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1.
Exp Clin Transplant ; 20(4): 342-354, 2022 04.
Article in English | MEDLINE | ID: covidwho-1744699

ABSTRACT

Due to the emergency nature of the pandemic, many anti-COVID-19 vaccines were rushed ahead into testing through emergency-use authorization, leading to questionable accuracy of data with regard to the short and long-term efficacy and safety and time span of immune protection of these vaccines. Several scientifically founded concerns, along with many questions, have been raised with no clear answers as to whether these vaccines will have the same efficacy across different populations, among distinct regions, and for any emerging new variants. These concerns are coupled with the variable levels of preventive, therapeutic, and protective measures, such as the recent imposition of the sanitary pass in some but not all countries. Given the lack of a universal policy in its application, the recently reported short-lived vaccine-induced protective immunity of a few months duration, the consequent growing number of newly diagnosed COVID-19 cases in the most vaccinated countries, the equal spread of the Delta variant among vaccinated and unvaccinated individuals, the significantly lesser virulence of the Delta variant as reflected by the lower rate of hospitalization and death, and the recent admission by the US Centers of Disease Control and Prevention of the poor specificity of the COVID-19 polymerase chain reaction diagnostic panel in detection of SARS-CoV-2, this scientifically unfounded sanitary pass, based on recently emerging data from the most vaccinated countries, not only seems obsolete but can also be regarded as a tool of indirect coercion, forcing vaccination on those who may be vaccine prudent, therefore jeopardizing the essence of an individual's freedom of choice that is guaranteed by all international laws. In the presence of these concerns and many unanswered questions, it becomes evident that the informed consent rather than the sanitary pass should be enforced and should become not only a necessity but also mandatory.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Treatment Outcome
2.
Exp Clin Transplant ; 19(8): 753-762, 2021 08.
Article in English | MEDLINE | ID: covidwho-1359392

ABSTRACT

Vaccines are among some of the most efficacious medical and public health methods ever employed to contain a pandemic, in addition to providing protective and preventive measures. Evaluation of vaccineassociated adverse events through experimentation and empirical evidence is an integral part ofthoroughly assessing the safety of vaccines before authorization of their widespread use. History has highlighted the importance of continuous search for possible vaccine-related adverse effects and vaccine-induced immunogenicity long afterlicensure, suggesting that a primary concern with new vaccines is not only efficacy but also safety, particularly overthe long term. Many of the various anti-COVID-19 vaccines have used different types of technology, with some being introduced for the first time or rushed shortly into testing, bypassing animal experimentations. They have been adopted for use through emergency use authorizations, leading to a less than optimal collection of broad data on safety, immunogenicity, effectiveness, and time span of protection, as well as short follow-up of few months, despite many infectious disease experts arguing thatit takes 10 years to develop a vaccine. Given the valid concerns on well-recognized short-term and long-term safety issues, such as antibody-dependent enhancement and other processes like molecular mimicry and potential genomic transformation, the experimental nature of the vaccination process, the limited shortterm follow-up in the main trials, and the dismissal by law of pharma companies and health care providers from any medico-legal responsibilities, the application of an informed consent should become not only a necessity but also mandatory by law in accordance with all declarations on human rights. Such information should be provided to every potential recipient in the form of an official written digital consent prior to the registration for or the receipt of the vaccine.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Clinical Trials as Topic , Drug Approval , Informed Consent , Vaccination , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/adverse effects , Humans , Patient Safety , Risk Assessment , Treatment Outcome , Vaccination/adverse effects
3.
Exp Clin Transplant ; 19(7): 627-634, 2021 07.
Article in English | MEDLINE | ID: covidwho-1194785

ABSTRACT

One year has elapsed since a team of Chinese scientists reported the first case of COVID-19 in Wuhan, China on January 8, 2020, after sequencing the first viral genetic material. Since then, many vaccines were rushed into testing, bypassing animal experimentations, with more than 200 pharma companies in different countries declaring the development of different vaccines, each with their own strategy for generating immunity, despite the arguments of many infectious disease experts that 18 months for a first vaccine is an incredibly aggressive schedule because it takes an average of 10 years to develop a vaccine. Ten vaccine candidates have already entered phase 3 clinical trials in humans. These vaccines rely on different types of technology, the most innovative of which use the genetic material messenger RNA. Many provocative questions and genuine concerns have been raised, such as short durations of efficacy and safety follow-ups, lack of identified correlates of protection, morbidity and mortality cases reported shortly after vaccination, uncertainties regarding the risk of enhanced disease on exposure to the virus in the long-term, the possibility of viral transmission after vaccination, the reported reduced efficacies of these vaccines against new variants, the efficacy and safety of these vaccines in the previously excluded subgroups (such as children, pregnant women, the frail elderly high-risk population, and immunocompromised individuals), the unknown risk of immunogenicity-induced autoimmune diseases, cancer and chronic inflammation, the risk of genome transformation (mainly in the presence of reverse transcriptase), and finally the potential coercion that may be imposed by either public or private sectors on citizens to receive the vaccine. Many plausible questions are apparent, with no clear and convincing answers.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , Humans , RNA, Messenger/adverse effects
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