14ymedio, Havana, 15 October 2019 — While a commission of the Ministry of Public Health investigates the causes of the death, on October 9 in Havana, of Paloma Domínguez Caballero, and the hospitalization of four more children, experts point to the two most likely hypotheses: a manufacturing defect in the mumps, rubella and measles vaccine given to the one-year-old baby; or a failure to preserve the product.
In the first case, the responsibility would fall on the world’s largest vaccine producer, Serum Institute of India. In the second, the fault would be on the Cuban side.
Although this company is endorsed by the World Health Organization (WHO), its name is associated with the death of three other children in Nuevitas, Camagüey, in 2002. On that occasion the use of a non-sterile dissolvent. Also in 2004, another minor died due to “a breach of the rules” in the application of the vaccine.
“The deaths of all those killed on that occasion were due to mishandling with the dissolvent” a pediatrician insists to 14ymedio speaking about what happened 17 years ago in Nuevitas. “The dissolvent was damaged because the recommended practices for its use were not followed and all the children who died were vaccinated at the same health center,” he says.
The pediatrician points out that “there were other children with adverse reactions but they stabilized and managed to survive.” At that time “social networks did not exist and the information circulated very little, among doctors and their families, as well as in Nuevitas where the families of dead children lived,” he continues.
But, unlike what happened with Paloma Domínguez, “there was no official note and what was heard in the streets were rumors. The Ministry of Public Health never confirmed what happened,” he says. According to this doctor, the medical personnel involved in the error received “fundamentally administrative sanctions but no legal sanctions.”
Outside of Cuba there is another precedent that involves the same company. Tresivac, the brand of vaccine produced by the Serum Institute of India was involved in 2008 in the death of a 17-year-old in Ukraine and, two days later, 60 people were hospitalized after being immunized with it. UNICEF then denied problems with the firm and claimed that the septic shock that caused the adolescent’s death “was not related to immunization.” The investigation revealed that there had been at least six violations in the immunization process.
Cuba has an immunization rate of over 98% according to data from the United Nations Children’s Fund (UNICEF). To comply with the program, the Island uses domestically manufactured vaccines with the exception of the BCG against tuberculosis, the polio vaccine and the measles, mumps and rubella vaccine (MMR), precisely those vaccines involved in these cases.
Nations fundamentally acquire their vaccines through two agencies that mediate and provide funds, the Unicef Supply Division (between 80 and 100 countries) and the Revolving Fund, integrated into the Pan American Health Organization (about 41 countries of Latin America and the Caribbean).
These channels also allow countries to obtain medicines at a lower price, since by acquiring huge volumes and guaranteeing payment through international organizations, they can negotiate under more advantageous conditions. Cuba joined the Revolving Fund in April of last year; before that it was Unicef that acquired the vaccines for the Island.
Unicef has been buying MMR vaccines from the Serum Institute of India Ltd. since at least 2006, which ensures that the company’s products meet the acceptability criteria required by the United Nations. The involvement of Unicef and the Revolving Fund are precisely the guarantees that nations do not randomly choose suppliers. According to the UN agency for children, they can show their preferences when choosing a provider but they can only select prequalified vaccines.
What could have happened in the case of Paloma? The national director of the Maternal and Child Program (PAMI), Dr. Roberto Álvarez Fumero, phoned her mother, Yaima Caballero, to offer his condolences and told her that the cause was not related to the vaccine “because it had been used in the rest of the country without incident.”
However, he added, “something happened” in the polyclinic where it was administered to the girl. According to a Cuban doctor specializing in primary medicine, a break in the chain of refrigeration may be behind the matter.
“The process required by vaccines to maintain an adequate temperature is called the cold chain. In the conditions in our polyclinics that process cannot occur efficiently,” he explains.
“This process has always had problems at the national level. In most polyclinics there is no specialized equipment to store vaccines, so they are stored in domestic refrigerators. Nor are there specialized thermometers that go inside the refrigeration equipment for vaccines that let you know if the temperature has exceeded 8 degrees Celsius. So keeping vaccines at an optimal temperature is a utopia,” he says.
This situation could have been further complicated by the fuel crisis if the appropriate measures were not been taken. “To that it is added that the majority of the vaccines come in packages of 10 doses and the bulb is taken out of the cold 10 times. Nor are there the thermal cellars necessary to transport the bulbs and many nurses carry them in an ice pack,” he adds.
However, Cuba is fit according to the Gavi Alliance with regards to the criteria for effective vaccine management and its cold chain capacity.
Gavi is currently the largest financing channel for immunization in the world. Founded in 2000 by a group of donors, international organizations and part of the industry, it is a public-private organization that works to accelerate the implementation of new vaccines and improve immunization coverage.
The Alliance works in cooperation with Unicef and the Revolving Fund and provides five-year financial assistance to countries that meet certain requirements, including a gross national product per capita of less than US $1,500, corrected for inflation.
The countries that are admitted to receive help from the alliance enter a five-year program during which the total price of the vaccine is financed in the first year with the support decreasing progressively until in the fifth year the country must bear the total cost.
Countries that do not receive these grants also get the drugs through Gavi, but at higher prices. Cuba receives three types of vaccines through this fund, among which the MMR vaccine is not included.
However, Gavi audited the Cuban refrigeration system for the 2014-2019 program and, in its report, concludes that at the central level there were two storage chambers, one for conservation with a capacity of 2793 cubic meters for medicines, reagents and vaccines, and another freezer capacity of 200 cubic meters.
At the provincial level, 20 refrigerated chambers of 2,640 cubic meters with a temperature between 4ºC and 8ºC were counted, for a storage period of more than 6 months and 80 cold boxes of 20 liters each, distributed in the 15 provinces of the country and the municipality of Isla de la Youth.
Since 2016, Cuba has obtained the MMR triple viral vaccine fundamentally through an agreement between Iberia and Unicef. The Spanish airline created a microcredit campaign in 2013 where travelers, when buying a ticket, could donate money to UNICEF for immunization campaigns in the world. In the last three years the program, initiated in Chad and Angola, was extended to Cuba and in the past year alone 95,000 Cuban children were vaccinated against MMR, 80% of those under one year old.
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