Polio eradication campaign aims to increase use of injectable vaccines

excerpted from US FDA and The Economist

US Food and Drug Administration (FDA) is a collaborator

Few diseases in U.S. history have been as devastating as polio. At the height of the epidemic in 1952, there were nearly 60,000 cases in the United States and more than 3,000 deaths.

The crippling, highly infectious disease is caused by a virus that invades the nervous system and can paralyze a person in a matter of hours. It mainly affects children under 5, but can cause paralysis in unvaccinated adults. The most famous victim of polio was President Franklin D. Roosevelt, who contracted it at age 39, paralyzing him from the waist down.

A successful vaccination program has wiped out polio in the U.S. But the disease still exists in some parts of the world and can easily spread to countries where it has previously been eradicated, requiring continued vaccination of the entire world population.

FDA works with the World Health Organization (WHO) and other partners [including Rotary] to make safe and effective vaccines available all over the world.

In 1988, when WHO proposed the goal of complete polio eradication, more than 350,000 people were paralyzed by polio in 125 countries on all continents. Compare this with just 223 cases in 2012 in five countries. This is the good news.

However, the bad news is that WHO's original target for eradicating polio was 2000. "Thirteen years later, we're still not there," says Konstantin Chumakov, Ph.D., associate director for research within FDA's Office of Vaccines Research and Review.

Chumakov gives two main reasons for this: "We didn’t realize how tough this job would be, and there was a scientific realization that the viruses in the oral vaccine used in the eradication campaign can mutate to virulent forms that circulate in the population."

The vaccine used globally in resource-limited countries is the oral vaccine (OPV) made from a live virus. It is inexpensive and easy to give—a volunteer worker can place a drop on a child’s tongue.

The injectable polio vaccine (IPV) used in the U.S. and other developed countries is made from the killed (inactivated) virus. It is injected into the muscle, and must be given by a health care professional. It cannot mutate and cause polio. But it costs dollars versus pennies per dose.

The inactivated virus vaccine is made from highly virulent strains, says Chumakov. To prevent the virus from being accidentally released into the environment, manufacturers must maintain complex, expensive biosecurity measures. There are only a few manufacturers who supply the killed virus vaccine.

For all these reasons, WHO, Rotary International, the Bill and Melinda Gates Foundation and other organizations support scientists working on the development of new vaccines against poliovirus. "This is critical," says Chumakov. "Without new vaccines, we will not be able to achieve and maintain eradication."

 Indian company wants to reduce cost of IPV

The Serum Institute is the world’s number one producer of measles and DTP (diphtheria, tetanus and pertussis) vaccines. The company founder, Cyrus Poonawalla met Bill Gates at a dinner last year; their conversation led Mr Poonawalla to purchase a Dutch pharma company, Bilthoven Biologicals, which makes IPV. This move allowed the Serum Institute to become a principal supplier of this type of vaccine.

Currently, Sanofi and GlaxoSmithKline are the primary producers of IPV. They sell it to UNICEF for more than $5 per dose, says Mr Poonawalla. But Serum will now offer it for nearly half that price. And Mr Poonawalla wants to “crash” the price further, to $1.60.

The steep drop is simply a matter of numbers, he explains. Once larger quantities are purchased (upwards of 5m doses—which is expected as more countries transition from OPV to IPV) it will become financially viable to sell the vaccine at this price.

The French company Sanofi  supplied 1.5m doses of IPV to Indonesia at no cost. The donation was part of a study to see how the tropical climate might affect the vaccine. Sanofi also has plans to expand its IPV production capacity.