Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Influenza A (H1N1) - a new communicable disease Role and activities of the Health Authorities and International Organizations in relation to the current H1N1 influenza pandemic ***

Syed Irshad Rizvi (Abschlußjahr: 2010)

Language: English

The Pandemic (H1N1) 2009 is a strain of influenza A which can be transmitted from person to person. New strains of seasonal influenza A circulate every year in flu season. Moreover, the available Influenza vaccines are one of the most effective ways to protect people from contracting illness during influenza epidemics and pandemics. These vaccines will boost immunity against the new influenza, and help ensure public health as the pandemic evolves.

The past changes in public health including decay in infrastructure, lack of vaccination, resistance, increasing travel, increasing trade, urbanization, deforestation, agricultural practice, climate change, and the complacency among public health officials, policy makers, and the public contributed a dramatic resurgence of Influenza A (H1N1) virus.

This thesis summarized the roles and responsibilities of different health authorities in an outbreak situation of influenza and to monitor the post marketing activities. The Health authorities and organizations are well prepared to respond to potential disruptions to their operations and protect the well-being of peoples whether caused by pandemic or other unforeseen events. In most of the countries the Ministry of Health is piloting the vaccination plan. However in countries where service delivery is fully decentralized the authorities in charge of healthcare are leading the response. In other countries specific agencies have been charged to prepare the plan. On front line, vaccination is performed mainly by general Practitioners for the population and health care providers have to vaccinate their staff.

Only limited data on safety and immunogenicity of influenza A/H1N1 vaccines will be available when Member States start using them. In addition, due to the continuous mutation of the influenza virus, the effectiveness of vaccines will need to be constantly measured. The pharmacovigilance of vaccines after their marketing is crucial because, prior to its availability on the market, the size of clinical trials is insufficient to identify rare or deferred adverse effects. Therefore a Risk Management Plan (RMP) for vaccines is essential. Article 8 (3) (ia) of directive 2001/83EC, as amended, requires the applicant to submit “a detailed description of the pharmacovigilance and, where appropriate, of the risk management system which the applicant will introduce.

Influenza A (H1N1) are emerging or re-emerging as a major public health problem in Europe, USA and other parts of the world. It is important to understand the strategy to prevent the pandemic, their transmission and virus densities in an affected area. The challenge of reversing the trend of emergent of influenza virus is quite difficult but not impossible.

57 pages, annexes: 2 pages