Use of Prevnar, ActHIB Vaccines Halted in Japan After Child Deaths

Four children have died in Japan after being vaccinated with <"">Prevnar and ActHIB. According to the Wall Street Journal, the Japanese government has stopped use of these vaccines and, now, international health authorities are looking into potential side effects from the drug.

Health officials in the United States are not concerned, saying that there are no new reports in the U.S. concerning adverse reactions with these vaccines, said the Journal.

This week, Japan’s health ministry reported that the children were from six months to six years of age and died after receiving either one or a combination of both vaccinations; the deaths were reported from March 2nd and 4th, wrote the Journal. The ministry noted that the suspension would be in place pending the investigation’s outcome, which could come as early as today.

Pfizer Inc., the maker of Prevnar, and Sanofi-Aventis SA, maker of ActHIB, said that their vaccines are safe, there are no plans to issue a recall, and they are cooperating with the investigation, said the Journal. Both vaccinations are widely administered globally and have long been used in the prevention of bacterial infections that cause pneumonia and meningitis; Pfizer sold over 360 million Prevnar doses and Sanofi over 200 million doses of ActHIB, both in over 100 countries, said the Journal.

Meanwhile, in 2009, we reported that three babies died within a two-week period after receiving inoculations with Prevener—also known as Prevnar—according to authorities in Holland, who banned the batch linked to the deaths. The babies all died within two weeks of receiving the vaccination. Pfizer quarantined the batch, which contained over 100,000 doses. The Journal pointed out that it was later found that there was no link between the deaths and the vaccines.

At that time, we also wrote that a baby girl in India died in 2008 during a clinical trial for Prevnar over what were described as “supervisory shortcomings,” not because of vaccine problems. According to a prior Journal piece, the result of an Indian investigation into the child’s death was expected to raise more questions about how well Western drug companies oversee clinical trials in developing countries like India. The baby’s death during the Prevnar-13 trial prompted officials in that country to shut down the study.

The Prevnar used in Japan today is an older version not used in the U.S. where a newer formulation was approved in February 2010 and was created to protect against additional strains of bacteria, the Journal pointed out. According to the U.S. Centers for Disease Control and Prevention’s (CDC) Tom Skinner, there are no “immediate plans to change any recommendations for use,” quoted the Journal.

The European Medicines Agency began reviewing its database of side effect reports and advised member countries to do the same, said the Journal. “We are looking carefully to see if we need to have a new look at the product,” said Sabine Haubenreisser, the European Medicines Agency (EMEA) spokeswoman, quoted the Journal. Haubenreisser noted that ActHIB is not approved in Europe; however a spokeswoman from Sanofi said some countries license it and the medication is often part of a combination vaccine, added the Journal.

This entry was posted in Pharmaceuticals and tagged , , , , , . Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.