Deaths resume with return of Quinvaxem vaccine to Vietnam

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Health authorities deny any causal links between recent fatalities and the reintroduction of the controversial vaccine; Indian doctor warns about connections between WHO and vaccine manufacturers

A baby being vaccinated in Da Nang. An Indian pediatrician has warned Vietnam against taking the World Health Organization's advice on giving babies the 5-in-1 Quinvaxem, claiming WHO has a vested interest in promoting the vaccine. Two babies have died in Vietnam after getting Quinvaxem shots since a ban on the vaccine - slapped in May following several deaths - was lifted in October. Photo by Dieu Hien  

Nguyen Thi Ngoc Thanh is reluctant to have her three-month-old baby vaccinated following more reports of babies dying after taking the five-in-one Quinvaxem vaccine.

"My husband said he would not have our son taking any kind of vaccine, fearing it will harm the baby who is the only child of his generation in the family line," said the farmer from Long An Province.

"I had disagreed with him at first, but was very worried after learning about another death after taking the vaccine over the past days," she said.

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In two months since a ban slapped on the Dutch-made vaccine was lifted, at least two more children have died after getting shots, but health officials say the vaccine was not to blame.

They have defended Quinvaxem despite an Indian doctor's accusation that the World Health Organization (WHO) was irresponsible for advising Vietnam to use it.

Tran My Ngoc, a five-month-old girl from the Mekong Delta province of Bac Lieu, became the latest victim on November 24, dying a few hours after being administered Quinvaxem.

She received the shot at a commune medical station with 17 other babies, and went into seizures on the way home, the family said.

Her eyes stopped moving, her mouth foamed, her body turned black and blue, and breathing became difficult.

She was rushed to the district general hospital, where she was given medicine and put on intravenous fluids, but sadly died.

The Ministry of Health, which sent experts to the province, said in a statement November 26 that the child had died of respiratory and cardiologic decline, "possibly due to anaphylactic shock after the vaccination. It is also unclear if the baby had other conditions that caused the death."

The ministry denied that the vaccine was responsible, saying the same batch had been used for nearly 400,000 shots nationwide since October.

Earlier Bui Quoc Nam, director of the Bac Lieu Department of Health, had said doctors had diagnosed the cause of death as vaccination shock.

The department has sealed the batch of vaccines and taken samples for testing, and has suspended the use of Quinvaxem in the province. It paid the family compensation of VND40 million (US$1,900). 

Deaths follow vaccine's reintroduction

Some parents prefer to pay VND500,000 ($24) per shot for their children to get shots of Pentaxim, an acellular five-in-one shot made by French drug company Sanofi Pasteur with purified antigens that are supposed to be safer than the whole-cell preparations found in the whooping cough component of Quinvaxem.

Quinvaxem, a liquid injection vaccine which has been pre-qualified by the WHO, is distributed in Vietnam by the Berna Biotech Korea Corporation and given to babies from two months old, three times over two months, to immunize them against diphtheria, tetanus, whooping cough, hepatitis B, and Hib (Haemophilus influenza Type B).

It costs VND77,000 a dose and has been pushed in low-income countries since it was introduced globally in 2006 by the Netherlands-based biopharmaceutical company Crucell.

Quinvaxem was temporarily banned in May after nine infants died since November last year, but the ban was lifted in October on the recommendation of the WHO, which said tests found no problem with the vaccine.

After it was reintroduced, a three-month-old boy in the north-central province of Quang Tri died November 10, five days after he got his first Quinvaxem shot.

The family said he started crying uncontrollably sixteen hours after the vaccination and refused to be breastfed. He turned black and blue and was taken to Quang Tri General Hospital.

After his death, an autopsy found pneumonia to be the cause, and the Ministry of Health issued a statement denying allegations that Quinvaxem was to blame.

In Hanoi, at least 37 babies have been admitted to hospital since October after being given Quinvaxem. They had high fevers, seizures, and rashes on their body. Hundreds of other similar cases have been reported nationwide, according to local media.

Thankfully, none of those cases have ended in death.

Of 47,000 kids who got the vaccine in Hanoi, 113 developed complications. But Nguyen Tran Hien, director of the National Extended Vaccination Program, said the rate of complications was acceptable based on WHO standards.

International organizations and Big Pharma

After tests at WHO-contracted laboratories found samples sent from Vietnam comply with the quality specifications it stated, the WHO advised Vietnam to resume Quinvaxem use.

A statement on the WHO website said in July: "On 20 June, 2013, the Ministry of Health of Vietnam announced the resumption of use of Quinvaxem."

In reality, Vietnam only re-allowed the vaccine in October.

As of press time, the WHO did not respond to Vietweek questions about the statement and a list of other questions regarding the use of Quinvaxem in Vietnam.

Quinvaxem is either banned or not used in the US, Canada, Europe, and Japan and not used in South Korea, where it is produced.

It is pushed in low-income countries because it only costs less than four US dollars a dose, or a 10th of the price of newer, safer alternatives.

Jacob Puliyel, head of pediatrics at St. Stephens Hospital in New Delhi, said Vietnamese authorities and the WHO are not doing their job in overlooking the deaths caused by vaccine.

"There are deaths following this vaccine in nearly every country using the vaccine. It affects only a few who are sensitive, so to speak," Puliyel told Vietweek.

"Other children vaccinated from the same vial have no reactions. This phenomenon is well known with drug allergies. Some are affected others are unharmed," he said.

"Just because some children escape, it does not mean the vaccine cannot be blamed."

According to Puliyel, in India early data showed the vaccine caused one death in 10,000 vaccinated children (or one death for 30,000 doses as each child receives 3 doses). That means if a birth cohort of 25 million is vaccinated, it will cause 3,000 deaths of healthy children.

"Only 350 children die from Hib [Haemophilus influenza, which can lead to meningitis and pneumonia], but using the vaccine to prevent 350 deaths will itself cause 3,000 deaths," he said.

"If the vaccine is killing children, why do we continue with it?

"The point being made is that we cannot give vaccines that are causing deaths and serious adverse effects, just to profit vaccine manufacturers."

The vaccine is given to completely healthy babies and it is not acceptable that any healthy baby die from a vaccine, he said.

Puliyel advised Vietnam to generate local data on disease and the efficacy of the vaccine locally.

"International organizations try to project Hib as a much bigger problem [than it is]. Only a local analysis will tell you if pentavalent vaccine [like Quinvaxem] is a "˜smart' option. My guess is that - like in other Asian countries - the problem of Hib may be very small in Vietnam."

According to Puliyel, the WHO and the Global Alliance for Vaccines and Immunizations have a public private partnership (PPP) with vaccine manufacturers to supply the vaccines.

"As a result of the PPP, the WHO is responsible for promoting the vaccine, no matter how low its efficacy (in reducing disease burden), and no matter how many adverse events occur."

PROBLEMATIC SHOTS

 JUNE 2010: Quinvaxem was introduced in Vietnam and given for free under the National Expanded Immunization Program, paid for by international donations.

 MAY 4, 2013: Vietnam suspends the use of Quinvaxem vaccine in the wake of nine deaths after vaccination between December 2012 and March 2013.

 JUNE 9, 2013: the Health Ministry's Preventive Health Department, which is in charge of overseeing quality control for vaccines in the country, proposed that the central government approve the resumption of Quinvaxem, following WHO advice.

 OCTOBER 2013: Vietnam reintroduces Quinvaxem. Since then, two children have died after taking the vaccine but health officials rejected any causal links. Hundreds of cases of adverse effects following immunization have been reported nationwide.

 SINCE 2010, 43 cases of serious reactions after using Quinvaxem have been reported. Nine cases that were identified to have links with the vaccine have recovered. The rest, including 27 deaths, were declared unrelated to Quinvaxem.

 Worldwide, more than 400 million doses of Quinvaxem have been used in 91 countries. About 14 million doses have been given to children in Vietnam.

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By Vietweek Staff, Thanh Nien News (The story can be found in the December 6th issue of our print edition, Vietweek)

(An Dien contributed to this report)

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