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1.
PLoS One ; 17(6): e0269885, 2022.
Article in English | MEDLINE | ID: covidwho-2021808

ABSTRACT

Monitoring the levels of IgG antibodies against the SARS-CoV-2 is important during the coronavirus disease 2019 (COVID-19) pandemic, to plan an adequate and evidence-based public health response. After this study we report that the plasma levels of IgG antibodies against SARS-CoV-2 spike protein were higher in individuals with evidence of prior infection who received at least one dose of either an mRNA-based vaccine (Comirnaty BNT162b2/Pfizer-BioNTech or Spikevax mRNA-1273/Moderna) or an adenoviral-based vaccine (Vaxzervia ChAdOx1 nCoV-19 /Oxford-Astra Zeneca) (n = 39) compared to i) unvaccinated individuals with evidence of prior infection with SARS-CoV-2 (n = 109) and ii) individuals without evidence of prior infection with SARS-CoV-2 who received one or two doses of one of the aforementioned vaccines (n = 342). Our analysis also revealed that regardless of the vaccine technology (mRNA-based and adenoviral vector-based) two doses achieved high anti- SARS-CoV-2 IgG responses. Our results indicate that vaccine-induced responses lead to higher levels of IgG antibodies compared to those produced following infection with the virus. Additionally, in agreement with previous studies, our results suggest that among individuals previously infected with SARS-CoV-2, even a single dose of a vaccine is adequate to elicit high levels of antibody response.


Subject(s)
COVID-19 , Viral Vaccines , Antibodies, Viral , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Cyprus , Humans , Immunoglobulin G , RNA, Messenger , SARS-CoV-2 , Seroepidemiologic Studies , Spike Glycoprotein, Coronavirus
2.
Front Immunol ; 13: 882918, 2022.
Article in English | MEDLINE | ID: covidwho-1993786

ABSTRACT

In light of the decreasing immune protection against symptomatic SARS-CoV-2 infection after initial vaccinations and the now dominant immune-evasive Omicron variants, 'booster' vaccinations are regularly performed to restore immune responses. Many individuals have received a primary heterologous prime-boost vaccination with long intervals between vaccinations, but the resulting long-term immunity and the effects of a subsequent 'booster', particularly against Omicron BA.1, have not been defined. We followed a cohort of 23 young adults, who received a primary heterologous ChAdOx1 nCoV-19 BNT162b2 prime-boost vaccination, over a 7-month period and analysed how they responded to a BNT162b2 'booster'. We show that already after the primary heterologous vaccination, neutralization titers against Omicron BA.1 are recognizable but that humoral and cellular immunity wanes over the course of half a year. Residual responsive memory T cells recognized spike epitopes of the early SARS-CoV-2 B.1 strain as well as the Delta and BA.1 variants of concern (VOCs). However, the remaining antibody titers hardly neutralized these VOCs. The 'booster' vaccination was well tolerated and elicited both high antibody titers and increased memory T cell responses against SARS-CoV-2 including BA.1. Strikingly, in this young heterologously vaccinated cohort the neutralizing activity after the 'booster' was almost as potent against BA.1 as against the early B.1 strain. Our results suggest that a 'booster' after heterologous vaccination results in effective immune maturation and potent protection against the Omicron BA.1 variant in young adults.


Subject(s)
Antibodies, Neutralizing , COVID-19 , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Humans , SARS-CoV-2 , Vaccination , Young Adult
3.
Nat Commun ; 13(1): 4710, 2022 Aug 11.
Article in English | MEDLINE | ID: covidwho-1991589

ABSTRACT

Comparative analyses of the immunogenicity and reactogenicity of homologous and heterologous SARS-CoV-2 vaccine-regimens will inform optimized vaccine strategies. Here we analyze the humoral and cellular immune response following heterologous and homologous vaccination strategies in a convenience cohort of 331 healthy individuals. All regimens induce immunity to the vaccine antigen. Immunity after vaccination with ChAdOx1-nCoV-19 followed by either BNT162b2 (n = 66) or mRNA-1273 (n = 101) is equivalent to or more pronounced than homologous mRNA-regimens (n = 43 BNT162b2, n = 59 mRNA-1273) or homologous ChAdOx1-nCoV-19 vaccination (n = 62). We note highest levels of spike-specific CD8 T-cells following both heterologous regimens. Among mRNA-containing combinations, spike-specific CD4 T-cell levels in regimens including mRNA-1273 are higher than respective combinations with BNT162b2. Polyfunctional T-cell levels are highest in regimens based on ChAdOx1-nCoV-19-priming. All five regimens are well tolerated with most pronounced reactogenicity upon ChAdOx1-nCoV-19-priming, and ChAdOx1-nCoV-19/mRNA-1273-boosting. In conclusion, we present comparative analyses of immunogenicity and reactogenicity for heterologous vector/mRNA-boosting and homologous mRNA-regimens.


Subject(s)
COVID-19 Vaccines , COVID-19 , 2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Humans , RNA, Messenger , SARS-CoV-2/genetics , Vaccination/adverse effects
4.
J Nepal Health Res Counc ; 20(1): 59-64, 2022 Jun 02.
Article in English | MEDLINE | ID: covidwho-1988988

ABSTRACT

BACKGROUND: The COVID-19 pandemic has challenged the entire globe and the need for a vaccine is supreme. Since many vaccines along with Covishield have been granted emergency use authorization, the evaluation and monitoring of safety are crucial. Covishield was rolled out in Nepal on January 27, 2021. So through this study, we aim to identify the prevalence of Adverse Events Following Immunization in general with the first dose of Covishield vaccine, compare Adverse Events Following Immunization in prior COVID-19 positive cases and Adverse Events Following Immunization in co-morbid individuals. METHODS: This was a descriptive cross-sectional study conducted in 440 sample from May 2021 till July 2021 in a provincial government hospital of western Nepal. Ethical approval was received from Ethical Review Board, Nepal Health Research Council (Registration no: 279/2021 P). Simple random sampling was used. Point estimate was done at 95% confidence interval and descriptive analysis was done to identify the prevalence of Adverse Events Following Immunization within one week after Covishield vaccination in the studied population. RESULTS: 79.77% of the study population complaint at least one or more Adverse Events Following Immunization. Fever, myalgia, headache, pain at the injection site, arthralgia, chills, and fever are the most common Adverse Events Following Immunization. 42.73% of the study population self-medicated to manage Adverse Events Following Immunization, 7.89% took leave from work while 0.28% needed medical attention. No major Adverse Events Following Immunization relevance with prior-COVID history or co-morbidity was seen. CONCLUSIONS: Majority of the vaccinated participants had minor adverse effects on the first-day post-vaccination while most of the Adverse Events Following Immunization subsided within seven days.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Cross-Sectional Studies , Humans , Immunization , Nepal/epidemiology , Pandemics/prevention & control , Vaccination/adverse effects , Vaccines/adverse effects
5.
PLoS One ; 17(8): e0272729, 2022.
Article in English | MEDLINE | ID: covidwho-1987160

ABSTRACT

BACKGROUND: Adverse events following immunization (AEFI) against SARS-CoV-2 are common as reported by clinical trials and contemporary evidence. The objective of the present study was to evaluate the local and systemic adverse events following vaccination with ChAdOx1 nCoV-19 and BBIBP-CorV among the healthcare professionals (HCPs) of Nepal. METHODS: This cross-sectional study was conducted among 606 vaccinated HCPs of Kathmandu, Nepal. Data was collected from June 15 to 30, 2021 using a self-administered online survey tool. Multiple binary logistic regression models were used to predict the adverse events according to the vaccine types and doses after adjusting for age, sex, comorbidity and previous SARS-CoV-2 infection. RESULTS: The mean (SD) age of the participants was 35.6 (13.2) years and 52% of them were female. Almost 59% of participants were vaccinated with two doses and around 54% of total of them took the ChAdOx1 nCoV-19 vaccine. At least one local and systemic adverse event was reported by 54% and 62% of participants after the first dose and 37% and 49% after the second dose of ChAdOx1 nCoV-19 and by 37% and 43% after the first dose and 42% and 36% after the second dose of BBIBP-CorV vaccine respectively. Injection site pain, swelling and tenderness at the injection site were the most frequently reported local AEFI while, fatigue, headache, fever and myalgia were the most frequently reported systemic AEFI. The logistic model demonstrated that the risk of both local and systemic adverse events was higher among the ChAdOx1 nCoV-19 vaccine recipients compared to the BBIBP-CorV vaccine. Almost 10% of individuals reported a post-vaccination SARS-CoV-2 infection and most of them occurred after taking the first dose of vaccine. CONCLUSIONS: Recipients of both the ChAdOx1 nCoV-19 and BBIBP-CorV vaccine among the HCPs of Nepal reported only mild and constitutional symptoms including injection site pain and tenderness, headache, fever, fatigue, etc. after vaccination.


Subject(s)
COVID-19 , ChAdOx1 nCoV-19 , Adult , COVID-19/epidemiology , COVID-19/prevention & control , Cross-Sectional Studies , Delivery of Health Care , Fatigue/etiology , Female , Headache/chemically induced , Headache/epidemiology , Humans , Immunization , Male , Nepal/epidemiology , Pain/etiology , SARS-CoV-2 , Vaccination/adverse effects
6.
Lancet Infect Dis ; 22(6): 791-801, 2022 06.
Article in English | MEDLINE | ID: covidwho-1984271

ABSTRACT

BACKGROUND: COVID-19 vaccines have proven highly effective among individuals without a previous SARS-CoV-2 infection, but their effectiveness in preventing symptomatic infection and severe outcomes among individuals with previous infection is less clear. We aimed to estimate the effectiveness of four COVID-19 vaccines against symptomatic infection, hospitalisation, and death for individuals with laboratory-confirmed previous SARS-CoV-2 infection. METHODS: Using national COVID-19 notification, hospitalisation, and vaccination datasets from Brazil, we did a test-negative, case-control study to assess the effectiveness of four vaccines (CoronaVac [Sinovac], ChAdOx1 nCoV-19 [AstraZeneca], Ad26.COV2.S [Janssen], and BNT162b2 [Pfizer-BioNtech]) for individuals with laboratory-confirmed previous SARS-CoV-2 infection. We matched cases with RT-PCR positive, symptomatic COVID-19 with up to ten controls with negative RT-PCR tests who presented with symptomatic illnesses, restricting both groups to tests done at least 90 days after an initial infection. We used multivariable conditional logistic regression to compare the odds of test positivity and the odds of hospitalisation or death due to COVID-19, according to vaccination status and time since first or second dose of vaccines. FINDINGS: Between Feb 24, 2020, and Nov 11, 2021, we identified 213 457 individuals who had a subsequent, symptomatic illness with RT-PCR testing done at least 90 days after their initial SARS-CoV-2 infection and after the vaccination programme started. Among these, 30 910 (14·5%) had a positive RT-PCR test consistent with reinfection, and we matched 22 566 of these cases with 145 055 negative RT-PCR tests from 68 426 individuals as controls. Among individuals with previous SARS-CoV-2 infection, vaccine effectiveness against symptomatic infection 14 or more days from vaccine series completion was 39·4% (95% CI 36·1-42·6) for CoronaVac, 56·0% (51·4-60·2) for ChAdOx1 nCoV-19, 44·0% (31·5-54·2) for Ad26.COV2.S, and 64·8% (54·9-72·4) for BNT162b2. For the two-dose vaccine series (CoronaVac, ChAdOx1 nCoV-19, and BNT162b2), effectiveness against symptomatic infection was significantly greater after the second dose than after the first dose. Effectiveness against hospitalisation or death 14 or more days from vaccine series completion was 81·3% (75·3-85·8) for CoronaVac, 89·9% (83·5-93·8) for ChAdOx1 nCoV-19, 57·7% (-2·6 to 82·5) for Ad26.COV2.S, and 89·7% (54·3-97·7) for BNT162b2. INTERPRETATION: All four vaccines conferred additional protection against symptomatic infections and severe outcomes among individuals with previous SARS-CoV-2 infection. The provision of a full vaccine series to individuals after recovery from COVID-19 might reduce morbidity and mortality. FUNDING: Brazilian National Research Council, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro, Oswaldo Cruz Foundation, JBS, Instituto de Salud Carlos III, Spanish Ministry of Science and Innovation, and Generalitat de Catalunya.


Subject(s)
COVID-19 Vaccines , COVID-19 , Ad26COVS1 , BNT162 Vaccine , Brazil/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , Case-Control Studies , ChAdOx1 nCoV-19 , Humans , SARS-CoV-2
7.
Cochrane Database Syst Rev ; 8: CD015021, 2022 08 09.
Article in English | MEDLINE | ID: covidwho-1981526

ABSTRACT

BACKGROUND: High efficacy in terms of protection from severe COVID-19 has been demonstrated for several SARS-CoV-2 vaccines. However, patients with compromised immune status develop a weaker and less stable immune response to vaccination. Strong immune response may not always translate into clinical benefit, therefore it is important to synthesise evidence on modified schemes and types of vaccination in these population subgroups for guiding health decisions. As the literature on COVID-19 vaccines continues to expand, we aimed to scope the literature on multiple subgroups to subsequently decide on the most relevant research questions to be answered by systematic reviews. OBJECTIVES: To provide an overview of the availability of existing literature on immune response and long-term clinical outcomes after COVID-19 vaccination, and to map this evidence according to the examined populations, specific vaccines, immunity parameters, and their way of determining relevant long-term outcomes and the availability of mapping between immune reactivity and relevant outcomes. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register, the Web of Science Core Collection, and the World Health Organization COVID-19 Global literature on coronavirus disease on 6 December 2021.  SELECTION CRITERIA: We included studies that published results on immunity outcomes after vaccination with BNT162b2, mRNA-1273, AZD1222, Ad26.COV2.S, Sputnik V or Sputnik Light, BBIBP-CorV, or CoronaVac on predefined vulnerable subgroups such as people with malignancies, transplant recipients, people undergoing renal replacement therapy, and people with immune disorders, as well as pregnant and breastfeeding women, and children. We included studies if they had at least 100 participants (not considering healthy control groups); we excluded case studies and case series. DATA COLLECTION AND ANALYSIS: We extracted data independently and in duplicate onto an online data extraction form. Data were represented as tables and as online maps to show the frequency of studies for each item. We mapped the data according to study design, country of participant origin, patient comorbidity subgroup, intervention, outcome domains (clinical, safety, immunogenicity), and outcomes.  MAIN RESULTS: Out of 25,452 identified records, 318 studies with a total of more than 5 million participants met our eligibility criteria and were included in the review. Participants were recruited mainly from high-income countries between January 2020 and 31 October 2021 (282/318); the majority of studies included adult participants (297/318).  Haematological malignancies were the most commonly examined comorbidity group (N = 54), followed by solid tumours (N = 47), dialysis (N = 48), kidney transplant (N = 43), and rheumatic diseases (N = 28, 17, and 15 for mixed diseases, multiple sclerosis, and inflammatory bowel disease, respectively). Thirty-one studies included pregnant or breastfeeding women. The most commonly administered vaccine was BNT162b2 (N = 283), followed by mRNA-1273 (N = 153), AZD1222 (N = 66), Ad26.COV2.S (N = 42), BBIBP-CorV (N = 15), CoronaVac (N = 14), and Sputnik V (N = 5; no studies were identified for Sputnik Light). Most studies reported outcomes after regular vaccination scheme.  The majority of studies focused on immunogenicity outcomes, especially seroconversion based on binding antibody measurements and immunoglobulin G (IgG) titres (N = 179 and 175, respectively). Adverse events and serious adverse events were reported in 126 and 54 studies, whilst SARS-CoV-2 infection irrespective of severity was reported in 80 studies. Mortality due to SARS-CoV-2 infection was reported in 36 studies. Please refer to our evidence gap maps for more detailed information. AUTHORS' CONCLUSIONS: Up to 6 December 2021, the majority of studies examined data on mRNA vaccines administered as standard vaccination schemes (two doses approximately four to eight weeks apart) that report on immunogenicity parameters or adverse events. Clinical outcomes were less commonly reported, and if so, were often reported as a secondary outcome observed in seroconversion or immunoglobulin titre studies. As informed by this scoping review, two effectiveness reviews (on haematological malignancies and kidney transplant recipients) are currently being conducted.


Subject(s)
COVID-19 , Hematologic Neoplasms , Vaccines , Ad26COVS1 , Adult , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , ChAdOx1 nCoV-19 , Child , Female , Humans , Pregnancy , SARS-CoV-2 , Vaccination
8.
West Afr J Med ; 39(7): 769-771, 2022 Jul 31.
Article in English | MEDLINE | ID: covidwho-1980941

ABSTRACT

INTRODUCTION: The association of kidney disease and COVID-19 vaccination has been reported with minimal change disease being a common presentation. CASE REPORT: Index patient is a 54-year-old female who presented with a history of reduction in urine output within 3 weeks of receiving the Oxford-AztraZeneca COVID-19 vaccine. Her serum creatinine on admission was 1,057 µmol/L with a premorbid serum creatinine of 78 µmol/L. Her vital signs were stable. She was on antihypertensive and antidiabetic medications for hypertension and diabetes mellitus, respectively. Renal biopsy was precluded by her morbid obesity and she was commenced on oral prednisolone. She had 5 sessions of hemodialysis and her serum creatinine gradually reduced to 106 µmol/L, and she is being followed up on an outpatient basis. CONCLUSION: We report a case of a female patient with acute kidney injury following COVID-19 Oxford-AztraZeneca vaccination. Further studies are required to better understand the pathogenesis of the renal affectation post-vaccination.


INTRODUCTION: L'association de la maladie rénale et de la vaccination COVID-19 a été signalée, la maladie à changement minimal est une présentation courante. RAPPORT DE CAS: La patiente à l'étude est une femme de 54 ans qui a présenté des antécédents de réduction du débit urinaire dans les 3 semaines après avoir reçu le vaccin COVID-19 d'Oxford-AztraZeneca. Sa créatinine sérique à l'admission était de 1 057 µmol/L avec une créatinine sérique prémorbide de 78 µmol/L. Ses signes vitaux étaient stables. Elle prenait des médicaments antihypertenseurs et antidiabétiques pour l'hypertension et le diabète sucré, respectivement. Une biopsie rénale était impossible à cause de son obésité morbide et elle a été mise sous prednisolone par voie orale. Elle a subi 5 sessions d'hémodialyse et son taux de créatinine sérique a progressivement à 106 µmol/L, et elle est suivie en ambulatoire. CONCLUSION: Nous rapportons le cas d'une patiente souffrant d'une lésion rénale aiguë après la vaccination par le COVID-19 Oxford-AztraZeneca. D'autres études sont nécessaires pour mieux comprendre la pathogenèse de l'affectation rénale post-vaccination. Mots-clés: Vaccin COVID-19, Événement Indésirable, Lésion Rénale Aiguë.


Subject(s)
Acute Kidney Injury , COVID-19 , ChAdOx1 nCoV-19 , Acute Kidney Injury/chemically induced , COVID-19/prevention & control , ChAdOx1 nCoV-19/adverse effects , Creatinine , Female , Humans , Middle Aged , Nigeria
9.
Nat Commun ; 13(1): 4610, 2022 Aug 08.
Article in English | MEDLINE | ID: covidwho-1977995

ABSTRACT

ChAdOx1 nCoV-19 (AZD1222) is a replication-deficient simian adenovirus-vectored vaccine encoding the spike (S) protein of SARS-CoV-2, based on the first published full-length sequence (Wuhan-1). AZD1222 has been shown to have 74% vaccine efficacy against symptomatic disease in clinical trials. However, variants of concern (VoCs) have been detected, with substitutions that are associated with a reduction in virus neutralizing antibody titer. Updating vaccines to include S proteins of VoCs may be beneficial, even though current real-world data is suggesting good efficacy following boosting with vaccines encoding the ancestral S protein. Using the Syrian hamster model, we evaluate the effect of a single dose of AZD2816, encoding the S protein of the Beta VoC, and efficacy of AZD1222/AZD2816 as a heterologous primary series against challenge with the Beta or Delta variant. Minimal to no viral sgRNA could be detected in lungs of vaccinated animals obtained at 3- or 5- days post inoculation, in contrast to lungs of control animals. In Omicron-challenged hamsters, a single dose of AZD2816 or AZD1222 reduced virus shedding. Thus, these vaccination regimens are protective against the Beta, Delta, and Omicron VoCs in the hamster model.


Subject(s)
COVID-19 , Viral Vaccines , Animals , Antibodies, Viral , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Cricetinae , Humans , Mesocricetus , SARS-CoV-2
10.
Eur Rev Med Pharmacol Sci ; 26(14): 5297-5306, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1975731

ABSTRACT

OBJECTIVE: To gain insight into the different protective mechanisms of approved vaccines, this study focuses on the comparison of humoral and cellular immune responses of five widely used vaccines including ChAdOx1 (AZD1222, AstraZeneca), BNT162b2 (Pfizer), mRNA-1273 (Moderna), BBIBP-CorV (Sinopharm), and Gam-COVID-Vac (Sputnik V). MATERIALS AND METHODS: Isolated plasma from 95 volunteers' blood samples was used to measure anti-SARS-CoV-2 humoral and cellular immune responses. Positive controls were recovered patients from COVID-19 (unvaccinated). Specific quantification kits for anti-nucleocapsid IgG, anti-Spike protein IgG, neutralizing antibodies as well as specific SARS-CoV-2 antigens for T-cell activation were used and Spearman correlation and matrix analyses were performed to compare overall immune responses. RESULTS: Nucleocapsid antibodies were significantly higher for the BBIBP-CorV and convalescent group when compared to other vaccines. In contrast, subjects vaccinated with BNT162b2 and mRNA-1273 presented significantly higher anti-spike IgG. In fact, 9.1% of convalescent, 4.5% of Gam-COVID-Vac, 28.6% of ChAdOx1, and 12.5% of BBIBP-CorV volunteers did not generate anti-spike IgG. Similarly, a positive correlation was observed after the neutralization assay. T-cell activation studies showed that mRNA-based vaccines induced a T-cell driven immune response in all cases, while 55% of convalescents,  8% of BNT162b1,  12,5% of mRNA-1273, 9% of Gam-COVID-Vac,  57% of ChAdOx1,  and  56% of BBIBP-CorV subjects presented no cellular response. Further correlation matrix analyses indicated that anti-spike IgG and neutralizing antibodies production, and T-cell activation follow the same trend after immunization. CONCLUSIONS: RNA-based vaccines induced the most robust adaptive immune activation against SARS-CoV-2 by promoting a significantly higher T-cell response, anti-spike IgG and neutralization levels. Vector-based vaccines protected against the virus at a comparable level to convalescent patients.


Subject(s)
COVID-19 Vaccines , COVID-19 , 2019-nCoV Vaccine mRNA-1273 , Antibodies, Neutralizing , BNT162 Vaccine , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Humans , Hungary , Immunoglobulin G , RNA, Messenger , SARS-CoV-2 , Vaccination
11.
Elife ; 112022 07 04.
Article in English | MEDLINE | ID: covidwho-1975325

ABSTRACT

ChAdOx1 nCov-19 and Ad26.COV2.S are approved vaccines inducing protective immunity against SARS-CoV-2 infection in humans by expressing the Spike protein of SARS-CoV-2. We analyzed protein content and protein composition of ChAdOx1 nCov-19 and Ad26.COV2.S by biochemical methods and by mass spectrometry. Four out of four tested lots of ChAdOx1 nCoV-19 contained significantly higher than expected levels of host cell proteins (HCPs) and of free viral proteins. The most abundant contaminating HCPs belonged to the heat-shock protein and cytoskeletal protein families. The HCP content exceeded the 400 ng specification limit per vaccine dose, as set by the European Medicines Agency (EMA) for this vaccine, by at least 25-fold and the manufacturer's batch-release data in some of the lots by several hundred-fold. In contrast, three tested lots of the Ad26.COV2.S vaccine contained only very low amounts of HCPs. As shown for Ad26.COV2.S production of clinical grade adenovirus vaccines of high purity is feasible at an industrial scale. Correspondingly, purification procedures of the ChAdOx1 nCov-19 vaccine should be modified to remove protein impurities as good as possible. Our data also indicate that standard quality assays, as they are used in the manufacturing of proteins, have to be adapted for vectored vaccines.


Subject(s)
COVID-19 , SARS-CoV-2 , Ad26COVS1 , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Humans
13.
Bull World Health Organ ; 100(8): 474-483, 2022 Aug 01.
Article in English | MEDLINE | ID: covidwho-1974569

ABSTRACT

Objective: To investigate the incidence of coronavirus disease 2019 (COVID-19) cases, hospitalizations and deaths in Iranians vaccinated with either AZD1222 Vaxzevria, CovIran® vaccine, SARS-CoV-2 Vaccine (Vero Cell), Inactivated (lnCoV) or Sputnik V. Methods: We enrolled individuals 18 years or older receiving their first COVID-19 vaccine dose between April 2021 and January 2022 in seven Iranian cities. Participants completed weekly follow-up surveys for 17 weeks (25 weeks for AZD1222) to report their COVID-19 status and hospitalization. We used Cox regression models to assess risk factors for contracting COVID-19, hospitalization and death. Findings: Of 89 783 participants enrolled, incidence rates per 1 000 000 person-days were: 528.2 (95% confidence interval, CI: 514.0-542.7) for contracting COVID-19; 55.8 (95% CI: 51.4-60.5) for hospitalization; and 4.1 (95% CI: 3.0-5.5) for death. Compared with SARS-CoV-2 Vaccine (Vero Cell), hazard ratios (HR) for contracting COVID-19 were: 0.70 (95% CI: 0.61-0.80) with AZD1222; 0.73 (95% CI: 0.62-0.86) with Sputnik V; and 0.73 (95% CI: 0.63-0.86) with CovIran®. For hospitalization and death, all vaccines provided similar protection 14 days after the second dose. History of COVID-19 protected against contracting COVID-19 again (HR: 0.76; 95% CI: 0.69-0.84). Diabetes and respiratory, cardiac and renal disease were associated with higher risks of contracting COVID-19 after vaccination. Conclusion: The rates of contracting COVID-19 after vaccination were relatively high. SARS-CoV-2 Vaccine (Vero Cell) provided lower protection against COVID-19 than other vaccines. People with comorbidities had higher risks of contracting COVID-19 and hospitalization and should be prioritized for preventive interventions.


Subject(s)
COVID-19 , Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , ChAdOx1 nCoV-19 , Cohort Studies , Hospitalization , Humans , Iran/epidemiology , SARS-CoV-2 , Vaccination
14.
Blood ; 140(5): 478-490, 2022 08 04.
Article in English | MEDLINE | ID: covidwho-1974106

ABSTRACT

Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are based on a range of novel platforms, with adenovirus-based approaches (like ChAdOx1 nCov-19) being one of them. Recently, a novel complication of SARS-CoV-2-targeted adenovirus vaccines has emerged: immune thrombocytopenia, either isolated, or accompanied by thrombosis (then termed VITT). This complication is characterized by low platelet counts, and in the case of VITT, also by platelet-activating platelet factor 4 antibodies reminiscent of heparin-induced thrombocytopenia, leading to a prothrombotic state with clot formation at unusual anatomic sites. Here, we detected antiplatelet antibodies targeting platelet glycoprotein receptors in 30% of patients with proven VITT (n = 27) and 42% of patients with isolated thrombocytopenia after ChAdOx1 nCov-19 vaccination (n = 26), indicating broad antiplatelet autoimmunity in these clinical entities. We use in vitro and in vivo models to characterize possible mechanisms of these platelet-targeted autoimmune responses leading to thrombocytopenia. We show that IV but not intramuscular injection of ChAdOx1 nCov-19 triggers platelet-adenovirus aggregate formation and platelet activation in mice. After IV injection, these aggregates are phagocytosed by macrophages in the spleen, and platelet remnants are found in the marginal zone and follicles. This is followed by a pronounced B-cell response with the emergence of circulating antibodies binding to platelets. Our work contributes to the understanding of platelet-associated complications after ChAdOx1 nCov-19 administration and highlights accidental IV injection as a potential mechanism of platelet-targeted autoimmunity. Hence, preventing IV injection when administering adenovirus-based vaccines could be a potential measure against platelet-associated pathologies after vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , ChAdOx1 nCoV-19 , Thrombocytopenia , Animals , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19/adverse effects , Immunity , Mice , Platelet Factor 4 , SARS-CoV-2 , Spleen , Thrombocytopenia/etiology
15.
Chest ; 162(2): e85-e88, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1972016

ABSTRACT

CASE PRESENTATION: A 54-year-old man with chronic hepatitis B was admitted to the hospital with progressive dyspnea on exertion. He reported experiencing intermittent fever, dyspnea on exertion, and relapsing pleuritic chest pain starting 6 months prior, after his first dose of the ChAdOx1 nCoV-19 vaccine. In the past 2 months, he had been admitted to the hospital twice and diagnosed with recurrent pneumonia. Under antibiotic treatment, his dyspnea and low-grade fever demonstrated waxing and waning behaviors. Migratory pulmonary consolidation, which moved from the left lower lobe to the right middle lobe, was identified and diagnosed as relapsing pneumonia. Chest CT scan was performed in a previous admission 2 months earlier that revealed multifocal peripheral consolidation in the left lower lobe and right middle lobe. His occupation required the maintenance of overall fitness, and he denied immunosuppressant use, illicit drug abuse, cigarette smoking, suspicious travel, suspicious contact, or family history. No recent history of trauma, surgery, or air travel was reported.


Subject(s)
ChAdOx1 nCoV-19 , Lung Diseases , Chest Pain/diagnosis , Diagnosis, Differential , Dyspnea/diagnosis , Dyspnea/etiology , Fever/diagnosis , Humans , Lung Diseases/diagnosis , Male , Middle Aged , Tomography, X-Ray Computed
16.
Front Public Health ; 10: 907652, 2022.
Article in English | MEDLINE | ID: covidwho-1963639

ABSTRACT

Reports of side effects of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are increasing worldwide. Capillary leak syndrome and vaccine-induced immune thrombotic thrombocytopenia are very rare but life-threatening adverse events that should be identified early and treated. However, isolated thrombocytopenia can indicate pseudothrombocytopenia. In certain people, ethylenediaminetetraacetic acid (EDTA) induces an in vitro platelet aggregation, resulting in misleading underestimation of platelet counts. It is essential to recognize pseudothrombocytopenia to prevent diagnostic errors, overtreatment, anxiety, and unnecessary invasive procedures. We present a case who developed generalized edema and persistent pseudothrombocytopenia after the first dose of the ChAdOx1 nCoV-19 vaccine (AstraZeneca).


Subject(s)
COVID-19 , Thrombocytopenia , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Edema , Humans , SARS-CoV-2 , Thrombocytopenia/chemically induced , Thrombocytopenia/diagnosis , Vaccination/adverse effects
19.
Am J Manag Care ; 28(7): e244-e247, 2022 07 01.
Article in English | MEDLINE | ID: covidwho-1955605

ABSTRACT

OBJECTIVES: Covishield and Covaxin vaccines have been introduced after rapid approval in India, the nation that has the second most COVID-19 cases globally. These vaccines have been administered in a 2-dose schedule since January 16, 2021. This study deals with the clinical profile of individuals who developed COVID-19 infection post COVID-19 vaccination. This is the first study of its kind in India. STUDY DESIGN: Descriptive cross-sectional study. METHODS: The study population was composed of individuals who were COVID-19 positive more than 4 weeks post vaccination and were compared with individuals who were COVID-19 positive within the first 4 weeks of vaccination. Data were collected in a digital questionnaire format and analyzed with SPSS version 23 software. Clinical features were profiled in detail. Chi-square analysis was done to find out the association of various demographic features with the severity of the disease. RESULTS: In the study population, fever was the most common symptom (75.1%), followed by anosmia (72.1%) and shortness of breath (16.3%). There was a lower incidence of fever, cough, dyspnea, and requirement of hospitalization in the study population compared with the control group and previous epidemiological data. The time required for complete recovery and disease severity was favorable in our study population. There was a significant correlation in the rate of hospitalization among the study group and the comparative group (P = .0001) and between the number of doses of COVID-19 vaccine and the lowest oxygen saturation recorded (P = .001). CONCLUSIONS: The findings of this study should boost the ongoing initiative of maximizing the vaccinated population countrywide and emphasize the need for 2 doses of vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Cross-Sectional Studies , Humans , Vaccination , Vaccines
20.
Front Public Health ; 10: 896343, 2022.
Article in English | MEDLINE | ID: covidwho-1952855

ABSTRACT

Healthcare workers were prioritized in vaccination campaigns globally because they are exposed to the highest risk of contamination by SARS-CoV-2. This study evaluated the self-reported post-vaccination side effects of inactivated (BBIBP-CorV and CoronaVac) and adenoviral vector-based (AZD1222, Gam-COVID-Vac and Ad26.COV2.S) vaccines among Algerian healthcare workers using a validated questionnaire. The final analysis included 721 healthcare workers, with a predominance of females (59.1%) and younger individuals 20-30 years old (39.4%). Less than half (49.1%) of the respondents reported at least one local side effect, while 53.8% reported at least one systemic side effect. These side effects were more prevalent among viral vector vaccinees than inactivated virus vaccinees. The most common local side effects were injection site pain (39%) and arm pain (25.4%), while fatigue (34.4%), fever (28.4%), headache (24.8%) and myalgia (22.7%) were the most prevalent systemic side effects. The side effects appeared earlier among inactivated virus vaccines recipients and generally lasted for 2 to 3 days for the two vaccinated groups. The risk factors associated with a higher prevalence of side effects included female gender, allergic individuals, individuals with regular medication, those who contracted the COVID-19 disease and those who received two doses for both inactivated and viral-based vaccines groups. Despite the higher prevalence of post-vaccination side effects among adenoviral vector vaccines recipients, both vaccines groups were equally effective in preventing symptomatic infections, and no life-threatening side effects were reported in either vaccine group.


Subject(s)
COVID-19 , Influenza Vaccines , Ad26COVS1 , Adult , Algeria/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , ChAdOx1 nCoV-19 , Female , Health Personnel , Humans , Male , Pain , SARS-CoV-2 , Young Adult
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