Real-world effectiveness of COVID-19 vaccines and anti-SARS-CoV-2 monoclonal antibodies against postacute sequelae of SARS-CoV-2: analysis of a COVID-19 observational registry for a diverse US metropolitan population

Objectives
We evaluated the effectiveness of COVID-19 vaccines and monoclonal antibodies (mAbs) against postacute sequelae of SARS-CoV-2 infection (PASC).

Design and setting
A retrospective cohort study using a COVID-19 specific, electronic medical record-based surveillance and outcomes registry from an eight-hospital tertiary hospital system in the Houston metropolitan area. Analyses were replicated across a global research network database.

Participants
We identified adult (≥18) patients with PASC. PASC was defined as experiencing constitutional (palpitations, malaise/fatigue, headache) or systemic (sleep disorder, shortness of breath, mood/anxiety disorders, cough and cognitive impairment) symptoms beyond the 28-day postinfection period.

Statistical analysis
We fit multivariable logistic regression models and report estimated likelihood of PASC associated with vaccination or mAb treatment as adjusted ORs with 95% CIs.

Results
Primary analyses included 53 239 subjects (54.9% female), of whom 5929, 11.1% (95% CI 10.9% to 11.4%), experienced PASC. Both vaccinated breakthrough cases (vs unvaccinated) and mAb-treated patients (vs untreated) had lower likelihoods for developing PASC, aOR (95% CI): 0.58 (0.52–0.66), and 0.77 (0.69–0.86), respectively. Vaccination was associated with decreased odds of developing all constitutional and systemic symptoms except for taste and smell changes. For all symptoms, vaccination was associated with lower likelihood of experiencing PASC compared with mAb treatment. Replication analysis found identical frequency of PASC (11.2%, 95% CI 11.1 to 11.3) and similar protective effects against PASC for the COVID-19 vaccine: 0.25 (0.21–0.30) and mAb treatment: 0.62 (0.59–0.66).

Conclusion
Although both COVID-19 vaccines and mAbs decreased the likelihood of PASC, vaccination remains the most effective tool for the prevention of long-term consequences of COVID-19.

Leggi
Aprile 2023

Stroke After SARS-CoV-2 mRNA Vaccine: A Nationwide Registry Study

Stroke, Ahead of Print. BACKGROUND:Whether the SARS-CoV-2 mRNA vaccines may cause a transient increased stroke risk is uncertain.METHODS:In a registry-based cohort of all adult residents at December 27, 2020, in Norway, we linked individual-level data on COVID-19 vaccination, positive SARS-CoV-2 test, hospital admissions, cause of death, health care worker status, and nursing home resident status extracted from the Emergency Preparedness Register for COVID-19 in Norway. The cohort was followed for incident intracerebral bleeding, ischemic stroke, and subarachnoid hemorrhage within the first 28 days after the first/second or third dose of mRNA vaccination until January 24, 2022. Stroke risk after vaccination relative to time not exposed to vaccination was assessed by Cox proportional hazard ratio, adjusted for age, sex, risk groups, health care personnel, and nursing home resident.RESULTS:The cohort included 4 139 888 people, 49.8% women, and 6.7% were ≥80 years of age. During the first 28 days after an mRNA vaccine, 2104 people experienced a stroke (82% ischemic stroke, 13% intracerebral hemorrhage, and 5% subarachnoid hemorrhage). Adjusted hazard ratios (95% CI) after the first/second and after the third mRNA vaccine doses were 0.92 (0.85–1.00) and 0.89 (0.73–1.08) for ischemic stroke, 0.81 (0.67–0.98) and 1.05 (0.64–1.71) for intracerebral hemorrhage, and 0.64 (0.46–0.87) and 1.12 (0.57–2.19) for subarachnoid hemorrhage, respectively.CONCLUSIONS:We did not find increased risk of stroke during the first 28 days after an mRNA SARS-CoV-2 vaccine.

Leggi
Marzo 2023

Neonatal outcomes and indirect consequences following maternal SARS-CoV-2 infection in pregnancy: a systematic review

Objectives
To identify the association between maternal SARS-CoV-2 infection in pregnancy and individual neonatal morbidities and outcomes, particularly longer-term outcomes such as neurodevelopment.

Design
Systematic review of outcomes of neonates born to pregnant women diagnosed with a SARS-CoV-2 infection at any stage during pregnancy, including asymptomatic women.

Data sources
MEDLINE, Embase, Global Health, WHOLIS and LILACS databases, last searched on 28 July 2021.

Eligibility criteria
Case–control and cohort studies published after 1 January 2020, including preprint articles were included. Study outcomes included neonatal mortality and morbidity, preterm birth, caesarean delivery, small for gestational age, admission to neonatal intensive care unit, level of respiratory support required, diagnosis of culture-positive sepsis, evidence of brain injury, necrotising enterocolitis, visual or hearing impairment, neurodevelopmental outcomes and feeding method. These were selected according to a core outcome set.

Data extraction and synthesis
Data were extracted into Microsoft Excel by two researchers, with statistical analysis completed using IBM SPSS (Version 27). Risk of bias was assessed using a modified Newcastle-Ottawa Scale.

Results
The search returned 3234 papers, from which 204 were included with a total of 45 646 infants born to mothers with SARS-CoV-2 infection during pregnancy across 36 countries. We found limited evidence of an increased risk of some neonatal morbidities, including respiratory disease. There was minimal evidence from low-income settings (1 study) and for neonatal outcomes following first trimester infection (17 studies). Neonatal mortality was very rare. Preterm birth, neonatal unit admission and small for gestational age status were more common in infants born following maternal SARS-CoV-2 infection in pregnancy in most larger studies.

Conclusions
There are limited data on neonatal morbidity and mortality following maternal SARS-CoV-2 infection, particularly from low-income countries and following early pregnancy infections. Large, representative studies addressing these outcomes are needed to understand the consequences for babies born to women with SARS-CoV-2.

PROSPERO registration number
CRD42021249818.

Leggi
Marzo 2023

Study: No New SARS-CoV-2 Variants in Recent Outbreak in China

After relaxing its “zero-COVID policy” in early December 2022, China’s SARS-CoV-2 infections surged, stoking concerns that new variants might appear. But none emerged in a genomic analysis of 413 COVID-19 cases collected in Beijing between November 14 and December 20, 2022. Two Omicron subvariants—BA.5.2 and BF.7—represented more than 90% of local infections, researchers in China reported in The Lancet.

Leggi
Marzo 2023

Investigation of SARS-CoV-2 seroprevalence in relation to natural infection and vaccination between October 2020 and September 2021 in the Czech Republic: a prospective national cohort study

Objective
Examine changes in SARS-CoV-2 seropositivity before and during the national vaccination campaign in the Czech Republic.

Design
Prospective national population-based cohort study.

Setting
Masaryk University, RECETOX, Brno.

Participants
22 130 persons provided blood samples at two time points approximately 5–7 months apart, between October 2020 and March 2021 (phase I, before vaccination), and between April and September 2021 (during vaccination campaign).

Outcome measures
Antigen-specific humoral immune response was analysed by detection of IgG antibodies against the SARS-CoV-2 spike protein by commercial chemiluminescent immunoassays. Participants completed a questionnaire that included personal information, anthropometric data, self-reported results of previous RT-PCR tests (if performed), history of symptoms compatible with COVID-19 and records of COVID-19 vaccination. Seroprevalence was compared between calendar periods, previous RT-PCR results, vaccination and other individual characteristics.

Results
Before vaccination (phase I), seroprevalence increased from 15% in October 2020 to 56% in March 2021. By the end of phase II, in September 2021, prevalence increased to 91%; the highest seroprevalence was seen among vaccinated persons with and without previous SARS-CoV-2 infection (99.7% and 97.2%, respectively), while the lowest seroprevalence was found among unvaccinated persons with no signs of disease (26%). Vaccination rates were lower in persons who were seropositive in phase I but increased with age and body mass index. Only 9% of unvaccinated subjects who were seropositive in phase I became seronegative by phase II.

Conclusions
The rapid increase in seropositivity during the second wave of the COVID-19 epidemic (covered by phase I of this study) was followed by a similarly steep rise in seroprevalence during the national vaccination campaign, reaching seropositivity rates of over 97% among vaccinated persons.

Leggi
Marzo 2023

Patterns of utilisation of specialist care after SARS-Cov-2 infection: a retrospective cohort study

Objective
To explore the pattern of health services utilisation of people who had had a documented SARS-Cov-2 infection.

Design
Retrospective cohort study.

Setting
The Italian province of Reggio Emilia.

Participants
36 036 subjects who recovered from SARS-CoV-2 infection during the period September 2020–May 2021. These were matched for age, sex and Charlson Index with an equal number of subjects never found positive at the SARS-Cov-2 swab test over the study period.

Main outcome measures
Hospital admissions for all medical conditions and for respiratory or cardiovascular conditions only; access to emergency room (for any cause); outpatient specialist visits (pneumology, cardiology, neurology, endocrinology, gastroenterology, rheumatology, dermatology, mental health) and overall cost of care.

Results
Within a median follow-up time of 152 days (range 1–180), previous exposure to SARS-Cov-2 infection was always associated with higher probability of needing access to hospital or ambulatory care, except for dermatology, mental health and gastroenterology specialist visits. Post-COVID subjects with Charlson Index≥1 were hospitalised more frequently for heart disease and for non-surgical reasons than subjects with Charlson index=0, whereas the opposite occurred for hospitalisations for respiratory diseases and pneumology visits. A previous SARS-CoV-2 infection was associated with 27% higher cost of care compared with people never infected. The difference in cost was more evident among those with Charlson Index >1. Subjects who had anti-SARS-CoV-2 vaccination had lower probability of falling in the highest cost quartile.

Conclusions
Our findings reflect the burden of post-COVID sequelae, providing some specific insight on their impact on the extra-use of health services according to patients’ characteristics and vaccination status. Vaccination is associated with lower cost of care following SARS-CoV-2 infection, highlighting the favourable impact of vaccines on the use of health services even when they do not prevent infection.

Leggi
Marzo 2023

Great escape: how infectious SARS-CoV-2 avoids inactivation by gastric acidity and intestinal bile

The study by Lee et al1 showed that the short-term current use of proton pump inhibitors (PPIs) for less than 1 month was associated with severe clinical outcomes for patients with COVID-19. The authors speculated that individuals taking PPIs had increased gastric pH, leading to higher SARS-CoV-2 viral loads associated with a severe course of COVID-19. Many studies suggested that a proportion of patients with COVID-19 experiencing GI symptoms such as diarrhoea, nausea and vomiting had overall more severe disease.2 However, it is not clearly understood how SARS-CoV-2 could survive the passage through the harsh gastric acidity and persist through the intestinal contents to infect the intestinal epithelia. It is known that the gastric pH varies greatly, depending on whether the individual is in a fasting or feeding state (between 1.23 and 6.7, respectively).3 Similarly, bile concentrations in the small intestine can fluctuate from…

Leggi
Marzo 2023

Serological responses to three doses of SARS-CoV-2 vaccination in inflammatory bowel disease

We read with interest the article by Kennedy et al, which demonstrated adequate serological responses to two-dose regimens of SARS-CoV-2 vaccination in individuals with IBD.1 However, a decay in antibody levels has been shown in the IBD population after two vaccine doses, with anti-tumour necrosis factor (anti-TNF) therapies associated with a more rapid decline.2–4 Despite recommendations for three-dose vaccine regimens for individuals with IBD,5 the uptake has been low in this population.6 We examined the serological response following three doses of mRNA SARS-CoV-2 vaccines in persons with IBD, the factors associated with antibody titres and the decay of antibody titres over time. Adults aged 18 years or older with a confirmed diagnosis of IBD who received three doses of an mRNA SARS-CoV-2 vaccine (Pfizer-BioNTech BNT162b2 mRNA (Comirnaty) or NIH-Moderna mRNA-1273 (Spikevax)) were recruited from 25 June 2021…

Leggi
Marzo 2023