A Case Study

In

Sanofi Pasteur: The Dengue Vaccine Dilemma

Prepared by:

CHRISTINE JOY C. PAZ, LPT

Submitted to:

Prof. Maybelle A. Paulino, PhD, LPT, CSP, CMP

 Sanofi Pasteur: The Dengue Vaccine Dillema

Part 1: Facts of the Case

Sanofi Pasteur is the world’s largest vaccine company and serves as the vaccines division

of multinational pharmaceutical company Sanofi. It produced vaccines for about 20 bacterial and

viral diseases. Influenza vaccines, polio vaccines, adult and adolescent booster vaccines,

vaccines against meningitis and pneumonias were launched by Sanofi in several countries with

widespread health issues.

Sanofi Pasteur is one of the five major players which dominates the global vaccine

market such as GlaxoSmithKline (GSK), Merck Pfizer and Novartis. On the demand side, there

were three major customer segments for vaccine: the public or government market, the private

sector and the targeted travelers. These customer groups yielded the company with $1.51 billion,

of which 17.3% of the adult vaccine market in 2011.

Dengue fever also known as “breakbone fever” is a disease transmitted by the bite of the

Aedes mosquito carrying one of the 4 dengue viruses. It is a viral infection transmitted by

mosquitos in tropical and subtropical regions of the world. The disease is endemic in over 100

countries, many of which were low- or middle income countries, in America, South and

Southeast Asia and Sub-Saharan Africa and Western Pacific. Each year, 390 million people are

infected, of which 96 million people show clinical symptoms. An estimated 500,000 people with

severe dengue require hospitalization each year, and about 2.5% of those affected die from

dengue.

Dengue can cause debilitating disease marked by prolonged episodes of high fever and

severe joint pain. Infected individuals has 4-10 days flu-like symptoms after infection and
included severe headaches, pain behind the eyes, nausea, vomiting, swollen glands, muscle and

joint pains and rushes. Severe dengue also known as “hemorrhagic fever” has 3-7 days flu-like

symptoms, it has complications in severe abdominal pain, persistent vomiting, rapid breathing,

bleeding gums, blood in vomit, fatigue and restlessness. There was no known drug or specific

treatment for dengue fever. For severe dengue, physicians and nurses’ medical care can save

lives. Maintenance of the patient’s body fluid volume is critical to severe dengue care. Vector

control helps reduce mosquito population and minimizing mosquito to human contact.

Sanofi Pasteur began developing a live, attenuated vaccine in 1994. It became the first

pharmaceutical company to invest in R&D of a dengue vaccine. In June 2010, US FDA granted

the fast-track status to the dengue candidate. Sanofi had dedicated significant resources toward

the vaccine: set up industrial capacity and prepare the market-entry launch in parallel. It spent

$398 million on a new French factory to produce the vaccine. In 2015, Sanofi Pasteur introduced

the first dengue vaccine which is registered in several of the most endemic countries in the

world.

Part 2: Operational Lapses

Sanofi Pasteur has operational lapses in deciding to make an unusual, high risk

advancement to develop a dengue vaccine which requires industrial capacity and prepare the

market-entry launch in parallel. Building a new factory for the dengue vaccine costs $398

million even though the clinical trials were not finished yet. They gamble on making the largest

investment for the vaccine before knowing whether the Phase IIb clinical trials would be positive

or not. The company has to immediately employ more employees and has to develop an
innovative organizational model. Another lapses in their operations is that they have to keep

autonomous function in the Research and Development, Industrial Operations and Commercial

Operations without disintegrating some areas, all are equally important.

The potential market for the dengue vaccine would be the first adopters in which such

countries have been conducted with vaccine’s clinical trials. Another lapses is that they decided

to have an annual plant capacity for up to 100 million doses, which would be sufficient to

vaccinate 33 million people. This quantity is not enough for everybody, if Sanofi Pasteur

becomes the sole producer for a few years. The production costs were fixed for 60% or semi-

fixed for 25% and variable costs for 15%, regardless of volume. The company is hoping to have

a 70% overall target efficacy of the vaccine.

Sanofi Pasteur makes a first in the history, only to find out that the vaccine’s Phase IIb

efficacy and protection works against only three of the four sub-strains. The full analysis of

vaccine efficacy per serotype showed vaccine efficacy of 61.2% against DEN-1, 81.9% against

DEN-3, and 90% against DEN-4. One of the dengue virus types (DEN-2) eluded the vaccine;

efficacy was statistically not superior to 0. The overall efficacy rate dropped to 30.2% compared

to the anticipated 70% overall efficacy.

Part 3: Alternative Course of Action

First, Sanofi Pasteur should have decided to prolong the testing Phase and should have

waited for a 70% overall efficacy of Phase III clinical trials of the dengue vaccine before

deciding of putting up the largest investment they ever made. As for me, being the CEO of the

company, I will not sign anything that is not 100% safe and effective. Although the situation of
dengue cases in several countries was very alarming, public health was amidst the stand of low

and middle income countries. This issue will never be resolved if the efficacy is about 30.2%.

Sanofi Pasteur is putting all the lives of children and adults at high risks.

Secondly, since the company already invested large amounts to R&D and infrastructure,

there will be high risks again but it might be worth it. Continuing to go ahead with the larger

trials for Phase III efficacy for the 4 serotypes of dengue. If the result becomes better, achieving

at least 70% of overall efficacy, this might be enough to get the vaccine out on the market.

Reintroducing the dengue vaccine, achieving its target rate, is already a milestone in

Pharmaceutical Manufacturers and Pediatric Dengue Vaccine Initiative. Besides timeliness and

prompt solution of vaccine are one of the world’s answers to public health issues.

Another option left is to start a new dengue vaccine development. Due to uncertainty of

the future results of larger Phase III trials, which is beyond Sanofi’s control, it may be difficult to

get the approval of national regulatory authorities. Some additional costs will have to be incurred

in the process, like retrofitting the factory before proceeding with further experimentation.

Lastly, the vaccine should be rolled out in a few provinces first to demonstrate and test its

effectiveness. If there is certain set of group of patients who agreed to test the effectiveness of

the dengue vaccine in their bodies, it will be easy for the company to decide. Especially if the

results are better. In layman’s term, do sampling first before deciding to vaccinate all 33 million

people without having a concrete results and data at hand.

Part 4: Recommendations

Given the opportunity to become the CEO, I would recommend to closely monitor the

effectiveness of vaccines before selling it out on the market. The lives of every dengue patient

will be at risk. It would be beneficial for the company having a breakthrough in Pharmaceutical

Manufacturing and Vaccines. Making a remarkable changes in the world’s public health issues.

Saving lives through science is a sign of service. Also, it would be best if the company has set

and define its pricing standards to the public sector, private sector and targeted travelers.