Japanese health officials have suspended the use of two pediatric vaccines as a precaution following the deaths of four young children, according to multiple media reports.
The Ministry of Health, Labor, and Welfare has said that Pfizer's Prevnar and Sanofi Pasteur's ActHIB cannot be used until a panel of experts concludes an investigation into whether there is a causal link between the vaccines and the deaths, which reportedly occurred in children ages 6 months to 2 years.
The panel is expected to issue a report tomorrow.
A spokesperson for Sanofi Pasteur confirmed in an e-mail that, on March 4, the Japanese health authorities suspended use of ActHIB after the deaths of four children, three of whom received ActHIB in conjunction with at least one other vaccine from another manufacturer.
Three of the four infants received Prevnar and ActHIB together, and at least two also received a combination vaccine against diphtheria, pertussis, and tetanus, according to Reuters.
The Sanofi spokesperson said that the company is fully cooperating with the Japanese investigation, noting that ActHIB has not been recalled.
"To our knowledge to date, there is no reason for such a recall, nor for the customers to return the product," she wrote in an e-mail.
A representative from Pfizer wrote in an e-mail, "Pfizer thoroughly reviews and continually monitors all of its medicines and vaccines as safety is our top priority. No causal relationship has been established between the events reported in Japan and vaccination to date. We are conducting a thorough evaluation of these cases in cooperation with the relevant regulatory health authorities."
A similar incident happened last year in the Netherlands, where health officials concluded that Prevnar was not responsible for the deaths of three vaccinated infants, the Reuters report noted.