Japan has temporarily stopped using vaccines from U.S. drugmaker Pfizer Inc. and Sanofi-Aventis SA of France while it investigates the deaths of four children who were inoculated, the health ministry said Monday.
The decision to halt the vaccines against pneumonia, some types of meningitis and other infections was made Saturday.
The government is hearing from experts at a meeting Tuesday, the health ministry said.
The four children, from under six months to 2 years old, died between March 2 and March 4. The deaths occurred the same day to three days after the vaccines were administered, the ministry said.
The vaccination began in Japan about a year to two years ago. The vaccines have been administered to 1 million to 1.5 million children, according to the ministry.
Pfizer's Prevnar 13 vaccine is approved for use in Canada, as is Sanofi's ActHib vaccine, according to Health Canada's online database.
"Prevnar 13 is the approved vaccine available for use in children in Canada. Its safety profile remains unchanged," Leah Olson, manager of corporate communications for Pfizer Canada, said in a statement to CBC News.
Prevnar 13 is the only version of the vaccine that is available for distribution in Canada, Olson added.
Pfizer in Japan said the company was co-operating with the investigation on the Prevnar 7 vaccine, which Olson said is not sold in Canada.
Three of the children who died in Japan were administered Prevnar together with ActHib. As well, three of the children also received a mixed vaccine against diphtheria, whooping cough and tetanus on the same day they received the other vaccines, Reuters reported.
The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention "will continue to monitor the safety of all vaccines, including" the two at issue from Pfizer and Sanofi, FDA spokeswoman Shelly Burgess said in a statement.
Sanofi Pasteur’s Hib vaccine was licensed in Europe and Canada in 1992, in the U.S. in 1993 and in Japan in 2007, the company said.
"It is a safe and efficacious vaccine against Hib infections, and over 200 million doses have been administered to children in well over 100 countries with an excellent safety profile," said Nancy Simpson, director of communication for Sanofi Pasteur in Toronto.