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Dutch Ban Prevnar After Infant Death

Nov 6, 2009 | Parker Waichman LLP

Following the deaths of three babies within a two-week period, authorities in Holland have banned a batch of Prevenar, also known as Prevnar, reported Reuters. The babies all died within two weeks of receiving the vaccination.

"On average about five to 10 deaths are reported annually after babies get vaccines," said a spokeswoman for the Dutch health institute RIVM, quoted Reuters. "We now have three cases in a short period, that is unusual and the reason for suspending the batch," she added, noting that RIVM is looking into the infants’ cause of death.

Meanwhile, Prevenar, which is known as Prevnar in the United States, will continue to be used. Other batches of the medication will continue to be used in the Netherlands, said Reuters. London’s European Medicines Agency is working with Dutch authorities.
Pfizer manufactures the anti-infection vaccination, considered one of the most popular worldwide, generating U.S. sales for Wyeth in the amount of $2.7 billion last year, said Reuters. Wyeth was recently acquired by “U.S. rival Pfizer,” and requested “suspension of” Prevenar batch D66977 of Prevenar, said RIVM in a statement, reported Reuters.

Pfizer spokeswoman Gwen Fisher, said early investigations by the drug maker and health authorities had not revealed a link between the drug and the fatalities, said Reuters. According to Fisher, Pfizer has “quarantined” the batch, which contains over 100,000 doses, reported Reuters.
Prevenar is used in the prevention of pneumonia and other similar infections. The three babies who received the vaccination and later died reportedly received two other vaccinations, reported Reuters.

We recently wrote that a baby girl in India who died last year during a clinical trial for Prevnar did so because of “supervisory shortcomings,” not because of vaccine problems. According to a prior Wall Street Journal piece, the result of an Indian investigation into the child’s death will likely raise more questions about how well Western drug companies oversee clinical trials in developing countries like India.

The death of an Indian infant during a trial for Prevnar-13 prompted officials in that country to shut down the study. The child died within a week of receiving the third dose of the standard (not the experimental version) Prevnar vaccine. The Journal previously reported that the girl never should have been allowed to participate in the trial. According to a report from the Drugs Controller General of India, the child’s medical file indicated that a sibling died of a cardiac problem at four months of age. The Journal said that fact should have been a “red flag” to prompt medical personnel involved in the Prevnar trial to test the infant for a heart condition.

The dead child’s medical records also indicate that when she was given the third Prevnar dose she had a cough and diarrhea. According to the Journal, the baby was admitted to the pediatric ward less than a week later with a cough and noisy breathing. A chest X-ray revealed an enlarged heart. A day later, she died of cardiac arrest, the investigative report says.

Wyeth offered a detailed plan to Indian regulators to correct problems identified at the Bangalore hospital where the death occurred and asked Indian authorities to allow it to restart Prevnar trials at sites other than the Bangalore hospital that were halted as a result of the infant death.

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