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In a report in the journal Science of the directors of America’s largest health institutes and leaders of the development effort. effective vaccines, establishes the basic strategic principles of vaccine development for him crown. Professors of the Therapeutic Clinic of the Faculty of Medicine of the National and Kapodistrian University of Athens. Efstathios Kastritis and Thanos Dimopoulos (Rector of EKPA) summarized the basic data of the publication.
In a comment signed by the Director of the National Institutes of Health (NIH) Francis S. Collins, MD, Ph.D., the Director of the National Institute of Allergy and Infectious Diseases (NIAID) Anthony S. Fauci, MD, or Professor from the Department of Vaccines and Infectious Diseases at the Fred Hutchinson Cancer Research Center in Seattle Lawrence Corey, MD, and John R. Mascola, MD, Director of the NIAID Vaccine Research Center. The main challenges of developing effective vaccines for the new coronavirus are listed below.
1. The first problem that the researchers raised is The relatively limited knowledge we have about the immune response to the coronavirus. Patient data show relatively high levels of immune responses after infection, however, we do not have data on the type or level of immunity required to protect against disease recurrence or the potential duration of this protection.
2. The security it is a primary target for any widely used vaccine. The researchers also cited the theoretical risk that vaccination could make subsequent SARS-CoV-2 infection more severe due to an asymmetric (excessive) immune response. They then developed in detail four specific points of specific vaccines. The first is the endpoint on which clinical trials of vaccine development should be based.
Main end points Determining the effectiveness of a vaccine is (i) protection against infection and (ii) prevention of symptomatic and especially serious diseases (eg, requiring hospitalization in the ICU). Vaccination should be evaluated in both young and old populations, as well as other vulnerable groups.
As it stands out, Reduction of clinically “severe” disease is difficult to assess since it is estimated that 20-40% of COVID-19 cases are asymptomatic infections and lack of exact knowledge of infection incidence rates. Also emphasized is the need for reliable serological tests (i.e., reliable antibody tests) and the ability to distinguish the immune response resulting from vaccination against the immune response resulting from infection. Regarding controlled clinical trials, in which a small number of volunteers are vaccinated and then exposed to SARS-CoV-2, the researchers are quite negative (unlike the WHO, which recently established this perspective to accelerate the growth of vaccines).
The second important question raised by the authors is choosing the most suitable vaccine development platform, that is, the type of vaccine. It is encouraging that several different types of vaccines are undergoing clinical evaluation. These include vaccines with recombinant proteins, with or without viral replication, and approaches that use DNA and mRNA. Each of these vaccine platforms has advantages and limitations.
Important features include speed and flexibility of construction, safety and induction of a satisfactory immune response, chemical and cellular immunogenicity profile, duration of immunity, scale and cost of construction, stability of the vaccine. The most likely scenario is that no single vaccine or vaccine platform can meet all of the world’s needs on its own. They are currently undergoing clinical trials or starting clinical trials on nucleic acid-based vaccines (from Moderna, BioNTech / Pfizer, CuraVac (development of mRNA-based vaccine) and Inovio (development of DNA-based vaccine).
Vaccines with administration recombinant protein The virus develops in Sanofi and Novavax. The adenovirus virus vaccine is being developed by Janssen Pharmaceuticals, with recombinant chimpanzee adenovirus (ChAdOx1), developed by the University of Oxford and AstraZeneca, and transported by VSV de Mer. According to the authors, we will need more than one type of vaccine to meet the different needs that may exist in different parts of the world and in different populations (for example, younger than older, special vulnerable groups, etc.).
The A third important issue concerns the necessary strategic partnerships between private and academic state agencies and other organizations worldwide and not local. They also highlighted the need to develop main harmonized protocols so that a transparent evaluation of the relative effectiveness of each vaccine is possible. This harmonization can best be achieved through public-private partnerships, in which central public laboratories and independent biostatistics will be the primary evaluators of effectiveness.
Highlight the need for data to be communicated between companies and to be provided for an independent statistical evaluation. The last issue that the authors have emphatically raised is the need for mass production of vaccines, which will require a commitment to the crown vaccine production capacity of almost everyone. They emphasize the need to finance the infrastructure needed for vaccine production and point out possible obstacles to possible vaccine delivery, including costs, distribution systems, and possible special storage requirements.
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