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smallpox vaccine and vaccination in the intensified ... - libdoc.who.int

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11. VACCINATION IN THE INTENSIFIED PROGRAMME 569<br />

Development of <strong>the</strong> Bifurcated Needle<br />

The bifurcated needle was <strong>the</strong> result of a developmental study by staff at Wyeth<br />

Laboratories but <strong>the</strong> orig<strong>in</strong>al idea can be traced back to <strong>the</strong> early 19th century (D. Baxby,<br />

personal communicatio~, 1983). "This operation [<strong>vacc<strong>in</strong>ation</strong>] is usually perfdr&ed with-a<br />

common lancet :but one which is fissured by a longitud<strong>in</strong>al slit, like a writ<strong>in</strong>g pen, succeeds<br />

ra<strong>the</strong>r better" (Moore, 181 7).<br />

Of <strong>the</strong> needle's more recent history, B. A. Rub<strong>in</strong> (personal communication, 1980)<br />

wrote :<br />

"In 1961, I started to test new methods of dispens<strong>in</strong>g <strong>the</strong> <strong>vacc<strong>in</strong>e</strong> while also consider<strong>in</strong>g<br />

<strong>the</strong> methods of scarification. I collaborated with <strong>the</strong> Read<strong>in</strong>g Textile Mach<strong>in</strong>e Com~anv<br />

0 I I<br />

(now a division of Rockwell International) <strong>in</strong> needle design. We experimented with<br />

various textile needles <strong>and</strong> filament guides with st<strong>and</strong>ard open<strong>in</strong>gs as methods for<br />

dispens<strong>in</strong>g <strong>vacc<strong>in</strong>e</strong>. It <strong>the</strong>n occurred to me that a pronged needle would reta<strong>in</strong> <strong>the</strong> capillary<br />

activity of a loop, <strong>and</strong> that it might have simultaneous utility <strong>in</strong> scarification. I <strong>the</strong>refore<br />

suggested <strong>the</strong> use of a sew<strong>in</strong>g needle <strong>in</strong> which <strong>the</strong> loop end was ground down to give a<br />

pronged fork. A system was devised <strong>in</strong> which a piece of wire was cut to <strong>the</strong> right length, <strong>and</strong><br />

<strong>the</strong>n stamped to give <strong>the</strong> fork shape, with such dimensions so that <strong>the</strong> prongs would hold<br />

exactly 1 mg of water by capillarity. The mach<strong>in</strong>e company <strong>the</strong>n used a mass tumbl<strong>in</strong>g<br />

system that could sharpen <strong>the</strong> prongs of <strong>the</strong> forks of large numbers of needles.<br />

"The sharpened fork was retested <strong>and</strong> found to hold 1 mg of water quite firmly. When<br />

tested with reconstituted lyophilized <strong>vacc<strong>in</strong>e</strong>, <strong>the</strong> reta<strong>in</strong>ed volume tended to be somewhat<br />

greater because of <strong>the</strong> <strong>in</strong>creased viscosity. But <strong>the</strong> liquid <strong>vacc<strong>in</strong>e</strong> adhered firmly to <strong>the</strong><br />

needle. Thus, when <strong>the</strong> bifurcated tip of <strong>the</strong> needle is dipped <strong>in</strong>to <strong>the</strong> <strong>vacc<strong>in</strong>e</strong>, a constant<br />

amount is suspended between <strong>the</strong> prongs, ready for <strong>in</strong>oculation."<br />

vacc<strong>in</strong>ator to learn. It became <strong>the</strong> st<strong>and</strong>ard<br />

method of <strong>vacc<strong>in</strong>ation</strong> throughout <strong>the</strong> world.<br />

It was observed that, if certa<strong>in</strong> vacc<strong>in</strong>ators<br />

recorded more <strong>vacc<strong>in</strong>ation</strong> failures than expected,<br />

it was often because <strong>the</strong>y were too<br />

gentle, partly because of <strong>the</strong> above-mentioned<br />

belief that bleed<strong>in</strong>g at <strong>the</strong> <strong>in</strong>oculation site<br />

reduced <strong>the</strong> take rate. However, experience<br />

showed that this belief was unfounded, <strong>and</strong><br />

vacc<strong>in</strong>ators were advised to use <strong>the</strong> multiple<br />

puncture method with <strong>the</strong> bifurcated needle<br />

with enough force to cause slight bleed<strong>in</strong>g.<br />

Take rate. Tests carried out <strong>in</strong> Egypt, Kenya<br />

<strong>and</strong> Liberia (Table 11.16) showed that take<br />

rates by <strong>the</strong> multiple puncture method were<br />

<strong>in</strong> <strong>the</strong> range of 98-100% <strong>in</strong> primary <strong>vacc<strong>in</strong>ation</strong>s<br />

<strong>and</strong> that reactions specified as major (see<br />

Chapter 7) occurred <strong>in</strong> 56-82% of re<strong>vacc<strong>in</strong>ation</strong>s.<br />

In experiments by Dr Shafa <strong>in</strong> Egypt, <strong>in</strong><br />

which <strong>the</strong> same <strong>in</strong>dividuals were <strong>in</strong>oculated<br />

on opposite arms by different methods <strong>the</strong><br />

take rates for re<strong>vacc<strong>in</strong>ation</strong> by scarification<br />

were slightly lower than those obta<strong>in</strong>ed with<br />

<strong>the</strong> bifurcated needle.<br />

Amount of <strong>vacc<strong>in</strong>e</strong>. The amount of reconstituted<br />

<strong>vacc<strong>in</strong>e</strong> taken up by <strong>the</strong> bifurcated<br />

needle was tested <strong>in</strong> <strong>the</strong> ~mall~ox<br />

unit <strong>in</strong> Geneva <strong>and</strong> <strong>the</strong> results were confirmed<br />

<strong>in</strong> <strong>the</strong> field. It was estimated that one<br />

dip of <strong>the</strong> needle po<strong>in</strong>t lifted an average of<br />

0.0025 m1 of reconstituted <strong>vacc<strong>in</strong>e</strong> between<br />

<strong>the</strong> prongs. S<strong>in</strong>ce <strong>the</strong> amount of reconstituted<br />

<strong>vacc<strong>in</strong>e</strong> used <strong>in</strong> conventional <strong>vacc<strong>in</strong>ation</strong> was<br />

about 0.01 ml, <strong>vacc<strong>in</strong>ation</strong> with <strong>the</strong> bifurcated<br />

needle saved <strong>vacc<strong>in</strong>e</strong>, permitt<strong>in</strong>g 4 times as<br />

many <strong>vacc<strong>in</strong>ation</strong>s to be adm<strong>in</strong>istered with a<br />

given quantity of <strong>vacc<strong>in</strong>e</strong>.<br />

Design of <strong>the</strong> b$urcated needle. The orig<strong>in</strong>al<br />

needle developed by Wyeth Laboratories was<br />

designed to be used once only <strong>and</strong> <strong>the</strong>n<br />

discarded. However, for <strong>the</strong> global eradication<br />

programme it was essential to be able to<br />

reuse <strong>the</strong> needles several times <strong>and</strong> to make<br />

<strong>the</strong>m as cheaply as possible. In collaboration<br />

with a metallurgical firm, WHO <strong>in</strong>vestigated<br />

methods of <strong>in</strong>creas<strong>in</strong>g <strong>the</strong> carbon content so<br />

as to produce <strong>the</strong> hardest possible steel that<br />

would not rust. When this steel was used,<br />

metallurgical test<strong>in</strong>g showed that <strong>the</strong>re was<br />

no change <strong>in</strong> <strong>the</strong> "hardness <strong>in</strong>dex" after a<br />

bifurcated needle was flamed <strong>in</strong> a spirit lamp<br />

up to 50 times, for 3 seconds on each occasion,<br />

but that <strong>the</strong> <strong>in</strong>dex decreased considerably if a<br />

Eradication needle was flamed for 5 seconds on 25 or more

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