Dataset Information

Lead SARS-CoV-2 Candidate Vaccines: Expectations from Phase III Trials and Recommendations Post-Vaccine Approval.

ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted primarily through respiratory droplets/aerosols and it causes COVID-19. The virus infects epithelial cells by using the spike protein on its surface to bind to angiotensin-converting enzyme 2 receptor on the cells. Thus, candidate vaccines targeting the spike protein are currently being developed to prevent against infections. Approximately 44 SARS-CoV-2 candidate vaccines are in clinical trials (phase I-III) and an additional 164 candidates are in preclinical stages. The efficacy data from phase I/II trials of lead candidate vaccines look very promising with virus-neutralizing geometric mean antibody titers in the range of 16.6-3906. Most recently, two SARS-CoV-2 candidate vaccines, BNT162b2 and mRNA-1273, have been granted the first emergency use authorization (EUA) in the U.S.; BNT162b2 has also been granted an EUA in the United Kingdom, Canada, and in the European Union. This review assesses whether SARS-CoV-2 candidate vaccines (with approved EUA or in phase III trials) meet the criteria for an ideal SARS-CoV-2 vaccine. The review concludes with expectations from phase III trials and recommendations for phase IV studies (post-vaccine approval).

SUBMITTER: Tumban E

PROVIDER: S-EPMC7824305 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Lead SARS-CoV-2 Candidate Vaccines: Expectations from Phase III Trials and Recommendations Post-Vaccine Approval.

Tumban Ebenezer E

Viruses 20201231 1

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted primarily through respiratory droplets/aerosols and it causes COVID-19. The virus infects epithelial cells by using the spike protein on its surface to bind to angiotensin-converting enzyme 2 receptor on the cells. Thus, candidate vaccines targeting the spike protein are currently being developed to prevent against infections. Approximately 44 SARS-CoV-2 candidate vaccines are in clinical trials (phase I-III) and an addi ...[more]

PMID: 33396343

Similar Datasets

Project description:Very young children (under 2 years old) have high risk for influenza-related complications. Children 6 months or older in the US are recommended to receive influenza vaccination annually, yet uptake is substantially lower than other routinely-recommended vaccines. Existing nationally-representative studies on very young child influenza vaccine uptake has several limitations: few examine provider-verified influenza vaccination (relying on parental report), few contain parental vaccine attitudes variables (known to be crucial to vaccine uptake), and none to our knowledge consider intersectionality of social disadvantage nor how influenza vaccine determinants differ from those of other recommended vaccines. This nationally-representative study examines provider-verified data on 7,246 children aged 6-23 months from the most recent (2011) National Immunization Survey to include the restricted Parental Concerns module, focusing on children up-to-date on a series of vaccines (the 4:3:1:3:3:1:4 series) but not influenza vaccines ("hidden vulnerability to influenza"). About 71% of children were up-to-date on the series yet only 33% on influenza vaccine recommendations by their second birthday; 44% had hidden vulnerability to influenza. Independent of parental history of vaccine refusal and a myriad of health services use factors, no parental history of delaying vaccination was associated with 7.5% (2.6-12.5) higher probability of hidden vulnerability to influenza despite being associated with 15.5% (10.8-20.2) lower probability of being up-to-date on neither the series nor influenza vaccines. Thus, parental compliance with broad child vaccine recommendations and lack of vaccine hesitancy may not indicate choice to vaccinate children against influenza. Examination of intersectionality suggests that maternal college education may not confer improved vaccination among non-Hispanic Black and Hispanic children despite that it does for non-Hispanic White children. Policymakers and researchers from public health, sociology, and other sectors need to collaborate to further examine how vaccine hesitancy and intersectional social disadvantage interact to affect influenza vaccine uptake in young US children.

Project description:Nowadays, the vaccination with COVID-19 vaccines is being promoted worldwide, professionals and common people are very concerned about the efficacy and safety of COVID-19 vaccines. No published systematic review and meta-analysis has assessed the efficacy and safety of the COVID-19 vaccines based on data from phase III clinical trials. Therefore, this study has estimated the efficacy and safety of COVID-19 vaccines and the differences between vaccine types. PubMed, Embase, the Cochrane Library, CNKI, Wanfang, medRxiv databases and two websites were used to retrieve the studies. Random-effects models were used to estimate the pooled efficacy and safety with risk ratio (RR). A total of eight studies, seven COVID-19 vaccines and 158,204 subjects were included in the meta-analysis. All the vaccines had a good preventive effect on COVID-19 (RR = 0.17, 95% CI: 0.09-0.32), and the mRNA vaccine (RR = 0.05, 95% CI: 0.03-0.09) was the most effective against COVID-19, while the inactivated vaccine (RR = 0.32, 95% CI: 0.19-0.54) was the least. In terms of safety, the risk of overall adverse events showed an increase in the vaccine group after the first (RR = 1.46, 95% CI: 1.03-2.05) or second (RR = 1.52, 95% CI: 1.04-2.20) injection. However, compared with the first injection, the risk of local (RR = 2.64, 95% CI: 1.02-6.83 vs. RR = 2.25, 95% CI: 0.52-9.75) and systemic (RR = 1.33, 95% CI: 1.21-1.46 vs. RR = 1.59, 95% CI: 0.84-3.01) adverse events decreased after the second injection. As for the mRNA vaccine, the risk of overall adverse events increased significantly, compared with the placebo, no matter whether it was the first (RR = 1.83, 95% CI = 1.80-1.86) or the second (RR = 2.16, 95% CI = 2.11-2.20) injection. All the COVID-19 vaccines that have published the data of phase III clinical trials have excellent efficacy, and the risk of adverse events is acceptable. The mRNA vaccines were the most effective against COVID-19, meanwhile the risk and grade of adverse events was minimal, compared to that of severe symptoms induced by COVID-19.

Dataset Information

Lead SARS-CoV-2 Candidate Vaccines: Expectations from Phase III Trials and Recommendations Post-Vaccine Approval.

Publications

Lead SARS-CoV-2 Candidate Vaccines: Expectations from Phase III Trials and Recommendations Post-Vaccine Approval.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure