Stages of Vaccine Development

Bolstering the health development in India, delivering vaccines to ensure immunization is result of year’s extensive research and discovery. Minute amount of candidate vaccines progress through licensing, that adds to the Research and development cost of the immunization. Likewise, the various stages of developing vaccines help in determining its cost and the subsequent health schedule promoting global health. The stages of development can be broadly divided into two groups:

1. Pre-Clinical Development

It involves research that is carried out on animals and lab assays. The development process consists of the following steps:

• Identification and screening of the relevant antigens
• Conceptualizing and creating the vaccination concept
• Evaluation of the medicinal efficiency— testing on animals
• Manufacturing and formulation of vaccines as per the laid down standards

2. Clinical Development

The process involves testing the viability of the vaccines on humans. The clinical process of vaccine development covers four stages from initial testing trials on humans to induction and beyond. Clinical development is based on ethical principles consented from volunteers reiterating issues like vaccinum safety and its optimum efficacy. The four stages are elaborated as under:

• Phase 1 – Clinical trials to asses whether the developed vaccine is safe on humans and what sort of immune response it evokes.
• Phase 2 – trial to asses the efficacy of the drug against artificial infection or clinical disease. Aspects pertaining to vaccine safety, analysis of side-effects and efficiency optimization are addressed.
• Phase 3 – Vaccines are studied under larger lens, evaluating its performance amidst natural disease conditions, after testing the resilience of the vaccines, authorities regulate the license for market distribution.
• Phase 4 – Post-marketing surveillance, this stage strives to eliminate rare defects and long-term efficiency analysis of the vaccinum.

The Conclusion

Vaccines are developed, tested and distributed in a very similar manner like other drugs; the only difference in clinical trials is wide range of human subjects that needs to be taken care. The monitoring of the developed vaccines is closely examined by the Centers for Disease Control and FDA.

Ways to Optimize Vaccine Allocation During Epidemic

The vaccine optimization, in first place is essential to curb the malady of endemic diseases. The next issue is to ensure the allocation of optimized vaccines before letting pandemic outbreaks to catch up. Taking the case of HINI virus irruption, the onslaught initiated in April 2011, but the vaccines were not available late until the secondary outbreak inflicted humanity by October.

The strategy to cure the speedy transmission

To strategically place the vaccine formulation development in the areas as per geographical demography is the challenge. The vaccination research labs across continents primarily focus upon even and rapid dispersion. As a result, development of deterministic endemic model within disparate age groups is devised. The model is bifurcated in two divisions, adult and children and is subdivided further on the basis of risk levels— high and low.

Methods and Findings

The setting in the model is a replication of a developed country wherein children account for 25% of the total population. For each of these populations, the mortality rate or the hospitalization is minimized. The next step is to formulate an optimal vaccination strategy that gives the best vaccine allocation, given a starting vaccination time and vaccine coverage level. 

The location of the population structure is identified, as it is an important factor in influencing the optimal vaccine distribution. Moreover, the optimal policy is subjected to radical changes.  For example, with 30% vaccine coverage, it is judicious to safeguard the high-transmission groups before this point, but it is ideal to protect the most vulnerable and prone groups afterwards urgently.

Elaborating the scenario for a developed economy, as the vaccine supply escalates it becomes imperative to allocate the resources in the high-transmission group, which counts for children as the target victims. Only after protecting the highly vulnerable groups the chain of transmission can be curtailed from advancing its ensnaring claws further.

Summing up

Choosing the optimal scheme before or early in the epidemic makes a significant difference in minimizing the number of endemic afflictions, and consequently the helps in cutting down over the death toll or mortality rates.

What are the New Approaches in Vaccine Development?

The present-day vaccine manufacturing sector has undergone several changes. The demand for human vaccination is anticipated to shoot up – especially in the underdeveloped and developing parts of the world. The emerging countries require affordable vaccines. Only a small portion of a large population of an underdeveloped country has access to high-quality heat stable vaccines. It’s predicted that by circa 2015, the entire vaccine market will be worth USD 25 billion.

Vaccine development in the Asia Pacific Region

Many vaccine researchers as well as manufacturers have taken note of low immunization rates in Asia Pacific regions. The regions have three things in common: burgeoning population, increased personal wealth and enhanced govt. funding. Each of these factors contributes to improving personal health of the population. Vaccine growth in Asia Pacific is up to 65 percent.

New approaches

Increased demands for vaccination have put new challenges for vaccinologists and researchers. As the market grows, fresh, innovative approaches are developed to build effective vaccines. Health policy makers are leaving no stone unturned to make vaccines easily accessible.  The policy makers adopt a large set of improved technologies for making vaccines easily available. 

Accelerated sterility testing – One of the most significant approaches that are adopted by contemporary vaccinologists is improved sterility testing. The main purpose of accelerated sterility testing is providing biosafety to a vaccine. In simple terms, the test helps determine whether a vaccine has fungi/bacteria or not. Accelerated sterility testing helps vaccinologists perform quick checks upon a vaccine and saves a lot of time.

Real-time detection – The absence or presence of mycoplasma can now be analysed via RNA detection. The RNA detection uses new types of kits and technologies. Such revolutionary detection kits require a meagre (20 ml) of test article.

Such type of technologies has transformed the entire realm of vaccine preparation. With such cutting-edge technologies by our side, we can hope the future to be better and healthy.

Innovation in Vaccines against Enteric Diseases

What are Enteric Diseases?

Disseminating the word Enteric to its origin, it is derived from the Greek word Enteron, which means intestine. In simple terms, Enteric diseases are infections caused by viruses and bacteria. These bacteria generally enter our body through mouth or intestinal system. A bacterium named salmonella is one of the common causes behind enteric diseases. 

 Causes of Enteric Diseases

Primary Cause- as a result of consuming contaminated food or liquids.

Secondary Cause- as a result of being directly exposed to contaminated feces is a secondary way of contracting enteric ailments.

Children, people with disabilities and elderly individuals are easy target to enteric diseases owing to weak immune system. Chronic stomach ache, diarrhea, a nauseating feeling are some of the most common side effects of enteric diseases. Death is possible in extreme of cases, even if a strong immune system tries to defend our body against pathogens, diarrhea and nausea could lead to dehydration. The duration of enteric ailments depends upon the intensity of the infection incurred. More than a year long infection could result in severe malnutrition, impaired cognitive development and stunned growth.   

Enteric Vaccine Development

Gastrointestinal (Enteric) diseases are major cause of towering mortality rate among children especially in developing countries. As per the WHO’s staggering reports, the impact of enteric infection has been largely unnoticed. The death toll ensnared nearly 1 million lives of below five years of age. UNICEF achieved some success in 80s through Diarrheal Disease Control Program. 

The Quick-Action Strategy

 Adequate research in the field of enteric vaccine development is a challenge. Gastrointestinal diseases are caused by number of pathogens including viruses, bacteria and parasites. The complexity lies in the large number of existence of these pathogens because immunization exists for few. The innovative drive in formulation development of enteric vaccine lies in using combination of approaches to protect the patient against infection.  Apart from improving sanitary conditions, quick treatment through proven therapeutics including ORS and zinc is highly beneficial to curb the epidemic.

Targeting Low-Income Countries With Cost-Effective Rotavirus Vaccines

Rotavirus is a common type of virus that infects the intestine in human body. Easily spread among infants and children, this virus is the most communal cause of diarrhea across the globe, which has caused the death of approximately 500,000 children annually.In few cases even adults become infected of the virus, however the illness is usually mild. 

It is observed that almost 95% of the respective virus happens in young children who belong to low-income countries including Asia and Africa. This can be due to the fact that lifesaving care is limited or not available at all in underdeveloped countries. 

 

In order to prevent oneself, vaccination is the best way that is highly contagious and easily responds to traditional diarrhea prevention methods.Since the year 2006, vaccination for rotavirus infection has been available in the market for public.

The Vaccines

In order to fight against rotavirus, a new vaccine by the name of ROTAVAC® is awaiting licensure in India. If approved, this vaccine could transform the rotavirus children prevention motive including adults cure. The vaccination will be as cheap as $1 per dose to protect children. PATH, a cross-sector partnership led by Indian Government was involved in the development of vaccine. It provided technical support on various basic as well as critical clinical trials and manufacturing issues. PATH is also in close coordination with the manufacturers in China, India, and the United States to safeguard other rotavirus vaccine candidates, out of whom some are under clinical trials.

Apart from this, there are two existing rotavirus vaccines available across the geographies and are highly safe to use. These vaccinations are so effective that countries have seen drastic reductions in severe and fatal diarrhea. 

The Future

After receiving license for ROTAVAC in India, the owners can submit the vaccine to World Health Organization for prequalification. This will be a significant step in targeting effected children all over the countries with the pocket-friendly vaccine.

What are The Myths Associated to Vaccine?

Misunderstandings go hand in hand with vaccines. Such misapprehensions exist because many do not understand the way vaccines function. Every strategic advisory group has strived to spread the correct information about vaccines. The knowledge of vaccines in India is still less. Several vaccine-related myths populate the memory of a large part of Indian population. Let us debunk myths associated to vaccinums. Continue reading...

Myth 1 – Getting an overwhelming dose of vaccines can be harmful for a child’s immune system

The immunisation schedule for many parents is daunting. Parents, however, must realize that every immunization schedule is designed keeping in mind a child’s growth and development. Vaccinums never badly affects a child’s immune system. The bodies of babies are immunologically challenged every second by the dust they breathe, and the food (having traces of bacteria) they eat. Hence, babies have the capacity to react safely to the immunological challenges put up by a vaccine.

Myth 2 – Other children’s vaccinations can support a child’s immune system

Skipping vaccination sessions is never done in a child’s interest. By ignoring vaccine programs, parents put their child’s life in danger. The phenomenon to enjoy the protection got from a group of vaccinated individuals is known as herd immunity. The herd immunity, however, does work when a large number of vaccinated children/people exist. If the number of vaccinated people is low, then herd immunity can’t be enjoyed. The herd immunity for measles will be achieved only when 95 percent of population is vaccinated.

Myth 3 – No vaccinations are required as major illnesses have disappeared

Mankind has possibly controlled major diseases. Still it is not easy to say that the global population does not require any type of vaccines. To date, a few diseases – such as pertussis and measles – have the capacity to infect a large amount of population. In 2003 in the U.S., many children died due to pertussis.

These and many other myths surround vaccinations. Getting vaccinated is important for children as well as adults. The advances in medicine and vaccinology have helped in achieving success with vaccine optimization.