[afro-nets] AMANET Call for European Candidate Malaria Vaccines

General afro-nets
1

AMANET Call for European Candidate Malaria Vaccines Ready for
Clinical Development in Africa
-------------------------------------------------------------

http://www.amanet-trust.org/ext/csg/calls/2005/eurovaccines.htm

BACKGROUND

The mission of AMANET is to promote capacity strengthening and
networking of malaria R&D in Africa. Presently, the focus is on
the development of candidate malaria vaccines which meet rele-
vant requirements and are ready for evaluation in malaria-
endemic areas at phase I and II clinical trials. This is compli-
mented with capacity strengthening and site development activi-
ties for strategically preparing African research centres to un-
dertake the clinical evaluation of potential candidate vaccines
according to ICH-GCP guidelines. The role of AMANET in malaria
R&D is based on the need to shorten the time and investment be-
tween discovery of potential interventions and their deployment.
Recognising the lack of mechanisms outside pharmaceutical indus-
try for developing malaria vaccines, the European Commission's
EuropeAid Co-operation (AIDCO) has made funds available to
AMANET to enable this as well as build its own capacity for un-
dertaking the responsibility of the sponsor of clinical trials
under international guidelines and standards.

THIS CALL IS INVITING EUROPEAN SCIENTISTS OR INSTITUTIONS inter-
ested in collaborating with AMANET and have malaria vaccine can-
didates which are ready for clinical evaluation in Africa.

WHAT AMANET IS OFFERING:

1. Not-for-profit investment in further clinical development of
candidate malaria vaccines

2. Role of sponsor for phase I and II vaccine trials within Af-
rica

3. Funding of phase I and II malaria vaccines clinical trials in
African malaria-endemic countries

4. Clinical evaluation centres prepared for malaria vaccine tri-
als

5. Efficient, flexible and transparent decision-making mecha-
nisms

6. Partnership in vaccine development including possibility to
out-source relevant specialised activities.

WHO CAN APPLY?

European scientists and institutions that hold patents over ma-
laria vaccine candidate molecules which meet the profile for en-
demic country evaluation are invited. The restriction to Euro-
pean products is a requirement from the funding authority.

VACCINE CANDIDATE PROFILE

The following are important considerations for the vaccine to be
acceptable to this call:

1. Documentation to demonstrate ownership of the molecule by the
applying institution or scientist

2. Proven and convincing vaccine development rationale as evi-
denced in published preclinical studies

3. Completion of adequate preclinical and toxicological evalua-
tion in at least two animal models

4. Demonstrated safety in humans in a phase Ia trial

5. Certification of current Good Manufacturing Practice (cGMP)
for all the clinical lots used in the early development of the
product

6. Acceptable batch release protocol/certificate for the clini-
cal lots

7. Feasibility of vaccine production up-scaling under cGMP con-
ditions

8. Provision of up-to-date Investigator's Brochure (IB) and suf-
ficient information for European regulatory registration of the
product

9. Provision of all information necessary for developing a com-
prehensive clinical development plan

10. Agreement to make vaccine readily accessible at affordable
cost in Africa should it eventually become licensed

11. Willingness to work with other collaborators such as EDTCP

HOW TO APPLY

Interested persons/institutions should submit a letter of inter-
est highlighting the above requirements and curriculum vitae of
the involved key scientists.

All applications must be directed to:

The Managing Trustee
African Malaria Network Trust (AMANET)
Tanzania Commission for Science and Technology Building
Ali Hassan Mwinyi Road
P O Box 33207
Dar es Salaam, Tanzania
Tel: +255-22-2700-018
Fax: +255-22-2700-380
mailto:info@amanet-trust.org
or mailto:wlkilama@amanet-trust.org

--
Charles Wanga
Communications Officer
African Malaria Network Trust (AMANET)
Tanzania Commission for Science and Technology Building
Ali Hassan Mwinyi Road
P O Box 33207
Dar es Salaam, Tanzania
Cell:+255-748-337232
Tel: +255-22-2700-018
Fax: +255-22-2700-380
mailto:clwanga@amanet-trust.org
http://www.amanet-trust.org

2

AMANET Call for European Candidate Malaria Vaccines (2)
-------------------------------------------------------

A respectful note of caution on vaccine roll-out in the Washing-
ton Post today:
http://www.washingtonpost.com/wp-dyn/content/article/2005/12/18/AR2005121801069.html?sub=AR

Lives Lost As Vaccine Programs Face Delays
Efforts to Get Medicine To Poor Children Falter

By Justin Gillis
Washington Post Staff Writer
Monday, December 19, 2005; Page A01

Companies have developed two vaccines that theoretically could
save the lives of several million children over the next decade,
but efforts to get them to the poor countries that need them
most are lagging.

One vaccine, which protects against a life-threatening form of
pneumonia, has been available to children in the United States
for five years and has had a dramatic impact on disease here.
The other, a vaccine that protects against a deadly form of di-
arrhea, is poised for a rollout soon among middle-income coun-
tries in Latin America. **

The vaccines are the subject of special programs designed to
speed them to poorer countries. With the Bill & Melinda Gates
Foundation spending billions of dollars to improve global health
and encouraging efforts to solve long-standing problems, excited
doctors have been trying to create a system that would get such
vaccines to rich and poor alike at the same time.

But the efforts have faltered amid a dizzying array of snafus,
misjudgments and business difficulties. One company cannot pro-
duce enough vaccine, and studies needed to support widespread
use of another have been slowed by behind-the-scenes squabbling.
The problems have proved so vexing that the vaccines are ex-
pected to take an additional three to five years to reach the
poorest villages.

Historically, vaccine companies rarely focused on lower-income
markets and would not scale their manufacturing plants to pro-
duce excess vaccine for them. Life-saving shots would trickle
down to poor countries after decades on the market, costing many
lives.

To break that cycle, the Global Alliance for Vaccines and Immu-
nization, a disease-fighting coalition in Geneva, selected the
pneumonia and diarrhea vaccines for special emphasis three years
ago. The alliance of governments and organizations, known as
GAVI, is closely tied to the World Health Organization but re-
ceives much of its funding from the Gates Foundation in Seattle.

In establishing the program to accelerate a vaccine against the
diarrhea-causing intestinal germ called rotavirus, organizers
said in a statement, they aimed to ensure "that rotavirus vac-
cine is available to children in developing countries at the
same time as those living in the developed world."

That is now all but certain not to happen, nor has it happened
with the pneumonia vaccine. Some experts see the problems as a
harbinger of bigger trouble to come, as the Gates Foundation
funds development of vaccines for malaria and tuberculosis that
could save tens of millions of lives but might face similar de-
ployment hurdles.

Prevnar, the pneumonia vaccine sold by Wyeth, a drugmaker in
Madison, N.J., has had a sharp impact in the United States.
Though expensive, it has been a runaway success, with sales top-
ping $1 billion a year -- a first in the history of vaccines.

The company initially underestimated demand even in rich coun-
tries and has struggled to expand a complex manufacturing proce-
dure. Wyeth says it is working on a version of the vaccine that
it hopes to sell to poor countries at reduced prices, but many
public-health experts believe the supply situation will not be
solved until new manufacturers come into the market in several
years.

Wyeth's critical supply decisions had already been made by the
time GAVI funded a $30 million program at Johns Hopkins Univer-
sity nearly three years ago to accelerate introduction of Prev-
nar or a similar vaccine to poor countries.

The director of that project, Orin Levine, has worked with Wyeth
to refine its long-term plans but has focused mainly on laying
the groundwork for a rollout in poor countries once competing
vaccines are licensed. Levine's efforts have received high
marks, even though doctors are disappointed to see lives lost to
a vaccine-preventable disease. The germ in question,
*Streptococcus pneumoniae* , kills an estimated 1.6 million peo-
ple a year, about half of them children in poor countries.

The case of rotavirus vaccine is more troubling to many experts,
for a plentiful vaccine that became available last year is not
being widely used.

Most people have never heard of rotavirus, but every child in
the world contracts it early in life. In such places as the
United States, some children are hospitalized with rotavirus di-
arrhea, but they get good care and do not die. In countries with
poor health systems, children often progress to catastrophic de-
hydration and an estimated 440,000 die of rotavirus every year.