Outcome of Glomerular Disease Manifesting After Vaccination Against Severe Acute Respiratory Syndrome Coronavirus 2.

Introduction Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can upregulate the immune system and may contribute to glomerular disease (GD). Here, we describe a spectrum of GD that manifested following vaccination against SARS-CoV-2 (COVID-19 vaccinations). Material and methods This was a descriptive study of 10 cases enrolled between January 2021 and January 2023. Patients with biopsy-proven GD that manifested following COVID-19 vaccinations were included. Results We found 10 cases of biopsy-proven GD following the COVID-19 vaccination. This included five cases of minimal change disease (MCD), three cases of focal segmental glomerulosclerosis (FSGS), one case of C3 glomerulonephritis (C3GN), and one case of IgA nephropathy (IgAN). The pre-existing disease was found in the last two patients (IgAN and C3GN) who got unmasked following vaccination. We did not observe any relation between vaccine type (Covisheld; six cases vs. Covaxin; four cases) and GD. In most cases (8/10 cases, 80.0%), GD developed after a repeat dose (second or booster dose). The onset time following vaccination was typically less than a week, and even less following a repeat dose. Conclusion Post-vaccination GD can be either de novo or a flare-up of a pre-existing one. The onset time following vaccination was typically less than a week for both Covishield and Covaxin.

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.

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.

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.

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.

Adverse events following Covaxin administration among adolescents (15-18 years) - A pharmacovigilance study in a district in Northern India.

Introduction: The study was undertaken to observe the adverse event following immunization (AEFI) to the Covaxin vaccine in young adolescents in the age group of 15-18 years in a district in Northern India. The study was conducted to assess the safety profile of the COVAXIN vaccine. Methodology: This was a prospective observational study conducted at rural and urban health centers of a district in Northern India. We included the beneficiaries of the COVAXIN between the age of 15 and 18 years. The administration of the COVAXIN occurred in our district from January 2022. Periodic visits were conducted to the urban and rural health centers of the city to record any suspected adverse drug reaction following immunization in the defined population. The study was conducted for a period of 1 year (January 2022 to December 2022). Results: A total of 72,771 adolescents (15-18 years) received the first dose of Covaxin and 49,046 received the second dose. No adverse drug event following immunization was reported during the study. Conclusion: Thus, it can be concluded that Covaxin was found to be safe in adolescents (15-18 years).

Vaccination and Its Impact on Lung Involvement in COVID-19 Patients: A Retrospective Study in India.

Background COVID-19, caused by SARS-CoV-2, led to a global pandemic necessitating urgent vaccine development and deployment. By the end of 2020, several vaccines had reached their clinical trial endpoints. India, leveraging its pharmaceutical prowess, developed two primary vaccines: CoviShield® and Covaxin®. Despite the availability of these vaccines, vaccine hesitancy became a notable challenge. This study aimed to assess the correlation between vaccination status and lung involvement in COVID-19 patients, aiming to fortify trust in vaccines and enhance vaccine uptake in India. Methods This retrospective cross-sectional study analyzed data from 272 patients treated at a designated COVID-19 Care Center in Chennai, India, from May to July 2021. Patients were divided into vaccinated and unvaccinated groups, with vaccinated individuals further categorized based on the type and dose of vaccine received (CoviShield® or Covaxin®). Lung involvement was assessed through CT chest scans, and statistical analyses were performed to compare the severity of lung involvement across different groups. Results The vaccinated group demonstrated significantly lower mean lung involvement (28%) compared to the unvaccinated group (34.8%). Within vaccinated individuals, no significant differences were observed between different vaccine types and doses, suggesting a generalized protective effect of COVID-19 vaccination against severe lung involvement. Conclusion Vaccination against COVID-19 significantly reduces the severity of lung involvement among patients, irrespective of the vaccine brand or dose. This study reinforces the importance of vaccination in mitigating the impact of COVID-19 and supports ongoing vaccination efforts.

Assessment of the Knowledge, Attitudes, and Practices of Indian Medical Students Towards Coronavirus Disease 2019 (COVID-19) After Two Doses of Vaccination and Their Approach Towards the Third (Booster) Dose.

Background and objectives Medical students not only directly impact coronavirus disease 2019 (COVID-19) transmission due to their behavior and perceptions but also play an important role in influencing the behavior and vaccine intentions of their families and the community at large. The study's objective was to assess the knowledge, attitudes, and practices of medical students who have completed two doses of the COVID-19 vaccine towards the disease and their approach towards the third (booster) dose. Methods A total of 705 individual responses were obtained from a cross-sectional web-based study deployed using Google Forms. After getting consent and basic information, data was obtained regarding knowledge of the disease, attitudes towards the disease, and practices regarding the same. The mean score was calculated for the above different categories and compared with their respective cut-offs using a one-sample t-test. Data was also collected regarding their approach towards the booster dose of the COVID-19 vaccine, and the proportion of each response for different categories of questions was calculated. Results Participants were found to have mean scores in the range of moderate knowledge in the first part (47.67±4.49) and the second part (6.96±1.10) of the questionnaire and moderate practices (30.6±4.27) regarding COVID-19 disease. However, they had a mean score in the range of low attitude (39.79±4.07). The majority of participants acknowledge the role of vaccines in preventing the severity and spread of the disease (71.95%) and its effect on workers and medical professionals (60.26%). Mixed opinions were obtained for concerns regarding its pre-market testing and adverse effects and the government's vaccination policy. Interpretation and conclusion Responses of the medical students obtained in this study were majorly positive and in accordance with pre-vaccination studies concerning knowledge and practices. However, the low mean score in attitude obtained can be possibly explained due to their lack of direct exposure to patient management during the pandemic. The majority of participants had a positive response towards the use of the vaccine and the effectiveness of the booster dose, but concerns regarding pre-market testing, adverse effects, and the government's vaccination policy suggested the role of awareness campaigns and government endeavors to curb the same.

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-19 Vaccination in a Patient With Gluten Enteropathy: A Case Report.

In India, the COVID-19 vaccination for adolescents aged 15-17 years has been started since January 2022. Gluten enteropathy, also known as celiac or nontropical sprue, can arise as an autoimmune disease of the small intestines. We report a 15-year-old female with a history of allergy to gluten-containing products who came for the first dose of the COVID-19 vaccination to adult vaccination OPD at All India Institute of Medical Sciences, Jodhpur. After taking a detailed history, she had an allergy to gluten-containing products for five years. She had no previous history of allergic reactions to injections or medicines. The first dose of Covaxin was given to this female under proper supervision, and she was followed up for any adverse events. We did not find any evidence of adverse events following the COVID-19 vaccination in people with gluten enteropathy. The patient was discharged after one hour of observation. To date, no cases of Covaxin vaccination have been reported among gluten enteropathy patients. We discuss the current evidence relating to Covaxin vaccinations, highlighting that administering the vaccine to gluten-sensitive individuals did not cause any adverse reactions. However, proper history taking and other standard procedures should be followed while administering Covaxin to any known allergies.

A Systematic Review of the COVID Vaccine's Impact on the Nervous System.

AIMS & OBJECTIVES: The objective of this study was to conduct a systematic review of research pertaining to the COVID-19 vaccine and its association with neurological complications. METHOD: We performed a comprehensive search of the literature using Google Scholar, PubMed, and NCBI databases from December 2021 to December 2022. For Google Scholar, PubMed, and NCBI databases we used the following key search terms: "neurological adverse effects", "COVID-19 vaccination", "SARS-CoV-2", CNS complications, and CNS adverse effects. Two reviewer authors individually searched and assessed the titles and abstracts of all articles. The third reviewer resolved the disagreement between them. Data were documented regarding title, study location, type of study, type of COVID-19 vaccine, type of neurological complications/adverse effects, and sample size. RESULTS: From our findings, it is confirmed that these neurological complications like GuillainBarre syndrome (23.6%), Neuromyelitis Optica spectrum disorder (5.5%), Neuropathy (6.9%), Transverse Myelitis (8.3%) and Acute disseminated Encephalomyelitis (4.1%) are majorly affected in most of the people. The increase in risks associated with SARS-CoV-2 infection far outweighs any previously reported associations with vaccination. CONCLUSION: We found no safety signal was observed between COVID-19 vaccines and the immune-mediated neurological events. Before assuming a causal relationship, the side effects of the COVID-19 vaccine should first be carefully examined to rule out known associated factors. Symptom onset was within two weeks of vaccination in the majority of cases; as such, this seems to be a high-risk period warranting vigilance.

COVID-19 vaccination: Immune response in healthcare workers-A study with review of literature.

Background: As the world has been going through a pandemic of coronavirus disease 2019 (COVID-19) for the past two years, a safe and effective vaccine was urgently needed. Vaccination against the disease was launched in India on January 16, 2021 with healthcare workers, frontline workers, and the elderly above 60 years being the first beneficiaries. Vaccines being used in India are Covishield and Covaxin. Materials and Methods: Fifteen healthcare workers (HCWs) who were vaccinated with Covishield or Covaxin were included in the study, and T cell, B cell and antibody response of the HCWs were analyzed. Blood samples collected from every subject were sent for antibody analysis, hematological workup for cell counts, and flow cytometry was performed for various subsets of lymphocytes. Hematological variables in naïve HCWs (who never had any natural infection) and recovered HCWs (those recovered from natural infection) were compared. Results: Antibody index among recovered HCWs was significantly higher than the naïve HCWs. All the leucocyte parameters showed a higher median value in the recovered group except total leucocyte count (TLC), T helper cell count (Th cell), T helper cell to T cytotoxic cell (Th cell: CTL) ratio and natural killer (NK) cell. But only Th: CTL ratio showed a statistically significant difference. Conclusion: This study shows that the antibody index among individuals who had both vaccination and COVID-19 infection is significantly higher than those who just had vaccination. T helper cell to T cytotoxic cell ratio is lowered in the recovered HCWs as compared to the naïve HCWs and this finding is statistically significant.

A Study to Describe the Pattern of Cutaneous Adverse Effects of COVID-19 Vaccines (Covishield and Covaxin).

Background: Vigorous administration of COVID-19 vaccines to tackle the ongoing pandemic has led to increasing research on adverse effects including both systemic and cutaneous. Objective: A prospective observational study to delineate the cutaneous adverse effects of two vaccines, namely Covishield and Covaxin, administered in two doses in northern India. Materials and Methods: The study was conducted in a tertiary hospital in northern India wherein patients were asked to report voluntarily any cutaneous adverse effects after COVID-19 vaccination to the dermatology department. The data were collected using excel sheets and later analyzed taking into consideration the age, vaccine types, and duration of onset of adverse effects. Results: Of the 19,672 vaccination jabs, 296 (1.5%) developed cutaneous adverse effects of which the incidence was higher in Covishield vaccine group compared to Covaxin vaccine group. The incidence of side effects was more with the first dose of either vaccine compared to the second dose. All the side effects were benign and were managed symptomatically or were self-limiting. Limitations: The number of vaccine recipients was limited and there was a considerable overlap of adverse effects with both vaccines. Voluntary reporting of cases is not an accurate representation of the scale of patients with adverse effects. Conclusion: Rampant administration of vaccines along with widespread advertisement of vaccine-induced side effects via social media has created apprehension in the general population. This warrants studies improving awareness about the most vital preventive measure available to halt and eventually end the COVID-19 pandemic.

Estimation of SARS-CoV-2 IgG Antibodies in Healthcare Worker-Administered Covishield and Covaxin Vaccines at a Tertiary Care Hospital in Jharkhand, India.

Introduction To mitigate the impact of the COVID-19 pandemic caused by the SARS-CoV-2 virus, global distribution of vaccines such as Covishield and Covaxin has been undertaken. This research aimed to assess the responses and potential differences between these vaccines by examining the presence and levels of SARS-CoV-2 IgG antibodies in healthcare professionals who received them. Methodology A comprehensive cross-sectional study was conducted at a tertiary care facility in Ranchi involving 227 healthcare professionals who had completed both doses of either Covishield or Covaxin. Blood samples were collected and subjected to chemiluminescence immunoassay analysis to measure IgG antibodies. Demographic data, immunization records, and previous COVID-19 infections were recorded. Statistical analyses, including analysis of variance (ANOVA), linear regression, and independent sample t-tests were performed. Results Antibody titers exhibited variability, potentially influenced by factors. There was no difference in antibody titers between recipients of Covishield and Covaxin vaccines. Linear regression analysis revealed a correlation between antibody levels and the number of days after vaccination. Factors such as age, gender, blood group, and prior COVID-19 infections did not significantly impact antibody titers. Conclusions This study contributes to responses elicited by Covishield and Covaxin vaccines among healthcare workers. The results highlight that Covishield showed a higher mean titer value than Covaxin, which is not statistically significant. The overall model showed statistically significant results indicating age, type of vaccine, number of days after vaccination, blood group, and previous history of COVID-19 infection collectively influenced the CoV-2 IgG titer values. The findings indicate that age, number of days after vaccination, and prior history of COVID-19 infection have substantial relationships with the CoV-2 IgG titer, but sex, vaccine type, and blood group show lesser, nonsignificant associations.

How safe is COVID-19 vaccination among pregnant women and its outcome - A hospital-based retrospective study in Indian population.

Background: Although getting the Covid infection is equal for every person, during pregnancy, the women's immunity is a little lower than usual, so they are more prone to infection. That is why they should be taken care of with more precautions. A vaccine is the best weapon to fight such infection. Covishield and Covaxin are the two vaccines first introduce in country India including for pregnant women. The safety of the vaccine was a big concern as one of them is a newer type of vaccine. The current study was planned with objectives to understand the safety aspect of Covid19 vaccine on pregnancy outcome and Adverse events following immunization (AEFI) following vaccination. Materials and Methods: This was a hospital-based retrospective cohort study. The sample size was all the pregnant women who delivered a baby from July 2021 to April 2022 at the tertiary care hospital in Vadodara. These women were retrospectively assessed for the status of vaccination based on the record and other information related to ANC from the record. Total of 1974 women were eligible for study after inclusion-exclusion criteria. The collected data was analysed. Result: Of the 1974 pregnant women, 531 (27%) took any of one covid19 vaccine and 1443 (73%) did not take vaccine. There were 511 (96%) women opted for Covishield vaccine and 20 (4%) women who opted for Covaxin. Of 531 women who took vaccination, 46% women had AEFI. The risk of low birth weight (LBW) baby was 40% among vaccinated v/s 39% among non-vaccinated and congenital malformation was 0.6% among vaccinated v/s 1% among non-vaccinated women. On the contrary, the risk of premature birth was 8% among the vaccinated group v/s 13% among the non-vaccinated group and NICU admission following delivery was 8% among the vaccinated group v/s 12% among the non-vaccinated group. Conclusion: AEFI among pregnant women were found less compared to the general population. The study also revealed that both Covishield and Covaxin are found safe for pregnancy outcomes and can be given to pregnant women during any trimester of pregnancy message for a family physician.

Evaluation of SARS-CoV-2 Specific IgG Antibodies in Individuals Vaccinated with Covaxin (BBV152): An Independent Assessment.

Post vaccination with Covaxin (BBV152), Serum from healthcare professionals of Microbiology Department at apex tertiary referral hospital of India were tested for SARS-CoV-2 specific IgG antibodies. 70% individuals at 14-30 days, 63.1% individuals at 30-60 days but only 36.8% individuals at 60-90 days after second dose of vaccine had detectable SARS-CoV-2 spike protein specific IgG antibodies. However, 80% individuals at 14-30 days, 89.4% individuals at 30-60 days while 94.7% individuals at 60-90 days after second dose of vaccine had detectable SARS-CoV-2 whole cell antigen specific IgG antibodies. Males were lacking SARS-CoV-2 spike protein specific IgG antibodies in higher proportion than females and had lower index wherever detected. Age and co-morbidities were non-significant factors for post vaccination IgG response but not in breakthrough infection. 8.3% individuals developed mild COVID-19 symptoms post 14-90 days of second dose and none had severe COVID-19. SARS-CoV-2 spike protein specific IgG antibodies induced by Covaxin are drastically reduced in 60-90 days among fully vaccinated individuals which could be a potential risk for breakthrough SARS-CoV-2 infection, if not severe COVID-19. It may be essential to have additional antigenic stimulations/boosters for continued protection.

Vaccination Can Prevent Severe Pulmonary Disease in COVID-19 Positive Patients: A Case-Control Study.

BACKGROUND: The COVID-19 pandemic was a global health emergency, which brought lives to a standstill. To combat this deadly virus, two vaccines were deployed widely: COVISHIELD (ChAdOx1 nCoV-19) and COVAXIN (BBV152). These were approved based on the immunological response they elicit in standardized conditions; however, the real-life scenario after deployment was completely different. Only in such situations can the true effectiveness of vaccines be assessed. The primary objective was to assess the effectiveness (VE) of COVAXIN/COVISHIELD in preventing severe pulmonary disease in RT-PCR-positive COVID-19 patients greater than 18 years of age. MATERIALS AND METHODS: A case-control study was conducted among 260 subjects aged above 18 years, positive for COVID-19 through RT-PCR. 130 cases and 130 controls were enrolled. Radiological findings were obtained and subjects with >50% lung involvement were considered as cases. Subjects were interviewed about their vaccination status. Odds ratio was calculated, and the adjusted odds ratio was estimated for vaccine effectiveness, using the formula (1-adjusted ODDS ratio)*100. RESULTS: The vaccine effectiveness for a single dose of vaccine was 55.2% (95% C.I. 11.0%-77.5%) and with two doses was 98.0% (95% C.I. 85.0%-99.7%). Hence two doses are highly effective than a single dose of vaccine in reducing lung involvement. CONCLUSION: Two doses of vaccine are more effective than a single dose vaccine in reducing lung involvement. Since sporadic cases of COVID-19 still persist, it is important to emphasize the role of vaccination in preventing severe COVID-19 infections, particularly in the elderly and those with comorbidities.

Case report on meningoenceplapathy in an Indian patient post CoViD vaccination.

The SARS-COV-2 infection-related severe illness is prevented by vaccinations. Therefore, it is relevant to report a case of post vaccine meningoencephalitis in a 30 year old male Indian patient, who presented with weakness in all the extremities, episodes of loose stool, fever, vomiting, tachypnea and loss of consciousness immediately following the 2nd dose of the COVID vaccination (COVAXIN).

Immunological survey of COVID-19 among medicos of tribal preponderant state of India.

Background: Immunological Survey or serosurveys have yielded useful information regarding the spread of the COVID-19 pandemic in the general population, but the impact of the continuing pandemic on the medical students in India is yet to be fully recognised. In this study we assessed the students who had received at least two doses of the COVID-19 vaccine for their antibody response. Methodology: A Hospital based, age-stratified, cross-sectional Analytical study design was adopted for the survey, carried out in tribal state of India among medical students. Consecutive sampling method was used where serum samples were tested for antibodies against the SARS-CoV-2 nucleocapsid (N) protein. Result: The vaccinee group comprised of 187 students mostly aged between 18-23 years 68.4% were females, 56.6 % were vaccinated with covishield. The mean IgG (Immunoglobin G) titre was 7343.74 AU/Ml, less than 1000 AU/Ml was found in 8% of participants, while more than 8000 AU/Ml was found in 32.1%. Participants who got the covaxin vaccine had a higher median IgG titre (median 6491.8 AU/mL, interquartile range 8898 AU/mL).The antibody titre of male was 0.328 times lower than that of female. Conclusion: Despite the fact that covishield's mean antibody titre was higher, covaxin's protection lasted longer.

Development of liquid chromatography-triple quadrupole mass spectrometric method for the quantitative determination of a novel adjuvant, Imidazoquinoline gallamide in aluminum hydroxide gel-Imidazoquinoline gallamide and COVAXIN.

Imidazoquinoline gallamide is a toll-like receptor 7/8 agonist, belongs to the imidazoquinoline class, has the potential to activate antigen-presenting cells, and enhances immune response, primarily Th1 response. The COVAXIN is a whole virion inactivated Coronavirus disease 2019 vaccine formulated with this novel adjuvant called, aluminum hydroxide gel Imidazoquinoline gallamide, wherein, Imidazoquinoline gallamide is chemisorbed onto aluminum hydroxide gel. Herein, an analytical method based on liquid chromatography-tandem mass spectrometry was developed to identify and quantify Imidazoquinoline gallamide in aluminum hydroxide gel Imidazoquinoline gallamide and COVAXIN. The multiple reaction monitoring transitions were optimized for Imidazoquinoline gallamide quantification are [M+H]+ ions with 512.24→343.19 m/z (quantifier ion) and 512.24→360.22 m/z (qualifier ion). The developed method was validated as per the international conference on harmonization quality2 revison1 guidelines. The method was linear in the range of 0.025-10 µg/mL with a coefficient of determination of 0.9985 and the limit of quantification is 0.025 µg/mL. The accuracy was in the range of 82-121 % and intra- and inter-day precision was less than 7.1% and 5.39%, respectively. The expanded uncertainty results are 9.2% for Imidazoquinoline gallamide in the sample. The validated method was successfully applied to evaluate Imidazoquinoline gallamide concentration in every batch of COVAXIN.