Safety and Immunogenicity of COVID-19 BBIBP-CorV Vaccine in Children 3–12 Years Old

Background and Objectives: In the current COVID-19 pandemic, children below the age of 12 could manifest COVID-19 symptoms and serve as a reservoir for the virus in the community. The present study was conducted to evaluate the reactogenicity, and immunogenicity of BBIBP-CorV, prior to involving this age group in the vaccination program in the kingdom of Bahrain. Subjects and Methods: The study included 582 children from 3 to 12 years old of Bahraini and non-Bahraini nationality, all of which contributed to the reactogenicity study. Of those, 401 contributed to the immunogenicity study. All children received 2 doses of BBIBP-CorV inactivated virus 3 weeks apart. To assess reactogenicity, children were followed up for 5 weeks to evaluate any vaccine-related adverse events (AE). To assess immunogenicity, blood was collected on day 0 and day 35 to assess antibody titer against S, N, and neutralizing antibody. Results: Of the 582 participants, (45.4%) were female, (54.61%) were male, with 49% in 9–12 age group. Of the 401 children contributing to the immunogenicity study, 274 (68.3%) had no prior exposure to COVID-19. The overall incidence of AE was 27.7%. No significant difference was found among different age groups. The most frequent AE was local (at the injection site) and occurred in 16% of children, followed by fever in 9.3%. No serious adverse events were reported. The Seroconversion rate was 100% among children with no prior exposure to COVID-19. Children with previous COVID-19 exposure had higher averages of anti-S (2379 U/mL compared to 409.1), anti-N (177.6 U/mL compared to 30.9) and neutralizing antibody (93.7 U/mL compared to 77.1) than children with no prior exposure at day 35. Conclusions: Two doses of COVID-19 BBIBP-CorV on the subjects aged between 3 to 12 has good safety and tolerance and can induce an effective immune response and neutralizing antibody titer

Evaluation of rapid antigen tests using nasal samples to diagnose SARS-CoV-2 in symptomatic patients

Introduction: The best way to mitigate an outbreak besides mass vaccination is via early detection and isolation of infected cases. As such, a rapid, cost-effective test for the early detection of COVID-19 is required.Methods: The study included 4,183 mildly symptomatic patients. A nasal and nasopharyngeal sample obtained from each patient was analyzed to determine the diagnostic ability of the rapid antigen detection test (RADT, nasal swab) in comparison with the current gold-standard (RT-PCR, nasopharyngeal swab).Results: The calculated sensitivity and specificity of the RADT was 82.1 and 99.1%, respectively. Kappa's coefficient of agreement between the RADT and RT-PCR was 0.859 (p Conclusion: Our study's results support the potential use of nasal swab RADT as a screening tool in mildly symptomatic patients, especially in patients with higher viral loads.</p

Safety and immunogenicity of COVID-19 BBIBP-CorV vaccine in children 3-12 years old

Background and objectives: In the current COVID-19 pandemic, children below the age of 12 could manifest COVID-19 symptoms and serve as a reservoir for the virus in the community. The present study was conducted to evaluate the reactogenicity, and immunogenicity of BBIBP-CorV, prior to involving this age group in the vaccination program in the kingdom of Bahrain.Subjects and methods: The study included 582 children from 3 to 12 years old of Bahraini and non-Bahraini nationality, all of which contributed to the reactogenicity study. Of those, 401 contributed to the immunogenicity study. All children received 2 doses of BBIBP-CorV inactivated virus 3 weeks apart. To assess reactogenicity, children were followed up for 5 weeks to evaluate any vaccine-related adverse events (AE). To assess immunogenicity, blood was collected on day 0 and day 35 to assess antibody titer against S, N, and neutralizing antibody.Results: Of the 582 participants, (45.4%) were female, (54.61%) were male, with 49% in 9-12 age group. Of the 401 children contributing to the immunogenicity study, 274 (68.3%) had no prior exposure to COVID-19. The overall incidence of AE was 27.7%. No significant difference was found among different age groups. The most frequent AE was local (at the injection site) and occurred in 16% of children, followed by fever in 9.3%. No serious adverse events were reported. The Seroconversion rate was 100% among children with no prior exposure to COVID-19. Children with previous COVID-19 exposure had higher averages of anti-S (2379 U/mL compared to 409.1), anti-N (177.6 U/mL compared to 30.9) and neutralizing antibody (93.7 U/mL compared to 77.1) than children with no prior exposure at day 35.Conclusions: Two doses of COVID-19 BBIBP-CorV on the subjects aged between 3 to 12 has good safety and tolerance and can induce an effective immune response and neutralizing antibody titer.</div

Evaluation of an adjusted MEWS (Modified Early Warning Score) for COVID-19 patients to identify risk of ICU admission or death in the Kingdom of Bahrain

Background: While most COVID-19 cases have uncomplicated infection, a small proportion has the potential to develop life-threatening disease, as such development of a prediction tool using patients baseline characteristics at the time of diagnosis should aid in early identification of high-risk groups and devise pertinent management. Hence, we set up this retrospective study to determine preadmission triaging tool to predict the development of severe COVID-19 in the Kingdom of Bahrain Materials and methods: A retrospective study was conducted from 1 September 2020 to 30 November 2020 with enrolment of all SARS-CoV-2 PCR-confirmed persons aged ≥ 14 years who attended Al-Shamil Field Hospital (SFH) in the Kingdom of Bahrain for triaging and assessment with recording of the following parameters: systolic blood pressure, heart rate, respiratory rate, temperature, the alert, verbal, pain, unresponsive neurological score, age, oxygen saturation, comorbidities, Body Mass Index (BMI), duration of symptoms and living with immunocompromised populations to develop our local adjusted MEWS as predictor for ICU admission &amp; for consideration of suitable isolation at home.Follow up data of all patients was obtained from the electronic medical records system including CXR findings, treatments/medications received, need of oxygen supplements /intubation, needs of ICU care, and the outcome (death /discharged alive)IBM SPSS statistic version 21 program was used for data analysis. Results: Our study showed that using the locally developed adjusted MEWS score, there was an significant association between high value of this adjusted MEWS score and abnormal radiographic finding (49.7 % Vs. 17 % for patients with high score Vs. those with low score respectively). Out of the 181 patients with high scores on adjusted MEWS; 38.7 % required oxygen via nasal cannula, 14.4 % required face mask and 8.3 % non-rebreather mask; this proportion was significantly higher than their counterpart patients who score low on adjusted MEWS (20.9 %, 7.7 %, 4.8 %respectively) with statistically significance difference between the two groups (p value of 0.00, 0.00,.004 respectively)Requirement of ICU admission was significantly higher among patients with high score in comparison to those with low score (14.4 % vs. 3 %) with significant p value (0.00)But higher score value was not associated significantly with increase mortality rate among COVID patients. Conclusion: Development of our new Adjusted MEWS score system by adding the additional elements of age, oxygen saturation, comorbidities, Body Mass Index (BMI) and duration of symptoms found to be very useful predictor tool for preadmission triaging of COVID patients based on their risk assessment to help clinician to decide on the appropriate placement to different level of isolation facilities

Safety and efficacy of COVID-19 prime-boost vaccinations: homologous BBIBP-CorV versus heterologous BNT162b2 boosters in BBIBP-CorV-primed individuals

Background: Booster vaccine doses against SARS-CoV-2 have been advocated to address evidence of waning immunity, breakthrough infection, and the emergence of immune-evasive variants. A heterologous prime-boost vaccine strategy may offer advantages over a homologous approach, but the safety and efficacy of this approach with the mRNA vaccine BNT162b2 (BNT: Pfizer) and inactivated BBIBP-CorV (BBIBT: Sinopharm) vaccines have not been studied. Methods: We conducted a non-randomized, non-blinded phase II observational community trial across Bahrain, investigating the reactogenic and immunogenic response of participants who had previously received two doses of BBIBP, followed by a third booster dose of either BBIBP (homologous booster) or BNT (heterologous booster). Immunogenicity through serological statuswas determined at baseline and on the following 8th week. Reactogenicity data (safety and adverse events) were collected throughout study period, in addition to participant-led electronic journaling. Results: 305 participants (152 BBIBP and 153 BNT booster) were enrolled in the study,with 246 (127 BBIBP and 119 BNT booster) included in the final analysis. There was a significant increase in anti-SARS-CoV-2 antibody levels post booster administration in both groups; however, the heterologous BNT arm demonstrated a significantly larger mean increase in the level of spike (S) antigen-specific antibodies (32.7-fold increase versus 2.6, p Conclusion: Heterologous prime-boost vaccination with the mRNA BNT162b2 (Pfizer) vaccine in those who had received two doses of inactivated virus BBIBP-CorV (Sinopharm) vaccine demonstrated a more robust immune response against SARS-CoV-2 than the homologous BBIBP booster and appears safe and well tolerated. Clinical Trial Registry Number (ClinicalTrials.gov): NCT04993560.</p

IS STRESS A RISK FACTOR FOR HEMORRHOIDS IN ELDERLY PATIENTS?

Background: The incidence of hemorrhoids requiring medical attention among the elderly has been increasing. This study aimed to determine stress as a risk factor for hemorrhoids among elderly patients. Methods: A cross sectional study needs to be carried out to understand emotional stress as the risk factor for hemorrhoids. The study population is older people with conditions of hemorrhoids. The participants for this cross sectional study are older patients of age 45 to 65, with higher incidences of hemorrhoids. A total of 40 patients with hemorrhoids have been included in the study. The risk factors and the clinical symptoms related to the incidence of hemorrhoids were documented and analyzed. Results: The study included 306 participants from elderly population. Participants reported suffering from hemorrhoid since once a year (n= 105, 34.3%) and once every more than one year (n= 105, 34.3%). There were 82 participants reported that there is a tissue coming out of the rectum at the time of bowel movement (26.8%). Among these participants, 43 of them mentioned that it goes back spontaneously while 39 of them had to push it back. The most frequent symptom among study participants was bleeding (n= 95, 31%). More than half of study participants were stressful before having hemorrhoids (n= 194, 63.4%). Furthermore, 172 participants think that they are facing digestive issues more often since they are stressed (56.2%). More than one third of study participants had signs of constipation prior to stressful feeling (n= 109, 35.6%). Conclusion: The current study showed that participants were complaining from hemorrhoids since a year. Some of them reported tissue coming out from rectum. The most frequent symptom was bleeding and the most frequent symptom during stress was abdominal cramps. More than half of participants were stressed prior to the diagnosis of hemorrhoids. Larger cohort studies are encouraged to confirm the current observation