Cuba

Child dies in Cuba after receiving vaccine made in India. It’s not the first time

The Cuban government has confirmed that five children suffered severe reactions and one of them — a 1-year-old girl — died after receiving a vaccine. The serum came from the same company in India that produced vaccines linked to the deaths of three other children following inoculations administered in Cuba in 2002.

The toddler, Paloma Domínguez Caballero, died last week, two days after receiving a vaccine against mumps, rubella and measles known as MMR. After her mother shared the circumstances of her child’s death on social media and with independent news outlets on the island alleging that, “They killed my daughter,” the Public Health Ministry confirmed Saturday that five children indeed suffered adverse reactions tied to the vaccine.

“The remaining four children remain hospitalized, one of them under intensive care but stable, and the others are progressing favorably,” said the ministry’s communique. All the children were vaccinated at the same clinic in the Alamar neighborhood east of Havana.

Yaíma Caballero, the mother of the deceased child, told el Nuevo Herald that doctors had told her the baby had a “very strong and aggressive” reaction to the vaccine but offered no further details.

Caballero added that she had not yet received her daughter’s death certificate but was told by public health officials that it should be ready Thursday or Friday.

Caballero posted on her Instagram account Monday that the national director of the government’s Maternal Infant Program, Dr. Roberto Álvarez Fumero, has called her to offer his condolences and assure her that he is investigating the cause of her baby’s death. He told her the vaccine was not the cause “because it had been used in the rest of the country without incident,” she added.

El Nuevo Herald contacted Álvarez Fumero by phone, who said the death was under investigation and that he could provide any further details.

“The MMR vaccine has been used in Cuba for years, is imported from India, has been approved by the World Health Organization and certified by the State Control Center for Medicines, Medical Equipment and Devices,” the health ministry statement said.

A State Control Center document says the vaccine is produced by Serum Institute of India Ltd., the same company that produced a measles vaccine that caused adverse reactions in 42 Cuban children in May 2002, including three who died.

At that time, the health ministry said the children died after receiving “apparently contaminated” doses of “an anti-measles vaccine manufactured by the Serum Institute of India.”

That statement also noted the vaccine had been certified by the World Health Organization (WHO).

WHO did not immediately reply to a request for comment. An employee at Serum Institute of India who answered the phone said there was no one available to handle news media questions.

Serum Institute of India produces 26 vaccines distributed in 80 countries, most of them with low or medium levels of income.

The three Cuban children who died after receiving the measles vaccines in 2002 suffered toxic shock syndrome, according to a report published later by doctors and officials at the Cuban health ministry. Another report by Cuban doctors and government officials said the deaths were caused by contaminated diluting agents.

The Indian company’s website shows its vaccines are sold with their diluting agents.

The State Control Center’s certification of the MMR vaccine produced by Serum Institute of India says the product “must be reconstituted with the specific diluting agent provided by the manufacturer.”

One of the studies by Cuban public health officials reported 13 “unusual” events from 1999 to 2008 in children younger than 16 after receiving vaccines — 10 deaths and three cases resulting in disabilities. But a “commission of experts” determined that only eight of the 13 cases were linked to vaccines.

Severe reactions to vaccines are rare, although the handling of the doses can bring about complications. The State Control Center says the MMR vaccine must be kept at temperatures between 38.5 and 46.4 degrees Fahrenheit.

A Cuban physician who specializes in primary care told el Nuevo Herald by phone that “the process required by the vaccines to maintain an adequate temperature” is not not always “efficient” in Cuba.

“This process has always had problems across the nation. Most of the clinics do not have the specialized equipment for keeping the vaccines, so they are kept in home refrigerators,” the doctor said, asking to remain anonymous because of fears of reprisals.

“They also don’t have the special thermometers used in the refrigeration equipment for the vaccines that would allow us to know whether the temperature has gone above” the limit, he added. “So, keeping the vaccines at an optimum temperature is Utopia.”

That problem has been aggravated because Cuba is suffering through a fuel crisis and many of the centers where the vaccines are administered lack independent power generators, the doctor said.

Cuba has one of the broadest vaccine programs in the region, and the government has reacted angrily to criticisms over the death of the baby Paloma Domínguez Caballero.

“Painful loss of baby Paloma. Condolences to her parents. MINSAP (Public Health Ministry) investigating and jealously guards other affected children,” Cuban leader Miguel Díaz-Canel Tweeted. “Political manipulation by adversaries insults and wounds. Nothing more important than a child for the Cuban Revolution.”

The baby’s mother replied on Instagram.

“It’s a shame that he cares more about what the adversaries say than what the parents feel,” she wrote. “My girl was named Paloma Domínguez Caballero, and it was a triple loss because they killed her and her parents.”

Follow Nora Gámez Torres and Mario J. Pentón on Twitter: @ngameztorres and @mariojose_cuba.

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