Policies for malaria vaccine

Policies in health management are very important for the day to day operation of any health organization. When dealing with diseases that are targeted for eradication by vaccination, like malaria, policies give a general direction in which to proceed. They include statements that identify the rules that govern vaccine manufacture and administration, and give reasons for why such rules exist. The policies are also expected to tell us when the vaccine rules apply and when they don't. They must tell us who is covered, who is not and the consequences of not being vaccinated.

Since an effective first generation vaccine against malaria is already in the works, (RTS,S/AS01 is in Phase III clinical trials right now), to begin utilizing it soon after licensure, severely affected endemic countries must have a time targeted policy in place by now.

The Malaria Vaccine Initiative (www.malariavaccine.org) has developed a tool for use by countries that helps expedite the decision making process. The tool, called the 'Malaria Vaccine Decision - Making Framework', helps in data collection, in time with the licensure process of the vaccine to ensure that the countries that need it are prepared and ready for it.

The tool basically divides data that can be collected into global data and national level data. Some of these like the impact of current interventions and their cost effectiveness are critical global data, that play a major part in the feasibility and success of eradication strategies. Other data such as national affordability, epidemiology profile by state/region/county are critical local data. By combining these, countries can start important processes and create the infrastructure needed. Important processes include establishing a technical working group at the national level, integrating the vaccine into the countries' multiyear strategic plan (on the basis of which funds get distributed at the national level), engaging local pharmaceutical companies, creating a national expert group on recommendations on vaccine introduction, creating advocacy groups, creating advertisements for extension activities etc.

Deciding to set up a vaccine plan or policy takes considerable time. A country cannot decide suddenly that they want to begin using the vaccine, without any formal rules in place. The progress in policy making and setting up a framework has been different in different countries. Here are some updates from some African countries (I acknowledge that the sampling of countries is biased. I chose these countries because I have friends from these places):

Uganda : has a nation specific framework in place and has a committee on malaria vaccines, that was established in 2009, that meets regularly.

Ghana :Held kick off consultations, created a national framework for decision making, created a technical working group which has met regularly since 2009 and is working to collect data on malaria vaccine introduction. Ghana is also a Phase III clinical trial testing site.

Kenya : Has held national stakeholder consultations to discuss trials and have revised the framework to suit their national conditions and are in the process of creating a working group. Kenya is also a testing site for the phase III trials

Zimbabwe : is yet to set up plans

There are other endemic nations that are potential candidate countries for vaccine introduction, but are sitting on the fence right now, because of the unavailability of data from phase III trials and licensure proceedings. Also, other diseases may be on their priority list because of ease of elimination and the availability of a licensed vaccine. For example, malaria is endemic in India, but the government is not scrambling to get a policy in place to be able use the malaria vaccine upon licensure. Reasons include the facts that malaria is not high on the priority list, is curable, has a complex lifecycle that involves invertebrate vectors (which have to be eliminated) and has a lower disease burden in terms of hospital hours and lost work hours, than say chikungunya (which is also transmitted by mosquitoes). On the other hand, polio which has a cheap, effective oral vaccine, has proven itself as an eradicatable disease in other parts of the world and so is an easier target.(The Indian government has policies in place for polio vaccination, which is now mandatory, with no exemptions. The policies were drawn up as a part of a five year plan. The importance of incorporating vaccine policies into long term plans cannot be emphasised enough, because that is the only way something can be achieved).

In conclusion, vaccine policies are meant to build up the health of people and lift communities as a whole. Just as little drops make an ocean, small decisions made at the right time can cause effects that are greater than one's imagination.

References :
 Malaria Vaccine Initiative http://www.malariavaccine.org/preparing-decision-making.php
http://www.malariavaccine.org/files/MVI-GSK-PhaseIIIfactsheetFINAL-web.pdf
Malaria Vaccine Decision making framework http://malvacdecision.net/2012/04/noor/
http://malvacdecision.net/see-the-progress-in-my-country/
http://malvacdecision.net/wp-content/themes/malaria-vaccine/DMF-data-and-processes-April2012.pdf