Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance

Authors: Katherine E. Fleming-Dutra, MD1Amadea Britton, MD1,2Nong Shang, PhD1et al May 13, 2022 JAMA. Published online May 13, 2022. doi:10.1001/jama.2022.7493

Key Points

Question  Does the estimated effectiveness of 2 doses of the BNT162b2 COVID-19 vaccine against symptomatic SARS-CoV-2 Omicron variant infection (based on the odds ratio for the association of prior vaccination and infection) wane rapidly among children and adolescents, as has been observed for adults?

Findings  In a test-negative, case-control study conducted from December 2021 to February 2022 during Omicron variant predominance that included 121 952 tests from sites across the US, estimated vaccine effectiveness against symptomatic infection for children 5 to 11 years of age was 60.1% 2 to 4 weeks after dose 2 and 28.9% during month 2 after dose 2. Among adolescents 12 to 15 years of age, estimated vaccine effectiveness was 59.5% 2 to 4 weeks after dose 2 and 16.6% during month 2; estimated booster dose effectiveness in adolescents 2 to 6.5 weeks after the booster was 71.1%.

Meaning  Among children and adolescents, estimated vaccine effectiveness for 2 doses of BNT162b2 against symptomatic infection decreased rapidly, and among adolescents increased after a booster dose.Abstract

Importance  Efficacy of 2 doses of the BNT162b2 COVID-19 vaccine (Pfizer-BioNTech) against COVID-19 was high in pediatric trials conducted before the SARS-CoV-2 Omicron variant emerged. Among adults, estimated vaccine effectiveness (VE) of 2 BNT162b2 doses against symptomatic Omicron infection was reduced compared with prior variants, waned rapidly, and increased with a booster.

Objective  To evaluate the association of symptomatic infection with prior vaccination with BNT162b2 to estimate VE among children and adolescents during Omicron variant predominance.

Design, Setting, and Participants  A test-negative, case-control analysis was conducted using data from 6897 pharmacy-based, drive-through SARS-CoV-2 testing sites across the US from a single pharmacy chain in the Increasing Community Access to Testing platform. This analysis included 74 208 tests from children 5 to 11 years of age and 47 744 tests from adolescents 12 to 15 years of age with COVID-19–like illness who underwent SARS-CoV-2 nucleic acid amplification testing from December 26, 2021, to February 21, 2022.

Exposures  Two BNT162b2 doses 2 weeks or more before SARS-CoV-2 testing vs no vaccination for children; 2 or 3 doses 2 weeks or more before testing vs no vaccination for adolescents (who are recommended to receive a booster dose).

Main Outcomes and Measures  Symptomatic infection. The adjusted odds ratio (OR) for the association of prior vaccination and symptomatic SARS-CoV-2 infection was used to estimate VE: VE = (1 − OR) × 100%.

Results  A total of 30 999 test-positive cases and 43 209 test-negative controls were included from children 5 to 11 years of age, as well as 22 273 test-positive cases and 25 471 test-negative controls from adolescents 12 to 15 years of age. The median age among those with included tests was 10 years (IQR, 7-13); 61 189 (50.2%) were female, 75 758 (70.1%) were White, and 29 034 (25.7%) were Hispanic/Latino. At 2 to 4 weeks after dose 2, among children, the adjusted OR was 0.40 (95% CI, 0.35-0.45; estimated VE, 60.1% [95% CI, 54.7%-64.8%]) and among adolescents, the OR was 0.40 (95% CI, 0.29-0.56; estimated VE, 59.5% [95% CI, 44.3%-70.6%]). During month 2 after dose 2, among children, the OR was 0.71 (95% CI, 0.67-0.76; estimated VE, 28.9% [95% CI, 24.5%-33.1%]) and among adolescents, the OR was 0.83 (95% CI, 0.76-0.92; estimated VE, 16.6% [95% CI, 8.1%-24.3%]). Among adolescents, the booster dose OR 2 to 6.5 weeks after the dose was 0.29 (95% CI, 0.24-0.35; estimated VE, 71.1% [95% CI, 65.5%-75.7%]).

Conclusions and Relevance  Among children and adolescents, estimated VE for 2 doses of BNT162b2 against symptomatic infection was modest and decreased rapidly. Among adolescents, the estimated effectiveness increased after a booster dose.Introduction

In December 2021 and January 2022, the spread of the SARS-CoV-2 Omicron variant led to the highest rates of COVID-19 cases among children 5 to 15 years old1 and the highest rate of pediatric hospitalizations (age ≤17 years) with COVID-19 to this point in the pandemic.2,3 Randomized trials of the BNT162b2 mRNA COVID-19 vaccine (Pfizer-BioNTech), the only COVID-19 vaccine authorized for use in children and adolescents 5 to 15 years of age, were conducted before the emergence of the Omicron variant and demonstrated high efficacy of 2 doses against COVID-19 (100% and 91% among those aged 12-15 and 5-11 years, respectively).4,5 The US Food and Drug Administration issued Emergency Use Authorization for BNT162b2 (2 doses of 30 μg) for those aged 12 to 15 years on May 10, 2021,6 and for those aged 5 to 11 years (2 doses of 10 μg) on October 29, 2021.7 Evidence that estimated vaccine effectiveness (VE) waned over time among adults and adolescents8 contributed to a recommendation on January 5, 2022, for a booster (30-μg dose) 5 months or more after the second dose for adolescents 12 to 15 years old.9

Observational studies in adults documented lower protection from mRNA vaccines against the Omicron variant compared with the Delta variant and rapid waning of protection.10,11 However, observational estimates of VE among children 5 to 11 years old and adolescents 12 to 15 years old during Omicron variant predominance are lacking but needed to inform COVID-19 vaccine policy and use of nonpharmaceutical interventions in these age groups. The objectives of this analysis were to use the odds ratio (OR) for the association of prior vaccination and symptomatic infection to estimate BNT162b2 VE during Omicron variant predominance of (1) 2 doses among children 5 to 11 years old and adolescents 12 to 15 years old over time since the second dose and (2) 3 doses among adolescents 12 to 15 years old.Methods

This activity was determined to be public health surveillance as defined in 45 CFR §46.102(l) (US Department of Health and Human Services [HHS], Title 45 Code of Federal Regulations, §46 Protection of Human Subjects); thus, it was not submitted for institutional review board approval and informed consent was not needed.Data Source

Data from the Increasing Community Access to Testing (ICATT) platform were used. ICATT is an HHS program that contracts with 4 commercial pharmacy chains to facilitate drive-through SARS-CoV-2 testing nationally.8,10,12,13 No-cost testing is available to anyone regardless of symptom or exposure status, and sites were selected to address COVID-19 health disparities by increasing access in racially and ethnically diverse communities and areas with moderate to high social vulnerability based on the Social Vulnerability Index (SVI).14 During the analysis period, contracted pharmacy chains used different versions of the registration questionnaire and not all captured data on booster doses. This analysis was, therefore, limited to a single chain, which collected data on booster doses and provided 82% of tests platform-wide for children and adolescents aged 5 to 15 years during the analysis period.

When registering for SARS-CoV-2 testing, individuals or parents/guardians of minors answered a questionnaire (available in English or Spanish) to self-report demographic information (including race and ethnicity selected from fixed categories, shown in the Table), COVID-19–like illness symptoms (fever, cough, shortness of breath, recent loss of sense of smell or taste, muscle pain, fatigue, chill, headache, sore throat, congestion or runny nose, vomiting, or diarrhea; reported to HHS as asymptomatic or symptomatic with ≥1 symptom), and vaccination status.10 Race and ethnicity were collected as part of the HHS COVID-19 laboratory reporting requirements.15 Self-reported COVID-19 vaccination data included number of doses received up to 4, and for each dose, vaccine product and month and year received. For doses reported in the same month or the month before test registration, the registrant was asked whether the most recent dose was administered at least 2 weeks before the test date. Reporting of vaccination status was neither mandatory nor verified. Test registrants were also asked to self-report underlying health conditions, including immunocompromising conditions (defined in the questionnaire as “immunocompromising medications, solid organ or blood stem cell transplant, HIV, or other immunocompromising conditions”), and whether they had previously tested positive for SARS-CoV-2 (within 90 days and/or >90 days before test registration); answers were not verified.

Nasal swabs were self-collected at drive-through sites and tested for SARS-CoV-2 either onsite with the ID Now (Abbott Diagnostics Scarborough Inc) rapid nucleic acid amplification test (NAAT) or at contracted laboratories using laboratory-based NAAT (TaqPath COVID-19 Combo Kit [Thermo Fischer Scientific Inc] or COVID-19 RT-PCR Test [Laboratory Corporation of America]). Deidentified questionnaire data, specimen collection date, test type, test result, and testing site location and census tract SVI14 were reported to HHS with an approximate 3-day lag.Study Design

A test-negative, case-control analysis16 was conducted to estimate BNT162b2 VE against symptomatic infection. This analysis used rapid and laboratory-based NAATs from children and adolescents aged 5 to 15 years reporting 1 or more symptoms tested at the pharmacy chain from December 26, 2021, to February 21, 2022 (data downloaded February 22, 2022). The unit of analysis was tests, because unique identifiers for individuals were not available. Cases were defined as those with positive SARS-CoV-2 NAAT results, and controls were those with negative NAAT results. Tests from children and adolescents meeting any of the following criteria were excluded: indeterminate test results, missing assay type, reported an immunocompromising condition (because COVID-19 vaccine recommendations differ for these individuals),9 unknown vaccination status, vaccine product other than BNT162b2, receipt of 1 vaccine dose or receipt of the second or third dose within 2 weeks of the test date, vaccination before the month of the recommendation by the Advisory Committee on Immunization Practices (for children 5-11 years, November 2021; for adolescents 12-15 years, May 2021 for the primary series and January 2022 for the booster dose),9,17,18 receipt of more than the authorized number of doses for nonimmunocompromised individuals (>2 for children 5-11 years, >3 for adolescents 12-15 years), receipt of a third dose less than 4 months after the second dose (for adolescents 12-15 years),9 or inconsistent vaccination information (eg, reported vaccine receipt but missing dose dates, reported no vaccine receipt but doses reported).Exposure

The exposures of interest were 2 BNT162b2 doses for children 5 to 11 years old and 2 or 3 BNT162b2 doses for adolescents 12 to 15 years old. Cases and controls were considered unvaccinated if tests were from children and adolescents who received no COVID-19 vaccine before the SARS-CoV-2 test. Cases and controls were considered vaccinated with 2 or 3 doses if tests were from children and adolescents who reported receiving the second or third dose 2 weeks or more before their SARS-CoV-2 test.Outcome

The outcome measure was symptomatic SARS-CoV-2 infection determined by positive NAAT result in a person reporting COVID-19–like illness.Statistical Analysis

Associations between symptomatic SARS-CoV-2 infection and BNT162b2 vaccination were estimated by comparing the odds of prior vaccination with 2 or 3 doses (exposed) vs no vaccination (unexposed) in cases vs controls using multivariable logistic regression. The OR was used to estimate VE, where VE = (1 – OR) × 100%. Logistic regression models were adjusted for calendar day of test (continuous variable), race, ethnicity, sex, testing site region, and testing site census tract SVI (continuous variable).14 Tests with missing sex and site census tract SVI were not included in adjusted analyses. Unknown race and ethnicity were coded as categorical levels within each variable to retain those tests in regression models.

Adjusted OR and corresponding VE of 2 doses were estimated by age group (5-11 years and 12-15 years) and month since the second dose. Because only vaccination month and year but not exact calendar dates of each dose were reported, month since the second dose was calculated as the difference between the month and year of testing and the month and year of the second vaccine dose (at least 2 weeks after the second dose). The range of possible days after the second dose for month 0 was 14 to 30 days; month 1, 14 to 60 days; month 2, 30 to 90 days; month 3, 60 to 120 days, and so on (assuming 30 days per month). Because of potential imprecision of month since vaccination based on calendar month of vaccination and testing rather than exact dates, a simulation analysis (of scenarios with rapid vs slow vaccine uptake and varying date of vaccine introduction) and an analysis of previously published data from this platform8 were conducted to compare VE estimates using this approach with those with exact number of days since the second dose (eAppendix in the Supplement).

The maximum difference between calendar month of SARS-CoV-2 test and calendar month of the second dose was 3 months for children 5 to 11 years old (tested during February 2022 and second dose received in November 2021) and 9 months for adolescents 12 to 15 years old (tested during February 2022 and second dose received in May 2021). However, VE was not calculated for the last month since the second dose (month 3 for children and month 9 for adolescents) because the number of possible days since the second dose was limited in the last month. This was a result of both the timing of vaccine authorization (children became eligible for second doses in late November 202118 and adolescents in late May 202117) and by the timing of the end of the study period (test dates were only included through February 21, 2022) (eAppendix in the Supplement). For adolescents 12 to 15 years of age, the maximum possible time after a booster was 6.5 weeks (tested February 21, 2022, and booster dose received after recommendation by the Advisory Committee on Immunization Practices on January 5, 2022).9

To assess the effect of reported prior SARS-CoV-2 infection on estimated 2-dose VE (by age group and month since the second dose), 3 sensitivity analyses were conducted. The first analysis included only tests from individuals without any reported prior SARS-CoV-2–positive test result. The second analysis included only tests from individuals without reported prior SARS-CoV-2–positive test result within 90 days, because a recent prior positive test result could have been due to prolonged NAAT positivity,19 multiple tests within the same illness episode (eg, confirming an at-home test), or reinfection with a different variant in the setting of Omicron variant emergence. The third analysis included only tests from individuals without reported prior SARS-CoV-2–positive test result more than 90 days prior to the test date, because prior SARS-CoV-2 infection provides infection-induced immunity in both vaccinated and unvaccinated individuals.20

The adjusted OR and corresponding VE of 3 doses among adolescents 12 to 15 years old were estimated overall (ie, not by month since the second dose) due to the short timeframe (6.5 weeks) since booster recommendation.

Statistical analyses were performed in R (version 4.1.2; R Foundation) and SAS (version 9.4; SAS Institute Inc). OR and VE estimates were presented with 95% CIs. To compare the waning pattern for estimated VE since the second dose between children and adolescents, an interaction term between age group (5-11 vs 12-15 years) and month after the second dose (for months 0, 1, and 2) was added to the model; a likelihood ratio test comparing the models with and without the interaction term was used to evaluate the interaction. Two-sided P values comparing the magnitude of the association of vaccination and infection between the 2 age groups and across study months were estimated; a P value less than .05 was considered significant. Because of the potential for type I error due to multiple comparisons, findings should be interpreted as exploratory.Results

A total of 121 952 tests from children and adolescents aged 5 to 15 years at 6897 sites across 49 states (all states except North Dakota), Washington, DC, and Puerto Rico, met inclusion criteria (Figure 1), including 53 272 cases (43.7%) and 68 680 controls (56.3%). The median age among individuals with included tests was 10 years (IQR, 7-13); 61 189 (50.2%) were female, 75 758 (70.1%) were White, and 29 034 (25.7%) were Hispanic/Latino. Among 74 208 included tests from children 5 to 11 years old, 58 430 (78.4%) were from unvaccinated children and 15 778 (21.3%) from those vaccinated with 2 doses. Among 47 744 included tests from adolescents 12 to 15 years old, 24 767 (51.9%) were from unvaccinated adolescents, 22 072 (46.2%) from those vaccinated with 2 doses, and 905 (1.9%) from those with booster doses.

Included tests were more frequently rapid NAAT (66.3%) than laboratory-based NAAT (33.7%), and controls were more often tested by rapid NAAT than cases (70.5% vs 60.2% for children; 71.5% vs 60.8% for adolescents) (Table). Cases vs controls were more often tests from persons from the South Atlantic region (27.6% vs 22.3% for children; 27.9% vs 23.7% for adolescents). Report of prior positive SARS-CoV-2 test result within 90 days of the test date was more common among cases than controls (22.0% vs 13.0% for children; 21.1% vs 15.5% for adolescents), while report of a positive test result more than 90 days before the test date was less common among cases than controls (4.9% vs 11.1% for children; 6.5% vs 13.4% for adolescents).

Among children 5 to 11 years old, the adjusted OR for symptomatic infection for tests performed during month 0 after the second dose was 0.40 (95% CI, 0.35-0.45; estimated VE, 60.1% [95% CI, 54.7%-64.8%]) and during month 2 after the second dose was 0.71 (95% CI, 0.67-0.76; estimated VE, 28.9% [95% CI, 24.5%-33.1%]) (Figure 2). For adolescents 12 to 15 years old, the adjusted OR during month 0 after the second dose was 0.40 (95% CI, 0.29-0.56; estimated VE, 59.5% [95% CI, 44.3%-70.6%]), during month 2 after the second dose was 0.83 (95% CI, 0.76-0.92; estimated VE, 16.6% [95% CI, 8.1%-24.3%]), and was no longer significantly different from 0 during month 3 after the second dose (OR, 0.90 [95% CI, 0.82-1.00]; estimated VE, 9.6% [95% CI, −0.1% to 18.3%]). Estimated VE was not significantly different between children and adolescents during months 0 and 1 after the second dose, but estimated VE in children was significantly higher than in adolescents during month 2 (P value for month 0: .99; month 1: .40; month 2: .01; and for months 0-2 combined: .06).

The simulation analysis showed that estimated VE waning curves that used either the exact number of days or calculated months since the second dose were in close agreement in scenarios with rapid and slow vaccine uptake and vaccine introduction on day 1 and day 16 of month 0 (eFigures 1-2 in the Supplement). The analysis of previously published data from this platform showed estimated monthly VE waning curves aligned well with daily VE waning curves (eFigures 3-4 in the Supplement).

Sensitivity analyses limited to those without any prior SARS-CoV-2–positive test result (eFigure 5 in the Supplement), without prior SARS-CoV-2–positive test result within 90 days of test date (eFigure 6 in the Supplement), and without prior SARS-CoV-2–positive test result more than 90 days prior to test date (eFigure 7 in the Supplement) yielded estimated VE at month 0 of 60.4% to 66.4% among children 5 to 11 years old and 58.3% to 64.3% among adolescents 12 to 15 years old. These were similar to the main analysis results that did not take prior infection into account. However, estimated VE in the sensitivity analyses was somewhat more sustained over time relative to the main analysis, particularly for the model limited to tests from individuals without any reported prior infection (estimated VE among children was 39.8% during month 2; among adolescents, estimated VE was significantly different from 0 until month 7) and the model limited to tests from those without infection within 90 days (estimated VE among children was 39.8% at month 2; among adolescents, estimated VE was significantly different from 0 until month 5).

Among adolescents, the adjusted OR for a booster dose 2 to 6.5 weeks after the dose was 0.29 (95% CI, 0.24-0.35; estimated VE, 71.1% [95% CI, 65.5%-75.7%]).Discussion

This analysis estimated BNT162b2 VE among children 5 to 11 years old and adolescents 12 to 15 years old with COVID-19–like illness tested for SARS-CoV-2 using NAAT at drive-through US pharmacy sites from December 26, 2021, to February 21, 2022. It found the estimated VE of the BNT162b2 2-dose primary series against symptomatic infection with the Omicron variant was modest and decreased over time since vaccination in both age groups, similar to the pattern observed in adults during Omicron variant predominance.10 A booster dose was associated with increased protection against symptomatic infection in adolescents.

Previous analyses among adults have shown lower estimated VE against the Omicron variant than against the Delta variant and waning of mRNA vaccine protection against symptomatic infection, regardless of predominant variant.8,10,11 A recent analysis from the same testing platform as this analysis demonstrated the estimated VE of the 2-dose BNT162b2 primary series against symptomatic Omicron infection among adults 18 years or older was 42% at 2 to 4 weeks after the second dose. This decreased to not significantly different from 0 by 3 months after the second dose.10 In this analysis, the estimated VE against symptomatic infection among adolescents 12 to 15 years old also was not significantly different from 0 during month 3 after the second dose. Among children 5 to 11 years old, the duration of protection could only be assessed up through month 2 since the second dose, and continued monitoring will be important.

Among adolescents 12 to 15 years old, the estimated VE against symptomatic infection increased after a booster dose. This finding is consistent with data on adults from this platform and from other studies among adults and adolescents during Omicron variant predominance, which provide evidence of increased protection following mRNA vaccine booster dose.10,21,22 Given the well-established pattern of waning mRNA VE after 2 doses and early evidence of waning of booster dose protection in adults,22 monitoring the duration of protection from booster doses in adolescents will be important. Booster doses may be needed to optimize protection against symptomatic infection with the Omicron variant in children 5 to 11 years old as well.

Children aged 5 to 11 years receive a lower-dose formulation (10 μg) of BNT162b2 than adolescents and adults (30 μg), and limited observational data are available on VE with the 10-μg dose. In this analysis, the similar starting VE among children and adolescents and slower waning seen in children than adolescents suggest the 10-μg dose performed as well or better in children than the 30-μg dose in adolescents. These findings are consistent with the phase 2-3 trial in which immunogenicity of the 10-μg dose among children 5 to 11 years old, as measured by geometric mean titers of neutralizing antibodies 1 month after the second dose, was not significantly different from that generated by 30 μg in persons 16 to 25 years old.4 Furthermore, recent studies indicate estimated 2-dose BNT162b2 VE is similar among children 5 to 11 years old and adolescents 12 to 15 years old against any Omicron infection with or without symptoms (31% and 59%, respectively, with overlapping CIs)23 and against emergency department and urgent care visits due to COVID-19 (51% among children 5-11 years vs 45% among adolescents 12-15 years, with overlapping CIs).21

Prior SARS-CoV-2 infection may influence estimated VE in various ways. Unvaccinated persons with prior infection may have infection-induced immunity, which could bias VE estimates toward the null, whereas vaccinated persons with prior infection may have higher levels of protection than those with vaccination alone.20 Additionally, the proportion of the population with prior infection and how protective prior infection from a previous variant is against currently circulating variants can also influence estimated VE. The sensitivity analysis including only children and adolescents without any reported prior infection showed that waning of estimated VE was less pronounced than in the main analysis, which may provide the clearest picture of protection provided by vaccination. However, prior SARS-CoV-2 infection is increasingly common; the estimated SARS-CoV-2 infection–induced antibody seroprevalence among US children 0 to 17 years old who had blood specimens tested at commercial laboratories (for reasons unrelated to COVID-19) was 45% in December 2021.24 Although history of SARS-CoV-2 infection was self-reported in this analysis and is an imperfect measure, 27% of tests were from persons reporting prior infection. Thus, inclusion of tests from persons with prior infection may more accurately reflect vaccine performance under current conditions in the US.

Although estimated VE against symptomatic infection waned quickly in this analysis, vaccine protection against symptomatic infection is harder to achieve than protection against severe disease. For mRNA vaccines including BNT162b2, estimated VE against severe disease and hospitalization has been higher and waned more slowly than estimated VE against infection among adolescents and adults during Delta predominance25 and Omicron predominance.21,22 While estimated VE against symptomatic infection is an important end point to inform nonpharmaceutical intervention policy decisions and can provide an early warning signal of declining VE, estimated VE against severe disease is needed for children and adolescents during Omicron variant predominance.Limitations

This analysis is subject to several limitations. First, vaccination status was self-reported, which may lead to misclassification. Second, approximately 12% of tests were from people who did not report vaccination status, and 8% had missing symptom data. Exclusion of these tests may have biased results. Third, vaccination dose dates were provided as month and year rather than exact calendar date, which could affect the estimated VE over time through imprecise classification of months since vaccination. A simulation analysis and an analysis of previously published data from this platform8 (eAppendix in the Supplement) suggested that the magnitude and patterns of estimated VE over time would be similar when estimated by day or month since second dose and additionally would be robust to different speeds of vaccine uptake and timing of vaccine authorization.

Fourth, person-level identifiers were not available; therefore, the unit of analysis was tests, not individuals. The analysis was restricted to symptomatic children and adolescents tested within a 2-month timeframe, likely reducing the number of individuals contributing multiple tests. Fifth, these data are from children and adolescents who sought testing at ICATT sites and may not be generalizable to the US population. Nonetheless, these data represent a large sample of children and adolescents 5 to 15 years old tested at 6897 sites nationally. Sixth, primary series vaccine coverage among children 5 to 11 years old and booster coverage among adolescents 12 to 15 years old remained low in the US during the time of this study.26 Children who received the primary series and boosted adolescents may differ in meaningful and unmeasured ways from unvaccinated children and unboosted adolescents.

Seventh, due to the short time (6.5 weeks) since adolescents 12 to 15 years old were recommended for a booster dose, this analysis was unable to estimate booster VE over time in adolescents. Eighth, this analysis includes both rapid and laboratory-based NAAT. While there may be slight variation in the sensitivity of assays performed at different laboratories, NAAT, including rapid NAAT, is the most sensitive method available for detection of SARS-CoV-2 infection.27 Simulations of the effect of test sensitivity on influenza VE estimates using the test-negative design suggest that estimated VE remains relatively stable over a range of test sensitivity from 80% to 100%.28Conclusions

Among children and adolescents, estimated VE for 2 doses of BNT162b2 against symptomatic infection was modest and decreased rapidly. Among adolescents, the estimated effectiveness increased after a booster dose.

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20.Hall  V, Foulkes  S, Insalata  F,  et al; SIREN Study Group.  Protection against SARS-CoV-2 after COVID-19 vaccination and previous infection.   N Engl J Med. 2022;386(13):1207-1220. doi:10.1056/NEJMoa2118691PubMedGoogle ScholarCrossref

21.Klein  NP, Stockwell  MS, Demarco  M,  et al.  Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA vaccination in preventing COVID-19-associated emergency department and urgent care encounters and hospitalizations among nonimmunocompromised children and adolescents aged 5-17 years: VISION Network, 10 states, April 2021-January 2022.   MMWR Morb Mortal Wkly Rep. 2022;71(9):352-358. doi:10.15585/mmwr.mm7109e3PubMedGoogle ScholarCrossref

22.Ferdinands  JM, Rao  S, Dixon  BE,  et al.  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.   MMWR Morb Mortal Wkly Rep. 2022;71(7):255-263. doi:10.15585/mmwr.mm7107e2PubMedGoogle ScholarCrossref

23.Fowlkes  AL, Yoon  SK, Lutrick  K,  et al.  Effectiveness of 2-dose BNT162b2 (Pfizer BioNTech) mRNA vaccine in preventing SARS-CoV-2 infection among children aged 5-11 years and adolescents aged 12-15 years: PROTECT cohort, July 2021-February 2022.   MMWR Morb Mortal Wkly Rep. 2022;71(11):422-428. doi:10.15585/mmwr.mm7111e1PubMedGoogle ScholarCrossref

24.Centers for Disease Control and Prevention. COVID data tracker: nationwide COVID-19 infection-induced antibody seroprevalence (commercial laboratories). Accessed March 9, 2022. https://covid.cdc.gov/covid-data-tracker/#national-lab

25.Tartof  SY, Slezak  JM, Fischer  H,  et al.  Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study.   Lancet. 2021;398(10309):1407-1416. doi:10.1016/S0140-6736(21)02183-8PubMedGoogle ScholarCrossref

26.Centers for Disease Control and Prevention. COVID data tracker: trends in demographic characteristics of people receiving COVID-19 vaccinations in the United States. Accessed February 13, 2022. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends

27.Food and Drug Administration. In vitro diagnostics EUAs: molecular diagnostic tests for SARS-CoV-2. Accessed March 17, 2022. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-22

8.Jackson  ML, Rothman  KJ.  Effects of imperfect test sensitivity and specificity on observational studies of influenza vaccine effectiveness.   Vaccine. 2015;33(11):1313-1316. doi:10.1016/j.vaccine.2015.01.069PubMedGoogle ScholarCrossref

Pfizer Jab In Young People Only 20% Effective After 60 Days, 0% After 5 Months

Authors:  Zachary Stieber May 14, 2022 The Epoch Times

The Pfizer COVID-19 vaccine turned negatively effective after five months, according to a new study

The Pfizer COVID-19 vaccine turned negatively effective after five months, according to a new study.

Researchers with the U.S. Centers for Disease Control and Prevention (CDC) analyzed test results from sites across the United States and determined that the vaccine was 60 percent effective two to four weeks after 12- to 15-year-olds got the second of the two-dose primary regimen.

But the effectiveness, measured against symptomatic illness, quickly plummeted, hitting 20 percent around month two and zero around month five.

After that, recipients in the age group were more likely to be infected by the disease caused by the CCP (Chinese Communist Party) virus, also known as SARS-CoV-2, the virus causes COVID-19.

Vaccine effectiveness “was no longer significantly different from 0 during month 3 after the second dose,” the researchers wrote in the study, which was published by the Journal of the American Medical Association.

Pfizer, its partner BioNTech, and the CDC didn’t respond to requests for comment.

The analyzed tests were performed between Dec. 26, 2021, and Feb. 21, 2022. Some 47,700 tests among 12- to 15-year-olds were included, with about half being unvaccinated. The testing data was on the Increasing Community Access to Testing, a program funded by the U.S. Department of Health and Human Services that contracts with pharmacy chains to perform drive-through testing. The testing data was supplemented by information in questionnaires filled out by adults with the adolescents.

Limitations of the study included vaccination being self-reported.

The study was funded by the U.S. government.

The study also found that vaccine effectiveness against symptomatic infection plunged quickly for those 5 to 11 years old, starting at 60 percent but hitting 23 percent just one month later.

One way to combat the negative effectiveness, researchers said, was to get a booster dose.

Of the 906 12- to 15-year-olds who got a third, or booster, dose, the effectiveness was measured at 71 percent two to six weeks after receipt.

Other studies, though, show that the protection from a booster, like that from the primary regimen, quickly wanes.

“Given the well-established pattern of waning mRNA VE after 2 doses and early evidence of waning of booster dose protection in adults, monitoring the duration of protection from booster doses in adolescents will be important,” researchers said.

Both the Pfizer and Moderna vaccines are built on messenger RNA (mRNA) technology. VE refers to vaccine effectiveness.

In another study published by the same journal on May 13, New York researchers reported the gap of infection and hospitalization risk between unvaccinated and vaccinated youth narrowing over time, with vaccinated 5- to 11-year-olds being infected at a rate of 62 per 100,000 and unvaccinated being infected at a rate of 70 per 100,000.

That was an incidence rate ratio of 1.1; the rate ratio for 12- to 17-year-olds was 2.

The protection also waned considerably against hospitalization over time, researchers found.

They said that the findings support “efforts to increase vaccination coverage in children and adolescents.”

The Pfizer Clinical Trial: Is There Evidence of Fraud?

Authors:  Michelle Edwards -May 12, 202

Was the clinical trial for Pfizer’s mRNA-based gene-therapy “vaccine” fraudulent? Many are asking that question, and rightly so. Documents released in Nov. 2021 by the FDA as part of the court-mandated document dump show evidence of clinical trial enrollment at one particular trial site happening rapidly and just in time to meet the safety deadline for the FDA’s VRBPAC meeting on Dec. 10, 2020, to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 jab in individuals 16 and older. Presented on Twitter by Jikkyleaks, the report has raised critical questions.  

The allegedly suspicious-looking clinical trial data surrounds “the biggest recruiter by far,” site 1231 (site 4444 was assigned site id 1231) in Argentina. Adding to the confusion, in five short days before the safety deadline (including a Sunday, 9/27/20), the trial recruited 1,275 of the 4,501 people using site number 4444. In just three weeks, the site recruited 4,501 patients—10% of the entire trial at one site. Overall, Pfizer rapidly recruited roughly 44,000 people for their trial, which took place at 152 locations worldwide and was overseen by numerous investigators, including Dr. Fernando Polack, who led the Argentinian study at Hospital Militar Central

As pointed out by Steve Kirsch, Polack is the Scientific Director of the INFANT Foundation in Buenos Aires. The Vanderbilt-affiliated foundation gives participants the opportunity to conduct biomedical translational research or pediatric rotations at hospitals and medical centers in Buenos Aires. Polack coordinates 26 hospitals in Argentina involving 467 doctors who were instantly recruited into the Pfizer trial. Kirsch said the “new data on Site 1231/4444 looks too good to be true,” but he also noted that all things considered, “it’s quite possible they pulled it off” and coordinated the trial in record time. Noting the infrastructure already in place at Hospital Militar Central, Kirsch referenced an article from Sept. 10, 2020, adding: 

“So if all 26 hospitals participated fully then that’s 57 patients per week per hospital which is possible if the sites have done this before and have a coordination framework for getting all 26 sites up and running at the same time. This means that everyone who was doing something else dropped what they were doing to switch over to the trial all at the same time.”

Still, as Professor Norman Fenton of Queen Mary London University pointed out, the circumstances surrounding the trial are remarkable. Fenton refers to a Substack two-part series on the Site 1231/4444 documents by el gato malo, who wrote that it is “basically impossible,” no matter who you are, to run a clinical trial this quickly. Malo added, “if this really happened, it would be a wonder of the world, and they should publish the process with pride and win 27 different prizes for it.” Malo continued, saying:

“They claim to have enrolled seven days a week for three weeks with zero gaps. Each patient requires a 250-page case report form. The lead investigator seems to have been Fernando Polack.

If indeed, the best way to get things done is to give them to busy people, then this was a great choice because, from the look of things, Fernando is one busy fellah and connected up the wazoo to boot. He also works with Vanderbilt, the FDA, and the Infant Foundation, funded by the Gates Foundation and the NIH.”

Kirsch remarked that Polack is the first author in the New England Journal of Medicine’s (NEJM) article on the Pfizer “vaccine,” titled “Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine.” Interestingly, in the disclosure form for the authors of the NEJM paper, Polack reported receiving personal fees from companies including Pfizer, Janssen, Regeneron, and Merck. Likewise, he disclosed grants from Novavax, Inc. Kirsch (who shared a video on Polack, but noticed no real “smoking gun”) highlighted a few exerts from the Dec. 31, 2020 paper, including:

“About 5,800 volunteers were enrolled, half getting the active vaccine. This is almost 4 times more than the next largest centre in this trial. Amazingly 467 doctors were almost instantly signed up and trained as assistant investigators in the study. Fernando was in command as Pfizer’s Principal Investigator.

Neither Augusto’s pericardial effusion, nor another volunteer’s penile vein thrombosis, appear to have found their way into the reported side effects of this trial.”

Editor of the British Medical Journal tells the FDA about Serious Concerns over Pfizer Trial Data Integrity

And the lack of FDA oversight

Dr Doshi in an associate professor of pharmaceutical health at the University of Maryland School of Pharmacy, as well as a senior editor at the British Medical Journal. “His research focuses on the drug approval process, how the risks and benefits of medical products are communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications.”

In the most recent Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee meeting in the US (6 April 2022), Peter dialled in to the Open Public Hearing Session. This is where members of the public can present their own information to the FDA. The committee was meeting to discuss considerations for the use of COVID-19 vaccine boosters and the process for COVID-19 vaccine strain selection to address current and emerging variants.

Peter told the FDA about Brook Jackson, a whistle-blower from Ventavia, which ran Pfizer’s vaccine trials. He discussed how unblinding of trial participants seems to have occurred and how this creates serious concerns about data integrity.

Last November, The BMJ reported the disclosures of a whistle-blower named Brook Jackson, who worked for Ventavia, a contract research company that ran three of the clinical trial sites for Pfizer’s vaccine. Jackson alleged the company had falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events. She provided The BMJ with company emails, internal documents, text messages, photos and recordings of her conversations with company employees.

This photo, for example, shows vaccine packaging materials that are only supposed to be seen by unblinded staff, just left out in the open.

And unblinding may have occurred on a far wider scale. Here you can see the document containing the instructions Ventavia staff were given to file each trial participant’s randomization and drug assignment confirmation sheet into each participant’s chart. This contained unblinded information.

Unblinding, as I think everybody knows, creates serious concerns about data integrity. Once this massive error was discovered, Ventavia asked staff to go through each and every chart to take out the randomization and drug assignment confirmations. You can see here an email from Ventavia’s COO reacting after discovery of the problem: they had not even realized that the drug assignment confirmation contained unblinding information.

In the heat of a pandemic, it’s not hard to imagine that corners were cut and mistakes were made. Some mistakes are benign, but others carry serious consequences to data integrity. One hopes Ventavia is an extreme outlier, but we need more than just hope. We need evidence that the data were dealt with properly. We need regulatory oversight. But despite whistleblower Brook Jackson’s direct complaint to the FDA, FDA never inspected Ventavia. In fact, FDA only inspected 9 of the trial’s 150-plus sites before approving the vaccine. Just 9 sites. And Pfizer continues to use Ventavia for trials.

What about Moderna? FDA had over a year and inspected just one – ONE – of the trial’s 99 sites. How can FDA feel confident in the Moderna data based on a 1% sample?

Data integrity requires adequate regulatory oversight. Trustworthy science requires data transparency. It’s been over a year, but anonymised participant level data remain inaccessible to doctors, researchers, and the public. The public paid for these products, and the public takes on the balance of benefits and harms post vaccination. The public has a right to data transparency, and FDA has an obligation to act. Thank you.

The video for the meeting is below. Peter Doshi’s statement starts at 5:34:44 but all of the public presentations are interesting and these begin at around 5:15.

Pfizer-BioNTech Vaccine Much Weaker in Kids Against Omicron and More

Authors: Mark Terry Published: Mar 01, 2022  BIOSPACE

Pfizer-BioNTech Vaccine Only 12% Effective Against Omicron in 5-11-Year-Olds 

In a new study that is yet to be peer-reviewed, the New York State Department of Health found that the PfizerBioNTech vaccine was only about 12% effective for children ages 5 to 11 years against the Omicron variant. In that age group, it was about 68% effective against Delta, but the effectiveness dropped significantly during the Omicron surge from Dec. 13, 2021, to Jan. 24, 2022. Protection against hospitalization also plummeted from 100% to 48% in the same period. 

The authors of the report think this drop may be the result of the lower dosage the children received. They were dosed with two 10-microgram shots, compared to 30-microgram doses for children 12 to 17 years of age.  

“Given rapid loss of protection against infections, these results highlight the continued importance of layered protections, including mask-wearing, for children to prevent infection and transmission,” the authors wrote. 

Pfizer-BioNTech Vaccine Integrates into Liver Cells in Cell Cultures 

Researchers at Lund University in Sweden conducted research into the Pfizer-BioNTech COVID-19 vaccine and human liver cell lines to determine what kind of effect the vaccine might have on liver cells. The research was published in Current Issues in Molecular Biology. The authors, noting the safety and efficacy of the vaccine against COVID-19, also point out that long-term studies have not been conducted. They note pharmacokinetics data provided by Pfizer to the European Medicines Agency (EMA) showed that the “injection site and the liver were the major sites of distribution, with maximum concentrations observed at 8-48 hours post-dose.

Furthermore, in animals that received the BNT162b2 injection, reversible hepatic effects were observed, including an enlarged liver, vacuolation, increased gamma-glutamyl transferase levels, and increased levels of aspartate transaminase (AST) and alkaline phosphatase (ALP).” They add that transient liver effects caused by the lipid nanoparticle (LNP) delivery systems used with mRNA vaccines have been previously reported, although LNP with no mRNA in it doesn’t cause any significant liver injury. 

Working with the specific human liver cell line Huh7 and the Pfizer-BioNTech vaccine, they found that the vaccine was able to enter the cell line as quickly as six hours after exposure. They cite a report saying some people who received the vaccine developed autoimmune hepatitis, and they question if the human liver cells, integrating the vaccine mRNA, produce SARS-CoV-2 spike protein that then catches the attention of the body’s immune system, inadvertently attacking the liver.

However, there does not appear to have been many other cases of this happening, which would make it extremely rare, assuming it was actually caused by the vaccine and not something else. 

The researchers note, “At this stage, we do not know if DNA reverse transcribed from BNT162b2 is integrated into the cell genome. Further studies are needed to demonstrate the effect of BNT162b2 on genomic integrity, including whole genome sequencing of cells exposed to BNT162b2, as well as tissues from human subjects who received BNT162b2 vaccination.” 

Adamis’ COVID-19 Trial Surpasses Enrollment Expectations 

San Diego-based Adamis Pharmaceuticals reported that due to the acceleration of enrollment in its Phase II/III study for Tempol for COVID-19, its Data Safety Monitoring Board (DSMB) decided the study could continue. No safety or clinical problems were observed. The data from the first 50 participants will be reviewed again in March as part of the first planned interim analysis. 

Tempol has strong, broad in vitro anti-cytokine activity, and in animal studies, appeared to have anti-inflammatory effects in the lungs. 

“We are pleased with the progress of the trial, which has already exceeded the required number of subjects (124) for the second planned interim DSMB analysis,” said Dr. Dennis J. Carlo, president and CEO of Adamis. “We appreciate the feedback from the DSMB. Following the first planned interim analysis, if the DSMB advises for the study to continue, we will also report on the second planned DSMB review following its completion, which may provide additional insight into the safety and clinical results at that time.” 

Study into mRNA vaccine death rates sends ‘danger signals’

A new Danish study reveals disparities in all-cause mortality between mRNA and adenovirus vaccines

Do the covid vaccines save lives? That is the question on many people’s minds, that has led to heated discussions across the world.

A bombshell new study by a distinguished team of Danish researchers led by Prof. Christine Stabell-Benn suggests a surprisingly nuanced answer. In the randomized trials of the covid vaccines, the adenovector-based vaccines, including the AstraZeneca and Johnson & Johnson vaccines, reduced all-cause mortality of study participants relative to people randomly assigned a placebo. Indeed, the reduction in mortality is larger than expected from the Covid effect and may suggest additional beneficial “non-specific effects” from those vaccines against other health threats.

On the other hand, Stabell-Benn and her colleagues found no statistically meaningful evidence in the trial data that the mRNA vaccines reduced all-cause mortality. The numbers of deaths from other causes including cardiovascular deaths appear to be increased in this group, compensating for the beneficial effect of the vaccines on Covid. Stabell-Benn is keen to stress that the sample is relatively small and is calling for further investigation, and also that the study took place during very low levels of Covid, so the relative advantage of protection against Covid would have been smaller at that time compared to at other points in the pandemic.

However, these preliminary results stand in sharp contrast to the unambiguous message from public health agencies and governments worldwide, which granted emergency authorization to the vaccines based on evidence from the trials that the vaccines reduce the likelihood of getting symptomatic covid. From a purely scientific perspective, preventing symptomatic covid is an interesting outcome to study. From a public health perspective, prevention of covid symptoms is not as important as prevention of death or disease transmission, which the randomized trials did not study. Dr. Stabell Benn and her colleagues have now looked at overall mortality for the first time.

At the very least, the plain implication (since both sets of vaccines are available) is that public health authorities should have recommended the cheaper adenovector vaccines over the mRNA vaccines all along for most patients.

In other words, the international move to de-authorise the AstraZeneca vaccine across Europe and elsewhere looks like it may have been a mistake, and that AZ was actually a better option than the Pfizer or Moderna vaccines.

It offers a potential contributory explanation for the better overall mortality outcomes in the UK (which overwhelmingly used the AZ vaccine) than much of continental Europe (which phased out the AZ vaccine) after the vaccine programme in the second half of 2021. 

Since its publication in pre-print, the Stabell-Benn study has received very little coverage in the media. As Dr Stabell-Benn told Freddie Sayers in her UnHerd interview, she has become used to this reticence: I have been in this game for now almost thirty years, studying vaccines and finding these non-specific effects which have been very controversial. There are strong powers out there that don’t really want to hear about them. But to me this is good news: it means that we can optimize the use of vaccines to not only be strong protective effects against vaccine disease, but we can also optimize their use in terms of overall health. – PROFESSOR CHRISTINE STABELL-BENN, UNHERD

The reaction 

For a study with such a consequential conclusion, review from independent experts is crucial. In the past, such peer-review took place in anonymity, behind the closed doors of a scientific journal, with a single editor or associate editor serving as an umpire. Because of the small number of people involved in the review, the peer-review process is subject to well-known biases and long delays (months or longer). Worse, the public never had access to these deliberations and was asked to take it as an article of faith that a published peer-reviewed paper presented accurate conclusions.

A better process for the scientific review of some important papers has emerged during the pandemic – open peer review whereby the public can see the conversation among scientific experts. Though the Danish team released their paper in early April, it was an online review by vaccine safety expert and world-renowned epidemiologist Martin Kulldorff that catalyzed a discussion by scientists about it.

In his review, Kulldorff pointed to the clear implication of the results of the Danish paper. When both mRNA and adenovector vaccines are available, it’s better to take the vaccine with good randomized evidence of reductions in all-cause mortality rather than taking a vaccine where we cannot tell from the best evidence whether it reduces mortality. Kulldorff called for a new randomized controlled trial of the mRNA vaccine to find out if they can compete with the adenovirus-vector vaccines – as should occur in medicine whenever an effective intervention exists and another intervention seeks to show that it is as good or better. He also suggested that it is inappropriate to mandate vaccines for which the randomized clinical trials show a null result for mortality. 

Kulldorff’s open peer-review stoked some discussion among scientists about the feasibility of running a randomized trial comparing the vaccines. Mortality rates from covid infection – due partly to high levels of population immunity from covid recovery – are low, so a large sample size would be necessary to detect a difference. Whether such a study is even feasible is an open question, as is the importance of such a study. This kind of constructive discussion happens all the time in science.

However, some scientists – including zero-covid advocate Deepti Guradsani – reacted to Kulldorff’s article with public smears, false accusations of spreading vaccine misinformation, and the usual claims about right-wing connections. Even Jeremy Farrar, the head of the Wellcome Trust and a prominent architect of the pandemic policy in the UK, joined the fray by promoting such smears on his Twitter feed. 

Kulldorff is a prominent vaccine scientist who has presented his honest views on the covid vaccines, even when they go against the established narrative. In March 2021, he lost his position as an advisor to the US CDC for recommending against pausing the Johnson & Johnson vaccine for older Americans – an action that effectively killed the demand for the adenovirus vector vaccines in the US. He is the only person I know who the CDC has fired for being too pro-vaccine.  

When scientists slander prominent vaccine scientists, that damages vaccine confidence. Scientists should be encouraged to evaluate, compare and discuss the strengths and weaknesses of different vaccines, and to be free to advocate for one vaccine over another. Farrar’s promotion of the lies is particularly insidious because it sends a signal to scientists who might be interested in funding from the Wellcome Trust to shy away from voicing their honest thoughts about the Danish study or vaccines in general.

The stakes in the discussion about this paper are tremendously high. Of course, for the public at large, what covid vaccine is best for them is literally a life-and-death question. For scientists, at stake is the ability to participate honestly in open scientific reviews of hot button topics without having to face smears and reputational damage based on lies by other prominent scientists. If scientists lose their ability to reason publicly about studies like the ground-breaking Danish study, physicians will have no solid basis for their advice to patients on this topic or much else, and the public will have no reason to trust physicians and scientists.

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021

Authors: Matthew E. Oster, MD, MPH; David K. Shay, MD, MPH; John R. Su, MD, PhD, MPH; Julianne Gee, MPH; C. Buddy Creech, MD, MPH; Karen R. Broder, MD; Kathryn Edwards, MD; Jonathan H. Soslow, MD, MSCI; Jeffrey M. Dendy, MD; Elizabeth Schlaudecker, MD, MPH; Sean M. Lang, MD; Elizabeth D. Barnett, MD; Frederick L. Ruberg, MD; Michael J. Smith, MD, MSCE; M. Jay Campbell, MD, MHA; Renato D. Lopes, MD, PhD, MHS; Laurence S. Sperling, MD; Jane A. Baumblatt, MD; Deborah L. Thompson, MD, MSPH; Paige L. Marquez, MSPH; Penelope Strid, MPH; Jared Woo, MPH; River Pugsley, PhD, MPH; Sarah Reagan-Steiner, MD, MPH; Frank DeStefano, MD, MPH; Tom T. Shimabukuro, MD, MPH, MBA
IMPORTANCE Vaccination against COVID-19 provides clear public health benefits, but
vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19
vaccination are unclear.

OBJECTIVE

To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US.

DESIGN, SETTING, AND PARTICIPANTS

Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021.

EXPOSURES

Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna).

MAIN OUTCOMES AND MEASURES

Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes.

RESULTS

Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%).

CONCLUSIONS AND RELEVANCE

Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination. JAMA. 2022;327(4):331-340.

doi:10.1001/jama.2021.24110
Supplemental content
Author Affiliations: US Centers for Disease Control and Prevention,
Atlanta, Georgia (Oster, Shay, Su, Gee, Broder, Sperling, Marquez, Strid, Woo, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro); School of Medicine, Emory University, Atlanta, Georgia (Oster, Sperling); Children’s Healthcare of Atlanta, Atlanta, Georgia (Oster); Vanderbilt University
Medical Center, Nashville, Tennessee (Creech, Edwards, Soslow, Dendy); Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio (Schlaudecker, Lang); Boston Medical Center, Boston, Massachusetts (Barnett, Ruberg); Duke University, Durham, North Carolina (Smith, Campbell, Lopes); US Food and Drug Administration, Silver Spring, Maryland (Baumblatt, Thompson).
Corresponding Author: Matthew E. Oster, MD, MPH, US Centers for Disease Control and Prevention,
1600 Clifton Rd, Atlanta, GA 30333 (eocevent416@cdc.gov). Research J

To Read The Full Journal Publication in JAMA Click Below:

https://jamanetwork.com/ on 01/25/2022

American Scientists Confirm Toxic Graphene Oxide, and More, in Covid Injections

Authors: RHODA WILSON   

It is a human right, and global law governed under the Nuremberg Code, that vaccine specific ingredient information is disclosed.  It is critical, required and necessary information so anyone, from any country in the world, can make an informed decision whether or not to consent to medical intervention.  Because the full list of ingredients of the Covid “vaccines” have not been made available, Dr. Robert Young and his team conducted research to identify the specific ingredients in the Pfizer, Moderna, AstraZeneca and Johnson & Johnson Covid injections.  On 20 August, they published their findings.

Dr. Young is a biochemist, microbiologist, and clinical nutritionist.  He and his team of scientists have confirmed what the La Quinta Columna researchers found – toxic nanometallic content which are magneticotoxic, cytotoxic and genotoxic to plants, insects, birds, animals and humans – all life on the planet.  One of the “vaccines” even contained life-threatening parasites. Taken together, the “vaccine” components – which include graphene oxide among many others and which may be influenced by radiation sources external to us – create a toxic chemical and radiative soup inside our bodies.  Anyone who has a Covid injection is seriously putting their lives at risk.

We previously covered some of La Quinta Columna’s research in two articles: Spanish Researchers Find Covid-19 Vaccines Contain TOXIC Levels of Graphene Oxide; and, The real pandemic – Covid-19 or Graphene Oxide? Poisonous Nano-Material found in Covid Vaccines and Face Masks. For additional resources visit Orwell City, a website that translates, transcribes and adds English subtitles to a good portion of La Quinta Columna’s materials.

“Vaccines” from the four major pharmaceutical companies were analysed by Dr. Young: Pfizer/BioNTech (“Pfizer”); Moderna/Lonza mRNA-1273 (“Moderna”); Vaxzevria by AstraZeneca (“AstraZeneca”); and, Janssen by Johnson & Johnson (“Janssen”).

Liposome capsids are fatty lipid capsules. We are told their purpose is to envelope the mRNA to protect the genetic material from breaking down before it has reached its target – our body’s cells.  All four Covid “vaccines” contain relatively high levels of graphene oxide but both the Pfizer and Moderna liposome capsids are 100% graphene oxide (after extracting the mRNA). 

Graphene oxide is cytotoxic, genotoxic, and magneticotoxic.  The image below shows the liposome capsid containing graphene oxide in the Pfizer “vaccine.” The liposome delivers the graphene oxide to specific organs, glands and tissues, namely: the ovaries and testes; bone marrow; heart; and, brain.

Liposome Capsid from the Pfizer Covid injection

Also found in the Pfizer injection was Trypanosoma cruzi – a parasite of which several variants are lethal and is one of many causes of acquired immune deficiency syndrome or AIDS.  It’s not known if this was just a random ingredient or was purposefully placed and will be found in all Pfizer “vaccines.”

Trypanosoma parasite found in the so-called Pfizer “vaccine”

In the AstraZeneca “vaccines,” Dr. Young and his team identified histidine, sucrose, poly-ethylene glycol (“PEG”) and ethylene alcohol, which were also contained in the Pfizer, Moderna and Janssen Covid injections. PEG was the only adjuvant declared on the data sheet listing the ingredients of the AstraZeneca injection.

The injection of PEG and ethylene alcohol are both known to be carcinogenic and genotoxic.

Janssen also contains particles which are composed of stainless steel which are glued together with a “Carbon-based glue” of reduced graphene oxide.

This aggregate is highly magnetic and can trigger pathological blood coagulation and the “Corona Effect” or the “Spike Protein Effect”

Cells on the left are healthy, concave. Cells on the right are hollow, not concave, they have lost their haemoglobin which is the “Spike Protein Effect” or “Corona effect”
Coagulation of the blood. On the left, white blood cells with lactic and citric acid crystals and pathological blood coagulation. On the right, blood analysis showing disseminated intravascular coagulation, thrombosis, immature neutrophils, the ‘Corona Effect’ and Acanthocytosis

The Moderna “vaccine” also contains many spherical foreign bodies with some bubble-shaped cavities. These highly toxic nano particulate composition are quantum dots of cadmium selenide which are cytotoxic and genotoxic. Quantum dots are semiconductor nanoparticles that glow a particular colour after being illuminated by light. The colour they glow depends on the size of the nanoparticle.  The black spots on the image below are graphene oxide.

Nano dots and graphene oxide found in the Moderna so-called “vaccine”

Dr. Young’s paper concludes, these Covid injections “are NOT vaccines but nanotechnological drugs working as a genetic therapy … All these so-called “vaccines” are patented and therefore their actual content is kept secret even to the buyers, who, of course, are using taxpayers’ money. So, consumers (taxpayers) have no information about what they are receiving in their bodies by inoculation.”

Summary of undisclosed ingredients extracted from Dr. Young’s published scientific paper

According to Dr. Young an estimated 500 million people worldwide have already been injured, with potentially 35 million deaths, due to Covid injections. This is likely to increase in the coming months with people who have had two injections being 13 times more likely to be injured, hospitalized or killed by the “Delta variant” compared to those with natural immunity. But what is actually causing the Covid “variants” and future “waves”?

The genetic code for the Spike Protein in the “vaccines” is computer generated, it is “man-made”, and can be easily altered.  And, the graphene oxide in the body’s tissues – brain, connective tissue, potentially in the muscles – will interact with pulsating frequencies within the 5G range, said Dr. Young, this will be what causes the next “wave” predicted in October.

Stop putting poison into your body, Dr. Young said, “these [Covid] inoculates are dangerous because the nano particulates can pass right through the blood-brain barrier, they can pass right through the air-blood barrier.  That’s why these inoculations are so dangerous.  It’s because the particulates break through: the blood-brain barrier, which is protected; the air-blood barrier; and, the testicular or ovarian-blood barrier.  The particulates go right in.” To poison the body in order to heal the body makes no sense – it is a failed narrative.

Dr. Young’s published scientific paper, Scanning & Transmission Electron Microscopy Reveals Graphene Oxide in CoV-19 Vaccines, can be read by following this LINK or in the pdf document as attached:Robert-Young-GrapheneOxideVaccinePaperUpdatedDownload

The paper is technical and those of us who have not made a career in science or medicine may struggle to understand its full implications.  Dr. Young discussed his findings in depth during an interview which you can watch HERE.  Beginning at the one hour mark he works methodically through the paper’s highlights.  What he has to say is of enormous importance to us all. Whether we have had, are considering having or decline to have a Covid injection it’s worth taking the time to hear what he has to say.

Further reading:

Why would they put graphene oxide in the Covid injections?  At the end of July a Pfizer whistle-blower, Karen Kingston, confirmed there is undisclosed graphene oxide in the Covid injections.  She gives some insight as to the reason why which aligns with that given by Dr. Young.  You can watch Kingston’s interview HERE.

On 26 August, Japan announced it was suspending the use of the Moderna “vaccines” due to reports of contamination with “a substance that reacts to magnets … it could be metal.”

Previously all Covid injections had emergency use authorization only but on 23 August, for America, the FDA approved the Pfizer “vaccine”.  Last Wednesday in a second interview Kingston discussed the impact this approval had on disclosure of ALL ingredients, including those not previously disclosed: https://rumble.com/embed/vj26z2/?pub=4#?secret=puKEYSNBOa


Changing recommendations for boosters lead to confusion for the vaccinated and their doctors

Author: Carissa Wolf, Frances Stead Sellers, Ashley Cusick, Kim Mueller  1 day ago

Even in Idaho, which has one of the lowest coronavirus vaccination rates in the country, clinics have been gearing up for an onslaught of calls and emails requesting booster shots.

Administrators at the Primary Health Medical Group updated their website Thursday and then set about revising it Friday when government eligibility recommendations for boosters suddenly changed to include workers in high-risk jobs. Even then, the clinic’s chief executive had to figure out which occupations that meant.

“Who’s at high risk? I had to look it up. Is it firemen? I don’t know,” said David Peterman. “This is so confusing to the public and creates mistrust. And we can’t have that right now. Right now, we need the public to say, ‘Let’s get vaccinated.’ And for those that need boosters, we need to say that ‘This is safe, and this is what we need to do.’”

Confusion over boosters, which has been brewing for months, heightened over the past week as government regulators and advisers met to hash out the pros and cons of administering third doses.

Hours of meetings were followed by a dramatic decision Thursday: The Centers for Disease Control and Prevention’s advisory group narrowed the Food and Drug Administration’s recommendation for who should get a third Pfizer shot, only to be overruled in a late-night announcement by the CDC director: Along with Americans 65 and older, nursing home residents and people ages 50 to 64 with underlying medical conditions, who the advisory panel had suggested should get shots, Rochelle Walensky added the people in high-risk jobs.

“It’s a communications crisis,” said Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, who said he received worried calls Thursday evening from health-care workers who thought they would not be eligible for the shots, followed by messages Friday from colleagues wondering when and where to go.The deluge of phone calls about booster shots to Primary Health clinics in Southwestern Idaho began weeks ago. On Friday morning, the group’s Garden City clinic, where Maddie Morris fields inquiries, saw an increase in calls, mostly from senior citizens.

“The calls seem pretty nonstop,” the customer service representative said. “It seems like a lot of people are anxious to get a booster.”

Doctors say confusion clouds patients’ willingness to receive boosters. In Idaho, the problem coincides with the primary health-care system’s struggle to meet the demands of the latest covid-19 crush, which earlier this month plunged the state into crisis standards of care — essentially the rationing of health care as demand overwhelms resources.Four patients, two dialysis machines: Rationing medical care becomes a reality in hospitals overwhelmed with covid patients

Peterman expects the new booster guidelines to prompt an increase in inquiries just as the number of providers out sick is at an all-time high.

“We went from 40,000 phone calls daily at 21 clinics to 80,000. Eighty thousand! On top of that, we went from maybe 20 of our employees being out a day to 30 to 40,” Peterman said.

“In the next 72 hours, I want [the CDC] to answer our phones,” he said.

Many newly eligible patients are over 65 and not comfortable using the Internet to find information. So the phones keep ringing at Morris’s desk.

“You really can’t take a breather. You just have to jump to the next call,” she said. And Peterman says he has had to ask staffers to take extra shifts and work long into the night to help close the staffing gap.

Much of the muddle stems from legacy systems at the FDA and CDC that were set up to handle routine drug approvals and childhood vaccinations, not a fast-moving public health crisis involving the entire population, said Jay A. Winsten, the founding director of the Center for Health Communications at the Harvard T.H. Chan School of Public Health.

The CDC’s Advisory Committee on Immunization Practices includes infectious-disease specialists, obstetricians and pediatricians who grappled Thursday with questions in which they have no expertise, such as whether offering boosters might undermine public confidence in the vaccines’ efficacy.

“What’s missing from the equation are communication experts,” said Winsten, including specialists in public-opinion polling and behavior change. “They need a seat at the table.”

Health-care providers across the nation have been helping patients for weeks to filter through not just misinformation and disinformation about boosters but also a surfeit of real-time information.

“That’s the biggest problem,” said Clay Marsh, a pulmonary critical care doctor and executive dean for health sciences at West Virginia University. “The amount of information is dizzying,” Marsh said, “It creates chaos.”

Across the New Orleans metropolitan area, new CDC guidelines had failed to trickle down to many administration sites by Friday morning.

The Louisiana National Guard, which helps to run testing and vaccination sites, was still awaiting clarity.

“We are just administering the first and second doses,” said Sgt. Gaynell Leal, a guard spokeswoman. “As far as the booster part of it, that hasn’t come our way yet.”

“The biggest thing is gaining people’s confidence in science,” Leal said. “My civilian job is I’m a funeral director. So I’ve seen this on both sides.”

On the ground, some National Guard-run sites did offer booster shots Friday, but the eligibility benchmarks they used had not yet caught up with the CDC’s latest guidelines.Tracking the coronavirus vaccine

At a drive-through testing and vaccine site in Meraux, La., just east of New Orleans, medics offered booster shots to those who met the requirements laid out on a “self-risk attestation form” issued in mid-August by the Louisiana Department of Health. That form offered a checklist of reasons one might qualify for a third dose, including active cancer treatment, HIV infection, immunodeficiency issues or the use of immunosuppressants. The form did not account for the age or job-related eligibility factors the CDC announced late this week.

In the French Quarter, Tara Thompson, 53, enjoyed a drink in Pirate’s Alley with her husband.

Thompson said that although she took the vaccine to spend time with her elderly parents, she hoped this week’s guidelines would not lead to booster shots soon being pushed on the public.

“I personally don’t want it if I don’t have to have it,” she said. “It’s a matter of trusting the science that seems to be skewed toward the benefit of certain political mind-sets.”

Thompson said she could change her mind if the shots help with travel.

“Or, if the booster shots help Mardi Gras to happen,” she said. “I might consider it then.”

In Chalmette, La., Kerissa Fernandez, 37, wanted more clarity on how the new booster shot guidelines applied to her.

Fernandez, a family nurse practitioner, said she and the staff at the small urgent care clinic she runs with her husband all meet the front-line worker requirement for booster shots. But none of the staffers at the Bayou Urgent Care Clinic had received the Pfizer vaccine, she said.

“I had Moderna. We all got Moderna,” she said. But when the delta variant reached record numbers in Louisiana, she and her husband both ended up with breakthrough infections.

Knowing firsthand the virus’s ability to shape-shift, Fernandez said she and her staff are all eager to get booster shots.

Many newly eligible people say they aren’t waiting for the rules and recommendations to change again. Ann Mackey, 66, qualifies for a booster shot.

“I have a doctor’s appointment next week, so I might see if they can jab me then,” she said from her high-rise apartment in downtown Kansas City, Mo.

The former FDA employee said the government’s conflicting messages have been confusing. She doesn’t understand why she can receive a Pfizer booster, but her friends and family can’t get their third Moderna shot. She is confused about how the government defines “high risk” and who will enforce the newest set of recommendations. And she worries that public confusion will provide another excuse for people to avoid getting their first dose.

“There already is a lot of vaccine hesitancy, and they are just looking for reasons not to get vaccinated,” Mackey said.Americans are sneaking extra coronavirus shots as officials weigh who should get them

Others are considering creative ways to get boosters.

Derek Hoetmer has been following the news closely, hoping he and his wife, a nurse who worked on a covid response team, could get a booster before the Missouri winter.

The problem is that the rules keep changing — and not in the Hoetmers’ favor. They were pleased to wake Friday morning to find the vaccination door had been opened to people in high-risk jobs.

But not wide enough for the Hoetmers, who won’t qualify because their first two doses were Moderna jabs.

With the Missouri winter only two months away, Hoetmer is considering his options. He has heard that other Americans who do not qualify are secretly getting boosters, anyway.

n situation in letter to opposition

Even in Idaho, which has one of the lowest coronavirus vaccination rates in the country, clinics have been gearing up for an onslaught of calls and emails requesting booster shots.© Scott Olson/Getty Images HINES, ILL. – SEPTEMBER 24: Lalain Reyeg administers a coronavirus booster vaccine and an influenza vaccine to Army veteran William Craig at the Edward Hines Jr. VA Hospital on September 24, 2021 in Hines, Ill. (Photo by Scott Olson/Getty Images)

Administrators at the Primary Health Medical Group updated their website Thursday and then set about revising it Friday when government eligibility recommendations for boosters suddenly changed to include workers in high-risk jobs. Even then, the clinic’s chief executive had to figure out which occupations that meant.

“Who’s at high risk? I had to look it up. Is it firemen? I don’t know,” said David Peterman. “This is so confusing to the public and creates mistrust. And we can’t have that right now. Right now, we need the public to say, ‘Let’s get vaccinated.’ And for those that need boosters, we need to say that ‘This is safe, and this is what we need to do.’”

Confusion over boosters, which has been brewing for months, heightened over the past week as government regulators and advisers met to hash out the pros and cons of administering third doses.

Hours of meetings were followed by a dramatic decision Thursday: The Centers for Disease Control and Prevention’s advisory group narrowed the Food and Drug Administration’s recommendation for who should get a third Pfizer shot, only to be overruled in a late-night announcement by the CDC director: Along with Americans 65 and older, nursing home residents and people ages 50 to 64 with underlying medical conditions, who the advisory panel had suggested should get shots, Rochelle Walensky added the people in high-risk jobs.

“It’s a communications crisis,” said Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, who said he received worried calls Thursday evening from health-care workers who thought they would not be eligible for the shots, followed by messages Friday from colleagues wondering when and where to get them.

“Everyone is kind of confused,” he said. The current discontent has deep roots. In April, Pfizer chief executive Albert Bourla said a third coronavirus dose was “likely” to be needed. In late July, Pfizer-BioNTech announced that their vaccine’s efficacy waned over time. Data from Israel confirmed a drop. Then, last month, as the delta variant of the coronavirus surged and the World Health Organization decried the distribution of third shots in wealthy countries while poor countries were lacking first doses, President Biden announced that most Americans could begin getting boosters of the Pfizer and Moderna vaccines Sept. 20 — subject to the government’s regulatory processes, which unfolded in recent days and focused only on Pfizer. R22egulators already allowed third shots for the immunocompromised who have received Pfizer or Moderna shots but have not yet made recommendations for all recipients of the Moderna and Johnson & Johnson vaccines.People who got Johnson & Johnson’s coronavirus shot feel left behind in push for boosters

The deluge of phone calls about booster shots to Primary Health clinics in Southwestern Idaho began weeks ago. On Friday morning, the group’s Garden City clinic, where Maddie Morris fields inquiries, saw an increase in calls, mostly from senior citizens.

“The calls seem pretty nonstop,” the customer service representative said. “It seems like a lot of people are anxious to get a booster.”

Doctors say confusion clouds patients’ willingness to receive boosters. In Idaho, the problem coincides with the primary health-care system’s struggle to meet the demands of the latest covid-19 crush, which earlier this month plunged the state into crisis standards of care — essentially the rationing of health care as demand overwhelms resources.Four patients, two dialysis machines: Rationing medical care becomes a reality in hospitals overwhelmed with covid patients

Peterman expects the new booster guidelines to prompt an increase in inquiries just as the number of providers out sick is at an all-time high.

“We went from 40,000 phone calls daily at 21 clinics to 80,000. Eighty thousand! On top of that, we went from maybe 20 of our employees being out a day to 30 to 40,” Peterman said.

“In the next 72 hours, I want [the CDC] to answer our phones,” he said.

Many newly eligible patients are over 65 and not comfortable using the Internet to find information. So the phones keep ringing at Morris’s desk.

“You really can’t take a breather. You just have to jump to the next call,” she said. And Peterman says he has had to ask staffers to take extra shifts and work long into the night to help close the staffing gap.

Much of the muddle stems from legacy systems at the FDA and CDC that were set up to handle routine drug approvals and childhood vaccinations, not a fast-moving public health crisis involving the entire population, said Jay A. Winsten, the founding director of the Center for Health Communications at the Harvard T.H. Chan School of Public Health.

The CDC’s Advisory Committee on Immunization Practices includes infectious-disease specialists, obstetricians and pediatricians who grappled Thursday with questions in which they have no expertise, such as whether offering boosters might undermine public confidence in the vaccines’ efficacy.

“What’s missing from the equation are communication experts,” said Winsten, including specialists in public-opinion polling and behavior change. “They need a seat at the table.”

Health-care providers across the nation have been helping patients for weeks to filter through not just misinformation and disinformation about boosters but also a surfeit of real-time information.

“That’s the biggest problem,” said Clay Marsh, a pulmonary critical care doctor and executive dean for health sciences at West Virginia University. “The amount of information is dizzying,” Marsh said, “It creates chaos.”

Across the New Orleans metropolitan area, new CDC guidelines had failed to trickle down to many administration sites by Friday morning.

The Louisiana National Guard, which helps to run testing and vaccination sites, was still awaiting clarity.

“We are just administering the first and second doses,” said Sgt. Gaynell Leal, a guard spokeswoman. “As far as the booster part of it, that hasn’t come our way yet.”

“The biggest thing is gaining people’s confidence in science,” Leal said. “My civilian job is I’m a funeral director. So I’ve seen this on both sides.”

On the ground, some National Guard-run sites did offer booster shots Friday, but the eligibility benchmarks they used had not yet caught up with the CDC’s latest guidelines.Tracking the coronavirus vaccine

At a drive-through testing and vaccine site in Meraux, La., just east of New Orleans, medics offered booster shots to those who met the requirements laid out on a “self-risk attestation form” issued in mid-August by the Louisiana Department of Health. That form offered a checklist of reasons one might qualify for a third dose, including active cancer treatment, HIV infection, immunodeficiency issues or the use of immunosuppressants. The form did not account for the age or job-related eligibility factors the CDC announced late this week.

In the French Quarter, Tara Thompson, 53, enjoyed a drink in Pirate’s Alley with her husband.

Thompson said that although she took the vaccine to spend time with her elderly parents, she hoped this week’s guidelines would not lead to booster shots soon being pushed on the public.

“I personally don’t want it if I don’t have to have it,” she said. “It’s a matter of trusting the science that seems to be skewed toward the benefit of certain political mind-sets.”

Thompson said she could change her mind if the shots help with travel.

“Or, if the booster shots help Mardi Gras to happen,” she said. “I might consider it then.”

In Chalmette, La., Kerissa Fernandez, 37, wanted more clarity on how the new booster shot guidelines applied to her.

Fernandez, a family nurse practitioner, said she and the staff at the small urgent care clinic she runs with her husband all meet the front-line worker requirement for booster shots. But none of the staffers at the Bayou Urgent Care Clinic had received the Pfizer vaccine, she said.

“I had Moderna. We all got Moderna,” she said. But when the delta variant reached record numbers in Louisiana, she and her husband both ended up with breakthrough infections.

Knowing firsthand the virus’s ability to shape-shift, Fernandez said she and her staff are all eager to get booster shots.

Many newly eligible people say they aren’t waiting for the rules and recommendations to change again. Ann Mackey, 66, qualifies for a booster shot.

“I have a doctor’s appointment next week, so I might see if they can jab me then,” she said from her high-rise apartment in downtown Kansas City, Mo.

The former FDA employee said the government’s conflicting messages have been confusing. She doesn’t understand why she can receive a Pfizer booster, but her friends and family can’t get their third Moderna shot. She is confused about how the government defines “high risk” and who will enforce the newest set of recommendations. And she worries that public confusion will provide another excuse for people to avoid getting their first dose.

“There already is a lot of vaccine hesitancy, and they are just looking for reasons not to get vaccinated,” Mackey said.Americans are sneaking extra coronavirus shots as officials weigh who should get them

Others are considering creative ways to get boosters.

Derek Hoetmer has been following the news closely, hoping he and his wife, a nurse who worked on a covid response team, could get a booster before the Missouri winter.

The problem is that the rules keep changing — and not in the Hoetmers’ favor. They were pleased to wake Friday morning to find the vaccination door had been opened to people in high-risk jobs.

But not wide enough for the Hoetmers, who won’t qualify because their first two doses were Moderna jabs.

With the Missouri winter only two months away, Hoetmer is considering his options. He has heard that other Americans who do not qualify are secretly getting boosters, anyway.

“I won’t lie. I’ve thought about that option,” Hoetmer said. “I would rather go about it the right way and not take away someone’s booster shot.”

FDA grants full approval to Pfizer-BioNTech’s Covid shot, clearing path to more vaccine mandates

Authors: Berkeley Lovelace Jr. @BERKELEY JR PUBLISHED MON, AUG 23 20219:37 AM EDTUPDATED AN HOUR AGO

KEY POINTS

  • The FDA granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine.
  • The move may encourage some unvaccinated Americans to get the shots as well as give more private businesses across the nation greater confidence to implement vaccine mandates.
  • Up until now, the mRNA vaccine was on the U.S. market under an Emergency Use Authorization.

The Food and Drug Administration on Monday granted full approval to Pfizer and BioNTech Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates.

Up until now, the mRNA vaccine, which will be marketed as Comirnaty, was on the U.S. market under an Emergency Use Authorization that was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention.

Federal health officials had been under mounting pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May. The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up.

FDA scientists evaluated “hundreds of thousands of pages” of vaccine data, according to the U.S. agency.

Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet Woodcock said in a statement. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

The FDA is holding a media briefing at 11 a.m. Monday to discuss the approval.

Although more than 60% of the total U.S. population has had at least one dose of a Covid vaccine, many Americans say they are still hesitant about getting vaccinated, even as the highly contagious delta variant spreads. Full approval may convince some Americans that the shots are safe, doctors and epidemiologists say. In fact, a survey from the Kaiser Family Foundation found 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines receives full approval.

CNBC Health & Science