Daily Current Affairs – 12th September, 2016

Daily Current Affairs – 12th September, 2016

India to lead global coalition to fight epidemics

Being a key member of newly formed Coalition for Epidemic Preparedness Innovations (CEPI), India is all set to lead the global fight against epidemics.

Background

  • Recent epidemics (Ebola in West Africa and Zika in S. America) have exposed serious flaws in the world’s capacity to prepare for and respond to infectious disease outbreaks.
  • Existence of vaccines could have slowed, halted or even prevented an epidemic in each outbreak, thereby saving many lives and prevent profound social and economic disruption in the countries affected.
  • Though Ebola proved that vaccines can be developed quickly but it is not rational to continue to rely on ad-hoc partnerships and the goodwill of a handful of companies.
  • Hence, there was a need of sustainable model for epidemic vaccine development.

Coalition for Epidemic Preparedness Innovations (CEPI)

  • Mission– to stop future epidemics by developing new vaccines for a safer world.
  • Challenges
    • Vaccine development is not quick enough to start long before an epidemic so that final clinical trials or emergency deployment can begin swiftly in an outbreak.
    • It typically takes more than 10 years to make vaccines that work and are safe.
    • Once a vaccine is created, complex regulations and laws that vary from country to country can delay getting vaccines to the people who desperately need them.
  • CEPI aims to overcome these barriers with a new model for funding vaccine developments against epidemic diseases to contribute to the health security the world needs. (The idea of CEPI was planted in a journal report ‘“Establishing a Global Vaccine-Development Fund” in 2015)
  • CEPI-the institution– It is a new alliance between governments, industry, academia, philanthropy, intergovernmental institutions, such as the World Health Organization, and civil society.
  • Founding partners: Dept of Biotechnology, Ministry of S&T, Government of India, Government of Norway, Wellcome Trust, Bill and Melinda Gates Foundation and World Economic Forum
  • Governed by- Interim Board chaired by Professor K VijayRaghavan, Secretary, Department of Biotechnology.

India’s role as a leader

  • The intensity of disease outbreak depends on the mode of transmission which can spread it rapidly to affect people very far from where the outbreak starts. Here, vaccines offer the potential to be deployed rapidly and on scale to prevent both disease and its further transmission of diseases that are known and yet to be known.
  • In such case, India has recognised the preparedness to handle such disease outbreaks which also includes strategies for prevention.
  • Also, India has the scientific talent and capacity to respond to any exigency, as was witnessed in case of H1N1 outbreak. With right incentives and partnerships, India could help countries, regional or international agencies to respond to any pandemic or epidemic in a quick, efficient and affordable manner.
  • India will prepare vaccines for diseases that have the potential for causing outbreaks and not focus only on common diseases like rotavirus.Rotavirus vaccine by Bharat biotech was the last vaccine developed in India which underwent an ‘effectiveness or efficacy’ study. It is currently being used by the MOHFW in four States. Chikungunya vaccine made in India remains to be evaluated for its effectiveness.
  • Thus, India will collaborate with governments and agencies like WHO, the Wellcome Trust and others to develop the strategies forpartnerships, technical development, regulatory and ethical approaches and find the resources and commitments needed for the coalition.

 

Human trials precaution

  • Phase 1- The vaccine is first tested in a small number of healthy people as for testing any new vaccine, safety is paramount.
  • Phase 2- Next slightly larger number of people to figure out what dose is best to produce the best immune response.
  • Phase 3- The larger scale phase 3 efficacy studies to test whether the vaccine can prevent disease in its target populations.
  • While the phase 1 and 2 studies can be done anywhere, phase 3 studies require a population where the disease is reasonably likely to occur/occurring.
  • The new coalition plans to develop vaccines through phase 1 and 2, by applying the highest standards for safety in these studies.
  • Controlled Human Infection Model (CHIM)- In more industrialised countries, a unique form of volunteer studies is being introduced wheredisease is actually induced in people in a tightly controlled setting and the ability of the vaccine to prevent disease is characterised. This puts few people at risk when testing vaccines.
    • However, this requires volunteers who are altruistic and have great understanding of the risks of the experiments.
    • There are currently no plans to do such studies in India.

Targeted Diseases

  • The vaccines will be chosen from a list of 11 that WHO put together as part of a report called An R&D Blueprint for Action to Prevent Epidemics.
  • It includes Chikungunya, Middle East Respiratory Syndrome (MERS) and the related severe acute respiratory syndrome, Crimean-Congo Haemorrhagic fever, Nipah virus.
  • However, Ebola vaccine will be a priority.
  • CEPI will prioritise infectious diseases that have:
    • The potential to become global public health emergencies
    • Feasible development approaches for vaccines
  • The coalition will focus on diseases which do not have a large market in global terms.

Ethical practices

  • There is a perception that India will be the pharmaceutical hub of the world and also the laboratory for the world. Thus, under this new role, India will have to ensure global leadership, especially in having a say on ethical practices in these sectors.
  • Ethical practices relate to
    • The development of drugs, vaccines and other products which is the domain of academia and regulatory authorities.
    • Manufacturing of drugs and to their marketing and use, where manufacturers have the greatest role.
  • In development and testing, adherence to the highest ethical standards ensuring that participants in studies completely understand the purpose as well as the risks and benefits of their participation.
  • This requires strong credible academic partners and regulations, and the Drugs Controller General of India has already taken the lead in improving the standards of clinical testing in India.

Conclusion

  • India is home to one sixth of the world’s people who live and travel everywhere. Thus, India will play a role in working with less resourced countries of Asia and Africa along with industrialised countries.
  • The India-Africa Health Summit, organised by the ICMR is an example of the kind of engagement where India could work with African countries that are likely to be affected by outbreaks and need to build capacity in science, medicine and manufacturing.

Connecting the dots:

  • Initiation of Coalition for Epidemic Preparedness Innovations (CEPI) gives a hope for epidemic free world. Explain the need of CEPI and role of India in this organisation

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