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Sanofi’s 100% Mexican Influenza Vaccine Still Awaits Approval by Cofepris

This year you will not get the vaccine against influenza 100 percent mexican made by Sanofiand it is that they are still waiting for an approval by the Federal Commission for the Protection against Sanitary Risks (Cofepris), contrary to what had been announced last February.

“Today we have approved by Cofepris, the antigen production flow in Ocoyoacac, and the formulation together with the filling and conditioning in France. To make the formulation and packaging in Azteca, the new plant in Cuautitlán, we have to receive approval from Cofepris for the production flow”, explained María Pardo, director of Vaccines for the Cuautitlán Izcalli plant.

At the beginning of the year, the pharmaceutical company estimated that the flu vaccination campaignwhich starts in September, could already have the vaccines 100 percent made at the Cuautitlán Izcalli plant, however, it is time that Cofepris has not approved the new manufacturing process, although it assured that they are ready as soon as they are told.

“We are very on time and in line with what we had planned to do in Azteca, today we have our employees trained, and we are ready to when we can have this 100 percent Mexican production, Sanofi it always accompanies all regulatory processes in compliance”, Pardo said.


He explained that the manufacturing process currently takes 8 months, the first phase is carried out in Mexico, while for the second and third phase of calibration, packaging and packaging it is done in France.

These other phases are for which the plant in Mexico is already enabled and with the approval of Cofepris as physical facilities, but not to be part of the manufacturing process.

Total manufacturing in Mexico will have a time saving of about a month still month and a half.

“We are still in the production campaign of the antigens, we are going to about 90 percent of the production, of the 35 million doses, and the antigens they are sent every period of time, staggered, so that the process in France is not saturated either ”, said Julia Morfín, director of vaccines for Sanofi.


At the conference they announced that the pharmaceutical company invested 3.5 billion pesos in its three production plants (2 in Ocoyoacac and Azteca de Cuautitlán Izcalli) in the period from 2019 to 2023.

Among its three facilities, the company produces 200 million units of medicines and vaccines that care for 60 million patients in Mexico, mainly with insulin, antihypertensives, paracetamol, among others.

Some of its well-known brands are Histiacil, Aderogyl, Allegra, Melox, Sinuberase, among others.

2023-06-01 21:44:00
#Cofepris #stops #Sanofis #Mexican #influenza #vaccine

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