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alpacashutΒιοτεχνολογία

10 Δεκ 2012 (πριν από 4 χρόνια και 6 μήνες)

191 εμφανίσεις

‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
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‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)


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Shanghai Institute of Biological Products (SIBP), Sinovac Biotech Co., Ltd ·≈– Hualan Biological Engineering
Inc. ·≈– Ì“π—°ß“π„À≠à ¢Õß The China National Biotec Corporation (CNBC) ¢Õ¢Õ∫§ÿ≥ ».¿≠. ÿ¡π“ ¢¡«‘≈—¬ ·≈–
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‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
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∫∑ √ÿªºŸâ∫√‘À“√ 6
Executive summary 8
°√–∫«π°“√®—¥∑Ì“¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ 10

∫∑∑’Ë 1 ∫∑πÌ“·≈–°√Õ∫·π«§‘¥°“√®—¥∑Ì“¬ÿ∑∏»“ µ√å 12

1.1 ·π«§‘¥„π°“√®—¥∑Ì“¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ 14
1.2 ¢âÕ¡Ÿ≈®Ì“‡æ“–¢Õß«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ ·≈–«—§´’π‰¢âÀ«—¥„À≠à„π™à«ß°“√√–∫“¥„À≠à 20
1.3  ∂“π¿“悧√ß √â“ßæ◊Èπ∞“π„π°“√º≈‘µ«—§´’π √–¥—∫«‘®—¬ √–¥—∫°÷ËßÕÿµ “À°√√¡ ·≈–√–¥—∫Õÿµ “À°√√¡ 31

1.4 °√Õ∫¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬ 31

∫∑∑’Ë 2 ¬ÿ∑∏»“ µ√å∑’Ë 1: ¬ÿ∑∏»“ µ√å°“√´◊ÈÕ«—§´’π‰¢âÀ«—¥„À≠à‡æ◊ËÕ°“√ Ì“√Õß 35

2.1 «—§´’𠓬æ—π∏åÿµà“ßÊ ∫√‘…—∑∑’Ë®—¥®Ì“Àπà“¬·≈–°“√ —Ëß´◊ÈÕ®“°ºŸâº≈‘µ 37
2.2 °“√°Ì“Àπ¥°≈ÿࡪ√–™“°√∑’Ë®–‰¥â√—∫«—§´’π°àÕπÀ≈—ß (vaccine prioritization) „π¿“«–°“√√–∫“¥„À≠à 40
2.3 ª√‘¡“≥«—§´’π‡æ◊ËÕ°“√ Ì“√Õß 44
2.4 ª√–¡“≥°“√ß∫ª√–¡“≥„π°“√®—¥´◊ÈÕ«—§´’π Ì“√Õß 46
2.5 ¢âÕæ÷ßæ‘®“√≥“Õ◊Ëπʇ°’ˬ«°—∫°“√ Ì“√Õß«—§´’π‡æ◊ËÕ„™â„π¿“«–©ÿ°‡©‘π 47
2.6 ∫∑ √ÿª ¬ÿ∑∏»“ µ√å∑’Ë 1: ¬ÿ∑∏»“ µ√å°“√´◊ÈÕ«—§´’π‰¢âÀ«—¥„À≠à‡æ◊ËÕ°“√ Ì“√Õß 48

∫∑∑’Ë 3 ¬ÿ∑∏»“ µ√å∑’Ë 2: ¬ÿ∑∏»“ µ√å°“√·∫àß∫√√®ÿ«—§´’π‰¢âÀ«—¥„À≠à„πª√–‡∑» 50

3.1 ·π«§‘¥„π°“√·∫àß∫√√®ÿ«—§´’π 52
3.2 Àπ૬ߓπ∑’Ë¡’»—°¬¿“æ„π°“√·∫àß∫√√®ÿ 53
3.3 ‡ªÑ“À¡“¬°“√·∫àß∫√√®ÿ«—§´’π 56
3.4 ª√–¡“≥°“√ß∫ª√–¡“≥ 56
3.5 ∫∑ √ÿª ¬ÿ∑∏»“ µ√å∑’Ë 2: ¬ÿ∑∏»“ µ√å°“√·∫àß∫√√®ÿ«—§´’π‰¢âÀ«—¥„À≠à„πª√–‡∑» 58

∫∑∑’Ë 4 ¬ÿ∑∏»“ µ√å∑’Ë 3: ¬ÿ∑∏»“ µ√å°“√ª√—∫‚√ßß“πº≈‘µ«—§´’π —µ«å‡æ◊ËÕ°“√º≈‘µ«—§´’π§π„π¿“«–©ÿ°‡©‘π 59
4.1 ·π«§‘¥·≈–‡Àµÿº≈„π°“√ª√—∫‚√ßß“π‚√ßß“πº≈‘µ«—§´’π —µ«å‡æ◊ËÕ°“√º≈‘µ«—§´’π§π„π¿“«–©ÿ°‡©‘π 60
4.2  ∂“π¿“æ·≈–°Ì“≈—ß°“√º≈‘µ¢Õß Ì“π—°‡∑§‚π‚≈¬’™’«¿—≥±å —µ«å °√¡ª»ÿ —µ«å 60
4.3 ¢âÕ¡Ÿ≈‚√ßß“π«—§´’π —µ«åªï°∑’Ë “¡“√∂ª√—∫¡“º≈‘µ«—§´’π§π 62
4.4 ·π«∑“ß„π°“√ª√—∫ª√ÿß‚√ßß“π«—§´’π —µ«åªï°‡æ◊ËÕº≈‘µ«—§´’π§π„π°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à 67
4.5 °“√§Ì“π«≥°Ì“≈—ß°“√º≈‘µ¢Õß‚√ßß“π«—§´’π —µ«åªï°¿“¬À≈—ß°“√ª√—∫ª√ÿß„Àâº≈‘µ«—§´’π Ì“À√—∫§π„π°√≥’‡°‘¥ 73

°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à

4.6 ª√–¡“≥°“√ß∫ª√–¡“≥∑’Ë„™â„π°“√‡µ√’¬¡°“√ 74
4.7 ·ºπ°“√¥Ì“‡π‘π°“√‡æ◊ËÕª√—∫ª√ÿß‚√ßß“π«—§´’π„π —µ«åªï°‡æ◊ËÕ°“√º≈‘µ«—§´’π§π 75
4.8 ∫∑ √ÿª¬ÿ∑∏»“ µ√å∑’Ë 3: ¬ÿ∑∏»“ µ√å°“√ª√—∫‚√ßß“πº≈‘µ«—§´’π —µ«å‡æ◊ËÕ°“√º≈‘µ«—§´’π§π„π¿“«–©ÿ°‡©‘π 77



¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à
°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬

C ONT E NT
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∫∑∑’Ë 5 ¬ÿ∑∏»“ µ√å∑’Ë 4: ¬ÿ∑∏»“ µ√å°“√ √â“ß‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à‡æ◊ËÕ√Õß√—∫°“√√–∫“¥„À≠à 79
5.1 ·π«§‘¥„π°“√®—¥µ—Èß‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à¢Õߪ√–‡∑»‰∑¬ 80
5.2 ·π«∑“ß·≈–¢âÕæ‘®“√≥“„π°“√ √â“ß‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à„πª√–‡∑»‰∑¬ 81
5.3 ∫∑ √ÿª ¬ÿ∑∏»“ µ√å∑’Ë 4: ¬ÿ∑∏»“ µ√å°“√ √â“ß‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à‡æ◊ËÕ√Õß√—∫°“√√–∫“¥„À≠à 88

∫∑∑’Ë 6 ¢π“¥°Ì“≈—ß°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈·≈–«—§´’π‰¢âÀ«—¥„À≠à°√≥’√–∫“¥„À≠à 91

6.1 °√Õ∫·π«§‘¥„π°“√«‘‡§√“–Àå 92
6.2 °“√æ‘®“√≥“¢π“¥°Ì“≈—ß°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à°√≥’√–∫“¥„À≠à „π‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ 93

6.3 °“√ª√–À¬—¥µàÕ¢π“¥¢Õßµâπ∑ÿπ°“√≈ß∑ÿπº≈‘µ«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ 98
6.4 °“√æ‘®“√≥“¢π“¥¢Õß°Ì“≈—ß°“√º≈‘µ«—§´’π®“°¥â“πª√– ‘∑∏‘¿“æ¢Õß°“√„™â«—§´’πªÑÕß°—π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ 100
6.5 ∫∑ √ÿª‡√◊ËÕß¢π“¥¢Õß°Ì“≈—ß°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à 114

∫∑∑’Ë 7 ¡“µ√∞“π°“√º≈‘µ °√Õ∫°ÆÀ¡“¬ ·≈–√–‡∫’¬∫∑’˧«√æ‘®“√≥“„π°“√¢÷Èπ∑–‡∫’¬π«—§´’π„π¿“«–©ÿ°‡©‘π 117
7.1 ¡“µ√∞“π°“√º≈‘µ¥â“π GMP (Good Manufacturing Practice) 118
7.2 °√Õ∫°ÆÀ¡“¬·≈–√–‡∫’¬∫∑’˧«√æ‘®“√≥“„π°“√¢÷Èπ∑–‡∫’¬π«—§´’π„π¿“«–©ÿ°‡©‘π (Fast Track Registration) 125

∫∑∑’Ë 8  √ÿª¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ ¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à°√≥’‡°‘¥°“√√–∫“¥„À≠à 139

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8.1  √ÿª¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à °√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬ 140
8.2 ∫∑∫“∑¢Õ߬ÿ∑∏»“ µ√å∑—Èß ’˵àÕ§«“¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à„π°√≥’‡°‘¥°“√√–∫“¥„À≠à 142
8.3 §«“¡°â“«Àπâ“¢Õß∫√‘∫∑∑’ˇ°’ˬ«¢âÕß 147
8.4 ¢âÕ‡ πÕ·π–Õ◊ËπÊ 147

¿“§ºπ«° 149

1. °“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à‚¥¬„™â√–∫∫ Baculovirus Expression Insect Cell System 150
2. π‚¬∫“¬°“√„™â«—§´’π‰¢âÀ«—¥„À≠à„π°√≥’ª°µ‘ ·≈–°√≥’‡°‘¥°“√√–∫“¥„À≠à„π¡πÿ…¬å 156
3. ¡“µ√∞“π Specific Pathogen Free egg (SPF egg) 161
4. °“√‡ª√’¬∫‡∑’¬∫ ACTD ·≈– ICH CTD ´÷Ë߇ªìπ‡Õ° “√ª√–°Õ∫°“√¬◊Ëπ¢Õ¢÷Èπ∑–‡∫’¬π¬“ 163
5. √“¬™◊ËÕ‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à (Õߧ尓√Õπ“¡—¬‚≈°) 177
6. »—°¬¿“æ·≈– ∂“π¿“æ„π°“√º≈‘µ«—§´’π„πª√–‡∑»‰∑¬ 179
7. §Ì“π«≥°“√º≈‘µ SPF egg ¢Õß Ì“π—°‡∑§‚π‚≈¬’™’«¿—≥±å —µ«å °√¡ª»ÿ —µ«å 184
8.  √ÿª√“¬ß“π°“√‡¢â“‡¬’ˬ¡™¡‚√ßß“π«—§´’π‰¢âÀ«—¥„À≠à/‰¢âÀ«—¥π° «—π∑’Ë 5-10 惻®‘°“¬π 2549 187
≥ ª√–‡∑» “∏“√≥√—∞ª√–™“™π®’π

9. ·ºπ°“√Ωñ°Õ∫√¡∫ÿ§≈“°√¥â“π GMP 194
10. √“¬™◊ËÕ∫√‘…—∑ºŸâ√—∫°àÕ √â“ß·≈–®Ì“Àπà“¬Õÿª°√≥å·≈–‡§√◊ËÕß®—°√∑’ˇ°’ˬ«¢âÕß°—∫°“√º≈‘µ«—§´’π 195
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
6

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6,000 ≈â“π§π ¬‘Ë߉ª°«à“π—Èπ‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à‡°◊Õ∫∑—ÈßÀ¡¥µ—ÈßÕ¬Ÿà„πª√–‡∑»æ—≤π“·≈â« ª√–‡∑»
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7

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1
 ¡¡ÿµ‘∞“π«à“ ®– “¡“√∂¡’ seed virus ∑’Ëæ√âÕ¡ ”À√—∫°“√º≈‘µ«—§´’π‰¥â¿“¬„π 4  —ª¥“ÀåÀ≈—ß¡’°“√ª√–°“»°“√√–∫“¥
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
8


The 2004 unprecedented epidemics of highly pathogenic avian influenza H5N1 among poultry starting in Asia and
later spreading to many regions has stimulated concerns on global pandemic influenza. Thai government has taken this
threat seriously. In May 2005, Thailand has launched National Strategic Plan for Avian Influenza Control and Influenza
Pandemic Preparedness in Thailand, 2005-2007. Research and development is a sub-component of one of seven preparing
strategies. Four sub-committees were set up to take care of Pandemic influenza vaccine. One of these committees is
responsible for conducting a feasibility analysis of pandemic influenza vaccine preparation.

A
working group comprising researchers from various institutions has collaborated to carry out this study. Many
approaches were applied for this study such as literature reviews, series of brainstorming, consultation meetings with
internal and international experts, mapping facilities, and field visits. A mapping of facilities related to vaccine research and
production both for humans and animals covering both private and public organizations indicated that universities had high
capacity in research and development phase. The process of influenza vaccine production in pilot and industrial scale was
not available locally. However, there are some facilities that can be modified to do some production.

T
he working group has proposed four strategies on pandemic influenza vaccine preparation as follow :
Strategy A: Purchasing finished vaccine
Strategy B: Filling vaccine from bulk stock
Strategy C: Modifying available vaccine plants
Strategy D: Building a new vaccine plant:

S
trategy A and Strategy B are immediate preparing for pandemic by stockpiling. The coverage of these
strategies is to cover frontline national protection. Strategy B was proposed to reduce the bottle-neck problem of vaccine
production, to have some cost saving and to promote available filling capacity in the country. However, both strategies may
not be applicable in pandemic situation with concerns on the mismatch issue between stockpiled strain and pandemic
strain, the unavailability of vaccine supply globally, and the inability to cover all population.
Strategy C is on modification of Bureau of Veterinary Biologics (BVB) plant. Similar technology platform (egg-based
technology), good infrastructure, skill and experience personnel, shortest time for start-up production, and limited investment
are main reasons to propose this plant as a contingency plan for emergency production as global vaccine supply is limited.
This plant needs upgrading on downstream process and detailed production process. The potential limitations of this
strategy are bureaucratic will and perception, not technical issues. This option is valued for thorough evaluation as a security
back-up while a new production plant is not available.
Executi ve Summary
çNational Strategies on Pandemic Influenza Vaccine Preparation for Thailandé
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9
Strategy D on building a new vaccine plant is a long-term strategy for national security on pandemic influenza
vaccine self-reliance. With available information and accessibility of technology, egg-based technology was proposed to be
technology platform for this new production plant. Scale of production was proposed based on the number of doses
needed during the pandemic situation, economy of investment scale, and economic evaluation of seasonal influenza
vaccine. Issues on management, organization structure and staffing, main equipments of production process, crude
estimation of investment and timeframe of establishing new plant were discussed. Critical success factors including
continuous supply chain of raw material (eggs), research and development, human resource preparation, and preparation for
technology transfer were proposed.
In additional to this, key issues on Good manufacturing Practice (GMP) and Fast Track Registration were herein
discussed in detail. Lastly, the report was finalised on issue of the relationships among the four strategies. Strategy A on
purchasing finished vaccine and Strategy B on filling the bulk stock was temporary strategy for short-term period. Strategy
C was the plan for medium-term period while waiting for Strategy D to be ready to be long-term security tool for the
country. However, after the new plant was available, Strategy C could also function as a back-up capacity to Strategy D to
increase vaccine availability for the whole population of in emergency period. As none of the four strategies was a perfect
strategy for all periods of time, therefore selecting the right combination of all four strategies was the critical point for
Pandemic vaccine preparation. All strategies shall be implemented in proper timeframe with good coordination from relevant
stakeholders in order to achieve mission on the better preparation for protecting Thai people from the coming Pandemics.
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
10


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1. °“√ª√–™ÿ¡ 2. °“√ª√–™ÿ¡ºŸâ‡™’ˬ«™“≠ 3. °“√‡¢â“√à«¡ª√–™ÿ¡ 4. °“√‡¬’ˬ¡™¡‚√ßß“π 5. °“√‡¬’ˬ¡™¡‚√ßß“π
§≥–∑”ß“π ·≈–ºŸâ‡°’ˬ«¢âÕß µà“ߪ√–‡∑» «—§´’π¿“¬„πª√–‡∑» «—§´’πµà“ߪ√–‡∑»

§√—Èß∑’Ë 1 28 °æ. 49 §√—Èß∑’Ë 1 20 °æ. 49

(°√Õ∫·π«§‘¥°“√»÷°…“)


§√—Èß∑’Ë 2 2-3 ¡’§. 49

Mr. Alan Hampson
(°“√æ‘®“√≥“∑“߇≈◊Õ°
‡∑§‚π‚≈¬’)
§√—Èß∑’Ë 3 31 ¡’§. 49 °“√‡¬’ˬ¡™¡‚√ßß“πº≈‘µ‰¢à SPF

(¬ÿ∑∏»“ µ√å∑’Ë 1)  ”π—°‡∑§‚π‚≈¬’™’«¿—≥±å —µ«å
°√¡ª»ÿ —µ«å
§√—Èß∑’Ë 2 18 ‡¡¬. 49 §√—Èß∑’Ë 4 11 ‡¡¬. 49 30 æ§. 49

(¬ÿ∑∏»“ µ√å∑’Ë 2: ¬ÿ∑∏»“ µ√å
°“√æ÷Ëßµπ‡Õß„π√–¬–¬“«
(1-5ªï)) çInter-country workshop °“√‡¬’ˬ¡™¡‚√ßß“π«—§´’π
§√—Èß∑’Ë 3 9 æ§. 49 to strengten SEA ¢Õß
§√—Èß∑’Ë 4 17 æ§. 49 regionûs capacity in  ”π—°‡∑§‚π‚≈¬’™’«¿—≥±å —µ«å

§√—Èß∑’Ë 5 28-30 ¡‘¬. 49 production influenza °√¡ª»ÿ —µ«å

Prof. Henry Wang vaccineé 2 ¡‘¬. 49
6-8 ¡‘¬. 49
ª√–‡∑»Õ‘π‡¥’¬ °“√‡¬’ˬ¡™¡ ∫. Õߧ尓√‡¿ —™°√√¡
§√—Èß∑’Ë 6 14 °§. 49 -‡¡Õ√å√‘‡ÕÕ√å™’««—µ∂ÿ ®°.
§√—Èß∑’Ë 5 18 °§. 49 ∫. Baxter International Inc çStudy visit on human 26 ¡‘¬. 49

(cell-baseed technology) and avain influenza

vaccine research, °“√‡¬’ˬ¡™¡
development and ∫. Õߧ尓√‡¿ —™°√√¡
§√—Èß∑’Ë 6 11  §. 49 productioné -‡¡Õ√å√‘‡ÕÕ√å™’«««—µ∂ÿ ®°.

 “∏“√≥√—∞ª√–™“™π®’π 19 °¬. 49

§√—Èß∑’Ë 7 30 °¬.- 1 µ§. 49 30 °§. - 5  §. 49

Mr. Nadir Harjee
°“√‡¬’ˬ¡™¡ ”π—°‡∑§‚π‚≈¬’-
çGlobal pandemic ™’«¿—≥±å —µ«å °√¡ª»ÿ —µ«å
§√—Èß∑’Ë 8 24 µ§. 49 influenza vaccine 9 µ§. 49

Mr. Nadir Harjee action plan: Moving
forwardé
Quebec, Canada °“√‡¬’ˬ¡™¡ ”π—°‡∑§‚π‚≈¬’- °“√‡¥‘π∑“߇æ◊ËÕª√–‡¡‘π
20 µ§. 49 ™’«¿—≥±å —µ«å °√¡ª»ÿ —µ«å °—∫ ‡∑§‚π‚≈¬’°“√º≈‘µ
§√—Èß∑’Ë 7 16 æ¬. 49 Mr. Nardir Harjee (Technical trip) ¢Õß
§√—Èß∑’Ë 8 27 æ¬. 49 12 µ§. 49 ‚√ßß“πº≈‘µ«—§´’π
§√—Èß∑’Ë 9 12 ∏§. 49 ‰¢âÀ«—¥„À≠à
Mr. Nadir Harjee ª√–‡∑» “∏“√≥√—∞

ª√–™“™π®’π
5-10 æ¬. 49
1
1
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1
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
14

∫∑∑’Ë 1 ∫∑πÌ“·≈–°√Õ∫·π«§‘¥°“√®—¥∑Ì“¬ÿ∑∏»“ µ√å
1.1 ·π«§‘¥„π°“√®—¥∑Ì“¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬
1.2 ¢âÕ¡Ÿ≈®Ì“‡æ“–¢Õß«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ ·≈–«—§´’π‰¢âÀ«—¥„À≠à„π™à«ß°“√√–∫“¥„À≠à
1.3  ∂“π¿“悧√ß √â“ßæ◊Èπ∞“π„π°“√º≈‘µ«—§´’π√–¥—∫«‘®—¬ √–¥—∫°÷ËßÕÿµ “À°√√¡ ·≈–√–¥—∫Õÿµ “À°√√¡
1.4 °√Õ∫¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à °√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬


1.1 ·π«§‘¥„π°“√®—¥∑Ì“¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬

‚√§‰¢âÀ«—¥„À≠à‡°‘¥®“°‰«√— ‰¢âÀ«—¥„À≠à
(influenza virus) ∑’ËÕ¬Ÿà„π °ÿ≈ Orthomyxoviridea ‰«√— ‰¢âÀ«—¥„À≠à¡’ “√æ—π∏ÿ°√√¡
·∫∫Õ“√å‡ÕÁπ‡Õ “¬‡¥’ˬ«‡ âπ≈∫ (negative sense - single strand RNA)  “¡“√∂·∫àß™π‘¥¢Õ߉«√— ‰¢âÀ«—¥„À≠à‰¥â‡ªìπ 3 ™π‘¥ §◊Õ
™π‘¥ A B ·≈– C ‰«√— ∑’Ë “¡“√∂°àÕ‚√§„π¡πÿ…¬å‰¥â∫àÕ¬·≈–√ÿπ·√ß §◊Õ ™π‘¥ A ‚¥¬¡’≈—°…≥–∑“ߧ≈‘π‘°∑’Ë Ì“§—≠§◊Õ ¡’‰¢â Ÿß·∫∫
∑—π∑’∑—π„¥ ª«¥»’√…– ª«¥‡¡◊ËÕ¬°≈â“¡‡π◊ÈÕ ÕàÕπ‡æ≈’¬ ™π‘¥ B ∑Ì“„À⇰‘¥°“√√–∫“¥„πæ◊Èπ∑’Ë√–¥—∫¿Ÿ¡‘¿“§  à«π™π‘¥ C ¡—°‡ªìπ°“√
µ‘¥‡™◊ÈÕ∑’Ë· ¥ßÕ“°“√Õ¬à“ßÕàÕπÀ√◊Õ‰¡à· ¥ßÕ“°“√ ·≈–‰¡à∑Ì“„À⇰‘¥°“√√–∫“¥ ¬’‚π¡¢Õ߉«√— ‰¢âÀ«—¥„À≠à¡’®Ì“π«π∑—ÈßÀ¡¥ 8 ™‘Èπ
¬àÕ¬ (segmented genome) ∂Õ¥√À— ‰¥â‚ª√µ’π∑—ÈßÀ¡¥ 10 ™π‘¥ §◊Õ PB2, PB1, PA, HA, NP, NA, M1, M2, NS1 ·≈– NS2 ¥—ß
√“¬≈–‡Õ’¬¥· ¥ß„π√Ÿª∑’Ë
1.1 „π®Ì“π«ππ’È¡’‚ª√µ’π·Õ𵑇®π´÷ËßÕ¬Ÿà∫πº‘«‰«√— Õ¬Ÿà 3 ™π‘¥ §◊Õ HA, NA ·≈– M2 ‰«√— ‰¢âÀ«—¥„À≠ଗß
 “¡“√∂·∫à߉¥â‡ªì𠓬æ—π∏åÿ¬àÕ¬µ“¡™π‘¥¢Õß‚ª√µ’π·Õ𵑇®π 2 µ—« §◊Õ HA ·≈– NA ´÷Ëß¡’®Ì“π«π 16 ·≈– 9 ™π‘¥¬àÕ¬µ“¡≈Ì“¥—∫
·µà¡’‡æ’¬ß·§à “¬æ—π∏åÿ H1, H2 ·≈– H3 ‡∑à“π—Èπ∑’Ë¡’√“¬ß“π°“√°àÕ‚√§„π¡πÿ…¬å ∂Ⓣ¡àπ—∫√«¡°“√Õÿ∫—µ‘„À¡à¢Õ߉¢âÀ«—¥π°„π¡πÿ…¬å
∑’Ëæ∫°“√µ‘¥‡™◊ÈÕ‰¢âÀ«—¥π° “¬æ—π∏åÿ H5, H7 ·≈– H9 „π¢≥–∑’Ë∑ÿ° “¬æ—π∏åÿ “¡“√∂æ∫°“√µ‘¥‡™◊ÈÕ‰¥â„ππ°πÈ”
°“√√–∫“¥¢Õ߉¢âÀ«—¥„À≠à
¡’∑—Èß°“√√–∫“¥„π∑âÕß∂‘Ëπ (endemic) ´÷Ëß¡—°‡°‘¥∑ÿ° 1-3 ªï ·≈–°“√√–∫“¥„À≠à∑—Ë«‚≈°
(pandemic) ´÷Ëßæ∫∑ÿ° 10-40 ªï ‡°‘¥®“°°“√∑’ˇ™◊ÈÕ¡’ antigenic shift °≈à“«§◊Õ¡’°“√·≈°‡ª≈’ˬπ™‘Èπ¢Õ߬’‚π¡°—π¢Õ߉«√— ∑’Ëæ∫„π§π
·≈–„π —µ«åÀ≈“¬™π‘¥ ‡™àπ  ÿ°√  —µ«åªï° ¡â“ ‡ªìπµâπ ‡¡◊ËÕ¡’‰«√— ™π‘¥¬àÕ¬„À¡à‡°‘¥¢÷Èπ·≈– “¡“√∂∑Ì“„À⇰‘¥°“√‡®Á∫ªÉ«¬„π§π·≈–
·æ√à√–∫“¥®“°§πÀπ÷Ë߉ª ŸàÕ’°§πÀπ÷Ëß ‡π◊ËÕß®“°ª√–™“°√∑—Ë«‚≈°¬—߉¡à¡’¿Ÿ¡‘§ÿâ¡°—πµàÕ‰«√— ™π‘¥„À¡àπ’È ‚√§®–°√–®“¬‰ªÕ¬à“ß
√«¥‡√Á«„π∑ÿ°°≈ÿà¡Õ“¬ÿ∑”„À⇰‘¥°“√√–∫“¥‰ª∑—Ë«‚≈°‰¥â

ª√–«—µ‘°“√√–∫“¥„À≠à¢Õ߉¢âÀ«—¥„À≠à„πÕ¥’µ ·≈–·π«‚πâ¡°“√√–∫“¥„À≠à„πÕ𓧵

„π™à«ß»µ«√√…∑’˺à“π¡“
°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à (pandemic influenza) ‡°‘¥¢÷Èπ¡“·≈â« 3 §√—Èß ‡°‘¥®“°‡™◊ÈÕ‰«√— 
™π‘¥ A ∑—Èß ‘Èπ ·µà≈–§√—Èß∑Ì“„Àâ¡’ºŸâ‡ ’¬™’«‘µ‡ªìπ®Ì“π«π¡“° ·≈–°àÕ„À⇰‘¥§«“¡ Ÿ≠‡ ’¬∑“߇»√…∞°‘®·≈– —ߧ¡Õ¬à“ß¡À“»“≈ ‚¥¬
§√—Èß∑’Ë√⓬·√ß∑’Ë ÿ¥§◊Õ Spanish flu ‡°‘¥¢÷Èπ„πªï æ.». 2461 › 2462 (§.». 1918 - 1919)  “‡Àµÿ‡°‘¥®“°‰«√—  H1N1 ∑Ì“„Àâ¡’ºŸâ‡ ’¬™’«‘µ
¡“°∂÷ß 40 ≈â“π§π∑—Ë«‚≈° ´÷Ë߇ªìπ®Ì“π«π∑’Ë¡“°°«à“ºŸâ‡ ’¬™’«‘µ®“° ß§√“¡‚≈°§√—Èß∑’Ë 1 (√Ÿª∑’Ë 1.2) °“√√–∫“¥„À≠à§√—Èß∑’Ë 2 ‡°‘¥¢÷Èπ„π
ªï æ.». 2500 › 2501 (§.». 1957 - 1958) ‡ªìπ∑’Ë√Ÿâ®—°°—π„ππ“¡ Asian flu ‡°‘¥®“°‰«√—  H2N2 ¡’ºŸâ‡ ’¬™’«‘µ∑—Ë«‚≈°√“« 1 · π§π ·≈–
°“√√–∫“¥„À≠à§√—Èß∑’Ë 3 ‡°‘¥¢÷Èπ„πªï æ.». 2511 › 2512 (§.». 1968 - 1969) ¡’ºŸâ‡ ’¬™’«‘µ√“« 7 · π§π∑—Ë«‚≈° ´÷Ëß°“√√–∫“¥„À≠à∑—Èß
3 §√—Èßπ’È¡’¢âÕ —ππ‘…∞“π«à“‡°‘¥®“°‰«√— ‰¢âÀ«—¥„À≠à„π —µ«å







∫ ∑ ∑’Ë 1
∫∑π”·≈–°√Õ∫·π«§‘¥°“√®—¥∑”¬ÿ∑∏»“ µ√å
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15
Õߧ尓√Õπ“¡—¬‚≈° À√◊Õ World Health Organization (WHO) ‰¥â®—¥√–¥—∫‡°≥±å«—¥§«“¡‡ ’ˬ߄π°“√‡°‘¥°“√√–∫“¥„À≠à¢Õß
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§«“¡·µ°µà“ß®“°∑’ËÕ¬Ÿà„π Ÿµ√«—§´’π‰¥â πÕ°®“°π’È°“√°≈“¬æ—π∏åÿ¢Õ߉«√— ‰¢âÀ«—¥„À≠àºà“π°≈‰° antigenic shift (™π‘¥¢Õß
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æÕ∑’Ë®–°àÕ°“√√–∫“¥‰ª∑—Ë«‚≈° (pandemic influenza) ‰¥â¿“¬„π√–¬–‡«≈“‰¡à°’ˇ¥◊Õπ ´÷Ëß∂â“À“°‡°‘¥°“√√–∫“¥¢Õß‚√§‰¢âÀ«—¥„À≠à
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√Ÿª∑’Ë 1.1 ¿“æµ—¥¢«“ߢÕßÕπÿ¿“§‰«√— ‰¢âÀ«—¥„À≠à · ¥ß·Õ𵑇®π¿“¬πÕ° ·≈– ®’‚π¡∑—Èß 8 ∑àÕπ¬’π

‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
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√Ÿª∑’Ë 1.2 Spanish flu (1918-1919) ¡’ºŸâ‡ ’¬™’«‘µ 40 ≈â“π§π∑—Ë«‚≈°





















√Ÿª∑’Ë 1.3 √–¥—∫§«“¡‡ ’ˬ߄π°“√‡°‘¥°“√√–∫“¥„À≠à¢Õ߉¢âÀ«—¥„À≠à (Õâ“ßÕ‘ß®“° http://www.who.int)
1.‡°‘¥‡™◊ÈÕ‰«√—  “¬æ—π∏ÿå„À¡à„π —µ«å
·µà‰¡à¡’§«“¡‡ ’ˬߵàÕ§π
2. ‰¡àæ∫°“√µ‘¥‡™◊ÈÕ„π§π
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6. ‡°‘¥°“√√–∫“¥„À≠à
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√Ÿª∑’Ë 1.4 ·ºπ∑’Ë‚≈°√“¬ß“π°“√µ‘¥‡™◊ÈÕ‰«√—  H5N1 „π§π µ—Èß·µà ªï æ.». 2546 › 31  ‘ßÀ“§¡ 2550 (Õâ“ßÕ‘ß®“° http://www.who.int)

°“√§“¥°“√≥åº≈°√–∑∫∑“߇»√…∞°‘®·≈– —ߧ¡¢Õß°“√√–∫“¥„À≠à¢Õ߉¢âÀ«—¥„À≠à
À“°‡°‘¥°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à¢÷Èπ®–°àÕ„À⇰‘¥°“√‡ ’¬™’«‘µ¢Õߧπ‡ªìπ®Ì“π«π¡“° ·≈–§“¥°“√≥å«à“®–°àÕ„Àâ

°‘ ¥§«“¡ Ÿ≠‡ ’ ¬∑“߇»√…∞°‘ ®·≈– — ߧ¡Õ¬à “ß¡À“»“≈ ‡π◊ Ë Õß¡“®“°®–¡’ §π®Ì “π«π¡“°∑’ Ë ªÉ «¬·≈–‡ ’ ¬™’ «‘ µ¥â «¬‚√§‰¢â À«— ¥„À≠à
∑Ì “„Àâ ‡°‘ ¥¿“«–°“√¢“¥·§≈π·√ßß“π®π°à Õ„Àâ ‡°‘ ¥§«“¡‡ ’ ¬À“¬µà Õ√–∫∫°“√º≈‘ µ °“√¢π à ß ·≈–°“√µ‘ ¥µà Õ ◊ Ë Õ “√ √«¡∑— È ß
∫ÿ§≈“°√∑“ß°“√·æ∑¬å ·≈– “∏“√≥ ÿ¢¥â«¬ ´÷Ëß¡’°“√§Ì“π«≥®“°ºŸâ‡™’ˬ«™“≠¥â“π√–∫“¥«‘∑¬“«à“ ®–¡’ºŸâ‡ ’¬™’«‘µ∑—Ë«‚≈°¡“°°«à“
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®“°°“√‡¥‘π∑“ߢÕߧπ‡ªìπ®Ì“π«π¡“° ¬“µâ“π‰«√— ·≈–«—§´’π∑’Ë¡’Õ¬Ÿà‰¡à‡æ’¬ßæÕ √«¡∑—Èߢ“¥·§≈πÕÿª°√≥å·≈–∫ÿ§≈“°√∑“ß°“√
·æ∑¬å·≈– “∏“√≥ ÿ¢ ´÷Ëß∫ÿ§≈“°√ à«πÀπ÷ËßÕ“®ªÉ«¬·≈–‰¡à “¡“√∂∑Ì“ß“π‰¥â ∑Ì“„À⺟â§π≈⡵“¬‡ªìπ®Ì“π«π¡“° ‡°‘¥§«“¡ Ÿ≠
‡ ’¬∑“߇»√…∞°‘®Õ¬à“ß¡À“»“≈ ¥—ßπ—Èπ‡æ◊ËÕ°“√‡µ√’¬¡æ√âÕ¡√—∫¡◊Õ°—∫°“√‡°‘¥°“√√–∫“¥„À≠à Õߧ尓√Õπ“¡—¬‚≈°‰¥âÕÕ°¡“‡µ◊Õπ
∑ÿ°ª√–‡∑»∑—Ë«‚≈°„Àâ¡’·ºπ‡µ√’¬¡æ√âÕ¡°“√√–∫“¥„À≠à∑’ËÕ“®‡°‘¥¢÷Èπ
„πª√–‡∑»‰∑¬
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(√âÕ¬≈–10 ®“°ª√–™“°√∑—ÈßÀ¡¥) ·≈–Õ“®¡’ºŸâ‡ ’¬™’«‘µ ª√–¡“≥ 65,000 §π (√âÕ¬≈– 1)
(πæ.»ÿ¿¡‘µ√ ™ÿ≥Àå ÿ∑∏‘«—≤πå, °“√ —¡¡π“«‘™“°“√
Influenza Inter-Pandemic Preparedness Plan Episode III, ¿Ÿ‡°Áµ, 2549)
·≈–À“°®–‡ª√’¬∫‡∑’¬∫°—∫°“√‡°‘¥°“√√–∫“¥¢Õß‚√§∑“߇¥‘πÀ“¬„®
‡©’¬∫æ≈—π√ÿπ·√ßÀ√◊Õ SARS (Severe Acute Respiratory Syndrome) „πªï æ.». 2546 (§.». 2003) ∑’ˇ°‘¥¢÷Èπ„πª√–‡∑»®’𠇫’¬¥π“¡
ŒàÕß°ß ·≈–√—∞‚µ√Õπ‚µ ª√–‡∑»·§π“¥“ πÌ“‡Õ“¢âÕ¡Ÿ≈¡“§“¥°“√≥åº≈°√–∑∫∑“߇»√…∞°‘®·≈– —ߧ¡ ‚√§ SARS ∑Ì“„Àâ¡’ºŸâªÉ«¬
8,000 §π ·≈–ºŸâ‡ ’¬™’«‘µ√«¡ 800 §π ‡°‘¥°“√À¬ÿ¥™–ß—°¢Õß∏ÿ√°‘®µà“ßÊ ‡™àπ °“√∑àÕ߇∑’ˬ« °“√‡¥‘π∑“ß °“√§â“¢“¬ ‚√ß·√¡ √â“π
Õ“À“√ √«¡∂÷ß°√–∫«π°“√º≈‘µµà“ßÊ ¥â«¬ ‡°‘¥°“√¢“¥·§≈π·√ßß“π ∑Ì“„Àâ¡’º≈°√–∑∫µàÕ‡»√…∞°‘®¢Õß‚≈°ª√–¡“≥ 18 æ—π≈â“π
‡À√’¬≠ À√—∞œ À√◊Õ§‘¥‡ªìπª√–¡“≥ 0.6% ¢Õß§à“ GDP (Global Development Finance, °“√æ—≤π“¥â“π°“√‡ß‘π¢Õß‚≈°) πÕ°®“°
π—Èπ Asian Development Bank (ADB) ¡’°“√»÷°…“«à“À“°‡°‘¥°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à„π ∂“π°“√≥剡à√ÿπ·√ß¡“° ®–
∑Ì“„Àâ¡’Õ—µ√“°“√ªÉ«¬ 20% ·≈–¡’Õ—µ√“°“√‡ ’¬™’«‘µ 0.5% °“√»÷°…“æ∫«à“º≈°√–∑∫∑“߇»√…∞°‘®¢Õß∑«’ª‡Õ‡™’¬Õ¬Ÿà√–À«à“ß 110-
300 æ—π≈â“π‡À√’¬≠ À√—∞œ ª√–°Õ∫°—∫¡’§«“¡‡ ’ˬߠŸß∑’Ë∑Ì“„Àâ°“√‡µ‘∫‚µ∑“߇»√…∞°‘®À¬ÿ¥µ—«≈ß π—ËπÀ¡“¬∂÷ßµ≈“¥°“√§â“¢“¬
 ‘π§â“·≈–∫√‘°“√¢Õß‚≈°®–≈¥≈ß∂÷ß 14% ´÷Ë߇∑à“°—∫ 2.5 ≈â“π≈â“π‡À√’¬≠ À√—∞œ
(Asian Development Bank, 2006)
Areas with confirmed human cases
Areas with confirmed human cases of H5N1 avian influenza since 2003*
Status as of 31 August 2007
Latest available update
Azerbaijan
Cases: 8
Deaths: 5
Iraq
Cases: 3
Deaths: 2
Djibouti
Cases: 1
Deaths: 0
T
urkey
Cases: 12
Deaths: 4
Egypt
Cases: 38
Deaths: 15
Country, area or territory
Cases:
cumulative number
Deaths: cumulative number
Thailand
Cases:
25
Deaths: 17
Indonesia
Cases:
105
Deaths: 84
Combodia
Cases:
7
Deaths: 7
Viet Nam
Cases:
100
Deaths: 46
China
Cases:
25
Deaths: 16
Nigeria
Cases: 1
Deaths: 1
Lao Peopleʼs
Democratic Republic
Cases:
2
Deaths: 2
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
18
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√“¬ß“π‡¡◊ËÕ«—π∑’Ë 28 ¡’π“§¡ 2548 ‰¥â«‘‡§√“–Àåº≈°√–∑∫¢Õß°“√·æ√à√–∫“¥¢Õ߉¢âÀ«—¥π°µàÕ√–∫∫‡»√…∞°‘®¢Õ߉∑¬ ‡ª√’¬∫
‡∑’¬∫‡ªìπ 2 °√≥’ §◊Õ 1.  —µ«å Ÿà§π ·≈– 2. §π Ÿà§π ‚¥¬„™â ¡¡µ‘∞“π∑’Ë Ì“§—≠ ¥—ßπ’È

1.
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2. º≈°√–∑∫µàÕ°“√∑àÕ߇∑’ˬ«¢Õ߉∑¬„π°√≥’∑’ˇ°‘¥‚√§√–∫“¥√–À«à“ß¡πÿ…¬å ‡ªìπ‡™àπ‡¥’¬«°—∫°“√√–∫“¥¢Õß SARS
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’ Ë  Ì“π—°ß“π„À≠à WHO (8 æ.¬. 2548) °≈à“««à“ ‡π◊ËÕß®“°¢≥–π’Ȭ—߉¡à¡’√“¬≈–‡Õ’¬¥¢Õß°“√»÷°…“‡√◊ËÕß¡Ÿ≈§à“§«“¡‡ ’¬À“¬Õ—π‡°‘¥
®“°°“√√–∫“¥¢Õß‚√§‰¢â À«— ¥„À≠à „π√–¥— ∫∑— Ë «‚≈° ·µà  “¡“√∂Õâ “ßÕ‘ ß∂÷ ߢâ Õ¡Ÿ≈°“√»÷ °…“¢Õߪ√–‡∑» À√— ∞Õ‡¡√‘ °“„πªï 1999
»÷°…“∂÷ߺ≈°√–∑∫∑“߇»√…∞°‘®·≈– —ߧ¡®“°°“√‡°‘¥°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à (‚¥¬Õ“»—¬¢âÕ¡Ÿ≈¢Õß°“√√–∫“¥¢Õß
‚√§Õ◊Ëπ∑’Ë√–∫“¥À≈—ß®“°‡°‘¥ ß§√“¡‚≈°§√—Èß∑’Ë 2) ª√–¡“≥«à“®–¡’ºŸâ‡ ’¬™’«‘µ 1 - 2 · π§π„πª√–‡∑» À√—∞Õ‡¡√‘°“ º≈®“°Õ—µ√“
°“√µ“¬·≈–Õ—µ√“°“√ªÉ«¬ ∑Ì“„Àâ¡’§«“¡‡°’ˬ«æ—π°—∫°“√ Ÿ≠‡ ’¬∑“߇»√…∞°‘®∂÷ß 100-200 ≈â“π≈â“π‡À√’¬≠ À√—∞œ (®“°¡Ÿ≈§à“¢Õß
‡À√’¬≠ À√—∞œ ªï æ.». 2547) À“°§Ì“π«≥º≈°√–∑∫∑“߇»√…∞°‘®¢Õߪ√–‡∑» À√—∞Õ‡¡√‘°“¡’¡Ÿ≈§à“°“√ Ÿ≠‡ ’¬√«¡∑—Èߺ≈°√–∑∫
∑“߇»√…∞°‘®·≈– —ߧ¡ 71.3 - 166.5 ≈â“π≈â“π‡À√’¬≠ À√—∞œ ·≈–‡¡◊Ëէ̓π«≥º≈°√–∑∫∑“߇»√…∞°‘®®“°ª√–‡∑»∑’Ëæ—≤π“·≈â«
∑—ÈßÀ¡¥¡’§«“¡ Ÿ≠‡ ’¬∂÷ß
550 ≈â“π≈â“π‡À√’¬≠ À√—∞œ ´÷ËßÀ“°√«¡ª√–‡∑»∑’Ë°Ì“≈—ßæ—≤π“®–¡’º≈°√–∑∫∑“߇»√…∞°‘®∑’Ë Ÿß°«à“π’È
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2551-2553 ‚¥¬ ”π—°
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(«‘‚√®πå, 2548)
µ“√“ß∑’Ë 1.1 µ“√“ߺ≈°√–∑∫µàÕ¿“æ√«¡‡»√…∞°‘®‰∑¬ ( Ì“π—°ß“π‡»√…∞°‘®°“√§≈—ß, 2548)


°“√‡ª≈’ˬπ·ª≈ß ªï 2548 °√≥’∑’Ë 1 ªï 2548 °√≥’∑’Ë 2
1. Õ—µ√“°“√¢¬“¬µ—«∑“߇»√…∞°‘® ≈¥≈ß 0.20-0.25% ≈¥≈ß 0.25-0.35%
2. °“√∫√‘‚¿§‡π◊ÈÕ‰°à¿“¬„πª√–‡∑» ™–≈Õµ—«‡≈Á°πâÕ¬ ‡™àπ‡¥’¬«°—∫°√≥’∑’Ë 1
3. °“√ àßÕÕ°‡π◊ÈÕ‰°à µ≈“¥‡π◊ÈÕ‰°à·ª√√Ÿª·∑π∑’ˇπ◊ÈÕ‰°à·™à·¢Áß ‡™àπ‡¥’¬«°—∫°√≥’∑’Ë 1
4. ¥ÿ≈∫√‘°“√ (°“√∑àÕ߇∑’ˬ«) ‰¡à àߺ≈ π—°∑àÕ߇∑’ˬ«≈¥≈߇™àπ‡¥’¬«°—∫
°“√√–∫“¥¢Õß SARS
5. ¥ÿ≈°“√§≈—ß ‡ß‘π™à«¬‡À≈◊Õ¡“®“°ß∫°≈“ß ‡™àπ‡¥’¬«°—∫°√≥’∑’Ë 1

(‡ß‘π™à«¬‡À≈◊Õ·≈–™¥‡™¬)

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2. ¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡‡«™¿—≥±å «— ¥ÿ Õÿª°√≥å∑’ˮ̓‡ªìπ
3. ¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡§«“¡æ√âÕ¡§«∫§ÿ¡°“√√–∫“¥©ÿ°‡©‘π
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„π‡¥◊Õπ¡°√“§¡ §.». 2004 ‰¥â¡’√“¬ß“π°“√µ‘¥‡™◊ÈÕ‰¢âÀ«—¥π° “¬æ—π∏åÿ H5N1 „π¡πÿ…¬å„π‡«’¬¥π“¡ ·≈–‰¥â¡’°“√·¬°
‰«√— ∑’Ë°àÕ°“√µ‘¥‡™◊ÈÕ„π§√—Èßπ’È‚¥¬ÀâÕߪؑ∫—µ‘°“√„πŒàÕß°ß·≈–≠’˪ÿÉπ ·≈–»÷°…“≈—°…≥–¢Õ߉«√— ∑—Èß∑“ßæ—π∏ÿ°√√¡·≈–·Õ𵑇®π

π°“√π’ È Õß§å °“√Õπ“¡— ¬‚≈°‰¥â ·∂≈ß«à “∂â “∑ÿ °ΩÉ “¬ªØ‘ ∫— µ‘ µ“¡·π«∑“ß∑’ Ë ∑“ßÕß§å °“√œ ‰¥â °Ì “Àπ¥‰«â ·≈–„Àâ §«“¡√à «¡¡◊ Õ°— ∫Àâ Õß
ª
Ø‘ ∫— µ‘ °“√‡§√◊Õ¢à“¬¢ÕßÕߧ尓√œ ®– “¡“√∂ √â“߉«√— µâπ·∫∫‡æ◊ËÕ‡ªìπ«—§´’π‰¥â¿“¬„π 4  —ª¥“Àå
µàÕ¡“„π‡¥◊Õπ‡¡…“¬π §.». 2004 Õߧ尓√Õπ“¡—¬‚≈°‰¥â·∂≈ß«à“‰¥âº≈‘µµâπ·∫∫«—§´’π (Prototype seed vaccine) ¢Õß
‰«√—  “¬æ—π∏åÿ H5N1 ‡ √Á® ‘Èπ·≈â« ´÷ËߺŸâº≈‘µ«—§´’π “¡“√∂¢Õ«—§´’πµâπ·∫∫π’ȇæ◊ËÕ°“√º≈‘µ Ì“À√—∫°“√∑¥ Õ∫·≈–»÷°…“∑“ߧ≈‘π‘§
‰¥â Õ¬à“߉√°Áµ“¡¡’ºŸâº≈‘µ‡æ’¬ß 2 √“¬‡∑à“π—Èπ∑’Ë¢Õ√—∫µâπ·∫∫«—§´’ππ’ȇæ◊ËÕπÌ“ Ÿà°“√º≈‘µ„π√–¥—∫‡≈Á° Ì“À√—∫°“√∑¥ Õ∫„π√–¥—∫§≈’π‘§
§
◊Õ Õ‡«πµ’  ª“ ‡µÕ√å (´“‚πøïò ª“ ‡µÕ√å „πªí®®ÿ∫—π) ·≈– ‰§√Õπ (Chiron)
„π‡¥◊Õπ情¿“§¡ §.». 2005 Õߧ尓√Õπ“¡—¬‚≈°‰¥â·∂≈ß«à“‰¥â∑Ì“°“√»÷°…“§ÿ≥≈—°…≥–¢Õ߉«√—  H5N1 ∑’Ë·¬°‰¥â®“°
¡πÿ…¬å·≈– —µ«å„πÀ≈“¬ª√–‡∑» ·≈–‰¥â°Ì“Àπ¥§ÿ≥≈—°…≥–∑“ß·Õ𵑇®π·≈–æ—π∏ÿ°√√¡¢Õ߉«√—  H5N1 ∑’ˇÀ¡“– ¡ Ì“À√—∫°“√º≈‘µ
‡ªìπ«—§´’π ´÷Ë߉«√— ∑’Ë„™â‡ªìπµâπ·∫∫„π°“√æ—≤π“§◊Õ A/Vietnam/1194/04, A/Vietnam/1203/04 ·≈– A/Hongkong/213/03 πÕ°®“°π’È
Õߧ尓√Õπ“¡—¬‚≈°¬—߉¥â°≈à“««à“°“√„™â‡∑§π‘§ reverse genetic „π°“√«‘®—¬ “¡“√∂∑Ì“‰¥â‚¥¬‰¡àµ‘¥ªí≠À“‡√◊ËÕß∑√—æ¬å ‘π∑“ߪí≠≠“
Õ¬à“߉√°Áµ“¡ ‡°≥±å∑’Ë„™âπ’ȉ¡à‡°’ˬ«¢âÕß°—∫°“√º≈‘µ‡æ◊ËÕ°“√§â“


ºŸâº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à “¡“√∂µ‘¥µàÕ‡æ◊ËÕ√—∫µâπ·∫∫«—§´’π‡æ◊ËÕ°“√º≈‘µ‰¥â∑’Ë WHO Global Influenza Programme À√◊Õ
 ∂“∫—π¥—ßπ’È


- National Institute for Biological Standards and Control ª√–‡∑»Õ—ß°ƒ…
- CDC ª√–‡∑» À√—∞Õ‡¡√‘°“
- St. Jude Childrenûs Research Hospital ª√–‡∑» À√—∞Õ‡¡√‘°“


ª√–‡∑» À√— ∞Õ‡¡√‘ °“¡’ °“√«à “®â “ß∫√‘ …— ∑ ´“‚πøï ò ª“ ‡µÕ√å º≈‘ µ«— §´’ π‰¢â À«— ¥π°™π‘ ¥ H5N1 ·≈–æ∫«à “ “¡“√∂
‡Àπ’ˬ«πÌ“„À⇰‘¥¿Ÿ¡‘§ÿâ¡°—π„πÕ“ “ ¡—§√‰¥â®√‘ß
·µàµâÕß„™âª√‘¡“≥·Õ𵑇®π∂÷ß 90 ‰¡‚§√°√—¡ ©’¥‡ªìπ®Ì“π«π 2 §√—Èß ∑—Èßπ’È Õ“®‡π◊ËÕß
¡“®“°¡πÿ…¬å‰¡à‡§¬ —¡º— °—∫‰«√— ‰¢âÀ«—¥π°¡“°àÕπ ∑Ì“„Àâ®Ì“‡ªìπµâÕß„™âª√‘¡“≥·Õ𵑇®π∑’Ë Ÿß„π°“√°√–µÿâπ¿Ÿ¡‘§ÿâ¡°—π

¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à
°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬

21
1.2.2 ™π‘¥¢Õß«—§´’π‰¢âÀ«—¥„À≠à
«—§´’π‰¢âÀ«—¥„À≠à¡’ 2 ™π‘¥ §◊Õ

1.2.2.1 «—§´’π™π‘¥‡™◊ÈÕµ“¬ (Inactivated influenza vaccine)

‡ªì π«— §´’ π∑’ Ë ¡’  à «πª√–°Õ∫¢Õ߇™◊ È Õ‰«√—  ∑’ Ë ‰¡à ¡’ ™’ «‘ µ „πªí ®®ÿ ∫— π«— §´’ π‰¢â À«— ¥„À≠à µ“¡ƒ¥Ÿ°“≈∑’ Ë ¡’ ®Ì “Àπà “¬∑— Ë «
‚≈°‡ªì π™π‘ ¥ inactivated vaccine ∂÷ß 90% ‚¥¬¡’ à«πª√–°Õ∫¢Õ߇™◊ÈÕ‰«√— ‰¢âÀ«—¥„À≠à 3  “¬æ—π∏åÿ §◊Õ influenza A (H3N2),
influenza A (H1N1) ·≈– influenza B ª√‘¡“≥Õ¬à“ß≈– 15 ‰¡‚§√°√—¡ (√«¡ 45 ‰¡‚§√°√—¡) „π 1 ‚¥ 

«—§´’π‡™◊ÈÕµ“¬¡’ 4 ™π‘¥§◊Õ



whole-cell influenza vaccine ‡ªìπ«—§´’π∑’ËπÌ“‡Õ“‰«√— ∑—ÈßÕπÿ¿“§‰ª∑Ì“„ÀâÀ¡¥ ¿“æ„π°“√µ‘¥‡™◊ÈÕ‡ ’¬°àÕπ

‡≈‘°„™â‰ªµ—Èß·µàªïæ.».2544 ‡π◊ËÕß®“°‡°‘¥º≈¢â“߇§’¬ß¡“°



subvirion (split virion) ‡ªìπ«—§´’πª√–°Õ∫¥â«¬ à«πª√–°Õ∫µà“ßÊ¢Õ߉«√—  ‡°‘¥®“°°“√ºà“π°√–∫«π°“√∑’Ë

πÌ“‡™◊ÈÕ‰«√— ‰ª∑Ì“„Àâ·¬°µ—«®“°Õπÿ¿“§‡¥‘¡


purified surface-antigen vaccine ‡ªìπ«—§´’π∑’ˇՓ‡™◊ÈÕ‰«√— ºà“π°√–∫«π°“√∑Ì“„Àâ∫√‘ ÿ∑∏‘Ï‚¥¬·¬°‡Õ“‡©æ“–

 à«π∑’ˇªìπ Haemagglutinin (HA) ·≈– Neuraminidase (NA) À√◊Õ∑’ˇ√’¬°«à“ surface antigen


virosomal vaccines ‡ªìπ«—§´’π∑’ËπÌ“‡Õ“‰«√— ∑—ÈßÕπÿ¿“§‰ªºà“π°√–∫«π°“√‡æ◊ËÕ‡Õ“ “√æ—π∏ÿ°√√¡ÕÕ°∑—ÈßÀ¡¥

‡À≈◊Շ撬߇ª≈◊Õ°Àÿ⡉«√—  (virus envelope) ∑Ì“„À≡ࠓ¡“√∂‡æ‘Ë¡®Ì“π«π‰¥â ·≈–¢“¥§ÿ≥ ¡∫—µ‘„π°“√∑Ì“„Àâ

‡´≈≈嵑¥‡™◊ÈÕ ‡√’¬°Õπÿ¿“§π’È«à“ Virosome ´÷Ëß “¡“√∂°√–µÿâπ„À⇰‘¥¿Ÿ¡‘§ÿâ¡°—π‰¥â πÕ°®“°π’Ȭ—ß¡’°“√»÷°…“¥â“π

°“√πÌ“‰ª„™â‡ªìπ adjuvant ¥â«¬
 “¬æ—π∏åÿ¢Õ߇™◊ÈÕ‰«√— ‰¢âÀ«—¥„À≠à¡’°“√‡ª≈’ˬπ·ª≈ß∑ÿ°ªï‡π◊ËÕß®“°‡™◊ÈÕ‰«√— ‰¢âÀ«—¥„À≠à‡°‘¥ Antigenic drift ®“°
°“√»÷°…“µà“ßÊ æ∫«à“ «—§´’π¡’ª√– ‘∑∏‘º≈ª√–¡“≥√âÕ¬≈– 70-80 (range 50-95%) ∑—Èßπ’È ¢÷ÈπÕ¬Ÿà°—∫«à“ “¬æ—π∏åÿ¢Õ߇™◊ÈÕ‰«√— „π
«—§´’πµ√ß°—∫ “¬æ—π∏åÿ∑’Ë√–∫“¥„π∑âÕß∂‘Ëππ—ÈπÊ ¡“°‡∑à“„¥ √«¡∑—Èß Õ“¬ÿ·≈–¿“«–¿Ÿ¡‘§ÿâ¡°—π¢ÕߺŸâ√—∫«—§´’π¥â«¬

«—§´’π‰¢âÀ«—¥„À≠à¡’°“√„™âÕ¬à“ß·æ√àÀ≈“¬‡ªìπ‡«≈“¡“°°«à“ 60 ªï¡“·≈â« ¡’§«“¡ª≈Õ¥¿—¬ Ÿß¡“° πÕ°‡Àπ◊Õ®“°
Õ“°“√ª«¥‡¡◊ËÕ¬‡©æ“–∑’˪√–¡“≥ 1-2 «—π ·≈–‡°‘¥º≈¢â“߇§’¬ßπâÕ¬¡“° ‡π◊ËÕß®“°°√–∫«π°“√‡æ“–‡™◊ÈÕ‰«√— „π‰¢à‰°àøí° ¥—ßπ—Èπ®÷ß
‰¡à·π–πÌ“„Àâ„™â„π∫ÿ§§≈∑’Ë¡’ª√–«—µ‘·æ₪√µ’π®“°‰¢à Õ¬à“߉√°Áµ“¡«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈π’ȉ¡à “¡“√∂ªÑÕß°—π‚√§‰¢âÀ«—¥π°
À√◊Õ‰¢âÀ«—¥„À≠à∑’Ë®–‡°‘¥°“√√–∫“¥„À≠à„πÕ𓧵‰¥â ‡π◊ËÕß®“° “¬æ—π∏åÿ∑’Ë„™âº≈‘µ«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈‡ªì𠓬æ—π∏åÿ‰«√— 
∑’Ë·µ°µà“ß®“°‰«√— ‰¢âÀ«—¥π°À√◊Õ‰¢âÀ«—¥„À≠à∑’Ë®–‡°‘¥°“√√–∫“¥„À≠à










√Ÿª∑’Ë 1.5 «—§´’π™π‘¥‡™◊ÈÕµ“¬

1.2.2.2 «—§´’π™π‘¥‡™◊ÈÕ‡ªìπ (Live-attenuated influenza vaccine (LAIV))

®“°°“√∑’Ë«—§´’π‰¢âÀ«—¥„À≠à∑’Ë„™â·æ√àÀ≈“¬µâÕß„Àâ‚¥¬°“√©’¥ 1-2 ‡¢Á¡µàÕªï°àÕ„À⇰‘¥º≈‡ ’¬µàÕ°“√¬Õ¡√—∫¢ÕߺŸâ√—∫
«—§´’π·≈–§√Õ∫§√—« √«¡∑—Èß·æ∑¬åºŸâ¥Ÿ·≈ ®÷ß¡’°“√æ—≤π“«—§´’π‰¢âÀ«—¥„À≠à™π‘¥‡™◊ÈÕ‡ªìπ ´÷Ëß„™â‚¥¬°“√æàπ∑“ß®¡Ÿ° (Intranasal) ‡æ◊ËÕ
‡≈’¬π·∫∫°“√µ‘¥‡™◊ÈÕ‚√§‰¢âÀ«—¥„À≠à ‚¥¬∏√√¡™“µ‘ «—§´’π™π‘¥π’Ȫ√–°Õ∫¥â«¬‡™◊ÈÕ‰«√— ‰¢âÀ«—¥„À≠à™π‘¥‡™◊ÈÕ‡ªìπÕàÕπƒ∑∏‘Ï 3  “¬
æ—π∏åÿ‡À¡◊Õπ°—∫«—§´’π‡™◊ÈÕµ“¬ ´÷Ëß„π¢≥–π’È«—§´’π‡™◊ÈÕ‡ªìπ¬—߉¡à¡’®Ì“Àπà“¬„πª√–‡∑»‰∑¬ ¡’®Ì“Àπà“¬„πª√–‡∑» À√—∞Õ‡¡√‘°“¿“¬„µâ
™◊ËÕ∑“ß°“√§â“«à“ Flumist˙ ‚¥¬∫√‘…—∑ MedImmune ·≈–¡’°“√„™âÕ¬à“ß·æ√àÀ≈“¬„πª√–‡∑»√— ‡´’¬‡ªìπ‡«≈“°«à“ 50 ªï
whole-cell influenza vaccine Subvirion (split virion) purified surface-antigen vaccine virosome
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
22
 √ÿª¢âÕ¥’·≈–¢âÕ‡ ’¬√–À«à“ß«—§´’π™π‘¥‡™◊ÈÕµ“¬·≈– «—§´’π™π‘¥‡™◊ÈÕ‡ªìπ ¥—ß· ¥ß„πµ“√“ß∑’Ë 1.2

µ“√“ß∑’Ë 1.2 °“√‡ª√’¬∫‡∑’¬∫¢âÕ¥’·≈–¢âÕ‡ ’¬¢Õß«—§´’π™π‘¥‡™◊ÈÕµ“¬·≈–«—§´’π™π‘¥‡™◊ÈÕ‡ªìπ


™π‘¥¢Õß«—§´’π ¢âÕ¥’ ¢âÕ‡ ’¬
1. «—§´’π™π‘¥‡™◊ÈÕµ“¬ 1. ¡’ª√– ‘∑∏‘¿“æª√–¡“≥√âÕ¬≈– 70-80 1. ‰¡à “¡“√∂„™â„πºŸâ∑’Ë·æ₪√µ’π®“°‰¢à‰°à‰¥â

2. ¡’§«“¡ª≈Õ¥¿—¬ Ÿß
2. «—§´’π™π‘¥‡™◊ÈÕ‡ªìπ 1. πÌ“‡¢â“ Ÿà√à“ß°“¬ßà“¬ 1. √“§“·æß

2. º≈º≈‘µµàÕ batch  Ÿß°«à“‡™◊ÈÕµ“¬ 30 ‡∑à“ 2. „™â‰¥â„π‡¥Á°∑’Ë¡’Õ“¬ÿµ—Èß·µà 5 ªï¢÷Èπ‰ª

3.  √â“ß¿Ÿ¡‘§ÿâ¡°—π™π‘¥‡©æ“–∑’Ë (local Ig A)‰¥â Ÿß ∂÷ߺŸâ„À≠àÕ“¬ÿ 49 ªï
4. ª√– ‘∑∏‘º≈¢Õß«—§´’πÕ¬Ÿà‰¥âπ“π°«à“ 1 ªï 3. ‰¡à§«√„™â„πºŸâªÉ«¬∑’Ë¡’¿“«–¿Ÿ¡‘§ÿâ¡°—π≈¥≈ß

À√◊Õ∫°æ√àÕß®“° “‡Àµÿ„¥Ê°Áµ“¡




1.2.3 °√–∫«π°“√º≈‘µ·≈–√–¬–‡«≈“„π°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à


°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à®–‡√‘Ë¡®“°°“√πÌ“‰«√— µ—Èßµâπ (Seed virus)  “¬æ—π∏åÿ∑’˧“¥«à“®–¡’°“√√–∫“¥¡“‡æ‘Ë¡®Ì“π«π
„π‰¢à‰°àøí° À√◊Õ„π‡´≈≈å —µ«å‡≈’Ȭß≈Ÿ°¥â«¬π¡ ·≈â«∑Ì“°“√‡°Á∫‡°’ˬ« (harvest) ‰«√— ∑’Ë„™â‡ªìπ«—§´’π ´÷Ëß∑—ÈßÀ¡¥π’ȇªìπ™à«ß upstream
process ®“°π—Èπ®–‡¢â“ Ÿà°√–∫«π°“√ downstream process ´÷Ë߇°’ˬ«¢âÕß°—∫°“√ °—¥„Àâ∫√‘ ÿ∑∏‘Ï·≈–°“√∑Ì“„À⇪ìπ«—§´’π (formulation)
·≈–°“√∫√√®ÿ (filling and packaging) ‚¥¬¢—ÈπµÕπ upstream ·≈– downstream process „™â‡«≈“ª√–¡“≥ 3 ‡¥◊Õπ ¿“¬À≈—ß®“°
downstream process µ—«Õ¬à“ߢÕß«—§´’π®–∂Ÿ°πÌ“‰ª∑¥ Õ∫ (clinical trial) ‡æ◊ËÕ∑Ì“ lot release ´÷Ëß®–„™â‡«≈“ª√–¡“≥ 2-3 ‡¥◊Õπ
¥—ßµ—«Õ¬à“ß„π√Ÿª∑’Ë 1.6 ´÷Ë߇ªìπ°“√º≈‘µ«—§´’π‚¥¬„™â‰¢à












√Ÿª∑’Ë 1.6 µ—«Õ¬à“ß°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à‚¥¬„™â‰¢à‰°à · ¥ß√–¬–‡«≈“„π°“√º≈‘µ



°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ (Seasonal influenza vaccine) ·≈–«—§´’π‰¢âÀ«—¥„À≠à„π™à«ß°“√√–∫“¥„À≠à
(Pandemic influenza vaccine) π—Èπ„™â«‘∏’·≈–°√–∫«π°“√‡¥’¬«°—π ¥—ßπ—È𧫓¡ “¡“√∂„π°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈®–
‡ªìπµ—«™’ȧ«“¡ “¡“√∂„π°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à„π™à«ß°“√‡°‘¥°“√√–∫“¥„À≠à¥â«¬ ¢—ÈπµÕπÀ≈—°„π°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à
¡’ 4 ¢—ÈπµÕπ ¥—ßπ’È

Weeks
WHO
Isolates
Strain
WHO
Analyze strain
Strain Development (Classic Reassortment)
SRD Reagent Preparation
Manufacturer
Lot Release Testing
Formulation & Filling
Monovalent Batch Production
Seed Strain Incubation and Isociation
Egg Growth (Seed)
Egg Growth (Production)
1 2
3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à
°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬

23
1.2.3.1 °“√º≈‘µ‰«√— ‡√‘Ë¡µâπ (Seed lot production)

À≈—ß®“°‰¥â‰«√—  “¬æ—π∏åÿ∑’ˇÀ¡“– ¡®“° WHO ·≈â«®–µâÕߺ≈‘µ‰«√—  seed lot ®“°‰¢à ‚¥¬®–µâÕß∑Ì“À≈“¬§√—Èß
(passages) ®π‰¥âª√‘¡“≥‰«√— ¡“°æÕ‡æ◊ËÕ°“√º≈‘µ®√‘ß ‚¥¬¡’°“√µ√«®π—∫‰«√— ·≈–∑Ì“ seed lot release

„π°“√‡µ√’¬¡°“√º≈‘µ«—§´’π Ì“À√—∫ Pandemic influenza π—Èπ¡’§«“¡‡ ’ˬßÕ¬Ÿà√–¥—∫Àπ÷Ëß ‡π◊ËÕß®“°°“√√–∫“¥¢Õß
avian influenza (H5N1) ∑—Ë«‚≈°π—Èπ¡’À≈“¬ subtype ®÷ß¡’§«“¡‡ªìπ‰ª‰¥â Ÿß∑’Ë„π¿“«– pandemic Õ“®‡°‘¥®“°‰«√—  H5N1 subtype ∑’Ë
‰¡àµ√ß°—∫«—§´’π∑’ˇµ√’¬¡‰«â √«¡∑—È߬—ßæ∫«à“§ÿ≥ ¡∫—µ‘„π°“√‡ªìπ·Õ𵑇®π¢Õß HA antigen ¢Õß H5N1 „π°“√‡ªìπ«—§´’π‡æ◊ËÕ„™â
°“√°√–µÿâπ¿Ÿ¡‘§ÿâ¡°—π„π¡πÿ…¬åπ—Èπ¥âÕ¬°«à“
HA antigen ¢Õ߉«√— ‰¢âÀ«—¥„À≠à∑—Èß H1N1 ·≈– H3N2 ¥—ßπ—Èπ°“√»÷°…“·≈–æ—≤π“‡æ◊ËÕ
º≈‘µ«—§´’π∑’Ë¡’ª√– ‘∑∏‘¿“æ„Àâ∑—π°—∫§«“¡µâÕß°“√À“°‡°‘¥°“√√–∫“¥®÷ß¡’§«“¡ Ì“§—≠Õ¬à“߇√àߥà«π

ªí®®ÿ∫—πª√–‡∑»‰∑¬ “¡“√∂‡µ√’¬¡ Seed vaccine ‚¥¬«‘∏’°“√ reverse genetics À√◊Õ °“√∑Ì“ cold adapted seed
strain ‰¥â‡Õß∑’˧≥–·æ∑¬»“ µ√å »‘√‘√“™æ¬“∫“≈ ¡À“«‘∑¬“≈—¬¡À‘¥≈ ‚¥¬À“°‡°‘¥°“√√–∫“¥¢Õ߉«√—  “¡“√∂∑Ì“°“√‡µ√’¬¡
seed virus subtype ∑’Ë√–∫“¥„πª√–‡∑»‰¥â À√◊ÕÕ“®¢Õ√—∫ Seed virus ®“° NIBSC (National Institute for Biological Standards and
Control)


1.2.3.2 °“√‡æ‘Ë¡®Ì“π«π‰«√—  À√◊Õ à«πª√–°Õ∫¢Õ߉«√— ∑’Ë„™â‡ªìπ«—§´’π (Upstream process)

„πªí®®ÿ∫—π°“√º≈‘µ‰«√—  “¡“√∂º≈‘µ‰¥â‚¥¬„™â‡∑§‚π‚≈¬’ 3 ·∫∫¥—ßπ’È
1) ‡∑§‚π‚≈¬’°“√„™â‰¢à‰°à (Egg-based technology)
2) ‡∑§‚π‚≈¬’°“√„™â‡´≈≈å (Cell-based technology)
3) ‡∑§‚π‚≈¬’∑“߇≈◊Õ° ‡™àπ Recombinant HA vaccine, M2: Universal vaccine, DNA-based vaccine ·≈–

recombinant protiein ®“° Baculovirus Expression Insect Cell System ´÷Ëß„π∑’Ëπ’È®–°≈à“«∂÷ß·µà‡©æ“–°“√„™â

Baculovirus Expression Insect Cell System
√“¬≈–‡Õ’¬¥¢Õß·µà≈–‡∑§‚π‚≈¬’ ¥—ßπ’È
1) ‡∑§‚π‚≈¬’°“√„™â‰¢à ‰°à (Egg-based technology)

‡∑§‚π‚≈¬’ °“√º≈‘ µ«— §´’ π‚¥¬„™â ‰¢à ‡ªì π‡∑§‚π‚≈¬’ ∑’ Ë „™â „π°“√º≈‘ µ«— §´’ π‰¢â À«— ¥„À≠à ¡“°«à “ 50 ªï ®÷ ߇ªì π
‡∑§‚π‚≈¬’∑’ˇ™◊ËÕ∂◊Õ‰¥â„π·ßà§ÿ≥¿“æ¢Õß«—§´’π∑’˺≈‘µ‰¥â °“√º≈‘µ«—§´’π‡√‘Ë¡®“°°“√πÌ“‰¢à‰°àøí°∑’˵√«® Õ∫·≈â««à“Õ¬Ÿà„π ¿“æ¥’ Õ“¬ÿ
9
- 11 «—π ¡“©’¥‡™◊ÈÕ (Seed virus) ∑’ˇµ√’¬¡‰«â´÷ËßÕ“®∑Ì“‰¥â‚¥¬„™â‡§√◊ËÕßÕ—µ‚π¡—µ‘À√◊Õ„™â§π©’¥·≈â«∫ࡉ«â‡ªìπ‡«≈“ 3 «—π À≈—ß®“°π—Èπ
®–∑Ì“°“√µ√«® Õ∫‚¥¬°“√ àÕ߉ø¥Ÿ«à“‰¢à∑’Ë∫ࡉ«â¡’√Õ¬·µ°À√◊Õ¡’°“√ªπ‡ªóôÕπÀ√◊Õ‰¡à ·≈â«πÌ“¡“·™à‡¬Áπ∑’ËÕÿ≥À¿Ÿ¡‘ 2- 8 Ì C ‡æ◊ËÕ∑Ì“
„Àâ embryo µ“¬ ·≈â«∑Ì“°“√‡°Á∫ (harvest) à«π allantoic fluid ¢Õ߉¢à‰°à∑’˵‘¥‡™◊ÈÕ ‚¥¬¡’°√–∫«π°“√º≈‘µ¥—ß· ¥ß„π√Ÿª∑’Ë 1.7


2) ‡∑§‚π‚≈¬’°“√„™â‡´≈≈å (Cell-based technology)

°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠àπ—Èπ·¡â«à“®–¡’°“√º≈‘µ‚¥¬°“√‡æ‘Ë¡®Ì“π«π‰«√— „π‰¢à‰°à¡“π“π·≈â« ·µàºŸâº≈‘µ«—§´’π à«π
„À≠à‡ÀÁπ«à“°“√º≈‘ µ«— §´’ π‚¥¬„™â ‡´≈≈å ∑’ Ë ‡®√‘ ≠„π∂— ßÀ¡— °‡ªì π·À≈à ߺ≈‘ µ‰«√—   πà “®–‡ªì π«‘ ∏’ °“√∑’ Ë ‡À¡“– ¡„πÕ𓧵 ¿“¬À≈— ß
πÌ “‡´≈≈å ¡“‡æ“–‡≈’Ȭ߷≈â«∑Ì“°“√πÌ“ Virus seed ∑’ˇµ√’¬¡‰«â¡“∑Ì“°“√ infect ‡æ◊ËÕ‡æ‘Ë¡®Ì“π«π¿“¬„π‡´≈≈å‡À≈à“π’È √«¡‡«≈“¢Õß
°√–∫«π°“√ª√–¡“≥ 37 «—π √“¬≈–‡Õ’¬¥¥—ß· ¥ß„π√Ÿª∑’Ë 1.8

™π‘¥¢Õß cell line ∑’Ë„™â„π°“√º≈‘µ‰«√— ‰¢âÀ«—¥„À≠à„πªí®®ÿ∫—π §◊Õ
1. MDCK (Madin-Darby canine kidney)  “¡“√∂º≈‘µ‰«√— ‰¥â¡“°·≈–∑Ì“„Àâ∫√‘ ÿ∑∏‘ω¥âßà“¬ ªí®®ÿ∫—π

ª√–‡∑»‡π‡∏Õ√å·≈π¥åÕπÿ≠“µ„Àâº≈‘µ‰¥â ·µà„πª√–‡∑» À√—∞Õ‡¡√‘°“¬—߉¡àÕπÿ≠“µ ‡π◊ËÕß®“°¬—ß¡’§«“¡°—ß«≈

„π‡√◊ËÕß°“√¡’‚Õ°“ „π°“√‡°‘¥ tumor ®“° agents „π«—§´’π
2. Vero cell (African green monkey kidney) ‰¥â√—∫°“√√—∫√Õßµ“¡¡“µ√∞“𧫓¡ª≈Õ¥¿—¬·≈â« ·µà«à“

„Àâº≈º≈‘µ‰«√— ‰¥âπâÕ¬
3. PerC.6 (Human fetal retinoblast) ®“° ∫√‘…—∑ Crucell




‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
24
¢âÕ¥’¢Õß«‘∏’°“√π’È §◊Õ °“√¢¬“¬¢π“¥°“√º≈‘µ∑Ì“‰¥â‚¥¬‰¡à¬ÿà߬“° ·≈–‰¡à¡’¢âծ̓°—¥„π‡√◊ËÕߪ√‘¡“≥‡´≈≈å∑’Ë„™â´÷Ëß
°“√„™â‰¢àÕ“®æ∫ªí≠À“‰¢à‰¡àæÕ‰¥â ¢âծ̓°—¥¢Õ߇∑§‚π‚≈¬’°“√„™â‡´≈≈å§◊Õ‡∑§‚π‚≈¬’π’Ȭ—ßæ—≤π“‰¡à ¡∫Ÿ√≥å ¬—߉¡à¡’¢âÕ¡Ÿ≈∑’Ë™—¥‡®π
‡æ’¬ßæÕ«à“‡´≈≈å™π‘¥‰Àπ Õ“À“√‡≈’Ȭ߇´≈≈å®–‡À¡“– ¡°—∫°“√‡≈’Ȭ߉«√— ‰¢âÀ«—¥„À≠à „πªí®®ÿ∫—π«—§´’π∑’˺≈‘µ®“°‡´≈≈嬗ßÕ¬Ÿà„π¢—Èπ
°“√«‘®—¬§âπ§«â“„πÀâÕߪؑ∫—µ‘°“√ À√◊Õ°“√∑¥ Õ∫„π¿“§ π“¡§≈’𑧠(clinical trial) ¬—߉¡à¡’°“√®Ì“Àπà“¬«—§´’πªÑÕß°—π‰¢âÀ«—¥„À≠à
∑’˺≈‘µ®“°‡∑§‚π‚≈¬’°“√„™â‡´≈≈å  Ì“À√—∫ª√–‡∑»‰∑¬¡’π—°«‘®—¬∑’Ë∑Ì“°“√»÷°…“‡√◊ËÕߺ≈‘µ«—§´’πªÑÕß°—π‰¢âÀ«—¥„À≠ஓ°‡´≈≈å ·µà‡ªìπ
„π√–¥— ∫Àâ Õߪؑ ∫— µ‘ °“√ °“√‡¢â “∂÷ ߇∑§‚π‚≈¬’ π’ È „π√–¥— ∫Õÿ µ “À°√√¡§“¥«à “®–¡’ ¢â Õ®Ì “°— ¥¡“° ¢â Õ¡Ÿ≈Õ¬à “ß‰¡à ‡ªì π∑“ß°“√æ∫«à “
‡ß◊ËÕπ‰¢°“√¢Õ√—∫°“√∂à“¬∑Õ¥‡∑§‚π‚≈¬’π’ȵâÕß„™â§à“„™â®à“¬‡∫◊ÈÕßµâπ°«à“ 160 ≈â“π‡À√’¬≠ À√—∞ ∑—Èßπ’ȉ¡à√«¡§à“„™â®à“¬Õ◊Ëπ·≈–§à“
royaltee fee ∑’˵âÕß®à“¬‡¡◊ËÕ¡’°“√º≈‘µ«—§´’πÕÕ° Ÿàµ≈“¥ À√◊ÕÕ¬à“ßπâÕ¬ª√–‡∑»∑’Ë®–¢Õ√—∫°“√∂à“¬∑Õ¥‡∑§‚π‚≈¬’µâÕ߇§¬‡ªìπ≈Ÿ°§â“
°—∫∫√‘…—∑º≈‘µ«—§´’π´÷Ëß¡’‡∑§‚π‚≈¬’π’È‚¥¬¡’®Ì“π«π´◊ÈÕ«—§´’π‡ªìπª√‘¡“≥°«à“ 10
≈â“π‚¥ µàÕªï ‡ªìπ‡«≈“À≈“¬ªïµ‘¥µàÕ°—π ´÷Ëß®–
∑Ì“„Àâ¡’‚Õ°“ ¢Õ√—∫°“√∂à“¬∑Õ¥‡∑§‚π‚≈¬’®“°∫√‘…—∑‡®â“¢Õß ‘∑∏‘ω¥â
‡∑à“∑’˺à“π¡“ª√–‡∑»‰∑¬¡’°“√„™â«—§´’πªÑÕß°—π‰¢âÀ«—¥„À≠à
µ“¡ƒ¥Ÿ°“≈∑—Èß¿“§√—∞·≈–‡Õ°™π√«¡°—πª√–¡“≥ 300,000 - 400,000 ‚¥ µàÕªï


3. ‡∑§‚π‚≈¬’°“√„™â Baculovirus (⁄Baculovirus Expression Insect Cell System)

‡ªìπ°“√º≈‘µ‚ª√µ’π™‘Èπ à«π¢Õ߉«√—  influenza ‡™àπ haemagglutinin À√◊Õ neuraminidase ‚¥¬°“√∑Ì“æ—π∏ÿ«‘»«°√√¡
πÌ“¬’π¢Õ߉«√—  influenza ¡“µ—¥µàÕ‡¢â“°—∫æ—π∏ÿ°√√¡¢Õß·∫§§‘«‚≈‰«√—  ·≈–πÌ“·∫§‘«‚≈‰«√— ∑’ˉ¥â‰ª infect ‡¢â“ Ÿà‡´≈≈å·¡≈ß´÷Ë߇ªìπ
‡´≈≈凮â“∫â“π (host) ¢Õß·∫§§‘«‚≈‰«√—  ∑Ì“„À⇴≈≈å·¡≈ß¡’°“√º≈‘µ‚ª√µ’π¢Õ߉«√—  influenza µ“¡™π‘¥¢Õ߬’π∑’ËπÌ“¡“∑Ì“æ—π∏ÿ
«‘»«°√√¡ ‰¥âº≈º≈‘µ‡ªìπ recombinant protein ‡æ◊ËÕπÌ“¡“„™â‡ªìπ«—§´’π √Ÿª∑’Ë 1.9
(‚ª√¥¥Ÿ√“¬≈–‡Õ’¬¥¢Õß°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à‚¥¬„™â
Baculovirus „π¿“§ºπ«°∑’Ë 1)
¢â Õ¥’ ¢Õß«‘ ∏’ °“√π’ È §◊ Õ ‰¡à µâ Õß√–«— ߇√◊ Ë Õߧ«“¡ª≈Õ¥¿— ¬¢ÕߺŸâ ªØ‘ ∫— µ‘ ß“πÀ√◊ Õ ‘ Ë ß·«¥≈â Õ¡ ‡π◊ Ë Õß®“°‰¡à ‰¥â ªØ‘ ∫— µ‘
ß“π°— ∫‰«√—  ‚¥¬µ√ß ¥— ߇™à π  Õß«‘ ∏’ °“√∑’ Ë °≈à “«¡“·≈â «¢â “ßµâ π ¥— ßπ— È π°“√ÕÕ°·∫∫ √â “ß‚√ßß“π®÷ ß„™â ‡æ’ ¬ß·µà ¡“µ√∞“π°“√º≈‘ µ
¬“‚¥¬∑— Ë «‰ª¢â Õ®Ì “°— ¥ Ì “§— ≠¢Õ߇∑§‚π‚≈¬’ π’ È §◊ Õ¢â Õ°— ß«≈‡°’ Ë ¬«°— ∫§«“¡ª≈Õ¥¿— ¬„π¥â “π§ÿ ≥¿“æ¢Õß«— §´’ π´÷ Ë ßº≈‘ µ®“°‡´≈≈å ¢Õß
·¡≈ß ‡π◊ËÕß®“°¡’¢âÕ¡Ÿ≈πâÕ¬‡°’ˬ«°—∫«—§´’π∑’˺≈‘µ‚¥¬‡∑§‚π‚≈¬’π’È ·≈–¬—߉¡à¡’«—§´’π®“°‡∑§‚π‚≈¬’π’È¢÷Èπ∑–‡∫’¬π„πª√–‡∑»‰∑¬
πÕ°®“°π’È¢âծ̓°—¥‡√◊ËÕß°“√‡¢â“∂÷߇∑§‚π‚≈¬’„π√–¥—∫Õÿµ “À°√√¡ „π À√—∞¡’∫√‘…—∑ Protein Sciences ‡ªìπºŸâº≈‘µ«—§´’πªÑÕß°—π
‰¢âÀ«—¥„À≠à¥â«¬‡∑§‚π‚≈¬’π’È¿“¬„µâ™◊ËÕ°“√§â“«à“ Flu Blok ´÷Ëß∫√‘…—∑Õ¬Ÿà√–À«à“ߢ—Èπ ÿ¥∑⓬¢Õß°“√¢Õ¢÷Èπ∑–‡∫’¬π«—§´’ππ’È„π À√—∞
·≈–∫√‘…—∑¥—ß°≈à“«‰¥â∑Ì“¢âÕµ°≈߇æ◊ËÕ∂à“¬∑Õ¥‡∑§‚π‚≈¬’°“√º≈‘µ«—§´’ππ’È„Àâ°—∫∫√‘…—∑ UMN ¢Õߪ√–‡∑»≠’˪ÿÉπ

 √ÿª¢âÕ¥’·≈–¢âÕ‡ ’¬¢Õ߇∑§‚π‚≈¬’°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à∑—Èß
3 ‡∑§‚π‚≈¬’‰«â¥—ßµ“√“ß∑’Ë 1.3 ªí®®ÿ∫—πª√–‡∑»‰∑¬¬—߉¡à¡’
‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à °“√¥Ì“‡π‘π°“√º≈‘µ«—§´’π Ì“À√—∫¡πÿ…¬å∑’Ë¡’Õ¬Ÿàπ—Èπ¡’‡æ’¬ß à«ππâÕ¬∑’˥̓‡π‘π°“√º≈‘µµ—Èß·µàµâ𠇙àπ
°“√º≈‘µ«—§´’π JE ¢ÕßÕߧ尓√‡¿ —™°√√¡ ·≈–°“√º≈‘µ«—§´’π¢Õß ¿“°“™“¥‰∑¬ ´÷Ëß°√–∫«π°“√∑—ÈßÀ¡¥§àÕπ¢â“ß·µ°µà“ß°—∫°“√º≈‘µ
«—§´’π‰¢âÀ«—¥„À≠à
Õ¬à“߉√°Áµ“¡∑’Ë  Ì“π—°‡∑§‚π‚≈¬’™’«¿—≥±å —µ«å °√¡ª»ÿ —µ«å‰¥â¡’‚√ßß“πº≈‘µ«—§´’π Ì“À√—∫ —µ«å‚¥¬„™â‡∑§‚π‚≈¬’
°“√º≈‘µ®“°‰¢àª≈Õ¥‡™◊ÈÕ °“√º≈‘µ«—§´’π®“°‡´≈≈å ·≈– Baculovirus ¡’°“√¥Ì“‡π‘π°“√„π√–¥—∫ÀâÕß∑¥≈Õß„πÀπ૬«‘®—¬„π
¡
À“«‘∑¬“≈—¬·≈–„π°√–∑√«ß “∏“√≥ ÿ¢·µà‰¡à¡’°“√º≈‘µ„π√–¥—∫°÷ËßÕÿµ “À°√√¡ (pilot scale) ·≈–√–¥—∫Õÿµ “À°√√¡ (industrial scale)











¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à
°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬

25
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
26
Develop
SRD Reagents
(45 days)
Isolate
Circulating
Strain
(3 days)
Diafiltration
Formulation
Sterile Filtration
Finishing
V
ial filling
(1 day)
Develop
Seed Strain
Reverse Genetics
(18 days)
Select
High Growth
Strain
1 mL. Reactor
(3.5 days)
10 mL. Reactor
(3.5 days)
100mL. Reactor
(3.5 days)
1 L. Reactor
(3.5 days)
10 mL. Reactor
(3.5 days)
100mL. Reactor
(3.5 days)
1000L.Reactor
(3.5 days)
10 k. L. R
(3.5 days)
√Ÿª∑’Ë 1.8 °√–∫«π°“√º≈‘µ‰«√— ‚¥¬‡∑§‚π‚≈¬’°“√„™â‡´≈≈å (Cell-based technology) (Wang, 2006)
¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à
°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬

27
Genetic Engineering of baculovirus
containing influenza virus gene suce
as HA gene and NA gene
Up Stream
infection of genetig engineered
baculovirus into insect cell culture
Production of recombinant influenza
protien by infected insect cells
Harvest recombinant influenza
protiens from insect cell culture
Purification of recombinant
influenza virus protien
Down Stream
√Ÿª∑’Ë 1.9 ¢—ÈπµÕπ°“√º≈‘µ‚ª√µ’π™‘Èπ à«π¢Õ߉«√—  influenza ‚¥¬„™â Baculovirus
√Ÿª∑’Ë 1.10 °√–∫«π°“√º≈‘µ«—§´’π„π¢—ÈπµÕπ Downstream process ¢Õß«—§´’π„π√Ÿª·∫∫µà“ßÊ

Concentrate by filtration/Purification
by zonal centrifuqation
Treatment with formalin or ß - propiolactone
Treatment with Detergent
Purification by Chromatography
Harvesting of the virus vaccine
Live Attenuated Vaccine
Whole Inactivated Vaccine
Inactivated Split Vaccine
Inactivated Subunit Vaccine
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
28
µ“√“ß∑’Ë 1.3 °“√‡ª√’¬∫‡∑’¬∫¢âÕ¥’¢âÕ‡ ’¬¢Õ߇∑§‚π‚≈¬’°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à


‡∑§‚π‚≈¬’°“√º≈‘µ ¢âÕ¥’ ¢âÕ‡ ’¬
1. ‡∑§‚π‚≈¬’°“√„™â‰¢à‰°à 1. ª√‘¡“≥¢Õ߉«√— ∑’ˇ®√‘≠„π‰¢à Ÿß°«à“ 1. °“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à¡’¢âծ̓°—¥Õ¬Ÿà

‡¡◊ËÕ‡∑’¬∫°—∫°“√„™â‡´≈≈å ‡©æ“– “¬æ—π∏åÿ∑’ˇ®√‘≠‰¥â¥’„π‰¢à

2. ‰¡à¡’ “√¿“¬πÕ° 2. ®Ì“‡ªìπµâÕß„™â‰¢à·≈–·√ßß“π§π

3. ‰¡à¡’ “√°àÕ¡–‡√Áß ‡ªìπ®Ì“π«π¡“°

4. «—§´’π¡’ antigenicity ¥’ 3. Õ“®¡’°“√‡ª≈’ˬπ·ª≈߇°‘¥¢÷Èπ„π‚ª√µ’π

HA ¢Õ߉«√— ‰¢âÀ«—¥„À≠à∑’ˇ®√‘≠„π‰¢à

4. Õ“®‡°‘¥º≈¢â“߇§’¬ßÕ¬à“ß√ÿπ·√ß

„πºŸâ∑’Ë·æ₪√µ’π®“°‰¢à
2. ‡∑§‚π‚≈¬’°“√„™â‡´≈≈å 1. °“√‡µ√’¬¡‡´≈≈剡à¬ÿà߬“° 1. ‰¥âº≈º≈‘µ‰«√— µË”

2.  “¡“√∂§«∫§ÿ¡°√–∫«π°“√º≈‘µ 2. °“√‡≈’Ȭ߇´≈≈åµàÕ‡π◊ËÕß (serial passage)

·≈–‡æ‘Ë¡ª√‘¡“≥°“√º≈‘µ‰¥â¥’ ∑Ì“„À⇠’ˬߵàÕ°“√‡æ‘Ë¡ adventitious agents

3. ‰¡àµâÕß„™â Thimerosol 3. µâÕß„™â microcarrier À√◊ÕÕÿª°√≥å„À⇴≈≈å

4. ¡’ antigenicity ∑’ˇÀ¡◊Õπ°—π ‡°“– „™â trypsin ·≈– FBS

4. ¡’‚Õ°“ ‡°‘¥ tumor ®“° agents „π«—§´’π
∑’˺≈‘µ®“°‡´≈≈å MDCK
3. ‡∑§‚π‚≈¬’°“√„™â Baculovirus 1. Baculovirus ·≈–‡´≈≈å·¡≈ß¡’ 1. ‡´≈≈å·¡≈ß¡’°√–∫«π°“√ post translation

§«“¡ª≈Õ¥¿—¬µàÕ¡πÿ…¬å modification ∑’˵à“ß®“° —µ«å‡≈’Ȭß≈Ÿ°¥â«¬

2. ‰¡à¡’ªí≠À“‡√◊ËÕßÕ“°“√·æ₪√µ’π π¡ ®÷ßµâÕß¡’°“√µ√«® Õ∫§ÿ≥ ¡∫—µ‘¢Õß

®“°‰¢à‰°à ‡π◊ËÕß®“° recombinant protein «—§´’πÕ¬à“߇¢â¡ß«¥ Õ¬à“߉√°Áµ“¡º≈

∑’˺≈‘µ‰¥â¡’§«“¡∫√‘ ÿ∑∏‘ϧàÕπ¢â“ß Ÿß °“√»÷°…“°“√∑¥ Õ∫∑“ߧ≈’π‘°¢Õß

3. º≈‘µ‰¥âßà“¬°«à“ whole virus particle «—§´’π‰¢âÀ«—¥„À≠à™π‘¥ recombinant ∑’Ë
‡π◊ËÕß®“°‡ªìπ«—§´’π™π‘¥ subunit ´÷Ë߉¡à ºà“π¡“„Àâº≈¥’¡“° · ¥ß«à“ recombinant

µâÕß°—ß«≈„π¥â“𧫓¡ª≈Õ¥¿—¬„π√–À«à“ß vaccine ®“°√–∫∫π’È„™â‰¥â¥’ ‰¡à¡’ªí≠À“

°“√º≈‘µ ·≈–‰¡àµâÕß„™â√–∫∫ BSL3 ®“°§«“¡·µ°µà“ߢÕß°√–∫«π°“√ post

4. °“√¢¬“¬¢π“¥√–¥—∫Õÿµ “À°√√¡ translation modification „π°“√°√–µÿâπ

¡’§«“¡‡ªìπ‰ª‰¥â Ÿß ‡π◊ËÕß®“°¡’°“√º≈‘µ ¿Ÿ¡‘§ÿâ¡°—π

recombinant protein ™π‘¥Õ◊ËπÊ ‚¥¬„™â
√–∫∫π’ÈÕ¬Ÿà·≈â«
5. ‡∑§‚π‚≈¬’∑’Ëæ—≤π“„π√–∫∫π’È “¡“√∂πÌ“
¡“„™âº≈‘µ recombinant vaccine ®“° “¬

æ—π∏åÿ∑’Ë°Ì“≈—ß√–∫“¥‰¥â∑—π∑’ ·≈–„™â “¬

°“√º≈‘µ “¬æ—π∏åÿµà“ßÊ ·∫∫‡¥’¬«°—π

6. ‰¡à¡’ªí≠À“¥â“π genetic heterogeneity ´÷Ëß
À“°∑”„π‰¢àµâÕß¡’°“√µ√«® Õ∫Õ¬à“߇¢â¡
ß«¥ ‡π◊ËÕß®“°¡’°“√ passage ‰«√— „π‰¢à‰°à
Õ¬à“ßµàÕ‡π◊ËÕß
7. «—§´’π∑’ˉ¥â‰¡àµâÕߺà“π°√–∫«π°“√
inactivation ®÷߉¡à¡’°“√ªπ‡ªóôÕπ®“° “√
‡§¡’∑’Ë„π°√–∫«π°“√ inactivation ‰«√— 
¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à
°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬

29
1.2.3.3 °√–∫«π°“√πÌ“·Õ𵑇®π¡“º≈‘µ‡ªìπ«—§´’π (Downstream process)

°√–∫«π°“√πÌ“·Õ𵑇®π¡“º≈‘µ‡ªìπ«—§´’π À√◊Õ Downstream process ‡ªìπ¢—ÈπµÕππ—∫µ—Èß·µà°“√πÌ“·Õ𵑇®π∑’Ë
º≈‘µ‰¥â¡“ºà“π°√–∫«π°“√µà“ßÊ ‡™àπ °“√∑Ì“§«“¡ –Õ“¥ °“√∑Ì“„À⇙◊ÈÕÀ¡¥ƒ∑∏‘Ï °“√∑Ì“„À⇢⡢âπ °“√‡µ‘¡ adjuvant °“√º ¡
·≈–°“√∫√√®ÿ‡ªìπ«—§´’πæ√âÕ¡„™â downstream process π’ȇªìπ¢—ÈπµÕπ∑’Ë°Ì“Àπ¥™π‘¥¢Õß«—§´’π∑’˺≈‘µ‰¥â«à“®–‡ªìπ«—§´’π‡™◊ÈÕ‡ªìπ (live
attenuated) «—§´’π‡™◊ÈÕµ“¬ (inactivated vaccine) ª√–‡¿∑ whole cell vaccine, split vaccine, À√◊Õ subunit vaccine (√Ÿª∑’Ë 1.10) ¥—ßπ—Èπ
§«“¡´—∫´âÕπ¢Õß downstream process ¢Õß°“√º≈‘µ«—§´’π·µà≈–™π‘¥®–¡’§«“¡·µ°µà“ß°—π «—§´’π∑’˺à“πÀ≈“¬¢—ÈπµÕπ∑Ì“„Àâ
º≈º≈‘µ∑’ˉ¥âπâÕ¬°«à“«—§´’π∑’˺à“π¢—ÈπµÕππâÕ¬‡π◊ËÕß®“°°“√ Ÿ≠‡ ’¬·Õ𵑇®π‰ª„π¢—ÈπµÕπ∑’ˇæ‘Ë¡¡“°¢÷Èπ

°“√º≈‘µ«—§´’π live attenuated influenza vaccine ¡’¢—ÈπµÕπ downstream process ∑’ˉ¡à´—∫´âÕπ°≈à“«§◊Õ
πÌ“
allantoic fluid ∑’Ë¡’‰«√— ∑’ˇ°Á∫ (harvest) ‰¥â¡“ªíòπ·¬° (centrifuge) ¥â«¬§«“¡‡√Á«√Õ∫µË”‡æ◊ËÕ·¬°‡ª≈◊Õ°‰¢àÕÕ° (Clarification)
πÕ°®“°π’ÈÕ“®¡’°“√∑Ì“„Àâ«—§´’π –Õ“¥‡æ‘Ë¡¢÷Èπ¥â«¬«’∏’·¬°·≈–°“√°√Õߥ⫬ ultracentrifuge ·≈– sterile filtration °àÕπ°“√‡µ‘¡ “√
„Àâ§ßµ—«·≈–∫√√®ÿ‡ªìπ«—§´’πæ√âÕ¡„™â ‡π◊ËÕß®“°ºà“π¢—ÈπµÕππâÕ¬°“√º≈‘µ«—§´’π™π‘¥‡™◊ÈÕ‡ªìππ’È®–„Àâº≈º≈‘µ∑’Ë Ÿß°«à“°“√º≈‘µ«—§´’π
‡™◊ÈÕµ“¬ ®“°¢âÕ¡Ÿ≈æ∫«à“‰¢à‰°àøí°Àπ÷ËßøÕß “¡“√∂πÌ“¡“º≈‘µ«—§´’π‡™◊ÈÕµ“¬‰¥âª√–¡“≥ 0.5-2 ‚¥ ¢÷ÈπÕ¬Ÿà°—∫ª√– ‘∑∏‘¿“æ¢Õß
°“√º≈‘µ „π¢≥–∑’Ë “¡“√∂º≈‘µ«—§´’π‡™◊ÈÕ‡ªìπ‰¥âª√–¡“≥ 30-100 ‚¥ 

°“√º≈‘µ«—§´’π‡™◊ÈÕµ“¬®“°‰¢à ¡—°‡√‘Ë¡®“°ºà“π°“√°√Õß ·≈–∑Ì“„À⇢⡢âπ¢÷Èπ¥â«¬«‘∏’ (√Ÿª∑’Ë 1.7 ·≈– 1.10) ‡™àπ
crossflow filtration ·≈â«∑Ì“°“√·¬°·∫∫ —¥ à«π¥â«¬ zonal centrifugation ´÷Ëß à«π∑’ˇªìπ‰«√— ®–Õ¬Ÿà„π sucrose band ∑’Ë·¬°ÕÕ°¡“
®“°‡§√◊ËÕß zonal centrifugation ‡ªìπ°“√·¬°‰«√— ®“°‚ª√µ’πªπ‡ªóôÕ𠇙à𠂪√µ’πÕ—≈∫Ÿ¡‘π®“°‰¢à ¢—ÈπµÕπÀ≈—ß®“°π’È®–·µ°µà“ß°—π
¢÷ÈπÕ¬Ÿà°—∫™π‘¥¢Õß«—§´’π∑’˵âÕß°“√ ‡™àπ À“°µâÕß°“√‡µ√’¬¡«—§´’π™π‘¥ inactivated vaccine ®–µâÕß¡’°√–∫«π°“√∑Ì“„À≫√— µ“¬
¥â«¬°“√‡æ‘Ë¡°√–∫«π°“√ inactivation ¥â«¬°“√‡µ‘¡ “√‡§¡’ ‡™àπ formalin ·≈–∂⓵âÕß°“√«—§´’π™π‘¥∑’ˇªìπ·∫∫ split type ¥â«¬ µâÕß
‡æ‘Ë¡¢—ÈπµÕπ°“√‡µ‘¡ “√‡§¡’Õ’° 1 ¢—ÈπµÕ𠇙àπ triton-X100 ´÷Ëß°“√„™â “√‡§¡’µà“ßÊπ—Èπ µâÕß¡’¢—ÈπµÕπ„π°“√°Ì“®—¥ “√‡§¡’ªπ‡ªóôÕπ
‡æ‘Ë¡„π°√–∫«π°“√¥â«¬ „π°“√ °—¥·¬°‰«√— À√◊Õ à«πª√–°Õ∫¢Õ߉«√— ∑’Ë„™â‡ªìπ«—§´’π ™π‘¥ Subunit vaccine π—Èπ µâÕß„™â«‘∏’ °—¥
¥â«¬‚§√¡“‚µ°√“øï ‡™àπ Gel filtration Chromatography ‡æ◊ËÕ·¬°‚ª√µ’πªπ‡ªóôÕπÕ◊ËπÊ¢Õ߉«√— ÕÕ°®“° Haemagglutinin (HA) ·≈–
Neuraminidase (NA) ∑’Ë„™â‡ªìπ«—§´’π ¿“¬À≈—ß®“°°“√¥Ì“‡π‘π°“√¥â«¬«‘∏’¥—ß°≈à“«¢â“ßµâπ·≈â« „π¢—Èπ ÿ¥∑⓬®–∑Ì“°“√ sterile filtration
‰¥â‡ªìπº≈‘µ¿—≥±å‡æ◊ËÕ√Õ°“√∫√√®ÿµàÕ‰ª ‚¥¬°√–∫«π°“√∑—ÈßÀ¡¥„™â‡«≈“ª√–¡“≥ 2-3 «—π ≈Ì“¥—∫¢—ÈπµÕπµà“ßʇÀ≈à“π’ÈÕ“®·µ°µà“ß
°—π∫â“ß„πºŸâº≈‘µ·µà≈–√“¬‡π◊ËÕß®“°‡ªìπ√“¬≈–‡Õ’¬¥‡™‘߇∑§π‘§„π°“√º≈‘µ„À≥âº≈º≈‘µ Ÿß ÿ¥ πÕ°®“°π’È«—§´’π∑ÿ°√ÿàπ (batch) µâÕß
∂Ÿ°∑¥ Õ∫«à“‰«√— À¡¥ ¿“æ®√‘ß( Ì“À√—∫«—§´’π‡™◊ÈÕµ“¬) ·≈–°“√∑¥ Õ∫Õ◊Ëπ‡æ◊ËÕª√–°—π§ÿ≥¿“æ«à“«—§´’π∑’˺≈‘µ‰¥â¡’§ÿ≥ ¡∫—µ‘∑’Ë
‡À¡“– ¡

Àπ÷Ëß„π¢—ÈπµÕπ°“√º≈‘µ«—§´’π‡™◊ÈÕµ“¬§◊Õ°“√‡µ‘¡ adjuvants ∑’ˇªìπ à«πª√–°Õ∫∑’ˇæ‘Ë¡‡¢â“‰ª„π«—§´’π‡æ◊ËÕ‡æ‘Ë¡°“√
µÕ∫ πÕß∑“ß¿Ÿ¡‘§ÿâ¡°—π¢ÕߺŸâ√—∫ ´÷Ëß∑”„Àâ “¡“√∂≈¥ª√‘¡“≥¢Õß·Õ𵑇®π (¢π“¥¢Õß‚¥ ) ∑’Ë„™â„π«—§´’π ¡’ adjuvant ‡æ’¬ß 2
™π‘¥‡∑à“π—Èπ ∑’ˉ¥â√—∫°“√√—∫√Õß¡“µ√∞“𧫓¡ª≈Õ¥¿—¬ ‰¥â·°à  “√ª√–°Õ∫‡°≈◊ÕÕ–≈Ÿ¡‘π—¡ (Aluminum salts) ·≈– MF59 (oil-in-
water emulsion) ´÷Ëß°√–µÿâπ„À⇰‘¥·Õπµ‘∫Õ¥’‰¥âπ“π°«à“·≈–¡’ à«π‡ √‘¡ cross neutralization of pathogenic H5N1 ·µà¡’¢âծ̓°—¥
¥â“π ‘∑∏‘∫—µ√  à«π adjuvants ∑’Ë„™â∫àÕ¬°—∫«—§´’πªÑÕß°—π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ ‡™àπ Alumimun salts π—Èπ‰¡à™à«¬„π°“√≈¥ª√‘¡“≥
·Õ𵑇®πµàÕ‚¥  Ì“À√—∫«—§´’πªÑÕß°—π‰¢âÀ«—¥π° H5N1 À√◊ÕÕ“®µâÕß„™â Aluminum salts „πª√‘¡“≥ Ÿß πÕ°®“°π’ȉ¥â¡’°“√»÷°…“À“
adjuvants „À¡àÊ¢÷È𠇙àπ AS03 ¢Õß∫√‘…—∑ GSK ´÷ËߢâÕ¡Ÿ≈®“°°“√∑¥ Õ∫æ∫«à“ “¡“√∂≈¥ª√‘¡“≥·Õ𵑇®π≈߉¥â∂÷ß 30 ‡∑à“
(DCVM 2006)
2
°“√‡¢â“∂÷ß adjuvants „À¡àÊ ‡À≈à“π’ȇæ◊ËÕ„™â„π°“√º≈‘µ«—§´’π¡’¢âծ̓°—¥‡π◊ËÕß®“°‡ß◊ËÕπ‰¢‡√◊ËÕß ‘∑∏‘∫—µ√ „πªí®®ÿ∫—π
Õߧ尓√Õπ“¡—¬‚≈°¬—߉¡à “¡“√∂ π—∫ πÿπtechnology ‡√◊ËÕ߇°’ˬ«°—∫ adjuvants „À¡àʉ¥â·µà‰¥â¡’°“√®—¥µ—Èß°≈ÿࡇæ◊ËÕ∑Ì“°“√»÷°…“
‡√◊ËÕß adjuvants ¢÷Èπ¡“·µà°≈ÿà¡«‘®—¬¥—ß°≈à“«¬—ßÕ¬Ÿà„π™à«ß‡√‘Ë¡µâπ‡∑à“π—Èπ
2
¢âÕ¡Ÿ≈®“° Adjuvants for pandemic influenza vaccine presentation to selected Developing Country Vaccine Manufactures as support to submission of
proposais, 8 Jan 2006, Geneva.
‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
30
 Ì “À√— ∫°“√‡µ√’ ¬¡«— §´’ π¢Õ߉«√—  ∑’ Ë ‰¥â ®“°‡´≈≈å π— È π ‡π◊ Ë Õß®“°‰«√—  Õ¬Ÿà „πÕ“À“√‡≈’ È ¬ß‡´≈≈å ´÷ Ë ß¡’  ‘ Ë ßªπ‡ªó ô Õππâ Õ¬°«à “‰«√—  
®“°‰¢à ¥— ßπ— È π«‘ ∏’ °“√‡µ√’ ¬¡«— §´’ π„Àâ ∫√‘  ÿ ∑∏‘ Ï ®“°‡´≈≈å ®÷ ß¡’ §«“¡¬ÿ à ߬“°πâ Õ¬°«à “ ‡™à π ¢— È πµÕπ°“√·¬°‰«√—  ¥â «¬‡§√◊ Ë Õß Zonal
centrifugation ·≈–µ— «Õ¬à “ß°√–∫«π°“√∑— È ßÀ¡¥ Ì “À√— ∫°“√º≈‘ µ«— §´’ π ¥— ß· ¥ß„π√Ÿª∑’ Ë 1.8 º≈º≈‘ µ«— §´’ πªÑ Õß°— π‰¢â À«— ¥„À≠à
®“°‡´≈≈å π— È πÕ“®‡ªì π„π√Ÿª whole, split À√◊ Õ subunit vaccine
°√–∫«π°“√º≈‘ µ·Õ𵑠‡®π¥â «¬ Baculovirus ·≈–‡´≈≈å ·¡≈ßπ— È π º≈º≈‘ µ∑’ Ë ‰¥â §◊ Õ ‚ª√µ’ π HA ·≈– NA ¢Õß influenza virus
®–∂Ÿ°‡°Á ∫‡°’ Ë ¬«·¬°®“°‡´≈≈å ·¡≈ß·≈–∑Ì “°“√ °— ¥¥â «¬«‘ ∏’ ‡™à 𠂧√¡“‚µ°√“øøï ‡æ◊ Ë Õ„Àâ ‰¥â ‚ª√µ’ π subunit ¢Õß influenza virus
∑’ Ë ∫√‘  ÿ ∑∏‘ Ï  Ì “À√— ∫πÌ “‰ª„™â ‡ªì π«— §´’ π ‡π◊ Ë Õß®“°º≈º≈‘ µ∑’ Ë ‰¥â ‡ªì π‚ª√µ’ π‰¡à „™à µ— «‰«√—   ¥— ßπ— È π®÷ ߉¡à ®Ì “‡ªì πµâ Õß¡’ °“√∑Ì “„Àâ ‡™◊ È Õµ“¬
À√◊ ÕÕà Õπ·√ß ¢— È πµÕπ downstream ®÷ ß¡’ ‡æ’ ¬ß°“√∑Ì “„Àâ ∫√‘  ÿ ∑∏‘ Ï ‡æ◊ Ë Õ·¬°‡´≈≈å ·¡≈ßÕÕ° (√Ÿª∑’ Ë 1.9)


1.2.3.4 °“√∑¥ Õ∫«—§´’π

„π°“√µ√«® Õ∫¡“µ√∞“π¢Õß«—§´’π‰¢âÀ«—¥„À≠à ‚¥¬∑—Ë«‰ª®–∑Ì“°“√µ√«®«—¥ª√‘¡“≥¢Õß Haemagglutinin (HA
content) ‚¥¬„™â‡∑§π‘§ Immunochemical single radial immunodiffusion (SRD) assay ‚¥¬„™â haemagglutinin antigen reagent ‡ªìπ
¡“µ√∞“πÕâ“ßÕ‘ß (reference) ∑’Ë°Ì“À𥂥¬ Àπ૬ߓπ¢Õß√—∞∑’˧«∫§ÿ¡¡“µ√∞“π¢Õß«—§´’π (National Control Laboratory, NCL) ¡’
À≈—°∞“π∑’Ë· ¥ß„Àâ‡ÀÁπ«à“ reference HA antigen ∑’˺≈‘µ®“°°“√„™â‰¢à∑’Ë„™âÕâ“ßÕ‘ß‚¥¬∑—Ë«‰ªπ—Èπ¡’§«“¡‡À¡“– ¡ Ì“À√—∫„™â∑¥ Õ∫
¡“µ√∞“π HA content ¢Õß«—§´’π∑’˺≈‘µ®“°‰¢à‡∑à“π—Èπ ‰¡à‡À¡“– ¡„π°“√πÌ“¡“„™âÕâ“ßÕ‘ß°—∫«—§´’π∑’˺≈‘µ®“°‡´≈≈å ´÷ËßÀ“°∑Ì“°“√
º≈‘µ«—§´’π„π√–∫∫‡´≈≈姫√®–µâÕߢէ̓·π–πÌ“®“° WHO  Ì“À√—∫°“√µ√«®«—¥ HA content „π pandemic vaccine π—ÈπºŸâº≈‘µ
«—§´’πÕ“®¬—߉¡à¡’ reference HA antigen ∑’Ë„™â‡ªìπ¡“µ√∞“π„π°“√µ√«® Õ∫ ¥—ßπ—ÈπÕ“®µâÕß„™â«‘∏’Õ◊Ëπ∑’Ë·π–πÌ“‚¥¬ WHO ·≈– NCL

 Ì“À√—∫«—§´’π∑’Ë¡’°“√„™â adjuvant º ¡¥â«¬π—Èπ adjuvant Õ“®®–¡’º≈µàÕ°“√µ√«®«—¥¥â«¬ SRD ºŸâº≈‘µÕ“®µâÕß∑Ì“
°“√µ√«®«—¥°àÕπ°“√º ¡ adjuvant À√◊Õ „™â«‘∏’°“√µ√«® Õ∫«‘∏’Õ◊Ëπʇæ◊ËÕ· ¥ß¡“µ√∞“π¢Õß«—§´’π§«∫§Ÿà‰ª¥â«¬ ‡™àπ °“√µ√«®«—¥
ª√‘¡“≥‚ª√µ’π HA ‚¥¬µ√ß À√◊Õ°“√»÷°…“ immunogenicity „π —µ«å·∑𠇪ìπµâπ


Immunogenicity test

„π°“√µ√«® Õ∫ª√– ‘∑∏‘º≈·≈–§«“¡ª≈Õ¥¿—¬¢Õß«—§´’ππ—Èπ ®Ì“‡ªìπµâÕßæ‘®“√≥“®“°º≈°“√∑¥ Õ∫∑“ߧ≈’π‘§
(Clinical trial) ´÷Ëß∑Ì“„Àâ∑√“∫∂÷ߪ√‘¡“≥°“√„™â·≈–«‘∏’°“√„™â«—§´’π∑’ˇÀ¡“– ¡ „π°“√∑¥ Õ∫π’Ȯ̓‡ªìπµâÕß¡’°“√µ√«®¿Ÿ¡‘§ÿâ¡°—π√à«¡
¥â«¬ ‚¥¬∑—Ë«‰ª®–∑Ì“°“√µ√«® Õ∫ª√– ‘∑∏‘º≈¢Õß«—§´’π„π°“√°√–µÿâπ¿Ÿ¡‘§ÿâ¡°—π¥â«¬«‘∏’ Hemagglutination inhibition (HI) antibody
assay ´÷Ë߇ªìπ°“√µ√«® Õ∫√–¥—∫·Õπµ‘∫Õ¥’∑’ˮ̓‡æ“–µàÕ HA antigen „ππÈ”‡À≈◊ÕߢÕß°≈ÿࡵ—«Õ¬à“ß¿“¬À≈—ß°“√©’¥«—§´’π ‚¥¬
«—§´’π‰¢âÀ«—¥„À≠à ®–µâÕß¡’§ÿ≥ ¡∫—µ‘„π°“√°√–µÿâπ¿Ÿ¡‘§ÿâ¡°—π ‚¥¬¡’ HI antibody titer 40 (´÷Ëßπà“®–‡ªìπ§à“¡“µ√∞“π Ì“À√—∫«—§´’π
 ”À√—∫°“√√–∫“¥
„À≠à¥â«¬) πÕ°®“°π’ȵâÕßµ‘¥µ“¡°“√‡ª≈’ˬπ·ª≈ß√–¥—∫°“√‡ª≈’ˬπ·ª≈ߢÕß·Õπµ‘∫Õ¥’ (seroconversion) ´÷Ëß
µâÕß Ÿß¢÷Èπ 4 ‡∑à“À≈—ß®“°°“√©’¥«—§´’π ‚¥¬§«√¡’°“√· ¥ß §à“‡©≈’ˬ¢Õß°≈ÿࡵ—«Õ¬à“ß (geometric mean titer, GMT) ¥â«¬

„π°“√µ√«® Õ∫ HI titer „π·µà≈–ÀâÕߪؑ∫—µ‘°“√π—ÈπÕ“®¡’ªí®®—¬À√◊ÕÕߧåª√–°Õ∫∑’Ë„™â„π°“√∑¥ Õ∫∑’Ë·µ°µà“ß
°—𠇙àπ  “¬æ—π∏åÿ¢Õ߉«√—  ™π‘¥·≈–·À≈àߢÕ߇¡Á¥‡≈◊Õ¥·¥ß∑’Ë„™â À√◊Õ°“√ªπ‡ªóôÕπ¢Õß “√∑’Ë¡’§ÿ≥ ¡∫—µ‘‡ªìπ “√¬—∫¬—Èß (inhibitors)
„ππÈ”¬“À√◊ÕÕ“À“√∑’ˇµ√’¬¡«—§´’π∑’ËÕ“®¡’º≈µàÕ°“√∑¥ Õ∫‰¥â ¥—ßπ—Èπ®÷ßµâÕß¡’°“√µ√«® Õ∫§«“¡∂Ÿ°µâÕß (validate) °“√µ√«® Õ∫
HI titer Õ¬à“ß√–¡—¥√–«—ß √«¡∑—ÈßÕ“®¡’°“√„™âº≈°“√µ√«® Õ∫¿Ÿ¡‘§ÿâ¡°—π™π‘¥Õ◊ËπÊ ‡™àπ microneutralization assay ª√–°Õ∫°“√
æ‘®“√≥“¥â«¬


Stability testing

°“√µ√«® Õ∫§«“¡§ßµ— «¢Õß«— §´’ π (Stability testing) ¢≥–‡°Á ∫∑’ Ë Õÿ ≥À¿Ÿ¡‘ ∑’ Ë ·π–πÌ “¡’ §«“¡ Ì “§— ≠Õ¬à “ß¡“°
‚¥¬ºŸâº≈‘µµâÕß· ¥ß„Àâ‡ÀÁπ«à“º≈‘µ¿—≥±å«—§´’π Ì“‡√Á®√ŸªÕ¬à“ßπâÕ¬
3 lot ¡’Õ“¬ÿ„π°“√‡°Á∫µ“¡¡“µ√∞“π∑’Ë°Ì“À𥂥¬ Àπ૬ߓπ
¢Õß√—∞∑’˧«∫§ÿ¡¡“µ√∞“π¢Õß«—§´’π (National Control Laboratory) ‰¥â·°à °Õß™’««—µ∂ÿ °√¡«‘∑¬“»“ µ√å°“√·æ∑¬å ‚¥¬∑—Ë«‰ªÕ“¬ÿ
¢Õß«—§´’π‰¢âÀ«—¥„À≠à¡—°‰¡à‡°‘π 1 ªï®“°«—πº≈‘µ‡π◊ËÕß®“° “¬æ—π∏åÿ¢Õ߉«√— Õ“®¡’°“√‡ª≈’ˬπ·ª≈ß¿“¬„πªï∂—¥‰ª∑Ì“„Àâ«—§´’π
‰¡à “¡“√∂§ÿâ¡°—π‚√§‰¥â
„π∫“ߪ√–‡∑»Õ“®°Ì“Àπ¥„Àâ¡’°“√·®âߪ√‘¡“≥ HA content ∑’Ë«—¥‰¥â„π«—π∑’Ë·®âß°“√À¡¥Õ“¬ÿ (expiry date)
¥â«¬ ‡æ◊ËÕ„™â‡ªìπ°“√µ√«® Õ∫§«“¡§ßµ—«¢Õß«—§´’π
¬ÿ∑∏»“ µ√å°“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à
°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬

31
1.3  ∂“π¿“悧√ß √â“ßæ◊Èπ∞“π„π°“√º≈‘µ«—§´’π¢Õߪ√–‡∑»‰∑¬ √–¥—∫«‘®—¬ √–¥—∫°÷ËßÕÿµ “À°√√¡ ·≈–√–¥—∫Õÿµ “À°√√¡
°“√æ—≤π“·≈–º≈‘µ«—§´’π·∫à߇ªìπ “¡√–¥—∫§◊Õ
°“√º≈‘µ„π√–¥—∫«‘®—¬ °“√º≈‘µ„π√–¥—∫°÷ËßÕÿµ “À°√√¡ ·≈–°“√º≈‘µ
„π√–¥—∫Õÿµ “À°√√¡
®“°°“√ Ì“√«®»—°¬¿“æ„π°“√æ—≤π“·≈–º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à„πª√–‡∑»‰∑¬ (mapping capacity)
√“¬≈–‡Õ’¬¥¥—ß· ¥ß„π¿“§ºπ«°
6 æ∫«à“„π√–¥—∫ÀâÕߪؑ∫—µ‘°“√ ¡À“«‘∑¬“≈—¬¢Õ߉∑¬¡’§«“¡ “¡“√∂„π°“√«‘®—¬·≈–æ—≤π“
«—§´’π‰¢âÀ«—¥„À≠à∑—Èß Ì“À√—∫ —µ«åªï°·≈–§π ·µàª√–‡∑»‰∑¬‰¡à ¡’ »— °¬¿“æ„π°“√º≈‘ µ«— §´’ π‰¢â À«— ¥„À≠à „π√–¥— ∫°÷ Ë ßÕÿ µ “À°√√¡
·≈–√–¥— ∫Õÿ µ “À°√√¡ Õ¬à “ß‰√°Á µ“¡„π√–¥— ∫Õÿµ “À°√√¡¡’‚√ßß“πº≈‘µ«—§´’πÕ◊Ëπ∑’Ë “¡“√∂ª√—∫ª√ÿ߇æ◊ËÕº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à
„π§π‰¥â„π°√≥’©ÿ°‡©‘π
„π°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à
«—§´’π∑’Ë„™â®–µâÕ߇ªìπ«—§´’π∑’˺≈‘µ®“°‡™◊ÈÕ‰¢âÀ«—¥„À≠à “¬æ—π∏åÿ∑’Ë°àÕ„À⇰‘¥
°“√√–∫“¥„π¢≥–π—Èπ ´÷Ëß°√–∫«π°“√æ—≤π“·≈–º≈‘µ«—§´’πµâπ·∫∫µâÕß„™â‡«≈“À≈“¬‡¥◊Õπ ·≈–®–º≈‘µ‰¥â‡©æ“–®“°‚√ßß“π∑’Ë
º≈‘ µ«— §´’ π‰¢â À«— ¥„À≠à Õ¬Ÿà „πªí ®®ÿ ∫— 𠧓¥«à “‡¡◊ Ë Õ¡’ °“√√–∫“¥„À≠à „π¡πÿ …¬å ª√–‡∑»ºŸâ º≈‘ µ«— §´’ π‰¢â À«— ¥„À≠à ´÷ Ë ß à «π„À≠à ‡ªì π
ª√–‡∑»Õÿµ “À°√√¡®–‰¡àÕπÿ≠“µ°“√®Ì“Àπà“¬«—§´’ππ’ÈÕÕ°πÕ°ª√–‡∑»®π°«à“®–¡’«—§´’π„™â‡æ’¬ßæÕ„πª√–‡∑»ºŸâº≈‘µ·≈â« ¥—ßπ—Èπ
À“°ª√–‡∑»‰∑¬‰¡à‡√‘Ë¡æ—≤π“°“√º≈‘µ¢÷Èπ‡ ’¬·µà„πªí®®ÿ∫—π ª√–‡∑»‰∑¬®–‰¡à¡’«—§´’πªÑÕß°—π‰¢âÀ«—¥„À≠à„™â‡¡◊ËÕ‡°‘¥°“√√–∫“¥ ®÷ß
§«√æ‘ ®“√≥“„Àâ ¡’ °“√º≈‘ µ«— §´’ π‰¢â À«— ¥„À≠à ¢÷ È π¿“¬„πª√–‡∑»‡æ◊ Ë Õ„Àâ ª√–‡∑»‰∑¬¡’ §«“¡ “¡“√∂æ÷ Ë ß擵π‡Õ߉¥â „π¬“¡©ÿ °‡©‘ π
ª√–‡∑»∑’Ë¡’»—°¬¿“æ„°≈⇧’¬ß°—∫ª√–‡∑»‰∑¬ ‡™àπ ª√–‡∑»‡«’¬¥π“¡ ª√–‡∑»Õ‘π‚¥π’‡´’¬ ·≈–ª√–‡∑»Õ‘π‡¥’¬ °Ì“≈—ß®—¥ √â“ß
‚√ßß“πº≈‘µ«—§´’π‰¢âÀ«—¥„À≠à¿“¬„πª√–‡∑»

1
.4 °√Õ∫¬ÿ∑∏»“ µ√å °“√‡µ√’¬¡æ√âÕ¡¥â“π«—§´’π‰¢âÀ«—¥„À≠à°√≥’‡°‘¥°“√√–∫“¥„À≠à¢Õߪ√–‡∑»‰∑¬
¿
“¬À≈— ß°“√«‘ ‡§√“–Àå ¢â Õ¡Ÿ≈æ◊ È π∞“π °“√ª√–™ÿ ¡ª√÷ °…“À“√◊ Õ°— ∫ºŸâ ‡™’ Ë ¬«™“≠∑— È ß„π·≈–µà “ߪ√–‡∑»·≈–°“√ª√–™ÿ ¡√–¥¡
 ¡ÕߢÕߧ≥–∑Ì “ß“π §≥–∑Ì “ß“π¢Õ‡ πÕ¬ÿ ∑∏»“ µ√å 4 ¢â Õ‡æ◊ Ë Õ°“√‡µ√’ ¬¡æ√â Õ¡¥â “π«— §´’ πªÑ Õß°— π‰¢â À«— ¥„À≠à „π°√≥’ √–∫“¥
„À≠à ¥—ßπ’È
¬ÿ∑∏»“ µ√å∑’Ë 1: ¬ÿ∑∏»“ µ√å°“√´◊ÈÕ«—§´’π‰¢âÀ«—¥„À≠à Ì“√Õß
¬ÿ∑∏»“ µ√å∑’Ë 2: ¬ÿ∑∏»“ µ√å°“√·∫àß∫√√®ÿ«—§´’π‰¢âÀ«—¥„À≠à„πª√–‡∑»
¬ÿ∑∏»“ µ√å∑’Ë 3: ¬ÿ∑∏»“ µ√å°“√ª√—∫‚√ßß“πº≈‘µ«—§´’π —µ«å‡æ◊ËÕ°“√º≈‘µ«—§´’π§π„π¿“«–©ÿ°‡©‘π
¬ÿ∑∏»“ µ√å∑’Ë 4: ¬ÿ∑∏»“ µ√å°“√ √â“ß‚√ßß“πº≈‘µ«—§´’π‡æ◊ËÕ√Õß√—∫°“√√–∫“¥„À≠à

¬ÿ∑∏»“ µ√å∑’Ë 1: ¬ÿ∑∏»“ µ√å°“√´◊ÈÕ«—§´’π‰¢âÀ«—¥„À≠à Ì“√Õß
¬ÿ∑∏»“ µ√åπ’ȇªìπ°“√®—¥´◊ÈÕ«—§´’π‰¢âÀ«—¥„À≠à∑’Ë¡’‚Õ°“ ®–‡ªìπ‡™◊ÈÕ∑’Ë∑Ì“„À⇰‘¥°“√√–∫“¥„À≠à‡ªìπ«—§´’π Ì“√Õß °“√®—¥´◊ÈÕ
§
«√®— ¥∑Ì “∑— π∑’ ‡π◊ Ë Õß®“°‰¡à  “¡“√∂§“¥«à “®–‡°‘ ¥°“√√–∫“¥„À≠à ¢÷ È π‡¡◊ Ë Õ„¥ ¬ÿ ∑∏»“ µ√å π’ È  “¡“√∂∑Ì “‰¥â „π√–¬–‡«≈“ — È π‡æ’ ¬ß
3-6 ‡¥◊ Õπ ·µà ¡’ §«“¡‡ ’ Ë ¬ß Ÿß«à “®–‰¥â  “¬æ— π∏å ÿ ¢Õ߉«√—  ∑’ Ë πÌ “¡“º≈‘ µ«— §´’ π‰¡à µ√ß°— ∫ “¬æ— π∏å ÿ ¢Õ߇™◊ È Õ∑’ Ë ∑Ì “„Àâ ‡°‘ ¥°“√√–∫“¥
„À≠à ¬ÿ ∑∏»“ µ√å π’ È „™â ‰¥â ‡©æ“–°à Õπ¡’ °“√√–∫“¥„À≠à ‡π◊ Ë Õß®“°Õÿ ª∑“π¢Õß«— §´’ π„πªí ®®ÿ ∫— π¡’ ®Ì “°— ¥·≈–§“¥«à “®”π«π«— §´’ π®–
¡’ ‰¡à ‡æ’ ¬ßæÕ„π™à «ß‡°‘ ¥°“√√–∫“¥„À≠à

¬ÿ∑∏»“ µ√å∑’Ë 2: ¬ÿ∑∏»“ µ√å°“√·∫àß∫√√®ÿ«—§´’π‰¢âÀ«—¥„À≠à„πª√–‡∑»
°“√πÌ“«—§´’π‡¢â“¡“·∫àß∫√√®ÿ„πª√–‡∑»®–∑Ì“„Àâ√“§“«—§´’π≈¥≈ß∫â“ß
¡’‚√ßß“π«—§´’π·≈–¬“À≈“¬·Ààß„πª√–‡∑»‰∑¬∑’Ë
 
“¡“√∂¥Ì “‡π‘ π°“√‰¥â ‚¥¬∑— Ë «‰ª°“√πÌ “«— §´’ π‡¢â “¡“∫√√®ÿ ‡ªì π®ÿ ¥‡√‘ Ë ¡µâ π°à Õπ¡’ °“√∂à “¬∑Õ¥‡∑§‚π‚≈¬’ °“√º≈‘ µ ‡™à π‡¥’ ¬«°— ∫
¬ÿ∑∏»“ µ√å∑’Ë 1 ¬ÿ∑∏»“ µ√å∑’Ë 2 ®–„™â‰¥â„π°√≥’°àÕπ°“√√–∫“¥„À≠à‡∑à“π—Èπ ‡¡◊ËÕ¡’°“√√–∫“¥„À≠৓¥«à“∑—Èß°“√®—¥À“«—§´’π∑—Èß„π
√Ÿª Ì“‡√Á®·≈–√Ÿª°àÕπ·∫àß∫√√®ÿ·≈–°“√¢π àß«—§´’π®–∑Ì“‰¥â¬“°¡“° „πªí®®ÿ∫—π‚√ßß“π¢Õß ∫√‘…—∑ Õߧ尓√‡¿ —™°√√¡-‡¡Õ√å√’‡ÕÕ√å
™’««—µ∂ÿ ®Ì“°—¥ ‰¥â¥Ì“‡π‘π°“√πÌ“«—§´’π‰¢âÀ«—¥„À≠൓¡ƒ¥Ÿ°“≈ Ì“À√—∫§π‡¢â“¡“·∫àß∫√√®ÿ ·µà¬—߉¡à¡’°“√πÌ“«—§´’π‰¢âÀ«—¥π°‡¢â“¡“
·∫àß∫√√®ÿ



‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
32
¬ÿ∑∏»“ µ√å∑’Ë 3: ¬ÿ∑∏»“ µ√å°“√ª√—∫‚√ßß“πº≈‘µ«—§´’π —µ«å‡æ◊ËÕ°“√º≈‘µ«—§´’π§π„π¿“«–©ÿ°‡©‘π
 Ì“π—°‡∑§‚π‚≈¬’™’«¿—≥±å —µ«å
°√¡ª»ÿ —µ«å ‡ªìπ‚√ßß“π∑’Ë¡’»—°¬¿“æ„π°“√æ—≤π“¢÷Èπ¡“‡ªìπ‚√ßß“π Ì“√Õ߇æ◊ËÕº≈‘µ«—§´’π‰¢â
À«—¥„À≠à Ì“À√—∫§π„π°√≥’©ÿ°‡©‘π °“√ÕÕ°·∫∫µ“¡¡“µ√∞“π¥â«¬√–∫∫ modular system ∑Ì“„Àâ “¡“√∂ª√—∫ª√ÿß·°â‰¢‰¥â‰¡à¬“°
¢âÕ‡¥àπ¢Õ߬ÿ∑∏»“ µ√å∑’Ë 3 π’ȧ◊Õ „™â‡«≈“∑’Ë —Èπ∑’Ë ÿ¥ª√–¡“≥ 1-2 ªï „π°“√æ—≤π“„Àâ¡’°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à„πª√–‡∑»‰∑¬
πÕ°®“°π’Ȫ√–¡“≥°“√«à“®–„™â‡ß‘π≈ß∑ÿπ‰¡à¡“°„π°“√ª√—∫ª√ÿß‚√ßß“π ∫ÿ§≈“°√¢Õß°√¡ª»ÿ —µ«å¡’§«“¡‡™◊ˬ«™“≠„π°“√º≈‘µ
«—§´’π¥â«¬‡∑§‚π‚≈¬’°“√º≈‘µ„π‰¢à‰°àøí°´÷Ë߇ªìπ‡∑§‚π‚≈¬’∑’Ëπ‘¬¡„™â„π°“√º≈‘µ«—§´’π‰¢âÀ«—¥„À≠à„π§π„πªí®®ÿ∫—π

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1 ∂÷ß ¬ÿ∑∏»“ µ√å∑’Ë 3 (∫∑∑’Ë 2 ∂÷ß∫∑∑’Ë 4)  Ì“À√—∫¬ÿ∑∏»“ µ√å∑’Ë 4 ®–·∫à߇ªìπ 2
 à«π §◊Õ √“¬≈–‡Õ’¬¥¢Õ߬ÿ∑∏»“ µ√å „π∫∑∑’Ë 5 ·≈–¢π“¥°Ì“≈—ß°“√º≈‘µ„π∫∑∑’Ë 6 πÕ°®“°π’È®–‰¥â¡’°“√πÌ“‡ πÕ‡√◊ËÕß¡“µ√∞“π
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33
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∑«’ ‚™µ‘æ‘∑¬ ÿππ∑å ·≈– πƒ¡≈  «√√§åªí≠≠“‡≈‘». µÌ“√“‚√§‰¢âÀ«—¥π°/‰¢âÀ«—¥„À≠à. °√ÿ߇∑æ¡À“π§√:  Ì“π—°æ‘¡æå°√ÿ߇∑懫™ “√, 2548.


∏𓧓√‚≈°. µ“¡µ‘¥‡»√…∞°‘®‰∑¬. ‡¡…“¬π 2548. ·À≈àß∑’Ë¡“: HYPERLINK çhttp://siteresources.worldbank.org/INTTHAILANDINTHAI/Resources/

486808-1104987185502/2005april-econ-monitor-th.pdfé http://siteresources.worldbank.org/INTTHAILANDINTHAI/Resources/486808-1104987185502/

2005april-econ-monitor-th.pdf


ª√–‡ √‘∞ ∑Õ߇®√‘≠. °≈ÿà¡Õ“°“√‚√§∑“߇¥‘πÀ“¬„®‡©’¬∫æ≈—π√ÿπ·√ß ‚√§´“√å  (Severe Acute Respiratory Syndrome SARS).

°√ÿ߇∑æ¡À“π§√: ∫√‘…—∑ ‚√ßæ‘¡æåª√–™“™à“ß ®Ì“°—¥, 2546.


ª√–‡ √‘∞ ∑Õ߇®√‘≠. ∂“¡-µÕ∫ ‡√◊ËÕ߉¢âÀ«—¥„À≠à·≈–‰¢âÀ«—¥π°.  ∂“π∑’˺≈‘µ: ¡Ÿ≈π‘∏‘ à߇ √‘¡°“√»÷°…“‰¢âÀ«—¥„À≠à.

·À≈àß∑’Ë¡“ : HYPERLINK çhttp://www.ift2004.org/faq/faq1.aspé http://www.ift2004.org/faq/faq1.asp


摉≈æ—π∏å æÿ∏«—≤π–. ‰«√— «‘∑¬“¢Õ߇™◊ÈÕ‰¢âÀ«—¥π° (H5N1 viruses). Siriraj Medical Journal 57 (July 2005): 283-290.


¡√°µ µ—𵑇®√‘≠ ·≈– πÌ“™—¬ ™’««‘«√√∏πå. 牢âÀ«—¥π°é ‚√§Õÿ∫—µ‘„À¡à∫π‚≈°„∫‡°à“. »Ÿπ¬åæ—π∏ÿ«‘»«°√√¡·≈–‡∑§‚π‚≈¬’™’«¿“æ·Ààß™“µ‘, 2548.


 “∏“√≥ ÿ¢, °√–∑√«ß. °√¡§«∫§ÿ¡‚√§. π‚¬∫“¬°“√„™â«—§´’π‰¢âÀ«—¥„À≠à„π°√≥’ª°µ‘ ·≈–°√≥’‡°‘¥°“√√–∫“¥„À≠à„π¡πÿ…¬å. √à“ß·ºπ°“√‡µ√’¬¡

§«“¡æ√âÕ¡√—∫¡◊Õ°“√√–∫“¥„À≠à¢Õß‚√§‰¢âÀ«—¥„À≠à ©∫—∫ª√—∫ª√ÿß «—π∑’Ë 27 ¡°√“§¡ 2549.


 ÿ«‘∑¬å «‘∫ÿ≈º≈ª√–‡ √‘∞ ·≈–§≥–. ·ºπ¬ÿ∑∏»“ µ√巰≢ªí≠À“‚√§‰¢âÀ«—¥π° ·≈–·ºπ¬ÿ∑∏»“ µ√凵√’¬¡§«“¡æ√âÕ¡„π°“√ªÑÕß°—π·≈–·°â‰¢ªí≠À“

°“√√–∫“¥„À≠à¢Õ߉¢âÀ«—¥„À≠à (æ.». 2548-2550). °√ÿ߇∑æ¡À“π§√: ‚√ßæ‘¡æå™ÿ¡πÿ¡ À°√≥å°“√‡°…µ√·Ààߪ√–‡∑»‰∑¬ ®Ì“°—¥, 2548.


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‡Õ° “√¢âÕ‡ πÕ‡™‘ßπ‚¬∫“¬ (Policy Recommendation Paper)
1
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‡Õ° “√Õâ“ßÕ‘ß (µàÕ)


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∫ ∑ ∑’Ë 2
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2
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2
36


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