A four-and-a-half-month girl died in India on June 15, 2019 a day after she was given the “five-in-one” pentavalent vaccine (diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influenzae type B) at a rural child care center in the village of Kudluru, India.1 2
Soon after she was vaccinated, the baby developed a fever. When the fever continued on the following day the parents of the child rushed her to a private hospital, where the doctors advised the parents to transfer their daughter to a hospital in the city of Mysuru. The child died on the way to the hospital.1 2
Although the cause of the child’s death has not been confirmed, a news report by India’s Express News Service stated that the death was “suspected to have been caused due to pentavalent vaccination.”1
A sample of the pentavalent vaccine that was administered has been sent for testing. Pending the results of the tests, pentavalent vaccinations have been suspended at other rural child care centers in the area.1 2
There have been numerous reports of other babies dying or becoming seriously ill after getting the pentavalent vaccine in India during the past two years.3
In India, pentavalent vaccines are manufactured by four pharmaceutical companies, including Serum Institute (Pentavac PFS),4 Panacea Biotecs (Easyfive TT),5 Biological E (ComBE Five)6 and Shantha Biotechnics (Shan5).7
A pentavalent vaccine, Pentacel, manufacturered by Sanofi Pasteur was licensed in the U.S. in 2008. Containing vaccines for diphtheria, tetanus, pertussis, polio and HIB, the five-in-one combination shot is approved by the Food and Drug Administration (FDA) for infants and children ages six weeks to four years old.8
In pre-licensure studies, more than half of infants and children who received Pentacel experienced fussiness/irritability and inconsolable crying. Other frequent systemic reactions included more then 30 percent becoming lethargic and not interested in or unable to participate in usual daily activities and up to 16 percent experiencing fever over 103F.
1 Express News Service. Baby dies a day after vaccination in Kodagu. The New Indian Express June 17, 2019.
2 TNN. Bengaluru: Infant dies a day after receiving vaccination. The Times of India June 17, 2019.
3 TVR Staff. Infant Boy in India Falls Unconscious and Dies After Vaccination. The Vaccine Reaction June 27, 2019.
4 Institute of India. PENTAVAC SD/PFS. SerumInstitute.com.
5 Panacea Biotec. Easyfive-TT. Panacea-Biotec.com.
6 CPhL-online. ComBE Five Pentavalent DTP-HepB-Hib. CPhL-online.com.
7 Sharma EK. Shantha Biotechnics’ Shan5 drug gets WHO nod. Business Today May 5, 2014.
8 Sanofi Pasteur. Highlights of Prescribing Information for Pentacel. FDA.gov January 2019.