ABSTRACT
Since the onset of the COVID-19 pandemic, there has been a significant surge in interest of COVID-19 vaccines in particular, and other traditional vaccines in general. This strong interest is expected to continue as the industry strives to manufacture safer and more effi cacious vaccines against COVID-19 and other infectious diseases. Vaccines are a unique class of products, being biologicals that are administered to healthy individuals to prevent diseases. The equitable distribution and availability of safe, efficacious and good quality vaccines are of utmost importance in preventing and controlling infections and safeguarding public health. The continued existence of poor- quality vaccines suggests a lack of control of manufacturing, storage, distribution, and possibly, their associated regulation. Nonetheless, all these situations - whether positive or negative, present opportunities for improvements. As regulatory authorities step up efforts in regulating existing traditional vaccines, advancements in vaccine research and development churn out novel vaccines that pose further manufacturing and regulatory challenges. This manuscript provides an overview of vaccines, both traditional and novel, and strives to identify challenges in the manufacture, storage, distribution, handling and their associated regulation. It also evaluates whether current regulatory frameworks are adequate, and where applicable, recommends areas for improvements. International harmonization and convergence of national regulatory framework with the view to facilitate quicker approval of safe, efficacious and good quality vaccines, that are accessible and affordable to patients worldwide, are also explored.
ABSTRACT
Today there are multiple types of flu vaccines. The emergence of nucleic acid technology used in vaccines against SARS-CoV-2 suggests its future application against this infection. Against influenza, two types of vaccines have been developed based on messenger RNA (mRNA): conventional or non-replicative and self-amplifying or replicative (auRNA), both included in lipid nanoparticles. Animal studies carried out with the former have shown their strong capacity to induce Th-1 antibodies and cellular immunity against influenza haemagglutinin (HA) with few side effects. Human trials have shown 87% seroconversion and 100% seroprotection. The auRNA vaccines have obtained similar results in animals but at a concentration 64 times lower than the conventional one. Vaccines based on mRNA platforms meet the WHO requirements for next generation influenza vaccines.
ABSTRACT
Today there are multiple types of flu vaccines. The emergence of nucleic acid technology used in vaccines against SARS-CoV-2 suggests its future application against this infection. Against influenza, two types of vaccines have been developed based on messenger RNA (mRNA): conventional or non-replicative and self-amplifying or replicative (auRNA), both included in lipid nanoparticles. Animal studies carried out with the former have shown their strong capacity to induce Th-1 antibodies and cellular immunity against influenza haemagglutinin (HA) with few side effects. Human trials have shown 87% seroconversion and 100% seroprotection. The auRNA vaccines have obtained similar results in animals but at a concentration 64 times lower than the conventional one. Vaccines based on mRNA platforms meet the WHO requirements for next generation influenza vaccines.
ABSTRACT
INTRODUCTION: Quantitative thorax Computed Tomography (CT) is used to determine the severity of COVID-19 pneumonia. With a new approach, quantitative thoracic CT is to contribute to the triage of patients with severe COVID-19 pneumonia in the ICU and to evaluate its relation with mortality by taking into account the vaccination status. METHODS: Fifty-six patients who had a diagnosis of COVID-19 pneumonia confirmed in the adult ICU were evaluated retrospectively. To evaluate the degree of parenchymal involvement, the quantitative CT "craniocaudal diameter of the thorax/craniocaudal largest lesion diameter (CCDT/CCDL)" ratio and semi-quantitative total CT severity scores (TCTSS) (0:0%; 1:1-25%; 2:26-50%; 3:51-75% and 4:76-100%) were calculated. Both methods were analyzed with comparative ROC curves for predicting mortality. The effects of vaccines on thorax CT findings and laboratory parameters were also investigated. RESULTS: The sensitivities and specificities were found to be 72.5%, 75.61%, and 80%, 73.33% when CCDT/CCDL and TCTSS cutoff value was taken <1.4, and >9, respectively, to predict mortality in COVID-19 pneumonia (Area Under the Curve = AUC = 0.797 and 0.752). Both methods predicted mortality well and no statistical differences were detected between them (p = 0.3618). In vaccinated patients, CRP was higher (p = 0.045), and LDH and ferritin were lower (p = 0.049, p = 0.004). The number of lobes involved was lower in the vaccinated group (p = 0.001). CONCLUSIONS: The quantitative CT score (CCDT/CCDL) may play as important a role as TCTSS in diagnosing COVID-19 pneumonia, determining the severity of the disease, and predicting the related mortality. COVID-19 vaccines may affect laboratory parameters and cause less pneumonia on thoracic CT than in unvaccinated individuals.
Subject(s)
COVID-19 , Adult , Humans , COVID-19/diagnostic imaging , SARS-CoV-2 , Length of Stay , Retrospective Studies , COVID-19 Vaccines , Tomography, X-Ray Computed/methods , Thorax/diagnostic imaging , Intensive Care Units , Lung/diagnostic imagingABSTRACT
With the exponential rise in infections by CoV-2 and the scarcity of antiviral therapeutics, the development of an effective vaccine for the SARS CoV-2 is critical. The emerging pandemic has prompted the international science community to seek answers in therapeutic agents, including vaccines, to battle the SARS CoV-2. The various scientific literature on SARS CoV, to a lesser degree, MERS (Middle East Respiratory Syndrome), has mentored vaccine techniques for the unique Coronavirus. This disease, COVID-19, is triggered by SARS-CoV-2 virus that causes COVID-19 that needs vaccine protection. Vaccines producing significant amounts of virus-neutralizing antibodies with high affinity may be the only way to combat infection while avoiding negative consequences. There is a summary of numerous vaccine contenders in the review, including nucleotide, vector-based vaccines, & subunit, and attenuated & killed types. That has previously shown preventive effects against the MERS-CoV & SARS-CoV, while suggesting that these candidates may yield a safe and efficient vaccine for SARS-CoV-2. Vector-based vaccines, monoclonal antibodies, genetic vaccines, and protein subunit types for passive immunization are among the vaccination platforms currently being evaluated for the CoV-2 virus;each has its own set of benefits and drawbacks. The clinical safety and effectiveness evidence is the main challenging research task for this possible vaccine developed in the lab. The most challenging aspect of production is constructing and validating distribution platforms worthy of mass-producing the vaccine on a larger scale. Since target vaccine groups include high-risk people above the age of 60, including severe co-morbid diseases, the healthcare staff, and those engaged in vital industries, an effective COVID-19 vaccine would need a careful confirmation of effectiveness and detrimental reactivity. The study summarises efforts devoted to developing an efficient vaccine for the new Coronavirus that devastated the global economy, people's health, and even their lives.
ABSTRACT
The Japanese government implemented a large-scale vaccination policy against the coronavirus disease 2019 (COVID-19) pandemic, primarily using messenger RNA vaccines in 2021. Its hallmark was prioritized vaccination for the elderly after healthcare workers in a short period of time. Vaccination for the elderly, vulnerable to infection and severe disease, was carried out rapidly in approximately 4 months since April 2021. We evaluated the impact of Japan's vaccination policy against COVID-19 during the pandemic, with a particular focus on how prioritized vaccination for the elderly affected the pandemic. We observed a remarkable decrease in the number of infections, cluster events in long-term care facilities, and severe disease among the elderly during the fifth wave (August 2021) despite rising incidence of infections in the overall population. In conclusion, we think that prioritized vaccination for the elderly was efficacious in preventing infections and severe COVID-19 among the elderly during the fifth wave in Japan.
ABSTRACT
Background: Vaccination against Coronavirus disease 2019 (COVID-19) is an important means of controlling the pandemic, however they are expected to stimulate immune responses when administered to confer immunity. In this review, we evaluated the clinical and laboratory features associated with BNT162b2 messenger RNA COVID-19 vaccine, Ad26.COV2.S and ChAdOx1 adenoviral vector COVID-19 vaccines, to determine their immunogenicity. Demographic distribution of pathogenic autoimmune response and time interval between vaccination and onset of symptoms were also assessed. This was to identify; persons at risk of developing auto-immune reactions and markers to enhanced occurrence of this event. Main body: Using relevant keywords, search was conducted in the databases of PubMed, Scopus, Web of Science and Google scholar from November 2020 to May 31, 2021. Additional article was also identified through hand-searching of reference lists, and the review was conducted in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines 2009. Study outcome measures were presence of antibodies after vaccination and evidence of autoimmune reactions, therefore studies relating these measures were considered eligible for this review. Studies showed stimulation of immune response with administration of BNT162b2 mRNA vaccine, ChAdOx1 and Ad26.COV2-S adenovirus vector-based vaccines. Aside SARS-CoV-2 spike protein antibodies, elevated D-dimers, presence of PF4 and low fibrinogen were most commonly seen laboratory features in persons with autoimmune reactions following vaccination. In addition, thrombotic thrombocytopenia was the commonest clinical features observed with ChAdOx1 and Ad26.COV2-S adenovirus vector-based vaccines. Findings from this study also suggest higher susceptibility of women of 22-60 years to the pathogenic immunogenicity that may particular result from exposure to ChAdOx1 and Ad26.COV2-S adenovirus vector-based vaccines. Time interval of 4-37 days was mostly observed between vaccination and occurrence of a symptom. Conclusion: Immune thrombotic thrombocytopenia and other PF4 dependent syndrome are likely associated with ChAdOx1 and Ad26.COV2.S adenovirus vector vaccines, mostly occurring in women usually within 4-37 days of first dose of vaccine. Enhanced knowledge about vaccine adverse effects and its distribution is crucial for effective vaccination strategies.
ABSTRACT
Publication indicates that antiviral therapies are definitely more harmful and less effective as well as less accessible than vaccinations. Antiviral therapies are generally not effective in phase II and III of the disease. The use of antiviral therapies in all patients would doom them to many side effects, and only 10% of patients go from phase I to phase II and require such treatment. The chance of curing COVID-19 patients in phase II and III of the disease is rapidly declining. Vaccinations, on the other hand, are very effective. Confirmed AEFI are rare and intensive research is underway to elucidate their etiopathogenesis. From a biotechnological point of view, vaccination leads to the production of CAR-T-like immunotherapy or monoclonal antibodies, that work from the 1st day of infection, not from the first day of symptom onset, when patients can start some pharmacological therapy. In the case of COVID-19, a clear advantage of vaccination over pharmacological therapy has emerged. Nevertheless, because vaccination may not be effective for all patients, working on therapy should also be intensively carried out. Proper pharmacotherapy administration depends on the quick cooperation of diagnosticians with doctors. It also depends on the development of tests to select therapies and determine in whom a disease such as COVID-19 will change from phase I to phase II. Vaccinated patients will probably respond better to treatments.