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143 result(s) for "Jodar, Luis"
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Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data
Following the emergency use authorisation of the Pfizer–BioNTech mRNA COVID-19 vaccine BNT162b2 (international non-proprietary name tozinameran) in Israel, the Ministry of Health (MoH) launched a campaign to immunise the 6·5 million residents of Israel aged 16 years and older. We estimated the real-world effectiveness of two doses of BNT162b2 against a range of SARS-CoV-2 outcomes and to evaluate the nationwide public-health impact following the widespread introduction of the vaccine. We used national surveillance data from the first 4 months of the nationwide vaccination campaign to ascertain incident cases of laboratory-confirmed SARS-CoV-2 infections and outcomes, as well as vaccine uptake in residents of Israel aged 16 years and older. Vaccine effectiveness against SARS-CoV-2 outcomes (asymptomatic infection, symptomatic infection, and COVID-19-related hospitalisation, severe or critical hospitalisation, and death) was calculated on the basis of incidence rates in fully vaccinated individuals (defined as those for whom 7 days had passed since receiving the second dose of vaccine) compared with rates in unvaccinated individuals (who had not received any doses of the vaccine), with use of a negative binomial regression model adjusted for age group (16–24, 25–34, 35–44, 45–54, 55–64, 65–74, 75–84, and ≥85 years), sex, and calendar week. The proportion of spike gene target failures on PCR test among a nationwide convenience-sample of SARS-CoV-2-positive specimens was used to estimate the prevelance of the B.1.1.7 variant. During the analysis period (Jan 24 to April 3, 2021), there were 232 268 SARS-CoV-2 infections, 7694 COVID-19 hospitalisations, 4481 severe or critical COVID-19 hospitalisations, and 1113 COVID-19 deaths in people aged 16 years or older. By April 3, 2021, 4 714 932 (72·1%) of 6 538 911 people aged 16 years and older were fully vaccinated with two doses of BNT162b2. Adjusted estimates of vaccine effectiveness at 7 days or longer after the second dose were 95·3% (95% CI 94·9–95·7; incidence rate 91·5 per 100 000 person-days in unvaccinated vs 3·1 per 100 000 person-days in fully vaccinated individuals) against SARS-CoV-2 infection, 91·5% (90·7–92·2; 40·9 vs 1·8 per 100 000 person-days) against asymptomatic SARS-CoV-2 infection, 97·0% (96·7–97·2; 32·5 vs 0·8 per 100 000 person-days) against symptomatic COVID-19, 97·2% (96·8–97·5; 4·6 vs 0·3 per 100 000 person-days) against COVID-19-related hospitalisation, 97·5% (97·1–97·8; 2·7 vs 0·2 per 100 000 person-days) against severe or critical COVID-19-related hospitalisation, and 96·7% (96·0–97·3; 0·6 vs 0·1 per 100 000 person-days) against COVID-19-related death. In all age groups, as vaccine coverage increased, the incidence of SARS-CoV-2 outcomes declined. 8006 of 8472 samples tested showed a spike gene target failure, giving an estimated prevalence of the B.1.1.7 variant of 94·5% among SARS-CoV-2 infections. Two doses of BNT162b2 are highly effective across all age groups (≥16 years, including older adults aged ≥85 years) in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalisations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant. There were marked and sustained declines in SARS-CoV-2 incidence corresponding to increasing vaccine coverage. These findings suggest that COVID-19 vaccination can help to control the pandemic. None.
Effectiveness of mRNA BNT162b2 COVID-19 vaccine up to 6 months in a large integrated health system in the USA: a retrospective cohort study
Vaccine effectiveness studies have not differentiated the effect of the delta (B.1.617.2) variant and potential waning immunity in observed reductions in effectiveness against SARS-CoV-2 infections. We aimed to evaluate overall and variant-specific effectiveness of BNT162b2 (tozinameran, Pfizer–BioNTech) against SARS-CoV-2 infections and COVID-19-related hospital admissions by time since vaccination among members of a large US health-care system. In this retrospective cohort study, we analysed electronic health records of individuals (≥12 years) who were members of the health-care organisation Kaiser Permanente Southern California (CA, USA), to assess BNT162b2 vaccine effectiveness against SARS-CoV-2 infections and COVID-19-related hospital admissions for up to 6 months. Participants were required to have 1 year or more previous membership of the organisation. Outcomes comprised SARS-CoV-2 PCR-positive tests and COVID-19-related hospital admissions. Effectiveness calculations were based on hazard ratios from adjusted Cox models. This study was registered with ClinicalTrials.gov, NCT04848584. Between Dec 14, 2020, and Aug 8, 2021, of 4 920 549 individuals assessed for eligibility, we included 3 436 957 (median age 45 years [IQR 29–61]; 1 799 395 [52·4%] female and 1 637 394 [47·6%] male). For fully vaccinated individuals, effectiveness against SARS-CoV-2 infections was 73% (95% CI 72–74) and against COVID-19-related hospital admissions was 90% (89–92). Effectiveness against infections declined from 88% (95% CI 86–89) during the first month after full vaccination to 47% (43–51) after 5 months. Among sequenced infections, vaccine effectiveness against infections of the delta variant was high during the first month after full vaccination (93% [95% CI 85–97]) but declined to 53% [39–65] after 4 months. Effectiveness against other (non-delta) variants the first month after full vaccination was also high at 97% (95% CI 95–99), but waned to 67% (45–80) at 4–5 months. Vaccine effectiveness against hospital admissions for infections with the delta variant for all ages was high overall (93% [95% CI 84–96]) up to 6 months. Our results provide support for high effectiveness of BNT162b2 against hospital admissions up until around 6 months after being fully vaccinated, even in the face of widespread dissemination of the delta variant. Reduction in vaccine effectiveness against SARS-CoV-2 infections over time is probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection. Pfizer.
Seasonal trends in COVID-19 cases, hospitalizations, and mortality in the United States and Europe
Determining whether SARS-CoV-2 exhibits seasonality like other respiratory viruses is critical for public health planning. We evaluated whether COVID-19 rates follow a seasonal pattern using time series models. We used time series decomposition to extract the annual seasonal component of COVID-19 case, hospitalization, and mortality rates from March 2020 through December 2022 for the United States and Europe. Models were adjusted for a country-specific stringency index to account for confounding by various interventions. Despite year-round disease activity, we identified seasonal spikes in COVID-19 from approximately November through April for all outcomes and in all countries. Our results support employing annual preventative measures against SARS-CoV-2, such as administering seasonal booster vaccines in a similar timeframe as those in place for influenza. Whether certain high-risk individuals may need more than one COVID-19 vaccine booster dose each year will depend on factors like vaccine durability against severe illness and levels of year-round disease activity.
Infections, hospitalisations, and deaths averted via a nationwide vaccination campaign using the Pfizer–BioNTech BNT162b2 mRNA COVID-19 vaccine in Israel: a retrospective surveillance study
On Dec 20, 2020, Israel initiated a nationwide COVID-19 vaccination campaign for people aged 16 years and older and exclusively used the Pfizer–BioNTech BNT162b2 mRNA COVID-19 vaccine (tozinameran). We provide estimates of the number of SARS-CoV-2 infections and COVID-19-related admissions to hospital (ie, hospitalisations) and deaths averted by the nationwide vaccination campaign. In this retrospective surveillance study, we used national surveillance data routinely collected by the Israeli Ministry of Health from the first 112 days (Dec 20, 2020, up to our data cutoff of April 10, 2021) of Israel's vaccination campaign to estimate the averted burden of four outcomes: SARS-CoV-2 infections and COVID-19-related hospitalisations, severe or critical hospitalisations, and deaths. As part of the campaign, all individuals aged 16 years and older were eligible for inoculation with the BNT162b2 vaccine in a two-dose schedule 21 days apart. We estimated the direct effects of the immunisation programme for all susceptible individuals (ie, with no previous evidence of laboratory-confirmed SARS-CoV-2 infection) who were at least partly vaccinated (at least one dose and at least 14 days of follow-up after the first dose). We estimated the number of SARS-CoV-2 infection-related outcomes averted on the basis of cumulative daily, age-specific rate differences, comparing rates among unvaccinated individuals with those of at least partly vaccinated individuals for each of the four outcomes and the (age-specific) size of the susceptible population and proportion that was at least partly vaccinated. We estimated that Israel's vaccination campaign averted 158 665 (95% CI 144 640–172 690) SARS-CoV-2 infections, 24 597 (18 942–30 252) hospitalisations, 17 432 (12 770–22 094) severe or critical hospitalisations, and 5532 (3085–7982) deaths. 16 213 (65·9%) of 24 597 hospitalisations and 5035 (91·0%) of 5532 of deaths averted were estimated to be among those aged 65 years and older. We estimated 116 000 (73·1%) SARS-CoV-2 infections, 19 467 (79·1%) COVID-19-related hospitalisations, and 4351 (79%) deaths averted were accounted for by the fully vaccinated population. Without the national vaccination campaign, Israel probably would have had triple the number of hospitalisations and deaths compared with what actually occurred during its largest wave of the pandemic to date, and the health-care system might have become overwhelmed. Indirect effects and long-term benefits of the programme, which could be substantial, were not included in these estimates and warrant future research. Israel Ministry of Health and Pfizer.
Burden of invasive group B Streptococcus disease in non-pregnant adults: A systematic review and meta-analysis
Streptococcus agalactiae or group B Streptococcus (GBS) has emerged as an important cause of invasive disease in adults, particularly among the elderly and those with underlying comorbidities. Traditionally, it was recognised as an opportunistic pathogen colonising and causing disease in pregnant women, neonates, and young infants. Reasons for the upsurge of invasive GBS (iGBS) among the elderly remain unclear, although it has been related to risk factors such as underlying chronic diseases, immunosenescence, impaired inflammatory response, and spread of virulent clones. Antibiotics are successfully as treatment or prophylaxis against iGBS. Several candidate vaccines against iGBS are under development. To conduct a systematic review of the current literature on invasive GBS in order to determine disease incidence and case fatality ratio (CFR) among non-pregnant adults. Additionally, information on risk factors, clinical presentation, serotype distribution, and antimicrobial resistance was also retrieved. Between January and June 2020, electronic searches were conducted in relevant databases: MEDLINE, EMBASE, Global Health, and SCOPUS. Studies were included in the systematic review if they met the inclusion/exclusion criteria. The authors assessed the selected studies for relevance, risk of bias, outcome measures, and heterogeneity. Meta-analyses on incidence and CFR were conducted after evaluating the quality of methods for assessment of exposure and outcomes. Pooled estimates of iGBS incidence in non-pregnant adults 15 years and older were 2.86 cases per 100.000 population (95% CI, 1.68-4.34). Incidence rates in older adults were substantially higher, 9.13 (95%CI, 3.53-17.22) and 19.40 (95%CI, 16.26-22.81) per 100.000 population [greater than or equal to]50 and [greater than or equal to] 65 years old, respectively. Incidence rates ranged from 0.40 (95% CI, 0.30-0.60) in Africa to 5.90 cases per 100.000 population (95% CI, 4.30-7.70) in North America. The overall CFR was and 9.98% (95% CI, 8.47-11.58). CFR was highest in Africa at 22.09% (95% CI, 12.31-33.57). Serotype V was the most prevalent serotype globally and in North America accounting for 43.48% (n = 12926) and 46,72% (n = 12184) of cases, respectively. Serotype Ia was the second and serotype III was more prevalent in Europe (25.0%) and Asia (29.5%). Comorbidities were frequent among non-pregnant adult iGBS cases. Antimicrobial resistance against different antibiotics (i.e., penicillin, erythromycin) is increasing over time. This systematic review revealed that iGBS in non-pregnant adults has risen in the last few years and has become a serious public health threat especially in older adults with underlying conditions. Given the current serotype distribution, vaccines including serotypes predominant among non-pregnant adults (i.e., serotypes V, Ia, II, and III) in their formulation are needed to provide breadth of protection. Continued surveillance monitoring potential changes in serotype distribution and antimicrobial resistance patterns are warranted to inform public health interventions.
Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine Against Invasive Disease Caused by Serotype 3 in Children
The 13-valent pneumococcal conjugate vaccine (PCV13) is the only licensed PCV with serotype 3 polysaccharide in its formulation. Postlicensure PCV13 effectiveness studies against serotype 3 invasive pneumococcal disease (IPD) in children have shown inconsistent results. We performed a systematic review and meta-analysis of observational studies to assess PCV13 vaccine effectiveness (VE) for serotype 3 IPD in children. We systematically searched PubMed, Embase, and the Cochrane library for studies published before 14 August 2017. We identified 4 published studies and 2 conference posters that provided PCV13 VE estimates stratified by serotype. The pooled PCV13 VE against serotype 3 IPD from the random-effects meta-analysis was 63.5% (95% confidence interval [CI], 37.3%–89.7%). A sensitivity analysis including conference posters gave a pooled VE estimate of 72.4% (95% CI, 56.7%–88.0%). The pooled data from case-control studies with similar methodologies and high quality support direct PCV13 protection against serotype 3 IPD in children.
Effectiveness of BNT162b2 XBB vaccine in the US Veterans Affairs Healthcare System
Data evaluating effectiveness of XBB.1.5-adapted vaccines against JN.1-related endpoints are scarce. This nationwide test-negative case-control study within the US Veterans Affairs Healthcare System aims to estimate vaccine effectiveness (VE) of BNT162b2 XBB.1.5-adapted vaccine compared to not receiving an XBB vaccine of any kind against COVID-19 hospitalization, emergency department or urgent care visits (ED/UC), and outpatient visits. Between September 25, 2023 and January 31, 2024, effectiveness was 24–35% during a period of JN.1 predominance and 50–61% during XBB predominance across all outcomes. VE within 60 days of vaccination during the likely JN.1 period was 32% (95% confidence interval 3–52%) against hospitalization, 41% (23–54%) against ED/UC visits, and 31% (1–52%) against outpatient visits. Corresponding VE during the likely XBB period was 62% (44–74%), 52% (37–63%), and 50% (25–66%) by setting, respectively. Here, we show the importance of strain match to maximize the public health impact of COVID-19 vaccination. This study evaluates the effectiveness of the BNT162b2 XBB.1.5-adapted vaccine against COVID-19 outcomes within the US Veterans Affairs Healthcare System, finding 50–61% during XBB predominance and 24–35% effectiveness during JN.1 predominance, emphasizing the importance of strain match.
Early effectiveness of the BNT162b2 KP.2 vaccine against COVID-19 in the US Veterans Affairs Healthcare System
This test-negative case-control study within the US Veterans Affairs Healthcare System aims to estimate early vaccine effectiveness (VE) of the BNT162b2 KP.2 vaccine (2024–2025 formulation) compared to not receiving the KP.2 vaccine against COVID-19 outcomes. The study includes adult patients (age ≥18 years) with an acute respiratory infection (ARI) in hospital, emergency department and urgent care (ED/UC), or outpatient settings between September 5 and November 30, 2024. Separate multivariable logistic regression models compare the odds of receiving BNT162b2 KP.2 vaccine among SARS-CoV-2 positive cases and test-negative controls within each ARI outcome category, while adjusting for potentially confounding variables. Among 44,598 ARI episodes, VE is 68% (42–82%), 57% (46–65%), and 56% (36–69%) against COVID-19-associated hospitalizations, emergency department and urgent care visits, and outpatient visits, respectively. Uptake of updated COVID-19 vaccines is low (3.7%). mRNA COVID-19 vaccines have been updated to the SARS-CoV-2 KP.2 variant of concern, due to its emergence in early 2024. Using data from the US Veterans Affairs Healthcare System, the authors here estimate that the BNT162b2 KP.2-adapted vaccine is 56‒68% effective at preventing a range of COVID-19 outcomes during the early part of the 2024–2025 respiratory virus season.
Tick-borne encephalitis vaccine uptake, effectiveness, and impact in Sweden from 2018 to 2022
Tick-borne encephalitis (TBE) is an increasing health threat in Sweden and elsewhere in Europe. TBE vaccination is commonly recommended in Sweden, but limited data are available on uptake, effectiveness, and impact of TBE vaccination. General population surveys conducted in 2019–2022 were used to estimated TBE vaccine uptake. TBE vaccine effectiveness (VE) was estimated using the screening method utilizing the surveys and public health TBE surveillance data, which predominately includes hospitalized TBE cases, from 2018 to 2022. Impact of TBE vaccination was calculated based on disease incidence and observed VE. In 2018–2022, 2,015 TBE cases were reported in Sweden; 82.8% (1,564/1,890) of cases with known TBE vaccination history were unvaccinated. Among persons surveyed from the general population with known vaccination history, 52.0% (11,562/22,247) were unvaccinated. Three dose VE against TBE was 89.0% (95% confidence interval 84.3–92.4). When stratified by age group, VE was 86.0% (55.7–95.6) in 1–15 years-of-age and 93.8% (87.5–96.9) in 16–49 years-of-age. In a conservative estimate, despite suboptimal compliance with TBE vaccination recommendations, vaccination averted an estimated thousand TBE cases, most resulting in hospitalization, in Sweden from 2018 to  2022. To prevent additional TBE cases in Sweden, enhanced efforts to increase TBE vaccine uptake and compliance to the TBE vaccination schedule are needed.
Real-world effectiveness of RSVpreF vaccination during pregnancy against RSV-associated lower respiratory tract disease leading to hospitalisation in infants during the 2024 RSV season in Argentina (BERNI study): a multicentre, retrospective, test-negative, case–control study
In March, 2024, Argentina became the first country to implement a national maternal immunisation programme with bivalent respiratory syncytial virus (RSV) prefusion F vaccine (RSVpreF) as the primary strategy to prevent RSV disease among infants. We aimed to evaluate vaccine effectiveness against RSV-associated lower respiratory tract disease (LRTD) and severe LRTD leading to hospitalisation among infants during the first season after implementation. A multicentre, retrospective, test-negative, case-control study was done during the 2024 RSV season in 12 hospitals across Argentina (BERNI study). We included infants aged 6 months or younger who were hospitalised with LRTD between April 1 and Sept 30, 2024, and tested for RSV using PCR or indirect immunofluorescence; cases were infants with any positive RSV test and controls were PCR-confirmed negative for RSV. Infants were considered born to an RSVpreF-vaccinated pregnant woman if RSVpreF was received between 32+0/7 weeks and 36+6/7 weeks of gestation and 14 days or more before delivery. We estimated vaccine effectiveness against RSV-associated LRTD requiring hospitalisation (primary outcome) and RSV-associated severe LRTD requiring hospitalisation (key secondary outcome) by comparing the odds of RSVpreF vaccination during pregnancy among infant cases versus controls using multilevel logistic regression adjusted for potential confounders. Of 633 infants hospitalised for LRTD between April 1 and Sept 30, 2024, 505 (286 cases and 219 controls) met full eligibility criteria for inclusion in the primary vaccine effectiveness analysis; 51 (18%) cases and 109 (50%) controls were born to individuals who received RSVpreF during pregnancy. Vaccine effectiveness against RSV-associated LRTD leading to infant hospitalisation was 78·6% (95% CI 62·1–87·9) from birth to age 3 months and 71·3% (53·3–82·3) from birth to age 6 months. Effectiveness against RSV-associated severe LRTD leading to hospitalisation was 76·9% (45·0–90·3) from birth to age 6 months. Three RSV-associated in-hospital deaths occurred, all among infants whose mothers did not receive RSVpreF during pregnancy. These real-world estimates for the 2024 RSV season in Argentina show high RSVpreF effectiveness against RSV-associated LRTD and severe LRTD leading to hospitalisation from birth to age 3 months and sustained to age 6 months. Pfizer. For the Spanish translation of the abstract see Supplementary Materials section.