By CAPosts 24 November, 2020 - 12:01am 82 views
Sergio and Elena are Mexican doctors who are now part of the 40 thousand volunteers participating in phase 3 of the international clinical study of the Chinese candidate vaccine (AD5-NCOV) that aims to generate neutralizing antibodies against the SARS-CoV-2 virus .
© Provided by Milenio Blood samples from patients participating in the CanSino coronavirus vaccine trial | Especial
CanSino Biologics and the Beijing Institute of Biotechnology will apply the vaccine or placebo to 15 thousand Mexican volunteers from 15 states of the country, through 20 private research centers, although in Mexico City the National Institute of Sciences will also participate Medical and Nutrition "Salvador Zubirán" .
It is about 37 percent of the total of 40 thousand volunteers required by the study to evaluate the efficacy, safety and immunogenicity of adenovirus type 5 among 18-year-old adults from Pakistan, Saudi Arabia, Russia, Chile and Argentina. Meanwhile, Canada will analyze the antibodies generated by the blood samples.
" Sergio , before applying the vaccine, we are going to take 25 milliliters of blood to measure your basal antibodies and after the vaccination, just a year, we are going to take another 25 thousand to analyze your antibodies and find out if they are protective against the disease" , explained Jorge Vázquez Narváez , in charge of the investigation in Morelia, Michoacán.
MILENIO was present in Sergio's vaccination process, who once he qualified as a candidate had to read around 14 pages of the informed consent, go through a medical review and rule out HIV.
After signing, a clinical file was opened and he took 25 millimeters of blood in test tubes to be sent to Canada .
Nurse Eloísa Martínez took the vaccine with or without the active substance from a special refrigerator, that is unknown to the researcher himself, and immediately applied the dose in the shoulder of the non-dominant arm (deltoid) .
“ A little peck. Ready!" , said the nurse who recommended Sergio to wait half an hour in the waiting room in case of presenting an allergic reaction, dizziness or any unexpected situation at that moment.
Meanwhile, Elena reads the informed consent in detail where she is told that to Participating in the clinical study must abstain, after vaccination, from sexual intercourse for 90 days, from donating blood, and must use a contraceptive method between heterosexual couples and exclude fertile same-sex couples.
"Squeezing his arm, I'm going to find out a little bit. One little snack and that would be all, ”nurse Eloísa Martínez informed Elena .
Sergio , 56 years old, explained that he decided to participate to contribute to this scientific project that involves qualified Mexican researchers.
"It is my way of cooperating with a grain of sand to a very serious, responsible and ethical project that will help many people in the not too distant future," he said.
“I have very close friends who are hospitalized, seriously, for covid-19 . Impossible not to show solidarity ”, clarified Sergio, who lacks risk factors and was classified as healthy.
Elena , also a 53-year-old doctor, considered that she has confidence in the researcher Jorge Vázquez to be able to tame the pandemic that has caused premature deaths and great pain among affected families.
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Like the rest of the participants from Chihuahua, Durango, Nuevo León, Jalisco, Aguascalientes, Michoacán, Guerrero, Oaxaca, Morelos, Quintana Roo, Veracruz, Puebla, Hidalgo, Coahuila and Mexico City, Sergio and Elena will receive, as part of the monitoring, 52 weekly text messages, 11 monthly telephone calls, two personal visits and the last blood draw in the twelfth month.
Reactions to the vaccine "are minimal", there may be pain in the injection site or head area that is immediately monitored
"There are minimal risks but in case of contagion, there is insurance and all care is given to patients, regardless of whether they received a placebo or the vaccine," explained Vázquez Narváez , infectious disease specialist and head of research at Hospital Ángeles Morelia.© Provided by Milenio
The technology used to develop the candidate vaccine, he explained, is based "on the adenovirus five that is incomplete, this mocho, cut, sticks in the virus particle that is protein S, where the virus bites are produced, the spike as they are also called
“They are not putting the virus on you at all, it is a fraction and what it does is form antibodies. When the virus enters the body, it will be blocked and will not cause disease, "he added.
Vázquez Narváez clarified that “this vaccine cannot generate HIV / AIDS, as some have suggested, nor will it produce the disease. We are complying with all the requirements demanded by Cofepris, it is the guarantee that we are doing the right thing. ”
Healthy people or people with diabetes, controlled hypertension, even obesity can participate in the clinical study.
But people who had covid-19, under 18 years of age, pregnant women, people with cancer, arthritis or an immunosuppressive disease such as HIV.
"We have verified with a single dose a 90 percent protection and if the provisions of the World Health Organization are complied with , to protect 80 percent of the population, we will be able to reduce mortality, hospitalizations by almost 90 percent. and intubations. That 10 percent who can get sick will have mild symptoms. "
The disease causes people to get sick for a few days, then it stabilizes and after 10 days you start to have pneumonia ”; He said after referring that the vaccine is not aimed at children but at those who live with them.
"Why aren't children affected as much as adults? They don't have as many type 2 pneumocytes; however, in their upper respiratory tract they have the virus and it is a hundred times more contagious for an adult ”, said the doctor.
The research will also cover, in another phase, determining the period that the vaccine will protect people, whether one, two or three years. Also, how you will avoid reinfections.
“I have three re-infected patients and thank God all with mild symptoms. They tested positive, then healed, tested negative, and after three or four months they had symptoms again. There are reports in the international literature of deaths during the second event ", he clarified.
CanSino's candidate vaccine research will last one year in Mexico and is expected to be ready by the end of 2021. If the results of phase 3 are successful, Mexico will purchase 35 million doses, in accordance with the signed agreements