The date of the massive application of the Mexican vaccine against covid-19, Patria, is still a question mark. The speed of contagion and the arrival of new variants of the virus have modified the schedule of the federal government, which initially proposed Patria as a feasible option to stop contagion and attend to the health emergency at a low cost. Now, the high rates of immunization in the population, the lack of more resources to carry out massive clinical studies, the emergence of new variants such as omicron and the lack of experience in developing vaccines have played against the development of the national biological in the time that the pandemic required it, warn specialists.
In April 2021, the director of the Science and Technology Council (Conacyt), María Elena Álvarez-Buylla, declared that after passing the preclinical studies in mice and pigs, they would begin tests in humans. “If everything goes as expected, we would have a Mexican vaccine by the end of this year,” she declared. At that time, officials made optimistic calculations about savings of more than 800% with respect to purchases of doses abroad and there was even talk of export plans. However, a year after these enthusiastic declarations, the Patria vaccine project is still parked in phase 2, waiting to gather volunteers with the necessary requirements to advance in clinical trials that will allow it to continue to the next stage and thus obtain the authorization of the Federal Commission for the Protection against Sanitary Risks (Cofepris) for its massive application.
Finding the right candidates for clinical trials has been an uphill race. The director of Conacyt acknowledged at a conference at the end of April that three out of four volunteers have been rejected because they do not meet the required antibody levels. Before the arrival of the omicron variant, the rejection rate, explained the director, was 50%, but as advances were made in vaccination, the rejection levels rose considerably, since it is more difficult to find people with that level of antibodies when they have already received a dose of a vaccine.
Patria will be a biologic against the SARS-CoV-2 virus for intramuscular and intranasal application that has required an outlay of 150 million pesos by the federal government. The vaccine, developed by the private laboratory Avimex, uses technology from the Icahn School of Medicine at Mount Sinai (New York) and the HexaPro protein from the University of Texas at Austin.
The infectologist Alejandro Macías believes that it seems like a good vaccine, but stresses that the studies to ensure its safety and efficacy have not been completed. “Phase 3 studies are lacking. Ideally, the vaccine would have been in time to be applied during the pandemic, but here what is intended is to have a platform in Mexico for the development of vaccines that could have the country in a better position. to respond to future pandemics,” he declares.
“The development of vaccines is not easy at all, the studies cost billions of pesos, that is not the budget Patria has, no matter how well it is subsidized, no matter how much money has been put in from Conacyt and other sources , does not have those resources to do the studies faster. They have had to go at a much slower speed, and yet the first studies that have been done have shown that it is an effective vaccine and one advantage it has is that it is a platform for other coronavirus vaccines and other types of vaccines. Macias says.
Given the delay in its development, Patria went from being the Mexican alternative to tackle the pandemic to a universal reinforcement option against the virus. Last March, Undersecretary Hugo López-Gatell invited Mexicans to participate in clinical trials for the development of the biological: “For a whole year he will be under medical observation, receiving a series of evaluations that are of additional importance to immunity.” , said. The undersecretary pointed out that in the second half of 2022 it will be possible to use the biological in a generalized way.
According to the current protocol for participation in clinical trials of the biological, participants will have a blood test taken, if the level of antibodies is high they will not be able to participate in the trial. This phase requires 400 volunteers. Candidates for the phase 2 study must live in Mexico City, be over 18 years of age, have received a complete vaccination schedule four months previously; not have presented respiratory diseases during the last 21 days; if they are women, not pregnant, and not participating in another study protocol.
While the development of Patria progresses slowly, the importation of vaccines maintained a rhythm with the purchase of biologicals from Russia, the United States and China, in addition to Foreign Minister Marcelo Ebrard’s trips to destinations such as India to look for upcoming acquisitions of doses. Recently, President López Obrador announced that children under 11 years of age will be immunized with the Cuban Abdala vaccine, although this dose has not yet received authorization for pediatric use by Cofepris.
Mauricio Rodríguez, spokesman for the University Commission for the Attention of the Coronavirus Emergency of the UNAM, explains that Patria is advancing in phase 2, but warns that there is not much public information on its development. “Right now you can only evaluate it as a booster vaccine, because practically the entire population is vaccinated. Surely by the end of the year they will have enough data to move on to the next regulatory stage and in 2023 the vaccine will be ready,” he says.
The specialist acknowledges that unlike countries like Cuba or Brazil, Mexico opted a couple of decades ago to import biologicals, because at that time it was more profitable in economic terms. At the end of the 1980s, the country still exported its vaccines to 15 countries, but the same authorities acknowledge that as of 1999, Mexico ceased to be self-sufficient in this matter. “We arrived late as a country, because in the last 30 years they did not invest enough, they made us dependent on foreign biotechnology, so there was no way to arrive early. The problem occurred 20 years ago, when they stopped producing vaccines in Mexico and removed incentives for vaccines. They did not adequately develop the biotechnology agenda in the country”, affirms the UNAM expert.
In tune with the narrative of national sovereignty that has marked his Government, President López Obrador defends that with the development of the Patria vaccine, a firm step is being taken towards the recovery of the national biological industry, however, the speed at which that the pandemic and its variants advanced closed the deck of options to search abroad, biologicals with which 86.3 million people in the country have been immunized.
subscribe here to newsletter of EL PAÍS Mexico and receive all the informative keys of the news of this country