Ramiro Alejandro Aguirre García, 28, felt nervous and very excited. The young man is one of 3,000 Mexican volunteers who will test the efficacy of the vaccine from German laboratory CureVac.
“It’s a great opportunity to get vaccinated against SARS-CoV-2 and to be able to support the entire population in finding a solution to the pandemic,” he said.
He reported having felt no discomfort or side effects during the 30-minute observation and recovery period.
Participating in the clinical trial meant Ramiro was able to get the vaccine in advance. Normally, due to his young age, he would have to follow the federal Ministry of Health’s vaccination plan and wait to be vaccinated in the coming months.
The study gets started
TecSalud has begun administering the CureVac laboratory’s research product to volunteers who will participate in the Phase 3 clinical trial of the Covid-19 messenger RNA vaccine.
At 7.00 a.m. on February 15, the first volunteers arrived at the Clinical Research Area for Vaccines at TecSalud’s Zambrano Hellion Hospital, which will be the center for administering vaccines and placebos to the group of 3,000 participating volunteers.
“By participating in testing of the German mRNA COVID-19 vaccine, a protocol authorized by COFEPRIS, Mexico is leading Latin America,” explained Guillermo Torre Amione, Rector of TecSalud and Vice President for Research at Tec de Monterrey.
“TecSalud is proud to be actively participating in research on the diagnosis and treatment of COVID-19, with the hope of fighting the disease,” he added.
Similarly, Torre stressed that this initiative was the result of authorities, academics, and civil society engaging in public-private collaboration, synergy, and multidisciplinary activities to stop the advance of the pandemic.
Safety and efficacy of the German CureVac vaccine
Servando Cardona, the National Director of Clinical Research at TecSalud, explained that this phase of clinical trials could be very promising.
“An efficacy rate of above 90% has been confirmed in the trial results available at the moment, with a higher range of safety than that of other vaccines. This is thanks to messenger RNA technology, which allows us to imprint the virus’s RNA in order to sequence its amino-acid chain and cause an immune response,” he added.
The expert said that this vaccine requires deep-freezing at -80 degrees but has been proven to be stable at higher temperatures and can be kept for up to three weeks.
Cardona said that, without a doubt, this is going to be a very important medical advance: never before in the history of mankind have drugs been tested at such scale and in such a short time.
“Recruiting 36,500 volunteers in two months around the world is the result of extraordinary logistics. It means that the vaccine can get everywhere and be applied following the same processes and to the same standards,” he said.
“An efficacy rate of above 90% has been confirmed in the trial results available at the moment, with a higher range of safety than that of other vaccines.”
Michel Martínez, leader of TecSalud’s Covid-19 Program and lead researcher for the clinical trial, explained that the vaccine is intended to be effective in preventing cases of COVID-19, as well as measuring other parameters.
“These are other so-called secondary efficacy parameters, which are: safety and, if the disease occurs, avoiding hospitalization or even death,” he shared.
Messenger RNA vaccines, unlike traditional vaccines, don’t require the injection of an attenuated or inactive virus, but rather convey information about proteins to teach our cells to produce the “spike protein” which lives on the surface of the virus.
“Since the body has already produced the protein, it has developed antibodies against it. When the virus arrives with this protein, it is rejected and cannot anchor itself,” said Martinez.
Participants in the CureVac mRNA vaccine Phase 3 clinical trial followed a detailed step-by-step process to register in order to ensure the safety of all participants.
First, they sent their contact information through the official TecSalud site; afterwards, they filled out a registration form which was evaluated. All volunteers were notified by email about whether they were eligible to participate in the study or not, according to the criteria specified by CureVac.
Volunteers confirmed as eligible scheduled their first visit to the Clinical Research Area for Vaccines at TecSalud’s Zambrano Hellion Hospital online, to undergo a medical evaluation and sign consent forms.
If the evaluation didn’t yield any additional data excluding them, participants could be given the first dose of the research product, which could be a vaccine or a placebo.
Two doses will be given, the second approximately one month after the first. The volunteers will make a total of 5 visits during a period of 393 days, as well as keeping an electronic diary and receiving advice and follow-up via phone calls.