Impact of Covishield Vaccination in Terms of SARS CoV-2 Neutralizing Antibody Expression.

The vaccination efficacy can indirectly be assessed through the quantification of neutralizing antibodies. Very few data are available on Covishield efficacy in terms of neutralizing antibody expression upon vaccination. This study is focused on profiling of neutralizing antibody expression during and after the Covishield two shot vaccination and observing COVID-19 infection in vaccinated participants during the period. SARS CoV-2 neutralizing antibody concentrations in samples were estimated using electrochemiluminescence immunoassay kit for Lifotronics eCL8000. The sampling had been done sequentially at 45th, 85th day after 1st dose and 15th day after 2nd dose Covishield vaccination. Parallelly, in order to confirm the total SARS CoV-2 IgG response in COVID-19 infection, measured the IgG using SARS CoV-2 IgG lateral flow immunoassay test kit. The subjects previously infected with COVID-19 before 1st dose vaccination demonstrated high neutralizing antibody (> 10AU/ml). In COVID-19 uninfected subjects, there was a sudden incline in neutralizing antibody after the 2nd dose. Infection with SARS CoV-2 between 1st and 2nd dose of Covishield vaccination implicate that the level of neutralizing antibody in serum after 1st dose was not adequate to combat the virus and prevent infection. We observed COVID-19 infection in participants even after 2nd dose of vaccination. Interestingly, there was no protection against SARS CoV-2 even with a high neutralizing antibody expression of 188.5 AU/mL after the 2nd dose. Findings of Covishield efficacy in different cohort samples before and after 2 doses of Covishield vaccination provide impetus for improvement or development of next generation vaccines.

Incidence of breakthrough infections after COVID-19 vaccination among the COVID-19 vaccine recipients at a Tertiary Care Hospital in Srinagar.

COVID-19 infections despite complete vaccination are called breakthrough infections. Breakthrough infections may decrease the vaccination confidence among people. This study was conducted soon after the Covishield vaccine was approved for use in J and K to find out the incidence of breakthrough infections among the recipients of the Covishield vaccine at SKIMS and to find out the associated factors. List of beneficiaries (between February 14, and May 15, 2021) was obtained from the records. Information was gathered telephonically. Incidence of breakthrough infections 6-month postvaccination was determined. Among 919 participants, the incidence of breakthrough infections was 2.7% (25 cases). The medical profession was associated with a higher frequency of breakthrough infections. Most infections were mild to moderate (96%). One (4%) person required hospitalization. Thus, COVID-19 infections can occur despite complete vaccination. Increased exposure places an individual at higher risk of breakthrough infections. Therefore, where exposure is high, COVID-appropriate behavior should be followed despite being vaccinated.

Determinants of associated events following AZD1222 (Covishield) vaccination in a high-risk population in Nepal.

BACKGROUND: Vaccination is the most effective method to prevent the spread of infectious diseases and helps reduce mortality rate and economic costs associated with the pandemic. Despite these advantages, misinformation on vaccine safety and efficacy can lead to increased hesitation towards vaccination. This study reports the incidence of adverse events following Covishield vaccination, their associated factors, medication used for their management, and attitudes about vaccine safety. METHODS: A cross-sectional study was conducted from the sample of Covishield-vaccinated individuals from a secondary hospital, two primary health centres, and 36 health posts in eastern Nepal. Individuals (n = 602) were randomly sampled from a population (n = 1013) who had received the first dose of Covishield, namely frontline workers and other high-risk populations. The second-round follow-up had 516 participants. Association of incidence and severity of post-vaccination events with socio-demographic variables, comorbidity status, and medication use were estimated. RESULTS: Among the 79.9% of participants who reported adverse events after receiving the first dose, two-thirds of complaints were mild (67.4%, 95% CI 63.2-71.6) with the most common complaint being pain at the injection site (86.5%). Paracetamol or its combination with NSAIDs were used in the majority of cases (95.2%). After the second dose, only 31.2% (95% CI 27.2-35.2) reported adverse events, the overwhelming majority of which were mild (95.7%) and required a lower frequency of medication (7.5% vs. 26.0%). Adverse event following immunization were significantly associated with being 18-30 years old (χ2 = 16.9, df = 3, p < 0.001) and female gender (χ2 = 5.2, df = 1, p < 0.05). Prior to the first dose, 86.0% of participants (95% CI 83.3-88.8%) perceived the vaccine to be safe, and 96.0% recommended the vaccine post-vaccination, while 96.8% were interested in receiving the second dose. AEFI severity was negatively associated with vaccine recommendation to the peers (odds-ratio 0.062, p < 0.05) following the first dose, whereas, the optimistic pre-vaccination perception was associated with positive vaccine recommendation post-vaccination (odds-ratio 28.658, p < 0.01). CONCLUSIONS: Overall, vaccination-associated events were mild and majority were managed with paracetamol or its combination. Effective counselling about adverse events before vaccination should be prioritized to reduce hesitation and fear.

Vaccine effectiveness to protect against moderate or severe disease in COVID cases: A prospective cohort study.

Background: This study was carried out to evaluate the effectiveness of partial and full vaccination with ChAdOx1 nCoV-19 (COVISHIELD) to prevent the development of moderate or severe illness among COVID-positive cases. Methods: This prospective cohort study was conducted among Armed Forces personnel deployed in Northern India who were found COVID positive during the study period between January and June 2021. Information about the vaccination status, age and comorbidities was collected at the time of diagnosis. Classification of COVID cases as moderate or severe was performed as per criteria given by the Government of India. Individuals were considered partially vaccinated three weeks after one dose and fully vaccinated two weeks after the second dose. Risk ratio and vaccine effectiveness (VE) to prevent moderate or severe disease among COVID cases were calculated. Results: A total of 2005 COVID-19 patients were included in our study. Partial vaccination and full vaccination with ChAdOx1 nCoV-19 offered 13% (95% credible interval (CI): -56.8%, 52.8%) and 66.6% (95% CI: 34.9%, 84.6%) protection against progression to moderate/severe illness among COVID-positive individuals. The risk of moderate-severe disease among COVID-positive cases occurring 4-11 weeks after the first dose was also lesser among those who had taken the second dose of vaccine than individuals who have been vaccinated with only one dose. Conclusion: Interval between the first and second doses of ChAdOx1 nCoV-19 vaccine should be reduced to 4-6 weeks, as partial vaccination offers lower protection against the development of moderate-severe illness after COVID infection.

Auto-immune hepatitis following COVID vaccination.

Unprecedented loss of life due to the COVID pandemic has necessitated the development of several vaccines in record time. Most of these vaccines have received approval without being extensively whetted for their adverse effect and efficacy profiles. Most adverse effects have been mild, nonetheless, more serious thromboembolic events have also been reported. Autoimmune hepatitis (AIH) can occur in predisposed individuals where an immune mediated reaction against hepatocytes is triggered by environmental factors. Vaccines are a very rare cause of AIH. We report two such cases of AIH triggered by COVID (Covishield) vaccination. While one patient made an uneventful recovery, another succumbed to the liver disease. Ours is the first report of Covishield vaccination related AIH and second ever after any form of COVID vaccination. We hope that our report does not deter COVID vaccination drives. However, we also hope to raise awareness of its potential side effects and the increased role of pharmacovigilance in guiding treatment.

COVID-19 vaccine hesitancy among medical students in India.

The coronavirus disease 2019 (COVID-19) vaccine was launched in India on 16 January 2021, prioritising health care workers which included medical students. We aimed to assess vaccine hesitancy and factors related to it among medical students in India. An online questionnaire was filled by 1068 medical students across 22 states and union territories of India from 2 February to 7 March 2021. Vaccine hesitancy was found among 10.6%. Concern regarding vaccine safety and efficacy, lack of awareness regarding their eligibility for vaccination and lack of trust in government agencies predicted COVID-19 vaccine hesitancy among medical students. On the other hand, the presence of risk perception regarding themselves being affected with COVID-19 reduced vaccine hesitancy as well as hesitancy in participating in COVID-19 vaccine trials. Vaccine-hesitant students were more likely to derive information from social media and less likely from teachers at their medical colleges. Choosing between the two available vaccines (Covishield and Covaxin) was considered important by medical students both for themselves and for their future patients. Covishield was preferred to Covaxin by students. Majority of those willing to take the COVID-19 vaccine felt that it was important for them to resume their clinical posting, face-to-face classes and get their personal life back on track. Around three-fourths medical students viewed that COVID-19 vaccine should be made mandatory for both health care workers and international travellers. Prior adult vaccination did not have an effect on COVID-19 vaccine hesitancy. Targeted awareness campaigns, regulatory oversight of vaccine trials and public release of safety and efficacy data and trust building activities could further reduce COVID-19 vaccine hesitancy among medical students.

COVISHIELD (AZD1222) VaccINe effectiveness among healthcare and frontline Workers of INdian Armed Forces: Interim results of VIN-WIN cohort study.

BACKGROUND: On 16 Jan 2021, India launched its immunization program against COVID-19. Among the first recipients were 1.59 million Health Care Workers (HCWs) and Frontline Workers (FLWs) of the Indian Armed Forces, who were administered COVISHIELD (Astra Zeneca). We present an interim analysis of vaccine effectiveness (VE) estimates till 30 May 2021. METHODS: The VIN-WIN cohort study was carried out on anonymized data of HCWs and FLWs of Indian Armed Forces. The existing surveillance system, enhanced for COVID-19 monitoring, was sourced for data. The cohort transitioned from Unvaccinated (UV) to Partially Vaccinated (PV) to Fully Vaccinated (FV), serving as its own internal comparison. Outcomes studied in the three groups were breakthrough infections and COVID related deaths. Incidence Rate Ratio (IRR) was used to compare outcomes among the three groups to estimate VE. RESULTS: Data of 1,595,630 individuals (mean age 27.6 years; 99% male) over 135 days was analysed. Till 30 May 21, 95.4% and 82.2% were partially and fully vaccinated. The UV, PV and FV compartments comprised 106.6, 46.7 and 58.7 million person-days respectively. The number of breakthrough cases in the UV, PV and FV groups were 10061, 1159 and 2512; while the deaths were 37, 16 and 7 respectively. Corrected VE was 91.8-94.9% against infections. CONCLUSION: Interim results of the VIN-WIN cohort study of 1.59 million HCWs and FLWs of Indian Armed Forces showed a ∼93% reduction in COVID-19 breakthrough infections with COVISHIELD vaccination.

Vaccination status and COVID-19 related mortality: A hospital based cross sectional study.

BACKGROUND: Efficacy of vaccines studied in clinical trial settings are likely to be different from their effectiveness in a real-world scenario. Indian Armed Forces launched its vaccine drive against COVID-19 on 16 Jan 2021. This study evaluated the effect of vaccination on mortality amongst hospitalized COVID patients. METHODS: A cross sectional study was done on all admitted moderate to severe COVID-19 patients at a designated COVID hospital in New Delhi. The primary outcome assessed the association of being fully vaccinated with mortality. Unadjusted odds ratios (OR) (with 95% CI) was performed for each predictor. Logistic regression was used for multivariable analysis and adjusted odds ratios obtained. RESULTS: The 1168 patients included in the study had a male preponderance with a mean age of 54.6 (± 17.51) years. A total of 266 (23%) patients were partially vaccinated with COVISHIELD® and 184 (16%) were fully vaccinated. Overall, 518 (44.3%) patients had comorbidities and 332 (28.4%) died. Among those fully vaccinated, there was 12.5% (23/184) mortality while it was 31.45 % (309/984) among the unvaccinated (OR 0.3, 95% CI 0.2 to 0.5, p<0.0001). In a logistic regression model, complete vaccination status and younger age were found to be associated with survival. CONCLUSIONS: Vaccination with two doses of COVISHIELD® was associated with lower odds of mortality among hospitalized patients with moderate to severe COVID.

Adverse events following ChAdOx1 nCoV-19 Vaccine (COVISHIELD) amongst health care workers: A prospective observational study.

BACKGROUND: During ongoing COVID-19 pandemic, researchers worked enormously to develop effective vaccines against COVID-19 infection. Two Indian-made vaccines [Covishield (ChAdOx1 nCoV-19) and Covaxin] were granted Emergency Use Authorization. India launched its COVID-19 vaccination drive starting with healthcare workers (HCW). Aim of the study was to evaluate adverse events following immunization (AEFI) amongst the HCW with two doses of Covishield vaccine. We also evaluated association of AEFI according to sex, profession and age groups. METHODS: A prospective observational study was conducted in a tertiary care COVID dedicated hospital of Southern India from 16 Jan - 15 Apr 2021. Nine hundred and eighty one HCW who received 2 doses (4 weeks apart) were enrolled. Active and passive surveillance was conducted after 48 hours, and at days 8,15, 22 and 28 for both doses. The rate of AEFI for each dose was determined. Incidence and association of AEFI with various demographic variables was determined. RESULTS: 1020 non-serious and two serious AEFI (altered sensorium) were reported within 48 hours of first dose. Two hundred and twenty non-serious AEFI were reported within 48 hours of second dose. No AEFI was reported after 15 days for both the doses. We found no association of AEFI with sex and profession ( p >0.5). Significant association of AEFI was found with age ( p <0.01). CONCLUSION: Short-term AEFI were predominantly observed in first 48 hours. Incidence decreased in subsequent weeks with no occurrence after 15 days in both doses. Symptoms were mild in severity and short-lived. No serious AEFI attributable to vaccines were reported.

Effect of Vaccination on Seroprevalence of COVID-19 among Blood donors - A cross-sectional Analytic Study from South India.

India achieved impressive strides by providing 1.7 billion doses of the COVID-19 vaccine to more than 940 million people, attaining 100% first dose coverage and 80% overall immunization coverage as of February 9, 2022. Compared to unvaccinated individuals, vaccinated people have considerably decreased risks of infection, serious illness, hospitalization, and death. With the help of this study, we determined the prevalence of COVID-19 IgG antibodies with respect to vaccination. The cross-sectional analytical study was conducted from July 2021 to April 2022 on 809 healthy donors. All donor samples were screened for COVID-19 IgG antibodies against S1 protein using IgG ELISA kits (Qualisa COVID-19 IgG kits, Tulip, Goa, India). Data regarding COVID-19 infection history, vaccination status, type of vaccine, and the number of doses were obtained. All data were entered in Microsoft Excel and analyzed using SPSS version 21. Out of 809 blood donors, a total of 650 participants were vaccinated, among which 89.5% had COVID-19 IgG antibodies and 10.5% had no antibodies. Out of the 159 who had not taken vaccination, 52.8% of the participants had COVID-19 IgG antibodies, and 47.2% of the donors had no COVID-19 IgG antibodies. A total of 617 participants have taken the Covishield vaccine, of which 90.2% had COVID-19 IgG antibodies. A total of 32 donors have taken Covaxin, of which 78.1% had COVID-19 IgG antibodies. The above study has shown that COVID-19 vaccination enhances covid antibody formation, and multiple doses of vaccine ensure longevity of these antibodies.

Immunogenicity of Covishield vaccine in patients with autoimmune rheumatic diseases.

Introduction: The Coronavirus disease 2019 (COVID-19) pandemic has been the biggest threat to humankind during the last 3 years. It has caused the loss of more than 6.9 million precious lives across the world. The only method by which the massacre could be stopped was by mass vaccination or mass immunization. The patients suffering from autoimmune rheumatic disorders (AIRDs) and treated with immunosuppressants were the high-priority candidates for vaccination. However, the data regarding the efficacy of COVID-19 vaccines in this group of patients are very less. Hence, this study was planned to study the immunogenicity of Covishield in patients with AIRDs attending the rheumatology OPD at DMCH, Ludhiana. Materials and Methods: It was a prospective cohort study and was planned by the Department of Biochemistry and Department of Clinical Immunology and Rheumatology at Dayanand Medical College and Hospital, Ludhiana. Fifty patients with AIRDs attending the DMCH rheumatology OPD and 52 age and sex-matched healthy controls who had received two doses of Covishield vaccine were included in this study. Patients having any other immunosuppressive conditions like uncontrolled diabetes, hepatitis, malignancy or HIV were excluded. Patients who had suffered from previous laboratory-confirmed COVID-19 infection (by RT-PCR) were also excluded. Blood samples were collected following all aseptic precautions from patients and controls on the 28th day after administration of a second dose of Covishield vaccine and total antibodies to the severe acute respiratory syndrome coronavirus 2 spike (S) protein receptor binding domain was measured using Elecsys Anti-SARS-CoV-2 S kit from Roche. Results: It was observed that no significant difference was there in antibody titre between cases and controls (6213 ± 4418 vs. 8331 ± 7979, P = 0.1022). It was also observed that no statistically significant difference in antibody titre in cases without prednisolone and those taking treatment with prednisolone was found (P = 0.7058). A similar observation was found in terms of methotrexate also (P = 0.457). No significant difference in antibody titres was there when compared with controls (for prednisolone, P = 0.169, for methotrexate, P = 0.078). We found that only the patients receiving mycophenolate mofetil showed a statistically significant decrease in antibody titre in comparison to healthy controls (P = 0.03). Our study showed no statistically significant difference in antibody titres between patients suffering from different AIRDs. Conclusion: Our study supplements the fact that patients with AIRDs in India can receive Covishield as the primary vaccine against COVID-19 without concerns regarding decreased immunogenicity or increased adverse effects.

Lichen planus triggered by COVID-19 vaccination: A case series.

Lichen planus, an autoimmune inflammatory condition, has been linked to medications, vaccinations, and infections. Several clinical studies have shown that majority of vaccines trigger a Th1 response, which raises the blood levels of IL-2, TNF & IFN, and may be linked to the development of lichen planus. It has recently been documented to happen with mRNA-based COVID-19 vaccinations, especially the Pfizer/BioNTech vaccine. We present a case series of lichen planus that appeared after receiving the COVISHIELD vaccine from Oxford-AstraZeneca. In order to rule out any further potential triggers, like recent infections, prior drug use, smoking, dental treatments, etc., a thorough history was collected in each instance. Skin biopsies were used to confirm each case's diagnosis. In nearly all of the cases, skin biopsies revealed typical dermatopathological features of lichen planus.

Post-vaccine immune status surveillance of Covishield vaccine and associated AEFI in previously SARS-Cov-2 infected seropositive and seronegative population in Assam.

Background: COVID-19 an infectious disease caused by the SARS-CoV-2 virus, started in late 2019 and became a pandemic within a short period. To respond to the pandemic vaccines like Covishield, Covaxin, Sputnik V, Covovax, etc., were developed rapidly. However, there were raising concerns about the development of immunity as well as adverse events following vaccination. Objectives: To compare anti-SARS-CoV-2 IgG antibody titres at different time-points post-vaccination between baseline seropositive and seronegative groups and to assess the adverse events following the 1st dose of Covishield vaccine among adult beneficiaries attending vaccination centre in a tertiary care hospital of Upper Assam. Materials and Methods: Prospective Cohort study was conducted from July 2021 to June 2022 among adult beneficiaries receiving the Covishield vaccine. The oral questionnaire was used incorporating socio-demographic variables, and clinical profiles including co-morbidities and adverse events following vaccination. Data analysis was done by Microsoft Excel and SPSS. Results: Out of a total of 146 study participants, IgG estimation showed 61% as seropositive and the rest as seronegative. A total of 55.40% had minor adverse events, majority of them were females (53.08%) and 88.80% belonged to 18-59 years compared to 11.11% above 60 years of age. The majority (71.60%) did not have any co-morbidities and the major AEFI was NIL among the study participants. The study group had 61% seropositive previously infected. Conclusion: Covishield vaccination induces an immune response and 90% seroconversion is achieved after 1st dose (booster dose). Antibody titres of the seropositive group by natural infection of SARS-CoV-2 were higher than seronegative cohort seroconverted by vaccination. The AEFI observed were minor and can be commented as safer.

Safety Surveillance of Covishield Vaccine-Associated Adverse Events During the COVID-19 Pandemic: A Retrospective Longitudinal Study.

BACKGROUND: Adverse events following immunization (AEFI) must be reported and assessed to promote patient safety. This longitudinal study examined the nature and severity of adverse events reported after Covishield (Serum Institute of India, Pune, India) vaccine administration to North Indians in a tertiary care hospital. METHOD: A retrospective evaluation of adverse drug reactions (ADRs) reported after Covishield vaccine administration in our hospital over 18 months was conducted. The assessment was carried out to analyze the pattern of ADRs reported by individuals receiving the Covishield vaccine from January 2021 to June 2022. Data such as age, gender, category, dose administered, type of ADR, duration of the event, medical history, and outcome of the reactions were collected. Each reported adverse event was assessed individually. Causality was determined using the WHO-UMC causality assessment scale. The data were analyzed and are expressed as mean ± standard deviation and percentage. RESULTS: A total of 14,590 individuals were vaccinated at our study center from January 2021 to June 2022. During this period, 146 AEFIs (1.0%) were reported at our ADR monitoring center, Employees' State Insurance Corporation Medical College and Hospital (ESIC MCH), Faridabad, India. The majority of AEFIs were systemic, were reported after the first dose, and had an onset within 12 hours after vaccination. Fever, injection site pain, drowsiness, headache, vomiting, swelling, tenderness, and body aches were the most commonly reported adverse effects. No significant relationships were observed between the administered vaccine dose and sex, severity, duration of the event, or outcome. However, the incidence of adverse events was greater with the first vaccine dose than with the second dose. The possibility of serious or fatal adverse events was lowest in the general population and higher in the elderly with comorbidities. CONCLUSION: The data suggest that the Covishield vaccine had mild to moderate adverse effects on the study population. This pharmacovigilance study will complement safety data and aid in the benefit-risk analysis of adverse effects associated with the Covishield vaccine. Additionally, healthcare professionals should be encouraged to conduct further safety studies by establishing robust vaccine safety monitoring systems in hospitals. Continuing medical education and workshops should also be conducted to educate healthcare workers about active surveillance.

An Analysis of Antibody Response to COVID-19 Vaccination Among Medicos in a Predominantly Tribal State in India: A Comparative Study.

Introduction Global health is still being impacted by the coronavirus disease 2019 (COVID-19) pandemic. Objectives We evaluated the antibody response in this study in individuals who received two doses of the COVID-19 vaccination, both with and without a history of SARS-CoV-2 infection. Methodology It was a hospital-based cross-sectional study conducted among healthcare personnel at a tertiary institution of a predominantly tribal state in India. Results A total of 187 medical students made up the vaccinee group; the majority (152; 81.3%) were between the ages of 18 and 23; 128 (68.4%) of the students were female; and 104 (55.6%) had received the Covishield (AstraZeneca plc, England, UK) vaccination. Of the subjects, 51 (27.3%) had a history of COVID-19 infection. For those who were infected, the antibody titer peaked after six months, whereas it took twice as long for those who were not. Up to a year later, the antibody titers for Covaxin (Bharat Biotech, Hyderabad, India) and Covishield remained equal; however, Covishield titers drastically decreased while Covaxin stayed constant when an infection history was present. Conclusion The study's findings show that immunization in individuals who have previously contracted COVID-19 induces a higher level of antibody response than immunization in individuals who have not previously contracted the virus.

Immunogenicity of SARS-CoV-2 vaccines BBV152 (COVAXIN®) and ChAdOx1 nCoV-19 (COVISHIELD™) in seronegative and seropositive individuals in India: a multicentre, nonrandomised observational study.

Background: There are limited global data on head-to-head comparisons of vaccine platforms assessing both humoral and cellular immune responses, stratified by pre-vaccination serostatus. The COVID-19 vaccination drive for the Indian population in the age group 18-45 years began in April 2021 when seropositivity rates in the general population were rising due to the delta wave of COVID-19 pandemic during April-May 2021. Methods: Between June 30, 2021, and Jan 28, 2022, we enrolled 691 participants in the age group 18-45 years across four clinical sites in India. In this non-randomised and laboratory blinded study, participants received either two doses of Covaxin® (4 weeks apart) or two doses of Covishield™ (12 weeks apart) as per the national vaccination policy. The primary outcome was the seroconversion rate and the geometric mean titre (GMT) of antibodies against the SARS-CoV-2 spike and nucleocapsid proteins post two doses. The secondary outcome was the frequency of cellular immune responses pre- and post-vaccination. Findings: When compared to pre-vaccination baseline, both vaccines elicited statistically significant seroconversion and binding antibody levels in both seronegative and seropositive individuals. In the per-protocol cohort, Covishield™ elicited higher antibody responses than Covaxin® as measured by seroconversion rate (98.3% vs 74.4%, p < 0.0001 in seronegative individuals; 91.7% vs 66.9%, p < 0.0001 in seropositive individuals) as well as by anti-spike antibody levels against the ancestral strain (GMT 1272.1 vs 75.4 binding antibody units/ml [BAU/ml], p < 0.0001 in seronegative individuals; 2089.07 vs 585.7 BAU/ml, p < 0.0001 in seropositive individuals). As participants at all clinical sites were not recruited at the same time, site-specific immunogenicity was impacted by the timing of vaccination relative to the delta and omicron waves. Surrogate neutralising antibody responses against variants-of-concern including delta and omicron was higher in Covishield™ recipients than in Covaxin® recipients; and in seropositive than in seronegative individuals after both vaccination and asymptomatic infection (omicron variant). T cell responses are reported from only one of the four site cohorts where the vaccination schedule preceded the omicron wave. In seronegative individuals, Covishield™ elicited both CD4+ and CD8+ spike-specific cytokine-producing T cells whereas Covaxin® elicited mainly CD4+ spike-specific T cells. Neither vaccine showed significant post-vaccination expansion of spike-specific T cells in seropositive individuals. Interpretation: Covishield™ elicited immune responses of higher magnitude and breadth than Covaxin® in both seronegative individuals and seropositive individuals, across cohorts representing the pre-vaccination immune history of most of the vaccinated Indian population. Funding: Corporate social responsibility (CSR) funding from Hindustan Unilever Limited (HUL) and Unilever India Pvt. Ltd. (UIPL).

Covid Antibody Titers in Cancer Patients Following Vaccination with ChAdOx1 nCOV-19 Vaccine.

Dr. Vikram GotaCovid-19 has led to significant mortality worldwide, with an increased risk in cancer patients. Vaccination provides significant protection against the infection. The study focuses on the immunogenicity and effectiveness of ChAdOx1 nCoV-19 vaccine in cancer patients within a real-world setting. Blood samples for measuring Covid antibody titers against the receptor binding domain were collected according to a convenient sparse sampling strategy in a real-world setting, with the days of the collection coinciding with their hospital appointment. The antibody titers between different groups were analyzed descriptively. A total of 56 patients were enrolled in the study. There was no apparent effect in antibody titers between patients with solid tumors and hematological malignancies (mean ± standard deviation [SD]: 36.80 ± 41.18 vs. 52.02 ± 26.27), among patients who were undergoing chemotherapy, immunotherapy, or local therapy (mean ± SD: 42.50 ± 44.46 vs. 50.06 ± 51.39 vs. 28.70 ± 25.03), and in patients with up to 90 days and more than 90 days' interval between their last treatment and date of vaccination (mean ± SD: 38.96 ± 42.66 vs. 40.51 ± 38.65). Additionally, there were only 2/56 patients with breakthrough infection, which points out the effectiveness of this vaccine in cancer patients. The ChAdOx1 nCoV-19 vaccine has activity in cancer regardless of the tumor type, type of treatment, or time from the last treatment.

Adverse Events Following COVISHIELD and VERO CELL Vaccination Campaigns Against COVID-19.

BACKGROUND: Vaccination against COVID-19 for Nepalese was initiated in January 2021 for various age groups. People were anxious about receiving the vaccines and were concerned about the safety profile of the vaccine they received. In this study, we have tried to observe the Adverse Events Following Immunization of two different vaccines namely COVISHIELD (ChAdOx1 nCOV-19) and VERO CELL (CZ02 strain), used in different phases of vaccination by the government of Nepal. METHODS: We conducted a cross-sectional study among people who received COVID-19 vaccines in this study using a self-administered questionnaire.  Data was cleaned and then exported to IBM SPSS v.20 for analysis, Chi-square test was used to see the association between different variables and a p-value<0.05 was considered statistically significant. RESULTS: Out of 303 respondents, all had received the first and 270 participants had received the second dose of the COVID-19 vaccine, among which, 133 (43.89%) reported at least one side effect after the first dose of vaccination while 58 (21.48%) had self-reported side effects after the second dose of vaccination. Seventeen percent of the respondents had COVID-19 infection within the past 3 months before receiving COVID-19 vaccine. Three percent of participants had re-infection with COVID-19 after receiving the first or the second dose of the COVID-19 vaccine. Among participants who experienced adverse events, 42% and 62.1% of participants experienced mild adverse events following the first dose and second dose of the vaccine, respectively.  Conclusions: The adverse events following immunization for both vaccines after both doses of vaccination were quite low, with 43.89% of participants reporting side effects after the first dose and 21.48% of participants reporting side effects after the second dose. Adverse events were most frequently reported within 24 hours of vaccination and were mostly mild. There was no statistical significance of adverse events between both vaccines.

Longitudinal Follow-Up Study on the Side Effects of COVID-19 Vaccines: A Telephonic Questionnaire Approach.

BACKGROUND: The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has prompted urgent efforts to develop and deploy effective vaccines. Covishield and Covaxin are two prominent COVID-19 vaccines authorized for emergency use; however, concerns regarding their safety persist. OBJECTIVE: This longitudinal follow-up study aimed to comprehensively assess and compare the demographic characteristics, frequencies, severities of reported side effects, and associations between vaccine type and demographic factors among individuals vaccinated with Covishield and Covaxin. METHODS: A telephonic questionnaire was used to collect data from individuals who attended COVID-19 vaccination programs between January 1, 2021, and January 1, 2022. Logistic regression analysis was performed to investigate the associations between vaccine type, demographic factors, and likelihood of experiencing side effects. RESULTS: Covaxin recipients exhibited a lower incidence of mild flu-like illness (16 cases) and post-vaccination infection (55 cases) than Covishield recipients (110 and 98 cases, respectively). However, Covaxin recipients reported more cases of soreness at the injection site (139 cases) than did Covishield recipients (172 cases). Logistic regression analysis revealed significantly higher odds of experiencing side effects among Covaxin recipients than among Covishield recipients (OR = 1.687, p < 0.001). Age was inversely associated with the likelihood of experiencing side effects (OR = 0.982, p < 0.001), while sex and ethnicity also exhibited significant associations. CONCLUSION: This study provides valuable insights into the safety profiles of the Covishield and Covaxin COVID-19 vaccines. These findings underscore the importance of ongoing surveillance and evaluation of vaccine safety and tolerability to inform public health policies and vaccination strategies.

Antibody response to non-mRNA SARS-CoV-2 vaccine in kidney transplant recipients.

BACKGROUND: Kidney transplant recipients (KTRs) show poor antibody response to the SARS-CoV-2 vaccine. There is limited data on immune response to non-mRNA vaccines in KTRs. We studied the antibody response to the SARS-CoV-2 non-mRNA vaccine in a cohort of kidney transplant recipients. METHODS: We included KTRs following up in the tertiary care transplant outpatient clinic from February to April 2022. SARS-CoV-2 spike protein IgG antibody titers were measured using chemiluminescence immunoassay. Data on demographic, clinical, and laboratory characteristics were collected, and patients were characterized by the history of Coronavirus disease 2019 (COVID-19) infection in the past and the number of vaccine doses received. Predictors of antibody response were obtained using multivariate regression analysis. RESULTS: S1/S2 IgG anti-SARS-CoV-2 antibodies were detected in 197 (87.94%) of 224 KTRs with a median [IQR] titers of 307.5 AU/ml [91 AU/ml - 400 AU/ml]. Neutralizing range antibody titers were found in 170/224 (75.9%) KTRs. Diabetes at the time of vaccination was associated with poorer antibody response (aOR 0.31, 95% confidence interval [CI] - 0.10, 0.90; p = 0.032) and vaccination with Covishield™ (ChAdOx1 nCoV- 19 Recombinant CoronaVirus Vaccine) showed higher antibody response as compared to Covaxin™ (BBV152) (aOR 5.04, 95% CI - 1.56, 16.22; p = 0.007). Graft dysfunction at baseline was associated with poorer antibody response. CONCLUSIONS: KTRs showed good antibody response after SARS-CoV-2 vaccination with non-mRNA vaccines. Diabetes and graft dysfunction were associated with poor seroconversion rates.