Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review DOI Creative Commons
Cindra Tri Yuniar,

Bhekti Pratiwi,

Ardika Fajrul Ihsan

и другие.

Vaccines, Год журнала: 2022, Номер 10(2), С. 313 - 313

Опубликована: Фев. 17, 2022

Assessing the quality of evidence from vaccine clinical trials is essential to ensure safety and efficacy further enhance public acceptance. This study aims summarize critically evaluate harm reporting on randomized controlled for COVID-19 determine factors associated with quality. We systematically searched literature using PRISMA guidelines (RCT) Vaccine until 30 December 2021. Published articles were electronic databases such as PubMed, Science Direct, Google Scholar, Bibliovid. Bias analysis was performed RoB-2 tools. The assessed by Consolidated Standards Reporting Trials (CONSORT) extension modified into 21 items. A total 61 RCT studies (402,014 patients) analyzed. Over half demonstrated adequate (59.02%), (34.4%) reported a low risk bias. All death serious adverse events (AEs), but only six mentioned how handle recurrent AEs. AEs in subgroup also poor (25%). RCTs less biased good based CONSORT extension. However, must be considered, especially balance information between effectivity safety.

Язык: Английский

Efficacy and safety of COVID-19 vaccines DOI
Carolina Graña, Lina Ghosn, Theodoros Evrenoglou

и другие.

Cochrane library, Год журнала: 2022, Номер 2023(3)

Опубликована: Дек. 7, 2022

Язык: Английский

Процитировано

267

Evaluation of the safety profile of COVID-19 vaccines: a rapid review DOI Creative Commons

Qianhui Wu,

Matthew Z. Dudley, Xinghui Chen

и другие.

BMC Medicine, Год журнала: 2021, Номер 19(1)

Опубликована: Июль 28, 2021

The rapid process of research and development lack follow-up time post-vaccination aroused great public concern about the safety profile COVID-19 vaccine candidates. To provide comprehensive overview vaccines by using meta-analysis technique.

Язык: Английский

Процитировано

215

Administration of COVID-19 vaccines in immunocompromised patients DOI Open Access
Manica Negahdaripour, Mojtaba Shafiekhani, Seyed Mohammad Iman Moezzi

и другие.

International Immunopharmacology, Год журнала: 2021, Номер 99, С. 108021 - 108021

Опубликована: Июль 28, 2021

Язык: Английский

Процитировано

72

Advances in the design and development of SARS-CoV-2 vaccines DOI Creative Commons
Xue‐Liang Peng,

Ji‐Si‐Yu Cheng,

Hai‐Lun Gong

и другие.

Military Medical Research, Год журнала: 2021, Номер 8(1)

Опубликована: Дек. 16, 2021

Abstract Since the end of 2019, coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome 2 (SARS-CoV-2) has spread worldwide. The RNA genome SARS-CoV-2, which is highly infectious and prone to rapid mutation, encodes both structural nonstructural proteins. Vaccination currently only effective method prevent COVID-19, proteins are critical targets for vaccine development. Currently, many vaccines in clinical trials or already on market. This review highlights ongoing advances design prophylactic therapeutic against including viral vector vaccines, DNA live-attenuated inactivated virus recombinant protein bionic nanoparticle vaccines. In addition traditional some novel based vectors, nanoscience synthetic biology also play important roles combating COVID-19. However, challenges persist trials.

Язык: Английский

Процитировано

69

An overview on inactivated and live‐attenuated SARS‐CoV‐2 vaccines DOI
Saeed Khoshnood,

Maniya Arshadi,

Sousan Akrami

и другие.

Journal of Clinical Laboratory Analysis, Год журнала: 2022, Номер 36(5)

Опубликована: Апрель 14, 2022

Abstract After about 2 years since severe acute respiratory syndrome coronavirus (SARS‑CoV‑2), first infections were detected in Wuhan city of China December 2019, which was followed by a worldwide pandemic with record 5.41 million deaths. Due to urgent need for the development safe and effective vaccine disease 2019 (COVID‐19), attempts producing efficient vaccines are inexhaustibly continuing. According report World Health Organization (WHO) on COVID‐19 tracker landscape, there 149 candidates all over world. Inactivated SARS‐CoV‐2 as conventional platform consist whole virus particles grown cell culture inactivated chemicals. Because benefits such antigenic similarity real virion inducing humoral cellular immune responses ease transport storage, these vaccines, including produced Bharat Biotech, Sinopharm, Sinovac, use at large scales. In this study, we have review that passing their phase 3 4 clinical trials, population included producers, efficiency, adverse effects, components other features.

Язык: Английский

Процитировано

65

A systematic review on mucocutaneous presentations after COVID‐19 vaccination and expert recommendations about vaccination of important immune‐mediated dermatologic disorders DOI
Farnoosh Seirafianpour, Homa Pourriyahi, Milad Gholizadeh Mesgarha

и другие.

Dermatologic Therapy, Год журнала: 2022, Номер 35(6)

Опубликована: Март 22, 2022

With dermatologic side effects being fairly prevalent following vaccination against COVID-19, and the multitude of studies aiming to report analyze these adverse events, need for an extensive investigation on previous seemed urgent, in order provide a thorough body information about post-COVID-19 immunization mucocutaneous reactions. To achieve this goal, comprehensive electronic search was performed through international databases including Medline (PubMed), Scopus, Cochrane, Web science, Google scholar July 12, 2021, all articles regarding manifestations considerations after COVID-19 vaccine administration were retrieved using keywords: vaccine, dermatology manifestations. A total 917 records final number 180 included data extraction. Mild, moderate, severe potentially life-threatening events have been reported with COVID vaccines, case reports, series, observational studies, randomized clinical trials, further recommendations consensus position papers vaccination. In systematic review, we categorized results detail into five elaborate tables, making what believe be extensively informative, unprecedented set topic. Based our findings, viewpoint pros cons vaccination, mostly non-significant, self-limiting reactions, more uncommon moderate guidelines could great importance those at higher risks specific worries flare-ups or inefficient immunization, sufficient safely schedule their doses, avoid if they discussed contra-indications.

Язык: Английский

Процитировано

54

Global prevalence and clinical manifestations of cutaneous adverse reactions following COVID‐19 vaccination: A systematic review and meta‐analysis DOI Creative Commons
Chanudda Washrawirul, Jidapa Triwatcharikorn, Jeerath Phannajit

и другие.

Journal of the European Academy of Dermatology and Venereology, Год журнала: 2022, Номер 36(11), С. 1947 - 1968

Опубликована: Июнь 6, 2022

Although vaccination is widely accepted as an effective method of preventing and controlling the COVID-19 pandemic, many people are concerned about possible cutaneous side-effects, which can delay or prevent them from being vaccinated. The objectives this systematic review were to assess global prevalence clinical manifestations adverse reactions following vaccination. PubMed Scopus databases searched for articles published 1 January 2019 31 December 2021, reference lists each selected article screened. Case reports, case series, observational studies randomized controlled trials that provided information on vaccines included. A total 300 included in a 32 with 946 366 participants meta-analysis. pooled was 3.8% (95% CI, 2.7%-5.3%). based mRNA platform had higher than other platforms at 6.9% 3.8%-12.3%). Various have been reported injection site reactions, most common (72.16%) uncommon such delayed inflammatory tissue filler (0.07%) flares pre-existing dermatoses (0.07%). Severe anaphylaxis also reported, but rare cases (0.05%). In conclusion, common, especially those receiving vaccines. Most mild not contraindications subsequent except anaphylaxis, rarely occurs. may be associated filler. Patients history allergies, skin conditions scheduled injections should receive additional precounselling monitoring. better understanding potential side-effects strengthen public confidence wary new vaccine technologies.

Язык: Английский

Процитировано

39

Recent developments in SARS‐CoV‐2 vaccines: A systematic review of the current studies DOI
Mona Sadeghalvad, Amir Hossein Mansourabadi, Maryam Noori

и другие.

Reviews in Medical Virology, Год журнала: 2022, Номер 33(1)

Опубликована: Май 1, 2022

Abstract Designing and manufacturing efficient vaccines against coronavirus disease 2019 (COVID‐19) is a major objective. In this systematic review, we aimed to evaluate the most important under construction worldwide, their efficiencies clinical results in healthy individuals those with specific underlying diseases. We conducted comprehensive search PubMed, Scopus, EMBASE, Web of Sciences by 1 December 2021 identify published research studies. The inclusion criteria were publications that evaluated immune responses safety COVID‐19 pre‐existing also searched VAERS database estimate incidence adverse events special interest (AESI) post vaccination. Almost all investigated well tolerated developed good levels both humoural cellular responses. A protective response develops after second or third dose vaccine longer interval (about 28 days) between first injections could induce higher antibody less immunogenic immunocompromised patients, particularly haematological malignancies. addition, found venous arterial thrombotic events, Bell's palsy, myocarditis/pericarditis common AESI. showed potency SARS‐CoV‐2 protect subjects disease. provision further effective safe necessary order reach high coverage immunisation programs across globe provide protection infection itself.

Язык: Английский

Процитировано

33

Variants of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Vaccine Effectiveness DOI Creative Commons
SubbaRao V. Tulimilli,

Siva Dallavalasa,

Chaithanya G. Basavaraju

и другие.

Vaccines, Год журнала: 2022, Номер 10(10), С. 1751 - 1751

Опубликована: Окт. 19, 2022

The incidence and death toll due to SARS-CoV-2 infection varied time-to-time; depended on several factors, including severity (viral load), immune status, age, gender, vaccination presence of comorbidities. RNA genome has mutated produced variants, which were classified by the Interagency Group (SIG) into four major categories. first category; “Variant Being Monitored (VBM)”, consists Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Epsilon (B.1.427, B.1.429), Eta (B.1.525), Iota (B.1.526), Kappa (B.1.617.1), Mu (B.1.621), Zeta (P.2); second “Variants Concern” Omicron (B.1.1.529). third fourth categories include Interest (VOI)”, High Consequence (VOHC)”, respectively, contain no variants currently under these surge in VBM VOC poses a significant threat public health globally as they exhibit altered virulence, transmissibility, diagnostic or therapeutic escape, ability evade host response. Studies have shown that certain mutations increase infectivity pathogenicity virus demonstrated case SARS-CoV-2, variant. It is reported variant >60 with at least 30 Spike protein (“S” protein) 15 receptor-binding domain (RBD), resulting rapid attachment target cells evasion. spread VOCs affected actual protective efficacy first-generation vaccines (ChAdOx1, Ad26.COV2.S, NVX-CoV2373, BNT162b2). Currently, data effectiveness existing against newer are very scanty; hence additional studies immediately warranted. To this end, recent initiated investigations elucidate structural features crucial proteins their involvement pathogenesis. In addition, intense research progress develop better preventive strategies halt COVID-19 caused variants. This review summarizes structure life cycle provides background information associated reviews safety vaccines/vaccine candidates approved its

Язык: Английский

Процитировано

31

Humoral and cellular immunity and the safety of COVID-19 vaccines: a summary of data published by 21 May 2021 DOI Creative Commons
Kun Xu, Lianpan Dai, George F. Gao

и другие.

International Immunology, Год журнала: 2021, Номер 33(10), С. 529 - 540

Опубликована: Сен. 7, 2021

Coronavirus disease 2019 (COVID-19) has caused millions of deaths, and serious consequences to public health, economies societies. Rapid responses in vaccine development have taken place since the isolation severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) release viral genome sequence. By 21 May 2021, 101 vaccines were under clinical trials, published data available for 18 them. Clinical study results from some indicated good immunogenicity acceptable reactogenicity. Here, we focus on these that had dissect induced humoral cellular immune as well their safety profiles protection efficacy.

Язык: Английский

Процитировано

41