FDA says no cause for alarm on vaccines for meningitis and pneumonia

By Dr. Ananya Mandal, MDMar 7 2011

According to US health officials there are no reports that arouse new safety concerns over two children’s vaccines that have been suspended in Japan following the deaths of four babies.

The researchers at the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) said that they “have not detected new safety concerns or unusual reporting patterns” in the vaccines against bacteria that can cause meningitis and pneumonia said FDA spokeswoman Shelly Burgess.

Earlier Japanese health authorities ordered doctors to stop using the two vaccines - Prevenar, made by US-based Pfizer, and ActHIB, made by the Sanofi Pasteur wing of Paris-headquartered Sanofi-Aventis. This step followed the deaths of four infants who were given the jabs alone or in combination with others drugs. All four infants were aged from two months to under two years of age and all of them died between March 2 and 4, Japanese officials said. Another infant died last November after receiving his second shot of the ActHIB vaccine added a Japanese health ministry official.

Burgess said that the FDA and CDC are aware of the babies’ deaths and of the suspension of the two vaccines in Japan. The agencies are on the alert and continuing to monitor the safety of all vaccines, including those against the haemophilus influenzae type b (Hib) bacteria and streptococcus pneumoniae targeted by ActHIB and Prevenar she added.