Coronavirus updates October 2021

[missy]

The latest​

An experimental pill can reduce the risk of death and hospitalization from covid-19, pharmaceutical company Merck and its partner, Ridgeback Biotherapeutics, announced in a news release Friday. They have applied to the Food and Drug Administration for emergency use authorization for the drug, molnupiravir. If authorized, the pill would be the first of its kind — an oral antiviral for covid-19. Such a drug would be especially welcome in parts of the world with less access to expensive monoclonal antibody treatments or vaccines.

More than a year-and-a-half into the pandemic, some things about the virus aren't clear — since, as reporters Joel Achenbach and Yasmeen Abutaleb write, U.S. data are a mess. Local health departments are left to collect information on hospitalizations, vaccinations and deaths, and the resulting patchwork quality of the country's pandemic statistics has hindered progress against the virus. President Biden's science adviser, Eric Lander, said this is a "question that pertains to the whole health-care and public health system. In the United States, our data systems are not interoperable. They don’t talk to one another."

Jobless benefits ended in September, marking the end of the longest period of unemployment help in American history. But the pandemic isn't over. The Post interviewed several men and women about the economic stresses they continue to face. Theirs are stories of avoiding homelessness, bills coming due and searching for employees.

 

[missy]

https://www.nejm.org/doi/full/10.1056/NEJMoa2113017?query=WB&cid=NEJM%20Weekend%20Briefing,%20October%202,%202021%20DM341691_NEJM_Non_Subscriber&bid=640393724

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Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase​

List of authors.

• Hana M. El Sahly, M.D.,
• Lindsey R. Baden, M.D.,
• Brandon Essink, M.D.,
• Susanne Doblecki-Lewis, M.D.,
• Judith M. Martin, M.D.,
• Evan J. Anderson, M.D.,
• Thomas B. Campbell, M.D.,
• Jesse Clark, M.D.,
• Lisa A. Jackson, M.D.,
• Carl J. Fichtenbaum, M.D.,
• Marcus Zervos, M.D.,
• Bruce Rankin, D.O.,
• et al.,
• for the COVE Study Group*

• Article
• Figures/Media

Metrics

• 26 References

Abstract​

BACKGROUND​

At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported.

METHODS​

We enrolled volunteers who were at high risk for Covid-19 or its complications; participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo, 28 days apart, at 99 centers across the United States. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The data cutoff date was March 26, 2021.

RESULTS​

The trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. More than 96% of participants received both injections, 2.3% had evidence of SARS-CoV-2 infection at baseline, and the median follow-up was 5.3 months in the blinded phase. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval [CI], 91.0 to 94., with 55 confirmed cases in the mRNA-1273 group (9.6 per 1000 person-years; 95% CI, 7.2 to 12.5) and 744 in the placebo group (136.6 per 1000 person-years; 95% CI, 127.0 to 146.. The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.

CONCLUSIONS​

The mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427. opens in new tab.)
The global morbidity, mortality, and societal disruption caused by the coronavirus disease 2019 (Covid-19) pandemic prompted accelerated clinical vaccine development and regulatory interventions to mitigate some of its consequences. Between December 2020 and February 2021, three vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) on the basis of data from observer-blinded, randomized, controlled trials demonstrating safety and efficacy against Covid-19 after a median follow-up of 2 months after vaccination.1-4 The short-term efficacy of the vaccines observed in the clinical trials was also observed after vaccine deployment in the general population.5-10 Longer-term safety and efficacy of the vaccines have remained open questions of public health import.
The phase 3 trial of mRNA-1273, a lipid nanoparticle–encapsulated mRNA expressing the prefusion-stabilized spike glycoprotein of SARS-CoV-2,11 showed a 94.1% vaccine efficacy against Covid-19, with an acceptable safety and side-effect profile after a median follow-up of 64 days.1 These early findings supported the issuance of the EUA, after which the protocol was amended to offer participants the option of having the group assignments unblinded and, for those who had received placebo, the option to receive the mRNA-1273 vaccine. Here we report the vaccine efficacy and safety results of the final analysis of the blinded phase of the trial, ending 5.3 months after the second dose, and in additional analyses in important subgroups of interest, as well as findings on the effect of vaccination on asymptomatic infection and on efficacy at various time intervals since vaccination.

Methods​

TRIAL OVERSIGHT​

In this phase 3, observer-blinded, randomized, placebo-controlled trial, adults in medically stable condition were enrolled at 99 sites in the United States.1 After the FDA issued an EUA for the use of mRNA-1273 in December 2020, the protocol was amended to include two parts (A and B; see Figs. S1 and S2 in the Supplementary Appendix, available together with the protocol with the full text of this article at NEJM.org). Part A, the observer-blinded phase of the trial, concluded when participants were informed of their group assignments; those in the placebo group were offered the opportunity to receive mRNA-1273 (the participant-decision visit). Part B, the open-label phase of the trial, is currently ongoing. Participants will continue to be followed for up to 2 years, as originally planned.
The trial is being conducted in accordance with the Good Clinical Practice guidelines of the International Council Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and applicable government regulations. The central institutional review board approved the protocol and the consent forms. All participants provided written informed consent.

PARTICIPANTS, RANDOMIZATION, AND DATA BLINDING​

Part A of the trial was a stratified, observer-blinded, randomized, placebo-controlled evaluation of the efficacy, safety, and immunogenicity of the mRNA-1273 SARS-CoV-2 vaccine as compared with placebo in eligible participants who were at least 18 years old and had no known history of SARS-CoV-2 infection and whose locations or circumstances put them at appreciable risk of acquiring SARS-CoV-2 infection or who were at high risk for severe disease (or both).1 Participants were randomly assigned in a 1:1 ratio to receive two doses of the mRNA-1273 vaccine (100 μg) or placebo and were stratified according to age and Covid-19 complications risk criteria (≥18 to <65 years and not at risk, ≥18 to <65 years and at risk, and ≥65 years). The trial design, efficacy assessments, and vaccine have been described previously.1

SAFETY ASSESSMENTS​

Safety measures included solicited local and systemic adverse events with onset during the 7 days after each injection; unsolicited adverse events with onset during the 28 days after each injection; adverse events leading to discontinuation from receiving injections, participating in the trial, or both; medically attended and serious adverse events occurring during the trial; and severity of the events, which were graded as described in the protocol. Safety data, all Covid-19 cases, and severe Covid-19 cases were continuously monitored by the data and safety monitoring board.

EFFICACY ASSESSMENTS​

Participants provided nasopharyngeal swab and blood samples before the first and second injections of vaccine or placebo and before the unblinding of the group assignments at the participant-decision visit. Efficacy assessments included surveillance for Covid-19 symptoms from enrollment throughout the trial. Efficacy end points were adjudicated by an independent adjudication committee whose members were unaware of group assignments.
For the primary end point, mRNA-1273 vaccine efficacy in preventing a first occurrence of Covid-19 with onset at least 14 days after the second injection, Covid-19 cases were defined by at least two systemic symptoms (temperature ≥38°C, chills, myalgia, headache, sore throat, or new olfactory or taste disorders), or at least one respiratory sign or symptom (cough, shortness of breath, or clinical or radiologic evidence of pneumonia), and were confirmed by positive SARS-CoV-2 reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay of nasopharyngeal swab, nasal, or saliva samples. Participants were monitored daily for at least 14 days after diagnosis or until symptoms resolved. Severe Covid-19 was defined as confirmed Covid-19 plus one clinical sign of severe systemic illness (Tables S1 and S2). Secondary end points include the efficacy of the mRNA-1273 vaccine in preventing severe Covid-19, Covid-19 after the first dose, Covid-19 regardless of prior SARS-CoV-2 infection, Covid-19 according to a secondary definition (the Centers for Disease Control and Prevention definition, requiring only one symptom), serologically confirmed SARS-CoV-2 infection (positive binding antibody against SARS-CoV-2 nucleocapsid protein in participants who were SARS-CoV-2–negative at baseline), SARS-CoV-2 infection (positive RT-PCR assay) regardless of symptom status, and asymptomatic SARS-CoV-2 infection (absence of symptoms, with infections starting at least 14 days after the second injection, including seroconversion at day 57 or at the participant-decision visit, or a positive RT-PCR assay at the participant-decision visit).

STATISTICAL ANALYSIS​

Determination of the sample size (30,000 participants) and aspects of the statistical analysis designed to demonstrate the efficacy of the mRNA-1273 vaccine as compared with placebo for the primary end point, prevention of Covid-19 starting at 14 days after the second dose, were described previously1 and are also provided in the protocol. Analysis populations included the randomization population; the full analysis population, comprising participants who had undergone randomization and received at least one dose of mRNA-1273 or placebo; the modified intention-to-treat population, consisting of participants in the full analysis population who had no immunologic or virologic evidence of SARS-CoV-2 infection before the first dose; the per-protocol population, consisting of participants in the modified intention-to-treat population who received two doses, with no major protocol deviations; and the solicited safety and safety populations (described in Table S3).
The prespecified primary efficacy analysis was performed in the per-protocol data set, starting 14 days after the second dose of vaccine or placebo. The efficacy of the mRNA-1273 vaccine was estimated with a stratified Cox proportional-hazards model. Incidence rates and vaccine efficacy were estimated by 1 minus the hazard ratio (mRNA-1273 vs. placebo), and the corresponding 95% confidence interval was based on the total number of cases adjusted according to total person-time. Additional details of the primary and secondary efficacy analyses are provided in Table S4 and in Supplementary Methods. The final efficacy analysis presented herein is based on cleaned data through the completion of the blinded phase, Part A, with a data cutoff date of March 26, 2021, when 95.0% of the trial participants had completed the participant-decision visit or had discontinued participation in the trial.

Results​

TRIAL POPULATION​

Figure 1.

Randomization and Analysis Populations.
From July 27 to October 23, 2020, a total of 30,415 participants underwent randomization; 15,206 were assigned to the placebo group and 15,209 to the mRNA-1273 group (Figure 1 and Fig. S2).1 More than 96% of participants (14,727 in the placebo group and 14,635 in the mRNA-1273 group) received second injections. A total of 531 participants (3.5%) in the placebo group and 453 (3.0%) in the mRNA-1273 group did not receive the second injection, mainly owing to confirmed SARS-CoV-2 infection or withdrawal of consent. Trial discontinuations in the placebo group (691 participants [4.5%]) and the mRNA-1273 group (440 participants [2.9%]) were most commonly due to protocol deviations, withdrawal of consent, or loss to follow-up. The imbalance of discontinuations between the placebo and mRNA-1273 groups coincided with the FDA issuance of the EUAs for Covid-19 vaccines and reflected the intent of placebo recipients to receive a vaccine under EUA as it became available (Fig. S3). By the data cutoff date (March 26, 2021), 27,109 participants had been informed of their group assignments at a participant-decision visit, and 1855 had been informed before the participant-decision visit because they intended to receive a vaccine under EUA through their provider. A total of 28,964 participants entered the open-label phase of the trial.
Vaccine safety was assessed among 30,346 participants in the safety population (Figure 1). The prespecified primary efficacy analysis was performed in the per-protocol population, which included 28,451 participants who were SARS-CoV-2–negative at baseline and had received two doses of vaccine by the final analysis in the blinded phase. The median duration of follow-up from randomization to data cutoff or trial discontinuation was 212 days (interquartile range, 193 to 225), the duration from the second dose to data cutoff or discontinuation was 183 days (interquartile range, 165 to 194), and the duration from randomization to unblinding was 148 days (interquartile range, 131 to 162). Baseline demographic and clinical characteristics were balanced between the placebo group and the mRNA-1273 group (Table S5).1

SAFETY​

At the end of the blinded phase, the frequencies of solicited local and systemic adverse events were consistent with those reported previously,1 with such events occurring less frequently in the placebo group (in 48% and 43% of participants after the first and second injections, respectively) than in the mRNA-1273 group (88% and 92%) (Fig. S4 and Tables S6 through S13). Women were slightly more likely than men to have grade 3 solicited adverse events after the first and second injections (Table S. Occurrences of solicited adverse events were generally similar with the two injections, regardless of severe Covid-19 risk status (Table S9), and were less common after both doses among participants with previous SARS-CoV-2 infection than among those without previous SARS-CoV-2 infection, with the exception of systemic adverse events after the first dose of mRNA-1273, which occurred more often in participants previously infected with SARS-CoV-2 (62% vs. 55%, respectively) (Tables S11 and S12). The incidence of local adverse events with delayed onset starting on day 8 after an injection was higher after the first injection (80 participants [0.5%]) than after the second injection (10 participants [<0.1%]), and the most common local adverse event reported on or after day 8 was erythema in the mRNA-1273 group after the first (68 participants [0.4%]) and second (6 [<0.1%]) injections (Table S13).
The frequencies of unsolicited, severe, and serious adverse events reported during the 28 days after either injection were generally similar in the two groups in the overall safety population, regardless of age or risk factors for severe Covid-19 (Tables S14 through S1. The frequency of grade 3 and medically attended adverse events that were considered to be related to injection of placebo or vaccine was lower in the placebo group (0.2% and 0.6%, respectively) than in the mRNA-1273 group (0.5% and 1.3%) (Table S14). Overall, 0.6% of placebo recipients and 0.4% of vaccine recipients had adverse events that resulted in their not receiving the second dose, and less than 0.1% in both groups discontinued trial participation because of adverse events after either injection. Adverse events that were considered to be related to the injections were reported by 8.5% of placebo recipients and 13.9% of mRNA-1273 recipients during the observation period of the study and were generally similar to those reported previously regardless of age (Tables S19 through S21). Serious injection-related adverse events occurred in 4 placebo recipients (<0.1%) and in 12 mRNA-1273 recipients (<0.1%).
Hypersensitivity reactions were reported in 1.8% of placebo recipients and in 2.2% of vaccine recipients, with anaphylaxis occurring in 2 participants (<0.1%) in each group (Table S22). Dermal filler reactions were reported in 14 placebo recipients (<0.1%) and in 20 mRNA-1273 recipients (0.1%) with a history of dermal filler injections (Table S23). Three cases of Bell’s palsy (<0.1%) were reported in the placebo group and 8 in the mRNA-1273 group (<0.1%); no case was considered to be related to the placebo or the vaccine (Table S24). Thromboembolic events were observed in 43 placebo recipients (0.3%) and in 47 mRNA-1273 recipients (0.3%) (Table S25). No cases of myocarditis were reported. Pericarditis events occurred in 2 participants each (<0.1%) in the placebo and mRNA-1273 groups (both events >28 days after the second dose) and were considered serious (Tables S20 and S21). A total of 32 deaths had occurred by completion of the blinded phase, with 16 deaths each (0.1%) in the placebo and mRNA-1273 groups; no deaths were considered to be related to injections of placebo or vaccine, and 4 were attributed to Covid-19 (3 in the placebo group and 1 in the mRNA-1273 group) (Tables S19 and S26). The Covid-19 death in the mRNA-1273 group occurred in a participant who had received only one dose; Covid-19 was diagnosed 119 days after the first dose, and the participant died of complications 56 days after diagnosis.

EFFICACY ANALYSES​

Figure 2.

Efficacy of the mRNA-1273 Vaccine in Preventing Covid-19.Figure 3.

Vaccine Efficacy for Primary and Secondary End Points.Figure 4.

Efficacy of the mRNA-1273 Vaccine in Preventing Covid-19 in Subgroups.Figure 5.

Incidence of Covid-19 According to Time Periods in the Per-Protocol Population.
A total of 799 adjudicated cases of Covid-19 in the per-protocol population were included in the primary efficacy analysis; 744 cases (5.3%) were in the placebo group and 55 (0.4%) were in the mRNA-1273 group (Figure 2 and Figure 3 and Tables S27 and S2. The vaccine efficacy was 93.2% for the prevention of Covid-19 starting at least 14 days after the second dose, with incidences of 136.6 cases per 1000 person-years (95% confidence interval [CI], 127.0 to 146. in the placebo group and 9.6 cases per 1000 person-years (95% CI, 7.2 to 12.5) in the mRNA-1273 group. The vaccine efficacy for adjudicated cases in the modified intention-to-treat population was 92.3% (95% CI, 90.1 to 93.9). Vaccine efficacy in preventing severe Covid-19, a key secondary end point, was 98.2% (95% CI, 92.8 to 99.6) in the per-protocol population, with 106 severe cases in the placebo group and 2 in the mRNA-1273 group. Vaccine efficacy was consistently high in subgroups, including participants 65 years of age or older and 75 years of age or older, those with coexisting conditions, those belonging to various racial and ethnic groups, and those with various categories of occupational risk exposures (Figure 4 and Table S29). When examined by specific time interval since completion of vaccination over the duration of follow-up, the efficacy of the mRNA-1273 vaccine in preventing Covid-19 remained consistent, with efficacy greater than 90% observed 4 months or more after the second injection (Figure 5, Fig. S5, and Table S30). Symptoms most commonly reported in the adjudicated Covid-19 cases in both groups were cough, fatigue, headaches, and nasal congestion; severe obesity and diabetes were contributing risk factors for severe Covid-19 (Tables S31 and S32).
Secondary end points (Figure 3 and Table S27) also included vaccine efficacy according to the secondary definition of Covid-19 (the Centers for Disease Control and Prevention definition, requiring only one symptom) starting 14 days after the second injection in the per-protocol population; according to the secondary definition, the vaccine efficacy was 93.4% (95% CI, 91.4 to 94.9). Among participants who were SARS-CoV-2–negative at baseline, a total of 712 participants (498 in the placebo group and 214 in the mRNA-1273 group) were found to be SARS-CoV-2–positive by RT-PCR assay or anti-nucleocapsid antibody test in the absence of symptoms starting 14 days after the second injection, through and including the participant-decision visit, and were considered to have asymptomatic infection (Figure 3 and Tables S27 and S2. Vaccine efficacy in preventing asymptomatic SARS-CoV-2 infection, based on the hazard ratio using the competing risk method, was 63.0% (95% CI, 56.6 to 68.5). In an analysis of asymptomatic infections after randomization, with data accrued up to and including the participant-decision visit, 157 participants in the placebo group and 153 in the mRNA-1273 group were RT-PCR–positive only; 306 participants in the placebo group and 48 in the mRNA-1273 group showed seroconversion by anti-nucleocapsid antibodies, and 115 participants in the placebo group and 7 in the mRNA-1273 group tested positive in both anti-nucleocapsid antibody testing and RT-PCR assay in the absence of symptoms. Findings for asymptomatic infection were similar in the modified intention-to-treat population (Table S2. For the secondary end point of prevention of SARS-CoV-2 infection (regardless of symptom or severity), the vaccine efficacy was 82.0% (95% CI, 79.5 to 84.2) beginning 14 days after the second injection in the per-protocol population, with 1339 participants in the placebo group and 280 in the mRNA-1273 group who had documented infection, defined as a positive result on RT-PCR assay at 14 days or more after the second injection or seroconversion at day 57 or later, through the participant-decision visit.
For the secondary end point of Covid-19 with onset at least 14 days after the first injection, the vaccine efficacy, based on adjudicated cases of Covid-19 in the per-protocol population among participants who received both injections (769 in the placebo group and 56 in the mRNA-1273 group), was 93.3% (95% CI, 91.1 to 94.9). In an exploratory analysis performed in a modified intention-to-treat subpopulation of 425 participants in the placebo group and 334 in the mRNA-1273 group who had no evidence of SARS-CoV-2 infection at baseline and who received only one injection, adjudicated Covid-19 cases were observed in 45 participants (10.6%) in the placebo group and in 4 participants (1.2%) in the mRNA-1273 group (Table S33). Six severe Covid-19 cases occurred in recipients of a single injection of placebo (1.4%), and one severe case occurred in a recipient of a single injection of the mRNA-1273 vaccine (0.3%).

Discussion​

The data compiled through the completion of the blinded phase of the COVE trial provide further evidence of the safety and efficacy of mRNA-1273 in preventing symptomatic Covid-19 as well as preventing SARS-CoV-2 infection regardless of symptom and severity in adults, including those 65 years of age or older and those with coexisting conditions, and across various ethnic and racial groups. These findings are based on a median follow-up of 148 days in the blinded phase and are similar to those observed previously at a median follow-up of 64 days, indicating that the high efficacy of the mRNA-1273 vaccine is maintained in the medium term. Of importance, the vaccine provided substantial protection against asymptomatic infection (63%; 95% CI, 56.6 to 68.5), though at a lower vaccine efficacy than that for symptomatic infection. The efficacy of the mRNA-1273 vaccine did not wane up to 4 months after the second injection and beyond. It is notable that the efficacies found in phase 3 trials of Covid-19 vaccines have thus far translated into high effectiveness in the general population, including effectiveness against variants of concern that are associated with reductions in neutralization, such as the B.1.351 (beta) and B.1.617.2 (delta) variants.8,12-15Additional data gathered from regions with current and potential surges in transmission of variants of concern are important toward informing strategies for administering additional doses of vaccine.
No safety concerns were identified in this trial. However, robust safety surveillance systems have identified rare events during the global distribution of Covid-19 vaccines that the phase 3 studies were not powered to detect; thus, continued vigilance is warranted, including monitoring for anaphylactic reactions, especially in persons with allergic phenotypes, and for other potential unexpected reactions, such as myocarditis in adolescents and young adults.16 Given the high efficacies of the vaccines1,3,17 and the burden of the pandemic, the risk–benefit ratio remains strongly in favor of broad deployment of the vaccines. Despite differences in the definitions of disease severity, the vaccine efficacy is supported by real-world data: vaccination has been shown to be highly effective in preventing severe Covid-19, associated hospitalizations, and deaths, as well as mild or asymptomatic infection, regardless of race and age.9,12,18-20
Several important limitations of the trial should be considered. At the trial design stage in early 2020, the efficacy and safety of the mRNA-1273 vaccine were unknown; for that reason, certain key populations such as pregnant women, children, and immunocompromised persons were not included in the trial. Studies in these populations are currently ongoing, and the data that are emerging in adolescents and pregnant women are reassuring.21-24 Although no safety concerns associated with the mRNA vaccines have been identified in immunocompromised persons, these vaccines appear to be less immunogenic in such persons.25,26 Given the period during which the blinded phase of the trial was conducted, assessment of vaccine efficacy in preventing Covid-19 caused by SARS-CoV-2 variants of concern is limited, since circulation of the variants was low. Future exploratory analyses are needed to probe this question. It should also be noted that the sensitivity of detection of asymptomatic infection in this trial was somewhat limited by the assessment of seroconversion at fixed time points, the kinetics of seroconversion of anti-nucleocapsid antibodies (which may take weeks to emerge after an initial infection and then wane relatively quickly), as well as the possible diminished detection of SARS-CoV-2 by RT-PCR, owing to a reduced duration of infection in vaccine recipients and the infrequent collection of samples from asymptomatic participants in the trial.
We found that the efficacy of the mRNA-1273 vaccine against Covid-19 and severe Covid-19 was maintained for more than 5 months after the second dose among all subgroups in the trial, including those at risk for severe complications. Asymptomatic SARS-CoV-2 infections were also reduced. No safety concerns were identified in this trial. The interplay of viral evolution with vaccine distribution in the next months will determine the trajectory of the pandemic, which continues to evade predictions and shape much of the social and economic life in the United States and worldwide.
Supported by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (contract 75A50120C00034), and by the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 6861, the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium leadership group 5 (UM1 AI148684-03).
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Drs. El Sahly and Baden contributed equally to this article.
This article was published on September 22, 2021, and updated on October 1, 2021, at NEJM.org.
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
We thank the participants in the trial and the members of the data and safety monitoring board (Richard J. Whitley, chair, University of Alabama School of Medicine; Abdel Babiker, MRC Clinical Trials Unit at University College, London; Lisa Angeline Cooper, Johns Hopkins University School of Medicine and Bloomberg School of Public Health; Susan Smith Ellenberg, University of Pennsylvania; Alan Fix, Vaccine Development Global Program Center for Vaccine Innovation and Access PATH; Marie Griffin, Vanderbilt University Medical Center; Steven Joffe, Perelman School of Medicine, University of Pennsylvania; Jorge Kalil, Clinics Hospital (HC-FMUSP), Universidade de São Paulo, Brazil; Myron M. Levine, University of Maryland School of Medicine; Malegapuru William Makgoba, University of KwaZulu-Natal; Anastasios A. Tsiatis, North Carolina State University; and Renee H. Moore, Emory University) and the adjudication committee (Richard J. Hamill, chair, Baylor College of Medicine; Lewis Lipsitz, Harvard Medical School; Eric S. Rosenberg, Massachusetts General Hospital; and Anthony Faugno, Tufts Medical Center) for their critical and timely review of the trial data. We also acknowledge the contribution from the mRNA-1273 Product Coordination Team from the Biomedical Advanced Research and Development Authority (BARDA) (Robert Bruno, Richard Gorman, Holli Hamilton, Gary Horwith, Chuong Huynh, Nutan Mytle, Corrina Pavetto, Xiaomi Tong, and John Treanor), as well as Frank J. Dutko (Moderna consultant) for editorial support and Katherine Kacena for input on statistics.

 

[missy]

Everyone take a deep breath on Merck pill​

Merck’s Covid pill is ushering fresh optimism about the course of this seemingly endless pandemic. Early studies show the drug has the potential to cut the rate of hospitalization and death by around 50% in mild to moderate Covid patients. It’s exactly the type of tool doctors need to keep patients from getting severely ill and clogging up emergency rooms. And it could become the first drug approved for Covid that doesn’t require a patient to visit a hospital or infusion center, potentially saving the health-care system millions of dollars. That’s all reason to celebrate, should Merck succeed in getting the nod from regulators. But the emergence of such a treatment shouldn’t be cause for complacency when it comes to the most effective tool to end this pandemic: vaccines. Thus far, the anti-vaccine movement has appeared to embrace drugs to treat Covid over getting the very shots that would stop people from contracting the virus in the first place. Merck’s antiviral pill molnupiravir. Merck The worst example of that is ivermectin, a horse deworming agent that’s gained underground popularity as a Covid treatment despite research showing it’s not effective and possibly even harmful for patients. If Merck’s new drug, molnupiravir, is being viewed as a solution for those who refuse to vaccinate, the Covid virus will continue to persist. That’s a problem for children who are too young to get shots yet or those who aren’t eligible for a vaccine. And if the virus continues to circulate, new mutations have the potential to emerge, potentially rendering vaccines less effective than they already are. Antivirals are a challenging class of drugs to develop. Merck, along with partner Ridgeback Biotherapeutics, said the incidence of drug-related adverse events was similar in the group that took molnupiravir and the one that took the placebo. Those rates were 12% and 11%, respectively. The details of that side-effect data will be key to figuring out how widely the drug can be deployed. It’s no question molnupiravir could be an answer for many patients, assuming it’s safe and regulators give it the green light. But the work being done by public health officials to promote vaccines is still critical given that those drugs have the potential to truly stop Covid in its tracks.—Cynthia Koons

​ ​ ​ ​ Track the vaccines​

More Than 6.3 Billion Shots Given​ Enough doses have now been administered to fully vaccinate 41% of the global population—but the distribution has been lopsided. Countries and regions with the highest incomes are getting vaccinated more than 20 times faster than those with the lowest. See the details here.

 

[tyty333]

Havent read all your post yet Missy...but will

A few of my neighbours have gotten Covid recently (past couple of months). Just wanted to report on that. The
neighbour across the street was not vaccinated and ended up being taken out by ambulance. I think he spent about a week
in the hospital and is now back home with an oxygen tank. He was never intubated. He now has an enlarged heart. I'm
hoping it's just while he finishes recuperating (still has low oxygen/low energy). I hope his heart goes back to normal.

His wife (also not vaccinated) and brother(vaccinated) also got Covid. His wife had a fairly mild case. His brother ended up
with a collapsed lung even though he thought he had a mild case. He has recovered and appears to be back to normal.

These folks are all in their mid-sixties I believe.

My other neighbour had a break through case (he was vaccinated). He is in his seventies but is fairly active. He said it knocked
him on his butt. Absolutely no energy for 2 weeks. He said that his lungs felt like they were on fire. So glad that he is doing
better!

I would be fairly devastated if any of my neighbors died from covid. Not that we're particularly close but that is just too close to
home for me.

Everyone stay safe out there!

 

[Dancing Fire]

The latest​

An experimental pill can reduce the risk of death and hospitalization from covid-19, pharmaceutical company Merck and its partner, Ridgeback Biotherapeutics, announced in a news release Friday. They have applied to the Food and Drug Administration for emergency use authorization for the drug, molnupiravir. If authorized, the pill would be the first of its kind — an oral antiviral for covid-19. Such a drug would be especially welcome in parts of the world with less access to expensive monoclonal antibody treatments or vaccines.

@missy , You posted some good news, finally!

 

[missy]

@missy , You posted some good news, finally!

I try @Dancing Fire but I have never been a Pollyanna nor have I ever seen the world through rose colored glasses.
Forgive a little threadjack if I may.

I am a realist though I admit also a dreamer because I always have hope and without dreams we cannot make the world a better place.

I see things as they are no matter how not pretty it may be. I see the truthful gritty side of humanity over some perfect but fake illusion. We must see the reality before we can change things. And I never give up hope that we can make things better.

But first we must see things as they are to make real change in the world.

I consider myself an optimistic realist.

 

[missy]

From the NYT.​ That two-month cycle​

Covid-19 is once again in retreat.​

The reasons remain somewhat unclear, and there is no guarantee that the decline in caseloads will continue. But the turnaround is now large enough — and been going on long enough — to deserve attention.​

The number of new daily cases in the U.S. has fallen 35 percent since Sept. 1:​

​

Worldwide, cases have also dropped more than 30 percent since late August. “This is as good as the world has looked in many months,” Dr. Eric Topol of Scripps Research wrote last week.​

These declines are consistent with a pattern that regular readers of this newsletter will recognize: Covid’s mysterious two-month cycle. Since the Covid virus began spreading in late 2019, cases have often surged for about two months — sometimes because of a variant, like Delta — and then declined for about two months.​

Epidemiologists do not understand why. Many popular explanations, like seasonality or the ebbs and flows of social distancing, are clearly insufficient, if not wrong. The two-month cycle has occurred during different seasons of the year and occurred even when human behavior was not changing in obvious ways.​

The most plausible explanations involve some combination of virus biology and social networks. Perhaps each virus variant is especially likely to infect some people but not others — and once many of the most vulnerable have been exposed, the virus recedes. And perhaps a variant needs about two months to circulate through an average-sized community.​

Human behavior does play a role, with people often becoming more careful once caseloads begin to rise. But social distancing is not as important as public discussion of the virus often imagines. “We’ve ascribed far too much human authority over the virus,” as Michael Osterholm, an infectious-disease expert at the University of Minnesota, has told me.​

The recent declines, for example, have occurred even as millions of American children have again crowded into school buildings.​

​ Hospitalizations, too​

Whatever the reasons, the two-month cycle keeps happening. It is visible in the global numbers, as you can see in the chart below. Cases rose from late February to late April, then fell until late June, rose again until late August and have been falling since.​

​

The pattern has also been evident within countries, including India, Indonesia, Thailand, Britain, France and Spain. In each of them, the Delta variant led to a surge in cases lasting somewhere from one and a half to two and a half months.​

In the U.S., the Delta surge started in several Southern states in June and began receding in those states in August. In much of the rest of the U.S., it began in July, and cases have begun falling the past few weeks. Even pediatric cases are falling, despite the lack of vaccine authorization for children under 12, as Jennifer Nuzzo of Johns Hopkins University told The Washington Post. (You can see the overall trends for every state here.)​

The most encouraging news is that serious Covid illnesses are also declining. The number of Americans hospitalized with Covid has fallen about 25 percent since Sept. 1. Daily deaths — which typically change direction a few weeks after cases and hospitalizations — have fallen 10 percent since Sept. 20. It is the first sustained decline in deaths since the early summer.​

​

​ ‘The last major wave’?​

This is the part of the newsletter where I need to emphasize that these declines may not persist. Covid’s two-month cycle is not some kind of iron law of science. There have been plenty of exceptions.​

In Britain, for example, caseloads have seesawed over the past two months, rather than consistently fallen. In the U.S., the onset of cold weather and the increase in indoor activities — or some other unknown factor — could cause a rise in cases this fall. The course of the pandemic remains highly uncertain.​

But this uncertainty also means that the near future could prove to be moreencouraging than we expect. And there are some legitimate reasons for Covid optimism.​

The share of Americans 12 and over who have received at least one vaccine shot has reached 76 percent, and the growing number of vaccine mandates — along with the likely authorization of the Pfizer vaccine for children ages 5 to 11 — will increase the number of vaccinations this fall. Almost as important, something like one-half of Americans have probably had the Covid virus already, giving them some natural immunity.​

Eventually, immunity will become widespread enough that another wave as large and damaging as the Delta wave will not be possible. “Barring something unexpected,” Dr. Scott Gottlieb, a former F.D.A. commissioner and the author of “Uncontrolled Spread,” a new book on Covid, told me, “I’m of the opinion that this is the last major wave of infection.”​

Covid has not only been one of the worst pandemics in modern times. It has been an unnecessarily terrible pandemic. Of the more than 700,000 Americanswho have died from it, nearly 200,000 probably could have been saved if they had chosen to take a vaccine. That is a national tragedy.​

Covid also isn’t going to disappear anytime soon. It will continue to circulate for years, many scientists believe. But the vaccines can transform Covid into a manageable disease, not so different from a flu or common cold. In the past few weeks, the country appears to have moved closer to that less grim future.​

Whatever this autumn brings, the worst of the pandemic is almost certainly behind us.​

Virus developments:​

The pandemic has made diapers more expensive and scarce. Johnson & Johnson is planning to ask for federal authorization for boosters this week.

 

[mellowyellowgirl]

‘Save Australia’ protest erupts in New York

Australia became the surprising focal point of an American anti vaccine mandate protest march for teachers in New York City overnight, with hundreds of demonstrators chanting “Save Australia” and some waving Aussie flags.

www.news.com.au

Was this actually a real thing???? We're fine!!! They're letting us out next week!

 

[missy]

‘Save Australia’ protest erupts in New York

Australia became the surprising focal point of an American anti vaccine mandate protest march for teachers in New York City overnight, with hundreds of demonstrators chanting “Save Australia” and some waving Aussie flags.

www.news.com.au

Was this actually a real thing???? We're fine!!! They're letting us out next week!

We are hearing all sorts of horrible things here about what they are doing in Australia to people and their animals. I am glad to hear you guys are A OK! Just goes to show we have to be skeptical about what we read all the time.

 

[missy]

"

COVID Prevention Tx Safe, Shows Efficacy in High-Risk Groups​

— But numbers small, and treatment still needs to find its "niche"​

by Molly Walker, Deputy Managing Editor, MedPage Today October 3, 2021


A monoclonal antibody cocktail designed for COVID-19 pre-exposure prophylaxis was safe, and appeared to be effective across populations at risk of severe COVID and who may have a subpar response to vaccination, a researcher said.

AZD7442 (tixagevimab/cilgavimab) met its primary endpoint, reducing the risk of symptomatic COVID-19 among high-risk populations by 77% (95% CI 46%-90%), though the absolute numbers were small (eight cases in the intervention group vs 17 in the placebo, HR 0.23, 95% CI 0.10-0.53), reported Myron Levin, MD, of the University of Colorado Denver School of Medicine in Aurora.



When stratifying by subgroups, such as older adults and those at high risk for severe COVID, there were numerically fewer cases in the intervention group versus placebo, but the numbers were small, and the confidence intervals were wide.

The treatment also appeared safe, with adverse events (AEs) balanced between groups, and no COVID-19 related deaths in the intervention group, Levin said at a late-breaking presentation at the virtual IDWeek.

Manufacturer AstraZeneca already released topline results of the PROVENT study in August, which showed that the treatment met the primary endpoint, but this presentation included data on subgroups, as well as safety data. It included a median 83 days of follow-up.

In August, FDA authorized an additional dose of mRNA vaccine for certain immunocompromised patients, such as solid organ transplant patients.

Levin noted the treatment would be targeted to individuals with "impaired immune responses and impaired immune function" who not only would be more likely to have severe COVID-19, but less likely to be protected against COVID-19.



"We know from ... vaccinology that prevention is always better than treatment if it's successful," he said.

Moreover, Levin pointed out that the treatment "successfully neutralized" the Delta variant.

The PROVENT trial was comprised of unvaccinated adults (ages 18 and up) at increased risk of inadequate response to vaccination or COVID-19 infection, who were randomized 2:1 to receive either the treatment or placebo. Overall, 3,460 adults received a single dose, including two intramuscular injections of AZD7442, and 1,737 adults received placebo.

Primary outcome was RT-PCR positive symptomatic illness, according to CDC criteria, which as Levin pointed out, "permits a very low bar for study endpoints to be observed," since it only requires one symptom.

About 1.4% of participants in the intervention group and 1.3% in the placebo group had at least one serious AE. There were four deaths each in the intervention and placebo groups, including from illicit drug overdose, renal failure, and myocardial infarction. The placebo group had two COVID-19 related deaths from acute respiratory distress syndrome.



Levin said the sample size for some groups was "limiting," but was consistent across subgroups. For example, adults, ages 60 and up, had three cases of COVID in the intervention group versus six in the placebo (RRR 75.1, 95% CI 0.5-93.. There were eight cases in the intervention group and 11 in the placebo (RRR 63.6, 9.4-85.4) among adults at high risk for severe COVID.

He described how future research will try to find the "niche" of individuals where the preventive treatment would work best.

"Clearly there are people ... who do not respond" to vaccination, Levin said, and the treatment is "designed for people who are not going to respond to the vaccine or lose response early on."

However, AZD7442 is not meant as a substitute for vaccination, he added.

He added that while the data indicate the treatment was effective for at least 3 months, the data cutoff could underestimate long-term efficacy, as pharmacokinetic modeling predicts the treatment may provide protection for up to 12 months.



IDWeek session moderator Adarsh Bhimraj, MD, of the Cleveland Clinic, spoke about the importance of doing "quality randomized controlled trials" even "in the midst of a raging pandemic."

"So far we've been using COVID therapies and studying them as blunt instruments and not as precision missiles, and hopefully in the future we'll have better studies," he said.

"

 

[MRBXXXFVVS1]

My COVID forecast (I am not a medical professional, just my speculation) is that cases may continue to decline throughout October and early November. They may rise again (and possibly peak) with the holidays. Once the vaccines are authorized for children, it will help to curb new cases. Cases may start declining after the New Year and may be at a low/manageable level in March (similar to this June). Just my prediction, barring any unexpected variants.

 

[missy]

My COVID forecast (I am not a medical professional, just my speculation) is that cases may continue to decline throughout October and early November. They may rise again (and possibly peak) with the holidays. Once the vaccines are authorized for children, it will help to curb new cases. Cases may start declining after the New Year and may be at a low/manageable level in March (similar to this June). Just my prediction, barring any unexpected variants.

Unfortunately that is the billion dollar question...are unexpected (or perhaps expected as the case may be unless more people get vaccinated) variants on the way? I hope I am wrong but I feel like this is a likely scenario.

Two studies suggest that newer variants of the coronavirus are better at traveling through the air. (Published 2021)

www.nytimes.com

Snip...

"

Newer variants of the coronavirus like Alpha and Delta are highly contagious, infecting far more people than the original virus. Two new studies offer a possible explanation: The virus is evolving to spread more efficiently through air.
The realization that the coronavirus is airborne indoorstransformed efforts to contain the pandemic last year, igniting fiery debates about masks, social distancing and ventilation in public spaces.
Most researchers now agree that the coronavirus is mostly transmitted through large droplets that quickly sink to the floor and through much smaller ones, called aerosols, that can float over longer distances indoors and settle directly into the lungs, where the virus is most harmful.
The new studies don’t fundamentally change that view. But the findings signal the need for better masks in some situations, and indicate that the virus is changing in ways that make it more formidable.
“This is not an Armageddon scenario,” said Vincent Munster, a virologist at the National Institute of Allergy and Infectious Diseases, who led one of the new studies. “It is like a modification of the virus to more efficient transmission, which is something I think we all kind of expected, and we now see it happening in real time.”"

New ‘mu’ COVID-19 variant now found in 49 US states

Since being discovered in Colombia in January, the mu variant of COVID-19 has spread to nearly four dozen countries and has made its presence known in Hawaii and Alaska. It has so far been found in 49 states with Nebraska...

www.seattletimes.com

 

[Dancing Fire]

New ‘mu’ COVID-19 variant now found in 49 US states

Since being discovered in Colombia in January, the mu variant of COVID-19 has spread to nearly four dozen countries and has made its presence known in Hawaii and Alaska. It has so far been found in 49 states with Nebraska...

www.seattletimes.com

Mu will be the next wave.

 

[mellowyellowgirl]

https://twitter.com/x/status/1446693452729573380

Isn't this incredible? 97% first doses in ACT Australia. And that's counting 12 years old plus.

Great place to live if you're extra cautious about Covid!

We're at 90% first doses in NSW but I don't think we can beat this.

 

[Daisys and Diamonds]

‘Save Australia’ protest erupts in New York

Australia became the surprising focal point of an American anti vaccine mandate protest march for teachers in New York City overnight, with hundreds of demonstrators chanting “Save Australia” and some waving Aussie flags.

www.news.com.au

Was this actually a real thing???? We're fine!!! They're letting us out next week!

people will protest about anything

i had a freind who was convinced the NZ govt was holding people in detention camps in quareteen

i dont know where people get all this sh*t from
andci actually read and watch a fair bit of Fox (they have great un-political human interest stories that would warm your heart and also alligator stories)

 

[Daisys and Diamonds]

We are hearing all sorts of horrible things here about what they are doing in Australia to people and their animals. I am glad to hear you guys are A OK! Just goes to show we have to be skeptical about what we read all the time.

the mind boggles

 

[Daisys and Diamonds]

https://twitter.com/x/status/1446693452729573380

Isn't this incredible? 97% first doses in ACT Australia. And that's counting 12 years old plus.

Great place to live if you're extra cautious about Covid!

We're at 90% first doses in NSW but I don't think we can beat this.

wow !
go the ACT !!!
apart from the obveouse we never heae much about those guys

 

[Daisys and Diamonds]

oh i gotta go and watch the news
but i got this today @missy
my 2nd jab
and about 6 people trying to fix my record as my first name is spelt wrong
(i have never ever been a Nicole)

 

[mellowyellowgirl]

people will protest about anything

i had a freind who was convinced the NZ govt was holding people in detention camps in quareteen

i dont know where people get all this sh*t from
andci actually read and watch a fair bit of Fox (they have great un-political human interest stories that would warm your heart and also alligator stories)

haha no detention camps here but they do have "Health" hotels

They can and have locked up an entire apartment complex and deliver groceries to you. Apparently with the groceries, you get what you get and you don't get upset!

Meh I don't mind it! We are generally an obedient bunch. I walked my dog at 8.30pm in the dark, had my mask under my chin because it was 8.30pm in the dark with no one else out.

Anyways about 15 minutes into it I see another person also walking across the road, fully masked. I felt really bad so put my mask back on even though I never crossed paths with them! Darn rule abiding people in my suburb!!!

But we can get rid of masks outdoors on Monday!!!!!! (Unless at a festival or in crowds).

 

[Daisys and Diamonds]

haha no detention camps here but they do have "Health" hotels

They can and have locked up an entire apartment complex and deliver groceries to you. Apparently with the groceries, you get what you get and you don't get upset!

Meh I don't mind it! We are generally an obedient bunch. I walked my dog at 8.30pm in the dark, had my mask under my chin because it was 8.30pm in the dark with no one else out.

Anyways about 15 minutes into it I see another person also walking across the road, fully masked. I felt really bad so put my mask back on even though I never crossed paths with them! Darn rule abiding people in my suburb!!!

But we can get rid of masks outdoors on Monday!!!!!! (Unless at a festival or in crowds).

i never understood what everyone was complaining about the mask wearing till they made it mandatory for customer gaving jobs and shopping etc
my nose is disgustingly zitty yet the inside of my nose is so dry im getting nose bleeds

 

[missy]

oh i gotta go and watch the news
but i got this today @missy
my 2nd jab
and about 6 people trying to fix my record as my first name is spelt wrong
(i have never ever been a Nicole)

YAY!!! Congrats on your getting your second dose Nikki!!!

 

[missy]

Wow. SMH.

UCLA Anesthesiologist Escorted Out of Work for Being Unvaccinated

Christopher Rake, MD, says he's 'willing to lose everything' to avoid COVID vaccine

www.medpagetoday.com

Working with patients who are in the hospital some terribly sick and some immune compromised. Not ok.

 

[Daisys and Diamonds]

Wow. SMH.

UCLA Anesthesiologist Escorted Out of Work for Being Unvaccinated

Christopher Rake, MD, says he's 'willing to lose everything' to avoid COVID vaccine

www.medpagetoday.com

Working with patients who are in the hospital some terribly sick and some immune compromised. Not ok.

we are just getting into that BS here
what planet do some people think they are living on ?

also teachers
as under 12's can't be vacinated yet

 

[Asscherhalo_lover]

we are just getting into that BS here
what planet do some people think they are living on ?

also teachers
as under 12's can't be vacinated yet

NYC lost a LOT of teachers and other school staff over the mandate. The biggest we lost from unfortunately was school safety and food services. I've heard many schools are literally giving out frozen food because there's no one to prep it and only kitchen staff are allowed to even use the microwaves. It's wild out there. We're one week into the mandate. So far I only know one teacher from one of my sites who has caved and will come back.

 

[Lookinagain]

I just wonder where all these folks leaving their jobs instead of getting vaccinated will work? Many private employers are requiring employees to be vaccinated too. Unemployment only lasts so long, and although it may sound like I'm a hard a** about this, ( I am) anyone who quits a job because they refuse to get vaccinated shouldn't qualify for unemployment benefits (and since this sounds like "voluntary" resignation it might not anyway). And maybe being vaccinated (if able) should be a condition of receiving welfare and food stamps? I don't know.

 

[Asscherhalo_lover]

I just wonder where all these folks leaving their jobs instead of getting vaccinated will work? Many private employers are requiring employees to be vaccinated too. Unemployment only lasts so long, and although it may sound like I'm a hard a** about this, ( I am) anyone who quits a job because they refuse to get vaccinated shouldn't qualify for unemployment benefits (and since this sounds like "voluntary" resignation it might not anyway). And maybe being vaccinated (if able) should be a condition of receiving welfare and food stamps? I don't know.

The one teacher I know who is staying out has a spouse who makes a good income. She's planning on starting an in home daycare for folks who also do not want the vaccine. I do think she'll have no issue finding clients in her area.

 

[Daisys and Diamonds]

NYC lost a LOT of teachers and other school staff over the mandate. The biggest we lost from unfortunately was school safety and food services. I've heard many schools are literally giving out frozen food because there's no one to prep it and only kitchen staff are allowed to even use the microwaves. It's wild out there. We're one week into the mandate. So far I only know one teacher from one of my sites who has caved and will come back.

the misinformation out there that people are believing is scary
both people with higher education and those without
i blame a lot on social media

here our mother's made us sandwhiches to take for our lunch so i dont really know how the lunch system works but home made sandwhichs sounds better than some microwave instant meal

 

[Daisys and Diamonds]

The one teacher I know who is staying out has a spouse who makes a good income. She's planning on starting an in home daycare for folks who also do not want the vaccine. I do think she'll have no issue finding clients in her area.

id put money on it turn into a virus cluster in no time

 

[Daisys and Diamonds]

I just wonder where all these folks leaving their jobs instead of getting vaccinated will work? Many private employers are requiring employees to be vaccinated too. Unemployment only lasts so long, and although it may sound like I'm a hard a** about this, ( I am) anyone who quits a job because they refuse to get vaccinated shouldn't qualify for unemployment benefits (and since this sounds like "voluntary" resignation it might not anyway). And maybe being vaccinated (if able) should be a condition of receiving welfare and food stamps? I don't know.

absolutly
the public purse pays for those benifits
the public deserve to be protected in return

 

[icy_jade]

https://twitter.com/x/status/1446693452729573380

Isn't this incredible? 97% first doses in ACT Australia. And that's counting 12 years old plus.

Great place to live if you're extra cautious about Covid!

We're at 90% first doses in NSW but I don't think we can beat this.

I’m super impressed! We still have our share of anti-vaxxers in Singapore but unvaxxed people will no longer be able to dine-in, go to shopping malls, or visit attractions from next Wednesday (Oct 13)… which makes it safer for the vaccinated folks to go to these places so I’m not complaining.

It’s like how I felt when smoking indoors was finally banned (yay happy lungs).