Panacea Biotec gets CDSCO nod Pentavalent vaccine for 5 deadly disease

This came in line with the proposal presented by Panacea Biotec for grant of marketing authorization along with Phase II/III clinical trial report of Diphtheria, Tetanus, Pertussis, Poliomyelitis (Inactivated) and Haemophilus influenzae Type b Conjugate Vaccine I.P. before the committee.

The pentavalent vaccine by Panacea Biotec is a life-saving vaccine that protects against five deadly diseases, mainly diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (Hib). It provides protection to a child from these five life-threatening diseases, Diphtheria, Pertussis, Tetanus, Hepatitis B, and Hib. DPT(Diptheria+Pertussis+Tetanus) and Hepatitis B are already part of routine immunization in India. The Haemophilus influenzae type b (Hib )vaccine is a new addition. Hib disease is a public health problem because it causes serious diseases that can result in hospitalization or death, including pneumonia (one of the major causes of death in children) and meningitis. Hib mostly affects children under five years of age. The children between four months and 18 months of age are most at risk.

Pentavalent Vaccine should be started for any child aged more than 6 weeks and can be given up to 1 year of age. By age of five years, most children have developed antibodies against the disease, hence serious diseases from Hib are uncommon in older children and adults. Together, the combination is called Pentavalent. Hib vaccine can prevent serious diseases caused by Haemophilus influenzae type b like pneumonia, meningitis, bacteremia, epiglottitis, and septic arthritis.

This combination vaccines significantly decreased the volume of immunization activities by reducing the number of injections, amount of pain, and accumulative exposure to preservatives and stabilizers that can contribute to adverse events. Furthermore, it has enabled the embodiment of additional vaccines into immunization schedules, thereby greater immunization coverage. Giving pentavalent vaccine reduces the number of pricks to a child, and provides protection from all five diseases. The pentavalent vaccine will replace the current Hepatitis B and DPT primary vaccination schedule in the immunization program.

At a recent SEC meeting for Vaccine, dated 21.02.2021 the committee extensively reviewed the protocol and the report of Phase II/III clinical trial report of Diphtheria, Tetanus, Pertussis, Poliomyelitis (Inactivated) and Haemophilus influenzae Type b Conjugate Vaccine presented by Panacea Biotec.

After detailed deliberation, the committee recommended for grant of approval to the vaccine.