Gates gives $287 million for HIV vaccine research

News about the Gates Foundation making an enormous contribution to global health has become nearly a weekly occurrence lately. Today's headline is the announcement of 16 grants totaling $287 million to continue work toward a possible HIV vaccine. Here's the New York Times story, the AP story, and the press release from Gates with an accompanying background document offering details on the recipients and their projects.

The amount of funding is impressive in isolation but is even more staggering when compared to the total dollars directed to HIV vaccine work in years past. In 2004, for example, U.S. research totaled $582 million, with an additional $120 million worldwide. Yesterday's announcement marks a significant investment in the work and another strong show of support for it from Gates.

The Gates Foundation has been an active supporter of HIV vaccine research for several years, playing central roles in the creation and launch of the Global HIV Vaccine Enterprise (which we previously wrote about here). In fact, it's often difficult to determine where the Gates Foundation ends and the Enterprise begins, and vice versa. The grants announced yesterday fund projects linked to the Scientific Strategic Plan of the Global Vaccine Enterprise, awarded to very prominent vaccine researchers including Barton Haynes of Duke and David Ho of Rockefeller University, among others.

Gates gives $27.8 million to study rollout of HPV vaccines in developing world

As Reuters and the Seattle Post-Intelligencer are reporting today, the Gates Foundation has awarded $27.8 million for HPV implementation research to PATH, a Seattle-based non-profit and frequent recipient of Gates funding. (In April, PATH received $75 million from Gates for research on next-generation pneumonia vaccines, as we discussed here.)

This project is intended to determine the best approach for introducing HPV vaccines to developing countries. Initially, PATH will conduct pilot studies in India, Peru, Uganda, and Vietnam. As the PATH press release describes, both Merck and GSK are onboard with this program, pledging to provide their vaccines (once licensed) to the research initiatives. Dr. Regina Rabinovich, director of infectious diseases at the Gates Foundation, describes PATH's objective this way:

"PATH will help determine how to deliver these vaccines in developing countries, where systems to reach young women with health services are fragile, and cervical cancer may not be seen as a problem because so few women are screened."

There's no doubt that HPV vaccines would prevent far more cervical cancer deaths in developing countries than in the developed world, yet its projected cost and a host of implementation challenges mean that those populations needing the vaccine most will likely be among the last to receive it. Ultimately, finding a way to reduce dramatically (or underwrite) the vaccine's cost will be the greatest obstacle to HPV vaccines' global availability, but today's news is, by any estimation, a positive step toward that goal.

$75 Million from Gates to PATH for pneumonia vaccine

The Seattle Post-Intelligencer reports this morning...

"Pneumonia is the leading killer of children worldwide, taking a life every 30 seconds, so the Bill & Melinda Gates Foundation has awarded Seattle-based PATH $75 million to create inexpensive vaccines tailored specifically to the disease strains prevalent in poor countries."

The award will be announced today at the 5th International Symposium on Pneumococci and Pneumococcal Diseases in Australia. PATH, a non-profit that frequently receives support from Gates, describes its mission as "improv[ing] the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors."

The Seattle P-I continues...

"Children in the United States and Europe are routinely vaccinated against the leading strain of the bacteria, Streptococcus pneumoniae. But the Western vaccine does not protect well against varying strains found in developing countries -- where 90 percent of pneumococcal deaths occur.

Also, the current vaccine costs from $40 to $60 a dose -- a price that is completely unaffordable for most people in poor countries living on perhaps a dollar a day or less."

The vaccine referred to is Wyeth's Prevnar. Much like HPV, there are dozens of strains of pneumococcus, and Prevnar only provides protection against the 7 most common in the U.S. and elsewhere in the developed world. The stated goal of this project is to bring down dramatically the cost of a pneumonia vaccine (the story suggests $5/dose as a target) while developing candidate vaccines that are not specific to individual strains of the bacteria.

This news is only the most recent example of the leading role played by the Gates Foundation in steering vaccine research in new directions. Last week, we wrote about their commitment to a new tuberculosis vaccine for the developing world, and a few weeks earlier, we noted a Financial Times profile on Bill and Melinda Gates and their philanthropic efforts.

News that 'low-cost vaccine' may not be an oxymoron

The Financial Times has this story titled "Low-cost meningitis vaccine may be available in three years." Good news indeed, but if we read all the way to the third-from-last sentence in the story, we learn that the only 'news' is that phase I trial data for this vaccine candidate is positive, making the three-year prediction an optimistic (some might say best-case) scenario. Here's the press release from the Meningitis Vaccine Project, a Gates-funded consortium spearheaded by WHO and others.

Of course, anyone is free to issue a press releasing trumpeting the importance of their work, but it's an open question whether phase I trial results truly merit the media coverage they often receive. Given the years of additional research necessary and the high likelihood of failure along the way, such reports may only add to public confusion amid an already complex vaccine landscape. For this reason, you won't often see coverage of phase I vaccine trials here.

Why the exception this time? This passage in the FT story stood out:

"...The initiative would mark the first time a vaccine had been developed for and within the developing world, with an agreed low-cost price that was sustainable and profit-making for the manufacturer. It also marks a ground-breaking approach to developing the new medicines cheaply by using researchers from poorer countries, at a time when large western pharmaceutical groups claim it can cost $800m or more to produce drugs and vaccines.

By contrast, he said the Meningitis Vaccine Project was on budget to meet its objectives of developing, licensing, testing and introducing the vaccine in the period 2001-2011 for just $70m."

If this effort is ultimately successful (it's far too early to tell), it would mark a tremendous achievement for vaccines for the developing world.

There's no dispute that new vaccines against rotavirus and HPV would most greatly benefit developing countries, where the number of deaths caused by the viruses dwarf those in the U.S. and Europe. Sadly, however, the prices of these vaccines will limit their availability greatest in the parts of the world needing them most. With 2.1 million vaccine-preventable annual deaths (most of which involve much older and much cheaper vaccines), funding a new rotavirus series with a sticker price of $187.50/child would seem to face any number of challenges.

On the road with Bill and Melinda Gates

Today's Financial Times has a lengthy profile of Bill and Melinda Gates and their well-known philanthropic work. As it does at their foundation, vaccines are featured prominently in the story...

"Gates’s money also helped to develop a special ink for the labels of vaccine vials that changes colour at higher temperatures to show health workers when the vaccine has been spoilt and should not be used.

Both these simple but important technological developments have been supported by the Global Alliance on Vaccines and Immunisations (GAVI), a group set up with strong pressure from Gates, comprising representatives from governments, drugs companies and charities, that picked up the baton on immunisation in 2000 at a time when the large-scale campaigns of Unicef and the World Health Organisation were running out of steam.

GAVI is Gates’s response to criticism that he is obsessed with “blue sky” scientific research: supporting academics and pharmaceutical groups to develop vaccines and drugs for diseases such as HIV, malaria and tuberculosis which face such funding and scientific obstacles that they will take years to come to fruition, and may never prove successful."

As the story later explains, this approach too has been criticized by those believing funds could be better spent making proven therapies more widely available. Either way, it's hard to argue that any group has more influence than the Gates Foundation in shaping the future of global health.