Pfizer-BioNTech Vaccine Research Articles

Metabolic syndrome and the immunogenicity of Pfizer–BioNTech vaccine: a cross-sectional study in Japanese healthcare workers

BackgroundThe clustering of metabolic abnormalities may weaken vaccine-induced immunity, but epidemiological data regarding SARS-CoV-2 vaccines are scarce. The present study aimed to examine the cross-sectional association between metabolic syndrome (MetS) and humoral immune response to Pfizer–BioNTech vaccine among the staff of a research center for medical care in Japan.MethodsParticipants were the staff (aged 21–75 years) of the National Center of Global Health and Medicine who had completed the second dose of Pfizer–BioNTech vaccine 1–3 months before the survey. MetS was defined according to the Joint Interim Statement. SARS-CoV-2 spike immunoglobulin G (IgG) antibody was measured using quantitative assays. Multivariable linear regression was used to estimate the geometric mean titers (GMT) and geometric mean ratio (GMR) of IgG titers, relative to MetS status.ResultsOf 946 participants who received the second vaccine dose, 51 (5.4%) had MetS. Those with MetS had a significantly lower IgG titer (GMT 4125; 95% confidence interval [CI], 2885–5896) than those without MetS (GMT 5348; 95% CI, 3914–7309); the GMR was 0.77 (95% CI 0.64–0.93). Taking those having no MetS component as reference, fully adjusted GMR (95% CI) for those having 1, 2, 3 or ≥ 4 components was 1.00 (0.90, 1.11), 0.89 (0.77, 1.04), 0.86 (0.68, 1.10) and 0.61 (0.45, 0.82), respectively (P trend = 0.024).ConclusionResults suggest that having MetS and a greater number of its components are associated with a weaker humoral immune response to the Pfizer–BioNTech vaccine.

Recurrent and De Novo Toxoplasmosis Retinochoroiditis following Coronavirus Disease 2019 Infection or Vaccination.

This study reports three cases of toxoplasmosis retinochoroiditis following coronavirus disease 2019 (COVID-19) infection or vaccination from the national Canadian COVID-19 Eye Registry between December 2020 and September 2021. A 56-year-old male presented 15 days after a positive COVID-19 test with toxoplasmosis retinochoroiditis. He later relapsed 8 days following a first Pfizer-BioNTech vaccine dose. Two patients presented with toxoplasmosis retinochoroiditis following COVID-19 vaccination: A 58-year-old female presenting 4 days following a first Pfizer-BioNTech vaccine dose with anterior uveitis and a posterior pole lesion discovered 3 months later and a 39-year-old female presenting 17 days after a first Moderna vaccine dose. Resolution was achieved with oral clindamycin, oral trimethoprim/sulfamethoxazole, and topical prednisolone acetate 1%. Patients were offered prophylactic trimethoprim/sulfamethoxazole for subsequent doses without relapse. Following COVID-19 infection or vaccination, patients may be at risk for toxoplasmosis retinochoroiditis. Prophylactic antibiotics for future doses may be offered to patients with known ocular toxoplasmosis to prevent recurrence.

Estimated Infection and Vaccine Induced SARS-CoV-2 Seroprevalence in Israel among Adults, January 2020-July 2021.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in Israel in February 2020 and spread from then. In December 2020, the FDA approved an emergency use authorization of the Pfizer-BioNTech vaccine, and on 20 December, an immunization campaign began among adults in Israel. We characterized seropositivity for IgG anti-spike antibodies against SARS-CoV-2 between January 2020 and July 2021, before and after the introduction of the vaccine in Israel among adults. We tested 9520 serum samples, collected between January 2020 and July 2021. Between January and August 2020, seropositivity rates were lower than 5.0%; this rate increased from September 2020 (6.3%) to April 2021 (84.9%) and reached 79.1% in July 2021. Between January and December 2020, low socio-economic rank was an independent, significant correlate for seropositivity. Between January and July 2021, the 40.00–64.99-year-old age group, Jews and others, and residents of the Northern district were significantly more likely to be seropositive. Our findings indicate a slow, non-significant increase in the seropositivity rate to SARS-CoV-2 between January and December 2020. Following the introduction of the Pfizer-BioNTech vaccine in Israel, a significant increase in seropositivity was observed from January until April 2021, with stable rates thereafter, up to July 2021.

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.

IntroductionAlthough the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited.AimWe aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.MethodsWe retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021. We analyzed AEFI related to the mother and fetus/newborn. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines.ResultsDuring the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to the use in pregnancy. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses/newborns (n = 258). We identified 16,569 AEFI. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. Among pregnancy-related AEFI, the most reported was spontaneous abortion. Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69–0.93). Moderna and Oxford-AstraZeneca vaccines had a higher reporting probability of spontaneous abortion (ROR 1.2, 95% CI 1.05–1.38 and ROR 1.26, 95% CI 1.08–1.47, respectively), while a lower reporting probability was found for Pfizer-BioNTech vaccine compared with all other COVID-19 vaccines (ROR 0.73, 95% CI 0.64–0.84). In addition, 5.8% of ICSRs reported a fatal outcome.ConclusionsNo strong insight of unknown AEFI associated with COVID-19 vaccination in pregnant women was observed. Considering the high risk associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, our analysis suggests that the benefits of COVID-19 vaccines during pregnancy outweigh the possible risks. However, it is important to continue monitoring the safety profile of COVID-19 vaccines in this subpopulation.

Side effects of the Pfizer BioNTech vaccine in health workers of a hospital in the southeast of Mexico.

The goal of this study was to evaluate the side effects of application of the Pfizer BioNTech vaccine on the workers at a Mexican hospital. A cross-sectional study was carried out, in which 1351 workers from a tertiary care center in the Mexican southeast were included. Sociodemographic data, comorbidities, and side effects after the Pfizer BioNTech vaccine were obtained through an online survey. The variables were analyzed through descriptive statistics. The presence or absence of side effects was analyzed through the Chi-square test or t-test, as appropriate. The result was considered statistically significant at p < 0.05. A total of 1351 health workers participated in the online survey. The mean age was 37.8 ± 10.9 years and 56.4% were women. Among them, 8.2% suffered from high blood pressure. In addition, 76.7% manifested pain in the application area. The presence of side effects was associated with the female gender (p < 0.01). Side effects were more prevalent in younger age (37.2 ± 10.7) than older age (41.5 ± 10.8) (p < 0.01). There was no association with the presence of comorbidities (p > 0.05). The data suggest that pain in the application area is the most frequent side effect among workers in a Mexican hospital who received the Pfizer BioNTech vaccine against COVID-19. In addition, we observed sialorrhea as a side effect in the studied population and this had not previously been reported. The highest number of adverse events occurred between 24 to 72 hours after application.

A novel assessment method for COVID-19 humoral immunity duration using serial measurements in naturally infected and vaccinated subjects.

Collecting information on sustainability of immune responses after infection or vaccination is crucial to inform medical decision-making and vaccination strategies. Data on how long-lasting antibodies against SARS-COV-2 could provide a humoral and protective immunity and prevent reinfection with SARS-CoV-2 or its variants is particularly valuable. This study presents a novel method to quantitatively measure and monitor the diversity of SARS-CoV-2 specific antibody profiles over time. Serum samples from two groups were used in this study: Samples from 20 naturally infected subjects (followed for up to 1 year) and samples from 83 subjects vaccinated with one or two doses of the Pfizer BioNtech vaccine (BNT162b2/BNT162b2) (followed for up to 6 months). The Multi-SARS-CoV-2 assay, a multiparameter serology test developed for the serological confirmation of past-infections, was used to determine the reactivity of six different SARS-CoV-2 antigens. For each subject sample, 3 dilutions (1/50, 1/400 and 1/3200) were defined as an optimal set over the six antigens and their respective linear ranges. This allowed accurate quantification of the corresponding six antibodies. Nonlinear mixed-effects modelling was applied to convert intensity readings from 3 determined dilutions to a single quantification value for each antibody. Median half-life for the 20 naturally infected vs 74 vaccinated subjects (two doses) was 120 vs 50 days for RBD, 127 vs 53 days for S1 and 187 vs 86 days for S2 antibodies respectively. The newly proposed method, based on a series of a limited number of dilutions, can convert a conventional qualitative assay into a quantitative assay. This conversion helps define the sustainability of specific immune responses against each relevant viral antigen and can help in defining the protection characteristics after an infection or a vaccination.

P69 COVID vaccine uptake in young persons on immunosuppression under the care of tertiary paediatric rheumatology service

Introduction/BackgroundCOVID-19 disease, caused by SARS-CoV-2 virus, first emerged as a presentation of severe respiratory disease in 2019. Although children exhibit mild disease, concerns were raised about serious infection in immunocompromised children. The current national guidance recommends that immunocompromised children between 12 and 18 years of age should be offered three primary doses of the Pfizer BioNTech vaccine, 8 weeks apart, followed by a booster dose within 3 months. This audit looked at the awareness and uptake of this regime in young persons on immunosuppression. This information was disseminated to families during clinical contacts and automatic replies sent out from the team mailbox.Description/MethodTo collect the data for the audit, we used an anonymous questionnaire to capture the following information:• Diagnosis• Immunomodulatory/Immunosuppressive treatment• Their awareness of the regime for COVID vaccine (number of doses and interval)• Number of vaccines taken• If not taken, why?The questionnaires were handed out to 31 patients attending Paediatric Rheumatology day-care and outpatient clinics over a two-week period for their response. There were no non-responders. Patients who were not on any immunosuppressant medication were excluded.The split of their diagnoses and medications are summarised in tables 1 and 2:Patients with JIA (55%) unsurprisingly dominated the cohort, followed by JSLE, JDM and scleroderma. Only 3/31 patients (10%) were on any form of systemic steroid therapy (all on oral Prednisolone less than 0.5 mg/kg). Majority of the patients (21/31 – 68%) were on Methotrexate, either on its own, or in combination with one of the biologic agents (one scleroderma patient was on MTX + MMF). 14/21 (45%) patients were on one of the biologic agents, of which only one patient was on Rituximab.P69 Table 1:Patients' diagnosesDiagnosisNumber of respondentsJuvenile Idiopathic Arthritis (JIA)17 (2 – uveitis) – 55%Juvenile Systemic Lupus Erythematosus (JSLE)5 – 16%Juvenile Dermatomyositis (JDM)3 – 10%Localised scleroderma / Systemic Sclerosis3 – 10%ANCA Associated Vasculitis (AAV)1 – 3 %Systemic Autoinflammatory Disease2 (both Mevalonate Kinase deficiency) – 6%P69 Table 2:Patients' medicationsMedicationsNumber of respondentsSystemic steroids (on top of other medicines)3 (10%)Methotrexate (MTX)11 (35%)Methotrexate + Adalimumab6 (19%)Mycophenolate Mofetil (MMF)4 (13%)MTX + MMF1 (3%)Adalimumab3 (10%)MTX + Infliximab3 (10%)Canakinumab 2 (6%)Cyclophosphamide1 (3%)Discussion/ResultsThe results showed that only 6/31 (19%) of patients/their carers knew the correct number (3 + 1) of COVID vaccines recommended in this cohort. 18/31 (58%) patients had received the vaccine, of which 4 patients refused further doses due to side effects they had experienced following the first dose. Of the 13 young people who did not take the vaccine, 9 patients (29%) were unsure whether they need the vaccine. They did not know the benefits of the vaccine and were afraid it either could have a negative effect on immunocompromised children or just were not aware of the guidelines. The other 4 (13%) participants did not want to take the vaccine due to their own personal beliefs.Although concerns were raised about serious COVID-19 infection in immunocompromised children, there is currently very little evidence to suggest that the infection rate and severity of COVID-19 infection in children treated with Methotrexate or biologic agents is higher or the treatment needs to be discontinued or the doses adjusted. There is some emerging evidence to suggest that adults on Rituximab and to a lesser extend Mycophenolate may have increased risk of developing severe outcomes from COVID-19, which has not been replicated in children. The recommendation for third primary dose is based on preliminary results from UK studies of real-world vaccine effectiveness (VE) in persons who are immunosuppressed, suggesting a modest reduction in VE against symptomatic COVID-19. There is also emerging evidence that COVID vaccination significantly reduces the risk of Paediatric Inflammatory Multisystem Syndrome (PIMS-TS) in 12 – 18 year olds.Key learning points/ConclusionDespite the notion that the team had disseminated information on the vaccine regime to patients, only one fifth of the patients/carers knew the exact regime for COVID vaccine recommended in this group of young people.Just under 60% of the patients took the vaccine, with the rest choosing not to have it due to a mixture of lack of information and personal choice.The action plan was drawn up to:1. enquire about and document vaccination status, and provide advice and information during every clinical contact;2. include COVID vaccine in education sessions by nursing team;3. include the information as default in all clinic letters;4. reaudit in six months.

Is there any effect of COVID-19 mRNA vaccination on electrocardiographic parameters in patients without apparent cardiovascular disease?

Objective: Electrocardiographic alterations were investigated following the second dosage of COVID-19 mRNA vaccination. Methods: A total of 260 individuals after two doses of COVID-19 vaccine with Pfizer-BioNTech were included in the study. The electrocardiographic parameters recorded at baseline and approximately one week later after two doses of Pfizer-BioNTech vaccine were compared for all patients. Results: PR interval was increased and QTc maximum interval was decreased significantly after second dose COVID-19 mRNA vaccination. Baseline and post-second dose vaccination states regarding P wave dispersion and QT dispersion/Tp-e interval which have been recognized to imply inhomogeneous atrial conduction and heterogeneity in ventricular repolarization were similar between groups. Conclusion: Our findings suggest that there should be no concern related to asymptomatic involvement of the myocardium subsequent the second dose of COVID-19 mRNA vaccination.

Evaluating risk factors associated with COVID-19 infections among vaccinated people early in the U.S. vaccination campaign: an observational study of five states, January–March 2021

BackgroundCOVID-19 vaccines are an effective tool to prevent illness due to SARS-CoV-2 infection. However, infection after vaccination still occurs. We evaluated all infections identified among recipients of either the Pfizer-BioNTech or Moderna COVID-19 vaccine in five U.S. states during January–March 2021.MethodsUsing observational data reported to CDC, we compared the incidence of SARS-CoV-2 infection among vaccinated and unvaccinated persons, and the sex, age, and vaccine product received for individuals with vaccine breakthrough infections to those of the vaccinated population using Poisson regression models. We also compared the proportion of vaccine breakthrough cases due to a SARS-CoV-2 variant of concern to data reported to CDC’s national genomic surveillance program.ResultsThe age-adjusted incidence of reported SARS-CoV-2 infection was 97% lower among vaccinated as compared to unvaccinated persons aged ≥ 16 years (68 vs 2252 cases per 100,000 people). Vaccinated adults aged ≥ 85 years were 1.6 times (95% CI 1.3–1.9) as likely to become infected with SARS-CoV-2 than vaccinated adults aged < 65 years. Pfizer-BioNTech COVID-19 vaccine recipients were 1.4 times (95% CI 1.3–1.6) as likely to experience infection compared to Moderna COVID-19 recipients. The proportion of infections among vaccinated persons caused by SARS-CoV-2 variants of concern was similar to the proportion of circulating viruses identified as variants of concern in the five states during the same time.ConclusionsVaccinated persons had a substantially lower incidence of SARS-CoV-2 infection compared to unvaccinated persons. Adults aged ≥ 85 years and Pfizer-BioNTech vaccine recipients had a higher risk of infection following vaccination. We provide an analytic framework for ongoing evaluation of patterns associated with SARS-CoV-2 infection among vaccinated persons using observational surveillance and immunization data. Our findings reinforce the effectiveness of COVID-19 vaccines in preventing infection in real-world settings.

Advances in Research on COVID-19 Vaccination for People Living with HIV.

Advances in Research on COVID-19 Vaccination for People Living with HIV.

Design and in silico analysis of mRNA vaccine construct against Salmonella

Salmonella infections are continuously growing. Causative serovars have gained enhanced drug resistance and virulence. Current vaccines have fallen short of providing sufficient protection. mRNA vaccines have come up with huge success against SARS-CoV-2; Pfizer-BioNTech and Moderna vaccines have resulted in >90% efficacy with efficient translocation, expression, and presentation of antigen to the host immune system. Herein, based on the same approach a mRNA vaccine construct has been designed and analyzed against Salmonella by joining regions of genes of outer membrane proteins C and F of S. Typhi through a flexible linker. Construct was flanked by regulatory regions that have previously shown better expression and translocation of encoded protein. GC content of the construct was improved to attain structural and thermodynamic stability and smooth translation. Sites of strong binding miRNAs were removed through codon optimization. Protein encoded by this construct is structurally plausible, highly antigenic, non-allergen to humans, and does not cross-react to the human proteome. It is enriched in potent, highly antigenic, and conserved linear and conformational epitopes. Most conserved conformational epitopes of core protein lie on extended beta hairpins exposed to the cellular exterior. Stability and thermodynamic attributes of the final construct were found highly comparable to the Pfizer-BioNTech vaccine construct. Both contain a stable stem-loop structure downstream of the start codon and do not offer destabilizing secondary structures upstream of the start codon. Given structural and thermodynamic stability, effective immune response, and epitope composition the construct is expected to provide broad-spectrum protection against clinically important Salmonella serovars. Communicated by Ramaswamy H. Sarma

Topics and Sentiments Influence Likes: A Study of Facebook Public Pages' Posts About COVID-19 Vaccination.

In this study, we analyzed >200,000 posts collected from Facebook public pages that were published in December 2020 during the rollout of the first dose of the Pfizer-BioNTech vaccine to the American public. We ran both topic modeling and sentiment analysis of the posts and found that first Facebook posts talked about not only treatment effectiveness such as trial results and testing approaches but also other issues that surround vaccines such as approval and distribution. Second, although the general sentiment during this period was positive and anticipation was the highest emotion, Facebook posts expressed a salient amount of fear and sadness, especially when discussing emergency approval and trial results. Finally, we found that both topics and sentiments have a significant influence on user likes. Using the topic of vaccine distribution as a baseline, posts that discuss related aspects of vaccines (e.g., effectiveness, shipment, and testing), call for actions (e.g., use of masks) and indicate care to vulnerable groups (e.g., health care workers and seniors) received more likes. Posts with bad news (e.g., new cases and deaths) and doubts over the usefulness of vaccines received fewer likes. Regardless of their valences, approach emotions lead to more likes whereas withdrawal emotions lead to fewer likes. Our study suggests that to facilitate actions, using certain topics and approach emotions in the posts could be helpful.

Anaphylaxis after COVID-19 vaccination: A registry-based study

Anaphylaxis after COVID-19 vaccination: A registry-based study

Abnormal uterine bleeding after receiving COVID-19 vaccine among female in Saudi Arabia

Introduction: The Coronavirus disease 2019 (COVID-19) vaccine has been approved by the United States Food and Drug Administration as safe and effective against the virus. In addition to the vaccine known adverse effects, a lot of women worldwide have experienced abnormal uterine bleeding (AUB) after receiving the COVID-19 vaccine. This study aimed to figure out the relationship between AUB and the COVID-19 vaccine and to compare the effects of different vaccine types on AUB. Methods: An e-questionnaire-based cross-sectional study conducted between December 2021 to February 2022. The targeted population of the study was all COVID-19 vaccinated female in Saudi Arabia. A total of 1912 respondents participated in the survey, only 1533 were eligible for inclusion in the study. The collected data were analyzed using descriptive statistical methods via Statistical Packages for Social Sciences version 26. Result: Out of 1533 participants, 998 (64.4%) reported AUB in relation to the COVID-19 vaccine. The mean age of the participants was 31.2±8.4 years, and more than half of them (59.4%) were married. Majority had received the Pfizer-BioNTech vaccine in their three shots (77.1%), (78%), and (92.1%), respectively. The incidence of AUB was (82.7%) mainly in form of menorrhagia (38.3%) in the first shot and (88.8%) after the second dose also in the form of menorrhagia (39.1%). Only 3.8% of women had the third dose, the incidence of AUB was 65.8%, mainly in the form of oligomenorrhea (21.1%). Regarding different types of the vaccine in three doses, the Chi-square test (p=0.239), (p=0.200) and Fischer exact test (p=0.265) were statistically significant showing no difference in AUB with different COVID-19 vaccines. Conclusion: The majority of participants had AUB as a result of receiving the COVID-19 vaccine. Furthermore, there was no difference in the incidence of AUB between the Pfizer-BioNTech vaccination and the AstraZeneca Oxford vaccine for the two vaccine types investigated in the study.

Effectiveness of Booster Dose of Anti SARS-CoV-2 BNT162b2 in Cirrhosis: Longitudinal Evaluation of Humoral and Cellular Response.

Background: LC has been associated with hyporesponsiveness to several vaccines. Nonetheless, no data on complete serological and B- and T-cell immune response are currently available. Aims: To assess, in comparison with healthy controls of the same age and gender, both humoral and cellular immunoresponses of patients with LC after two or three doses of the mRNA Pfizer-BioNTech vaccine against SARS-CoV-2 and to investigate clinical features associated with non-response. Material and methods: 179 patients with LC of CTP class A in 93.3% and viral etiology in 70.1% of cases were longitudinally evaluated starting from the day before the first dose to 4 weeks after the booster dose. Their antibody responses were compared to those of healthcare workers without co-morbidities. In a subgroup of 40 patients, B- and T-cell responses were also compared to controls. Results: At d31, d90 and d180 after BNT162b2 vaccine, no detectable SARS-CoV-2 IgG response was observed in 5.9%, 3.9% and 7.2% of LC patients as compared to 0 controls (p < 0.03). A delay in B-cell and lack of prompt T-cell response compared to healthcare workers was also registered. A significant correlation between antibody titers and cellular response was observed. A MELD score > 8 was the only independent predictor of poor d31 response (p = 0.028). Conclusions: Our results suggest that cirrhotic patients have a slower and in <10% suboptimal immune response to SARS-CoV-2 vaccination. Rates of breakthrough infections were comparable between cirrhotics and controls. The booster dose was critical in inducing both humoral and cellular responses comparable to controls.

N-Gram-Codon and Recurrent Neural Network (RNN) to Update Pfizer-BioNTech mRNA Vaccine

In the fight against SARS-CoV-2, Pfizer BioNTech based on synthetic messenger RNA (mRNA) proved to be quicker and more effective even with a small dose of micrograms per injection. Unfortunately, such a vaccine requires very low temperatures to prevent degradation of mRNA. In this paper, we have developed three new models of recurrent neural network (1- simple LSTM 2-BDLSTM 3-BERT) using n-gram-codon technique for the codification of mRNA. The primary aim is to analyse the mRNA sequence and predict the stability/reactivity rates at various codon positions. The results of the predictions will be presented in the form of recommendations to support laboratories in updating Pfizer's BioNTech vaccine. The obtained results were validated by the Stanford OpenVaccine dataset and the evaluation measures recall, precision, f1-score, accuracy and loss.

Risk of Myopericarditis After COVID-19 Vaccination in Danish Children Aged 5 to 11 Years.

Myopericarditis is a severe adverse event to COVID-19 vaccines.1 The highest risk has been reported in males aged 12-29 years.2-4 According to the US Vaccine Adverse Event Reporting System (VAERS), the risk in children aged 5-11 years is low with 11 reported cases following 8.7 million doses of Pfizer-BioNTech vaccine.5 However, these numbers may be underestimated due to underreporting.6.

Human IgG antibody responses to severe acute respiratory syndrome coronavirus 2 viral antigens receptor-binding domain, spike, and nucleocapsid, in vaccinated adults from Merida, Mexico.

Several vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been approved for controlling the coronavirus disease 2019 (COVID-19) pandemic worldwide. Antibody response is essential to understand the immune response to different viral targets after vaccination with different vaccine platforms. Thus, the main aim of this study was to describe how vaccination with two distinct SARS-CoV-2 vaccine preparations elicit IgG antibody specific responses against two antigenically relevant SARS-CoV-2 viral proteins: the receptor-binding domain (RBD) and the full-length spike (S). To do so, SARS-CoV-2 protein specific in-house enzyme-linked immunosorbent assays (ELISAs) were standardized and tested against serum samples collected from 89 adults, recipients of either a single-dose of the Spike-encoding mRNA-based Pfizer/BioNTech (Pf-BNT) (70%, 62/89) or the Spike-encoding-Adenovirus-5-based CanSino Biologics Inc. (CSBIO) (30%, 27/89) in Merida, Mexico. Overall, we identified an IgG seroconversion rate of 88% (68/78) in all vaccinees after more than 25 days post-vaccination (dpv). Anti-RBD IgG-specific responses ranged from 90% (46/51) in the Pf-BNT vaccine at 25 dpv to 74% (20/27) in the CSBIO vaccine at 42 dpv. Compared to the S, the RBD IgG reactivity was significantly higher in both Pf-BNT (p < 0.004) and CSBIO (p < 0.003) vaccinees. Interestingly, in more than 50% of vaccine recipients, with no history of COVID-19 infection, antibodies against the nucleocapsid (N) protein were detected. Thus, participants were grouped either as naïve or pre-exposed vaccinees. Seroconversion rates after 25 and more dpv varies between 100% in Pf-BNT (22/22) and 75% (9/12) in CSBIO pre-exposed vaccinees, and 89% (26/29) and 73% (11/15) in Pf-BNT and CSBIO naïve vaccine recipients, respectively. In summary, observed seroconversion rates varied depending on the type of vaccine, previous infection with SARS-CoV-2, and the target viral antigen. Our results indicate that both vaccine preparations can induce detectable levels of IgG against the RBD or Spike in both naïve and SARS-CoV-2 pre-exposed vaccinees. Our study provides valuable and novel information about the serodiagnosis and the antibody response to vaccines in Mexico.

Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years

Limited postauthorization safety data for the Pfizer-BioNTech coronavirus disease 2019 vaccination among children ages 5 to 11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the United States coronavirus disease 2019 vaccination program in this age group. We analyzed data from 3 United States safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system comanaged by the Centers for Disease Control and Prevention and Food and Drug Administration; and the Vaccine Safety Datalink, an active surveillance system that monitors electronic health records for prespecified events, including myocarditis. Among 48 795 children ages 5 to 11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7578 adverse event reports; 97% were nonserious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in boys after dose 2 (reporting rate 2.2 per million doses). In the Vaccine Safety Datalink, no safety signals were detected in weekly sequential monitoring after administration of 726 820 doses. Safety findings for Pfizer-BioNTech vaccine from 3 United States monitoring systems in children ages 5 to 11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12 to 15 years.

SARS-CoV-2 S1-RBD IgG and IL-6 serum level reduction after 120 days (4 months) of the second dose of Pfizer–BioNTech vaccine administration to the medical students in the University of Diyala

Background: SARS-CoV-2 mRNA vaccines such as Pfizer–BioNTech have confirmed a high efficiency; however, there is a limitation of data existence about the duration of immune responses and their relation to age and side effects. The aim of this study is to estimate the SARS-CoV-2 S1-RBD IgG level after 30 days (1 month) and 120 days (4 months) of the second dose of Pfizer–BioNTech vaccine administered to the medical students of the University of Diyala. Methods: The study was conducted after the approval of the Medical College of Al-Iraqia University, the Medical College of the University of Diyala, and the Iraqi Ministry of Health. We selected 45 students from the Medical College of the University of Diyala randomly who were fully vaccinated (two doses of Pfizer–BioNTech vaccine, 0.5 ml of the vaccine for each dose), and they agreed to give 5 ml of their blood twice (after 1 month and 4 months), which was carried out in the Higher Education Laboratory inside the Medical College, University of Diyala. The period of sample collection was 5 months (from September 2021 until February 2022). A serological analysis to measure SARS-CoV-2 S1-RBD IgG was done by using Diasino, SARS-CoV-2 S1-RBD IgG ELISA Kit, China, which was carried out in the Higher Education Laboratory, inside the Medical College, University of Diyala. Demographic data were taken from the study participants (age and gender). The same individuals of the study were divided into two groups according to the time frame (1 month and 4 months) after the second dose of the Pfizer–BioNTech vaccine administration. For statistical analysis, we used SPSS version 26 and STATISTICA version 12 to input, check, and analyze data. For qualitative variables, standard approaches of frequencies and percentages were used, whereas for quantitative variables, mean and standard deviation were used. A P-value of less than 0.05 was considered as significant for SARS CoV-2 S1-RBD IgG plasma levels. Results: The study found that the male–female ratio was 17.8: 82.2, and the mean of the age of the vaccinated students was 20.977 years. The serum quantities of SARS-CoV-2 S1-RBD IgG and IL-6 levels post second dose of the Pfizer–BioNTech vaccine after 30 days (1 month) and 120 days (4 months) were shown to be statistically non-parametric. Using the independent two-sample Mann–Whitney test, a significant difference (P &lt; 0.05) was observed for SARS-CoV-2 S1-RBD IgG and IL-6 levels between 120 days (4 months) after the second dose of the Pfizer–BioNTech vaccine and 30 days (1 month). Conclusion: SARS-CoV-2 S1-RBD IgG and IL-6 levels decreased significantly after 120 days (4 months) of the second dose of Pfizer–BioNTech vaccination.