The production of vaccines from the universal program has been suspended in Biological and Reactive Laboratories of Mexico (Birmex) since 2019 when it stopped manufacturing oral doses against poliomyelitis, and although at the beginning of this administration there was a project to reactivate the activity with the investment of 27 million pesos to package biologicals, even against the SARS-CoV-2 coronavirus, since last year everything stopped.
The state-owned company lacks the Certificate of Good Manufacturing Practices, which is why it also stopped manufacturing fabotherapics (to neutralize the effect of snake and scorpion bites).
In 2021, Birmex began the process before the Federal Commission for the Protection against Sanitary Risks (Cofepris) to renew said certificate, but last June it stopped the process “due to the financial situation” of the company.
There is no production plan, was the response to the request for information from The Conference.
Off the market
In March 2021, the former director of Birmex, Pedro Zenteno Santaella, commented that the two vaccine and serum manufacturing chains were stopped, without equipment or the possibility of operating because in the past adjustments were not made to comply with sanitary regulations. (The Conference 29/3/2021).
During that year, obtaining the Cofepris certificate corresponding to the fabotherapeutic line was a priority; A critical path for monitoring the process was established, according to the Birmex activity report for 2021.
However, in June 2022, the board of directors decided to “momentarily suspend” the process, which is maintained. In his response to the request for information from The ConferenceBirmex indicated that until 2001 it manufactured the biological against BCG tuberculosis, and until 2019 that of diphtheria, whooping cough and infant tetanus, as well as anti-tetanus and anti-diphtheria for adults.
Regarding the immunogen against measles, which he developed for years, he pointed out that on the recommendation of the World Health Organization (WHO) and as part of the global strategy to eliminate the autochthonous circulation of the virus, in the early 2000s the majority of the countries introduced the triple viral (with inactivated virus) against measles, rubella and mumps.
Due to lacking the strains against the other two infections, Birmex was unable to continue the new version of the biologic. The last vaccine that stopped being manufactured in plants owned by the Mexican State is the oral one to eradicate poliomyelitis, after Mexico adopted the WHO recommendation to suspend its use. On November 5, 2019, the group of experts from the National Center for the Health of Children and Adolescents (Censia) of the Ministry of Health agreed to “carry out for the last time an oral vaccination campaign against polio in 2020 and immediately suspend its use in all health units in the country”.
The antigen continues to be applied in the injected hexavalent vaccine, which protects against diphtheria, whooping cough, tetanus, Haemophilus influence and hepatitis B, which the health system acquires from the Sanofi Pasteur laboratory, based on the contract in force until 2032.
Due to administrative and operational decisions, since 2019 Birmex has not carried out any work plan to produce biologicals that belong to the universal vaccination scheme or the preventive one for the coronavirus, the parastatal pointed out.
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