Attention " Fuzhou disease accuses " for oneself health adds cent
Many parents are right fast expiring vaccine
One kind is defied feeling,
Feel vaccine is fast expired,
Positive result was differred,
Do not think have an inoculation is fast overdue vaccine.
Today
Small make up talk about this topic to everybody.
One, vaccinal period of efficacy
Period of efficacy is to point to medicines and chemical reagents to assure the time of medicaments quality below reserve requirement of the regulation. Period of efficacy is the stability according to medicines and chemical reagents differs, of through stability experiment studies and leaving appearance to observe formulate.
Vaccine has certain term of validity. For example, leprosy decreases head of poisonous live vaccine, second to decrease the period of efficacy of poisonous live vaccine to be 18 months; The period of efficacy of 100 white broken vaccine, vaccine drifting a head is 2 years; The period of efficacy of second liver vaccine, 5 couplet vaccine is 3 years to wait.
2, period of efficacy is decided really
01
Vaccinal stability test
Be place manufacturing vaccine in certain maintenance the condition falls, successive inside period of time observation, detect feature of vaccinal physics, chemical, biology and protective effect. For example, set some vaccine 24 months continuously in 2-8 ℃ , at the 0th, 1, 3, 6, 9, 12, 15, 18, 21, 24 months part sampling, observe and detect vaccinal feature and protective effect, judge vaccinal security and effectiveness.
02
Vaccinal period of efficacy is decided really
A kind of vaccine appears on the market in approval before, want to decide vaccinal period of efficacy through long-term stability test, press the demand of concerned technology, want to decrease 6 months at least on the foundation that stability test asks, ability serves as vaccinal period of efficacy. For example, 100 white broken vaccine stipulate period of efficacy is 2 years on vaccinal manual, the time of test and verify of real stability test must exceed 2 years half. If save 2 years of time of half, 100 white broken vaccine are vaccinal still safe, effective, so the period of efficacy that 100 white broken vaccinal vaccine approve is 2 years.
Accordingly, vaccine is not to cross period of efficacy " invalidation " , still have the amortize time of at least 6 months however.
3, fast overdue vaccine whether vaccinal
Through vaccinal stability test we are informed, vaccinal " use time effectively " should compare vaccine " period of efficacy " grow 6 months at least.
Accordingly, fast expire, but the vaccine that did not expire and the vaccine that just manufactured are same, it is safety, effective. Darling parent need not worry, if be in the vaccine inside period of efficacy (include fast expiring vaccine) its are saved and carrying a process is qualification, OK and normal have an inoculation, can not increase vaccinal and harmful response, also won't reduce protective effect.
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