Russia and Mexico signed an agreement to ensure the supply of 32 million vaccines against COVID-19 , also known as the Sputnik V vaccine, whose distribution would start during November 2020, once they receive “approval from Mexican regulators,” according to the Russian Fund for Indirect Investment, said the state’s news agency, Sputnik.
One month ago, on August 11, the Russian government officially registered the first vaccine against coronavirus, which will be administered to risk groups, that is, elderly people o those with comorbidities, such as diabetes, hypertension, or obesity.
Although it was highly controversial among the international community due to the alleged lack of trials as well as the low profile kept by Vladimir Putin's government about it, the Mexican government did not rule out purchasing the drug and, through the Foreign Affairs Minister Marcelo Ebrard, it was informed that Russia would send Mexico 2,000 doses of the Sputnik V vaccine for phase 3 trials.
The latter was arranged just last week when, through a press release issued by Mexico’s Foreign Affairs Ministry (SER), it was known Russian authorities would share the results of phase 1 and 2 trials and that, should the phase 3 were authorized, Mexico could cooperate by administering the vaccine among up to 1,000 volunteers.
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Moreover, it was explained that the vaccine is administered in two doses. The second dose is applied 21 days after the first one.
This took place days before pharmaceutical Company AstraZeneca reported on Tuesday the temporary suspension of the trials for its potential vaccine that also involved Mexico and Argentina, in addition to Oxford, and the Carlos Slim Foundation, after detecting a patient developed a “potentially unexplainable” disease.
Regarding this obstacle, Mexico’s COVID-19 czar, Hugo López-Gatell, asserted that such a protocol is common in vaccine development when an undesired reaction is detected but the length of the suspension is still unknown.
Russia signed an agreement with Mexican laboratory Landsteiner Scientific without the intervention of the Mexican government to send 32 million vaccines against COVID-19 and cover 25% of the country’s population.
Yesterday, López-Gatell said that the Mexican Company had done preliminary agreements with the Russian government and that the Mexican government was not involved.
The COFEPRIS said it has not received any request to verify the effectiveness of the doses.
López-Gatell stressed that the COFEPRIS must verify the quality, safety, and effectiveness of the product before it is administered to the Mexican society.
“The Russian government has promoted its vaccine and has made preliminary agreements with a Mexican company focused on the distribution of supplies and the production of certain technical equipment. The purpose of this agreement is for the Russian government to have a mechanism to distribute the vaccine and in this case, it is a private entity, unrelated to the federal government. The government has no say in the agreement and could even ease access to the vaccine.”
He added the Mexican government will hold a meeting with the Russian government regarding Sputnik V. The Health official stressed that, regardless of the number of products that enter into the country, they must be verified by COFEPRIS.
“All doses must go under health verification , under the process of sanitary risk assessment. The times to solve are regularized; they are a couple of months since the requirement is presented and this does not mean bureaucratic obstacles but that no health authority should provide a fast process that ignores the scientific effectiveness or that there is no certainty of the products’ safety,” he said.
The Mexican Company confirmed the agreement and said that before distributing the doses among the population, it will be necessary to obtain COFEPRIS’ s approval.
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“This agreement aims to collaborate with Mexican authorities so that, once the phase 3 clinical trials of the vaccine are concluded, it can be analyzed by the country’s health authorities, obtain the sanitary registry by COFEPRIS, and begin its distribution throughout the territory.” It asserted.
It added that having a vaccine that combats the new coronavirus shows the commitment of the national pharmaceutical industry to contribute to tackling SARS-CoV-2.
Landsteiner Scientific highlighted that it will work with Mexican authorities at all times to follow each and every one of the clinical and regulatory guidelines so that the vaccine represents an efficient and safe alternative for addressing the COVID-19 pandemic in Mexico.
Juan de Villafranca, director of the Mexican Association of Pharmaceutical Laboratories (AMELAF) commented that the Landsteiner laboratory, which is part of the association, wants to be part of the solution against the pandemic just as the whole industry in Mexico.
“As the AMELAF’s director, I’m very respectful of what every laboratory handles, but it is great that they notice that Mexican laboratories can be part of the solution and can contribute to COVID-19 vaccine matters,” he said.
He added that in this case, the Russian government will be a supplier to Landsteiner Scientific and stressed the installed capacity of the pharmaceutical company.
“The terms of the agreement are private; we respect the agreements laboratories make with their suppliers, but it’s good to know Mexican laboratories can be part of the solution,.”
Regarding the role of COFEPRIS, the AMELAF’s director said it is very important because all clinical matters must be approved by the regulator.
“No medication, drug, or vaccine can reach the population without being approved by the COFEPRIS. Every clinical matter of the dose must be approved by the commission; they are protocols that must be followed; it’s important” he asserted.
mp