Will Promising New Malaria Vaccine Deliver?

Nairobi, Nov. 5, 2009 — -- A new vaccine offering the best hope in the fight against the killer disease malaria could be on the market for African children in three to five years -- but the real challenge may be in making sure that it's available to the babies and toddlers in some of the poorest, most remote areas of Africa.

With many life-saving medications in Africa, such as anti-retroviral drugs for HIV/AIDS, getting them out to people has been nearly as difficult to deal with as manufacturing the drugs themselves.

The vaccine for Hepatitis B, for example, took nearly 10 years after being approved to be available to the general African population. The Path Malaria Initiative, funded by the Bill and Melinda Gates Foundation and the pharmaceutical company GlaxoSmithKline, says it is taking unprecedented measures to try and ensure that countries will be ready to distribute the malaria vaccine, called RTSS, as soon as it's approved.

"It is important to start this process early because it takes time to generate the data that are going to be required to use or not to use the vaccine or to put in place the resources that are required for a maximum uptake," Christian Loucq, director of the Path Malaria Vaccine Initiative, told ABC News.

The vaccine is still in its final stage of development, but issues of distribution and implementation are being worked on in a parallel process along with the final phase of testing. While African scientists and doctors run the final trial using 16,000 babies and toddlers in seven different Sub-Saharan African countries, both GlaxoSmithKline and Path-MVI are working with African government health officials to make sure they have the capacity to get people vaccinated.

$500 million have been put into the making and testing of the RTSS vaccine so far, but making easily accessible will cost hundreds of millions of dollars more. The goal is for it to be free, and be included in the standard vaccination booster babies receive before their first birthday.

By giving the vaccine to children when they're young, scientists hope they will develop immunity to the disease as they grow up. There are already discussions with other aids groups and African governments on how to ensure the RTSS vaccine will be free to families.

"The malaria vaccine is something people are waiting for. There are organizations that pick up the cost of such immunizations in public programs," said Loucq. "We are informing those organizations where we are in the process. They've asked to be informed on a regular basis to get ready for the purchase of the vaccine when it's going to be available."

RTSS has been in development since 1987, and has been through two other trials in the last ten years. So far, the vaccine is proving about 50 percent affective in fighting malaria in children under the age of 18 months.

According to the World Health Organization, the disease kills an average of one child every 30 seconds, primarily in Africa, so even if the vaccine is not 100 percent affective, health experts say it will still save hundreds of thousands of lives.

In the Siaya District Hospital in Western Kenya, the area President Obama's father hails from and where members of his family still reside, malaria is a huge "burden," said Dr. Jackson Omoto, the head of one rural hospital. He said his hospital treats more than 70,000 malaria patients every year, most of them small children.

"Malaria is such a big problem," Omoto said. "There are various programs that have been going on over the years to control malaria. We've had mosquito nets, we've had indoor insidious spraying, but still the disease remains a huge problem."

"If this vaccine becomes available to the general pop it will reduce malaria within the community significantly."

Dr. Joel Cohen, the inventor of the vaccine at GlaxoSmithKline, said that while he is proud of what the RTSS has done so far, he eventually believes there will be a vaccine to eradicate almost all malaria, much as polio and measles have already been controlled.

"You think of the tremendous scientific challenge that making a malaria vaccine represents, 20 years ago there was a sense that it was going to be impossible," said Cohen. "Today I'm confident that there will be in the future a second-generation malaria vaccine. Most probably it will build on what we've learned from RTSS."