Wyeth suspends Prevnar pneumococcal vaccine batch following deaths of infants in The Netherlands

Wyeth’s Prevnar vaccine trials were suspended in India last year after reports of infant death

Prevnar (Prevenar) vaccine batch has been suspended in The Netherlands following the death of three infants.

On batch of Prevenar  (Prevnar is sold under the brand name Prevenar in EU countries), has been pulled out the Netherland’s market after three infants died within two weeks of getting the vaccine, Dutch health institute RIVM said.

Prevnar is a vaccine to provide immunity against the invasive pneumococcal disease in infants is marketed by Wyeth, which has just been acquired by the world’s largest drug maker Pfizer, worldwide.

Wyeth has ordered the suspension of Prevenar vaccines with batch number D66977, following the reports of infant deaths.

Even though about 5 to 10 deaths are reported annually after babies get vaccines on average, the three cases of infant deaths in a short period is unusual, RIVM sources were quoted as saying.

The suspension of Prevnar vaccine batch is a “precautionary measure” according to the European Medicines Agency officials who are working with the Dutch authorities to find out if there were any particular safety issues with the vaccine batch.

RIVM was investigating the cause of the infants’ deaths, which was not yet known, the spokeswoman said. Other batches of Prevenar, known as Prevnar in the United States, will continue to be used the spokeswoman said.

Prevnar is one of the most widely used vaccine in the world and generated sales of $2.7 billion in 2008.

Wyeth’s Prevnar vaccine vaccine was implicated in infant death earlier in India also.

Last year, clinical trials of an advanced version of Prevanar by the domestic unit of  Wyeth Inc. have been suspended by India’s drug regulator after reports of death of an infant on whom the vaccine was tested in a trial site in Bangalore.

The child had a pre-existing cardiac disorder. The inclusion of an infant with a cardiac condition in the Wyeth vaccine test violated India’s drug testing rules, said the Drug Controller Genaral of India (DCGI) as a reason for suspending all the Prevnar trials across the country.
“It seems that the ‘inclusion-exclusion’ criteria protocol has not been adhered to by the investigator,” said Surinder Singh, DCGI.

Under the inclusion-exclusion protocol, if the investigator or the company decides to include or exclude a subject from its trial not fitting into approved criteria such as age, weight and health conditions, it must take prior permission of the licensing authority.

Wyeth’s phase III trial was part of global clinical trials to assess the safety, tolerability and immunogenicity of the improvised version of pneumococcal conjugate vaccine that fights 13 strains of bacteria compared with seven strains in the company’s current Prevnar.

The vaccine trial was comparing efficacy of Prevenar and the new variant.

Wyeth. however, had maintained that the child who died had been administered Prevenar and not the new 13-strain variant.

“The event occurred in the control group, which used the current worldwide standard vaccine for prevention of pneumococcal disease and which has been administered safely more than 200 million times worldwide during the past seven years,” a company spokesperson had said.

Hower, the ban on Prevnar trials was lifted in May this year and allowed Wyeth and its CRO GVK Biosciences Pvt. Ltd, the Hyderbad-based clinical research organization to carry on with the trials.