Interview with Dr. Yair Quiñones Maya
What was the certification procedure for the Heberbiovac HB vaccine by the World Health Organization (WHO)?
In order for the World Health Organization (WHO) to prequalify a vaccine, so that it can be purchased for the United Nations Organizations, mainly the United Nations Children’s Fund (UNICEF), the requirements must be met, very briefly, next steps:
- Send a vaccine dossier to the WHO offices in Geneva, describing the manufacturing methods, the quality controls carried out on the vaccine under analysis and all the reports of the preclinical and clinical studies. made to the vaccine. This dossier is analyzed and evaluated by external experts hired by the WHO to determine if the vaccine in question meets the specificities established by the WHO, in particular those related to the efficacy and safety of the vaccine.
- Once the previous step has expired, a production “Site Visit” is carried out by another panel of experts, to determine if the production system complies with the requirements of Good Production Practices established by the WHO.
- Parallel to these steps, the WHO also conducts an evaluation concurrent with the evaluation of the producer, to the National Regulatory Authority, which must also comply with the requirements established by the WHO for these authorities.
For the vaccine to be certified, the three previous points must have a positive result.
In the case of the Heberbiovac HB® vaccine, all the certification work began in 1992, in the middle of the Special Period, which was a great challenge for the Center for Genetic Engineering and Biotechnology (CIGB), for the Scientific Pole of that time. and For the country. But our Commander Fidel, always visionary, supported us and infused us with all his energy to achieve the proposed objective, since achieving this certification of the Heberbiovac HB vaccine was almost a certification of the production system of the Scientific Pole and, therefore, a recognition international, not only to Cuban science, but to the ability to produce vaccines that meet the highest world standards.
He also enabled faster ways to achieve international commercialization of the Heberbiovac HB® vaccine.
For the certification work of the Heberbiovac HB® vaccine, some 40 Cuban institutions joined, almost all the centers of the old Scientific Pole, such as the Center for Biopreparations (BioCen), the Center for the Production of Laboratory Animals (Cenpalab), the Finlay Institute of Vaccines, Immunoassay Center, Ministry of Construction, Varona Metal Mechanic Company, Ministry of Public Health, among others.
The certification of the Heberbiovac HB® vaccine by the WHO was finally achieved in 2001, thanks to the intelligence, roots and commitment of each of the people involved in this work, from the simplest and most humble to the top managers of the country that constantly verified and supported this work, particularly by Dr. José Miyar (Chomi) on behalf of Fidel.
This result was the maximum expression, at that time, of the thought, of Fidel’s teachings and of the integration that was achieved between all the centers of the Scientific Pole and many other companies and ministries in the country. That alone was the only way to accomplish such a feat in the middle of the Special Period.
What did the WHO evaluate if the Cuban regulatory entity had already evaluated the efficacy and safety data of the vaccine?
At that time, the WHO re-evaluated the same information that the State Control Center for Medicines, Devices and Medical Equipment (CECMED) already had, as it should be clarified that together with the certification of the Heberbiovac HB® vaccine, the CECMED as an authority completely functional. Without this certification from CECMED, it would never have been possible to certify the vaccine.
This condition continues today. If the regulatory authority is not competent or not fully functional, no matter how good the entity that produces a vaccine is, it can never be certified by WHO.
From what moment did the Heberbiovac HB® vaccine begin to be marketed? Did we have to wait for the WHO certification?
The vaccine began to be marketed in Cuba as soon as it obtained CECMED approval in 1992.
Its first international commercializations were between 1993 and 1994. Colombia and Venezuela were among the first countries where it was commercialized. In other words, WHO certification was not required to market the vaccine. However, the sales figures for the Heberbiovac HB® vaccine started to rise after the WHO certification.
When was this vaccine included in the national immunization program?
Since 1992, as soon as it obtained the approval of CECMED.
How and why was it included in the immunization programs of WHO member countries?
The scientific evidence obtained from the use of the first vaccines produced against the hepatitis B virus, showed enormous benefit and immunity for children who were vaccinated. For this reason, WHO encouraged, as soon as possible, that countries include the use of this vaccine in their corresponding Immunization Programs.
This implied that in a relatively short time many vaccine producers appeared, of which the quality of their products was not known.
In addition, in 2000 the Global Alliance for Vaccine Immunization (GAVI) emerged with a fund of more than 750 million dollars to vaccinate children in poor countries. This further encouraged the appearance of more producers, but the quality of their products was still not clear.
To mitigate this quality issue, GAVI requested that WHO act as the guarantor of vaccine quality. Hence the issue of Prequalification of Vaccines as a mechanism to certify the quality, efficacy and safety of vaccines arose. In such a way that all the vaccines that GAVI would finance had to be certified by the WHO. Otherwise they were not entitled to GAVI funds.
Therefore, it was the combined action of the good results obtained with immunization with vaccines and the appearance of a source of financing, which encouraged many countries to include vaccines against hepatitis B in their immunization programs.
It must be added that if Cuba had not produced its own vaccine against the hepatitis B virus, we would never have been able to develop such a comprehensive and consistent vaccination plan throughout all these years. We did not have the millions of dollars or they prevented us from having the millions of dollars that were needed to implement a vaccination program like the one we have implemented and that we have maintained in Cuba to this day.
Why is it said that Cuba or the CIGB has experience in certification processes by the WHO?
Cuba has two vaccines certified by the WHO, Heberbiovac HB® and Quimi-Hib. This has allowed constant interaction with WHO, which has allowed us to gain experience in the issues associated with vaccine certification.
In what context and conditions does Cuba produce the Heberbiovac HB® vaccine?
The current external context in which the Heberbiovac HB® vaccine is produced is the most adverse we have faced in the last 20 years, with an intensified and inhuman blockade by the United States government and a complex epidemiological situation in the country and in the world, caused by COVID-19. Both aspects make the normal productive development of the Heberbiovac HB vaccine more complex.
Even in the midst of this situation, the Heberbiovac HB® vaccine is currently produced in adequate facilities, which comply with the requirements of current good practices for the production of drugs obtained with recombinant DNA techniques.
It has a robust production system, made up of analytical activities, manufacturing operations, logistics and quality assurance, which has demonstrated a high level of production consistency.
This has allowed all the people of Cuba under 20-25 years of age to be immunized against the hepatitis B virus: an indisputable achievement of Cuban science and the Cuban Revolution.
Anything you want to add… other memories …?
Many memories, but the one that gives me the most satisfaction was having achieved certification thanks to a tremendous will to “yes, we can” within the CIGB, having many colleagues dedicated body and soul to achieve the purpose. They were moments in the CIGB, of complete integration, of a very high spirit of winners, an enormous pride to be Cubans and to work in the CIGB. All that in the middle of the Special Period.
A beautiful memory is my wife, Maribel, who was part of this whole process. Without her, I would have achieved nothing.
A beautiful memory was the tremendous integration between all the centers of the old Scientific Pole, something that I know made Fidel very, very happy.
He showed that only in the union of all, for a noble idea, there is strength. We Cubans cannot afford to divide ourselves. All the good we have achieved is through unity and teamwork.
The other great memory is being able to work with Dr. Luis Herrera for many years, in which I learned a lot, thanks to his constant teaching and his high commitment to Fidel and the Revolution, and showing me that there is always a solution for problems.
PhD. Yair Quinones Maya
Chemical Engineer
Qualified Person since 2007
Coordinator of Validation and Certification CIGB Mariel Plant
Other positions, titles and experience
- Establishment and Scaling of the Production Processes of the recombinant Heberon® Alfa and the Heberbiovac HB® vaccine.
- Technology Transfer of the Hebebiovac HB®, Heberon® Alpha R, Heberitro® and Heberkinasa® vaccine to the Islamic Republic of Iran.
- Consultancy for the Design, Construction and Commissioning of the Espromed Bio Vaccine Plant in Venezuela.
- Founder and Deputy to the President of the Network of Vaccine Producers of Developing Countries (2000-2005).
- Coordinator of the Certification Project for Heberbiovac HB® and Quimi-Hib® vaccines by WHO (since 1992).
- Director of Regulatory Affairs and Quality Management at CIGB (2007-2021).
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