Christian Carlos. Peninsula 360 Press [P360].
Today, it has been 40 days since I had the opportunity to participate in phase 3 studies of the Ad5-nCoV vaccine, developed by the Chinese laboratory CanSino Biologics Inc. and whose trial was carried out in several countries: Argentina, Chile, Pakistan, United Arab Emirates and Mexico. According to the most restrictive specifications, in theory, the deadline has been met for my body to have generated immunity to SARS-CoV-2, the new coronavirus that causes the disease COVID-19 whose origin, it is believed, was found in a market of wild species for human consumption in the central city of Wuhan, in China and that 329 days after the World Health Organization declared a pandemic situation, it is estimated that it is a disease that has affected 1.5 percent of the world's population.
50/50
"Your chance to be assigned to one of the groups (?) is 50 percent," the document attached to the email notification warned.
It is possible that, on the day of the test, what I was given was the Ad5-nCoV vaccine or a simple placebo - a substance with no effect for trial control purposes. The probability of having obtained the placebo or the vaccine of Chinese origin was 50 percent, according to the research director, Dr. Guillermo M. Ruiz-Palacios y Santos of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, in Mexico City, who explained to a group of participants 10 points ranging from the objective of the investigation?to know the efficacy of the vaccine in a group of people? to the benefits or risks of participating in the trial ?from the side effects of the vaccine (in case of its application) to the contagion by COVID-19?
They have contemplated most of the possible scenarios. The fact that we had the opportunity to know, in writing, the specifications of the study and to have the personal attention of Dr. Ruiz-Palacios y Santos to answer any questions, were positive factors that gave me confidence to continue with the process.
It is important to note that, although I was selected a day before and notified via email about my participation in the clinical trial of the CanSino Biologics Inc. vaccine, at any time during the process it is possible, with complete freedom, to drop out of the clinical trial. In case of dropping out of the trial, in any of its stages, said Dr. Ruiz-Palacios y Santos, no person will be compromised in any of his or her situations -legal or health care-.
Procedure
Suddenly, when the email arrived notifying me of my participation in the clinical trial, my chances of getting the vaccine against the disease that has taken away my family and friends had suddenly increased by 50 percent. That is to say, the next day, the chances of getting the vaccine against COVID-19 were 50 percent and, later, zero percent in who knows how many months because, according to the "National Guiding Policy for Vaccination against SARS-CoV-2 for the prevention of COVID-19 in Mexico", it states that, according to my age - 28 years old - I could only be immunized with any of the vaccines available at the moment until June of this year and before March 2022.
So all of a sudden, I could accelerate that process, almost immediately, with a 50 percent chance.
CanSino Vaccine Requirements
To be of legal age; in Mexico, the age of majority is reached at the age of 18, the age at which one acquires the capacity to determine the effectiveness of his or her legal acts and is identified by the full independence of the person and the acquisition of full capacity to act (Tobeñas, 2000).
Being generally healthy was also one of the requirements for eligibility to participate in the clinical trial. The age limit was not a restriction for participation in the trial; the study also noted that "adequate contraception" was required 90 days after receiving treatment.
Suffering from illnesses caused by other viruses that compromise the body's immunity, such as the HIV virus, which causes AIDS, was an impediment to being eligible for treatment.
Side effects and symptoms
Being a vaccine that, up to that moment, only phases 1 and 2 of the vaccine had been completed in China and the results of phase 3 are being analyzed, it causes uncertainty; however, the use of the CanSino Biologics vaccine would have received the green light in that country to immunize medical and defense personnel.
This was the point that kept me awake last night, as the sample included just over 600 adults. Perhaps this was also the highest point of concern for all the participants because, according to the informative document, it was pointed out that the most common adverse effects occurred in a population equal to or greater than 10 percent, including symptoms of a common cold and pain at the injection site for a period of no more than 3 days. However, other adverse effects such as cough, sore throat, and joint pain were included in 10 to 1 percent.
"The evidence from these two studies - the phase 1 and phase 2 studies - shows that the vaccine is safe," the informed consent letter says.
Day of the visit
On that day alone, we would have received an email total of about 50 people; however, upon investigation, I had found that groups of people like ours had already visited the Institute on previous days to take part in the trial, so that suggested that we would not be the first or the last to participate in the vaccine trials.
The appointment was set for 1 p.m. at the National Institute of Medical Sciences and Nutrition Salvador Zubiran; at that time, Mexico City was in orange traffic light -the high risk level within the "risk traffic light" approved by the federal government- which meant to congregate 50 people for the test plus administrative staff, cleaning and health professionals in place. which meant to congregate 50 people for the test plus administrative staff, cleaning staff and health professionals in the place; however, the entrance, as well as the first waiting room and sanitary filters met the highest standards established for the new normality: the correct and mandatory use of masks at all times, maintaining "healthy distance" - concept in Mexico to designate the distance between the patient and the doctor.a concept in Mexico to designate physical distance? of at least 1.5 meters (4? 11?), coughing and sneezing etiquette, the extensive use of hydroalcoholic solution or antibacterial gel, and open windows to allow air to circulate in the most enclosed spaces where more than 20 people congregated.
I must point out that, in these 300 days of confinement, INCMNSZ is the place where I have seen how these measures have been complied with 100 percent.
There I met people visibly younger and older than me who were coming for the same reasons I was, to get a 50 percent chance of being immunized with the vaccine. Not having a known person, Ariel, a young man, served as a witness on the "informed consent letter" that we had to read, understand and sign to participate in the process, in which we both agreed to be nervous about the method of randomization.
Randomization method
According to the explanation given by the research director, Dr. Guillermo M. Ruiz-Palacios y Santos, the randomization of the two possibilities, receiving the Ad5-nCoV vaccine or the placebo, was carried out by a personal identifier assigned to the initials of our name to the CanSino Biologics Inc. systems and back to INCMNSZ via email where the unique identifier linked to our initials would also be linked to a unique identifier of the Ad5-nCoV vaccine doses or the placebo doses. and back to INCMNSZ via email where the unique identifier linked to our initials would also be linked to a unique identifier for the Ad5-nCoV vaccine doses or the placebo doses - both of which were already at the Institute - without being able to distinguish, at the time, between the two, without being able to distinguish, at the time, which one had been finally assigned to both health professionals and trial participants. If neither the staff administering the vaccine nor the trial participants know what our outcome is, the clinical trial is called "double-blind".
Ariel and I agreed that this procedure was like flipping a coin, "un volado," as we call it in Mexico.
No clinical study would be complete without a sample of our blood of 25 ml, this to inform us if we were at risk for any other disease caused by any other virus, such as HIV, if so, they would contact us to let us know if there was any abnormality in the studies and, in any case, guide us to follow an appropriate treatment.
Application of the CanSino vaccine
Unlike the Pfizer-BioNTech and Moderna vaccines that require a two-dose application to ensure a maximum of 95 percent effectiveness, the vaccine developed by CanSino Biologics Inc. requires a single application to achieve 97 percent effective immunity in 28 days.
During blood sampling, the randomization process takes place - the process that links the initial letters of our full name and either a dose of the CanSino Biologics Inc. vaccine or a placebo injection. In addition to the randomization process, there is a brief questionnaire from the physicians conducting the clinical trial process - who are not allowed to participate in the trial - where, perhaps for the last time, individual questions can be answered.
The letter of informed consent does not state any restrictions other than what they call adequate contraception for both men and women; the letter stipulates that heterosexual men must abstain from penile-vaginal intercourse, sperm donation and blood donation 90 days after the dose is administered.
At no point does the letter contemplate restricting any other activity. However, in China, drug trafficking is a felony punishable by death, so I assumed that, for that reason, the use of drugs or alcohol would be implicitly limited. According to the doctors conducting the process, there is no restriction on substance use; however, we were warned that we must give notice if our habits put our lung capacity at risk, for example, smoking tobacco.
Subsequently, the dose is applied to the "non-dominant arm" - in my case, the right arm because I am left-handed. For safety reasons, according to the protocol established by the Beijing Institute of Biotechnology and CanSino Biologics Inc. - sponsors of the study - photographs of the doses should be avoided.
The doses come in a white box, inside the box, a glass syringe with the dose already prepared that you have to remove the plastic needle protection. It is not a multi-use vial like the Pfizer-BioNtech vaccine - a 5-dose vial - or a vial. It is similar, they say, to the doses provided in Mexico's health sector for other vaccines.
"Seen and unseen," said Ariel who, at all times, remained ahead of me. I hadn't seen such discipline since high school, to tell the truth, everyone was numbered and preserved the order we were assigned from the beginning, even in the use of elevators. Also, we talked the least among ourselves; keeping conversations to a minimum is one more recommendation to avoid the dispersion of aerosols that can spread the coronavirus and preserve the life of mouth covers and masks.
Two nurses were in charge of dosing. One unpacked the syringe, removed the safety seals, and exchanged it for administration. The syringe had a small print inscription on it where I could identify the name of the vaccine "Ad5-nCoV", a serial number that I could not identify, and the unique identifier that was linked to our initials. I was more focused on what the application looked like than on the application itself: a liquid that, at first glance, looked clear and disappeared after application in less than five seconds.
Follow up
After its application, the protocol incubates a waiting time of 30 minutes - the same that is now expected in the application of vaccines that have already been approved - in order to rule out immediate adverse effects, such as an allergic reaction to the components of the vaccine.
Whether what Ariel and I were injected with was the Ad5-nCoV vaccine, from CanSino Biologics, we didn't know immediately; although, with a quick survey of the people in the waiting room we were able to make it evident that people with persistent injection site pain after 20 minutes had been injected with a dose of the vaccine and not the placebo.
"Whose arm hurts?" was heard from a young man who dared to ask us given the seriousness of the protocol. The pain in my arm was evident and, a few minutes later, I began to feel a constant tingling in my non-dominant arm.
Ariel, for her part, said she didn't feel anything else.
After 30 minutes, we went back to our assigned shift to return to the pair of nurses who administered the dose; after a brief questionnaire - which included general discomfort - and an inspection of the injected area with the syringe needle, if there were no major problems, we could go home. After a 4-5 hour process.
I'm immune thanks to CanSino's vaccine
An "antibody test" or "the presence of cold symptoms" are indicators of having been injected with the Ad5-nCOV vaccine; however, as Dr. Ruiz-Palacios and Santos mentioned, the first indicator eliminates one of the purposes of the clinical trial: blinding. The second may be subject to suggestion.
An antibody test done 25 days after the vaccine was given would show a high immune response. In conjunction with the symptoms I had during the early morning hours following the day of administration.
In the middle of the night, a headache, muscle and joint aches and pains strong enough to wake me up. We were advised to try to alleviate these symptoms with the usual medicines prescribed in advance according to our family doctors; if we did not have them, we had to call the number on our identity card.
An INCMNSZ ID card with instructions on what to do in case of serious adverse effects was provided to us upon departure. Along with a card that we must carry at all times in case of an emergent event specifying who to call and who to contact. The card specifies that we are part of a clinical trial of the COVID-19 vaccine. It is also an identifier that could be used to check our probable immunity to SARS-CoV-2.
We were additionally provided with a digital thermometer to check our body temperature at any time in case of a suspected fever that could be an early sign of COVID-19. I activated the thermometer upon awakening, but my body temperature was not a red flag - and even if it was, I should treat it as a side effect. Ibuprofen 600 mg and Paracetamol 500 mg. "That should do it," I thought. And it did. The next morning, the only thing that persisted was a slight general weakness - more accentuated in the arm of the injection.
The headache, muscle and joint pain disappeared for the rest of the night. My body temperature remained normal.
INCMNSZ offered us 24-hour medical care for the next 12 months in case we needed it.
The vaccine is new and safe; however, its long-term effects have yet to be studied. It is important to note that, inevitably, COVID-19 positive cases - even if they were administered with placebo or the CanSino Biologics vaccine - are expected within a year, asymptomatic or with the presence of symptoms; however, people administered with the Ad5-nCoV vaccine are expected to reduce their mortality and case fatality rate to 0 percent.
Conclusion
As Dr. Guillermo M. Ruiz-Palacios y Santos of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán explained, people who test positive for the new SARS-CoV-2 coronavirus eliminate the risk of having severe symptoms of COVID-19 and even eliminate the risk of dying from the disease altogether if they take the SARS-CoV-2 vaccine.
That is why it is important to administer the vaccine. In principle, by believing in the advancement of science.
Despite being sociologists, science remains the same," said Manuel Ortiz, sociologist and professor at the Faculty of Political and Social Sciences (FCPyS) of the National Autonomous University of Mexico (UNAM), and continued: "We are scientists. We do science, and in science is the search for truth.
"That's right," I thought.
Science is synonymous with truth. Science is to prove what exists, not to prove what does not exist. Using science to prove what does not exist is nonsense," said Sandra Oceja Limón, also a professor at the FCPyS, UNAM.
Secondly, to honour the 159,533 people who have died in my country because of the pandemic and because, worldwide, 2,236,454 people have died. People who lost their lives and who died, with the most serious complications of COVID-19, waiting for a solution to the pandemic.
One solution is to protect yourself from the coronavirus by getting the vaccine that is available.
Thirdly, to reduce by up to 97 percent - in the specific case of the CanSino Biologics vaccine - the chances of contracting the new coronavirus; which, in turn, means that we are not carriers of SARS-CoV-2 and, therefore, eradicate its transmission.
Transmission of SARS-CoV-2 - the new coronavirus that causes COVID-19 disease - can be eradicated by vaccination.
Unfortunately, the vaccine is not 100 percent effective; however, should we fall into the remaining three percent and become infected with the new coronavirus - SARS-CoV-2 - it is very likely that we will be asymptomatic patients with a low viral load and not suffer from the disease - COVID-19 - thanks to the vaccine.
In the event that vaccinated persons become ill with COVID-19, the effects of the disease as well as its complications are reduced.
Getting a COVID-19 vaccine, according to Dr. Ruiz-Palacios y Santos, eliminates the risk of dying from this disease.
