Professional Documents
Culture Documents
Disease surveillance
Clinical trials
Vaccine development
Technology Transfer
Vaccine
demonstration
projects
Vaccine introduction
and Advocacy
Oral inactivated
Cholera vaccine
Typhoid and
paratyphoid
conjugate vaccines
Vaccines
Pharmaceuticals
Focus on prevention
not patients, but healthy people
Focus on treatment
patient is generally sick
Pharmaceuticals
Medium manufacturing complexity
Easier to manage chemical synthesis in
most cases
Supply chain complexity generally require Supply chain less complex, many drugs
stored at room temperature
storage at or below 4oC
Very few generic products
(Due to manufacturing complexity)
Market Type
Clients
Geographical areas
Mainly for developed
countries
Market organization
Commercial Market
Biggest markets in
value by far
Public or private
Donor Market
Biggest markets in
doses but low in
value
Managed by
Poor or developing
International
countries
organizations such
as WHO, UNICEF,
PAHO and GAVI**
Closed market
Local clients
Strongly regulated
market where
competition exists.
Number of doses
16
14
11.4
billion doses
12
billion US$
5.6
13.7
10
8
6
3.1
3
1.7
1.6
0
Poor
0.8
0.7
Middle
Rich
Total
Countries
0
Poor
Middle
Rich
Countries
Total
Supply to UNICEF
WHO prequalification
Most vaccines for national immunization programs in developing countries are acquired through procurement by UNICEF.
Vaccines must be prequalified by the WHO to be considered in these tenders.
Prequalification involves the National Regulatory Authority as well as the manufacturing company. Prequalification is
specific to a certain vaccine produced by a certain company. It does not mean that the company can apply for tender for all
its products only those that are prequalified.
How important is prequalification:
Manufacturers of
Pentavalent vaccine
Country
Bharat Biotech
India
No
Panacea Biotech
India
Yes
Shantha Biotechnics
India
Yes
Berna Biotech/Crucell
Republic of
Korea
Yes
Serum Institute
India
No
Biological E
India
No
Blockbusters in 2008
Sales greater than 1 billion US$
Vaccines approved in last five years have created new markets. These
leading products in 2008 totaled to US$10 billion
Worldwide markets more than doubled in last three years. It is forecasted that
sales will double again to US$50.7 billion by 2013.
Product
Company
Sales US$
Prevnar
Wyeth
2.7 billion
Gardasil
Merck
1.4 billion
Proquad/Varivax
Merck
1.3 billion
Infantrix
GSK
1.3 billion
Polio/whooping
cough/Hib vaccines
Sanofi Pasteur
1.1 billion
Influenza
Sanofi Pasteur
1.1 billion
Hepatitis Vaccines
GSK
1.2 billion
www. pipeline review. com . LaMerie Biologic Report Recommendation: The new vaccines
Vaccine Development
1910-2010
Trends
Combination vaccines
To reduce the number of vaccinations children receive
vaccines are increasingly becoming multivalent.
3 valent
4 valent
5 valent
6 valent
DTwP
DTwP-Hep B
DTwP-Hep B-Hib
DTaP-Hep B-Hib-IPV
Measles
Measles/Mumps/Rubella
Trends
Multivalent vaccines
Protect against more strains.
Differentiation of one companies product from another to gain
market advantage.
Rotavirus
Rotarix (GSK)
1 strain G1[P8]
Rota Teq (Merck) 5 strains G1,G2, G3, G4, [P7, P1A]
HPV
Gardasil (Merck) types 16, 18, 6 and 11
Cervarix (GSK) types 16 and 18
Pnuemococcal conjugate
Prevnar (Wyeth now Pfizer) - (originally 7 valent)
Prevnar 13 (Wyeth now Pfizer) - (now 13 valent)
Trends
Safety
Increased emphasis on safety
Oral Live attenuated polio vaccine (OPV) has been replaced by the inactivated
polio (IPV) in industrialized countries. Issues with reversion to virulence with
one of the three strains in the OPV
Whole cell pertussis (wP) which is reactogenic has been replaced with acellular
pertussis (aP) in industrialized countries. Currently aP is too expensive for
routine use in developing countries.
Single use auto-disable syringes so that syringes cannot be reused.
Preservatives such as thiomersal being excluded from formulations (particularly
single dose presentations)
Trends
Manufacturing
Stronger emphasis on Validation
Use of single use technologies has
simplified validation.
Single use technologies are easier to
install and facilitate earlier time to
market than conventional equipment
Challenges
cGMP compliance
Vaccine manufacturers must comply with current Good Manufacturing Practice
(GMP), keeping track of the latest guidelines is time consuming and difficult.
cGMP is a part of the quality system used in the manufacturing, testing and
development of vaccines
Challenges
Limited manufacturing capacity
Very little surge capacity as redundant capacity is costly, long timelines to
respond to increased demand.
For many vaccines there are only one or two producers.
Demand for pediatric vaccines is predictable and is related to the birth cohort.
Challenges
As disease is controlled by vaccination the need for vaccination is less obvious.
Pressure from anti vaccine groups can also reduce vaccine acceptance and
coverage.
Complacency can lead to re-emergence of disease as occurred in Russia in the
1990s
Adjuvants
An immunologic adjuvant acts to accelerate, prolong,
or enhance antigen-specific immune responses when
used in combination with specific vaccine antigens
Aluminum salts were first used in the 1920s.
New adjuvants introduced in the last decade.
Adjuvant
Name
Class
Company
Indications
Status
Alum
Mineral salts
Various
Various
MF59
Oil-in-water emulsion
Novartis
Influenza
Marketed (EU)
AS03
Oil-in-water emulsion
GSK
Influenza
Marketed (EU)
AS04
GSK
AS01
GSK
Hepatitis B, human
Marketed (EU, USA)
papillomavirus
Malaria
Phase 3
Intradermal delivery.
Microneedles impregnated
with antigen dissolve in the
dermis to deliver the
vaccine.
Sanofi have just licensed
Fluzone for intradermal
delivery very narrow
needle 1.5mm long and 9mg
per strain instead of 15mg
Stabilization
Storage of vaccines is costly, generally require refrigeration
Experience with monovalent H1N1 vaccine for the 2009/2010 season.
Significant losses due to expiry of product.
- US: 71 out of 162 million doses.
- Australia: 9.7 out of 19 million doses.
Future
Phase III vaccines in development
Disease
Company
Drug Name
Smoking addiction
Nabi Biopharmaceuticals
NicVAX
Grass Allery
ALB Abello
GRAZAX
Grass Allery
Allergy Therapeutics
Ragweed Allergy
Allergy Therapeutics
Grass Allery
Fornix Biosciences
Grass Allery
Greer Labs
Sublingual-oral immuno-therapy
Grass Allery
Paladin Labs
Oralair Grasses
Pollen Allergy
Schering-Plough/Merck
Dengue
Sanofi Pasteur
ChimeriVax
Diabetes
Diamyd Medical
Diamyd
ETEC infection
Intercell
Herpes virus
GlaxoSmithKline
Simplirix
Leishmaniasis
Alum-ALM
Malaria
GlaxoSmithKline
Mosqurix
Shigellosis
NICHHD, NIH
N/A
Alzheimer's
Phase II
Ebola
Phase II
Hepatitis C
Phase II
Hypertension
Phase II
HIV/AIDS
Various phases
MRSA
Phase II
Multiple Sclerosis
Phase II
Obesity
Preclinical
Cancer
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