Serum to launch late phase human trials on inhalable measles vaccine in India

Serum Institute of India, the leading vaccine maker from the country, will carry out phase 2 and phase 3 human trials to test the efficacy of an investigational dry powder measles vaccines which is administered through inhalation.

Serum Institute haas been given the permission to conduct advanced human studies for the inhalable measles vaccine in the country by the Central Drugs Standard Control Organisation (CDSCO)–India’s apex drug regulatory authority, Minister of State for Health and Family Welfare Dinesh Trivedi informed the the Indian parliament.

Serum has been conducting phase 1 clinical trials for evaluating the safety and efficacy of the measles inhalable vaccine in India.

Serum is granted permission to conduct phase 2 and 3 clinical trials after satisfactory evaluation of data generated from the phase 1 trial of the measles inhalable vaccine, the minister informed.

Trivedi said the trials of the measles inhalable vaccine are co-sponsored by the World Health Organisation (WHO).

If approved to be marketed, the measles inhalable vaccine could be the first dry powder vaccine that can be inhaled directly into the lungs.

The dry powder vaccine contains weakened measles virus mixed with supercritical liquified carbon dioxide to produce microscopic bubbles and droplets. These droplets are then dried to make an inhalable powder.

The powder is administered using a a small, cylindrical, plastic sack, with an opening like the neck of a plastic water bottle.

Unlike the traditional liquid vaccines, which needs to be administered through injection, the new powdered measles vaccine can be taken in by one deep breath from the sack.

The new dry powder vaccine may reduce the risk of infection from unsterilised needles and may also prove more effective against the disease.

This new prick-free method would also ensure compliance among kids who often refuse inoculations because of their fear of needles.

The dry powder inhalable vaccine is also a “perfect fit”  for use in backward areas of developing countries, which often lack the electricity for refrigeration, clean water, and sterile needles needed to administer traditional liquid vaccines, according to Dr. Robert Sievers, who led the team that developed the vaccine.

Childhood vaccines that can be inhaled and delivered directly to mucosal surfaces have the potential to offer significant advantages over injection. Not only might they reduce the risk of infection from HIV, hepatitis, and other serious diseases due to unsterilized needles, they may prove more effective against disease, Dr Sievers stated.

Measles virus, like many other viruses, can enter the body through inhalation.

Dry powder measles vaccine has the potential to effectively vaccinate infants, children and adults by inhalation, avoiding the problems associated with liquid vaccines delivered by injection, he added.

Dr Sievers, of the University of Colorado, Boulder, has a patented process known as the Carbon Dioxide-Assisted Nebulization with a Bubble Dryer (CAN-BD) for the inhalable measles vaccine.

Dr Sievers and his team are now working on an inexpensive dry powder inhaler that would deliver measles or influenza vaccines to developing nations.

The inhaler has been found to be just as effective in delivering measles vaccine as the traditional injection in animal tests.

Measles affects millions of infants and children, worldwide. Nearly 200,000 children die of measles and related complications in India every year, accorrding to estimates.

Serum Institute of India Ltd is expected to have a demand growing to 400 million doses of measles vaccine a year.