that “while vaccination still lowers the risk of infection, similar viral loads in vaccinated and unvaccinated individuals infected with Delta question how much vaccination prevents onward transmission… transmission reductions declined over time since second vaccination, for Delta reaching similar levels to unvaccinated individuals by 12 weeks for ChAdOx1 and attenuating substantially for BNT162b2. Protection from vaccination in contacts also declined in the 3 months after second vaccination…vaccination reduces transmission of Delta, but by less than the Alpha variant.”
23) Levine-Tiefenbrun, 2021 looked at Viral loads of Delta-variant SARS-CoV-2 breakthrough infections after vaccination and booster with BNT162b2, and reported the viral load reduction effectiveness declines with time after vaccination, “significantly decreasing at 3 months after vaccination and effectively vanishing after about 6 months.”
24) Puranik, 2021 looked at a Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence, reporting “In July, vaccine effectiveness against hospitalization has remained high (mRNA-1273: 81%, 95% CI: 33–96.3%; BNT162b2: 75%, 95% CI: 24–93.9%), but effectiveness against infection was lower for both vaccines (mRNA-1273: 76%, 95% CI: 58–87%; BNT162b2: 42%, 95% CI: 13–62%), with a more pronounced reduction for BNT162b2.”
25) Saade, 2021 looked at Live virus neutralization testing in convalescent patients and subjects vaccinated against 19A, 20B, 20I/501Y.V1 and 20H/501Y.V2 isolates of SARS-CoV-2, and reported as “Assessed the neutralizing capacity of antibodies to prevent cell infection, using a live virus neutralization test with different strains [19A (initial one), 20B (B.1.1.241 lineage), 20I/501Y.V1 (B.1.1.7 lineage), and 20H/501Y.V2 (B.1.351 lineage)] in serum samples collected from different populations: two-dose vaccinated COVID-19-naive healthcare workers (HCWs; Pfizer-BioNTech BNT161b2), 6-months post mild COVID-19 HCWs, and critical COVID-19 patients… finding of the present study is the reduced neutralizing response observed towards the 20H/501Y.V2 variant in fully immunized subjects with the BNT162b2 vaccine by comparison to the wild type and 20I/501Y.V1 variant.”
26) Canaday, 2021 looked at Significant reduction in humoral immunity among healthcare workers and nursing home residents 6 months after COVID-19 BNT162b2 mRNA vaccination, reporting “Anti-spike, anti-RBD and neutralization levels dropped more than 84% over 6 months’ time in all groups irrespective of prior SARS-CoV-2 infection. At 6 months post-vaccine, 70% of the infection-naive NH residents had neutralization titers at or below the lower limit of detection compared to 16% at 2 weeks after full vaccination. These data demonstrate a significant reduction in levels of antibody in all groups. In particular, those infection-naive NH residents had lower initial post-vaccination humoral immunity immediately and exhibited the greatest declines 6 months later.”
27) Israel, 2021 looked at Large-scale study of antibody titer decay following BNT162b2 mRNA vaccine or SARS-CoV-2 infection, and reported as “To determine the kinetics of SARS-CoV-2 IgG antibodies following administration of two doses of BNT162b2 vaccine, or SARS-CoV-2 infection in unvaccinated individuals…In vaccinated subjects, antibody titers decreased by up to 40% each subsequent month while in convalescents they decreased by less than 5% per month. Six months after BNT162b2 vaccination 16.1% subjects had antibody levels below the sero-positivity threshold of <50 AU/mL, while only 10.8% of convalescent patients were below <50 AU/mL threshold after 9 months from SARS-CoV-2 infection.”
28) Eyran, 2020 examined The longitudinal kinetics of antibodies in COVID-19 recovered patients over 14 months, and found “a significantly faster decay in naïve vaccinees compared to recovered patients suggesting that the serological memory following natural infection is more robust compared to vaccination. Our data highlights the differences between serological memory induced by natural infection vs. vaccination.”
29) Salvatore et al. examined the transmission potential of vaccinated and unvaccinated persons infected with the SARS-CoV-2 Delta variant in a federal prison, July-August 2021. They found a total of 978 specimens were provided by 95 participants, “of whom 78 (82%) were fully vaccinated and 17 (18%) were not fully vaccinated….clinicians and public health practitioners should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons.”
30) Andeweg et al. analyzed 28,578 sequenced SARS-CoV-2 samples from individuals with known immune status obtained through national community testing in the Netherlands from March to August 2021. They found evidence for an “increased risk of infection by the Beta (B.1.351), Gamma (P.1), or Delta (B.1.617.2) variants compared to the Alpha (B.1.1.7) variant after vaccination. No clear differences were found between vaccines. However, the effect was larger in the first 14-59 days after complete vaccination compared to 60 days and longer. In contrast to vaccine-induced immunity, no increased risk for reinfection with Beta, Gamma or Delta variants relative to Alpha variant was found in individuals with infection-induced immunity.”
31) Di Fusco et al. conducted an evaluation of COVID-19 vaccine breakthrough infections among immunocompromised patients fully vaccinated with BNT162b2. “COVID-19 vaccine breakthrough infections were examined in fully vaccinated (≥14 days after 2nd dose) IC individuals (IC cohort), 12 mutually exclusive IC condition groups, and a non-IC cohort.” They found that“of 1,277,747 individuals ≥16 years of age who received 2 BNT162b2 doses, 225,796 (17.7%) were identified as IC (median age: 58 years; 56.3% female). The most prevalent IC conditions were solid malignancy (32.0%), kidney disease (19.5%), and rheumatologic/inflammatory conditions (16.7%). Among the fully vaccinated IC and non-IC cohorts, a total of 978 breakthrough infections were observed during the study period; 124 (12.7%) resulted in hospitalization and 2 (0.2%) were inpatient deaths. IC individuals accounted for 38.2% (N = 374) of all breakthrough infections, 59.7% (N = 74) of all hospitalizations, and 100% (N = 2) of inpatient deaths. The proportion with breakthrough infections was 3 times higher in the IC cohort compared to the non-IC cohort (N = 374 [0.18%] vs. N = 604 [0.06%]; unadjusted incidence rates were 0.89 and 0.34 per 100 person-years, respectively.”
32) Mallapaty (NATURE) reported that the protective effect of being vaccinated if you already had infection is “relatively small, and dwindles alarmingly at three months after the receipt of the second shot.” Mallapaty further adds what we have been warning the public health community which is that persons infected with Delta have about the same levels of viral genetic materials in their noses “regardless of whether they’d previously been vaccinated, suggesting that vaccinated and unvaccinated people might be equally infectious.” Mallapaty reported on testing data from 139,164 close contacts of 95,716 people infected with SARS-CoV-2 between January and August 2021 in the United Kingdom, and at a time when the Alpha and Delta variants were competing for dominance. The finding was that “although the vaccines did offer some protection against infection and onward transmission, Delta dampened that effect. A person who was fully vaccinated and then had a ‘breakthrough’ Delta infection was almost twice as likely to pass on the virus as someone who was infected with Alpha. And that was on top of the higher risk of having a breakthrough infection caused by Delta than one caused by Alpha.”
33) Chia et al. reported that PCR cycle threshold (Ct) values were “similar between both vaccinated and unvaccinated groups at diagnosis, but viral loads decreased faster in vaccinated individuals. Early, robust boosting of anti-spike protein antibodies was observed in vaccinated patients, however, these titers were significantly lower against B.1.617.2 as compared with the wildtype vaccine strain.”
34) Wilhelm et al. reported on reduced neutralization of SARS-CoV-2 omicron variant by vaccine sera and monoclonal antibodies. “in vitro findings using authentic SARS-CoV-2 variants indicate that in contrast to the currently circulating Delta variant, the neutralization efficacy of vaccine-elicited sera against Omicron was severely reduced highlighting T-cell mediated immunity as essential barrier to prevent severe COVID-19.”
35) CDC reported on the details for 43 cases of COVID-19 attributed to the Omicron variant. They found that “34 (79%) occurred in persons who completed the primary series of an FDA-authorized or approved COVID-19 vaccine ≥14 days before symptom onset or receipt of a positive SARS-CoV-2 test result.”
36) Dejnirattisai et al. presented live neutralisation titres against SARS-CoV-2 Omicron variant, and examined it relative to neutralisation against the Victoria, Beta and Delta variants. They reported a significant drop in “neutralisation titres in recipients of both AZD1222 and BNT16b2 primary courses, with evidence of some recipients failing to neutralise at all.”
37) Cele et al. assessed whether Omicron variant escapes antibody neutralization “elicited by the Pfizer BNT162b2 mRNA vaccine in people who were vaccinated only or vaccinated and previously infected.” They reported that Omicron variant “still required the ACE2 receptor to infect but had extensive escape of Pfizer elicited neutralization.”
38) Holm Hansen et al.’s Denmark study looked at vaccine effectiveness against SARS-CoV-2 infection with the Omicron or Delta variants following a two-dose or booster BNT162b2 or mRNA-1273 vaccination series. A key finding was reported as “VE against Omicron was 55.2% initially following primary BNT162b2 vaccination, but waned quickly thereafter. Although estimated with less precision, VE against Omicron after primary mRNA-1273 vaccination similarly indicated a rapid decline in protection. By comparison, both vaccines showed higher, longer-lasting protection against Delta.” In other words, the vaccine that has failed against Delta is even far worse for Omicron. The table and figure below paint a devastating picture. See where the green dot is (Omicron variant) in the vertical lines (blue is Delta) and the 2 edges of the bars (upper and lower lips) 91 days out for Omicron (3 months). Both Pfizer and Moderna show negative efficacy for Omicron at 31 days (both are below the ‘line of no effect’ or ‘0’). The comparative table is even more devastating for it shows how much less vaccine effectiveness there is for Omicron. For example, at 1-30 days, Pfizer showed 55.2% effectiveness for Omicron versus 86.7% for Delta, and for the same period, Moderna showed 36.7% effectiveness for Omicron versus 88.2% for Delta.
39) UK reporting showed that boosters protect against symptomatic COVID-19 caused by Omicron for about 10 weeks; the UK Health Security Agency reported protection against symptomatic COVID-19 caused by the variant dropped from 70% to 45% following a Pfizer booster for those initially vaccinated with the shot developed by Pfizer with BioNTech. Specifically reporting by the UK Health Security Agency showed “Among those who received an AstraZeneca primary course, vaccine effectiveness was around 60% 2 to 4 weeks after either a Pfizer or Moderna booster, then dropped to 35% with a Pfizer booster and 45% with a Moderna booster by 10 weeks after the booster. Among those who received a Pfizer primary course, vaccine effectiveness was around 70% after a Pfizer booster, dropping to 45% after 10-plus weeks and stayed around 70 to 75% after a Moderna booster up to 9 weeks after booster.”
40) Buchan et al. used a test-negative design to assess vaccine effectiveness against OMICRON or DELTA variants (regardless of symptoms or severity) during November 22 and December 19, 2021. They included persons who had received at least 2 COVID-19 vaccine doses (with at least 1 mRNA vaccine dose for the primary series) and applied multivariable logistic regression modelling analysis to “estimate the effectiveness of two or three doses by time since the latest dose.” They included 3,442 Omicron-positive cases, 9,201 Delta-positive cases, and 471,545 test-negative controls. Following 2 doses, “vaccine effectiveness against Delta infection declined steadily over time but recovered to 93% (95%CI, 92-94%) ≥7 days after receiving an mRNA vaccine for the third dose. In contrast, receipt of 2 doses of COVID-19 vaccines was not protective against Omicron. Vaccine effectiveness against Omicron was 37% (95%CI, 19-50%) ≥7 days after receiving an mRNA vaccine for the third dose.”
41) Public Health Scotland COVID-19 & Winter Statistical Report ( Publication date: 19 January 2022) provided startling data on page 38 (case rates), page 44 (hospitalization), and page 50 (deaths), showing that the vaccination has failed Delta but critically, is failing omicron. The 2nd inoculation data is of particular concern. Table 14 age-standardized case data is very troubling for it shows across the multiple weeks of study that across each dose (1 vs 2 vs 3 booster inoculations) that the vaccinated are greatly more infected than the unvaccinated, with the 2nd dose being alarmingly elevated (see grey rows). Age-standardized rates of acute hospital admissions are stunningly elevated after 2nd inoculation (over the unvaccinated) during January 2022. Looking at table 16 that reports on the number of confirmed COVID-19 related deaths by vaccination status, we again observe massive elevation in death at the 2ndinoculation. This data indicates to us that the vaccine is associated with infection and is not optimally working against omicron and that the protection is limited, waning rapidly.
42) The UK’s COVID-19 vaccine surveillance report Week 3, 20 January 2022, raises very serious concern as to the failure of the vaccines on Delta (which is basically now being replaced by omicron for dominance) and omicron. When we look at table 9, page 34 (COVID-19 cases by vaccination status between week 51 2021 and week 2 2022), we see greater case numbers for the 2nd and 3rd inoculations. The important table on page 38, Figure 12 (unadjusted rates of COVID-19 infection, hospitalization and death in vaccinated and unvaccinated populations) shows us a continual pattern in the UK data over the last 2 to 3 to 4 months, with the present reporting showing that persons in receipt of the 3rd inoculation (booster) at far greater risk of infection/cases than the unvaccinated (30 years of age and above age strata).
43) In the recent UK Public Health surveillance reports Week 9, Week 8, as well as week 7 (UK COVID-19 vaccine surveillance report Week 7 17 February 2022), week 6 (COVID-19 vaccine surveillance report Week 6 10 February 2022) and week 5 for 2022 (COVID-19 vaccine surveillance report Week 5 3 February 2022) as well as the reports accumulated for 2021 since vaccine roll-out, we see that the vaccinated are at higher risk of infection and especially for age groups above 18 years old, as well as hospitalization and even death. This is particularly marked for those in receipt of double vaccinations. There is increased risk of death for those who are triple vaccinated and especially as age increases. The same pattern emerges in the Scottish data.
44.) Regev-Yochay et al. in Israel looked at (publication date March 16th 2022) the immunogenicity and safety of a fourth dose (4th) of either BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) administered 4 months after the third dose in a series of three BNT162b2 doses). This was an open-label, nonrandomized clinical study assessing the 4th dose in terms of need beyond the 3rd dose. Among the ‘1050 eligible health care workers enrolled in the Sheba HCW COVID-19 Cohort, 154 received the fourth dose of BNT162b2 and, 1 week later, 120 received mRNA-1273. For each participant, two age-matched controls were selected from the remaining eligible participants’.
Researchers further reported that ‘overall, 25.0% of the participants in the control group were infected with the omicron variant, as compared with 18.3% of the participants in the BNT162b2 group and 20.7% of those in the mRNA-1273 group. Vaccine efficacy against any SARS-CoV-2 infection was 30% (95% confidence interval [CI], −9 to 55) for BNT162b2 and 11% (95% CI, −43 to 44) for mRNA-1273…most of the infected participants were potentially infectious, with relatively high viral loads (nucleocapsid gene cycle threshold, ≤25)’. Results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses. More specifically, researchers ‘observed low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious. Thus, a fourth vaccination of healthy young health care workers may have only marginal benefits’.
These finding are not unknown to public health authorities. In fact, CDC Director Rochelle Walensky have said that the Covid vaccines are working “exceptionally well” against severe illness and death, but “what they can’t do anymore is prevent transmission.”
What these studies show, are that vaccines are important to reduce severe disease and death, but unable to prevent the disease from spreading and eventually infect most of us. That is, while the vaccines provide individual benefits to the vaccinee, and especially to older high-risk people, the public benefit of universal vaccination is in grave doubt. As such, Covid vaccines should not be expected to contribute to eliminating the communal spread of the virus or the reaching of herd immunity. This unravels the rationale for vaccine mandates and passports.