The World Health Organization (WHO) has confirmed compliance with international quality standards for the Inactivated Split Influenza Vaccine produced by the Saint Petersburg’s Scientific Research Institute of Vaccine and Serum (SPbSRIVS), which is the parent company of the Latin-American Institute of Biotechnology MECHNIKOV in Nicaragua and supplies the bulk product of the vaccine for formulation, filling and packaging in our Plant. “After receiving prequalification from the WHO, SPbSRIVS will be able to export its vaccine as part of the dispatch for international supply foundations”, – the representative of the SPbSRIVS told TASS on Friday.
In February, the official representative of the WHO, Dr. Ute Rosskopf, responsible for interaction with laboratories, regulatory activities and safety, confirmed the full compliance of the influenza vaccine produced by the SPbSRIVS with world quality standards. “The WHO test result supports the acceptability of the Inactivated Split Influenza Vaccine produced by SPbSRIVS, Russian Federation, for prequalification” – the statement said.
Prequalification is a service provided by WHO to assess the quality, safety and efficacy of medicines. Together with SPbSRIVS, the MECHNIKOV Institute plans to receive prequalification of its vaccine in 2021. Prequalification by the WHO is a crucial condition for the access to the markets worldwide.
The Mechnikov Institute, SA. In October 2020 has obtained the Sanitary Registration Certificate for the vaccine in the Republic of El Salvador. The Sanitary Registry granted by the National Directorate of Medicines of El Salvador is valid for 5 years.
Registration obtained in El Salvador will allow the country to have an affordable quality vaccine against influenza (Flu). The vaccine used in El Salvador is a Southern Hemisphere strain that begins the vaccination day from April of each year
According to the regulatory norms of any country it is necessary to register the product before its commercialization and distribution. The main objective of this is to allow the regulatory agency to ensure and guarantee the supervision, surveillance and quality control of the product.
Instituto Latinoamericano de Biotecnología MECHNIKOV with a mission to bring high-quality medicines to every country in Latin America and Caribbean,
With this motive, last year Institute MECHNIKOV iniciated the process of vaccine registration in Republic of Guatemala, which is mapped to be a country with high potentials for comercialization of such products.
In the process of product registration, many technical, scientific and legal documents were presented that are approved by the National Regulatory Agencies and Ministries to obtain the sanitary registration.
On 13 of October 2020 we obtained the Sanitary Registration for Influenza Vaccine (Split Viron) Inactivated.
With Obtaining the sanitary registration of the VAIF vaccine, which is manufactured in Central American region, guarantees access to the population of Guatemala to an affordable and high quality vaccine.
Today, December 28 of the current year, the Instituto de Latinoamérica de Biotecnología MECHNIKOV S.A. made a contribution to the Ministry of Health of the Republic of Nicaragua (MINSA) with 20 thousand doses of the fractionated inactivated influenza vaccine.
The delivery to the Health Ministry of Nicaragua made by the MECHNIKOV Institute is also a contribution in the fight against COVID-19, since the wide application of influenza vaccines is considered important for the early diagnosis of coronavirus infection and the innate immunity that it supposedly produces.
The MECHNIKOV Institute is the only plant in Central America that produces this type of vaccine, thus guaranteeing its distribution both in Central and Latin American countries. The manufacturing facility located in the Republic of Nicaragua, helps to supply with its vaccine to a large number of countries.
In the framework of the Conference organized by the Ministry of Industry and Trade of the Russian Federation together with the State Institute of Medicines and Good Practices, the General Manager of the Institute
MECHNIKOV Stanislav Uiba made a presentation on the Institute’s experience during the GMP Certification and Registration process by the Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) of Cuba.
In the round table it was agreed on some special aspects of the process and also the collaboration between both institutes with a special attention on CECMED to accompany in the process of prequalification of Institute’s fractionated inactivated influenza vaccine (VAIF) before the WHO
In past years, this Conference received representatives of the global pharmaceutical community from Russia, the United States, Austria, Spain, Japan, Switzerland, Italy, Mexico, Great Britain, Cuba, Germany, Brazil and other countries. Conference partners are leading Russian and international companies, some of the major players from the industry and also the professional communities.
Each year, the event takes place in a different region of Russia, helping organizers to demonstrate good manufacturing practices in various parts of the country and to familiarize participants with the regional aspect of organizing the health system and distribution of medicines.
On June 25, at the age of 67, pased away Dr. Rafael Pérez Cristiá, Director of the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED), Doctor of Medical Sciences, Head of the Academy of Sciences of Cuba.
The collaborators of the MECHNIKOV Institute mourn their irreparable loss and wish to extend their sincere condolences to the family and friends of the great man and scientist. He was the first to proclaim the thesis that Regulatory Authorities should be improved following the developers and manufacturers of modern medicines , and not limit with there inflexibility and instructions a world that changes rapidly and requires the introduction from new drugs in practice.
Dr. Rafael Pérez headed CECMED in 1999. The contribution of his knowledge to the strengthening of the drug regulatory policy in Cuba contributed to the categorization of CECMED as the National Regulatory Authority of Reference Medicines of PAHO for the Americas and National Regulatory Authority of Vaccines certified by WHO.
Dr. Pérez will forever remain in the history of Institute MECHNIKOV as one of the founding fathers, because it was largely, thanks to his efforts, that we were able to carry out the project of our Institute and complete the transfer of technology for the production of vaccines against the flu.
Dr. Pérez lived a brilliant and active life, he was distinguished for his deep humanity, genuine intelligence, high professionalism, love for life and optimism.
Today all the collaborators of the MECHNIKOV Institute are with the family of Dr Pérez and all Cuban citizens. The memory of Rafael Pérez will remain forever in our hearts.
A Companion. A Friend. A Teacher.
The Russian offer may be the best option for Latin America in the face of the coronavirus. The country has an advanced biotechnology industry and successful international experience. In this context, the Instituto de Latinoamérica de Biotecnología Mechnikov [ILBM], a vaccine plant installed in Nicaragua with Russian technology, is an exemplary case.
Its the general manager, Stanislav Uiba, indicated in conversation with Radio Sputnik that the innovative center – whose headquarters is the Scientific Research Institute of Vaccines and Serums of Saint Petersburg – will have in the medium term a vaccine that will guarantee immunity against COVID- 19, the result of “a fairly aggressive program” that is being carried out “at this time” to develop a definitive solution to the disease.
He reported that by this month of August there will be “at least three vaccine candidates” against the coronavirus, stating that, “they have passed the preclinical studies with success.”
Meanwhile, ILBM is already contributing to the public health of the region, its “main and initial product” being the influenza vaccine that activates immune mechanisms that not only fight the influenza, but also make the organism more resistant to other infectious diseases, including the coronavirus.
In addition to Nicaragua, the regional countries that are already receiving the vaccine are Cuba, Ecuador and Venezuela, with concrete steps to expand the geographic scope of supplies, a strategy that has the support of the National Committee for Economic Collaboration with the Countries of Latin America , a Moscow-based entity that is in charge of promoting ties between the parties.
“We also have other development vectors distributing other vaccines of interest here in Latin America, for example, against yellow fever, hepatitis or rotavirus,” he added.
The Latin American Institute of Biotechnology MECHNIKOV, on May 4 of this year, carried out a vaccination program against influenza for its collaborators and their families with the same vaccine manufactured by the Institute.
Preventive vaccination against Flu allows minimizing the risks of co-infection both in medical personnel and in risk groups, which coincide with the risk groups most affected by COVID-19. Reducing the burden of influenza virus infection on the health system and economies allows these resources to be dedicated to the fight against other diseases in the current global situation.
The WHO document “Guidelines for immunization during the COVID-19 epidemic” issued on March 26 of this year, points out the importance of preventive vaccination against influenza.
In the same way, masks are being used and the temperatures of employees and visitors are being mesured. Taking hygiene measures with hand washing, applying alcohol and cleaning the place with disinfectants at all times is a primary need in the current situation. We thank all the collaborators of the MECHNIKOV Institute for complying with hygiene and safety measures, and it is hoped that in this way we can protect ourselves against COVID-19.
Latin American Institute of Biotechnology MECHNIKOV delivered 600,000 doses of the influenza vaccine to the Nicaraguan Ministry of Health for the vaccination session.
The MECHNIKOV Institute guarantees the delivery of vaccines in thermal boxes with cold accumulators to guarantee the quality of the product in the temperature range required for its transportation from our plant to the MINSA facilities.
Russia collaborated in the delivery of 8,000 doses of Interferon Alpha 2B – a drug planned to be used against the Coronavirus – to Nicaragua, the St. Petersburg Institute for Scientific Research on Vaccines and Serums told TASS on Friday.
Interferon Alpha 2B was delivered to Nicaragua from Cuba with logistical coordination from the Latin American Institute of Biotechnology MECHNIKOV, a Russian-Nicaraguan JV manufacturer of biological drugs. The press service of the Institute of Vaccines and Serums of Saint Petersburg pointed out that considering the international situation this supply is significant for both Cuba and Nicaragua.
“We have responded to the request of our Cuban colleagues and developed the logistics of delivery of our influenza vaccine to Cuba in a way that allowed us to dispatch the Interferon on the same plane, which the people of Nicaragua need at this time,” said the director of the Mechnikov Institute, Stanislav Uiba.
Interferon has been recommended for COVID-19 patients in a number of countries, including Russia. The fifth edition of the temporary methodical recommendations on the prevention, diagnosis and treatment of coronavirus was published on Thursday. According to this document, Interferon Alpha 2B has anti-inflammatory, antiviral and immunomodulatory effects. According to the Russian Ministry of Health, the effects of the drug are based on “preventing the recurrence of viruses that enter the human body through the respiratory tract.”
According to statistics from the World Health Organization, Nicaragua has 6 registered cases of coronavirus as of April 10, 2020.
Original information https://tass.com/world/1142939
The Nicaraguan Mechnikov vaccine plant has all the capabilities to produce the retroviral used to counter the new coronavirus.
The executive president of the Nicaraguan Institute of Social Security (INSS), Roberto López, reported this Thursday that Interferon Alpha 2B, a Cuban drug that is used within the spectrum of drugs to treat patients infected by coronavirus, could begin to be produced in Nicaragua .
López, made a tour of the Mechnikov vaccine plant (Managua) together with the deputy director of the Center for Genetic Engineering and Biotechnology (CIGB) of Cuba, Marta Ayala. Both specialists valued the possibility of starting the preparation process for the production of the Cuban medicine.
Ayala, expressed that the visit is an expression of solidarity and brotherhood among the peoples of Latin America to share knowledge and fight together the coronavirus pandemic. “We think that from the governments, the authorities, we must be prepared for this epidemic, for which each one of the citizens must be very active, investigating ourselves, alerting but also preparing ourselves, therapeutically speaking, to be able to care for the sick that may arise” , he assured.
The intention of both governments is to have a retroviral production capacity in the Central American country to attend to its patients and at the same time function as the closest point of sale to the rest of the countries in the region under the operations of the Grupo de las Industrias Biotechnology and Pharmaceutical of Cuba (BioCubaFarma).
Russian delegation visits MECHNIKOV vaccine plant.
The Vice President of the State Duma of the Russian Federation, Olga Epifánova, visited the Latin American Institute of Biotechnology MECHNIKOV this Wednesday, December 11, as part of its activities framed by the celebration of the 75th Anniversary of the establishment of diplomatic relations of friendship, brotherhood and solidarity between Russia and Nicaragua.
“For me it has been very important to have come to this Institute that is made with the collaboration of our Federal Medico-Biological Agency, because for me, we can say, it is as if it were the first international swallow. It was very interesting to see, what are the plans, because Latin America is far from Russia and here we see another picture in terms of diseases, “said Epifánova.
During the visit he was able to learn about the operation and projections of the plant, since he is responsible for the Health Committee which allows him to be in contact with the medical society and be aware of what is happening in this area in Russia and abroad. she.
Epifánova stated that the Institute has the best technology, which opens opportunities for Nicaraguan personnel to obtain the best knowledge from Russian specialists.
“Young people in this country have the possibility of working with these technologies. It is a very great possibility for them,” Epifánova explained.