Egypt's participation in trials of Covid19 vaccine is important, minding patient rights
On September 12, the Minister of Health announced the start of clinical trials of Covid-19 vaccines in Egypt. This announcement came three weeks after the Parliament approved the amended version of the Clinical Trials Law, which was introduced in response to the recommendations made by the President in October 2018.
And because monitoring clinical trial procedures in general, and this important experiment in particular, is part of the role of civil society, a member of the EIPR team volunteered and joined this clinical trial. He followed the procedures and was registered among the trial participants after completing and fulfilling the conditions for participation.
EIPR closely follows the steps of the clinical trial, to evaluate it and transmit updates and impressions about all stages of the trial, and will answer the questions of interested researchers, journalists or the public, based on the practical experience from the perspective of an actual participant in it, by dedicating an account on Facebook and Twitter for this. EIPR is interested in following up the clinical trials file, building on the findings of its 2016 report entitled Ethical Questions About Clinical Trials in Egypt, as well as the comments it issued last September, titled "Clinical Trials", welcome amendments that reflect civil society proposals.
The Ministry had made it clear when it announced the start of these clinical trials that they were being carried out in cooperation with the Chinese government and the UAE G42 Healthcare Company, and were being conducted on vaccines that completed the first and second phase of human trials. The clinical trials target 6,000 research subjects in Egypt, out of 45,000 worldwide within the framework of international clinical trial called "For Humanity."
These clinical trials are of utmost importance for everyone in light of the continuing Covid-19 pandemic and the fear of the second wave in winter all over the world. Therefore, the participation of Egyptians in it is a positive thing in principle, however, provided that it is carried out in line with the Helsinki Declaration and the guidelines of the Council for International Organizations of Medical Sciences. Key among these principles are ensuring the transparency of the trial information, carrying out all steps and requirements for informed consent, and providing participants with health coverage.
It may be early to evaluate the performance of the national working group entrusted with supervising these clinical trials and developing vaccines, which was formed by a decision of the Minister of Health, and includes the Ministry of Health, the Medical Services Department in the Armed Forces, the Ministry of Justice, and the Egyptian Drug Authority. However, there are a number of striking scenes that the EIPR deems it necessary to refer to at this stage in order to address them.
As soon as the start of the clinical trials was announced, and within only three days of that, the steps accelerated significantly, inconsistent with the time frame that should govern the conduct of these clinical trials.
In just three days:
A site was launched for registering volunteers
The start of receiving volunteer applications
Announcement of the numbers of volunteer applicants and even the name of the first volunteer
Announcement of the actual start of clinical trials
Photographing participants in the research and the Minister’s visit to a research center, examining one of the vaccines, and then announcing its destruction
EIPR believes that:
These steps do not meet the requirements of informed consent in any way. The volunteering site does not contain any detailed information about the conditions for volunteering or what the volunteers are required to do, or any details about the trial or vaccines used in it. The site suffices with a registration form that does not necessarily fulfill sufficient digital security requirements to preserve the medical data that applicants send to volunteer.
Also, announcing the start of clinical trials on the same day that the volunteering portal was launched confirms that the most important requirements for informed consent are not necessarily fulfilled: one of the conditions for informed consent is that the participant is fully aware of all aspects of the clinical trials and that the research participant does not declare their consent until after at least 48 hours of studying the conditions of research, at home, without any influence from the researchers.
Also, photographing research participants and announcing their names to the media is a clear violation of the participants' data privacy and confidentiality.
Also, researchers and civil society organizations following up on these clinical trials lack all detailed information about the design of this study, and the mechanisms to ensure its accuracy and credibility, which are basic conditions according to the Helsinki Declaration. EIPR team was unable to find detailed information about the trial design except for a quick reference from the Minister of Health during a televised interview.
This ambiguity includes what was included in the press release announcing the start of clinical trials of two coronavirus vaccines, because it did not clarify their exact source. The statement mentioned the Chinese company, Sinopharm, and the Emirati partner, the G42 health company, but it has not yet been determined whether the two types of vaccines belong to the same two partners or if there is another source.
Note that there are four Chinese vaccines currently in the third phase of clinical trials, and the company that the statement mentioned, "Sinopharm" has two vaccines, one of which was developed by the Wuhan Institute of Biological Products and promising preliminary results were published for the first and second phase of its clinical trials. As for the second vaccine by Sinopharm, it is being developed by Beijing Institute of Biological Products, there are no results published about it in scientific journals yet.
Observations that were monitored through EIPR's participation in the volunteering program (from inside the lab):
The experience of registration and medical examination was smooth and organized to a great extent according to the volunteer's personal experience, and our colleague noticed a great turnout of women to participate, and he also praised the accuracy of the process of ensuring the volunteer’s validity to participate and the availability of conditions for joining the clinical trials, which was done through organized procedures and under the supervision of an international team.
Our colleague also noted that approval takes place after providing a paper document with details of the clinical trial, which volunteers are asked to read and then agree to before participating. But he clarified that the details are not explained by a specialized doctor, and the time required for the patient to make a decision (which should be between 24 to 48 hours of independent thinking) is not given.
Note also that the informed consent document indicates coordination between the research team and the "private insurance company to which the participant belongs", something that does not necessarily apply to Egyptian participants, most of whom are not affiliated with private insurance companies. When asked by the organizers, they explained that the wording of approval "came from the Emirates without modification."
EIPR will continue to closely follow the steps of the clinical trial, and it has dedicated an account on Facebook and on Twitter to publish the latest updates and impressions throughout the clinical trial, as well as answering questions of interested researchers, journalists or the public based on the practical experience from the perspective of an actual participant in the trial. You can follow up on the account: "1 out of 6000 - participant in the Covid-19 vaccine trial"
EIPR stresses the importance and priority of adhering to what is stated in the new Clinical Trials Law issued by the Parliament on August 24, 2020, taking into account the international guidelines for those trials, chief among them the Helsinki Declaration and the guidelines of the Council for International Organizations for Medical Sciences. On the one hand ensuring the transparency of information on study design and vaccine sources, and on the other, preserving the privacy of the participants' data and their informed consent to its terms, in order to ensure the accuracy of the results of these experiments while preserving the health, dignity and safety of the participants, so that scientific research in Egypt achieves the lead that everyone aspires to.