scholarly journals Vaccination against COVID-19 in Ukraine. Safety of Vaccines

2021 ◽  
Vol 6 (6) ◽  
pp. 200-206
Author(s):  
N. O. Iakovenko ◽  
◽  
M. V. Ogloblina ◽  
O. K. Nuzhna

COVID-19 is a life-threatening disease that can be asymptomatic in the form of a common ARVI, or in extremely severe forms, with serious long-term consequences. Vaccination against COVID-19 is critically important to restrain the pandemic. The purpose of the study was to analyze and systematize the data of pharmacological supervision of the use of vaccines against COVID-19. For this, methods of analysis, systematization and generalization of information were used using the databases of the State Expert Center of the Ministry of Health of Ukraine, Food and Drug Administration, World Health Organisation in the period from February 24, 2021 to October 31, 2021. Currently, such vaccines are registered and approved for use in Ukraine as AstraZeneca (Covishield, SKBio), Comirnaty / Pfizer-BioNTech, Moderna, CoronaVac / Sinovac Biotech. According to official data, the effectiveness of all these vaccines is quite high. They are especially effective in preventing severe course of disease, hospitalization, and death. Sometimes the vaccination process can be with the development of a number of side effects. Responsibility for the risks associated with the production and use of vaccines dictates the need for constant monitoring of these side effects. That is why we analyzed the data of the State Expert Center of the Ministry of Health of Ukraine about adverse events after immunization from COVID-19 in Ukraine. Thus, the analysis of adverse events reported showed that they took place in 0.018% cases of the total number of vaccine doses that were administered. In the context, for each vaccine separately, the number of adverse events reported were: Covishield – 1128 cases (0.23%), CoronaVac – 419 (0.008%), Comirnaty – 854 (0.02%), AstraZeneca – 540 (0.02%), Moderna – 393 (0.02%), respectively. It should be noted that most of the reported cases of adverse events reported in Ukraine during vaccination against COVID-19 are mild predictable reactions (88.72 – 93.38%). This result allows us to speak of a fairly high predictability of the adverse events reported after COVID-19 vaccination. This is confirmed by the data of world literature. After analyzing the presented data of the State Expert Center of the Ministry of Health of Ukraine, we found that the most of adverse events reported after COVID-19 vaccination are so-called general disorders and disorders at the injection site (fever, fatigue, chills, redness, pain and swelling at the injection site). Neurological disorders ranked second in terms of the number of adverse events reported, and musculoskeletal disorders ranked third. Adverse events reported manifestations from other organs and systems had isolated cases. After using all of the above vaccines, the percentage of adverse events reported was significantly higher in women than in men, which coincides with the data of the world literature. Conclusion. Thus, the analysis of the safety of vaccines against COVID-19, registered and authorized for use in Ukraine, shows that the risks of adverse events reported after COVID-19 vaccination are rare; the most of them are mild and predictable. At the same time, these manifestations of adverse events reported cannot be compared with the health and life risks associated with the COVID-19 disease itself. Ensuring continuous monitoring of the safety of vaccine use and identifying potential side effects will further reduce and manage the risks associated with vaccine use

2021 ◽  
Author(s):  
Khrystyna Hrynkevych

Vaccines are extremely effective public health tools which can dramatically improve the health of populations and individuals. Physicians who administer vaccines should familiarize themselves with the indications and contraindications of the specific product they use as well as its licensed and recommended dosing and schedules. Informed consent must be obtained according to local rules and regulations. Manufacturer requirements for shipping, handling, and storage should be followed to assure that the vaccine remains effective and safe for use. Different vaccines are administered by different routes – whether ID, SC, IM, or orally. The appropriate route should always be used as per the package insert. Vaccines do have side effects; most common are fever and reactions (pain, swelling, tenderness) at the injection site. These are usually mild, transient, and easily treated symptomatically. Providers should counsel vaccine recipients to anticipate such events. Care should be taken not to inappropriately attribute adverse events following immunization (AEFIs) to the respective vaccine as AEFIs can occur by chance (without immunization) as well. Anaphylaxis can be caused by all vaccines, but it is very rare. However, since it can be rapidly life-threatening, vaccinators must be prepared to treat this emergency.


Author(s):  
Joshua A. Sloan ◽  
Philip O. Katz

The medical and lay literature has exploded with reports of adverse events associated with proton pump inhibitors over the last 10 to 15 years. The dissemination of these reports to patients and clinicians have created substantial concerns regarding what has been an exceptionally valuable drug class, dramatically improving patient quality of life, and in many cases preventing life threatening side effects of other medication. Patients are more frequently seeking to avoid these medications, and practitioners are reducing or discontinuing them to the patient’s detriment due to a misunderstanding of the data. This review will discuss the data regarding the most commonly publicized adverse events and attempt to put them in perspective.


F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 243 ◽  
Author(s):  
Jacob Puliyel ◽  
Pathik Naik

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as “consistent with causal association with vaccine”, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is “no other factor intervening in the processes.” Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.


Author(s):  
Sheema Sabahath ◽  
Hussain Salah AL Sinan ◽  
Asalah Tariq Alsaigh ◽  
Rawan AlSalamah AlFadhli ◽  
Tahani Salman Al Mansour ◽  
...  

Ovarian torsion is among the gynecological life-threatening conditions that may require urgent surgical intervention among the appearance of clinical manifestations. The most common clinical manifestations include severe abdominal pain, nausea extending to vomiting. The ovarian torsion is not limited to children only. However, it can also occur in adult females, either pregnant or non-pregnant. The etiology of the disease tends to be related to the weakness of the uterine ligaments or malpositioning of it due to known and unknown causes. Despite that, the surgical intervention is needed to release the torsion. Sometimes, it can lead to adverse events or side effects such as decreased blood flow to the surrounding structures. Which by role may lead to unpleasant complications and clinical manifestations of hemorrhage and shock. In this article, we reviewed the topic of ovarian torsion from different aspects, including the definition, causes, clinical evaluation, and clinical management and its common complications.


2020 ◽  
Vol 5 ◽  
Author(s):  
Syazana Fauzi

This study seeks to ascertain the state actor dynamics in Brunei’s healthcare policies from the perspectives of an Islamic system of governance, by first identifying the state actors, or institutions, involved in influencing, formulating and implementing Brunei’s healthcare policies. The ‘IGC Matrix’ is employed to establish the Islamic health ‘sets of expectations’ (SoEs), particularly in terms of prevention and treatment, and medical ethics, primarily derived from the Qur’ān and Prophet Muhammadﷺ’s Sunnah, in order to construct for this study a framework of reference. The SoEs are then compared against Brunei’s healthcare policies and activities to determine how much of the Islamic health SoEs are met. This study reveals that Brunei’s healthcare policies are largely motivated by non-Islamic inspirations, specifically by the World Health Organisation (WHO), but with numerous overlaps with Islamic demands. In other words, Brunei’s healthcare policies may be stemmed from a non-Islamic influence, but it does not necessarily mean that they are un-Islamic. And most, if not all, of Brunei’s healthcare policies demonstrate a top-down approach, where the state actors play a crucial role in shaping Brunei’s dynamical SoEs.


2020 ◽  
Vol 49 (9) ◽  
pp. 661-668
Author(s):  
Alvin HY Lo ◽  
Adrian CL Kee ◽  
Andrew Li ◽  
Francesca Rubulotta

Sepsis is life-threatening and might potentially progress from dysregulation to severe organ dysfunction. It is recognised by the World Health Organisation as a global health priority. The mortality rate for sepsis has decreased in many countries, and this is credited to the earlier recognition and treatment of this complex syndrome. In 2002, the Surviving Sepsis Campaign was launched, and there have been several revisions to the sepsis recommendations therefrom. The latest sepsis guidelines focus on viral as well as bacterial infections, and advise that initiating resuscitation and management should take place within one hour from when sepsis is initially suspected. Numerous studies and guidelines pertaining to sepsis management have been published over the past 2 decades. The use of novel therapies and alternative adjunctive therapies has tremendous potential in sepsis management. Debates amongst intensivists exist with the creation of updated sepsis guidelines and advances in treatment. The present review article provides both a summary and recommendations based on the latest clinical evidence and controversies around sepsis management. Key words: Critical Care Medicine, Intensive Care Medicine, Respiratory Medicine, Sepsis, Sepsis Bundles, Sepsis Management


2018 ◽  
Vol 31 (2) ◽  
pp. 65-68
Author(s):  
Justyna Pasternak ◽  
Ewa Kliszczewska ◽  
Malgorzata Polz-Dacewicz

Abstract Polyomavirus (PyV) was discovered by accident in 1950 in the course of describing an infectious factor causing multiple tumours in rodents. The term is derived from two Greek words: poly (many) and oma (tumour). At present the family of human polyomaviruses (HPyV) consists of 10 members. One of the first members was BK virus, isolated in 1971 from the urine of a renal transplant patient. Serological examinations have shown that due to its ability to cause latent infection, about 90% of the general population can have specific antibodies attesting infection. In the case of infected persons with normal immunity, this virus is not dangerous. In the impaired immunity, however, loss of immunity results in virus reactivation and development of many life-threatening illnesses. Serological examinations have also reveal that BK polyomavirus considerably affects the development of cancers in humans. Hence, in 2012 a group of 26 researchers from 11 countries associated with the International Agency for Research on Cancer (a part of the World Health Organisation) classified BK polyomavirus within group 2B - “potentially carcinogenic to humans”


Author(s):  
І. О. Федяк ◽  
І. І. Іванюлик

<p><strong>Introduction.</strong> World Health Organization is worried about poor children vaccination inUkraine. After the signing of the coalition agreement between the main political parties, which were held into the Ukrainian Parliament of VII convocation, representatives of WHO and UNICEF welcomed «the inclusion of conditions of vaccines procurement together with international partners and organizations in the coalition agreement, and reaffirmed their willingness to purchase and contribute in response to corresponding request of the Ministry of Health care of Ukraine». However, coordinated decisions were not accepted. And the overall condition of financing the health care system and the Program of immunization as its component does not comply with the WHO’s requirements.</p><p><strong>Methods of research:</strong> bibliographical, analytical, systematic and logical.</p><p><strong>Results and discussion.</strong> According to the immunization Schedule in Ukraine, 10 infectious diseases, such as diphtheria, pertussis, rubeola, rubella, epidemic parotitis, polio, tetanus, tuberculosis, hemophilic infection, hepatitis B are subordinated to prevention by vaccination. Vaccines against these diseases in accordance with the law of Ukraine № 1645-14 «On protection of population against infectious diseases» are centrally purchased on a single state tender held by the Ministry of Health care of Ukraine. Nowadays, it is currently completing the implementation of current National program of immunization and population protection against infectious diseases for 2009-2015, which was adopted by the Law of Ukraine № 1658-VI, dated on 21<sup>st</sup> October, 2009.</p><p>The problem of infectious diseases immunization must be strategic in any socio-political circumstances of country’s life. However, according to analysis of the state funding of the health care system ofUkraineas in general and as its component – system of immunization inUkrainetraditionally faced a shortage of funds, along with the low cost effectiveness. This tendency has occurred not only in the current military conflict, but also has become a disappointing practice. So, the percentage of financing costs on the health care system from the State budget has traditionally been at the level of 3,7% of GDP and covers about 57% of the total population needs. However, the analysis of audits materials of the Accounting chamber of Ukraine shows that projected amount of funding from the State budget of the Program on immunization during 2009-2015 variances with the real allocations in 2011-2013 inaverage of 45,3%. Along with this, the conclusions of the Accounting chamber for 2007-2013, Ministry of health care traditionally does not provide efficient use of available funds of the State budget. This led to the fact that it was failed to reduce the level of infections, against which is held by means of immunization. This is demonstrated by the vaccination coverage of the population in 2014 at a level from 15 to 49% depending on infectious disease by the WHO recommendations – 95 %.</p><p><strong>Conclusions:</strong> reform of the Program of immunization financing must firstly focus on improving the efficiency of spending, particularly through the reform of sector procurement that is offered like in many countries to conduct through the mediation of WHO and UNICEF through the «framework» (directly long-term) agreements with suppliers of vaccines. And it already needs not declarative, but real political freedom.</p>


Author(s):  
Rishabh Dhabalia

The COVID-19 pandemic has spread its terror globally for over a year now. There is no continent that has been spared by this scourge. And perhaps a few small countries with no reported cases. Regardless, it is an irrefutable fact that this novel coronavirus pandemic has shaken the pillars of human civilization. For those unaware or living under a rock since the past year or so, the disease is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. The first cases were reported to the World Health Organisation as a cluster of pneumonia from unknown causes from Wuhan, China on the 31st December, 2019. And, thus began its reign of terror, spreading across the world, like hot cakes sold out in a carnival. That being said, humanity has suffered a lot at the hands of the pandemic. Innumerous deaths, sufferings, unending lockdowns and curfews, social problems, people losing their livelihoods and the list goes on. It is, thus, easy to give in to the mood of gloom and doom with all that is going on around us. However, just as with anything, there is a side too, that is scarcely talked about. There have also been some positive impacts of this pandemic that one couldn’t have foreseen beforehand. So, without further ado, below we have covered a few positive side effects of this curse of a pandemic!


2015 ◽  
Vol 2 (4) ◽  
pp. G25-G27 ◽  
Author(s):  
Vishal Sharma ◽  
Susan Alderton ◽  
Helen McNamara ◽  
Richard Steeds ◽  
Will Bradlow ◽  
...  

The World Health Organisation (WHO) launched the Surgical Safety Checklist in 2008. The introduction of this checklist resulted in a significant reduction in the incidence of complications and death in patients undergoing surgery. Consequently, the WHO Surgical Safety checklist is recommended for use by the National Patient Safety Agency for all patients undergoing surgery. However, many invasive or interventional procedures occur outside the theatre setting and there are increasing requirements for a safety checklist to be used prior to such procedures. Transoesophageal echocardiography (TOE) is an invasive procedure and although generally considered to be safe, it carries the risk of serious and potentially life-threatening complications. Strict adherence to a safety checklist may reduce the rate of significant complications during TOE. However, the standard WHO Surgical Safety Checklist is not designed for procedures outside the theatre environment and therefore this document is designed to be a procedure-specific safety checklist for TOE. It has been endorsed for use by the British Society of Echocardiography and the Association of Cardiothoracic Anaesthetists.


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