Sanofi’s Challenges in Developing Mexican Flu Vaccine – Implications for Vaccine Production in Today’s Regulatory and Political Environment

Sanofi’s aspirations, led by David Pinho in Mexico, to develop an all-Mexican flu vaccine have run into unexpected obstacles this year. Despite the company’s initial projections, which expected to have the dose ready for the vaccination campaign in September, the Federal Commission for Protection against Sanitary Risks (Cofepris), led by Alejandro Svarch, has not yet approved the new process for manufacturing.

This setback raises the question of whether companies like Liomont, which have proven their worth, should take the lead. This Mexican laboratory had an outstanding performance during the pandemic, after assuming the enormous responsibility for the packaging of AstraZeneca’s anti-Covid vaccine, during the contingency. But in an unfortunate twist, when Liomont wanted to make the biotech flu vaccine, his plans were stymied by Sanofi, which acquired the international company Liomont had been doing business with.

Let’s remember that in 2021, the Frenchwoman had to suspend the development of her own mRNA vaccine against Covid-19, due to challenges in maintaining her drug portfolio during the pandemic crisis. This circumstance raises concerns about the possibility of a vaccine production against influenza with little medical rigor in Mexico, since we must not ignore the criticism that the pharmaceutical company has faced for years in France; One of the most serious was the responsibility determined by a Madrid court for congenital malformations and autism spectrum disorders in adolescents, whose mothers took the antiepileptic drug Depakine, developed by Sanofi.

Despite this background, in our country the firm has maintained a long-lasting relationship that dates back to the 2009 influenza pandemic, when it produced the vaccine against the AH1N1 strain. A public-private partnership was established in 2018 in which Sanofi would build a plant on land provided by the federal government. Under the agreement, the pharmaceutical company would completely cede the facilities to the government by 2032, but in the meantime it will train Mexican personnel and ensure the supply of 32 million doses of influenza vaccines over 15 years.

However, the relationship of the company, which has had Paul Hudson as international CEO since 2019, with the current administration, headed by President Andrés Manuel López Obrador, seems to be worn out. In addition to the delay in the endorsement of Cofepris, the company has also faced legal and regulatory setbacks in relation to its generic drug rivaroxaban, a compound indicated for deep vein thrombosis (clots in the leg) and pulmonary embolism (clots in the lung). Although Sanofi obtained Cofepris’ sanitary registration in 2020, it was withdrawn, which led the company to file various injunctions against the government, particularly against IMSS and Insabi. These legal and regulatory issues appear to have influenced other areas of Sanofi’s business in Mexico. Reportedly, in Sanofi’s warehouses at its Ocoyoacac plant, there are 2,406,790 boxes of clonazepam ready for distribution to public health institutions, but to date they have not been requested by Zoé Robledo’s IMSS-Bienestar .

In summary, Sanofi’s recent challenges underscore the complexities of vaccine production in today’s regulatory and political environment. With drug and vaccine contracts now in transition to IMSS-Bienestar, it is essential to take a close look at how these issues will be handled in the future.

For more accredited As every June 9, today is World Accreditation Day, through this tool it is possible to enter new markets and for Mexico to increase its competitiveness by offering reliable and technically competent products and services. One of the key players in the matter is the Mexican Accreditation Entity (EMA), chaired by Raúl Tornel y Cruz, which to date has more than 7,600 accreditations granted for testing, calibration, clinical laboratories, units of inspection, certification bodies and validating verification bodies for greenhouse gases, among others. In addition to adding the highest international recognition in the field, it promotes the development of new areas of accreditation as it seeks to provide Mexico with a greater structure, in addition, this organization provides confidence and technical competence to open more markets and be more competitive.

voice in off. Ricardo Monreal did very well in his reunion with President Andrés Manuel López Obrador. The meeting of presidents of the Upper House, and the federal Executive leaves a very good taste in the mouth. The Zacatecan politician himself confirms that it was a “fortunate meeting, reinforcing our friendship and conviction to continue with the transformation that we dreamed of one day.”

Monreal stressed that it served to reinforce their friendship and the conviction to continue with the transformation they dreamed of…