Among 2.5 million patients who received the BNT162b2 mRNA vaccine in a large Israeli health care system, the incidence of myocarditis at 42 days was 2.13 cases per 100,000 persons, with the highest ...incidence (10.69 per 100,000 persons) among male patients between the ages of 16 and 29 years. Most cases of myocarditis were mild or moderate.
Breakthrough infections with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in fully vaccinated individuals are receiving intense scrutiny because of their importance in determining how ...long restrictions to control virus transmission will need to remain in place in highly vaccinated populations as well as in determining the need for additional vaccine doses or changes to the vaccine formulations and/or dosing intervals. Measurement of breakthrough infections is challenging outside of randomized, placebo-controlled, double-blind field trials. However, laboratory and observational studies are necessary to understand the impact of waning immunity, viral variants and other determinants of changing vaccine effectiveness against various levels of coronavirus disease 2019 (COVID-19) severity. Here, we describe the approaches being used to measure vaccine effectiveness and provide a synthesis of the burgeoning literature on the determinants of vaccine effectiveness and breakthrough rates. We argue that, rather than trying to tease apart the contributions of factors such as age, viral variants and time since vaccination, the rates of breakthrough infection are best seen as a consequence of the level of immunity at any moment in an individual, the variant to which that individual is exposed and the severity of disease being considered. We also address key open questions concerning the transition to endemicity, the potential need for altered vaccine formulations to track viral variants, the need to identify immune correlates of protection, and the public health challenges of using various tools to counter breakthrough infections, including boosters in an era of global vaccine shortages.
Many countries are experiencing a resurgence of COVID-19, driven predominantly by the delta (B.1.617.2) variant of SARS-CoV-2. In response, these countries are considering the administration of a ...third dose of mRNA COVID-19 vaccine as a booster dose to address potential waning immunity over time and reduced effectiveness against the delta variant. We aimed to use the data repositories of Israel's largest health-care organisation to evaluate the effectiveness of a third dose of the BNT162b2 mRNA vaccine for preventing severe COVID-19 outcomes.
Using data from Clalit Health Services, which provides mandatory health-care coverage for over half of the Israeli population, individuals receiving a third vaccine dose between July 30, 2020, and Sept 23, 2021, were matched (1:1) to demographically and clinically similar controls who did not receive a third dose. Eligible participants had received the second vaccine dose at least 5 months before the recruitment date, had no previous documented SARS-CoV-2 infection, and had no contact with the health-care system in the 3 days before recruitment. Individuals who are health-care workers, live in long-term care facilities, or are medically confined to their homes were excluded. Primary outcomes were COVID-19-related admission to hospital, severe disease, and COVID-19-related death. The third dose effectiveness for each outcome was estimated as 1 – risk ratio using the Kaplan-Meier estimator.
1 158 269 individuals were eligible to be included in the third dose group. Following matching, the third dose and control groups each included 728 321 individuals. Participants had a median age of 52 years (IQR 37–68) and 51% were female. The median follow-up time was 13 days (IQR 6–21) in both groups. Vaccine effectiveness evaluated at least 7 days after receipt of the third dose, compared with receiving only two doses at least 5 months ago, was estimated to be 93% (231 events for two doses vs 29 events for three doses; 95% CI 88–97) for admission to hospital, 92% (157 vs 17 events; 82–97) for severe disease, and 81% (44 vs seven events; 59–97) for COVID-19-related death.
Our findings suggest that a third dose of the BNT162b2 mRNA vaccine is effective in protecting individuals against severe COVID-19-related outcomes, compared with receiving only two doses at least 5 months ago.
The Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.
Nearly 600,000 people in a large health care organization were followed after vaccination for infection, hospitalization, and severe Covid-19. Estimated vaccine effectiveness in preventing death was ...72% during the period from day 14 through day 20 after the first dose, and for the period 7 or more days after the second dose, hospitalization was reduced by 87%. These results were similar to those reported in a randomized trial.
Questions arose after the publication of a study from Clalit Health Services in Israel, in which adverse events from BNT162b2 vaccination and from SARS-CoV-2 infection were examined. To address the ...many questions raised, the authors have generated a comprehensive table that provides the raw data on the consequences of vaccination and of infection.
In Israel, the use of a fourth dose of BNT162b2 vaccine was initiated on January 3, 2022. As of February 18, a fourth dose produced a 45% reduction in the incidence of infection, a 55% reduction in ...symptomatic infection, a 68% reduction in hospitalization, and a 74% reduction in Covid-19–related death 7 to 30 days after vaccination.
Israel's COVID-19 endgame Balicer, Ran D; Ohana, Reut
Science (American Association for the Advancement of Science),
05/2021, Letnik:
372, Številka:
6543
Journal Article
Recenzirano
Odprti dostop
As several countries now confront COVID-19 surges, Israel may be crossing over to other side of the pandemic. Whereas 5.5 million new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ...infections were reported globally last week, Israel reported only 398 (compared with >50,000 in January). Already, 54% of Israel's 9.2 million citizens have been fully vaccinated, considerably more than in most other countries. In the coming months, as restrictions continue to ease, the country should be optimistic, yet cautious, as risks of resurgence persist. Israel thus may well be an early case study for favorable outcomes of a mass-vaccination campaign.
A study involving more than 94,000 vaccinated and unvaccinated adolescents between the ages of 12 and 18 years in Israel showed increasing levels of protection against Covid-19 during the first month ...after receipt of two vaccine doses. The estimated vaccine efficacy at 7 to 21 days after receipt of two doses was 90% against infection and 93% against symptomatic disease.
Objective To directly compare the performance and externally validate the three most studied prediction tools for osteoporotic fractures—QFracture, FRAX, and Garvan—using data from electronic health ...records.Design Retrospective cohort study.Setting Payer provider healthcare organisation in Israel.Participants 1 054 815 members aged 50 to 90 years for comparison between tools and cohorts of different age ranges, corresponding to those in each tools’ development study, for tool specific external validation.Main outcome measure First diagnosis of a major osteoporotic fracture (for QFracture and FRAX tools) and hip fractures (for all three tools) recorded in electronic health records from 2010 to 2014. Observed fracture rates were compared to probabilities predicted retrospectively as of 2010.Results The observed five year hip fracture rate was 2.7% and the rate for major osteoporotic fractures was 7.7%. The areas under the receiver operating curve (AUC) for hip fracture prediction were 82.7% for QFracture, 81.5% for FRAX, and 77.8% for Garvan. For major osteoporotic fractures, AUCs were 71.2% for QFracture and 71.4% for FRAX. All the tools underestimated the fracture risk, but the average observed to predicted ratios and the calibration slopes of FRAX were closest to 1. Tool specific validation analyses yielded hip fracture prediction AUCs of 88.0% for QFracture (among those aged 30-100 years), 81.5% for FRAX (50-90 years), and 71.2% for Garvan (60-95 years).Conclusions Both QFracture and FRAX had high discriminatory power for hip fracture prediction, with QFracture performing slightly better. This performance gap was more pronounced in previous studies, likely because of broader age inclusion criteria for QFracture validations. The simpler FRAX performed almost as well as QFracture for hip fracture prediction, and may have advantages if some of the input data required for QFracture are not available. However, both tools require calibration before implementation.
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