CDSCO panel rejects Sanofi clinical study report on Hexavalent vaccine

This came following the committee's observation that the firm had not carried out the study in accordance with the approved clinical trial protocol.

At a recent SEC meeting for vaccines, the drug major Sanofi presented its proposal for grant of permission of Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA), Haemophilus influenza Type b Conjugate and Poliomyelitis (Inactivated) Vaccine (Adsorbed) (Hexavalent vaccine) for administration of booster dose by intramuscular administration in age group of 12-24 months along with the Phase III clinical trial report.

Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA), Haemophilus influenza Type b Conjugate and Poliomyelitis (Inactivated) Vaccine (Adsorbed) (Hexavalent vaccine) helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b.

Diphtheria is an infectious disease that usually first affects the throat. In the throat, the infection causes pain and swelling, which can lead to suffocation. The bacteria that cause the disease also make a toxin (poison) that can damage the heart, kidneys, and nerves.

Tetanus (often called lockjaw) is usually caused by the tetanus bacteria entering a deep wound. The bacteria make a toxin (poison) that causes spasms of the muscles, leading to an inability to breathe and the possibility of suffocation.

Pertussis (often called whooping cough) is a highly infectious illness that affects the airways. It causes severe coughing that may lead to problems with breathing. The coughing often has a "whooping" sound. The cough may last for one to two months or longer. Whooping cough can also cause ear infections, chest infections (bronchitis), which may last a long time, lung infections (pneumonia), fits, brain damage, and even death.

Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). In some people, the virus can stay in the body for a long time, and can eventually lead to serious liver problems, including liver cancer.

Poliomyelitis (often just called polio) is caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness, most commonly in the legs. Paralysis of the muscles that control breathing and swallowing can be fatal.

Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections and can cause meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness. Infection can also cause inflammation and swelling of the throat, leading to difficulties in swallowing and breathing, and infection can affect other parts of the body such as the blood, lungs, skin, bones, and joints.

At the recent SEC meeting for vaccines held on September 6, 2022, the expert panel reviewed the proposal for grant of permission for Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA), Haemophilus influenza type b conjugate, and Poliomyelitis (Inactivated) Vaccine (Adsorbed) (Hexavalent Vaccine) for administration of a booster dose by intramuscular administration in the age group of 12–24 months along with the Phase III clinical trial report.

After detailed deliberation, the committee noted that the firm has not conducted the study as per approved clinical trial protocol, and the committee recommended that the clinical study report is not acceptable as presented.