Coronavirus Updates September 2021

[missy]

Good morning and happy September all. We have seen progress with each month and let's hope that continues.

"Europe reached a goal of fully vaccinating 70% of its adult population as Israel reported a record number of new cases. In the march toward administering boosters, New York Governor Kathy Hochul is setting aside millions of dollars for the effort. In Colorado, a disturbing new trend is taking shape: children are being infected at the fastest rate in the state. Here’s the latest on the pandemic. "

 

[missy]

https://www.nejm.org/doi/full/10.1056/NEJMoa2110475?query=featured_coronavirus

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BACKGROUND​

Preapproval trials showed that messenger RNA (mRNA)–based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had a good safety profile, yet these trials were subject to size and patient-mix limitations. An evaluation of the safety of the BNT162b2 mRNA vaccine with respect to a broad range of potential adverse events is needed.

METHODS​

We used data from the largest health care organization in Israel to evaluate the safety of the BNT162b2 mRNA vaccine. For each potential adverse event, in a population of persons with no previous diagnosis of that event, we individually matched vaccinated persons to unvaccinated persons according to sociodemographic and clinical variables. Risk ratios and risk differences at 42 days after vaccination were derived with the use of the Kaplan–Meier estimator. To place these results in context, we performed a similar analysis involving SARS-CoV-2–infected persons matched to uninfected persons. The same adverse events were studied in the vaccination and SARS-CoV-2 infection analyses.

RESULTS​

In the vaccination analysis, the vaccinated and control groups each included a mean of 884,828 persons. Vaccination was most strongly associated with an elevated risk of myocarditis (risk ratio, 3.24; 95% confidence interval [CI], 1.55 to 12.44; risk difference, 2.7 events per 100,000 persons; 95% CI, 1.0 to 4.6), lymphadenopathy (risk ratio, 2.43; 95% CI, 2.05 to 2.78; risk difference, 78.4 events per 100,000 persons; 95% CI, 64.1 to 89.3), appendicitis (risk ratio, 1.40; 95% CI, 1.02 to 2.01; risk difference, 5.0 events per 100,000 persons; 95% CI, 0.3 to 9.9), and herpes zoster infection (risk ratio, 1.43; 95% CI, 1.20 to 1.73; risk difference, 15.8 events per 100,000 persons; 95% CI, 8.2 to 24.2). SARS-CoV-2 infection was associated with a substantially increased risk of myocarditis (risk ratio, 18.28; 95% CI, 3.95 to 25.12; risk difference, 11.0 events per 100,000 persons; 95% CI, 5.6 to 15. and of additional serious adverse events, including pericarditis, arrhythmia, deep-vein thrombosis, pulmonary embolism, myocardial infarction, intracranial hemorrhage, and thrombocytopenia.

CONCLUSIONS​

In this study in a nationwide mass vaccination setting, the BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined. The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events was substantially increased after SARS-CoV-2 infection. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.)

More than 1 year into the pandemic of coronavirus disease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), an unprecedented number of mass vaccination efforts are under way worldwide. Globally, nearly 3.4 billion doses of vaccine have been administered over the 6-month period since the first vaccines were approved.1
Phase 3 clinical trials showed that several Covid-19 vaccines were efficacious and had an acceptable safety profile.2-4 A number of potential adverse events were identified during these trials, including lymphadenopathy and idiopathic facial-nerve (Bell’s) palsy.2,3 Trials of the BNT162b2 vaccine (Pfizer–BioNTech) also showed a mild imbalance between the vaccinated and placebo groups with respect to the number of cases of appendicitis, hypersensitivity reactions, acute myocardial infarction, and cerebrovascular accidents.5 However, phase 3 trials may have inherent limitations in assessing vaccine safety because of a small number of participants and a healthier-than-average sample population. Hence, they are often underpowered to identify less common adverse events. Postmarketing surveillance is required to monitor the safety of new vaccines in real-world settings.

Much effort is currently focused on characterizing the safety profiles of the recently approved Covid-19 vaccines. Passive surveillance systems such as the Vaccine Adverse Event Reporting System (VAERS)6 collect information about adverse events that are potentially related to vaccination. This information is voluntarily reported by health care providers and the public. These systems are useful for quickly identifying potential safety signals, which, along with the findings of phase 3 trials, can be translated to lists of adverse events of interest for further exploration (such as that provided by the Safety Platform for Emergency Vaccines [SPEAC]).7,8 Active surveillance systems such as the Biologics Effectiveness and Safety (BEST) system (part of the Sentinel Initiative)9 aim to compare the incidence of adverse events of interest in large electronic health record databases with the background historical incidence. Although active surveillance can help highlight suspicious trends, the lack of a rigorously constructed comparable control group limits the ability of such surveillance to identify causal effects of vaccination.
The effectiveness of vaccines against SARS-CoV-2 has been confirmed in real-world studies,10,11 but high-quality real-world safety data on the messenger RNA (mRNA)–based Covid-19 vaccines remain relatively sparse in the literature. The results of a study based on data reported by more than 600,000 vaccinated persons were recently published12; that study mainly assessed common and mild side effects. Two additional studies, which were based on surveys of vaccinated participants, involved small cohorts,13,14 and another study analyzed adverse events reported in the VAERS database.15 All these studies lacked controls. One study that did incorporate a control group included 8533 long-term care facility residents who had received the first dose of vaccine.16 The authors of this study concluded that the mRNA-based vaccines had an acceptable safety profile, and no notable adverse events were reported.
As of May 24, 2021, nearly 5 million people in Israel, comprising more than 55% of the population, had received two doses of the BNT162b2 vaccine.1 In this study, we used the integrated data repositories of the largest health care organization in Israel to evaluate the safety profile of the BNT162b2 vaccine. We compared the incidence of a broad set of potential short- and medium-term adverse events among vaccinated persons with the incidence among matched unvaccinated persons. Potential adverse events related to medical interventions are best understood in the context of the risks associated with the disease that these interventions aim to prevent or treat, so we also estimated the effects of SARS-CoV-2 infection on this same set of adverse events.

Methods​

STUDY SETTING​

We analyzed observational data from Clalit Health Services (CHS) in order to emulate a target trial of the effects of the BNT162b2 vaccine on a broad range of potential adverse events in a population without SARS-CoV-2 infection. CHS is the largest of four integrated payer–provider health care organizations that offer mandatory health care coverage in Israel. CHS insures approximately 52% of the population of Israel (>4.7 million of 9.0 million persons), and the CHS-insured population is approximately representative of the Israeli population at large.17 CHS directly provides outpatient care, and inpatient care is divided between CHS and out-of-network hospitals. CHS information systems are fully digitized and feed into a central data warehouse. Data regarding Covid-19, including the results of all SARS-CoV-2 polymerase-chain-reaction (PCR) tests, Covid-19 diagnoses and severity, and vaccinations, are collected centrally by the Israeli Ministry of Health and shared with each of the four national health care organizations daily.
This study was approved by the CHS institutional review board. The study was exempt from the requirement for informed consent.

ELIGIBILITY CRITERIA​

Eligibility criteria included an age of 16 years or older, continuous membership in the health care organization for a full year, no previous SARS-CoV-2 infection, and no contact with the health care system in the previous 7 days (the latter criterion was included as an indicator of a health event not related to subsequent vaccination that could reduce the probability of receiving the vaccine). Because of difficulties in distinguishing the recoding of previous events from true new events, for each adverse event, persons with a previous diagnosis of that event were excluded.
As in our previous study of the effectiveness of the BNT162b2 vaccine,10 we also excluded persons from populations in which confounding could not be adequately addressed — long-term care facility residents, persons confined to their homes for medical reasons, health care workers, and persons for whom data on body-mass index or residential area were missing (missing data for these variables are rare in the CHS data). A complete definition of the study variables is included in Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org.

STUDY DESIGN AND OVERSIGHT​

The target trial for this study would assign eligible persons to either vaccination or no vaccination. To emulate this trial, on each day from the beginning of the vaccination campaign in Israel (December 20, 2020) until the end of the study period (May 24, 2021), eligible persons who were vaccinated on that day were matched to eligible controls who had not been previously vaccinated. Since the matching process each day considered only information available on or before that day (and was thus unaffected by later vaccinations or SARS-CoV-2 infections), unvaccinated persons matched on a given day could be vaccinated on a future date, and on that future date they could become newly eligible for inclusion in the study as a vaccinated person.
In an attempt to emulate randomized assignment, vaccinated persons and unvaccinated controls were exactly matched on a set of baseline variables that were deemed to be potential confounders according to domain expertise — namely, variables that were potentially related to vaccination and to a tendency toward the development of a broad set of adverse clinical conditions. These matching criteria included the sociodemographic variables of age (categorized into 2-year age groups), sex (male or female), place of residence (at city- or town-level granularity), socioeconomic status (divided into seven categories), and population sector (general Jewish, Arab, or ultra-Orthodox Jewish). In addition, the matching criteria included clinical factors to account for general clinical condition and disease load, including the number of preexisting chronic conditions (those considered to be risk factors for severe Covid-19 by the Centers for Disease Control and Prevention [CDC] as of December 20, 2020,18 divided into four categories), the number of diagnoses documented in outpatient visits in the year before the index date (categorized into deciles within each age group), and pregnancy status.
All the authors designed the study and critically reviewed the manuscript. The first three authors collected and analyzed the data. A subgroup of the authors wrote the manuscript. The last author vouches for the accuracy and completeness of the data and for the fidelity of the study to the protocol. There was no commercial funding for this study, and no confidentiality agreements were in place.

ADVERSE EVENTS OF INTEREST​

The set of potential adverse events for the target trial was drawn from several relevant sources, including the VAERS, BEST, and SPEAC frameworks, information provided by the vaccine manufacturer, and relevant scientific publications. We cast a wide net to capture a broad range of clinically meaningful short- and medium-term potential adverse events that would be likely to be documented in the electronic health record. Accordingly, mild adverse events such as fever, malaise, and local injection-site reactions were not included in this study. The study included 42 days of follow-up, which provided 21 days of follow-up after each of the first and second vaccine doses. A total of 42 days was deemed to be sufficient for identifying medium-term adverse events, without being so long as to dilute the incidence of short-term adverse events. Similarly, adverse events that could not plausibly be diagnosed within 42 days (e.g., chronic autoimmune disease) were not included.
Adverse events were defined according to diagnostic codes and short free-text phrases that accompany diagnoses in the CHS database. A complete list of the study outcomes (adverse events) and their definitions is provided in Table S2.
For each adverse event, persons were followed from the day of matching (time zero of follow-up) until the earliest of one of the following: documentation of the adverse event, 42 days, the end of the study calendar period, or death. We also ended the follow-up of a matched pair when the unvaccinated control received the first dose of vaccine or when either member of the matched pair received a diagnosis of SARS-CoV-2 infection.

RISKS OF SARS-COV-2 INFECTION​

To place the magnitude of the adverse effects of the vaccine in context, we also estimated the effects of SARS-CoV-2 infection on these same adverse events during the 42 days after diagnosis. We used the same design as the one that we used to study the adverse effects of vaccination, except that the analysis period started at the beginning of the Covid-19 pandemic in Israel (March 1, 2020) and persons who had had recent contact with the health care system were not excluded (because such contact may be expected in the days before diagnosis).
Each day in this SARS-CoV-2 analysis, persons with a new diagnosis of SARS-CoV-2 infection were matched to controls who were not previously infected. As in the vaccine safety analysis, persons could become infected with SARS-CoV-2 after they were already matched as controls on a previous day, in which case their data would be censored from the control group (along with their matched SARS-CoV-2–infected person) and they could then be included in the group of SARS-CoV-2–infected persons with a newly matched control. Follow-up of each matched pair started from the date of the positive PCR test result of the infected member and ended in an analogous manner to the main vaccination analysis, this time ending when the control member was infected or when either of the persons in the matched pair was vaccinated.
The effects of vaccination and of SARS-CoV-2 infection were estimated with different cohorts. Thus, they should be treated as separate sets of results rather than directly compared.

STATISTICAL ANALYSIS​

Because a large proportion of the unvaccinated controls were vaccinated during the follow-up period, we opted to estimate the observational analogue of the per-protocol effect if all unvaccinated persons had remained unvaccinated during the follow-up. To do so, we censored data on the matched pair if and when the control member was vaccinated. Persons who were first matched as unvaccinated controls and then became vaccinated during the study period could be included again as vaccinated persons with a new matched control. The same procedure was followed in the SARS-CoV-2 infection analysis (i.e., persons who were first matched as uninfected controls and then became infected during the study period could be included again as infected persons with a new matched control).
We used the Kaplan–Meier estimator19 to construct cumulative incidence curves and to estimate the risk of each adverse event after 42 days in each group. The risks were compared with ratios and differences (per 100,000 persons).
In the vaccination analysis, so as not to attribute complications arising from SARS-CoV-2 infection to the vaccination (or lack thereof), we also censored data on the matched pair if and when either member received a diagnosis of SARS-CoV-2 infection. Similarly, in the SARS-CoV-2 infection analysis, we censored data on the matched pair if and when either member was vaccinated. Additional details are provided in the Supplementary Methods 1 section in the Supplementary Appendix.
We calculated confidence intervals using the nonparametric percentile bootstrap method with 500 repetitions. As is standard practice for studies of safety outcomes, no adjustment for multiple comparisons was performed. Analyses were performed with the use of R software, version 4.0.4.

Results​

VACCINATION ANALYSIS​

Figure 1.

Study Population for the Vaccination Analysis.Table 1.

Baseline Characteristics of the Study Populations According to Vaccination Status and SARS-CoV-2 Infection Status.
A total of 1,736,832 persons were eligible for inclusion in the vaccination cohort (Figure 1). The median age in the eligible cohort was 43 years (Table S3). The final size of the study population differed for each studied adverse event because of adverse event–specific exclusion of persons with a history of that event. On average, across the adverse event–specific cohorts, 72.4% of the eligible persons were successfully matched. Table 1 shows the baseline characteristics of the total study population, with the mean distribution of characteristics across the various adverse event–specific cohorts. The characteristics of each adverse event–specific cohort are provided in Table S4. The vaccination cohorts included a mean of 884,828 vaccinated persons, with a median age of 38 years (5 years younger than the median age of the eligible cohort). A total of 48% of the population was female.
Table 2.

Adverse Events Associated with SARS-CoV-2 Vaccination.
The effect of vaccination on the various potential adverse events included in this study is presented in Table 2. The risk was substantially higher on either the multiplicative (risk ratio) or additive (risk difference) scales in the vaccinated group than in the unvaccinated group for myocarditis (risk ratio, 3.24; 95% confidence interval [CI], 1.55 to 12.44; risk difference, 2.7 events per 100,000 persons; 95% CI, 1.0 to 4.6), lymphadenopathy (risk ratio, 2.43; 95% CI, 2.05 to 2.78; risk difference, 78.4 events per 100,000 persons; 95% CI, 64.1 to 89.3), appendicitis (risk ratio, 1.40; 95% CI, 1.02 to 2.01; risk difference, 5.0 events per 100,000 persons; 95% CI, 0.3 to 9.9), and herpes zoster infection (risk ratio, 1.43; 95% CI, 1.20 to 1.73; risk difference, 15.8 events per 100,000 persons; 95% CI, 8.2 to 24.2). Vaccination was substantially protective against adverse events such as anemia, acute kidney injury, intracranial hemorrhage, and lymphopenia.
Figure S1 shows the cumulative incidence (risk) curves for each specific adverse event. Spikes in the incidence of lymphadenopathy were seen after both the first and second doses of vaccine, whereas the incidence of myocarditis spiked mainly after the second dose of vaccine.

SARS-COV-2 INFECTION ANALYSIS​

Figure 2.

Study Population for the SARS-CoV-2 Analysis.
A total of 233,392 persons (median age, 36 years) were eligible to be included in the SARS-CoV-2 infection cohort (Figure 2). On average, across the adverse event–specific cohorts, 75.8% of the eligible persons were successfully matched. Table 1 shows the average distribution of characteristics in these cohorts, across the two study groups (infected and noninfected). The characteristics of each adverse event–specific cohort are provided in Table S5. The cohorts for the analysis of SARS-CoV-2 infection comprised a mean of 173,106 SARS-CoV-2–infected persons (median age, 34 years). A total of 54% of these persons were female.
Table S6 shows the effect of SARS-CoV-2 infection on the incidence of various adverse events. Infection substantially increased the risk of many different adverse events, including myocarditis (risk ratio, 18.28; 95% CI, 3.95 to 25.12; risk difference, 11.0 events per 100,000 persons; 95% CI, 5.6 to 15., acute kidney injury (risk ratio, 14.83; 95% CI, 9.24 to 28.75; risk difference, 125.4 events per 100,000 persons; 95% CI, 107.0 to 142.6), pulmonary embolism (risk ratio, 12.14; 95% CI, 6.89 to 29.20; risk difference, 61.7 events per 100,000 persons; 95% CI, 48.5 to 75.4), intracranial hemorrhage (risk ratio, 6.89; 95% CI, 1.90 to 19.16; risk difference, 7.6 events per 100,000 persons; 95% CI, 2.7 to 12.6), pericarditis (risk ratio, 5.39; 95% CI, 2.22 to 23.58; risk difference, 10.9 events per 100,000 persons; 95% CI, 4.9 to 16.9), myocardial infarction (risk ratio, 4.47; 95% CI, 2.47 to 9.95; risk difference, 25.1 events per 100,000 persons; 95% CI, 16.2 to 33.9), deep-vein thrombosis (risk ratio, 3.78; 95% CI, 2.50 to 6.59; risk difference, 43.0 events per 100,000 persons; 95% CI, 29.9 to 56.6), and arrhythmia (risk ratio, 3.83; 95% CI, 3.07 to 4.95; risk difference, 166.1 events per 100,000 persons; 95% CI, 139.6 to 193.2).

BOTH ANALYSES​

Figure 3.

Risk Ratios for Adverse Events after Vaccination or SARS-CoV-2 Infection.Figure 4.

Absolute Excess Risk of Various Adverse Events after Vaccination or SARS-CoV-2 Infection.
Figure 3 shows estimated risk ratios in both the vaccination and SARS-CoV-2 infection analyses for adverse events in which vaccination or infection substantially increased the risk. Figure 4 shows the absolute risk associated with vaccination, alongside the absolute risk associated with SARS-CoV-2 infection, for the same adverse events.

Discussion​

We used a data set involving more than 2.4 million vaccinated persons from an integrated health care organization to evaluate the safety profile of the BNT162b2 mRNA Covid-19 vaccine. The main potential adverse events identified included an excess risk of lymphadenopathy (78.4 events per 100,000 persons), herpes zoster infection (15.8 events), appendicitis (5.0 events), and myocarditis (2.7 events).
To place these risks in context, we also examined data on more than 240,000 infected persons to estimate the effects of a documented SARS-CoV-2 infection on the incidence of the same adverse events. SARS-CoV-2 infection was not estimated to have a meaningful effect on the incidence of lymphadenopathy, herpes zoster infection, or appendicitis, but it was estimated to result in a substantial excess risk of myocarditis (11.0 events per 100,000 persons). SARS-CoV-2 infection was also estimated to substantially increase the risk of several adverse events for which vaccination was not found to increase the risk, including an estimated excess risk of arrhythmia (166.1 events per 100,000 persons), acute kidney injury (125.4 events), pulmonary embolism (61.7 events), deep-vein thrombosis (43.0 events), myocardial infarction (25.1 events), pericarditis (10.9 events), and intracranial hemorrhage (7.6 events).
An association between Covid-19 vaccination and myocarditis has been previously reported.20Although no cases of myocarditis were reported in the BNT162b2 (Pfizer–BioNTech),2 mRNA-1273 (Moderna),3 or ChAdOx1 nCoV-19 (AstraZeneca)4 phase 3 clinical trials, multiple cases of myocarditis after Covid-19 vaccination have recently been reported in the literature,21-25 and both the Israeli Ministry of Health26 and the CDC have investigated this association.27 The risk appears to be highest among young men.26,27 We found that the risk of myocarditis increased by a factor of three after vaccination, which translated to approximately 3 excess events per 100,000 persons; the 95% confidence interval indicated that values between 1 and 5 excess events per 100,000 persons were compatible with our data. Among the 21 persons with myocarditis in the vaccinated group, the median age was 25 years (interquartile range, 20 to 34), and 90.9% were male.
Another vaccine-related adverse event that has recently received attention in the medical literature is Bell’s palsy. In a recent article based on publicly available data from the BNT162b2 and mRNA-1273 vaccine trials, Ozonoff et al.28 suggested a possible association between these vaccines and Bell’s palsy and estimated a rate ratio of approximately 7.0. This conclusion differed from the Food and Drug Administration briefing on these vaccines in December 2020; that briefing considered the incidence of Bell’s palsy to be similar to the background incidence.5 A small number of cases of Bell’s palsy after Covid-19 vaccination have also been reported in the literature.29,30 In the current study, the effect estimate was consistent with a potentially mild increase in the risk of Bell’s palsy after vaccination, with a risk ratio of 1.32 (95% CI, 0.92 to 1.86). The absolute effect was small, with up to 8 excess events per 100,000 persons being highly compatible with our data according to the 95% confidence interval. Herpes zoster infection, the incidence of which we found to be increased after vaccination, is one of the potential causes of facial-nerve palsy.31
Another particularly notable class of adverse events that has been reported in the context of Covid-19 vaccines is thromboembolic events. These adverse events, which primarily affect young women, have been linked with the ChAdOx1 nCoV-1932 and Ad26.COV2.S (Johnson & Johnson–Janssen) Covid-19 vaccines,33 both of which are adenoviral vector vaccines. However, we did not find an association between the BNT162b2 vaccine and various thromboembolic events in this study.
Some initially unexpected effects were seen in the results of the current study. The BNT162b2 vaccine appears to be protective against certain conditions such as anemia and intracranial hemorrhage. These same adverse events are also identified in this study as complications of SARS-CoV-2 infection, so it appears likely that the protective effect of the vaccine is mediated through its protection against undiagnosed SARS-CoV-2 infection, which may be undiagnosed either because of a lack of testing or because of false negative PCR results.
This study has several limitations. First, persons in the study were not randomly assigned according to exposures (vaccinations and SARS-CoV-2 infections); this may have introduced confounding at baseline and selection bias at censoring, especially since a single set of confounders was used for adjustment in the assessment of many disparate adverse events. Second, the matching process that was necessary to attain exchangeability between the study groups resulted in a study population with a different composition than the eligible population (e.g., median age, 38 years rather than 43 years). Because this different composition changes the population over which the causal effect is being estimated, different estimates might be found for adverse events for which the incidence may differ substantially between subgroups (e.g., myocarditis). Also, we excluded certain populations (such as health care workers and persons residing in long-term care facilities) that could be at particularly high risk for certain adverse events. Both of these issues should be taken into account when considering the generalizability of the findings.
Third, some diagnoses that were recorded in out-of-network hospitals, which were delayed in being reported to the insurer and were not entered by the person’s general practitioner from the hospital discharge notes into the outpatient medical record, could have been missed. Fourth, it is possible that persons are more likely to increase their levels of clinical awareness, concern, or both after vaccination or SARS-CoV-2 infection, and thus they may be more likely to report or seek medical care for their symptoms, resulting in a spuriously increased incidence of the various adverse events in the vaccinated or infected groups. Similarly, among persons with SARS-CoV-2 infection, the spike in the incidence of certain adverse events in the first day of follow-up could indicate the initial clinical manifestation of the infection, but it could also be related to active testing for SARS-CoV-2. Fifth, all the effect measures that we presented are based only on a new incidence of the specific adverse event under study; thus, less light was shed on the potential additional risk among persons with a medical history of each of these adverse events. However, this choice was necessary to distinguish between true new diagnoses of a given adverse event and recoding of past diagnoses and to ensure the accuracy of the adverse-event labels.
In this study, we sought to place the increased risk of adverse events caused by the BNT162b2 vaccine in context by contrasting this risk with that of the same adverse events after documented infection with SARS-CoV-2. We thought that this was necessary because vaccination and its potential risks do not occur in a void but rather in the context of an ongoing pandemic. Although the general risks of hospitalization, severe disease, and death from Covid-19 are widely recognized, secondary complications of infection are less well known. Therefore, in this analysis, we sought to estimate the effects of SARS-CoV-2 infection on the incidence of the same list of adverse events examined in the vaccination analysis. Because the cohorts that we used to study the vaccine and infection effects were different in composition, care should be taken when comparing the resulting risk estimates. In addition, knowledge of these risks alone is insufficient for a complete decision-theoretic analysis. When a person decides to become vaccinated, this choice results in a probability of 100% for the vaccination, whereas the alternative of contracting SARS-CoV-2 infection is an event with uncertain probability that depends on the person, place, and time. Moreover, infection with SARS-CoV-2 has many other adverse effects beyond those considered here, including the risk of transmission to family members and others.
We estimated that the BNT162b2 vaccine resulted in an increased incidence of a few adverse events over a 42-day follow-up period. Although most of these events were mild, some of them, such as myocarditis, could be potentially serious. However, our results indicate that SARS-CoV-2 infection is itself a very strong risk factor for myocarditis, and it also substantially increases the risk of multiple other serious adverse events. These findings help to shed light on the short- and medium-term risks of the vaccine and place them in clinical context. Further studies will be needed to estimate the potential of long-term adverse events.
Supported by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute. Dr. Lipsitch receives support from the Morris–Singer Foundation.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Drs. Barda and Dagan and Drs. Reis and Balicer contributed equally to this article.
Because of data privacy regulations, the raw data for this study cannot be shared.
This article was published on August 25, 2021, at NEJM.org.
We thank Oren Miron for his valuable advice.

Author Affiliations​

From the Clalit Research Institute, Innovation Division (N.B., N.D., Y.B.-S., E.K., J.W., R.O., R.D.B.), and the Community Medical Services Division (D.N.), Clalit Health Services, Tel Aviv, and Software and Information Systems Engineering (N.B., N.D.) and the School of Public Health, Faculty of Health Sciences (R.D.B.), Ben-Gurion University of the Negev, Be’er Sheva — both in Israel; the Department of Biomedical Informatics (N.B., N.D., I.K.), and the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute (N.B., N.D., I.K., B.Y.R., R.D.B.), Harvard Medical School (B.Y.R.), the Departments of Epidemiology and Biostatistics (M.A.H.), CAUSALab (M.A.H.), and the Center for Communicable Disease Dynamics, Departments of Epidemiology and Immunology and Infectious Diseases (M.L.), Harvard T.H. Chan School of Public Health, and the Predictive Medicine Group, Computational Health Informatics Program, Boston Children’s Hospital (B.Y.R.) — all in Boston.
Address reprint requests to Dr. Balicer at the Clalit Research Institute, Innovation Division, Clalit Health Services, 101 Arlozorov St., Tel Aviv, Israel, or at [email protected].

Supplementary Material​

Supplementary Appendix	PDF	4450KB
Disclosure Forms	PDF	448KB

References (33)​

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[missy]

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Almost like clockwork​ ​

Has the Delta-fueled Covid-19 surge in the U.S. finally peaked?​

The number of new daily U.S. cases has risen less over the past week than at any point since June, as you can see in this chart:​

The New York Times​

There is obviously no guarantee that the trend will continue. But there is one big reason to think that it may and that caseloads may even soon decline.​

Since the pandemic began, Covid has often followed a regular — if mysterious — cycle. In one country after another, the number of new cases has often surged for roughly two months before starting to fall. The Delta variant, despite its intense contagiousness, has followed this pattern.​

After Delta took hold last winter in India, caseloads there rose sharply for slightly more than two months before plummeting at a nearly identical rate. In Britain, caseloads rose for almost exactly two months before peaking in July. In Indonesia, Thailand, France, Spain and several other countries, the Delta surge also lasted somewhere between 1.5 and 2.5 months.​

* Between February and July 2021, depending on the country.The New York Times​

And in the U.S. states where Delta first caused caseloads to rise, the cycle already appears to be on its downside. Case numbers in Arkansas, Florida, Louisiana, Mississippi and Missouri peaked in early or mid-August and have since been falling:​

The New York Times​

Two possible stories​ ​

We have asked experts about these two-month cycles, and they acknowledged that they could not explain it. “We still are really in the cave ages in terms of understanding how viruses emerge, how they spread, how they start and stop, why they do what they do,” Michael Osterholm, an epidemiologist at the University of Minnesota, said.​

But two broad categories of explanation seem plausible, the experts say.​

One involves the virus itself. Rather than spreading until it has reached every last person, perhaps it spreads in waves that happen to follow a similar timeline. How so? Some people may be especially susceptible to a variant like Delta, and once many of them have been exposed to it, the virus starts to recede — until a new variant causes the cycle to begin again (or until a population approaches herd immunity).​

The second plausible explanation involves human behavior. People don’t circulate randomly through the world. They live in social clusters, Jennifer Nuzzo, a Johns Hopkins epidemiologist, points out. Perhaps the virus needs about two months to circulate through a typically sized cluster, infecting the most susceptible — and a new wave starts when people break out of their clusters, such as during a holiday. Alternately, people may follow cycles of taking more and then fewer Covid precautions, depending on their level of concern.​

Whatever the reasons, the two-month cycle predated Delta. It has repeated itself several times in the U.S., including both last year and early this year, with the Alpha variant, which was centered in the upper Midwest:​

The New York Times​

What now?​ ​

We want to emphasize that cases are not guaranteed to decline in coming weeks. There have been plenty of exceptions to the two-month cycle around the world. In Brazil, caseloads have followed no evident pattern. In Britain, cases did decline about two months after the Delta peak — but only for a couple of weeks. Since early August, cases there have been rising again, with the end of behavior restrictions likely playing a role. (If you haven’t yet read this Times dispatch about Britain’s willingness to accept rising caseloads, we recommend it.)​

In the U.S., the start of the school year could similarly spark outbreaks this month. The country will need to wait a few more weeks to know. In the meantime, one strategy continues to be more effective than any other in beating back the pandemic: “Vaccine, vaccine, vaccine,” as Osterholm says. Or as Nuzzo puts it, “Our top goal has to be first shots in arms.”​

The vaccine is so powerful because it keeps deaths and hospitalizations rareeven during surges in caseloads. In Britain, the recent death count has been less than one-tenth what it was in January.​

In a few countries, vaccination rates have apparently risen high enough to break Covid’s usual two-month cycle: The virus evidently cannot find enough new people to infect. In both Malta and Singapore, this summer’s surge lasted only about two weeks before receding.​

More on the virus:​

Two top F.D.A. vaccine regulators — upset by President Biden’s announcement that adults should get coronavirus vaccine boosters — will leave the agency. A New Jersey woman who used the Instagram handle @AntiVaxMomma was charged with selling fake vaccine cards. Tom Wolf, Pennsylvania’s Democratic governor, will require mask-wearing in schools. "

 

[missy]

Just because a case is considered mild doesn’t mean it’s pleasant. Some people with so-called mild coronavirus cases report feeling the sickest in their lives, run down by symptoms such as persistent headaches and fatigue. Because the vaccines aren't perfect, a few people who are vaccinated may have mild cases — although the vaccines effectively prevent severe disease and hospitalization, they don't always stop infections. Even these mild cases in immunized people can feel like being “run over by a truck," as a vaccinated person said to Health reporter Fenit Nirappil.

Masks, in addition to vaccines, work. Lots of evidence in favor of masks has accumulated during the pandemic, but nothing quite like a new randomized trial that involved more than 340,000 adults in Bangladesh, some of whom were given masks and told to wear them. The groups that wore masks in this massive study had fewer symptomatic cases. “Anti-mask people keep saying, ‘Where’s the randomized controlled trial?’ Well, here you go,” as one doctor told me.

Here's a snapshot of the United States amid the delta surge: The seven-day average of new cases, above 160,000, has risen to its highest level since January. But Americans have stepped up the vaccination rate, with more people getting shots in August — about 14 million people had first shots last month — than in July. Meanwhile, unvaccinated people should not travel over Labor Day weekend, the Centers for Disease Control and Prevention warned.

Evidence does not support the use of ivermectin, an anti-parasitic drug, as a therapy for coronavirus infections. But a lack of scientific support for hasn't stopped covid-19 patients from asking doctors about ivermectin.Although some forms of ivermectin can be safely prescribed for parasites in humans, the drug may be harmful when abused. In July, poison control calls involving ivermectin were five times higher than typical, per the American Association of Poison Control Centers.

Billions and billions of dollars in pandemic aid, meant for hospitals and nursing homes, are caught up in a bottleneck: The Biden administration has yet to release the money. Among the funds awaiting release are $44 billion in a Provider Relief Fund as well as $8.5 billion allocated by Congress for rural medical care.

The coronavirus is already disturbing the consumer side of the winter holidays. Supply chain disruption, including a lack of shipping containers, means toys and other popular gifts will be in short supply come Christmas. Walmart and Home Depot have chartered their own shipping boats to collect cargo from overseas. If there's a gesture that might embody what the fall economy will look like, it's a shrug — because much is in limbo, including consumer sentiment and return-to-office dates.

 

[missy]

​

In June, a church sponsored a five-day teen camp and a two-day men's retreat in Illinois. Masks and vaccines weren't required. Those events were linked to at least 180 coronavirus infections, the CDC reports. People with long covid may have an increased risk of kidney damage, according to a study published today in the Journal of the American Society of Nephrology. As the new school year starts, people of color report more hesitancy than White people about sending kids to in-person classes. Two Food and Drug Administration officials, who oversee reviews of the coronavirus vaccines, plan to retire this fall. During the pandemic, 45.7 percent of 5- to 11-year-olds were considered overweight or obese, an increase of nearly 10 percentage points from before the pandemic. Also, if you have a child under 12, Post reporters want to hear about your experience raising a young child amid the delta surge.​

​

Guide to the pandemic​ Track confirmed cases, hospitalizations and deaths in the U.S. and the spread around the world. U.S. vaccine distribution and delivery, tracked by state. Guides: Finding vaccine appointments | Vaccines | Variants | Masks Follow updates about the pandemic from Post reporters across the globe. ​

 

[missy]

COVID-19 Vaccines Still Highly Effective Against Hospitalization, CDC Data Show​

Although COVID-19 vaccines are less effective against the Delta variant, they're still extremely effective in preventing hospitalization, according to data presented Monday to the CDC's Advisory Committee on Immunization Practices.

Since the Delta variant has become the dominant coronavirus strain, vaccine effectiveness against hospitalization has ranged from 75% to 95%.

In adults over age 75, vaccine effectiveness against hospitalization has dropped slightly but was still above 80% at the end of July. For ages 18-49, efficacy was around 94%.


"Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness," Sara Oliver, MD, the CDC scientist who presented the information, told the committee.

In a new data analysis released by the CDC on Sunday, unvaccinated adults were 17 times more likely to be hospitalized than vaccinated adults. Hospitalization rates were higher for unvaccinated people in all age groups.

Among the fully vaccinated, people who were hospitalized were much older, more likely to be nursing home residents and more likely to have three or more underlying medical conditions. Nearly a third had immunosuppressive conditions.

Since the Delta variant became dominant, vaccine effectiveness against preventing infection has ranged from 39% to 84%, Oliver said. The drop in efficacy could be linked with the highly contagious nature of the Delta variant and waning vaccine protection over time.



Oliver discussed the idea of booster COVID-19 doses, noting that it's not uncommon for some vaccines to require multiple doses, such as those for hepatitis and HPV. At the same time, she said, more information is needed before the FDA can provide regulatory clearance and the ACIP can give recommendations for use.

Pfizer has submitted documentation to the FDA for approval of a booster dose, according to CBS News. The data showed that a third shot provided a boost in antibodies between 5 and 8 months after the initial two doses.

The CDC committee will meet again in mid-September to discuss additional data from August as the Biden administration plans to roll out booster after Sept. 20, CBS News reported.

Importantly, Oliver added, those who face the highest risks for severe COVID-19 should receive priority for booster shots. About 1 million Americans have received an additional dose since Aug. 13, when the FDA and CDC cleared some immunocompromised people to get a third shot, CBS News reported.


If booster doses are approved for the general population, she said, the initial shots should go to nursing home residents, healthcare workers, adults over age 75 and frontline essential workers.


In addition, she noted, COVID-19 vaccines should be available to high-risk people worldwide, especially those in low-income countries who haven't yet received a first dose.


"Uncontrolled spread globally that could result in new variants threaten control of the pandemic everywhere," she said in the presentation. "Policy around booster doses should also consider equity in the U.S. population."

Sources​

CDC: "Framework for booster doses of COVID-19 vaccines, ACIP meeting, August 30, 2021."


medRxiv: "COVID-19-associated hospitalizations among vaccinated and unvaccinated adults >18 years – COVID-NET, 13 states, January 1 – July 24, 2021."


CBS News: "COVID-19 vaccine effectiveness in preventing hospitalization drops among oldest Americans, but still over 80%, CDC analysis finds."

 

[Asscherhalo_lover]

I had to go to my school board meeting last night. At the last one my district decided to have a mask mandate, before the state ordered one. Since then it has been ordered but I knew the anti-maskers would be there spewing their non-sense so I had to go. I'm glad I did, about three of them in a row went up and then I said my bit. I just can't believe how ignorant they are. It's so frustrating.

 

[missy]

I had to go to my school board meeting last night. At the last one my district decided to have a mask mandate, before the state ordered one. Since then it has been ordered but I knew the anti-maskers would be there spewing their non-sense so I had to go. I'm glad I did, about three of them in a row went up and then I said my bit. I just can't believe how ignorant they are. It's so frustrating.

Terrifying isn’t it. Human’s downfall -all human caused.
And we try taking everyone and everything with us.

 

[FL_runner]

Just wanted to pop in and let everyone know my husband is doing much better only a few days after his diagnosis! We are both so grateful that we were vaccinated with Moderna- I think that’s been a major factor in his boungi g back quickly and the fact that myself and my older child never caught it (he’s been good about isolating from the kiddos). My littlest is about 90% recovered, still taking long naps, but was bouncing around the house

On a side note, my sweetie has been trying to talk all his skeptical coworkers into getting vaccinated- he’s a trooper and never wants to admit he’s sick so he’s teleworked through his illness. He got a lot of “you’re vaccinated and got sick so why would I get vaccinated?” messages all week and he keeps telling them that it’s why it’s just been like a bad cold!

My older daughter is quarantined due to being a close contact but is 100% well and tested neg so far, but we were just notified that another student in her class is positive, and I know several teachers and other students in her school are out. There’s no virtual option this fall at her school so it’s a scramble to keep up, especially since I’m working while all this is going on. At least they are good about masking, covid protocols, Contact tracing, enforcing quarantine and notifying parents. It’s one of the reasons I’ve kept her in a private school as opposed to public here in FL for the past 2 years- Previously had always used public schools.

 

[dk168]

There is sufficient evidence to suggest the younger people are driving the current wave in UK since the majority of restrictions were lifted on 19 July 2021.

Although life is slowly getting back to normal, I was informed yesterday that one of my friends might have been infected after a busy 3-day weekend. He is currently awaiting the result of his PCR test.

He has been in close contact with other mutual friends in the last few days, so potentially they could be affected too.

I went for a scheduled diabetic health check yesterday, and asked the nurse-specialist whether I would be offered a booster, and he responded that my guess would be as good as anyone's at this stage.

I am feeling largely optimistic, however, there is a nagging concern that Covid-19 is far from over. The main concern for me right now is changes to travel restrictions to Canada as I am hoping to fly to Vancouver to visit my mum and bro in November 2021. Fingers firmly crossed that I would be able to go.

DK

 

[missy]

@FL_runner that is great news and I hope your DD continues to be negative and that your DH and little one continue to do well! And you too!

@dk168 I hope you get to visit your mom and brother in Vancouver in November and remain well. I agree with you. Covid 19 is not over by any means. I won't get on my soapbox as to the reason but we all know the reason.

 

[missy]

Has the Delta variant peaked? The New York Times explores the question.


Pennsylvania governor Tom Wolf (D) issued a statewide mask mandate for pre-K-to-12th grade public and private school students and day care centers. (Philadelphia Inquirer)
Meanwhile, parents in some states where masks aren't required at school and other protocols aren't enforced are struggling with their decision to send their children to school. (NBC News)

In a 5-4 vote, the Supreme Court upheld a Texas law that bans abortion after 6 weeks' gestation and allows Texans to sue anyone who "aided and abetted" an abortion. (NPR)


In other legal news, a federal judge has approved the bankruptcy settlement for OxyContin maker Purdue Pharma; it will protect members of the Sackler family, which founded the company, from individually having to pay claims related to the opioid medication. (The Hill)


Got travel plans for Labor Day weekend? You may want to reconsider, the CDC says. (CNN)


As of 8 a.m. EDT today, the unofficial COVID-19 toll in the U.S. was 39,399,080 cases and 642,093 deaths, increases of 198,329 and 1,972, respectively, from the same time yesterday.


An FDA advisory committee will meet on September 17 to consider approving a booster dose of the Pfizer-BioNTech COVID-19 vaccine for patients 16 and older.


A preprint study of 340,000 people in Bangladesh provides conclusive evidencethat surgical masks stop the spread of COVID-19, its authors say. (Washington Post)

The idea that COVID-19 is now a "pandemic of the unvaccinated" isn't really a useful paradigm, some experts are saying. (Associated Press)


The WHO is monitoring a new coronavirus variant called "mu," which it says could potentially evade immunity provided by a vaccine or previous coronavirus infection. (CNBC)


The Biden administration is weighing how to speed up implementation of a potential Medicare dental benefit if it's passed as part of an infrastructure bill being considered in Congress. (Washington Post)


The FDA has approved zanubrutinib (Brukinsa, BeiGene) for adults with Waldenström's macroglobulinemia.


With the "unprecedented strain" of surging COVID-19 at children's hospitals, the Children's Hospital Association is asking the public, the Biden administration, and Congress for help. (NPR)


Joe Rogan, a podcaster who previously questioned the need for COVID vaccines in some people, has contracted COVID-19 and had to postpone a live show. (Variety)

Another apparent long-haul sequelae of COVID-19: kidney damage. (New York Times)

Janssen announced FDA approval of its long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera) as a twice-yearly injectable for the treatment of schizophrenia in adults.


The American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists issued a joint statement "strongly opposing the ordering, prescribing, or dispensing of ivermectin" to prevent or treat COVID-19 outside of a clinical trial. The American College of Emergency Physicians issued a similar statement for the public.

 

[missy]

Rewind to mid-March of last year. There was a feeling that a few weeks of sheltering at home, combined with aggressive testing, tracing and isolation, would contain the epidemic in the U.S., much as aggressive actions in China and South Korea had.

That turned out to be wrong, of course. Many experts overestimated Americans' tolerance for mitigation measures and underestimated the virus's stealth and persistence. Non-pharmaceutical interventions wouldn't save us. The only way to end the pandemic was a vaccine.

This spring, with millions of shots administered each day in the U.S., there was hope that the inoculation campaign would put Covid mostly behind us — at least ending the surges that threatened to overwhelm hospitals. But again we were too optimistic about the willingness of Americans to get immunized and failed to account for the resilience of the virus and its variants.

We were too optimistic about the willingness of Americans to get vaccinated.

Photographer: Liz Sanders/Bloomberg

Some employers that had planned to reopen offices this month have delayed their timelines. If you envisioned that the third school year of Covid would trade masks, Zoom classes and illness for a restored sense of normalcy, this September is likely to disappoint.

As a nation, the U.S. hasn’t put Covid behind us. The public health emergency formally declared almost 18 months ago remains in place. In its early weeks, it felt like one. Now the state of emergency feels perhaps less urgent but permanent. And that requires a cognitive shift.

But that shouldn’t mean complacency. Most Covid deaths are now preventable, and we should try to prevent them. The number of Americans who died from Covid in just the last week of August, 7,843, exceeds the total killed in the 9/11 attacks and deaths of U.S. troops over 20 years of war in Afghanistan, combined.

Those events still reverberate, and Covid will too. In places like the U.S., with abundant access to vaccines, we have more power than ever to shape the future course of the pandemic. The question is how we will use it. —John Tozzi

 

[MamaBee]

Just wanted to pop in and let everyone know my husband is doing much better only a few days after his diagnosis! We are both so grateful that we were vaccinated with Moderna- I think that’s been a major factor in his boungi g back quickly and the fact that myself and my older child never caught it (he’s been good about isolating from the kiddos). My littlest is about 90% recovered, still taking long naps, but was bouncing around the house

On a side note, my sweetie has been trying to talk all his skeptical coworkers into getting vaccinated- he’s a trooper and never wants to admit he’s sick so he’s teleworked through his illness. He got a lot of “you’re vaccinated and got sick so why would I get vaccinated?” messages all week and he keeps telling them that it’s why it’s just been like a bad cold!

My older daughter is quarantined due to being a close contact but is 100% well and tested neg so far, but we were just notified that another student in her class is positive, and I know several teachers and other students in her school are out. There’s no virtual option this fall at her school so it’s a scramble to keep up, especially since I’m working while all this is going on. At least they are good about masking, covid protocols, Contact tracing, enforcing quarantine and notifying parents. It’s one of the reasons I’ve kept her in a private school as opposed to public here in FL for the past 2 years- Previously had always used public schools.

@FL_runner I don’t know how I missed that your husband and little one are sick with Covid. TG your husband was vaccinated. I hope you little one and hubby get back to 100% real soon. I can’t even imagine having children in school and navigating all that goes with that during Covid.

 

[Austina]

COVID-19: UK vaccine advisory body not recommending jabs for healthy 12 to 15-year-olds - but chief medical officers to review decision further — Sky News

Coronavirus vaccines for healthy children aged between 12 and 15 are not being recommended by the UK's vaccine advisory body - but the country's four chief medical officers are to review the matter further before a final decision is made.

apple.news

 

[Dancing Fire]

What is a mask? What is social distancing? . 109,000 in attendance at this Michigan game. Yesterday college football stadiums across the country were packed like sardines in a can.

Would you go to a football game next week?

 

[dk168]

The latest information received is that I am not eligible to receive a booster in the first cohort such as those who are severely immuno-depressed, which is understandable as my underlying health condition is far less serious compared with the others.

DK

 

[icy_jade]

What is a mask? What is social distancing? . 109,000 in attendance at this Michigan game. Yesterday college football stadiums across the country were packed like sardines in a can.

Would you go to a football game next week?

I always wonder how many people in the crowd will die of covid when I see pics like that. Is that being morbid?

 

[missy]

I always wonder how many people in the crowd will die of covid when I see pics like that. Is that being morbid?

Nope. Delta (and the ones coming after Delta which I understand are also quite bad) is very contagious.

The Delta Variant, Covid-19 Symptoms and Vaccine Efficacy: What to Know

Places with higher vaccination rates are keeping hospitalizations and deaths in check.

www.wsj.com

Snip...

"
British scientists estimate the Delta variant is from 40% to as much as 80% more infectious than the Alpha variant, or B.1.1.7, which was first identified in England last year, is now prevalent in the U.S. and is itself more contagious than the version of the virus that emerged in China in 2019.

Researchers in China reported in July that people infected with the Delta variant had about 1,000 times more viral particles in their respiratory tracts than those with the original strain. The researchers also reported that people become infectious sooner.

Wendy Barclay, professor of virology at Imperial College London, said swab tests suggest that Delta infects people with a greater virus load, which means they exhale more of it for others to catch. The mutations also appear to make the variant more effective at attaching itself to cells in human airways. The combination means that an infected person is—other things being equal—likely to infect more people and that people require less exposure to become infected."

 

[missy]

From Bloomberg COVID questions.

The unvaccinated are a risk to all of us


“ I've heard that the longer we have unvaccinated people around, the likelier it is that a new Covid variant will develop that resists vaccines. Is this true?

The number of unvaccinated Americans is certainly a major public health concern. According to the Centers for Disease Control and Prevention, about 25% of U.S. adults are still unvaccinated, and many are clustered in regions where inoculation rates are especially low. Those clusters can easily become hot spots because they give the virus so many vulnerable hosts to attack. Indeed, that’s what we’ve seen recently as cases skyrocketed in especially undervaccinated states like Louisiana and Arkansas.

As Christopher Martin, a professor of public health at West Virginia University, explains it, these undervaccinated pockets create more opportunity for the virus to mutate.

“Large numbers of unvaccinated people do make variants more likely,” he says.

The virus that causes Covid-19 replicates only when inside a human host, and it does so by hijacking our cellular machinery to make more copies of itself instead of more copies of human cells. But that process is messy, and mistakes in the genetic code occur frequently as the virus copies itself. Those mistakes often result in mutations that create slightly different versions of the invading pathogen.

“If any one of these random errors confers an advantage to that virus, such as making it more contagious like delta, that variant can quickly become the dominant one circulating in the population,” says Martin.


Clinicians work with a Covid-19 patient at Lake Charles Memorial Hospital in Louisiana, an under-vaccinated state that’s been coping with a surge fueled by the delta variant.
Photographer: Mario Tama/Getty Images
Martin explains that because our world is so interconnected, variants can spread quickly. The delta version, for example, was first identified in India in late 2020 and in the U.S in early May (though it was likely here earlier). By July it was accounting for 80% of new U.S. Covid cases. Even as delta drives the current surge in the U.S., there are four other variants scientists are concerned about.

“More are to be expected so long as the virus is circulating widely,” says Martin. And though the coronavirus does appear to be infecting vaccinated people as well in greater numbers than we expected, the unvaccinated are still far more likely to contract and spread the disease.

“Each of us remains at risk so long as there are large numbers of unvaccinated people anywhere in the world,” Martin says.
“

 

[Dancing Fire]

I always wonder how many people in the crowd will die of covid when I see pics like that. Is that being morbid?

Depends on whom you talk to. A lot of people are tired of being lock up in a cage for the past 15 months.

 

[missy]

From the NYT
“
One in 5,000
The C.D.C. reported a terrifying fact in July: Vaccinated people with the Delta variant of the Covid virus carried roughly the same viral load in their noses and throats as unvaccinated people.

The news seemed to suggest that even the vaccinated were highly vulnerable to getting infected and passing the virus to others. Sure enough, stories about vaccinated people getting Covid — so-called breakthrough infections — were all around this summer: at a party in Provincetown, Mass.; among the Chicago Cubs; on Capitol Hill. Delta seemed as if it might be changing everything.

In recent weeks, however, more data has become available, and it suggests that the true picture is less alarming. Yes, Delta has increased the chances of getting Covid for almost everyone. But if you’re vaccinated, a Covid infection is still uncommon, and those high viral loads are not as worrisome as they initially sounded.

How small are the chances of the average vaccinated American contracting Covid? Probably about one in 5,000 per day, and even lower for people who take precautions or live in a highly vaccinated community.

Or maybe one in 10,000
The estimates here are based on statistics from three places that have reported detailed data on Covid infections by vaccination status: Utah; Virginia; and King County, which includes Seattle, in Washington state. All three are consistent with the idea that about one in 5,000 vaccinated Americans have tested positive for Covid each day in recent weeks.

The chances are surely higher in the places with the worst Covid outbreaks, like the Southeast. And in places with many fewer cases — like the Northeast, as well as the Chicago, Los Angeles and San Francisco areas — the chances are lower, probably less than 1 in 10,000. That’s what the Seattle data shows, for example. (These numbers don’t include undiagnosed cases, which are often so mild that people do not notice them and do not pass the virus to anyone else.)

Here’s one way to think about a one-in-10,000 daily chance: It would take more than three months for the combined risk to reach just 1 percent.

“There’s been a lot of miscommunication about what the risks really are to vaccinated people, and how vaccinated people should be thinking about their lives,” as Dr. Ashish Jha of Brown University told my colleague Tara Parker-Pope. (I recommend Tara’s recent Q. and A. on breakthrough infections.)

For the unvaccinated, of course, the chances of infection are far higher, as Dr. Jeffrey Duchin, the top public-health official in Seattle, has noted. Those chances have also risen much more since Delta began spreading:


Source: Washington State Department of Health
Another way to understand the situation is to compare each state’s vaccination rate with its recent daily Covid infection rate. The infection rates in the least vaccinated states are about four times as high as in the most vaccinated states:


Data as of Sept. 2; cases are the 7-day daily average.The New York Times
If the entire country had received shots at the same rate as the Northeast or California, the current Delta wave would be a small fraction of its current size. Delta is a problem. Vaccine hesitancy is a bigger problem.

The science, in brief
These numbers help show why the talking point about viral loads was problematic. It was one of those statements that managed to be both true and misleading. Even when the size of the viral loads are similar, the virus behaves differently in the noses and throats of the vaccinated and the unvaccinated.

In an unvaccinated person, a viral load is akin to an enemy army facing little resistance. In a vaccinated person, the human immune system launches a powerful response and tends to prevail quickly — often before the host body gets sick or infects others. That the viral loads were initially similar in size can end up being irrelevant.

I will confess to one bit of hesitation about walking you through the data on breakthrough infections: It’s not clear how much we should be worrying about them. For the vaccinated, Covid resembles the flu and usually a mild one. Society does not ground to a halt over the flu.

In Britain, many people have become comfortable with the current Covid risks. The vaccines make serious illness rare in adults, and the risks to young children are so low that Britain may never recommend that most receive the vaccine. Letting the virus continue to dominate life, on the other hand, has large costs.

“There’s a feeling that finally we can breathe; we can start trying to get back what we’ve lost,” Devi Sridhar, the head of the global public health program at the University of Edinburgh, told The Times.


Theater employees checking vaccination cards as people returned to Broadway last week.Jutharat Pinyodoonyachet for The New York Times
I know that many Americans feel differently. Our level of Covid anxiety is higher, especially in communities that lean to the left politically. And there is no “correct” response to Covid. Different people respond to risk differently.

But at least one part of the American anxiety does seem to have become disconnected from the facts in recent weeks: the effectiveness of the vaccines. In a new ABC News/Washington Post poll, nearly half of adults judged their “risk of getting sick from the coronavirus” as either moderate or high — even though 75 percent of adults have received at least one shot.

In reality, the risks of getting any version of the virus remain small for the vaccinated, and the risks of getting badly sick remain minuscule.

In Seattle on an average recent day, about one out of every one million vaccinated residents have been admitted to a hospital with Covid symptoms. That risk is so close to zero that the human mind can’t easily process it. My best attempt is to say that the Covid risks for most vaccinated people are of the same order of magnitude as risks that people unthinkingly accept every day, like riding in a vehicle.

The bottom line
Delta really has changed the course of the pandemic. It is far more contagious than earlier versions of the virus and calls for precautions that were not necessary a couple of months ago, like wearing masks in some indoor situations.

But even with Delta, the overall risks for the vaccinated remain extremely small. As Dr. Monica Gandhi, an infectious-disease specialist at the University of California, San Francisco, wrote on Friday, “The messaging over the last month in the U.S. has basically served to terrify the vaccinated and make unvaccinated eligible adults doubt the effectiveness of the vaccines.” Neither of those views is warranted.
“

 

[HS4S_2]

I live in Florida so there are questionable Covid practices. My 16 year old daughter started back to her dual enrollment classes and it was announced on Monday that they will now be opening a new monoclonal antibody treatment center in our County. However, they failed to mention that it is in the SAME building as the classrooms. The students had to pick themselves through sick people today who were seeking treatment. Not only is it a safety concern to have a bunch of non students roaming around....they now will be exposed to ACTIVELY SICK PEOPLE. So tomorrow I get to spend my day moving her to online classes. This was such an exciting time for her to start her classes on campus since it was derailed this past year. She is vaccinated and wears a mask....but it isn't worth the risk. So frustrating. Also, the professors are being exposed as well to unnecessary risk. The whole thing is just so infuriating. Thanks for listening to my rant.

 

[missy]

I live in Florida so there are questionable Covid practices. My 16 year old daughter started back to her dual enrollment classes and it was announced on Monday that they will now be opening a new monoclonal antibody treatment center in our County. However, they failed to mention that it is in the SAME building as the classrooms. The students had to pick themselves through sick people today who were seeking treatment. Not only is it a safety concern to have a bunch of non students roaming around....they now will be exposed to ACTIVELY SICK PEOPLE. So tomorrow I get to spend my day moving her to online classes. This was such an exciting time for her to start her classes on campus since it was derailed this past year. She is vaccinated and wears a mask....but it isn't worth the risk. So frustrating. Also, the professors are being exposed as well to unnecessary risk. The whole thing is just so infuriating. Thanks for listening to my rant.

I know we cannot talk politics but just want to say that Florida's governor is not doing himself any favors. I hear rumors he has big dreams for his political future. I hope people are paying attention to what is happening right now.

Florida Struggling With COVID-19's Deadliest Phase Yet

State has outsize population of elderly people, vibrant party scene and Republican governor who has taken a hard line against mask requirements, vaccine passports and business shutdowns

www.voanews.com

"Governor Ron DeSantis has strongly opposed certain mandatory measures to keep the virus in check, saying people should be trusted to make decisions for themselves."

"In late July, DeSantis, a Republican, issued an executive order that directed the Florida Department of Education and the Florida Department of Health to issue emergency rules giving parents a choice on whether their children should wear masks in class. The state threatened to withhold funding from districts that violated the order and required masks for everyone."

"A Florida judge ruled against Gov. Ron Desantis on Wednesday and allowed schools in the state to mandate face-masks while the case is appealed at a higher level."

 

[missy]

The Los Angeles Unified School District, the nation's second-largest, could become the first to mandate vaccines for eligible, in-person students. (Los Angeles Times)

World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus, PhD, called on wealthy nations with large vaccine supplies to hold off on booster doses for the rest of this year. (AP)

Severe or critical breakthrough COVID cases tend to occur among older patients and those with comorbidities such as obesity or diabetes. (Lancet Infectious Diseases)


As of 8 a.m. ET on Thursday, the unofficial COVID-19 toll in the U.S. was 40,458,930 cases and 652,699 deaths, increases of 176,020 and 2,008, respectively, from this time a day ago.


Schools in Florida may mandate masks, a Florida judge ruled, again going against an executive order from Gov. Ron DeSantis (R) that barred such mandates. (Washington Post)


The University of Delaware asked faculty not to tell students if their classmates test positive for COVID. (Washington Post)


United Airlines employees granted religious or medical exemptions from the company's vaccine mandate must take temporary leaves of absence starting in October. (Washington Post)


The Biden administration is preparing to sue Texas over its new abortion law, which bans the procedure after the first 6 weeks of pregnancy. (Wall Street Journal)


In South Dakota, Gov. Kristi Noem (R) limited abortion access via an executive order, enacting restrictions on the use of medication abortion and telemedicine for discussing terminating a pregnancy. (USA Today)

 

[missy]

The NIH granted $1.67 million to researchers at five institutions to study potential links between COVID-19 vaccinations and menstruation changes. (Boston Globe)

In Caribbean and Latin American nations, the pandemic could "wipe away 20 years of hard-fought gains" in reducing maternal mortality, the WHO said. (New York Times)

A small French study found higher tumor burden among metastatic colorectal cancer patients who received their diagnosis after versus before pandemic lockdowns. (JAMA Network Open)

While associated with small gains in pain relief, there is not enough substantial evidence that medical cannabis helps most patients suffering from chronic pain, a meta-analysis concluded. (The BMJ)

FDA rejected an emergency use authorization for Humanigen's lenzilumab as a treatment for COVID-19, saying it was unable to conclude the possible benefits outweighed the potential harms.

The agency will hold a public workshop in October to consider "requiring mandatory prescriber education" for opioids.

Meanwhile, a patient advocacy group is suing to have the hair-loss drug finasteride (Propecia) pulled from the market, saying the FDA failed to act on evidence of serious side effects. (Reuters)

Finally, FDA also announced recalls on one lot of ICU Medical's intravenous amino acid injection (Aminosyn II, 15%) due to visible proteinaceous material in the solution, and on one lot of Azurity

Pharmaceuticals' oral vancomycin hydrochloride solution (Firvanq) 50 mg/mL kit, due to an incorrect diluent.


Last Updated September 09, 2021

 

[missy]

A new U.S. government study found unvaccinated people are 11 times more likely to die of Covid-19 as the delta variant continues to kill thousands of them daily while also triggering so-called breakthrough cases among the vaccinated. Vaccines for younger children will be reviewed as quickly as possible, U.S. regulators said, as infections among them rise. In the U.K., preparations are starting for a program of “mix and match” coronavirus vaccines as booster shots.
Here’s the latest on the pandemic.

 

[Daisys and Diamonds]

@mellowyellowgirl @Bron357
what's happening over there ?

Stuff

i.stuff.co.nz

i thought your premier was doing a reasonable job

how is NSW going to ever open up to the rest of Australia or NZ ? when the rest of us are still on the eliminating path

 

[Daisys and Diamonds]

meanwhile in Melbourne
do we learn nothing from what's happened in the rest of the world?

Stuff

i.stuff.co.nz

 

[Bron357]

Not much.
In another few days, provided you don’t live in a “hot area”, up to 5 adults, who are all fully vaccinated, who live in the same Local Government area or within 5 kms, can congregate in an outdoor environment.
People in “hot areas” can exercise outdoors for longer than hour. They still can only exercise with their household, they still can’t leave the local government area and the 5am to 9pm curfew still applies.
End of October school kids can go back to school and once NSW reaches 70% fully vaccinated (expected to be end Oct) we can start to do things. What things hasn’t been actually said. I hope it means Retail can re open and other small businesses can start working again.