Re-license your PCV-13 vaccine so it can be used more efficiently in developing countries


Re-license your PCV-13 vaccine so it can be used more efficiently in developing countries
The Issue
Every year 22 million children are not vaccinated globally. This results in around 1.5 million vaccine-preventable deaths of children under age 5 every year. This problem is being addressed mostly by humanitarian organizations. These organizations have made it their goal to get vaccines to even the most poor and neglected parts of the world.
Complications arrive, however, when the vaccines need to be temperature stable for the length of their journey from the warehouse to their remote village destination. It is incredibly difficult to maintain a stable temperature in countries where the temperature is very high and there is no air-conditioning or refrigeration.
Humanitarian organization, MSF (Doctors without Borders) has performed research that indicates it is safe to remove vaccines from their temperature controlled environment for the last part of the journey. That eliminates the need for unneccessary freezers, ice packs, etc. that make the process slow and difficult. It would increase efficiency and the amount of medicine that can get to these remote locations.
"That's great!" You say. "These organizations should start doing that immediately!"
There's a slight problem. Any change in a vaccine's packaging, formulation, administration, etc. (including new storage conditions) needs to be approved by the medicine regulatory agency of the country of manufacture. That means that before humanitarian organizations can store their vaccines in higher temperatures, it must first be re-licensed.
Re-licensing must be pursued by the manufacturer of the vaccine.
In this case, the PCV 13 vaccine, which prevents against pneumococcal disease has been proven to be stable for several days at high temperatures. However, it's producer, Pfizer, is not actively pursuing getting PCV 13 re-licensed to prove it can withstand higher temperatures. Why? Because it costs time and money.
Pfizer, please, re-license PCV 13 so it can be used more efficiently in developing countries.

The Issue
Every year 22 million children are not vaccinated globally. This results in around 1.5 million vaccine-preventable deaths of children under age 5 every year. This problem is being addressed mostly by humanitarian organizations. These organizations have made it their goal to get vaccines to even the most poor and neglected parts of the world.
Complications arrive, however, when the vaccines need to be temperature stable for the length of their journey from the warehouse to their remote village destination. It is incredibly difficult to maintain a stable temperature in countries where the temperature is very high and there is no air-conditioning or refrigeration.
Humanitarian organization, MSF (Doctors without Borders) has performed research that indicates it is safe to remove vaccines from their temperature controlled environment for the last part of the journey. That eliminates the need for unneccessary freezers, ice packs, etc. that make the process slow and difficult. It would increase efficiency and the amount of medicine that can get to these remote locations.
"That's great!" You say. "These organizations should start doing that immediately!"
There's a slight problem. Any change in a vaccine's packaging, formulation, administration, etc. (including new storage conditions) needs to be approved by the medicine regulatory agency of the country of manufacture. That means that before humanitarian organizations can store their vaccines in higher temperatures, it must first be re-licensed.
Re-licensing must be pursued by the manufacturer of the vaccine.
In this case, the PCV 13 vaccine, which prevents against pneumococcal disease has been proven to be stable for several days at high temperatures. However, it's producer, Pfizer, is not actively pursuing getting PCV 13 re-licensed to prove it can withstand higher temperatures. Why? Because it costs time and money.
Pfizer, please, re-license PCV 13 so it can be used more efficiently in developing countries.

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Petition created on July 23, 2014
