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result sql = Considerations for licensure of influenza vaccines with pandemic and prepandemic indications.

Considerations for licensure of influenza vaccines with pandemic and prepandemic indications.

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char = e;code = 101
char = w;code = 119
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char = s;code = 115
char = ;code = 32
char = w;code = 119
char = e;code = 101
char = l;code = 108
char = l;code = 108
char = ;code = 32
char = a;code = 97
char = s;code = 115
char = ;code = 32
char = d;code = 100
char = e;code = 101
char = v;code = 118
char = e;code = 101
char = l;code = 108
char = o;code = 111
char = p;code = 112
char = i;code = 105
char = n;code = 110
char = g;code = 103
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = r;code = 114
char = e;code = 101
char = g;code = 103
char = u;code = 117
char = l;code = 108
char = a;code = 97
char = t;code = 116
char = o;code = 111
char = r;code = 114
char = y;code = 121
char = ;code = 32
char = p;code = 112
char = a;code = 97
char = t;code = 116
char = h;code = 104
char = w;code = 119
char = a;code = 97
char = y;code = 121
char = s;code = 115
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char = n;code = 110
char = e;code = 101
char = e;code = 101
char = d;code = 100
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = o;code = 111
char = ;code = 32
char = s;code = 115
char = p;code = 112
char = e;code = 101
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = a;code = 97
char = v;code = 118
char = a;code = 97
char = i;code = 105
char = l;code = 108
char = a;code = 97
char = b;code = 98
char = i;code = 105
char = l;code = 108
char = i;code = 105
char = t;code = 116
char = y;code = 121
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char = o;code = 111
char = f;code = 102
char = ;code = 32
char = v;code = 118
char = a;code = 97
char = c;code = 99
char = c;code = 99
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = s;code = 115
char = ;code = 32
char = a;code = 97
char = g;code = 103
char = a;code = 97
char = i;code = 105
char = n;code = 110
char = s;code = 115
char = t;code = 116
char = ;code = 32
char = p;code = 112
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = e;code = 101
char = m;code = 109
char = i;code = 105
char = c;code = 99
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char = i;code = 105
char = n;code = 110
char = f;code = 102
char = l;code = 108
char = u;code = 117
char = e;code = 101
char = n;code = 110
char = z;code = 122
char = a;code = 97
char = .;code = 46
char = ;code = 32
char = I;code = 73
char = n;code = 110
char = ;code = 32
char = M;code = 77
char = a;code = 97
char = y;code = 121
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
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char = 0;code = 48
char = 7;code = 55
char = ,;code = 44
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = F;code = 70
char = D;code = 68
char = A;code = 65
char = ;code = 32
char = i;code = 105
char = s;code = 115
char = s;code = 115
char = u;code = 117
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = w;code = 119
char = o;code = 111
char = ;code = 32
char = f;code = 102
char = i;code = 105
char = n;code = 110
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = g;code = 103
char = u;code = 117
char = i;code = 105
char = d;code = 100
char = a;code = 97
char = n;code = 110
char = c;code = 99
char = e;code = 101
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char = d;code = 100
char = o;code = 111
char = c;code = 99
char = u;code = 117
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = s;code = 115
char = ,;code = 44
char = ;code = 32
char = o;code = 111
char = n;code = 110
char = e;code = 101
char = ;code = 32
char = d;code = 100
char = e;code = 101
char = s;code = 115
char = c;code = 99
char = r;code = 114
char = i;code = 105
char = b;code = 98
char = i;code = 105
char = n;code = 110
char = g;code = 103
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = c;code = 99
char = l;code = 108
char = i;code = 105
char = n;code = 110
char = i;code = 105
char = c;code = 99
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = d;code = 100
char = a;code = 97
char = t;code = 116
char = a;code = 97
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char = r;code = 114
char = e;code = 101
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = d;code = 100
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = o;code = 111
char = ;code = 32
char = s;code = 115
char = u;code = 117
char = p;code = 112
char = p;code = 112
char = o;code = 111
char = r;code = 114
char = t;code = 116
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = l;code = 108
char = i;code = 105
char = c;code = 99
char = e;code = 101
char = n;code = 110
char = s;code = 115
char = u;code = 117
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = n;code = 110
char = u;code = 117
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = f;code = 102
char = l;code = 108
char = u;code = 117
char = e;code = 101
char = n;code = 110
char = z;code = 122
char = a;code = 97
char = ;code = 32
char = v;code = 118
char = a;code = 97
char = c;code = 99
char = c;code = 99
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = s;code = 115
char = ,;code = 44
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = r;code = 114
char = ;code = 32
char = d;code = 100
char = e;code = 101
char = s;code = 115
char = c;code = 99
char = r;code = 114
char = i;code = 105
char = b;code = 98
char = i;code = 105
char = n;code = 110
char = g;code = 103
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = c;code = 99
char = l;code = 108
char = i;code = 105
char = n;code = 110
char = i;code = 105
char = c;code = 99
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = d;code = 100
char = a;code = 97
char = t;code = 116
char = a;code = 97
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char = r;code = 114
char = e;code = 101
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = m;code = 109
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char = n;code = 110
char = d;code = 100
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = t;code = 116
char = o;code = 111
char = ;code = 32
char = s;code = 115
char = u;code = 117
char = p;code = 112
char = p;code = 112
char = o;code = 111
char = r;code = 114
char = t;code = 116
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = l;code = 108
char = i;code = 105
char = c;code = 99
char = e;code = 101
char = n;code = 110
char = s;code = 115
char = u;code = 117
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = p;code = 112
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = e;code = 101
char = m;code = 109
char = i;code = 105
char = c;code = 99
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = f;code = 102
char = l;code = 108
char = u;code = 117
char = e;code = 101
char = n;code = 110
char = z;code = 122
char = a;code = 97
char = ;code = 32
char = v;code = 118
char = a;code = 97
char = c;code = 99
char = c;code = 99
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = s;code = 115
char = .;code = 46
char = ;code = 32
char = T;code = 84
char = h;code = 104
char = e;code = 101
char = s;code = 115
char = e;code = 101
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char = g;code = 103
char = u;code = 117
char = i;code = 105
char = d;code = 100
char = a;code = 97
char = n;code = 110
char = c;code = 99
char = e;code = 101
char = s;code = 115
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char = o;code = 111
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char = t;code = 116
char = a;code = 97
char = i;code = 105
char = n;code = 110
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char = s;code = 115
char = p;code = 112
char = e;code = 101
char = c;code = 99
char = i;code = 105
char = f;code = 102
char = i;code = 105
char = c;code = 99
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char = a;code = 97
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char = p;code = 112
char = r;code = 114
char = o;code = 111
char = a;code = 97
char = c;code = 99
char = h;code = 104
char = e;code = 101
char = s;code = 115
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char = t;code = 116
char = l;code = 108
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = b;code = 98
char = y;code = 121
char = ;code = 32
char = t;code = 116
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char = e;code = 101
char = ;code = 32
char = F;code = 70
char = D;code = 68
char = A;code = 65
char = ;code = 32
char = t;code = 116
char = o;code = 111
char = ;code = 32
char = a;code = 97
char = s;code = 115
char = s;code = 115
char = i;code = 105
char = s;code = 115
char = t;code = 116
char = ;code = 32
char = m;code = 109
char = a;code = 97
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char = u;code = 117
char = f;code = 102
char = a;code = 97
char = c;code = 99
char = t;code = 116
char = u;code = 117
char = r;code = 114
char = e;code = 101
char = r;code = 114
char = s;code = 115
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char = i;code = 105
char = n;code = 110
char = ;code = 32
char = d;code = 100
char = e;code = 101
char = v;code = 118
char = e;code = 101
char = l;code = 108
char = o;code = 111
char = p;code = 112
char = i;code = 105
char = n;code = 110
char = g;code = 103
char = ;code = 32
char = n;code = 110
char = e;code = 101
char = w;code = 119
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char = v;code = 118
char = a;code = 97
char = c;code = 99
char = c;code = 99
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = s;code = 115
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char = t;code = 116
char = o;code = 111
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char = i;code = 105
char = n;code = 110
char = c;code = 99
char = r;code = 114
char = e;code = 101
char = a;code = 97
char = s;code = 115
char = e;code = 101
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char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = s;code = 115
char = u;code = 117
char = p;code = 112
char = p;code = 112
char = l;code = 108
char = y;code = 121
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char = o;code = 111
char = f;code = 102
char = ;code = 32
char = s;code = 115
char = a;code = 97
char = f;code = 102
char = e;code = 101
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char = a;code = 97
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char = d;code = 100
char = ;code = 32
char = e;code = 101
char = f;code = 102
char = f;code = 102
char = e;code = 101
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char = t;code = 116
char = i;code = 105
char = v;code = 118
char = e;code = 101
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char = i;code = 105
char = n;code = 110
char = f;code = 102
char = l;code = 108
char = u;code = 117
char = e;code = 101
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char = z;code = 122
char = a;code = 97
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char = v;code = 118
char = a;code = 97
char = c;code = 99
char = c;code = 99
char = i;code = 105
char = n;code = 110
char = e;code = 101
char = s;code = 115
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char = f;code = 102
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = b;code = 98
char = o;code = 111
char = t;code = 116
char = h;code = 104
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = n;code = 110
char = u;code = 117
char = a;code = 97
char = l;code = 108
char = ;code = 32
char = a;code = 97
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char = d;code = 100
char = ;code = 32
char = p;code = 112
char = a;code = 97
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char = d;code = 100
char = e;code = 101
char = m;code = 109
char = i;code = 105
char = c;code = 99
char = ;code = 32
char = u;code = 117
char = s;code = 115
char = e;code = 101
char = .;code = 46
char = ;code = 32
char = I;code = 73
char = n;code = 110
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = i;code = 105
char = s;code = 115
char = ;code = 32
char = a;code = 97
char = r;code = 114
char = t;code = 116
char = i;code = 105
char = c;code = 99
char = l;code = 108
char = e;code = 101
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char = w;code = 119
char = e;code = 101
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char = d;code = 100
char = e;code = 101
char = f;code = 102
char = i;code = 105
char = n;code = 110
char = e;code = 101
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char = t;code = 116
char = h;code = 104
char = e;code = 101
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char = n;code = 110
char = o;code = 111
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char = e;code = 101
char = n;code = 110
char = c;code = 99
char = l;code = 108
char = a;code = 97
char = t;code = 116
char = u;code = 117
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = ";code = 34
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char = a;code = 97
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char = e;code = 101
char = m;code = 109
char = i;code = 105
char = c;code = 99
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char = ;code = 32
char = a;code = 97
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char = d;code = 100
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char = e;code = 101
char = p;code = 112
char = a;code = 97
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char = d;code = 100
char = e;code = 101
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char = s;code = 115
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char = o;code = 111
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char = y;code = 121
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char = h;code = 104
char = w;code = 119
char = a;code = 97
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char = f;code = 102
char = o;code = 111
char = r;code = 114
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char = i;code = 105
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char = s;code = 115
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char = i;code = 105
char = n;code = 110
char = f;code = 102
char = l;code = 108
char = u;code = 117
char = e;code = 101
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char = z;code = 122
char = a;code = 97
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char = v;code = 118
char = a;code = 97
char = c;code = 99
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char = n;code = 110
char = e;code = 101
char = s;code = 115
char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
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char = p;code = 112
char = a;code = 97
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char = i;code = 105
char = c;code = 99
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char = d;code = 100
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char = p;code = 112
char = r;code = 114
char = e;code = 101
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char = a;code = 97
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char = d;code = 100
char = e;code = 101
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char = i;code = 105
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char = u;code = 117
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char = e;code = 101
char = ,;code = 44
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char = o;code = 111
char = u;code = 117
char = t;code = 116
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char = n;code = 110
char = e;code = 101
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char = c;code = 99
char = o;code = 111
char = n;code = 110
char = s;code = 115
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char = d;code = 100
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char = r;code = 114
char = a;code = 97
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char = i;code = 105
char = o;code = 111
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char = s;code = 115
char = ;code = 32
char = f;code = 102
char = o;code = 111
char = r;code = 114
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char = e;code = 101
char = v;code = 118
char = a;code = 97
char = l;code = 108
char = u;code = 117
char = a;code = 97
char = t;code = 116
char = i;code = 105
char = n;code = 110
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char = p;code = 112
char = a;code = 97
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char = d;code = 100
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char = m;code = 109
char = i;code = 105
char = c;code = 99
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char = v;code = 118
char = a;code = 97
char = c;code = 99
char = c;code = 99
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char = n;code = 110
char = e;code = 101
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char = t;code = 116
char = h;code = 104
char = a;code = 97
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char = h;code = 104
char = a;code = 97
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char = e;code = 101
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char = b;code = 98
char = e;code = 101
char = e;code = 101
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char = f;code = 102
char = o;code = 111
char = r;code = 114
char = m;code = 109
char = u;code = 117
char = l;code = 108
char = a;code = 97
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char = e;code = 101
char = d;code = 100
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char = u;code = 117
char = s;code = 115
char = i;code = 105
char = n;code = 110
char = g;code = 103
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char = n;code = 110
char = e;code = 101
char = w;code = 119
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char = a;code = 97
char = p;code = 112
char = p;code = 112
char = r;code = 114
char = o;code = 111
char = a;code = 97
char = c;code = 99
char = h;code = 104
char = e;code = 101
char = s;code = 115
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char = s;code = 115
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char = c;code = 99
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char = a;code = 97
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char = c;code = 99
char = e;code = 101
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char = l;code = 108
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char = c;code = 99
char = u;code = 117
char = l;code = 108
char = t;code = 116
char = u;code = 117
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = n;code = 110
char = o;code = 111
char = n;code = 110
char = -;code = 45
char = a;code = 97
char = l;code = 108
char = u;code = 117
char = m;code = 109
char = i;code = 105
char = n;code = 110
char = u;code = 117
char = m;code = 109
char = ;code = 32
char = s;code = 115
char = a;code = 97
char = l;code = 108
char = t;code = 116
char = ;code = 32
char = a;code = 97
char = d;code = 100
char = j;code = 106
char = u;code = 117
char = v;code = 118
char = a;code = 97
char = n;code = 110
char = t;code = 116
char = s;code = 115
char = .;code = 46
char = <;code = 60
char = b;code = 98
char = r;code = 114
char = /;code = 47
char = >;code = 62
result sql = With over 409 human cases of avian influenza and over 256 deaths worldwide resulting from infection with avian influenza (H5N1), an influenza pandemic is still a real threat, especially with H5N1 continuing to evolve into antigenically distinct clades. The Food and Drug Administration (FDA) along with other national regulatory authorities (NRAs) recognize the important role that safe and effective vaccines will play in protecting the public health from the threat of an influenza pandemic. The challenges to the FDA and other NRAs are significant as regulatory agencies pursue the development of new scientific and regulatory criteria to evaluate vaccines against pandemic influenza strains for licensure. To this end, the FDA is actively utilizing current regulatory processes such as accelerated approval and priority review as well as developing the regulatory pathways needed to speed the availability of vaccines against pandemic influenza. In May of 2007, the FDA issued two final guidance documents, one describing the clinical data recommended to support the licensure of annual influenza vaccines, and the other describing the clinical data recommended to support the licensure of pandemic influenza vaccines. These guidances contain specific approaches outlined by the FDA to assist manufacturers in developing new vaccines to increase the supply of safe and effective influenza vaccines for both annual and pandemic use. In this article we define the nomenclature "pandemic" and "prepandemic," describe the regulatory pathway for licensing new influenza vaccines for pandemic and prepandemic use, and outline considerations for evaluating pandemic/prepandemic vaccines that have been formulated using new approaches such as cell culture and non-aluminum salt adjuvants.

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