Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2–18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study

Vadrevu, Krishna Mohan; Reddy, Siddharth; Jogdand, Harsh; Ganneru, Brunda; Mirza, Nizam; Tripathy, Virendra Nath; Singh, Chandramani; Khalatkar, Vasant; Prasanth, Siddaiah; Rai, Sanjay; Ella, Raches; Blackwelder, William C.; Prasad, Sai; Ella, Krishna M.

doi:10.1016/s1473-3099(22)00307-3

Cited by 29 publications

(22 citation statements)

References 26 publications

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“…Of the 88 articles included, there were 12 RCTs, two non-randomized clinical trials, 40 cohort studies, 19 cross-sectional studies, and 15 case‒control studies. In the studies included, 16 articles were available for immunogenicity analysis (Supplementary Table 2) [ 14 , 15 , 18 , 31 – 43 ]; 38 articles were available for effectiveness analysis (Supplementary Table 3) [ 14 , 17 , 19 , 31 , 44 – 77 ]; and 49 articles were available for safety analysis (Supplementary Table 4) [ 14 – 16 , 18 , 20 – 24 , 31 , 34 , 35 , 37 , 41 , 43 , 45 , 47 , 50 , 55 , 78 – 107 ]. Children and adolescents are involved in 27 countries, including the United States, China, Australia, Argentina, Italy, Israel, France, Denmark, and South Korea, which have larger cohorts (> 100,000 people).…”

Section: Resultsmentioning

confidence: 99%

Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2–18 years: an updated systematic review and meta-analysis

et al. 2023

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Background During the coronavirus disease 2019 (COVID-19) pandemic, there is an urgent need for safe and effective COVID-19 vaccines to protect children and adolescents. This study aims to provide scientific evidence and recommendations for the application of COVID-19 vaccines in children and adolescents by analyzing the latest studies. Methods We systematically searched MEDLINE (accessed through PubMed), Embase, and Web of Science from January 1, 2020, to October 8, 2022. Eligible clinical trials, cohort studies, case‒control studies, and cross-sectional studies with extractable data were included in immunogenicity, effectiveness, and safety analyses. According to the heterogeneity, we chose a fixed-effect model (when I 2 ≤ 50) or a random-effects model (when I 2 > 50) to pool effect values. Results A total of 88 articles were included. The seroconversion rates after the first, second, and third doses of the vaccines were 86.10%, 96.52%, and 99.87%, respectively. After the first and second doses, vaccine effectiveness (VE) against severe acute respiratory syndrome coronavirus 2 infection was 42.87% [95% confidence interval (CI) = 27.09%–58.65%] and 63.33% (95% CI = 52.09%–74.56%), respectively. After the first and second doses, VE against COVID-19 was 60.65% (95% CI = 44.80%–76.50%) and 75.77% (95% CI = 63.99%–87.56%), respectively. VE against hospitalization due to COVID-19 after the first and second doses was 72.74% (95% CI = 51.48%–94.01%) and 82.78% (95% CI = 75.78%–89.78%), respectively. The most common adverse events were injection site pain, fatigue/asthenia/tiredness, headache, myalgia/muscle pain, and chills. The incidence rate of myocarditis or pericarditis was 2.42/100,000 people. In addition, the subgroup analysis showed that children aged ≤ 5 years had the lowest incidence of adverse events, and the incidence rate of adverse events was higher for mRNA vaccines than for inactivated vaccines. Conclusions COVID-19 vaccines have good immunogenicity, effectiveness, and safety among children and adolescents. We recommend that children and adolescents be vaccinated as soon as possible to protect them and slow the spread of COVID-19. Supplementary Information The online version contains supplementary material available at 10.1007/s12519-022-00680-9.

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Section: Resultsmentioning

confidence: 99%

Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2–18 years: an updated systematic review and meta-analysis

et al. 2023

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“…Similar to the adult COVID-19 vaccine trial for the safety and efficacy of different COVID-19 vaccines, the children's trial, also in different age groups, has been conducted globally and data have been encouraging. Although World Health Organization (WHO) has approved the Pfizer-BioNTech (BNT162b2) vaccine and Moderna for children vaccination with an efficacy of 90.7% (5-11 years) and 100.0% (12-17 years), India's covaxine vaccine shows 95-98% efficacy (2-18 years) and Soberana 02 of Cuba (92.4%), Sinopharma, and Sinovac vaccine also shows a high level of safety and efficacy among children (9,(81)(82)(83)(84)(85)(86). There are 18 studies (19, 21, 22, 26, 27, 36, 39, 40, 51, 56, 57, 60, 69, 72-74, 76, 78) which favor COVID vaccination in children in relation to safety, efficacy, and effectiveness, similarly 6 studies (5,23,30,70,71,75) were raising concern about vaccine safety, efficacy, and effectiveness.…”

Section: Vaccine Safety E Cacy and E Ectivenessmentioning

confidence: 99%

Do we need to vaccinate every child against COVID-19: What evidence suggests—A systematic review of opinions

Paul

Mishra

2022

Front. Public Health

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It is still debatable whether all children should receive the COVID-19 vaccine. The comparatively mild cases and low risk of COVID-19 in children compared to adults, as well as the lack of clarity on the relative effects of the disease and vaccine, indicate that the risk-benefit ratio of vaccination in children is more nuanced. To consider and highlight the complexity of policy decisions regarding COVID-19 vaccination in children, we outlined the points regarding for and against vaccination of children against COVID-19 in this systemic review. Using Medical Search Headings (MeSH) terms and keywords, we searched PubMed, PubMed Central, Scopus, and Google Scholar. The primary search term was COVID-19 vaccination (all synonyms), factors (all synonyms), and among children (all synonyms). A total of 367 articles were searched. Finally, 64 articles met the inclusion criteria and were included in the review. The major theme/tone of 28 (43.75%) articles was in favor of children's COVID vaccination, and they were highlighting the positive factors, whereas the major theme/tone of 20 (31.25%) articles was against it. Approximately 16 (25.0%) articles were in a neutral position. Major factors highlighted by articles in favor of childhood COVID vaccination were as follows: the increasing rate of disease burden (29 articles), prevention of interruption of academic activities of children or school reopening (24 articles), and a role in defense against COVID infection (21 articles). Major factors against childhood vaccination were as follows: mild infection among children (27 articles), ethical concerns and legal problems regarding the consent of minors (17 articles), and vaccine hesitancy among parents for childhood vaccination (11 articles). Whereas, factors of uncertainty were the role in the reduction of community transmission (19 articles), protection against MIS-C (10 articles), and defense against long COVID (7 articles). Considering all the factors of COVID-19 disease progression among children, a cautious approach will be essential before proceeding with COVID-19 vaccination in children.

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“…Table 8 presents the results regarding the correlation between the fluorescence value (Fluor) of UMELISA SARS-CoV-2 Antigen and cut-off index (COI) of STANDARD F COVID-19 Ag FIA with the cycle threshold (Ct) of RT-PCR. Interpreting diagnostic test values for COVID-19 is essential for clinicians, epidemiologists and microbiologists [20][21][22][23][24][25]. Ct is a semiquantitative value inversely related to the amount of RNA in the sample, so that a low Ct number is related to higher viral load and vice versa [4,5,12,15,21,26].…”

Section: Discussionmentioning

confidence: 99%

Performance of UMELISA SARS-CoV-2 antigen and STANDARD F COVID-19 in the diagnosis of COVID-19 in Villa Clara, Cuba

García¹,

Bermudez²,

Laveaga³

et al. 2022

GSC Biol. Pharm. Sci.

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A cross-sectional descriptive study was carried out with the objective of describing the performance of UMELISA SARS-CoV-2 Antigen and STANDARD F COVID-19 Ag FIA in the diagnosis of COVID-19, at the Provincial Laboratory of Microbiology and Sanitary Chemistry of Villa Clara, during the month of February 2022. 1056 patients who underwent Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) using the QIAcube HT genome extraction technique, UMELISA SARS-CoV-2 Antigen and STANDARD F COVID-19 Ag FIA were included. Sensitivity, specificity, positive and negative predictive value were calculated as efficacy indicators and Spearman's Rho coefficient for the correlation between variables. The result was that 29.3% were sick, of which 189 were female, with a median age of 46 years. 74.8% had symptoms, most often fever, cough and runny nose. UMELISA SARS-CoV-2 Antigen showed higher specificity with 97.45%; while STANDARD F COVID-19 Ag FIA had higher sensitivity with 99.35%. It was shown that there is a significant inverse correlation between the RT-PCR cycle threshold and the fluorescence values of both techniques studied (p=0.000). About a third of the patients studied were sick with symptoms, with a predominance of females. UMELISA SARS-CoV-2 Antigen turned out to be more useful in confirming the presence of the disease, while STANDARD F COVID-19 Ag FIA showed better performance in ruling out the presence of the disease.

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Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2–18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study

Cited by 29 publications

References 26 publications

Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2–18 years: an updated systematic review and meta-analysis

Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2–18 years: an updated systematic review and meta-analysis

Do we need to vaccinate every child against COVID-19: What evidence suggests—A systematic review of opinions

Performance of UMELISA SARS-CoV-2 antigen and STANDARD F COVID-19 in the diagnosis of COVID-19 in Villa Clara, Cuba

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