Effectiveness of rAd26-rAd5, ChAdOx1 nCoV-19, and BBIBP-CorV vaccines for risk of infection with SARS-CoV-2 and death due to COVID-19 in people older than 60 years in Argentina: a test-negative, case-control, and retrospective longitudinal study

Rearte, Analía; Castelli, Juan Manuel; Rearte, Ramiro; Fuentes, Nora; Pennini, Velen; Pesce, Martina; Barbeira, Pilar Barcena; Iummato, Luciana Eva; Laurora, Melisa; Bartolomeu, María Lucía; Galligani, Guido; Juárez, María Del Valle; Giovacchini, Carlos; Adrián, Santoro; Esperatti, Mariano; Tarragona, Sonia; Vizzotti, Carla

doi:10.1016/s0140-6736(22)00011-3

Cited by 49 publications

(63 citation statements)

References 25 publications

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“…2,3 The epidemiology of adverse events following immunization (AEFI) occurring after SARS-CoV-2 vaccination, including GBS, remains incompletely understood, particularly in underdeveloped countries and underserved regions data on neurologic AEFI comes from a few countries and involves only a handful of vaccines. 4–6…”

Section: Introductionmentioning

confidence: 99%

Incidence of Guillain-Barré syndrome following SARS-CoV-2 immunization in Mexico: A nation-wide registry of seven COVID-19 vaccines

García‐Grimshaw

Galnares-Olalde

Bello‐Chavolla

et al. 2022

Preprint

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Background: Guillain-Barré syndrome (GBS) as an adverse event following immunization (AEFI) against SARS-CoV-2 has been linked to a few (ChAdOx1 nCov-19 and Ad26.COV2-S), but not all vaccines, including mRNA-based ones. Epidemiological information on GBS among recipients of other SARS-CoV-2-directed vaccines among Latinx/Hispanic recipients is scarce. Methods: We report GBS incidence per million administered doses from a nationwide Mexican retrospective registry of adult (>18 years) recipients of 81,842,426 doses of seven vaccines against SARS-CoV-2 immunized between December 24, 2020, and October 29, 2021. Cases were collected through a passive epidemiological surveillance system and defined as events occurring within 42 days from immunization. Vaccines were analyzed individually and by vector as either mRNA-based (mRNA-1273 and BNT162b2), adenovirus-vectored (ChAdOx1 nCov-19, rAd26-rAd5, Ad5-nCoV, and Ad26.COV2-S), or inactivated whole-virion-vectored (CoronaVac). Findings: We identified 97 patients (52 [53.6%] males; median age 44 years (interquartile range 33-60), for an overall observed incidence of 1.19/1,000,000 doses (95% confidence interval [CI] 0.97-1.45), higher among Ad26.COV2-S (3.86/1,000,000 doses, 95% CI 1.50-9.93) and BNT162b2 (1.92/1,00,000 doses, 95% CI 1.36-2.71) recipients. The overall interval from vaccination-to-GBS symptoms onset was 10 days (interquartile range 3-17). Preceding diarrhea (> 4 weeks) was reported in 21.6%, and four (4.1%) more had mild COVID-19. Only 18 patients were tested for Campylobacter jejuni infection; 16 (88.9%) were positive. Electrophysiological examinations were performed in 76 (78.4%) patients (axonal in 46 [60.5%] and demyelinating in 25 [32.8%]); variants were similar between platforms. On initial evaluation, 91.8% had a GBS disability score ≥ 3. Seventy-five (77.3%) patients received intravenous immunoglobulin, seven (7.2%) plasma exchanges, and 15 (15.5%) were treated conservatively. There were 10 (10.3%) deaths, and 79.1% of survivors were unable to walk independently at discharge. Interpretation: In our population, GBS was an infrequent AEFI, observed in less than 1.2/1,000,000 administered doses of vaccines against SARS-CoV-2. Observed incidences were higher among Ad26.COV2.S and BNT162b2 recipients individually and for mRNA-vectored vaccines as a group.

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Section: Introductionmentioning

confidence: 99%

Incidence of Guillain-Barré syndrome following SARS-CoV-2 immunization in Mexico: A nation-wide registry of seven COVID-19 vaccines

García‐Grimshaw

Galnares-Olalde

Bello‐Chavolla

et al. 2022

Preprint

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“…In The Lancet , Analia Rearte and colleagues 5 report a real-world evaluation of the effectiveness of the rAd26-rAd5 (Sputnik V), ChAdOx1 nCoV-19 (Oxford–AstraZeneca), and BBIBP-CorV (Sinopharm) vaccines. The large country-wide study in Argentina involved 1 282 928 individuals (693 170 [54·0%] women) aged 60 years or older.…”

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confidence: 99%

“…The work by Rearte and colleagues 5 is an important contribution that has ramifications for many low-income and middle-income countries because the choice of vaccines available in a country is rarely dependent on the effect size observed in the primary clinical trials, but rather on procurement negotiations with various manufacturers early on in the pandemic. Therefore, the findings are reassuring that these lower profile vaccines offer important prevention benefits, including in people older than 60 years who had not been adequately recruited in primary studies of the vaccines.…”

mentioning

confidence: 99%

“…Real-world evaluations cannot capture elusive behaviours that affect vaccine uptake and increased exposure, largely driven by social and cultural inclinations that are not part of a standard electronic medical record. 6 Still, assuming consistent application of the methods described in this Article by Rearte and colleagues, 5 all future estimates will be subject to the same sources of potential bias, thus providing a reliable tool for continuous monitoring of vaccine-induced immunity in the population, along with the changing of the seasons, and dominant variants.…”

mentioning

confidence: 99%

“…The roll-out in Argentina occurred when the lambda (C.37) variant was the dominant subtype in the continent of South America. 5 Argentina is now experiencing a surge in cases, most likely linked to omicron (B.1.1.529). 7 Unlike other continents, the delta (B.1.617.2) variant has not developed much of a foothold in the region, but the emergence of omicron as a highly transmissible variant now necessitates careful monitoring to determine the spread of it in South America and whether new mutations weaken the morbidity associated with infection.…”

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confidence: 99%

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Evaluating COVID-19 vaccines in the real world

Mills

Reis

2022

The Lancet

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Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis

Zhong

Lai

et al. 2023

JAMA Netw Open

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ImportanceImproper host response to COVID-19 vaccines could trigger immune-mediated adverse events. The question remains whether COVID-19 vaccination should be postponed until complete remission in patients with uveitis, a preexisting immune-related condition.ObjectiveTo compare recommendations for early and deferred COVID-19 vaccination with respect to uveitis outcomes.Design, Setting, and ParticipantsThis open-label, randomized clinical trial at a large, specialized teaching center for uveitis care in China enrolled unvaccinated patients with inactive uveitis between August 10, 2021, and February 22, 2022, with follow-up to June 6, 2022.InterventionsParticipants were randomly assigned to receive recommendation for early or deferred COVID-19 vaccination after complete remission of uveitis. Non–messenger RNA (non-mRNA) COVID-19 vaccines were available in China during the trial.Main Outcomes and MeasuresThe primary outcome was the time to symptomatic uveitis worsening during 3 months of follow-up. Secondary outcomes included uveitis activity and best-corrected visual acuity at 3 months.ResultsOf the 543 participants (304 women [56.0%]; median age, 35 [IQR, 26-49] years), 262 were recommended for early vaccination and 281 for deferred vaccination. By month 3, 109 patients (41.6%) in the early group had been vaccinated compared with 14 (5.0%) in the deferred recommendation group. In the intention-to-treat population, the time to symptomatic uveitis worsening was shorter in the early group than in the deferred group (hazard ratio, 1.68 [95% CI, 1.09-2.59]; P = .01 by log-rank test). Changes in anterior chamber cells, vitreous haze, and best-corrected visual acuity from baseline to month 3 appeared similar in the 2 groups in the evaluable population after the month 3 in-person visit.Conclusions and RelevanceIn this randomized clinical trial of patients with inactive uveitis, recommendation for early non-mRNA COVID-19 vaccination resulted in a higher incidence of self-reported symptomatic uveitis worsening with possible reporting bias compared with recommendation for deferred vaccination, but no adverse effects were observed in disease and visual prognosis at 3 months. These findings would be useful to guide the individual timing choices of non-mRNA COVID-19 vaccination in this clinically vulnerable population.Trial RegistrationChinese Clinical Trial Registry: ChiCTR2100049467

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Effectiveness of rAd26-rAd5, ChAdOx1 nCoV-19, and BBIBP-CorV vaccines for risk of infection with SARS-CoV-2 and death due to COVID-19 in people older than 60 years in Argentina: a test-negative, case-control, and retrospective longitudinal study

Cited by 49 publications

References 25 publications

Incidence of Guillain-Barré syndrome following SARS-CoV-2 immunization in Mexico: A nation-wide registry of seven COVID-19 vaccines

Incidence of Guillain-Barré syndrome following SARS-CoV-2 immunization in Mexico: A nation-wide registry of seven COVID-19 vaccines

Evaluating COVID-19 vaccines in the real world

Early vs Deferred Non–Messenger RNA COVID-19 Vaccination Among Chinese Patients With a History of Inactive Uveitis

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