scholarly journals A prospective observational safety study on ChAdOx1 nCoV- 19 corona virus vaccine (recombinant) use in healthcare workers- first results from India

2021 ◽  
Author(s):  
Upinder Kaur ◽  
Bisweswar Ojha ◽  
Bhairav Kumar Pathak ◽  
Anup Singh ◽  
Kiran R Giri ◽  
...  
Keyword(s):  
Virus Vaccine ◽  
Healthcare Workers ◽  
Safety Data ◽  
Vaccine Recombinant ◽  
Safety Study ◽  
Northern India ◽  
Corona Virus ◽  
First Results ◽  
Grade 3 ◽  
The Uk

Vaccines are an important public health measure for tiding over the COVID-19 pandemic. Several vaccines have been approved in different countries for emergency use. In India, two vaccines have been currently approved- COVISHIELD (Serum Institute of India (SII)) which is a recombinant simian adenovirus-based vaccine and COVAXIN (Bharat Biotech) which is an inactivated SARS-CoV-2 vaccine. Our current study provides the first post approval safety data on ChAdOx1 nCoV- 19 corona virus vaccine (recombinant) use in healthcare workers in northern India (n=804). Around one half of vaccinees developed adverse events at any time post vaccination with majority of reactions being mild to moderate in severity. AEFIs were seen in 40% participants after first dose and around 16% participants after second dose. This observed reactogenicity is much less compared to 60-88% reactogenicity rate observed with Oxford-AstraZenecas ChAdOx1 vaccine in the UK based population. Individually, fever, injection site pain and headache were the commonly observed AEFIs. Overall, the frequency of systemic events of severity grade 3 was only 0.5% and is much less than the reported rates for other recombinant adenoviral vaccines. The rate of serious AEFIs in our study was only 0.1% (n=1). There was a possibility of this AEFI being an immunization stress related response. No deaths were reported in the vaccinees in our study during the study period. Reactogenicity rate was observed to decrease with age and was higher in females. On the basis of interim findings of this safety study, it may be interpreted that the ChAdOx1 nCoV-19 corona virus vaccine (recombinant) (COVISHIELD, Serum Institute of India) carries a good safety profile overall.

scholarly journals Leukocytoclastic vasculitis as a cutaneous manifestation of ChAdOx1 nCoV ‐19 Corona Virus Vaccine (Recombinant)

2021 ◽  
Author(s):  
Sunmeet Sandhu ◽  
Anuj Bhatnagar ◽  
Harish Kumar ◽  
Prashant Kumar Dixit ◽  
Gourang Paliwal ◽  
...  
Keyword(s):  
Virus Vaccine ◽  
Leukocytoclastic Vasculitis ◽  
Cutaneous Manifestation ◽  
Vaccine Recombinant ◽  
Corona Virus

scholarly journals A Real World Evaluation of the safety and immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) in National Capital Region (NCR) of India: A preliminary report

2021 ◽  
Author(s):  
Sushia Kataria ◽  
Pooja Sharma ◽  
Vikas Deswal ◽  
Kuldeep Kumar ◽  
Manish Kumar Singh ◽  
...  
Keyword(s):  
Health Care ◽  
Adverse Events ◽  
Virus Vaccine ◽  
Health Care Workers ◽  
Real World ◽  
Vaccine Recombinant ◽  
Serious Adverse Events ◽  
Corona Virus ◽  
Care Workers ◽  
History Of

Background: The SARS-CoV-2 pandemic has severely impacted health systems, economic and social progress globally in 2020. The rollout of vaccines in several parts of the world is being hailed as a solution to the crisis. With newer and more virulent serotypes on the horizon and limited vaccine available, evaluation of safety and immunogenicity is critical for rationalization of vaccine use in public health. Objective To evaluate real world safety, and, immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) during the national vaccine roll out in the NCR, New Delhi. The safety is evaluated through Adverse Events and Serious Adverse Events reported though enhanced pharmacovigilance protocols, and, the immunogenicity by quantitative determination of anti-S1 and anti-S2 specific IgG antibodies to SARS-CoV-2 in serum samples collected before the receipt of the vaccine and 14 days after dose 1, using the fully automated LIAISON SARS-CoV-2 S1/S2 IgG test using the chemiluminescence immunoassay (CLIA) Results: In the two weeks after immunization with the Covishield vaccine {ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)}, none of the 1638 evaluated participants reported any serious adverse events (ie require hospitalization or emergency room visit). Solicited adverse events reported via daily diary cards included pain (62.7%) and soreness (24.1%) at injection site as most common, whereas fever (48.4%), headache (43.4%), myalgia (38.4%), fatigue (33.4%), joint pain (27.0%) and nausea (16.0%) were most common solicited systemic adverse events on day 1. Majority of local and systemic adverse events were seen in first 2 days post vaccination and thereafter they resolved. Lesser reactogenicity was observed in subjects with age >50 years. No major difference was observed in adverse events when subjects were stratified based on history of COVID 19 disease or baseline seropositivity. In our study serostatus improved from 48.2% positive at baseline to 79.0% positive 2 weeks following first dose of vaccination. After first dose of vaccination overall higher percentage (98.2%) of seropositivity rates were observed in those with past history of COVID 19 disease Conclusion: The Covishield vaccine {ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)}, was safe and reported mild self limiting adverse events over 2-4 days and had an good early (within 2 weeks) seroresponse .This holds the promise of far reaching impact on vaccine availability for a larger population and thereby providing a widespread coverage.

Efficacy and safety data for the Ab interno XEN45 gel stent implant at 3 Years: A retrospective analysis

2021 ◽  
pp. 112067212110143
Author(s):  
Itay E Gabbay ◽  
Mordechai Goldberg ◽  
Felicity Allen ◽  
Zhiheng Lin ◽  
Christine Morley ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Failure Rate ◽  
Open Angle Glaucoma ◽  
Safety Data ◽  
Angle Closure ◽  
Efficacy And Safety ◽  
Antihypertensive Medications ◽  
Uk National Health Service ◽  
The Uk ◽  
Comparative Audit

Purpose: To report efficacy and safety measures of the XEN45 gel stent at 36 months in the UK National Health Service setting. Methods: Retrospective non-comparative audit of the records of patients who underwent XEN45 implantation between June 2015 and May 2017 was performed. Main outcome measures were intraocular pressure and number of antihypertensive medications used. Failure was defined as need for further surgery or stent removal. Success was defined as a 20% decrease in intraocular pressure without the need for additional glaucoma medications or a reduction in antihypertensive medications without an increase in baseline intraocular pressure. Needling rates and preoperative factors effect were assessed. Results: The cohort included 205 patients (205 eyes) with primary open angle glaucoma (84.4%), angle closure glaucoma (7.8%), or refractory glaucoma (7.8%), 62.9% had a stand-alone procedure and 37.1%, a combined phaco-XEN45 procedure. Mean intraocular pressure was 22.6 ± 7.0 mmHg at baseline compared to 14.7 ± 3.8 mmHg at 24 months and 14.0 ± 2.9 mmHg at 36 months ( p < 0.001 for both). Mean number of medications used was 2.6 ± 1.1 at baseline compared to 0.5 ± 0.9 and 0.6 ± 1.0, at 24- and 36-months, respectively ( p < 0.001 for both). The failure rate at 36 months was 25%. Needling was required in 36.6%. Evaluation of background factors yielded an increased failure rate in non-Caucasians compared to Caucasians (74% vs 21%, p < 0.001). Conclusion: XEN45 implantation is effective and safe at 36 months’ follow-up. Patients should be advised regarding the risk of failure and possible need for bleb revisions. Careful patient selection may be required.

scholarly journals COVID-19 Vaccine Safety in Cancer Patients: A Single Centre Experience

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3573
Author(s):  
Alfred Chung Pui So ◽  
Harriet McGrath ◽  
Jonathan Ting ◽  
Krishnie Srikandarajah ◽  
Styliani Germanou ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Safety Data ◽  
Vaccine Safety ◽  
Phase Iii ◽  
Solid Malignancy ◽  
Common Grade ◽  
Phase Iii Trials ◽  
Oncology Care ◽  
Grade 3 ◽  
Oncology Centre

Emergency approval of vaccines against COVID-19 provides an opportunity for us to return to pre-pandemic oncology care. However, safety data in cancer patients is lacking due to their exclusion from most phase III trials. We included all patients aged less than 65 years who received a COVID-19 vaccine from 8 December 2020 to 28 February 2021 at our London tertiary oncology centre. Solicited and unsolicited vaccine-related adverse events (VRAEs) were collected using telephone or face-to-face consultation. Within the study period, 373 patients received their first dose of vaccine: Pfizer/BioNTech (75.1%), Oxford/AstraZeneca (23.6%), Moderna (0.3%), and unknown (1.1%). Median follow-up was 25 days (5–85). Median age was 56 years (19–65). Of the patients, 94.9% had a solid malignancy and 76.7% were stage 3–4. The most common cancers were breast (34.0%), lung (13.4%), colorectal (10.2%), and gynaecological (10.2%). Of the patients, 88.5% were receiving anti-cancer treatment (36.2% parenteral chemotherapy and 15.3% immunotherapy), 76.1% developed any grade VRAE of which 2.1% were grade 3. No grade 4/5 or anaphylaxis were observed. The most common VRAEs within 7 days post-vaccination were sore arm (61.7%), fatigue (18.2%), and headaches (12.1%). Most common grade 3 VRAE was fatigue (1.1%). Our results demonstrate that COVID-19 vaccines in oncology patients have mild reactogenicity.

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