Abstract
Long perceived as an unattractive segment of the pharmaceutical industry, most of the leading firms have stepped up vaccine investments in recent years. Unlike mainstream pharmaceuticals, vaccines generally treat healthy individuals, most are administered only once or very infrequently during a life time, and they engender positive externalities, because vaccinated individuals reduce the risk of transmission to unvaccinated persons, leading authorities to mandate some vaccinations. Resistance to vaccination may lead to immunization failure and disease resurgence.
The public and private market each account for about one-half of the global vaccine market in value. Bringing new vaccines to market requires carefully orchestrated programs targeting the multiple types of customers. For example, in parallel with the clinical development program designed to obtain FDA approval for its HPV vaccine Gardasil, Merck developed health-economic evidence to obtain a positive recommendation for vaccination and public financing. Physician educational programs and unbranded DTC campaigns were started many months prior to launch. Following FDA approval and positive vaccination and public financing recommendations, Merck developed market access programs targeted at states and private insurers, and launched branded physician and DTC campaigns.
Successful global diffusion of a vaccine generally requires the development of a tiered pricing policy which takes country differences in per capita income into account.
A successful launch often creates new problems for vaccine marketers. They must maintain the motivation to engage in and pay for vaccination despite the quasi-disappearance of the disease. And they must combat anti-vaccination information claiming that the vaccine is the cause of serious side effects.
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Notes
- 1.
Some vaccines can be used both for prevention and treatment. For example, rabies vaccines can also be administered after an individual has been exposed to the virus (e.g., following a bite by a rabid dog).
- 2.
Provenge’s sales have proven disappointing so far. http://blogs.wsj.com/health/2011/08/04/dendreon-shares-plummet-as-company-withdraws-provenge-sales-forecast/.
- 3.
Their slower onset of action compared with other therapeutic biologics represents a specific challenge for therapeutic vaccines.
- 4.
State-owned vaccine manufacturers include the China National Biotec Group (CNBG), the largest vaccine manufacturer in China, the Central Research Institute in India, Butantan and Fiocruz in Brazil, and PT Biofarma in Indonesia.
- 5.
On March 1, 2011, WHO announced that the national regulatory authority of China met WHO indicators for a functional vaccine regulatory system, which meant that Chinese-made vaccines were henceforth eligible to apply for WHO pre-qualification.
- 6.
The 4 % share refers to volume. The value share of non-Japanese manufacturers is estimated at 20 % (private communication, industry executive from Japan).
- 7.
Depending on the state, children must be vaccinated against some or all of the following diseases: mumps, measles, rubella, diphtheria, pertussis, tetanus, and polio.
- 8.
For example, state legislation in California requires that all students 19 years in state universities and the UC system provide proof of hepatitis B vaccination or a waiver. http://www.immunize.org/laws/hepbcollege.asp, accessed June 13, 2011.
- 9.
For example, New Hampshire requires that all hospital employees and inmates receive flu vaccination.
- 10.
http://www.vaccinesafety.edu/cc-exem.htm, accessed June 13, 2011.
- 11.
http://ecdc.europa.eu/en/publications/Publications/2011_June_measles_montly.pdf, accessed August 31.
- 12.
A comprehensive review by the IOM (Institute of Medicine) (2011) concluded that the evidence favors rejection of a causal relationship between measles–mumps–rubella (MMR) vaccine and autism, and that there is inadequate evidence to accept or reject a causal relationship between hepatitis B vaccine and multiple sclerosis.
- 13.
Some NITAGs have broader mandates to work in other areas of communicable disease control (Gessner et al. 2010).
- 14.
For example, the NITAG in the UK is the Joint Committee on Vaccination and Immunisation (JCVI) (Hall 2010). Australia has the Australian Technical Advisory Group on Immunisation (ATAGI) (Nolan 2010), China the Experts Advisory Committee on Immunization Program (EACIP) (Zheng et al. 2010), and South Africa the National Advisory Group on Immunization (NAGI) (Schoub et al. 2010). More information on NITAGs can be found in Vaccine 28S (2010).
- 15.
The SIVAC Initiative (Senouci et al. 2010) and PAHO’s ProVac Initiative (Jauregui et al. 2011), both funded by the Bill & Melinda Gates Foundation, have as their main mission to help countries establish or strengthen their NITAG’s capacity to make informed, evidence-based decisions on the introduction of new vaccines.
- 16.
As of 1 January 2010, ACIP liaison representatives include representatives from the American Academy of Family Physicians (AAFP), American Academy of Pediatrics (AAP; two representatives), American College of Obstetricians & Gynecologists (ACOG), American College of Physicians (ACP), and American Medical Association (AMA), among others (Smith 2010a)).
- 17.
The list includes 4 agencies in the Americas (United States, Canada, Brazil, and Cuba), 11 agencies in Europe, 5 in Asia (China, India, Indonesia, Japan, and Korea), Senegal, and Australia. http://www.who.int/immunization_standards/national_regulatory_authorities%20/offices/en/index.html/, accessed August 15, 2011. The Chinese State Food and Drug Administration (SFDA) achieved joined the list in March 2011, http://www.who.int/immunization_standards/vaccine_regulation/nra_china_functional/en/, accessed August 15, 2011. http://www.who.int/immunization_standards/national_regulatory_authorities/offices/en/index.html, accessed July 4, 2013.
- 18.
An example of a recent delisting announcement can be found at the following address: http://www.who.int/immunization_standards/vaccine_quality/DTP_mono_hepb_aug2011/en/index.html, accessed August 23, 2011.
- 19.
To make a UK NITAG recommendation binding, the recommendation must be based on a question specifically referred by the Secretary of State, be based on an assessment which demonstrates cost-effectiveness, and not relate to travel or occupational health (Hall 2010).
- 20.
CDC provides funds to states and other jurisdictions under the VFC program, which finances all ACIP-recommended childhood vaccines, and Section 317 funds, a program for which there are no eligibility requirements. The 317 funds must be appropriated each year by Congress.
- 21.
States purchase directly from a manufacturer when there is no federal contract for a specific vaccine, and when they are not allowed to rely on the federal contract for a vaccine, because they are using nonfederal funds, particularly funds from insurance companies (Benatar et al. 2010). Despite their smaller purchase volume, some states have reported instances in which they were able to negotiate a price below the federal contract price (Freed and Cowan 2002).
- 22.
The Gulf Cooperation Council (GCC), which procures vaccines for the UAE, Bahrain, Saudi Arabia, Oman, Qatar, and Kuwait, is another supranational vaccine procurement agency. See DeRoeck et al. (2006) for a review of the GCC.
- 23.
Excluding China, India, and Indonesia, 92 % of the 2007 birth cohort in low income and 47 % of the birth cohort in lower middle income countries were covered by UNICEF procurement. The percentage of UNICEF procurement in high income OECD countries was 0 %, 2 % in high income non-OECD countries, and 1 % in lower middle income countries (Rosenbom 2010).
- 24.
http://www.unicef.org/supply/index_vaccines.html, accessed August 22, 2011.
- 25.
UNICEF procures for governments, NGOs, UN agencies, international financial institutions, philanthropic organizations, and universities, but not for profit-making entities and individuals.
- 26.
- 27.
As of August 2001, the 35 member states include Argentina, Brazil, Canada, Mexico, and the United States, among others.
- 28.
http://new.paho.org/hq/index.php?option=com_content&view=article&id=1864&Itemid=2234&lang=en%20, accessed July 4, 2013.
- 29.
The number of potentially supported vaccines expanded from the initial three (vaccines against Hib, hepatitis B, and yellow fever) to currently six (pneumococcal, rotavirus, and meningococcal A conjugate vaccines).
- 30.
For GAVI-eligible countries in Latin America, PAHO is GAVI’s primary procurement partner (Anonymous 2011).
- 31.
http://www.unicef.org/supply/index_gavi.html, accessed August 23, 2011.
- 32.
http://www.gavialliance.org/library/news/press-releases/2011/donors-commit-vaccine-funding-to-achieve-historic-milestone-in-global-health/, accessed August 23, 2011. Donors (governments, foundations, private individuals, and companies) support GAVI through direct funding, long-term pledges to the International Finance Facility for Immunisation (IFFIm), an innovative financing mechanism which converts the commitments into immediately available cash resources by issuing bonds on the capital markets, and long-term pledges to the Advance Market Commitment (AMC) for pneumococcal disease (Kremer 2001a, b; Snyder et al. 2011).
- 33.
There is also an inofficial route in which pharmacists dispense a vaccine to regular clients, who subsequently return with the prescription obtained during the vaccine administration visit.
- 34.
Spreading purchases over several brands also reduces the profit margin because of higher purchase prices due to a lower purchase volume per brand.
- 35.
All new health plans, and health plans that lose their grandfathered status, must provide all ACIP-recommended vaccines delivered by an in-network provider at no cost sharing.
- 36.
http://www.cdc.gov/vaccines/vpd-vac/default.htm#newvacc, accessed August 28, 2011.
- 37.
The H1N1 pandemic raised fears that it might spread to the flocks that produce the eggs required for flu vaccine production and thereby strangle vaccine supply. This stimulated the development of new process technologies such as cell-based production systems which are expected to increase the speed and volume of flu vaccine supply (Extance 2011).
- 38.
- 39.
For example, in February 2011 Novavax received a contract from BARDA for up to $180 million for the development of a recombinant flu 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).
- 40.
In Skea et al.’s (2008) study, some parents were quite critical of other parents who did not vaccinate healthy children.
- 41.
27.8 % of parents agreed that “children get too many vaccines during the first 2 years of life,” and 21.9 % of them strongly/somewhat agreed with the statement “I am concerned that my child’s immune system could be weakened by too many vaccines.”
- 42.
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Angelmar, R., Morgon, P.A. (2014). Vaccine Marketing. In: Ding, M., Eliashberg, J., Stremersch, S. (eds) Innovation and Marketing in the Pharmaceutical Industry. International Series in Quantitative Marketing, vol 20. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7801-0_13
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