INVESTIGATING ANTIGENIC FEATURES OF THE SARS-CoV-2 ISOLATED IN RUSSIAN FEDERATION IN 2021-2022 BY HYPERIMMUNE MOUSE SERUM NEUTRALISATION.

Introduction. The rapid spread of a new coronavirus infection among populations in many countries worldwide has contributed to the genetic evolution of the virus, resulting in the emergence of multiple genetic variants of the SARSCoV-2 coronavirus. Mutations in the viral genome can affect the ability of the virus to bypass the immune system and complicate development of diagnostic and prophylactic drugs. Data on the neutralizing activity of the sera obtained against previously circulating genetic variants of the virus in relation to current SARS-CoV-2 strains may serve as a scientific basis for the selection of the antigens in vaccine development. The aim of this work was to study cross-reactivity of SARSCoV-2 coronavirus strains belonging to different genetic variants, which were isolated in the territory of the Russian Federation during 2020-2022 in the neutralization reaction using mouse hyperimmune sera. Materials and methods. Ten strains of SARS-CoV-2 coronavirus belonging to different genetic variants were used (three non-VOC strains, alpha, beta, gamma, delta, delta+AY, omicron 1 and omicron 2). The hCoV-19/Australia/VIC01/2020 strain (Wuhan) was included in the study as a prototypical variant. BALBc mice were immunized with inactivated concentrated antigen mixed with a 1:1 adjuvant, which was a virus-like immunostimulatory complex based on Quillaja saponaria (Quillaja saponaria). The antibody titer was determined in the neutralization reaction. Results. Essential decrease of neutralizing ability of antibodies specific to non-vOC genetic variants of SARS-CoV-2 coronavirus was revealed against beta VOC and to a lesser degree against alpha and gamma VOC variants. The differences in the neutralizing activity level of antibodies for alpha and beta VOC variants are not significant among themselves, and with gamma VOC variants - there are no significant differences. Neutralizing ability of antibodies specific to delta VOC against alpha and beta VOC variants decreased 4-fold. Neutralizing activity of sera obtained to omicron 1 and 2 variants in relation to the prototype coronavirus variant was reduced 18-fold, to the gamma variant - 12-fold, to delta variants - more than 30-fold;for other variants it was even lower. Conclusions. The results obtained testify to the presence of cross-reactivity between strains of coronavirus belonging to genetic lines Wuhan, alpha, beta, gamma;it is weaker for delta variants. Mutations in the genome of VOC omicron variants led to a significant decrease in antigenic cross-links with earlier genetic variants of the coronavirus. These findings explain the low efficacy of vaccines based on the Wuhan strain, synthetic immunogens, and recombinant proteins based on it against omicron VOC variants, which have caused a rise in morbidity since early 2022, as well as cases of re-infection of humans with new genetic variants of the coronavirus.Copyright © 2023 Saint Petersburg Pasteur Institute. All rights reserved.

mRNA versus inactivated virus COVID-19 vaccines in multiple sclerosis: Humoral responses and protectivity-Does it matter?

BACKGROUND: COVID-19 vaccines are recommended for people with multiple sclerosis (pwMS). Adequate humoral responses are obtained in pwMS receiving disease-modifying therapies (DMTs) after vaccination, with the exception of those receiving B-cell-depleting therapies and non-selective S1P modulators. However, most of the reported studies on the immunity of COVID-19 vaccinations have included mRNA vaccines, and information on inactivated virus vaccine responses, long-term protectivity, and comparative studies with mRNA vaccines are very limited. Here, we aimed to investigate the association between humoral vaccine responses and COVID-19 infection outcomes following mRNA and inactivated virus vaccines in a large national cohort of pwMS receiving DMTs. METHODS: This is a cross-sectional and prospective multicenter study on COVID-19-vaccinated pwMS. Blood samples of pwMS with or without DMTs and healthy controls were collected after two doses of inactivated virus (Sinovac) or mRNA (Pfizer-BioNTech) vaccines. PwMS were sub-grouped according to the mode of action of the DMTs that they were receiving. SARS-CoV-2 IgG titers were evaluated by chemiluminescent microparticle immunoassay. A representative sample of this study cohort was followed up for a year. COVID-19 infection status and clinical outcomes were compared between the mRNA and inactivated virus groups as well as among pwMS subgroups. RESULTS: A total of 1484 pwMS (1387 treated, 97 untreated) and 185 healthy controls were included in the analyses (male/female: 544/1125). Of those, 852 (51.05%) received BioNTech, and 817 (48.95%) received Sinovac. mRNA and inactivated virus vaccines result in similar seropositivity; however, the BioNTech vaccination group had significantly higher antibody titers (7.175±10.074) compared with the Sinovac vaccination group (823±1.774) (p<0.001). PwMS under ocrelizumab, fingolimod, and cladribine treatments had lower humoral responses compared with the healthy controls in both vaccine types. After a mean of 327±16 days, 246/704 (34.9%) of pwMS who were contacted had COVID-19 infection, among whom 83% had asymptomatic or mild disease. There was no significant difference in infection rates of COVID-19 between participants vaccinated with BioNTech or Sinovac vaccines. Furthermore, regression analyses show that no association was found regarding age, sex, Expanded Disability Status Scale score (EDSS), the number of vaccination, DMT type, or humoral antibody responses with COVID-19 infection rate and disease severity, except BMI Body mass index (BMI). CONCLUSION: mRNA and inactivated virus vaccines had similar seropositivity; however, mRNA vaccines appeared to be more effective in producing SARS-CoV-2 IgG antibodies. B-cell-depleting therapies fingolimod and cladribine were associated with attenuated antibody titer. mRNA and inactive virus vaccines had equal long-term protectivity against COVID-19 infection regardless of the antibody status.

Assessment of Post-Vaccination Immunologic Responses in Inactivated Virus COVID-19 Respondents.

Introduction: The Indonesian Government's plan to contain the COVID-19 pandemic, aside from implementing health protocols, also involves vaccinating everyone with the inactivated SARS CoV2 vaccine until herd immunity is reached. The aim of this study was to assess the post-vaccination immune response to inactivated SARS CoV2 vaccine, namely Sinovac/Sinopharm, by measuring the antibodies (IgM and IgG) in subjects after their second dose of vaccination. Materials and Methods: The design of the study was a cohort study using simple random sampling with 51 respondents aged 18-56 years who had received two doses of inactivated SARS-CoV-2 vaccine. All respondents were screened for SARS-CoV-2 infection prior to inclusion. Serum IgM and IgG antibodies were detected using a specific and sensitive automated chemiluminescent immunoassay (CLIA). CLIA uses the Cut Off Point (COI) value of >1 AU/ml for IgM and the Reactive Value of >10 AU/ml for IgG. Results: This study showed that the IgM levels using a reactive Cut Off Point (COI) >1 were 18% in the first month, 14% in the third month, and 10% in the sixth month. There was a constant decline in the third comparison. Meanwhile, compared to the first month, 59% of respondents had IgG levels with reactive values over 10 AU/ml, which after decreasing by 35% in the third month, the number increased by 47% in the sixth month. Conclusion: It has been evident that IgG and IgM antibody response could be induced by inactivated SARS-CoV-2 vaccine which can be influenced by age and detection time after the second dose of vaccination. Boosters, however, must be given after six months of the second dose, since antibody levels were seen to decrease after this period.

A case report of subacute thyroiditis after inactivated SARS-CoV-2 vaccine.

Subacute thyroiditis is an inflammatory thyroid disorder. It is often triggered following viral infections. Amid the current COVID-19 pandemic, several cases of subacute thyroiditis were reported worldwide related to SARS-CoV-2 infection and vaccines. We report a rare case of subacute thyroiditis possibly related to immunization with inactivated SARS-CoV-2 vaccine Sinopharm BIBP. A 29-year-old previously healthy Sri Lankan woman presented with anterior neck pain, low-grade fever and fatigue appearing 7 days after immunization with the second dose of inactivated SARS-CoV-2 vaccine Sinopharm BIBP. She apparently reported similar symptoms which subsided spontaneously within a few days, following immunization with first dose of vaccine. On examination, she had tenderness over the anterior neck. She was afebrile, not tachycardic and clinically euthyroid. Her inflammatory markers were elevated. An ultrasound scan of the neck demonstrated two low echogenic micronodules of 6 x 3 mm2 and 5 x 3 mm2 and low background thyroid vascularity. Technetium 99 m pertechnetate (Tc - 99 m) thyroidal uptake scan shows reduced thyroidal uptake suggestive of subacute thyroiditis. Thyroid function tests were normal at the time of the assessment. The patient was treated symptomatically with non-steroidal anti-inflammatory drugs. Her neck pain and tenderness resolved gradually. Serial measurements of thyroid functions during follow-up were within normal limits. Inflammatory markers normalized over the course of follow-up. Subacute thyroiditis following COVID-19 vaccination is a rare occurrence. However, due to its mild clinical course, it could very well be underreported. It is a mild and self-limiting illness with transient thyroid dysfunction; thus, it should be emphasized that the benefits of COVID-19 vaccination outweigh any rare and mild side effects reported.

CRISPR Technology and Its Importance in SARS-CoV-2 Treatment

Coronavirus disease-2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) predominantly affects the respiratory system. The COVID-19 pandemic has had devastating effects on the health system and the global economy worldwide. To reduce the worsening impact of the pandemic, various treatment options and vaccines have been developed. Despite these efforts the pandemic could not be stopped because of the single-stranded nature of the virus combined with the lack of proof-reading abilities of the RNA-dependent RNA polymerase (RdRp). This results in a high probability of error in the copying process and consequently, mutations occur. The increase in mutations in SARS-CoV-2 reduced the efficacy of antiviral medicines and vaccines. To fight this problem, studies were conducted on the efficacy and safety of using Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR) in the diagnosis and treatment of COVID-19. Initially, discovered in archaea, CRISPR is a gene-editing tool that works by altering specific parts of the genome. In this review, we focused on the efficacy and safety of CRISPR technology in the treatment of COVID-19.Copyright © 2023 Bilimsel Tip Yayinevi. All rights reserved.

Safety of COVID-19 vaccines in multiple sclerosis: A systematic review and meta-analysis.

BACKGROUND: Data are sparse regarding the safety of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with multiple sclerosis (MS). OBJECTIVE: To estimate (1) the pooled proportion of MS patients experiencing relapse among vaccine recipients; (2) the rate of transient neurological worsening, adverse events, and serious adverse events; (3) the previous outcomes of interest for different SARS-CoV-2 vaccine types. METHODS: Systematic review and meta-analysis of pharmacovigilance registries and observational studies. RESULTS: Nineteen observational studies comprising 14,755 MS patients who received 23,088 doses of COVID-19 vaccines were included. Mean age was 43.3 years (95% confidence interval (CI): 40-46.6); relapsing-remitting, secondary-progressive, primary-progressive MS and clinically isolated syndrome were diagnosed in 82.6% (95% CI: 73.9-89.8), 12.6% (95% CI: 6.3-20.8), 6.7% (95% CI: 4.2-9.9), and 2.9% (95% CI: 1-5.9) of cases, respectively. The pooled proportion of MS patients experiencing relapse at a mean time interval of 20 days (95% CI: 12-28.2) from vaccination was 1.9% (95% CI: 1.3%-2.6%; I2 = 78%), with the relapse risk being independent of the type of administered SARS-CoV-2-vaccine (p for subgroup differences = 0.7 for messenger RNA (mRNA), inactivated virus, and adenovector-based vaccines). After vaccination, transient neurological worsening was observed in 4.8% (95% CI: 2.3%-8.1%) of patients. Adverse events and serious adverse events were reported in 52.8% (95% CI: 46.7%-58.8%) and 0.1% (95% CI: 0%-0.2%) of vaccinations, respectively. CONCLUSION: COVID-19 vaccination does not appear to increase the risk of relapse and serious adverse events in MS. Weighted against the risks of SARS-CoV-2-related complications and MS exacerbations, these safety data provide compelling pro-vaccination arguments for MS patients.

Vaccine Development Against SARS-CoV-2: From Virology to Vaccine Clinical Trials

An urgent vaccine development is required against the recent pandemic of a novel coronavi-rus. Currently, there is no approved vaccine against COVID-19. Vaccination is proved to be the most beneficial way to protect humans from infections. Several vaccine candidates have been conducted to different phases of clinical trials, and more vaccine candidates are on the way to enter the trials. Different vaccine types have developed, including inactivated virus vaccines, subunit-based vaccines, adenovi-rus-vector vaccines, DNA-based vaccines, DC-based vaccines, and mRNA-based vaccines. The mRNA-1273 was the first vaccine candidate that started evaluating in the clinical trial. Also, AZD1222 is the first vaccine candidate that started phase II/III of clinical trials. Both of these vaccine candidates were considered as promising vaccine candidates against SARS-CoV-2. This review aims to overview and share various strategies to develop efficient therapeutic and preventive vaccines based on the origin, bi-ology, structure, and immune-evasion of SARS-CoV-2.Copyright © 2021 Bentham Science Publishers.

Risk of Exacerbation of Rheumatic Disease after COVID-19 Vaccination

Objectives: To investigate the risk of flare-ups after COVID-19 vaccination in patients with rheumatic disease. Method(s): A total of 1,617 patients with rheumatic diseases were identified from three rheumatology clinics. Patients were interviewed for demographic data, disease activity, and vaccination status. Disease flare-up was determined clinically by independent rheumatologists. Change of serum markers and medications were retrieved from medical records. The risk of exacerbation of rheumatic disease, change in serum markers, and escalation of rheumatic medications between vaccinated and nonvaccinated patients were determined using Cox, linear, and logistic regression models, respectively. Possible confounding factors were also taken into consideration. Result(s): Among 562 (34.76%) patients who received COVID-19 vaccination, rheumatic disease (HR = 2.10, P < 0.001), inflammatory arthritis (HR = 2.71, P < 0.001), rheumatoid arthritis (RA) (HR = 2.03, P = 0.002), spondyloarthritis (SpA) (HR = 4.78, P < 0.001), autoimmune disease (HR = 1.77, P = 0.01), and systemic lupus erythematosus (SLE) (HR = 1.99, P = 0.02) were associated with postvaccination clinical flare-up. Adult Still's disease (B = 12.76, P = 0.03) was associated with increased serum C-reactive protein (CRP). No association was found between vaccination and escalation of rheumatic medication. Subgroup analyses showed that only the mRNA vaccine was associated with flare-ups. Conclusion(s): COVID-19 vaccination was associated with minor disease flare-up but not escalation of rheumatic medications. In the absence of absolute contraindications, COVID-19 vaccination is recommended in patients with rheumatic disease. KEY MESSAGES 1. Vaccination is effective in the prevention of morbidity due to COVID-19 in patients with autoimmune diseases. 2. The mRNA vaccine was associated with mild rheumatic disease flare-up. 3. Inactivated virus vaccine is preferable to mRNA vaccine in patients with active autoimmune disease. Copyright © 2023 The Author(s).

Reported COVID-19 vaccines side effects among Algerian athletes: a comparison between inactivated virus, adenoviral vector, and mRNA COVID-19 vaccines.

OBJECTIVES: Many types of COVID19 vaccines are administered globally, yet there is not much evidence regarding their side effects among athletes. This study evaluated the selfreported postvaccination side effects of inactivated virus, adenoviral vector, and mRNA COVID19 vaccines among Algerian athletes. METHODS: A cross-sectional survey-based study was carried out in Algeria between March 01 and 4 April 2022. The study used a validated questionnaire with twenty-five multiple-choice items covering the participants' anamnestic characteristics, post-vaccination side effects (their onset and duration), post-vaccination medical care, and risk factors. RESULTS: A total of 273 athletes completed the survey. Overall, (54.6%) of the athletes reported at least one local side effect, while (46.9%) reported at least one systemic side effect. These side effects were more prevalent among the adenoviral vector group compared to the inactivated virus and mRNA groups. The most common local side effect was injection site pain (29.9%), while Fever (30.8%) was the most prevalent systemic side effect. The age group of 31-40 years, allergy, previous infection with COVID-19, and the first dose of vaccines were associated with an increased risk of side effects for all groups of COVID-19 vaccines. Logistic regression analysis further revealed that compared to males, the incidence of reported side effects was significantly higher in females (odd ratio (OR) = 1.16; P = 0.015*) only for the adenoviral vector vaccine group. In addition, a significantly higher percentage of athletes group of high dynamic/moderate static or high dynamic /high static components suffered from post-vaccination side effects compared to the group of athletes with high dynamic/low static components (OR = 14.68 and 14.71; P < 0.001, respectively). CONCLUSIONS: The adenoviral vector vaccines have the highest rate of side effects, followed by the inactivated virus and mRNA COVID-19 vaccines. COVID­19 vaccines were well-tolerated among Algerian athletes and there were no reports of serious side effects. Nevertheless, further long-term follow-up study with a larger sample size of athletes (from different types and sports categories) is warranted to establish the long-term safety of the COVID-19 vaccine.

Active pharmacovigilance in patients immunized with the CoronaVac vaccine in the port of Cartagena group.

Introduction: The crisis caused during the COVID-19 pandemic led scientists around the world to think about the creation of different vaccines against SARS-CoV-2. One of them was the inactivated virus vaccine CoronaVac, which was approved by Colombia's Ministry of Health. However, there are few pharmacovigilance studies conducted by occupational medicine to know the adverse events caused by vaccines. Objective(s): To estimate the safety of the CoronaVac vaccine. Methodology: Descriptive, retrospective and quantitative study, in which a population group of 508 workers from the port of Cartagena group was chosen, who were selected under inclusion criteria, during the second period of 2021 and the first of 2022. Result(s): 3.54 % of workers reported adverse events within the study population. Men had the most reports with 72.2% and women 27.8%. The most affected population group in terms of age was those aged 30 to 35 years, with a report of 44.4%. Likewise, the systems where there was a higher percentage of reports were the musculoskeletal, respiratory, and nervous system for first, second and third doses respectively;with symptoms such as headache, malaise, fever, muscle and joint pain, followed by pain in the injection area. Conclusion(s): In this study it was possible to identify the adverse events reported by the study population. However, none of the events presented had a serious or negative influence on the health and integrity of the workers during the study period. In this way, the safety of the vaccine was estimated. It should be noted that the CoronaVac vaccine did not prevent the spread or possible reinfection of the virus. Copyright © 2022, Editorial Ciencias Medicas. All rights reserved.

Autoimmune syndrome induced by adjuvants (asia) in a 71-year- old filipino female after an inactivated virus vaccine: A case report

Background: Autoimmune Syndrome Induced by Adjuvants, or ASIA, suggests certain environmental exposures, including vaccination can cause hyperstimulation of the innate and adaptive immune system leading to production of autoantibodies in a genetically predisposed individual. A diagnosis of exclusion, proposed diagnostic criteria suggested ASIA if specified major and minor criteria are fulfilled. Suspicion for ASIA was raised in our patient due to identified exposure accompanied by typical manifestations not explained by another cause. Case: A 71-year- old Filipino female with controlled hypertension and diabetes, came in due to progressive right eye pain, supraorbital headache, ptosis and limitation of extra-ocular movements for 3 weeks. No blurring of vision, color vision changes, or visual field cuts. She didn't have other systemic features but received 2 doses of inactivated COVID-19 vaccine 1 month (1st) and 1 day (2nd) prior to the symptom onset. The left eye was unremarkable. ESR was elevated (109) with normal CRP. ANA was 1:80 with a speckled pattern. The complements were normal and lupus confirmatory panel was negative. CSF studies showed slightly elevated protein and glucose with no pleiocytosis, IgG level was normal with negative oligoclonal panel and cultures. EMG-NCV showed acute partial incomplete bilateral facial neuropathy. Cranial MRI/MRA showed chronic lacunar infarct in the right corona radiata. The MRI of the orbits showed right optic nerve enhancement with hyperintense nerve sheath compatible with optic neuritis. She underwent pulse IV steroid therapy (Methylprednisolone 1 g) for 3 days and was maintained on oral steroid 1 mg/kg/day. There was minimal improvement of symptoms for which she received intravenous immunoglobulin for 5 days. Her symptoms gradually improved upon discharge. Conclusion(s): Identification of the possible autoimmunity from adjuvants is not to discourage vaccination but rather raise awareness of the need for further studies to screen who might be at risk and to prepare or even develop alternatives, such as vaccines with a different type of adjuvant.

Development and Evaluation of a Novel One-Step RT-qPCR Targeting the Vero Gene for the Identification of False-Positive Results Caused by Inactivated Virus Vaccine Contamination.

To identify false-positive SARS-CoV-2 test results caused by novel coronavirus inactivated vaccine contamination, a novel RT-qPCR targeting the ORF1ab and N genes of SARS-CoV-2 and Vero gene was developed. The amplification efficiency, precision, and lower limit of detection (LLOD) of the RT-qPCR assay were determined. A total of 346 clinical samples and 132 environmental samples were assessed, and the diagnostic performance was evaluated. The results showed that the amplification efficiency of the ORF1ab, N, and Vero genes was 95%, 97%, and 93%, respectively. The coefficients of variation of Ct values at a concentration of 3 × 104 copies/mL were lower than 5%. The LLOD for the ORF1ab, N, and Vero genes reached 8.0, 3.3, and 8.2 copies/reaction, respectively. For the 346 clinical samples, our RT-qPCR assay identified SARS-CoV-2-positive and SARS-CoV-2-negative samples with a sensitivity of 100.00% and a specificity of 99.30% and novel coronavirus inactivated vaccine-contaminated samples with a sensitivity of 100% and a specificity of 100%. For the environmental samples, our RT-qPCR assay identified novel coronavirus inactivated vaccine-contaminated samples with a sensitivity of 88.06% and a specificity of 95.38%. In conclusion, the RT-qPCR assay we established can be used to diagnose COVID-19 and, to a certain extent, false-positive results due to vaccine contamination.

Latest in COVID-19 Vaccine 'Candidates' Race.

Restoring everyday civil life from the devastating pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can be only by the development of an efficient vaccine. As of April 12, 2022, 497,960,492 confirmed cases of COVID-19 were reported, including 6,181,850 lives having been lost worldwide and completely paralyzing the d global economy. Detection of a novel coronavirus SARS-CoV-2 in Wuhan, in December 2019, and the genetic sequence of SARS-CoV-2 that was published on January 11, 2020, leads to a global race, to prepare for a preventive vaccine. No single institution can develop a vaccine individually because there are many stages for developing and producing a successful vaccine. Since this virus threatens the health, the economy, and society the demand for a fast-track vaccine is understandable. This article tries to give an overview of vaccine 'candidates' development and clinical trials, and it mentions some challenges of using these vaccines for managing SARS-CoV-2.

Evidence synthesis and pooled analysis of vaccine effectiveness for COVID-19 mRNA vaccine BNT162b2 as a heterologous booster after inactivated SARS-CoV-2 virus vaccines.

Introduction of primary COVID-19 vaccination has helped reduce severe disease and death caused by SARS-CoV-2 infection. Understanding the protection conferred by heterologous booster regimens informs alternative vaccination strategies that enable programmatic resilience and can catalyze vaccine confidence and coverage. Inactivated SARS-CoV-2 vaccines are among the most widely used vaccines worldwide. This review synthesizes the available evidence identified as of May 26, 2022, on the safety, immunogenicity, and effectiveness of a heterologous BNT162b2 (Pfizer-BioNTech) mRNA vaccine booster dose after an inactivated SARS-CoV-2 vaccine primary series, to help protect against COVID-19. Evidence showed that the heterologous BNT16b2 mRNA vaccine booster enhances immunogenicity and improves vaccine effectiveness against COVID-19, and no new safety concerns were identified with heterologous inactivated primary series with mRNA booster combinations.

Reactogenicity of COVID-19 Vaccines in Patients With a History of COVID-19 Infection: A Survey Conducted in Pakistan.

Introduction As coronavirus disease 2019 (COVID-19) immunizations become more common, concerns about their safety and reactogenicity have grown. It is important to assess and analyze the post-vaccination side effects of several COVID-19 vaccines that have been licensed in Pakistan. Methods and results A comparative cross-sectional study was conducted between October 2021 and January 2022 to collect data on the side effects produced by different COVID-19 vaccines. An online survey was conducted to gather data on participants' demographics, clinical profiles, COVID-19 profiles as well as the intensity and side effects of COVID-19 vaccines. Statistical Package for the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY) was used to analyze the data collected. Out of 421 participants, 63.2% were males, 36.8% of participants received messenger RNA (mRNA) vaccine, 33.2% received viral vector vaccine, 29.9% received inactivated vaccine, and further 71.7% of the total subjects were completely immunized. The majority of the symptoms were mild to moderate in degree. Approximately, 0.7% of the individuals reported experiencing serious adverse effects. Injection site pain (35.9%) was noted to be the most remarkable post-vaccination side effect followed by fever (33.2%) and fatigue (23.1%). Prior COVID-19 infection was not associated with the severity of any COVID-19 vaccine-related side effect (p > 0.05), except dyspnea. Younger participants and the female gender were substantially linked to post-vaccination adverse effects. Conclusion In comparison to viral vector and inactivated vaccines, our data suggest that the mRNA-based vaccination causes more severe adverse effects, and the majority of them were mild to moderate in severity. Participants who had previously contracted COVID-19 were not at a higher risk of developing additional vaccine-related side effects.

Short-Term Adverse Effects Following Booster Dose of Inactivated-Virus vs. Adenoviral-Vector COVID-19 Vaccines in Algeria: A Cross-Sectional Study of the General Population.

COVID-19 booster vaccines have been adopted in almost all countries to enhance the immune response and combat the emergence of new variants. Algeria adopted this strategy in November 2021. This study was conducted to consider the self-reported side effects of COVID-19 booster vaccines by Algerians who were vaccinated with a booster dose of one of the approved inactivated-virus vaccines, such as BBIBP-CorV and CoronaVac, or one of the adenoviral-vector-based vaccines, such as Gam-COVID-Vac, AZD1222 and Ad26.COV2.S, and to determine the eventual risk factors. A cross-sectional study using an online self-administered questionnaire (SAQ) was conducted in Algeria between 28 April 2022, and 20 July 2022. A descriptive analysis of the 196 individuals who were included showed a nearly equal distribution of adenoviral- (52%) and inactivated-virus vaccines (48%) and of males (49.5%) and females (50.5%). The results showed that 74.7% of the studied population reported at least one local or systemic side effect. These side effects were more frequent among adenoviral-vector vaccinees (87.3%) than inactivated-virus vaccinees (60.6%) (sig. < 0.001). Injection site pain (40.3%), heat at the injection site (21.4%), and arm pain (16.3%) were the most common local side effects. These signs generally appeared in the first 12 h (73.3%) and generally lasted less than 24 h (32.8%). More interestingly, these signs differed from those that followed the administration of primer doses (48.5%) and were generally more severe (37%). The same observation was reported for systemic side effects, where the signs were especially most severe in the adenoviral-vaccinated group (49.4% vs. 20.8%; sig. = 0.001). These signs generally appeared within the first day (63.6%) and mostly disappeared before two days (50.8%), with fatigue (41.8%), fever (41.3%), and headache (30.1%) being the most common. Adenoviral-vector vaccinees (62.7%) were more likely to use medications to manage these side effects than were inactivated-virus vaccinees (45.7%) (sig. = 0.035) and paracetamol (48.5%) was the most used medication. Adenoviral-based vaccines were the types of vaccines that were most likely to cause side effects. In addition, being female increased the risk of developing side effects; regular medication was associated with local side effects among inactivated-virus vaccinees; and previous infection with COVID-19 was associated with systemic and local side effects among adenovirus-based vaccinees. These results support the short-term safety of booster vaccines, as has been reported for primer doses.

Safety and Immunogenicity Outcomes of an Inactivated Viral Vaccine against SARS-CoV-2 (Covaxin)

Introduction: Bharat Biotech International Ltd in partnership with National Institute of Virology (NIV), has developed an indigenous whole virion inactivated Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) viral vaccine BBV-152 (Covaxin), formulated with Toll Like Receptors 7/8 agonist Imidazoquinoline (IMDG) molecule adsorbed to alum (Algel). Variety of factors other than environmental ones can affect vaccines efficiency outside the strict setting of clinical trials, like how the vaccine is stored or transported, and even how patients are vaccinated. In addition, the intrinsic capacity of the recipient to respond to a vaccine which is determined by sex, genetic factors, age, psychological stress, nutrition and other diseases are also likely to have an impact. Aim(s): To determine the safety, reactogenicity and immunogenicity of the inactivated whole virus vaccine (Covaxin) amongst hospital-based population groups. Material(s) and Method(s): The prospective analytical study was conducted in the Department of Microbiology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India, from January 2021 to March 2021.The study primarily included Healthcare Workers (HCWs) employed at SMS Medical college and attached hospitals. In-vitro quantitative IgG antibodies against SARS-CoV-2 spike Receptor Binding Domain (RBD) were measured using Chemiluminescence Immunoassay (CLIA) based Advia centaur SARS-CoV-2 IgG, manufactured by Siemens Pvt Ltd, Munich, Germany, as per manufacture's instructions. Result(s): Out of total 223 individuals, 61.88 % (138/223) showed neutralising antibody titre of >1 index value by CLIA, rest 38.12% (85/223) were non reactive i.e., titre <1 index value, after four weeks of receiving first dose of Covaxin. After 2 to 4 weeks of receiving second dose 84.30% (188/223) showed neutralising antibody titre of >1 index value by CLIA, rest 15.70% (35/223) were non reactive i.e., titre <1 index value. After receiving first dose, 100% (223/223) of the participants developed localised pain and bodyache 33.63% (75/223). None of the participants showed any anaphylactic reaction or any emergency condition just after vaccination. Conclusion(s): Covaxin is a well-tolerated vaccine, and induces good humoral response against SARS-CoV-2 with a significant rise in the neutralising antibody titres. Copyright © 2022 Journal of Clinical and Diagnostic Research. All rights reserved.

Hunting for COVID-19 vaccine.

COVID-19 disease is caused by a novel type of SARS-CoV-2 virus which was firstly described in Chinese Wuhan in December 2019. It is highly infectious disease manifested with fever, respiratory problems, muscle pains and tiredness. Up to now, no efficient medicine has been available, that is why research is focused on development of a vaccine. The vaccine research was launched immediately when the pandemic broke out. The main goal of vaccination against COVID-19 will be prevention of infection outbreak, prevention of reinfection, long-term protective effect and efficiency of vaccination in case of next potential waves of infection. The primary questions are if the effective vaccine against COVID-19 will be developed, how long it will take and who will be the first. The first pandemic disease caused by a novel SARS coronavirus emerged almost 20 years ago, the next MERS coronavirus disease 8 years ago and no effective vaccine against these diseases has been available so far. Presently, 179 candidate vaccines at minimum are at different stages of their development and 18 vaccines are at the stage of clinical evaluation. The surface S glycoprotein SARS-CoV-2 virus is considered the most promising vaccine antigen. Other options are the use of the whole virion or subunit S1 carrier. Currently, four types of potential vaccines have been developed. Whole virion vaccines (attenuated or killed vaccine) vector vaccines (most often using replicating or non-replicating viral vector) protein vaccines (subunit adjuvant vaccine or vaccine based on virus-like particles) and DNA, RNA vaccine. The key moment will be confirmation of the novel vaccine efficiency at the phase 3 of a clinical trial. Despite pressure and efforts to speed up the development of the vaccine, it is realistic to count on the possible vaccine in the year 2021 the earliest and the question is when it can be available in the Czech Republic. Copyright © 2020, Medakta s.r.o.. All rights reserved.

A comprehensive review of BBV152 vaccine development, effectiveness, safety, challenges, and prospects.

The world has responded to the COVID-19 pandemic with unprecedented speed and vigor in the mass vaccination campaigns, targeted to reduce COVID-19 severity and mortality, reduce the pressure on the healthcare system, re-open society, and reduction in disease mortality and morbidity. Here we review the preclinical and clinical development of BBV152, a whole virus inactivated vaccine and an important tool in the fight to control this pandemic. BBV152, formulated with a TLR7/8 agonist adjuvant generates a Th1-biased immune response that induces high neutralization efficacy against different SARS-CoV-2 variants of concern and robust long-term memory B- and T-cell responses. With seroconversion rates as high as 98.3% in vaccinated individuals, BBV152 shows 77.8% and 93.4% protection from symptomatic COVID-19 disease and severe symptomatic COVID-19 disease respectively. Studies in pediatric populations show superior immunogenicity (geometric mean titer ratio of 1.76 compared to an adult) with a seroconversion rate of >95%. The reactogenicity and safety profiles were comparable across all pediatric age groups between 2-18 yrs. as in adults. Like most approved vaccines, the BBV152 booster given 6 months after full vaccination, reverses a waning immunity, restores the neutralization efficacy, and shows synergy in a heterologous prime-boost study with about 3-fold or 300% increase in neutralization titers against multiple SARS-CoV-2 variants of concern. Based on the interim Phase III data, BBV152 received full authorization for adults and emergency use authorization for children from ages 6 to 18 years in India. It is also licensed for emergency use in 14 countries globally. Over 313 million vaccine doses have already been administered in India alone by April 18th, 2022.

A global epidemiological analysis of COVID-19 vaccine types and clinical outcomes.

OBJECTIVES: To compare messenger RNA (mRNA)-based and adenovirus-vectored vaccines (ADVVs) with inactivated virus vaccines (IVVs) using real-world aggregate data. METHODS: We performed longitudinal analyses of publicly accessible epidemiological, clinical, virological, vaccine-related, and other public health data from 41 eligible countries during the first half of 2021. The relationships between vaccination coverage and clinical outcomes were analyzed using repeated measures correlation analyses and mixed-effects modeling to adjust for potential mediating and confounding factors. RESULTS: Countries that used mRNA and/or ADVV (n = 31) vs IVV, among other vaccine types (n = 10), had different distributions of age (42.4 vs 33.9 years, respectively; P-value = 0.0006), gross domestic product per capita ($ 38,606 vs $ 20,422, respectively; P <0.0001), and population sizes (8,655,541 vs 5,139,162, respectively; P-value = 0.36). After adjustment for country differences, the stringency of nonpharmaceutical interventions, and dominant SARS-CoV-2 variant types, populations that received mRNA and/or ADVV had significantly lower rates of cases and deaths over time (P <0.001 for each analysis). Populations vaccinated with IVV, among others, had significantly higher rates of cases and deaths over time (P <0.05 for each analysis). CONCLUSION: The real-world effectiveness of IVV may be inferior to mRNA and/or ADVV, and prospective comparative studies are needed to critically evaluate the role of IVV in the context of contemporary SARS-CoV-2 variants.