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Qa Production Control PQ 11july2012
Qa Production Control PQ 11july2012
Questions & Answers (Q&A) - Production, Control and Prequalification process (PQ)
July 2012
GENERAL
What is polio?
Poliomyelitis (polio) is a highly infectious disease caused by a wild poliovirus that can be of any
of 3 serological types (type 1, 2 or 3). It invades the nervous system, and can cause paralysis or
even death in a matter of hours.
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How many times must OPV be given before children are fully immunized against polio?
Usually, after four doses of OPV, a child should be protected against polio. However, in
conditions that favour the poliovirus spread (i.e. hot weather, poor sanitary and hygienic
standards), it may take additional doses of polio vaccine for a child to be completely protected.
Therefore, even fully immunized children should be immunized during National Immunization
Days.
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Eradication Initiative; they have been licensed for use in endemic countries or for outbreak
control in situations where one or two types can re-emerge. Monovalent OPV against type 2 has
been licensed, but is expected to be used primarily for emergency response stockpiles.
Why are some industrialized countries using a different vaccine for polio than developing
countries?
The vast majority of developed countries in the world used OPV to eliminate polio and
continued using OPV, some until the late 1990s, when they switched to inactivated polio vaccine
because of decreasing risk of importations, due to progress towards polio eradication. To date
most countries (about 150 out of 193) still use OPV as it has a unique ability to induce intestinal,
local immunity which can actually interrupt wild poliovirus transmission in the environment.
This is not possible with IPV, an inactivated polio vaccine, which induces only very low levels
of immunity to poliovirus inside the gut, and as a result provides individual protection against
polio, but unlike OPV, cannot prevent the spread of wild poliovirus. In the near future, IPV
might be introduced in sequential schedule after 2 or 3 doses of OPV to fill the immunity gap
observed in the children below 5 and therefore play a role in the eradication endgame.
PRODUCTION
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absence of such agents is guaranteed through adherence to strict quality control procedures,
extensive testing during the production of the vaccine, and the independent review of all relevant
tests by national regulatory agencies prior to release of each batch of vaccine.
CONTROL
Each batch of OPV undergoes full testing by the manufacturer, and the test results are reviewed
by the National Regulatory Authority for biological substances (NRA) of the country where the
OPV is produced, prior to its release. In addition, the National Control Laboratory conducts a
battery of tests on randomly selected batches.
PREQUALIFICATION
What is WHO's prequalification programme and what checks are in place to ensure
continued compliance to international standards of quality, safety and efficacy?
Set up over 20 years ago, WHO's "seal of approval" (prequalification) is a mechanism to ensure
that all countries across the world have access to vaccines of assured and comparable high
quality.
Each application for prequalification of a vaccine is independently and rigorously undertaken.
The process includes:
scrutiny of information on production methods, vaccine composition, quality control and
clinical evaluation by a WHO team of experts;
independent consistency testing by WHO-qualified laboratories;
site audits of manufacturing facilities.
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Is the “prequalification” status continuously monitored?
WHO monitors the performance of UN supplied vaccines in the field on a continuing basis. This
monitoring includes testing of vaccine lots used in the field, review of complaints received from
users and investigation of reports of adverse events following immunization. In addition, WHO
reviews, on an annual basis, updated information submitted by manufacturers regarding
performance of their vaccine in other markets as well as any changes introduced in the
production or quality control methods. Full reassessments of prequalified products (similar to the
initial evaluation review) are undertaken by WHO-convened teams at regular intervals
(frequency depends on performance monitoring conducted by WHO). Site audits to the
manufacturing facilities can be triggered at any time if the outcome of the post-prequalification
monitoring is not satisfactory.
Is WHO providing support to countries not capable of controlling vaccines on their own?
All prequalified vaccines can be supplied to countries through United Nations agencies or
procured directly by countries. Countries which do not have the ability to conduct their own
checks of vaccine quality rely on WHO prequalification to guide their vaccine purchasing
choices.