In 2012, the defunct National Institute of Hygiene (INH) had 60,000 locally produced pentavalent vaccines ready for clinical trials. It was the last phase before applying them in the country’s health centers.
“We had the manual for rehearsal and logistics. And everything was forgotten”, says Gladys Álvarez. For almost 49 years she worked in the Biologicals Production area of the Institute, where she already produced DTP -diphtheria, tetanus, pertussis (whooping cough)- and other vaccines.
54 people, including professionals trained in Japan, Chile, Brazil and Cuba, were part of the plant that closed when the INH was divided in two. Álvarez continued for a time at the National Institute of Public Health Research (Inspi).
Then he went to Enfarma, the public company that never took off and is still in liquidation. It was there that he would continue directing the production of biologicals, but everything was left only in plans and budgets.
Now, China announces an initial investment of USD 50 million to start a local plant from scratch. This was agreed this week with the signing of a declaration of intent between the Sinovac Life Science laboratory and the Ministry of Public Health.
Setting up the infrastructure will take a year and a half and, possibly, it will be in Durán (Guayas). Its capacity is still being calibrated and production would start in two years.
Minister Ximena Garzón announced that they will not only make doses against SARS-CoV-2 (it is expected to have a formula against the Omicron variant), but also with the pentavalent, formulas against chickenpox, polio… The startup goal is to cover the market local with doses of the regular vaccination schedule and, in the long term, export.
For 10 years, when the production of biologicals stopped, Ecuador has depended on imports. Last year the country invested USD 66,100,151 to buy them from countries such as India, Belgium, Brazil and Hungary, after suffering a gap that left health centers without supplies for a few months, in the midst of the pandemic.
In the national vaccination schedule there are 17 formulas, mostly pediatric. In 2021, 12,927,240 doses were purchased and another 78,5945 arrived by donation. Among them are Td (tetanus and diphtheria), others for rotavirus, pneumococcus, hepatitis B and influenza.
For Luiggi Martini, the country suffered a setback in scientific research. The former director of the INH recalls that 60 years ago they were already generating biologicals such as antivenom serums with native snake venom, anti-rabies vaccines, they even made onco-BCG for the treatment of bladder cancer and lyophilized BCG -powdered, against tuberculosis. -.
“You don’t have to try to discover new things; We must return to the successful things that we have had (…). We Ecuadorians have the capacity to produce biologicals and not only to come to pack,” says Martini, who is part of the group of former ministers and directors who ask that the INH resume its functions.
An example of local capacity is in the SARS-CoV-2 vaccine prototypes that Espol is developing with other universities. The project is still in the preclinical phase, with tests on laboratory mice. “The mice generate antibodies against our laboratory proteins and the antibodies of infected people also recognize our protein,” says Washington Cárdenas, project leader and head of the Espol Biomedical Research Laboratory.
When thinking of producing for pilot tests, the only alternative they would have for now is in the veterinary vaccine laboratories. Cárdenas believes that it is feasible to set up a biological plant if there is expert advice, staff training and investment.
These are some of the points of the cooperation commitment with China. In addition, there is talk of conducting clinical trials and technology transfer.
“It is always easy to buy the vaccine already made -says the researcher-. But in the context of the pandemic, the country had to pay a high price in human lives.”
The economic cost has also been high. There are more than USD 300 million invested in the purchase of 34.1 million doses against covid-19, according to Health.
The former INH plant had been equipped by the Japanese Government. Álvarez remembers that since he entered he had filtered air cabins to avoid contamination in the packaging area, sealing machines and a purified water plant. All equipment was stored.
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