Efficacy and Safety of AZD1222, BNT162b2 and mRNA-1273 vaccines against SARS-CoV-2

2021 ◽  
Vol 5 (1) ◽  
pp. 791-796
Author(s):  
Ilir Alimehmeti
Keyword(s):  
Clinical Trials ◽  
Diagnostic Tests ◽  
Web Of Science ◽  
Rapid Development ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Vaccine Candidates ◽  
Genetic Sequence ◽  
Phase Iii Clinical Trials ◽  
Clinical Trial Results

SARS-CoV-2, the beta coronavirus causing COVID-19, was isolated and categorizes as a novel one on January 7th, 2020 in China.[1] To date, official reports depict that SARS-CoV-2 has already infected 88.828.387 persons and caused 1.926.625 deaths worldwide.[2] On January 12th, 2020, China officials made public its genetic sequence, thus paving the way towards the research and development of diagnostic tests and vaccines. With regard to vaccination, e large number of clinical trials were designed and are currently undergoing, of which 189 are listed in ClinicalTrials.gov. [3] However, up to date, only three vaccines have published their respective phase III clinical trial results in peer-reviewed medical journals. [4-6] Vaccines are needed to reduce the morbidity and mortality associated with Covid-19, and multiple vaccine platforms as AZD1222 (AstraZeneca) [4], BNT162b2 (Pfizer/BioNTech) [5] and mRNA-1273 (Moderna) have been involved in the rapid development of vaccine candidates. Methodology: In this review, PubMed, Embase, Web of Science, Scopus, medRxiv, and bioRxiv were systematically scrutinized for peer-reviewed and preprint articles on phase III clinical trials of vaccines against SARS-CoV-2. In total, only three peer-reviewed papers fulfilling the search criteria were identified. Conclusions; All vaccine candidates should publish in peer-reviewed journals their efficacy and safety well before requesting approval to the national or international authorities…

scholarly journals Low immunogenicity of tocilizumab in patients with rheumatoid arthritis

2016 ◽  
Vol 76 (6) ◽  
pp. 1078-1085 ◽  
Author(s):  
Gerd R Burmester ◽  
Ernest Choy ◽  
Alan Kivitz ◽  
Atsushi Ogata ◽  
Min Bao ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Safety Study ◽  
Phase Iii Clinical Trials ◽  
Injection Site Reactions ◽  
Antidrug Antibody

ObjectiveSubcutaneous (SC) and intravenous formulations of tocilizumab (TCZ) are available for the treatment of patients with rheumatoid arthritis (RA), based on the efficacy and safety observed in clinical trials. Anti-TCZ antibody development and its impact on safety and efficacy were evaluated in adult patients with RA treated with intravenous TCZ (TCZ-IV) or TCZ-SC as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).MethodsData from 5 TCZ-SC and 8 TCZ-IV phase III clinical trials and 1 TCZ-IV clinical pharmacology safety study (>50 000 samples) were pooled to assess the immunogenicity profile of TCZ-SC and TCZ-IV (8974 total patients). The analysis included antidrug antibody (ADA) measurement following TCZ-SC or TCZ-IV treatment as monotherapy or in combination with csDMARDs, after dosing interruptions or in TCZ-washout samples, and the correlation of ADAs with clinical response, adverse events or pharmacokinetics (PK).ResultsThe proportion of patients who developed ADAs following TCZ-SC or TCZ-IV treatment was 1.5% and 1.2%, respectively. ADA development was also comparable between patients who received TCZ monotherapy and those who received concomitant csDMARDs (0.7–2.0%). ADA development did not correlate with PK or safety events, including anaphylaxis, hypersensitivity or injection-site reactions, and no patients who developed ADAs had loss of efficacy.ConclusionsThe immunogenicity risk of TCZ-SC and TCZ-IV treatment was low, either as monotherapy or in combination with csDMARDs. Anti-TCZ antibodies developed among the small proportion of patients had no evident impact on PK, efficacy or safety.

Concordance between abstracts, virtual meeting (VM) presentations, and final publication of phase III clinical trials presented at the Annual Meeting of the American Society of Clinical Oncology.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6622-6622 ◽  
Author(s):  
Suneil Kumar Khanna ◽  
Matthew John Boyko ◽  
Daniel Yick Chin Heng ◽  
Michael M. Vickers ◽  
Vincent Channing Tam
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Annual Meeting ◽  
Primary Endpoint ◽  
Statistical Significance ◽  
Phase Iii ◽  
Key Comparisons ◽  
Inclusion Criteria ◽  
Phase Iii Clinical Trials ◽  
Clinical Trial Results

6622 Background: Phase III clinical trial results described in abstracts in the ASCO Annual Meeting Proceedings often differ from final results seen in publication. We hypothesize that the abstracts may act only as place holders, while the results presented at the ASCO Annual Meeting are more highly concordant with the final publication. Methods: A retrospective review of all abstracts submitted to the ASCO Annual Meeting in 2005 to 2007 was conducted. Inclusion Criteria: randomized, prospective phase III clinical trials of greater than 200 patients with at least one quantitative primary endpoint such as OS or PFS. For each abstract, we viewed the VM presentation and searched Pubmed and Medline for the corresponding publications. Data regarding the clinical trials was extracted from all three sources and statistical comparisons were made. Results: A total of 7,900 abstracts were screened from the ASCO 2005 and 2007 Annual Meetings, of which 124 met the inclusion criteria. An additional 43 studies were excluded due to absence of either a VM presentation or publication. The majority (96%) of these trials were presented as either an oral presentation or poster discussion. Key comparisons of the concordance between the abstract or VM presentation and the final publication are shown in the Table below. Conclusions: While the statistical significance of the primary endpoint and conclusions from all three sources are very similar, the results reported in VM presentations at ASCO Annual Meetings are a better representation of the final publication compared to the abstract. When relying on clinical trial results from these meetings to change clinical practice, physicians should refer to the VM presentation rather than the abstract. [Table: see text]

scholarly journals Tofacitinib in the treatment of ulcerative colitis: efficacy and safety from clinical trials to real-world experience

2019 ◽  
Vol 12 ◽  
pp. 175628481984863 ◽  
Author(s):  
Ferdinando D’Amico ◽  
Tommaso Lorenzo Parigi ◽  
Gionata Fiorino ◽  
Laurent Peyrin-Biroulet ◽  
Silvio Danese
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Real Life ◽  
Oral Formulation ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Treatment Algorithms ◽  
Phase Iii Clinical Trials ◽  
Real Life Data ◽  
Three Phase

Tofacitinib is an oral small molecule directed against the JAK/STAT pathway, blocking the inflammatory cascade. Oral formulation of tofacitinib has recently been approved for the treatment of patients with moderate–severe ulcerative colitis. Its efficacy and safety have been demonstrated in three phase III clinical trials and confirmed by promising real-life data. The purpose of this review is to summarize the available evidence on the efficacy and safety of tofacitinib and to define its role and position in the treatment algorithms for patients with ulcerative colitis.

Immunogenicity and Safety Profile of COVID-19 Vaccines- A Systematic Review (Preprint)

2020 ◽  
Author(s):  
Reeju Maharjan ◽  
Aditya Bamboria ◽  
Neelam Asghar ◽  
Manish Shrestha ◽  
Syed W H Rizvi
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Systematic Reviews ◽  
Neutralizing Antibodies ◽  
Phase Iii ◽  
Effective Vaccine ◽  
Efficacy And Safety ◽  
Vaccine Candidates ◽  
One Year ◽  
Meta Analyses

BACKGROUND An effective vaccine will be important in controlling severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. OBJECTIVE In this study, we aim to analyze the degree of immunogenicity that rises after administering different vaccines, and to study their efficacy. METHODS We systematically reviewed multiple vaccine candidates at different stages of clinical trials to prevent Coronavirus disease in 2019 (COVID-19). We reviewed literature from four major electronic databases (PubMed, MEDLINE, PubMed Central, and Google scholar) to identify studies on SARS-CoV-2 vaccine candidates. This article included studies that include clinical trials in multiple stages and systematic reviews published in 2020. We performed a quality assessment with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for our articles. RESULTS We included a total of 19 articles. This review article has a total of 24,342 individuals. These studies show promising results regarding vaccines candidates, safety profiles, and immunogenicity with the effective generation of neutralizing antibodies and specific T-cell responses. Adverse effects range from mild to moderate, with no serious adverse effects reported. It is unclear how long the generated immunity will last, and a follow up of the study participants for an extended one-year period will be needed. CONCLUSIONS Ascertaining vaccines' efficacy and safety in vulnerable populations is essential for the general use of vaccine use. A number of these vaccines are currently under phase III or to enter phase III and may increase vaccines' efficacy and safety in different populations.

scholarly journals COVID-19: Insights into Potential Vaccines

2021 ◽  
Vol 9 (3) ◽  
pp. 605
Author(s):  
Ke-Yan Loo ◽  
Vengadesh Letchumanan ◽  
Hooi-Leng Ser ◽  
Siew Li Teoh ◽  
Jodi Woan-Fei Law ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Viral Vector ◽  
Phase Iii ◽  
Effective Vaccine ◽  
Pharmaceutical Companies ◽  
Protein Subunit ◽  
Subunit Vaccines ◽  
Vaccine Candidates ◽  
Phase Iii Clinical Trials ◽  
Positive Results

People around the world ushered in the new year 2021 with a fear of COVID-19, as family members have lost their loved ones to the disease. Millions of people have been infected, and the livelihood of many has been jeopardized due to the pandemic. Pharmaceutical companies are racing against time to develop an effective vaccine to protect against COVID-19. Researchers have developed various types of candidate vaccines with the release of the genetic sequence of the SARS-CoV-2 virus in January. These include inactivated viral vaccines, protein subunit vaccines, mRNA vaccines, and recombinant viral vector vaccines. To date, several vaccines have been authorized for emergency use and they have been administered in countries across the globe. Meanwhile, there are also vaccine candidates in Phase III clinical trials awaiting results and approval from authorities. These candidates have shown positive results in the previous stages of the trials, whereby they could induce an immune response with minimal side effects in the participants. This review aims to discuss the different vaccine platforms and the clinical trials of the candidate vaccines.

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