Biomedical Engineering Reference
In-Depth Information
Vaccines which have been prequalifi ed can compete for UNICEF and PAHO
business. Because WHO prequalifi cation is a quality signal, many individual coun-
tries use the list of WHO prequalifi ed vaccines when purchasing directly from vac-
cine manufacturers (International AIDS Vaccine Initiative
2008a
). WHO prequalifi ed
vaccines are subject to routine site audits and can be delisted in case the require-
ments for prequalifi cation are not met.
18
13.3.5
Vaccine Purchasers
13.3.5.1
Public Purchasers
In public markets, the decision to purchase a vaccine, its procurement, and its fund-
ing is often under the responsibility of different organizations.
The Decision to Purchase a Vaccine
The decision to purchase a vaccine can be made by national and regional authorities.
For example, the US NITAG ACIP can add a vaccine to the federal VFC program,
which funds vaccines for low-income children. At the same time, individual states
can decide to purchase a vaccine for children not eligible for VFC, or to purchase a
vaccine not funded at all by a federal program (Orenstein et al.
2007
; Lindley et al.
2009
; Freed and Cowan
2002
).
A vaccine which has secured a recommendation from a country's NITAG has a
much greater chance of being purchased by that country's public purchasers than
one without. In most countries, NITAG recommendations are advisory, but some-
times they are mandatory, for example in the UK (Hall,
2010
), and in the U.S. when
ACIP designates a vaccine for VFC funding.
19
In Australia, a positive NITAG rec-
ommendation is a necessary condition for government funding of a new vaccine
(the government cannot fund without a positive recommendation), but is not suffi -
cient (the government is not obliged to fund when the recommendation is positive)
(Nolan
2010
).
Public opinion and political pressure can infl uence public vaccine purchasing.
For example, the initial negative recommendation concerning the HPV vaccine
Gardasil by the Australian NITAG immediately unleashed widespread opposi-
tion, prompting the Health Minister and the Prime Minister to express their
18
An example of a recent delisting announcement can be found at the following address:
http://
19
To make a UK NITAG recommendation binding, the recommendation must be based on a ques-
tion specifi cally 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
).
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