Tag Archives: immunization

Covid Vaccine Challenges – Abidance To Defined Health Norms Stays As Lifeguard

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There isn’t even a shade of doubt today that Covid-vaccines are coming. However, some critical questions in this area continue to hang in the air, and are expected to remain so for some more time. Thus, every news on the development of Covid vaccines, particularly in their late stages of clinical trials, fuels billions of hopes and excitement, across the world.

The same thing happened, when Pfizer and BioNTech announced on November 09, 2020, some key details on their vaccine candidate. These include, ‘vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis’ from Phase 3 studies. The release also highlighted, ‘Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.’

Amid these new developments, it is also now beyond doubt that the pandemic will be brought under control, eventually. Interestingly, none possibly knows when it will happen. There doesn’t seem to be any clearly charted – time-bound pathway in place for the same, either – not just yet. That said, from the overall developments in this area for the past 10 months, especially in India, – two other crucial questions also remain elusive, as follows:

  • Has the country started preparing itself against any Covid-like future biological threats? If so, in what manner?
  • As India conducts the world’s largest  Universal Immunization Program (UIP), how robust is the country’s vaccine supply chain to effectively inoculate every Indian with Covid-vaccine?

I have already deliberated on several aspects of the former question in one of my previous articles, in this write-up. Therefore, this write-up will focus on the second query, with a specific reference to the continued relevance of abidance of the defined health norms for some more time, especially for my pharma industry readers. Accordingly, all astute pharma professionals in India, need to accept this new reality, and rewrite their brand demand generation strategies for the new normal. Let me start with how the cold-chain logistics for vaccines, in general, work in the country.

The cold-chain logistics for vaccines:

A paper published by the BBC News, on November 11, 2020, captured how the cold-chain logistics for vaccines, in general, work almost in all countries, including India. The article is titled, ‘Coronavirus: How soon can we expect a working vaccine?’ The steps involved in this exercise are as follows:

  1. Vaccines transported to destination countries (imported varieties).
  2. Refrigerated trucks for transportation to designated cold rooms.
  3. Distribution in portable and appropriate ice boxes to regional centers.
  4. Stored in electric fridges between 2 degree to 10 degree Celsius (for most of the existing vaccines.)
  5. Carried in portable and appropriate ice boxes to local venues for vaccination to individuals.

Associated challenges:

As the above paper highlighted, some important associated challenges in this space, which are mostly faced by the developing countries, like India, are as follows:

  • Adding a new vaccine to the existing mix could pose huge logistical problems for those already facing a difficult environment.
  • According to prescribed norms, all Vaccines in India requires a storage temperature in the range of +2 degree to +8 degree Celsius, except for Oral Polio Vaccine which need to be stored in the frozen state (-25 degree – 15 degree Celsius) at all stores except PHC/ CHC/Health post. The new vaccine ROTAVAC (116E rotavirus) by Bharat Biotech is being recommended to be stored at (-15 to -25 degree Celsius) till the intermediate stores and to be stored in the range of +2 degree to +8 degree Celsius at the last storage points like PHC/ CHC/Health posts. This has not posed much of a challenge. However, expanding it to cover the entire population of the country can be an “immense task.”
  • It is worth noting, although, AstraZeneca vaccine would need the regular cold chain between 2C and 8C, the Pfizer and BioNTech vaccine would need ultra-cold chain – storage at around minus 70C to 80C.
  • ‘Maintaining vaccines under cold chain is already one of the biggest challenges’ that countries face, and this will be exacerbated with the introduction of a new Covid vaccine.
  • Thus, more cold chain equipment will require to be added, making sure that fuel is always available (to run the freezer and refrigerators in absence of electricity) and repair/replace them when they break and transport them wherever you need them.

Curiously, India’s cold-chain logistics that cater to one of the world’s largest immunization programs for children and mothers, may not be enough for Covid-19 vaccination of the country’s 1.3 billion population.

Why India’s cold-chain logistics may not be enough for Covid vaccination:

Before coming to the above question, it is important to note that India is not just the pharmacy of the world, contributing over 20 per cent by value to the global generics market, and over 40 per cent (by volume) of US drugs. According to a recent report of Bernstein Research, Indian vaccine producers, such as, Serum Institute of India supply the bulk – over 40% of the global capacity of 5.7 billion doses annually. Home to some of the world’s biggest vaccine makers, India produces 2.3 billion doses of vaccines yearly, with 74% for export, said the report.

Regardless of this fact, India’s cold-chain logistics may not be enough for Covid vaccination of its entire population, primarily because it is currently geared for children. ‘India Spend’ report of October 13, 2020 titled, ‘India’s COVID-19 Dilemma: Adults Need Vaccines, Supply Chains Geared For Children,’ presents several such interesting facts to ponder over the following points:

  • Being the world’s largest in the Universal Immunization Program (UIP), India targets 26.7 million newborns and 29 million pregnant women every year (55 million people in total, or 4% of the total population). This requires 390 million doses of vaccines, over nine million sessions. But, can this infrastructure effectively handle Covid vaccination of 1.3 billion people?
  • The above question arises, because India has planned to administer 400 to 500 million doses of a COVID-19 vaccine, mostly to its adult population by the first two quarters of 2021. For this effort, the country will have to nearly double the total number of vaccinations given in the public sector program. Thus, one can well imagine, what a humongous task, it will be for vaccination of 1.3 billion population, at the shortest possible time.

Which is why – although, over the last decades, India has created a primary vaccination infrastructure, and gained enough experience in this area, these may not be enough for Covid mass vaccination program, as stated above.

What it would it entail:

As the above ‘India Spend’ report indicates, this effort will entail:

  • Ramping up capacity to administer vaccines,
  • Expanding and further strengthening cold-chain infrastructure and process of storing and transporting vaccines safely, besides logistics,
  • Ensuring adequate availability of ancillary items, such as syringes, glass vials, and intensive training of healthcare workers.

Without these, even if there is a life-saving vaccine available for COVID-19, people will not have access to effective vaccines, the report reiterates. From this perspective, let’s now have a glance to India’s current vaccine cold-chain logistics and infrastructure.

India’s current vaccine cold-chain logistics:

Currently, most vaccines in India are distributed by the Governments UIP mechanism. Accordingly, for the child immunization program, almost the entire vaccine cold chain is publicly funded and managed.

Going by the official statistics, at present there are in total – about 7,645 cold storages in the countrywith 68 per cent of the capacity being used for potato, while 30 per cent is a multi-commodity cold storage. ‘Most of these cater to farm produce in rural areas with ambient temperature storage and therefore are not pharmaceutical ready.’ As the industry sources indicate, ‘only a small part of the remaining 10 per cent of the industry is organized and capable of playing a key role in the distribution of the Covid vaccine.’

The comprehensive multi-year UIP plan for 2018-22 of India also specifies, while India’s UIP is currently supported by more than 27,000 functional cold chain points, only 750 (3 per cent) are located at or above the district level. The rest is located below the district level.

Nevertheless, the ongoing pandemic prompts India to administer Covid vaccines to its entire population of 1.3 billion population, over the shortest possible period of time. To achieve this goal, the cold chain industry of the country is warming up to handle this vaccine distribution challenge, maintaining the integrity of the cold chain.

The only organized pan-India cold chain player with 31 facilities is, reportedly, Snowman Logistics. Other companies, who are mostly the regional operators in this business, include Coldex, ColdStar, Western Refrigeration and JWL. Yet another report indicates, Maersk, is also poised inking a global logistics deal with US-based COVID-19 vaccine candidate COVAXX, including India. Be that as it may, the bottom-line remains, effective Covid vaccination program would not possibly commence until this gap is successfully bridged.

Conclusion:

Meantime, as on November 15, 2020 morning, India recorded a staggering figure of 8,814,902 of Coronavirus cases with 129,674 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks, except Delhi. But, the threat of further spread of Covid infection, in waves, remains as it was before.

Robust and high-quality vaccine cold chain logistics in India assumes so much of importance, because of one critical factor – to preserve its effectiveness till administered to an individual. This is regardless of whether a person is located in cities, small towns or in the remote hinterlands of the country. The successful accomplishment of this task is crucial to combat Covid pandemic, until scientists find any predictable long-term solution.

The good news is, according to a new report: ‘Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021.’ BBC News also reported: ‘A group of Indian scientists are working on such a vaccine. The “warm” or a heat-stable vaccine, they claim, can be stored at 100C for 90 minutes, at 70C for about 16 hours, and at 37C for more than a month and more.’

While the world awaits to witness this happening, we all should recognize a current reality. Tough challenges are still looming large on the way of effective Covid mass vaccination programs, especially for all adult population in India. Thus, the gravity for abidance to basic infection avoidance norms – wearing masks, social distancing and avoiding crowded places, stay unchanged. Accordingly, all astute pharma professionals in India, I reckon, need to accept the prevailing reality, and rewrite their brand demand generation strategies for the new normal.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Sharper Focus On Vaccine: A Huge Scope To Reduce Disease Burden In India

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Several international research studies have conclusively established that the aggressive application of nationally recommended prevention activities could significantly reduce the burden of disease in several areas. Immunization or vaccination program is one such critical areas.

Several ailments, which used to be so common all over the world, can now be effectively prevented through vaccination. The most common and serious vaccine-preventable diseases are: diphtheria, Haemophilus influenzae serotype b (Hib), hepatitis B and C, measles, meningitis, mumps, pertussis, poliomyelitis, rubella, tetanus, tuberculosis, rotavirus, pneumococcal disease and yellow fever.  The list of the World Health Organization (WHO) indicates that vaccines are now available for 25 different diseases.

Thus, vaccination can save millions of lives and morbidity that such diseases still cause to a very large number of global population. Thanks to vaccines, two most scary diseases – small pox (totally) and polio (almost totally), have been eliminated from the world.

No doubt, why vaccination was voted as one of the four most important developments in medicine of the past 150 years, alongside sanitation, antibiotics and anesthesia by readers of the ‘British Medical Journal (BMJ)’ in 2007. It has been decisively proved that vaccines are one of the most successful and cost-effective public health interventions, which help preventing over 3 million deaths every year, throughout the world, topping the list in terms of lives saved.

In tandem, concerted efforts need to be made by both the industry and the Governments to improve affordable access to all these vaccines for a larger section of the population, especially in the developing world.

A crying need still exists:

Nevertheless, there is still a crying need for greater encouragement, more resource deployment and sharper focus towards newer vaccine development for many more dreaded and difficult diseases. One such area is malaria vaccine.

Some areas of new vaccine development:

Following is an example of some newer therapy areas where novel vaccines are now reportedly under development:

  • Malaria vaccine
  • Cancer vaccine
  • AIDS
  • Alzheimer’s disease

Malaria vaccine:

A July 24, 2015 article of the BBC News states, the ‘European Medicines Agency (EMA)’ gave a positive scientific opinion after assessing the safety and effectiveness of the first anti-malarial vaccine of the world – Mosquirix, developed by the British pharma major GlaxoSmithKline.

The vaccine reportedly targets the ‘P. falciparum’, the most prevalent malaria parasite and the deadlier of the two parasites that transmit the disease. At present, in the absence of any licensed vaccines for malaria, the main preventive measures to contain the spread of this parasitic disease are spraying of insecticides, use of other mosquito repellent and mosquito nets.

However, it was observed during its clinical trial that he best protection with this vaccine was achieved among children aged five to 17 months, receiving three doses of the vaccine a month apart, plus a booster dose at 20 months. In this group, cases of severe malaria were cut by a third over a four-year period, the report said.

Some concern was also expressed, as the effectiveness of the vaccine waned over time, making the booster shot essential, without which the vaccine did not cut the rate of severe malaria over the trial period. Moreover, the vaccine did not prove very effective in protecting young babies from severe malaria.

This caused a dilemma for the ‘World Health Organization (WHO)’. On the one hand, the stark reality of malaria killing around 584,000 people a year worldwide, and on the other, lack of conclusiveness in the overall results for this vaccine. Therefore, the world health body decided at that time to further consider about it, soon after the experts’ deliberation on whether to recommend it for children, among whom trials have yielded mixed results, gets completed.

The good news is, on November 18, 2016, Newsweek reported the announcement of the W.H.O, that Mosquirix will be piloted across sub-Saharan Africa in 2018, after a funding approval of US$ 15 million for this purpose.

Cancer vaccines:

According to the National Cancer Institute, which is a part of the National Institutes of Health (NIH) of the United States, cancer vaccines belong to a class of substances known as biological response modifiers. Biological response modifiers work by stimulating or restoring the immune system’s ability to fight infections and disease. There are two broad types of cancer vaccines:

  • Preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people.

-       Persistent infections with high-risk human papillomavirus (HPV) types can cause cervical cancer, anal cancer, oropharyngeal cancer, and vaginal, vulvar, and penile cancers. Three vaccines are approved by the US Food and Drug Administration (FDA) to prevent HPV infection: Gardasil®, Gardasil 9®, and Cervarix®.

-       Chronic Hepatitis B virus (HBV) infection can lead to liver cancer. The FDA has approved multiple vaccines that protect against HBV infection, such as, Engerix-B and Recombivax HB, which protect against HBV infection only.

  • Treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body’s natural immune response against the cancer. Treatment vaccines are a form of immunotherapy.

-       In April 2010, the USFDA approved the first cancer treatment vaccine. This vaccine, sipuleucel-T (Provenge®), is approved for use in some men with metastatic prostate cancer. It is designed to stimulate an immune response to prostatic acid phosphatase (PAP), an antigen that is found on most prostate cancer cells.

Another type of cancer vaccine is currently being developed, known as the Universal Cancer Vaccine.

  • Universal Cancer Vaccine,  June 1, 2016 issue of ‘The Independent’ reported that scientists of Johannes Gutenberg University in Germany have taken a “very positive step” towards creating a universal vaccine against cancer that makes the body’s immune system attack tumors as if they were a virus. The researchers had taken pieces of cancer’s genetic RNA code, put them into tiny nanoparticles of fat and then injected the mixture into the bloodstreams of three patients in the advanced stages of the disease. The patients’ immune systems responded by producing “killer” T-cells designed to attack cancer.

The vaccine was found to be effective in fighting “aggressively growing” tumors in mice. At the same time, such vaccines are fast and inexpensive to produce, and virtually any tumor antigen (a protein attacked by the immune system) can be encoded by RNA, the report said.

The analysts forecast the global cancer vaccines market to grow at a CAGR of 27.24 percent over the period 2014-2019.

HIV/AIDS Vaccine:

The 21st International AIDS Conference (AIDS 2016) held in Durban, South Africa from July 18 to 22, 2016, revealed that a vaccine against HIV will be trialed in South Africa later in 2016, after meeting the criteria needed to prove it, could help fight the epidemic in Africa. A small trial, known as HVTN100, took place in South Africa in 2015 to test the safety and strength of immunity the vaccine could provide, ahead of any large-scale testing in affected populations.

This development reportedly has its origin in a large landmark 2009 trial of RV 144 vaccine in Thailand, demonstrating the proof of concept that a preventive vaccine with a risk reduction of 31 percent could effectively work.  The trial was supported by the World Health Organization (WHO) and UNAIDS. The clinical trial participants who received Vacc-4x, reportedly “experienced a 70 percent viral load decrease relative to their level before starting Anti-Retroviral Therapy (ART), compared with no notable reduction among placebo recipients.”

Alzheimer’s disease vaccine:

A vaccine for Alzheimer’s disease could be trialed in human within the next 3-5 years, after researchers from the United States and Australia have uncovered a formulation that they say successfully targets brain proteins, which play a role in the development and progression of the disease, states a July 18, 2016 report published in the ‘Medical News Today (MNT)’.

This vaccine generates antibodies that target beta-amyloid and tau proteins in the brain – both of which are considered hallmarks of Alzheimer’s disease. In their study, the researchers found that the formulation was effective and well-tolerated in Alzheimer’s mouse models, with no reports of adverse reactions. The vaccine was also able to target the proteins in brain tissue from patients with Alzheimer’s.

Study co-author Prof. Michael Agadjanyan, Institute for Molecular Medicine, California said: “This study suggests that we can immunize patients at the early stages of AD (Alzheimer’s disease), or even healthy people at risk for AD, using our anti-amyloid-beta vaccine, and, if the disease progresses, then vaccinate with another anti-tau vaccine to increase effectiveness.”

If the vaccine continues to show success in these preclinical trials, the researchers envisage that they could be testing the vaccine in individuals at high risk for Alzheimer’s, or those in the early stages of the disease, within the next 3-5 years.

More details on vaccine development:

A 2012 report on vaccines, published by the Pharmaceutical Research and Manufacturers of America (PhRMA) give details of vaccines under development.

Vaccine requirements of the developing world: 

Developing countries of the world are now demanding more of those vaccines, which no longer feature in the immunization schedules of the developed nations. Thus, to supply these vaccines at low cost will be a challenge, especially for the global vaccine manufacturers, unless the low margins get well compensated by high institutional demand.

Issues and challenges:

To produce a safe, effective and marketable vaccine, besides R&D costs, it takes reportedly around 12 to 15 years of painstaking research and development process.

Moreover, one will need to realize that the actual cost of vaccines will always go much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for mass-scale production of vaccines, and then for the distribution of the same mostly using cold-chains.

Around 60 percent of the production costs of vaccines are fixed in nature (National Health Policy Forum. 25. January 2006:14). Thus, such products will need to have a decent market size to be profitable. Unlike many other medications for chronic ailments, which need to be taken for a long duration, vaccines are administered for a limited number of times, restricting their business potential.

Thus, the long lead time required for the ‘mind to market’ process for vaccine development together with high cost involved in their clinical trials/marketing approval process, special bulk/institutional purchase price and limited demand through retail outlets, restrict the research and development initiatives for vaccines, unlike many other pharmaceutical products.

Besides, even the newer vaccines will mostly be required for the diseases of the poor, like Malaria, Tuberculosis, HIV and ‘Non-Communicable Diseases (NCDs)’ in the developing countries, which may not necessarily guarantee a decent return on investments for vaccines, unlike many other newer drugs. Thus, the key issue for developing a right type of newer vaccine will continue to be a matter of pure economics.

India needs a vibrant vaccine business sector:

For a greater focus on all important disease prevention initiatives, there is a need to build a vibrant vaccine business sector in India. To achieve this objective the government should create an enabling ecosystem for the vaccine manufacturers and the academics to work in unison. At the same time, the state funded vaccine R&D centers should be encouraged to concentrate more on the relevant vaccine development projects, ensuring a decent return on their investments for long-term economic sustainability.

Often, these stakeholders find it difficult to deploy sufficient fund to take their vaccine projects successfully through various stages of clinical development to obtain marketing approval from the drug regulator, while earning a decent return on investments. This critical issue needs to be urgently addressed by the Government to make the disease prevention initiatives in the country sustainable.

A possible threat to overcome: 

As per reports, most Indian vaccine manufacturers get a major chunk of their sales revenue from exports to UN agencies, charitable organizations like, the Bill & Melinda Gates Foundation, GAVI, and other country-specific immunization programs.

The report predicts, the virtual monopoly that Indian vaccine manufacturers have enjoyed in these areas, will now be challenged by China, as for the first time in 2012, the Chinese national regulatory authority received ‘pre-qualification’ certification of WHO that allows it to approve locally manufactured vaccines to compete for UN tenders.

Conclusion:

Keeping this in perspective, vaccine related pragmatic policy measures need to be taken in the country for effective disease prevention, covering all recommended age groups, of course, with an equal focus on their effective implementation, without delay. Consequently, this will not only help reduce the disease burden in the country, but also provide the much-awaited growth momentum to the vaccine market in India.

Alongside, increasing number of modern imported vaccines coming in, would help India address one of its key healthcare concerns effectively, and in a holistic way.

It is about time to aggressively garner adequate resources to develop more modern vaccines in the country. In tandem, a rejuvenated thrust to effectively promote and implement vaccine awareness campaigns, would help immensely in the nation’s endeavor for disease prevention with vaccines, that offers a huge scope to reduce disease burden, for a healthier India.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Immunization Still Remains A Low-Budget Neglected Area In India

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Although India is a leading producer and exporter of vaccines, the country has the greatest number of deaths among children under 5, and the majority are from vaccine-preventable diseases. Less than 44 percent of India’s young children receive the full schedule of immunizations, commented a research study of Michigan University of the United States.

This is noteworthy, as vaccines are one of the most successful and cost-effective public health interventions. The World Health Organization (WHO) defines vaccines as:

“A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. Vaccines include, for example, suspensions of killed or attenuated microorganisms, or products or derivatives of microorganisms. The most common method of administering vaccines is by injection, but some are given by mouth or nasal spray.”

Vaccines help prevent over two to three million children each year. However, another 1.5 million children still die from diseases that could be prevented by routine vaccines, as estimated by the WHO.

“The developing world should no longer experience 450,000 preventable deaths each year from rotavirus, nor 145,000 from measles. By the same token, there should no longer be 2000 preventable deaths each year from influenza in Australia. It is time to use our global health efforts to address the most pressing risks, both at home and abroad,” expects another article published in the Volume 45, No.1, January-February 2016 edition of the journal of ‘Australian Family Physician (afp)’

Nevertheless, the bottom line is, an estimated 19.4 million infants worldwide is still missing out on basic vaccines, which otherwise come rather easily to the children of the developed nations of the world, as per the ‘Fact Sheet’ of the World Health Organization (W.H.O) of September 2016.

A commendable global initiative:

To resolve this inequity, in January 2000, the Global Alliance for Vaccines and Immunization (GAVI) was formed. This initiative was mainly aimed at generating sufficient fund to ensure availability of vaccines for children living in the 70 poorest countries of the world.

The GAVI Alliance has been instrumental in improving access to six common infant vaccines, including those for hepatitis B and yellow fever. GAVI is also working to introduce pneumococcal, rotavirus, human papilloma virus, meningococcal, rubella and typhoid vaccines in not too distant future.

Current ground situation in India:

In this area, the prevailing situation in India is much worse.

The Global consulting major – McKinsey in its report titled, “India Pharma 2020: Propelling access and acceptance, realizing true potential” stated that at 2 percent penetration, the vaccines market of India is significantly under-penetrated with an estimated turnover of around US$ 250 million, where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to US$ 1.7 billion by 2020.

Some of the important reasons for poor penetration of the vaccine market in India can be found in a March 02, 2016 research article published in the ‘Michigan News’ of the University of Michigan. The paper articulated some important facts, as follows:

  • Out of 26 million children born in India every year, two-thirds of them do not receive their vaccinations on time, prolonging their susceptibility to diseases and contributing to untimely deaths.
  • Only 18 percent of children are vaccinated with the recommended three doses of DPT vaccine.
  • Only 12 percent of children are vaccinated with the measles vaccine by the required age of 9 months, although 75 percent are vaccinated by age 5. This delay in vaccination can contribute to frequent outbreaks of measles in India.
  • India is adding vast numbers of new children who need vaccination, while the older ones remain under or unvaccinated because of immunization delays, is like “walking too slowly on a moving treadmill – you continually fall further back.”
  • India hopes to add rotavirus to its Universal Immunization Program, a free government-approved vaccination program that was looked at in this study.
  • The government has the infrastructure to deliver vaccines, but the motivations for delivering all vaccination doses decreases over time.
  • India hopes to add rotavirus to its Universal Immunization Program, a free government-approved vaccination program that was looked at in this study.

Needs both policy and budgetary support:

As stated above, the overall immunization scenario in India, as on date, is rather grim. Besides, in view of the humongous disease burden of India, immunization program with various types of vaccines should receive active encouragement from the government as disease prevention initiatives, at least, keeping the future generation in mind. In the next Union Budget of India, this issue should attract fresh policy measures, spearheaded by the Central Government, with requisite fund allocation both by the Central and State Governments.

Low immunization budget and other key barriers:

‘Health Affairs’ – a leading peer-reviewed journal on health policy thought and research, highlighted that India spends woefully little on routine immunization. Quoting data published by the Union Ministry of Health the report stated, only 2.1 percent of the national government’s health budget is allocated to routine immunization – a small amount given the country’s large population and the number of births. Although vaccines used in India are primarily provided free and through the government channels, over 30 percent of the population still purchase vaccines from the private market as a part of their out of pocket expenses.

Besides, there is a long list of other challenges to India’s immunization program. These include a shortage of trained personnel to manage the program at both the national and state levels; the need to undertake innovations in vaccines, disease surveillance, vaccine procurement, and effective vaccine management; the absence of good data on disease burden to inform vaccination priorities; the lack of baseline surveillance data for monitoring the effects of vaccination; and the absence of a system of routine reporting and surveillance, the report stated.

Everyone in the country is expected to fulfill the individual responsibility to get their own children properly vaccinated by properly following, and completing the vaccination schedule. Better all-round and ongoing communication of the long-term benefits of vaccination for many serious disease prevention against negligible side effects, could create greater awareness for compliance.

Indian vaccine market and the key local players:

A report titled ‘Vaccines Market in India 2013’, published by Netherlands Office of Science & Technology, New Delhi, estimated that vaccines contributed largest share in the total Biopharma sales with estimated sales of US$ 602 million in FY 2011-12 over US$ 417.5 million of the previous year. Over half of the top 10 firms in the industry are active in the private sector vaccines market has recorded a growth of about 25 percent.

India is not just a leading producer and exporter of vaccines, it develops and markets complex vaccines, such as, pentavalent rotavirus vaccine. There are around 13 major vaccine manufacturers in India. Companies like, Serum Institute, Shantha Biotecnics, Bharat Biotech and Panacea Biotech are taking commendable strides in this direction. Bharat Biotech is incidentally the largest Hepatitis B vaccine producer in the world.

Around 43 percent of the global Universal Immunization Program vaccine supply (more than 70 percent in the case of single vaccine) reportedly comes from India. Indian vaccine major Serum Institute is reportedly one of the largest suppliers of vaccines to over a 130 countries of the world and claim that ’1 out of every 2 children immunized worldwide gets at least one vaccine produced by Serum Institute.’

Expand Government immunization product spectrum:

It is high time for the Union Ministry of Health to expand the product spectrum for vaccines, as an integral part of its disease prevention program. It is recommended that the routine immunization program of India should now include other important vaccines, such as, Haemophilus influenzae type b, hepatitis B, and rotavirus, as recommended by the National Technical Advisory Board (DTAB) on Immunization.

Conclusion:

Against this backdrop, a holistic immunization program can no longer remain a low-budget and virtually neglected area in India.

Effective resolution of this important issue by the Government would require both the Union and the State Governments to increase their respective budget significantly. It would help launching a well-integrated multi-pronged approach to include most of the remaining one third of the population in the state-run immunization program.

In tandem a strategic pathway needs to be crafted to expand the immunization product spectrum, increase awareness to encourage more household to take part in the holistic immunization initiatives for disease prevention, and counter the anti-vaccine advocates effectively. There is also an urgent need to make more investments in disease surveillance. An integrated approach towards all these initiatives would significantly help reduce the overall burden of disease in the country.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.