Rxs for Vxs

The international and multilateral effort to deploy vaccines against the infectious diseases of childhood and poverty has resulted in millions of lives saved and illnesses averted, contributing substantially to personal and national health and well-being.  But at the same time, there are scientific and political challenges that are limiting the extension the benefits of vaccination.  To overcome these challenges, the experts of the vaccine community have identified a set of goals.  In the technical/scientific category these include:

  • Vaccines that confer long-lasting immunity with a single dose (e.g., through new adjuvants);
  • Vaccines that do not require refrigeration;
  • Alternatives to delivery via injection;
  • Antigen design especially for parasitic diseases; and
  • Curative vaccines (see Gates Grand Challenges 1-6 and 12).

Under policy goals there are:

  • Expansion of funding options, especially for the low- and middle-income countries;
  • Strengthening immunization delivery and monitoring systems;
  • Improving public acceptance of vaccination; and
  • Utilization of evidence-based vaccination programs (Cochi 2011).

Often overlooked by the experts though is the role the biopharmaceutical industry can have by improving existing vaccines, inventing new ones, and increasing access and affordability through competition.  Thanks to the Bill & Melinda Gates Foundation, progress was announced on three efforts involving industry in the past month.

In early October, PATH’s program to help Chinese vaccine manufacturers enter the global health vaccine market reached a milestone (PATH is a Seattle-based product development program largely funded by the Gates Foundation).  WHO announced that it had added a vaccine for Japanese encephalitis made by China National Biotec Group (CNBG) to its list of prequalified vaccines, meaning UN agencies like UNICEF can purchase the vaccine for their immunization programs and purchases by eligible countries may be subsidized by the GAVI Alliance (WHO press release).  PATH has spent a substantial sum (I’m not sure how much) and has provided expertise over the past ten years to Chinese companies and the Chinese drug regulatory authority to meet the stringent requirements of manufacturing quality and processes of prequalification program (see the 2011 interview with PATH’s China program leader).  Japanese encephalitis is an important vaccine target since the mosquito-borne disease is endemic in much of south Asia and causes 10-15,000 deaths per year and the other available vaccine is expensive and requires multiple doses (WHO JE vaccine).  To achieve prequalification status, PATH provided CNBG $39 million since 2004, and CNBG invested about $131 million (China Daily article).  According to the Financial Times, the CNBG vaccine costs $.30 per dose, eight times lower than the retail price of a competing vaccine (FT blog and FierceVaccines article).

Also, last week at the 9th annual Grand Challenges Meeting held in Rio de Janeiro, two steps were announced to involve industry and increase competition.  In the first, Trevor Mundel, president of global health for the Gates Foundation, said that the foundation is starting a Vaccine Discovery Partnership program (VxDP) through which it will be funding research at companies from preclinical to Phase II trials to “reduce the risks associated with early-stage vaccine research, and increase the likelihood that the most promising new vaccines are developed quickly, and at lower cost” (Mundel blog post).  Also announced were the first two company participants, GlaxoSmithKline (GSK) and Sanofi.  According to its press release, GSK and the VxDP will devote a combined $1.8 million to explore how to make adjuvants, compounds that are co-administered with vaccine antigens to stimulate a robust immune response, more heat stable and thus improving he heat-stability required for vaccines to be used in under-resourced environments where refrigeration is lacking (GSK press release).  Specifically, the work will focus on the adjuvant, AS01, that is a component of GSK’s malaria vaccine candidate, RTS,S.  RTS,S is in Phase III testing in partnership with the Gates-backed PATH Malaria Vaccine Initiative.  Also given in the release were the details that VxDP projects may include multiple partners including academic and not-for-profit organizations, that companies will agree to match foundation funding and to provide global access, and that projects may also address nontechnical problems like the affordability and delivery of vaccines.  Sanofi Pasteur, the vaccine group of Sanofi, also announced its participation in the VxDP in a press release but did not specify its projects or funding (Sanofi press release).  While the VxDP’s emphasis on funding early-stage and higher risk projects is good, as I have noted in the past, the Gates Foundation often shies away from providing meaningful funding for highly speculative research, such as may be found at small biotech companies, and the requirement for matching funding will likely exclude them.  But then until the VxDP puts up a website with information on how to apply for participation, the amounts and commitment of funds, and its coordination and management functions, the potential of the program to help vaccine development broadly is not clear.

Also announced at the conference was the Gates Foundation’s first grant, as far as I know, to a government to make a vaccine, and hence possibly improving the competitive landscape and resulting in lower prices cost and increased availability.  As was reported by Reuters (Reuters article), Brazil’s minister for health, Alexandre Padilha, said that Bio-Manguinhos, a unit of the government’s Oswaldo Cruz Foundation (Fiocruz), will make a new measles/rubella vaccine specifically for export to developing countries in Africa, Asia, and Latin America.  The Gates is providing a grant of $1.1 million and possibly additional funds for development.  The goal will be to produce 30 million doses per year starting in 2017.  Measles is a potentially fatal viral disease for children and rubella, while mild in children can be spread to pregnant women causing miscarriage and defects.  Combined vaccines now reach 80% of the world’s children before the age of one year, but an estimated 158,000 children still die of measles annually (WHO Fact Sheet).  This is a small, but possibly meaningful, step given that Fiocruz will need at least tens of millions of dollars more to get the vaccine to market, the vaccine will not be on the market for 4-5 years, and its market share will be small, 10-20% (according to the WHO 225 million doses of combined measles vaccines were given in 2011).  But Fiocruz is a unique government entity having extensive experience in vaccine development and production, including being the recipient of the transfer of the technology for the measles vaccine production from GSK (for more about Fiocruz, see the Fiocruz website and my 2010 posting, “Fio-Cruise”).  I’m guessing that the Gates grant is a one-time deal, but if it is part of a wider plan to improve the ability of vaccine manufacturing programs of governments to meet their and other countries’ needs for basic vaccines, it could be a significant move.

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