Vaccine Marketing - Innovation and Marketing in the Pharmaceutical Industry - page 394

and others with similar dynamics require periodic changes. A disease like HIV with
its high and unpredictable variation of HIV antigens represents a major challenge
for the development of HIV vaccines (Moxon and Siegrist 2011 ). The development
of vaccines with sustained effi cacy against dynamic target antigens would represent
a major scientifi c breakthrough with signifi cant commercial potential.
Berndt et al. ( 2009 ) compared development times, success probabilities, and
development costs of vaccines and other pharmaceuticals. Development times for
vaccines have been shorter than for other types of pharmaceuticals, while mean vac-
cine FDA approval times have been longer, particularly for follow-on vaccines. But
the average capitalized costs are probably similar. Light et al. ( 2009 ) estimated the
capitalized R&D costs (without taking into account the cost of failures) of Merck's
RotaTeq rotavirus vaccine at $205-644 million and of GSK's Rotarix at between
$172 and $551 million.
Because of their impact on public health, governments are more strongly involved
in the development of vaccines than of therapeutics. The 2010 U.S. National Vaccine
Health Plan defi nes as one of its goals the development of new and improved vac-
cines, requiring the prioritization of new vaccine targets of domestic and global
public health importance (U.S. Department of Health and Human Services 2010 ).
The U.S. Biomedical Advanced Research and Development Agency (BARDA)
issues requests for proposals for prioritized vaccines that include Target Profi le
Specifi cations (TPP) including desired indications, formulations, dosing, delivery
mechanisms, packaging, storage and transport, shelf life, or other considerations
(Institute of Medicine 2010 ). 38
Governments promote vaccine development through “push” and “pull” mechanisms.
“Push” mechanisms subsidize costs, whereas “pull” mechanisms increase demand.
Push mechanisms include direct fi nancing of vaccine development, facilitating
research, harmonizing regulatory requirements, and tax credits for vaccine research
(Lieu et al. 2005 ). 39 Advance Market Commitments (Kremer 2001a , b ; Snyder
et al. 2011 ), which guarantee that manufacturers will be able to recoup production
costs, as well as investments in development, manufacturing capacity, and production
costs, are an example of a “pull” mechanism.
Four models of organizing vaccine research and development have been identifi ed
(Wilson et al. 2007 ): (1) predominantly private sector development; (2) public sector
vaccine design, and transfer to the private sector for clinical trials and production;
(3) predominantly public sector development; and (4) coordination by a nonprofi t
entity, for example, by public-private product development partnerships (PDPs).
PDPs are involved in efforts to develop vaccines against AIDS (e.g., the International
AIDS Vaccine Initiative, IAVI), malaria (e.g., the Malaria Vaccine Initiative), and
tuberculosis (e.g., the Aeras Global TB Vaccine Foundation) (Institute of Medicine
2010 ; see also Eskola and Kilpi 2011 ).
38 https://www.medicalcountermeasures.gov/FederalInitiatives.aspx .
39 For example, in February 2011 Novavax received a contract from BARDA for up to $180 million
for the development of a recombinant fl u vaccine. And the US government invested over a billion
dollars to help vaccine companies make the transition from traditional egg-based to cell-based
production systems (Extance 2011 ).