Japan suspends two vaccines after infant deaths (Update)

Mar 07, 2011

Japan's health ministry has suspended two widely-used vaccines made by drugs giants Pfizer and Sanofi-Aventis as it investigates whether they are linked to the recent deaths of four infants.

The infants, aged from around six months to under two years old, died over a three-day period this month after receiving the vaccinations or in combination with other drugs, the health ministry said in a statement.

The two drugs -- used to prevent forms of pneumonia and meningitis -- are Prevenar made by New York-based Pfizer and ActHIB, a drug made by the Sanofi Pasteur wing of Paris-headquartered Sanofi-Aventis.

Sanofi's ActHIB is used in over 120 countries, according to the company.

The two vaccines have been administered to an estimated 1.5 million children in Japan, the ministry said.

There have been no reports so far from the doctors who treated the children that establish a causal relationship between the vaccines and their deaths, according to the Ministry of Health, Labor and Welfare.

In Japan the precautionary suspension remain until at least Tuesday pending the results of an investigation by a group of medical experts.

The ministry reported that three infants under the age of two died within three days of receiving the two vaccine shots, with two of the children also receiving DPT shots for diphtheria, whooping cough and tetanus.

A one year-old died a day after being administered Prevenar and a DPT shot, the ministry said, adding that some of the infants had underlying illnesses.

Prevenar and ActHIB became available in Japan around two years ago.

Authorities decided to suspend them after the four deaths occurred between March 2-4, the ministry said.

"Sanofi Pasteur would like to express its sincere condolences to the families affected by these losses", a spokesman told AFP.

"An investigation is underway to which Sanofi Pasteur intends to fully cooperate with health authorities by providing all data available regarding HIB."

In a statement Pfizer said it was fully cooperating with the ministry's suspension and was in the process of gathering information.

"Our company, taking the safety of patients as its top priority, has studied and assessed accumulated information, including that on causal relationships, with regard to the side effects of all products including Prevenar."

The suspension follows the deaths of two infants in southwest France in late February who had been administered Prevenar.

Health authorities on Thursday said the deaths were not linked to the drug.

In 2009, US firm Wyeth, which was later bought by Pfizer, suspended distribution and quarantined a batch of Prevenar in the Netherlands following reports of the deaths of three infants around the time of vaccination.

Dutch authorities and Wyeth in February 2010 determined there was no correlation between the three deaths and the vaccine injections.

In addition to the four cases, Japan's health ministry said another infant also died in November after receiving his second shot of the ActHIB vaccine, a ministry official said.

Explore further: Risk of antibiotic overuse in aged care settings

add to favorites email to friend print save as pdf

Related Stories

Kids' Swine flu shots recalled; not strong enough

Dec 15, 2009

(AP) -- Hundreds of thousands of swine flu shots for children have been recalled because tests indicate the vaccine doses lost some strength, government health officials said Tuesday.

Virus outbreak causes 40 child deaths in China

Apr 10, 2010

(AP) -- A top Chinese leader called for stepped-up research into vaccines and drugs for hand, foot and mouth disease after 40 children died from outbreaks last month, a state news agency said Saturday.

Japan reports bird flu outbreak on quail farm

Feb 27, 2009

An outbreak of bird flu has been reported on a quail farm in central Japan but no animals have died and no humans have been infected, the agriculture ministry said Friday.

Recommended for you

Supermaterial gives rejected drugs a new chance

4 hours ago

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

Risk of antibiotic overuse in aged care settings

Jul 21, 2014

Antibiotics are being overused in residential aged care facilities (RACFs), and more integrated efforts to improve antibiotic prescribing practices need to be introduced, researchers say. 

Ruconest approved for rare genetic disease

Jul 17, 2014

(HealthDay)—Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal ...

NIH system to monitor emerging drug trends

Jul 17, 2014

An innovative National Drug Early Warning System (NDEWS) is being developed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and to identify increased ...

User comments : 0