BEWARE!! GM Vaccines to capture Indian market!!

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Magic Shots

BV Mahalakshmi, Sudhir Chowdhary

Posted online: Monday , June 16, 2008 at 0111 hrshttp://www.financialexpress.com/news/Magic-Shots/323280/#

Vaccines

are hot. The global vaccine market, which was earlier thought as a low

margin, low growth industry, is now attracting the interest of all

major pharmaceutical giants. Market is already seeing growth rates

faster than the traditional pharmaceutical market. With many new

blockbuster potential vaccines likely to hit the market, the growth is

only expected to increase.

The global vaccine market is set to almost double by the year

2010—it is expected to reach $21.05 billion by 2010 from $11.42 billion

in 2006—fuelled by unprecedented product innovations and global

recognition of the benefits of immunisation. But just a few years ago,

vaccine makers were leaving the field, citing low profits and high

production costs. Now, new vaccines are hitting the market in adult,

therapeutic and influenza vaccine segments.(GM Vaccines!!!)

With healthcare reforms underway in Africa, Asia and Latin

America, Indian vaccine makers are bidding on capitalising the

opportunity round the corner. In the last couple of years, it has

become possible to produce new types of vaccines, which consist of

smaller entities of the disease-provoking micro organisms, such as

proteins, peptides, and deoxyribonucleic acid (DNA). The advantages of

the new vaccines are improved efficacy, less side-effects and at the

same time, preventing the risk of catching the disease.

In addition, domestic vaccine makers are looking to strengthen

their operations—research and development (R & D) as well as

marketing—to capitalise on opportunities emerging from Asia, Africa and

Latin America. The pressures of rising costs for the global vaccine

manufacturers has enabled the regional vaccine manufacturers from

places like India to enter into the global vaccines market and has also

provided them the platform to expand their presence.

Thus, biotech vaccines are starting to push back the

conventional ones. The days of injecting a single shot to keep

diseases, says cholera, tetanus, hepatitis or measles, are gone. Instead, what we have in the market are combination vaccines that are easy to administer, cheap and extremely effective.

Also, researchers are going beyond the lab levels and now to

space-based research. A recent report from BioSpace Technologies says

that biotech research has taken a giant leap following the launch of a

Nasa shuttle containing an experiment for development of a Salmonella

vaccine. Researchers believe that the conditions in space, particularly

the microgravity, provide a superior environment for the development of

a Salmonella vaccine.

Quite clearly, the biggest factor driving the vaccine market is

its potential to prevent deaths due to diseases. Every year, two

million deaths are averted through immunisation, says a recent World

Health Organisation (WHO) report, stressing with continued vaccine

developments, four to five million annual deaths could be prevented by

2015.

After all, the statistics on vaccine preventable diseases like

cholera, malaria, tuberculosis (TB) and typhoid are astounding. These

diseases kill 1.9 million children annually. Around 2,000 million are

infected by TB, another 2,400 million are affected by malaria and every

day, there are 15,000 new AIDS infections.

At present, paediatric vaccines account for almost two-thirds

of the global vaccine sales. Going forward, this segment will loose its

share to the adult, therapeutic and influenza vaccine segments. After

all, the battle against infectious diseases is far from over. We have

witnessed a growing number of new diseases emerging in the past couple

of years. Both the contemporary Sars and bird flu have been active all

over the world. However, several challenges still remain, one of the

biggest being the wide gap between the developed and the developing

world in terms of accessibility and quality of vaccines. According to a recent Frost & Sullivan report, the

developed markets in North America, Europe and Japan account for almost

80% of the global vaccine market. However, there is a set of emerging

markets such as Africa, Asia (India and China in particular) and Latin

America which are fast becoming the backbone for the growth of global

vaccines market. Developing and under developed markets in these

regions are being given a higher level of importance by WHO and

Pan-American Health Organisation (PAHO) to control several diseases by

effective immunisation. And, the funding for vaccination programmes in

these markets is drawn from developed markets, which indirectly

subsidise the cost of vaccines.

For the Indian vaccine makers, not only is there a real

opportunity to tap these emerging markets, they could also ramp up

their research and development (R & D) pipeline by attracting

billions of dollars of funding that are going into developing vaccines.

One of the ways they are doing this is by focusing their efforts on

biotech vaccines (Read Genetically Modified!!), which vaccine makers claim to be superior to the

conventional ones.

Traditionally, vaccines have consisted of weakened micro

organisms. Suchitra Ella, joint managing director, Bharat Biotech,

says, “Conventional bacterial vaccines for cholera and typhoid are

derived from inactivated or killed cell organelles. This makes them

more reactive thereby causing adverse reactions. The efficacy of these

vaccines is also of shorter duration.†Not surprising, conventional

viral vaccines such as those for rabies has given place to a tissue

culture-derived rabies vaccine of higher safety, purity and efficacy,

she informs.

According to Ella, recombinant DNA technology makes it

eminently possible to produce safe, pure and efficacious vaccines due

to identification of the appropriate antigen or subunit of the

organism. Hepatitis B vaccine is a classic example of a

biotechnology-derived vaccine. Human papilloma virus vaccine is another

fine example of a biotech product. The next generation vaccines such as

dengue vaccine, yellow fever vaccine, flu vaccine and Japanese

encephalitis vaccine will be completely biotech-derived, she adds.

“Conventional vaccines are sort of crude, whereas biotech

vaccines produced by recombinant DNA technology are highly defined and

more specific with batch-to-batch consistency and lesser side effects,â€

says Varaprasad Reddy, managing director, Shantha Biotechnics. The

company is working on Hepatitis B vaccine, DTP-HepB (tetravalent),

DTP-HepB-Hib (pentavalent) and the pipeline is targeted for rotavirus,

cholera and typhoid—all based on recombinant DNA technology.

Yet another success story is emerging from Indian

Immunologicals. The company is working on human vaccines in rDNA,

hepatitis B, measles, DPT, tetanus, among others. Serum Institute of

India, which supplies vaccines to over 137 countries across the world,

has tied up with Gates Foundation and PATH for accessing testing

technology for developing a pneumococcal vaccine. Biotech vaccine makers are gung ho on joining hands with

leading research institutes like National Institute of Cholera &

Enteric Diseases, Kolkata, National Institute of Immunology, All India

Institute of Medical Sciences, Central Drug Research Institute, among

others, for developing new generation vaccines.------------------------Posted by:Jagannath Chatterjee,Orissa State Head: India-Force, New Delhi, Loksatta, Hyderabad/Maharashtra, MANITHAM, Chennai.General Secretary: NOVAC (Network of Anti-Vaccination Activists)"It is now 30 years since I have been confining myself to the treatment of chronic diseases. During those 30 years I have run against so many histories of little children who had never seen a sick day until they were vaccinated and who, in the several years that have followed, have never seen a well day since. I couldn't put my finger on the disease they have. They just weren't strong. Their resistance was gone. They were perfectly well before they were vaccinated. They have never been well since. "---Dr. William Howard Hay

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