A Shot in the Arm

The end of a calendar year is a favorite time to look back.  (Hu)man of the year, movie of the year, event of the year, (w)rapper of the year, bozo of the year stories abound, but I’d rather look back only if it helps me figure out what may be coming.  Granted “past performance is no guarantee of future results” (but it’s the only thing we’ve got), I think it’s worthwhile to review my 2010 posts and guess what may be important stories in global health in 2011.  If frequency correlates to importance, then vaccines will be big news next year.  I wrote about vaccines at least 20% of the time, about 10 posts including:  the success in childhood vaccinations thanks to GAVI and the International Finance Facility for Immunisation (1/21), techniques for making vaccines faster and cheaper and the role of developing world manufacturers in meeting developing world needs and as a model for the Big Pharma vax companies (4/8), a possible therapeutic TB vaccine (6/24), new methods for administration like dry powder inhalation (10/7), possible preventative HIV vaccines (11/28 and 12/2), and the launch of a new meningitis vaccine (12/16).

Vaccines have a lot going for them and certainly my interest reflects recent scientific and technical advances as well as their “bang for the buck” in addressing global and public health problems.  Clearly, I am no expert and it is likely someone more knowledgeable and eloquent than I has written on the history of vaccines and their importance to human health (like the History of Vaccines which I’ll add to my to-read site list).  But here are what I think I know are the attributes of vaccines:

  • most vaccines prevent, rather than cure, disease (clearly a big cost-saver) and thus work by amplifying the activity of innate biology, the immune system, rather than poisoning the problematic organisms;
  • they have long history of safety over a broad range of diseases and ages, although concurrent illness or under-nutrition affects efficacy (a problem in low-resource settings);
  • with genomic sequencing, new understanding of immunity, and new screening techniques for antigens and adjuvants (non-antigenic immune system co-stimulants) (e.g., the approaches of Genocea, VaxInnate, and many other companies and academics), the invention of new vaccines should be easier;
  • as a biological product, vaccines are challenging to manufacture but there has been considerable commercial investment into new technologies to make processes more scalable, faster, and cheaper by companies (e.g., Novavax; Crucell, soon to be part of Johnson and Johnson; and Xcellerex) and the US government (e.g., DoD through DARPA, Advanced Manufacturing Program, and NIAID, Vaccine Research Center);
  • there is a growing worldwide manufacturing capability outside the traditional non-multinationals (e.g., the Serum Institute of India, Serum Institute of India and Bio-Manguinhos of Brazil);
  • vaccines are amenable to and affordable by public health distribution systems with material costs that can be as low as $0.50 to 3.50 per dose (e.g., Pfizer’s and GSK’s response to GAVI’s recent pneumonia vaccine Advanced Market Commitment, Bloomberg article) and delivery costs as low as $2.00 per person (e.g., Medecins Sans Frontieres 2006 report);
  • there are major donor-funded global health vaccine development programs like IVAI (IAVI), Malaria Vaccine Initiative (MVI), and the TB Vaccine Initiative (TBVI), and research institutes like the Hillman Laboratories, a joint Wellcome Trust-Merck institute in India (Hillman Press Release), and the Novartis Vaccine Institute for Global Health; and
  • the future need for vaccines, and therefore market, is likely infinite since the infectious agents will always be around (unless humans are the only reservoir as with smallpox) and they can mutate to decrease vaccine effectiveness.

So peering into the inky darkness of the future, what could be the big vaccine stories in 2011?  Here are a few guesses:

  • Novavax and Avimex Laboratories, their local partner in Mexico, announce positive clinical results from a Phase IIB pivotal study of a H1N1 pandemic influenza vaccine thus clearing the way for Mexican registration of the first Virus-Like Particle (VLP) vaccine, potentially a fast and cheap route to vaccines;
  • likewise, Archivel Farma S.L. of Badalona, Spain (Archivel) announces successful Phase II results for its therapeutic TB vaccine in individuals with or without concomitant HIV infection in South Africa;
  • the Global Polio Eradication Initiative (GPEI) announces that it is on track for success in 2012 after 22 years of effort;
  • after more than seven years and several major awards (MEND News), Medicine in Need, a non-profit research organization spun out from Harvard University and funded by at least $11 million of Gates Foundation money, announces it will start a human trial of its nanoparticle TB vaccine sometime in 2011 (or 2012 or later);
  • somewhat speculatively, after the 2010 success of its Advanced Market Commitment call for a pneumonia vaccine (Vaccine AMC),  GAVI announces an AMC for a “pediatric super-vax” to cover diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3, specifically to bring the cost down from $50 per dose (the price of GSK’s Pediarix®, CDC Vaccine Price List) to a more affordable $5.00 per dose; and
  • even more speculatively, the US government decides to donate the excise tax it collects on vaccines each year ($0.75 to 3.75 per dose, maybe about $50 million?) to GAVI for its new AMC and inspired by this largess, the American Pediatric Society, US branch of UNICEF, and concerned persons start a campaign to ask parents to donate a dollar when getting their kid vaccinated, raising another $10 million.

Wishing you a happy and prosperous 2011.

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