Polio Parallels

by Dr. Orin Levine - Executive Director, International Vaccine Access Center, Johns Hopkins University - huffingtonpost.com - October 27, 2011

Last week in Seattle, Bill Gates announced breakthrough results from a large malaria vaccine trial. The study, conducted in seven sub-Saharan African countries, showed that the most advanced malaria vaccine -- called RTS,S -- could cut the risk of malaria by as much as 56 percent among African children.

The results generated international buzz and raised the hopes that malaria, a disease that extracts a major toll in Africa and a handful of other countries, might be controllable through vaccination. What struck me most about this announcement is how it resembled -- and in some unfortunate ways, currently differs from -- the effort to develop a safe, effective polio vaccine as outlined by David Oshinsky in his award winning book, Polio: An American Story.

The first unmistakable parallel has been the role of the private foundation as the primary driver of vaccine development. In the case of polio, the National Foundation for Infantile Paralysis (later known as the March of Dimes) led the push for a vaccine. With malaria, it's been the Bill & Melinda Gates Foundation. At times, this has created tensions with a technical field that traditionally drew its funding -- and its leadership -- from scientific agencies and public institutions.

The second similarity has been the use of the announcement to generate major media attention. The results of the Francis Field Trials of the inactivated polio ("Salk") vaccine were announced at a press conference attended by national media. The timing of the announcement -- April 12 1955, the 10th anniversary of the death of president and polio survivor Franklin D. Roosevelt -- was designed to provide a poignant backdrop for the event. Last week in Seattle, the malaria announcement was made by Foundation leader Bill Gates himself before a sea of media at the Gates Foundation's Malaria Forum, a similarly symbolic setting.

The third parallel has to do with the vaccines themselves. Both are somehow regarded as the 'Rodney Dangerfields' of their scientific arenas -- inelegant workhorses rather than the carefully crafted examples of advanced scientific engineering that they actually are. Likewise, discussions of their respective levels of protection -- around 50% -- are as often accompanied by an apology as an amen. For a disease that causes hundreds of millions malaria of cases every year, takes nearly 800,000 children's lives and has been estimated by economist Jeff Sachs to reduce the economies of Africa by as much as 18%, a vaccine that prevents half those cases would seem to most people like a pretty big step forward. But to a technical community accustomed to other vaccines that routinely provide 80%, 90%, or even 95% protection, this level of protective efficacy is considered almost disappointing to some scientists.

Similarly, when the polio vaccine results were initially announced and the protective efficacy versus type 1 poliomyelitis was estimated at 60-70%, the results, according to Oshinsky's account, were at times turned around to describe the vaccine as 30-40% ineffective.

But there are also some particularly disappointing ways in which the polio and malaria efforts could differ.

Within a week of the announcement of the results from clinical trials back in 1955, the polio vaccine was licensed, and multiple manufacturers immediately lined up to produce the vaccine. What's more, the U.S. government stepped up to pay for the vaccine within a month despite the fact that there was a president in the White House with a predilection toward fiscal conservatism and free market solutions.

While more scientific evaluation of RTS,S is still underway and needs to be completed, this latest achievement should serve as an early signal for all parties to begin working earnestly to anticipate and overcome vaccine access issues. To date, RTS,S has not been approved by regulatory agencies, and the sole manufacturer of this vaccine - the international pharmaceutical company GSK -- has yet to name the vaccine's price. At least as importantly, the international donors who are likely going to have to pay for the vaccine have not yet made clear any intention to buy it.

For this malaria vaccine to have the kind of impact on improving health that polio vaccines have had, the time is now for two important steps. First, the Global Fund for AIDS, TB, & Malaria and the GAVI Alliance have the same major donors. These donors need to decide how their support will be used to fund this vaccine. Is it through the Global Fund, the GAVI Alliance, both or neither?

Second, given the lead time necessary to manufacture these vaccines, the manufacturer and the buyers (whomever is chosen) need to begin discussions about pricing and volumes of vaccine now - and need to move toward making development and purchasing commitments. Only by taking these steps now will we quickly realize the promise of RTS,S just like we did with the polio vaccine -- and begin saving the lives of those most desperately in need.

Follow Dr. Orin Levine on Twitter: www.twitter.com/orinlevine

http://www.huffingtonpost.com/dr-orin-levine/polio-malaria-vaccine_b_1033835.html