Havisure: India's First Indigenous Hepatitis A Vaccine

Indian Immunologicals Ltd (IIL), a Hyderabad-based biopharmaceutical company and a subsidiary of the National Dairy Development Board (NDDB), has recently introduced 'Havisure,' India's first domestically developed Hepatitis A vaccine.

Havisure: Inida's First Indigenous Hepatitis A Vaccine
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'Havisure' plays a crucial role in the prevention of Hepatitis A, a highly contagious liver infection that is transmitted through the faecal-oral route via contaminated food or water. This poses a significant public health challenge that needs to be addressed.

The development of 'Havisure' aligns with the Atma Nirbhar Bharat initiative, as it aims to reduce dependency on imported Hepatitis A vaccines. The efforts made by IIL in developing this vaccine demonstrate a strong commitment to self-reliance.

About Havisure Vaccine

• IIL has recently introduced the 'first' Hepatitis A vaccine that has been developed indigenously. IIL is a subsidiary of the National Dairy Development Board (NDDB), which was established in 1965 with the aim of using dairying as a means to uplift rural communities in India.

• One of the key advantages of this vaccine is that it reduces the dependency on imported Hepatitis A vaccines in our country. With the launch of this indigenously developed vaccine, the need for imports will be significantly reduced.

• For routine immunization in children, the vaccine is recommended to be administered in two doses. The first dose is given when the child is above 12 months of age, followed by the second dose at least 6 months after the first.

• Apart from routine immunization in children, the vaccine is also recommended for individuals who are at risk of exposure to Hepatitis A. This includes those who are traveling to regions with a high prevalence of hepatitis A, as well as individuals with occupational risk or those suffering from chronic liver diseases.

About Hepatitis desease

• Hepatitis A is an inflammation of the liver caused by the hepatitis A virus (HAV) and it is highly contagious. 

• The hepatitis A virus (HAV) can be transmitted through consuming contaminated food and water or by coming into direct contact with an infected individual.

• This disease is prevalent in low- and middle-income countries. Hepatitis A can be either an acute (short-term) or chronic (long-term) infection.

• There are various types of hepatitis, each with different causes: - Viral hepatitis, caused by hepatitis viruses A, B, C, D, and E, is the most common type. - Alcoholic hepatitis is caused by heavy alcohol use. - Toxic hepatitis can be caused by certain poisons, chemicals, medicines, or supplements. - Autoimmune hepatitis is a chronic type where the body's immune system attacks the liver.

• The exact cause is unknown, but genetics and environmental factors may play a role. Hepatitis B, hepatitis C, and hepatitis D are primarily spread through contact with infected blood. Hepatitis B and D can also spread through contact with other body fluids, such as through sharing drug needles or unprotected sex.

• Symptoms of hepatitis may not be present in some infected individuals but common symptoms include fever, malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, dark-colored urine, and jaundice.

• There is no specific treatment for hepatitis A. Recovery from symptoms may be slow and can take several weeks or months. Effective prevention methods include implementing improved sanitation practices, ensuring food safety, and administering immunizations.

Hardwork behind the 'Havisure' Development

• Currently, India imports Hepatitis A vaccines. According to K. Anand Kumar, the managing director of IIL, their vaccine, called Havisure, is a true representation of Atma Nirbhar Bharat (self-reliant India) after eight years of hard work.

• The vaccine has undergone extensive studies, including pre-clinical toxicology studies in animals, phase I trials in humans, and phase 2/3 trials in eight centers involving nearly 500 healthy volunteers of different age groups. In a non-inferiority study comparing it with the GSK vaccine, Havisure was found to be very comparable.

• IIL will manufacture Havisure at their Gachibowli plant in Hyderabad. Initially, their focus will be on the domestic market, aiming to achieve self-sufficiency by producing 1 million doses per year. The development costs were not disclosed, but there is potential to increase production capacity.

• In addition to the domestic market, IIL exports vaccines to 50 countries and plans to export the Hepatitis A vaccine as well. They will seek WHO pre-qualification for Havisure, which would provide access to many international markets. The MRP (Maximum Retail Price) of Havisure is set at Rs 2,150 per dose.

• Havisure is the third vaccine launched by IIL in a single year, which is considered a significant achievement by Mr. Kumar, who credits the success to his team. The other vaccines launched by IIL include the measles and rubella vaccine and the TD vaccine.

Efforts of Government to eradicate Hepatitis

The National Viral Hepatitis Control Program is dedicated to eradicating viral hepatitis as a significant public health concern by the year 2030. Hepatitis B has been incorporated into India's Universal Immunization Programme (UIP), which offers free vaccination services to ensure widespread protection against the disease.