AGENDA 1. Charge to the Committee 2. Type III

Home , Donald Henderson

AGENDA

1. Charge to the Committee Dr._ Luther Terry

2. Type III Oral Vaccine Associated Dr. Donald Henderson Cases and Type III Isolates Dr. James Bryan

3. Type III Vaccine Distribution and Use in the United States Dr. David Sencer

4. Analysis of Poliomyelitis Incidence in the United States - 1962 Dr. Donald Henderson

5. Laboratory Studies Pertaining to Suspect Cases Dr. Henry Gelfand

6. Discussion and Recommendations

August 9, 1962 I. Cases l) Clinical Poliomyelitis following Type III feeding

a) Vaccinees Oregon (4) Hichigan (l) Ohio (l) New York (l) Washington (1)

b) Contact of Vaccinees Ohio (l) Massachusetts (1)

2) Aseptic Meningitis Associated with Oral Vaccine Feeding Arizona (1) Oklahoma (2)

II. Type III vaccine distribution in the u.s.A.

l) Hap - 1962 2) List - 1962 3) List - 1961 4) List - Pfizer Lot. 1148

III. Analysis of Poliomyelitis Incidence in the U.S.A. - 1962

August 8, 1962 Communicable Disease Center Atlanta 22, Georgia (

I. Clinical Paralytic Poliomyelitis Following Type III Vaccine

A. Vaccinees case · Date Fed Virus Mfr. & No. State County Age Race Sex IPV Onset Type III Interval Isolated Lot No. - - I ---- Oregon F 0 /62 7 ~ III Pf. 1148 Oregon · t4 0 /62 23 I III Pf. 1148 H · /62 .,_ pf. 1148 "~~ 1 ~3 Oregon 0 ~ l 1 III 4 ·Oregon l1 0 · /62 9 1 . III . Pf. 1148 M lj. /62 ~t,~-l:u.iJ..·? ·_- t'rtt ~~~ Pf. 1151 5 Michigan ·I 6 New York M 0 , /62 f 26 J C - Pf. 1152 :> ~, lj. 7 Washington . /62 1.o/'C ' S' 1 - Pf. 1152? - r.re- !1/f-'6 ..v~.?-+h ~I.e 1151? 8 Ohio \ !1 0 /62 21 - Pf. 1151? 1153?

.- ·- fl 'f.rJ-t.- :1. q- ~ ~ .5€-t~~ B. Contacts of Vaccinees Contact Case Fed Vl.rus Hfr. & No. State County Age Race Sex ~ Onset Type III Interval Isolaterj Lot No. 9 Ohio · M 0 /62 33 III Pf. 111!.8 Lederle ~ Mass. F 1!. /62 23 Ne () (to-Y-

-....rt£

~ - -- --..;~ ~-

Para. Para.

No No

in in

Traumatic Traumatic

Brachial Brachial

eakness eakness

Pain Pain

secondary secondary

or or

Fed Fed

to to

Leg Leg

Encephalitis Encephalitis

III III

Drop Drop

anemia. anemia.

ent ent

hborhood. hborhood.

Plexus Plexus

to to

Concussion Concussion

Lassitude Lassitude

?Trauma ?Trauma

Transient Transient

r1umps r1umps

Foot Foot

Nei

Type Type Right Right

Diagnosis Diagnosis

Com

& &

ll48 ll48

1153 1153

No. No.

1153 1153

1149 1149

No. No. 1148 1148

03103 03103

Pf. Pf.

Wyeth Wyeth Pf. Pf.

Pf. Pf.

Wyeth Wyeth Lot Lot

Mfr. Mfr.

Pf. Pf.

Lot Lot

Hfr. Hfr.

) )

III III

III III III III

III III

III

III III

(

Isolated Isolated

Virus Virus

l l

9 9

7 7

9 9

8 8

2 2

28 28

G) G)

18 18

17 17

Interv

Vaccination Vaccination

Interval Interval

Feeding Feeding

Tith Tith

III III

Fed Fed

III III

•·

Fed Fed

0 0

Date Date

TyJe TyJe

Type Type

Date Date

Vaccine Vaccine

62 62

/62 /62

/62 /62 /62 /62

/62 /62

62 62

/62 /62

1962 1962

Oral Oral

Onset Onset

Associatjon Associatjon

Onset Onset

1, 1,

III III

5 5 4 4

- -

2 2 4 4

0 0

PV PV

0 0

4 4

0 0

4 4

IPV IPV

pril pril

Type Type

x x

Evident Evident

1 1

M M

F F

M M

F F

M M

F F

~~ ~~

F F

M M

Sex Sex

No No

ince ince

with with

s s

es es

Race Race

e~ e~

e e

Isola

· ·

Associated Associated

III III

oliomyeliti

County County

Type Type

County County

Conditions Conditions

lytic lytic

Meningitis Meningitis

Other Other

York York

on on

hio hio

Pa. Pa.

Ohio Ohio

Pa. Pa. N.H. N.H.

Illinois Illinois New New

Minn. Minn.

B. B.

Ore

California California

State State

Poliovirus Poliovirus

Virginia Virginia

A. A.

Oklahoma Oklahoma

Arizona Arizona Oklahoma Oklahoma

State State

Aseptic Aseptic

20 20

21 21 24 24

23 23

22 22

16 16

III. III. 15 15

18 18

19 19

17 17

No. No. 14 14

Case Case

No. No.

13 13

12 12

11 11

Case Case II. II.

1962 1962

PROGRAMS PROGRAMS

VACCINE VACCINE

ORAL ORAL

Ill Ill

TYPE TYPE

administered administered

. .

vaccine vaccine

State

KNOWN KNOWN

oral oral

Ill Ill

Type Type

throughout throughout

of of

doses doses

programs programs

of of

community community

in in

Thousands Thousands @ @ ESTIMATED DOSES OF TYPE III ORAL VACCINE FED IN 1962 BY STATE AND GEOGRAPHIC REGION (Community Programs Only)

State Counties Doses Estimated Proportion and with Fed by Manufacturer* Region Counties Program (Estimated) Lederle Pfizer Wyeth

~J B,rt•, rto UNITED STATES 3075 126 8!891,576 14% 76% 10%

NEW ENGLAND 67 15 1,218,640 Maine 16 1 25,000 100 New Hampshire 10 0 Vermont 14 0 Hassachusetts 14 14 1,188,640 88 12 Rhode Island 5 0 Connecticut 8 0 s,ooo 100

MIDDLE ATLANTIC 150 11 711,100 New York 62 9 698,100 19 81 New Jersey 21 0 Pennsylvania 67 2 13,000 100

EAST NORTH CENTRAL 436 22 2,916,164 Ohio 88 12 Indiana 92 0 Illinois 102 5 70,450 100 Michigan 83 3 23,700 41 59 Wisconsin 71 2 4,000 100

WEST NORTH CENTRAL 619 22 728,400 Minnesota 87 14 229,900 100 Iowa 99 2 42,500 100 Missouri 115 0 North Dakota 53 0 South Dakota 67 3 10,000 100 Nebraska 93 2 423,000 100 Kansas 105 1 23,000 100

* Leder1e- 1,237,880 doses Pfizer - 6,783,519 doses Wyeth 870,177 doses ESTIMATED DOSES OF TYPE III ORAL VACCINE FED IN 1962 (continued) BY STATE AND GEOGRAPHIC REGION (Community Programs Only)

State Counties Doses tstimated Proportion and with Fed by Manufacturer Region Counties Progr am (Estimated) Lederle Pfizer Wyeth

SOUTH ATLANTIC 555 4 54,500 Delaware 3 0 Maryland 24 0 District of Columbia 1 0 Virginia 100 0 West Virginia 55 0 North Carolina 100 0 South Carolina 46 1 4,500 100 Georgia 159 0 Florida 67 3 50,000 100

EAST SOUTH CENTRAL 364 8 195,552 Kentucky 120 8 195,552 5 95 Tennessee 95 0 Alabama 57 0 Mississippi 82 0

WEST SOUTH CENTRAL 470 2 44,000 Arkansas 75 0 Louisiana 54 0 Oklahoma 77 2 44,000 68 32 Texas 254 0

MOUNTAIN 281 26 1,736,259 Montana 57 0 Idaho 45 1 2,300 100 Wyoming 24 1 39,500 100 Colorado 63 15 698,217 2 98 New Mexico 32 0 Arizona 14 8 862,237 100 Utah 29 0 Nevada 17 1 134,000 100

PACIFIC 133 16 1,286,966 Washington 39 2 67,000 100 Oregon 36 11 657,966 100 California 58 3 562,000 100 Alaska Hawaii ESTIHATED TYPE III ORAL POLIO VACCINE* ADMINISTERED IN THE UNITED STATES, 1960-61

Estimated Number ·· Area of Doses

Middletown, Connecticut 10,000 Metropolitan Atlanta, Georgia 300,000 Monroe County, New York Cincinnati, 09io ~~ -2-8"Lp-o Harrisburg, Pennsylvania 105,000 Newberry County, South Carolina 22,000

Total 723,000

ESTIMATED TRIVALENT ORAL POLIO VACCINE* ADrUNISTERED IN THE UNITED STATES, 1962

Estimated Number Area of Doses

Dade County, Florida 1,036

Hillsborough County, Florida 180,000 (1st feeding) 196,000 (2nd feeding)

1; Sabin strains. Type II I Oral Polio Vaccine ·- Pfizer Lot 203-1148 Distribution and Best Estimate of Vaccinees (August 6, 1962)

Doses Vaccine Best Est. State Received\'; No. Fed In Stock

Alabama 1,000 1,000 Arizona 387,500 413,777 20,000 California* ~'; 42,800 2,800 Connecticut 500 500 Delaware 100,500 1,500 99,000 Florida 5,700 5,700 Georgia 4,200 4,200 Illinois 12,100 12,100 Indiana 2,000 2,000 Iowa 28,000 27,500 Louisiana 400 400 t-1aine 25,000 25,000 Massachusetts 2,600 2,600 Michigan 200 200 Minnesota 36,000 36,000 Missouri 2,600 2,600 Montana 200 200 Nebraska 14,400 14,400 Nevada 134,000 134,000 New York 6,100 6,100 North Carolina 200 200 North Dakota 500 500 Ohio 541,000 469,700 15,400

Oregon 650 5 000 640 5 867 300 Pennsylvania 400 400 Tennessee 800 BOO Texas 200 200 Washington 1,000 1,000

West Virginia 4,500 4 5 500 Wisconsin 2,000 2,000

Totals 2,006,400 1,812,744 134,700

* The number fed plus vaccine in stock may not equal doses received due to wastage.

** 29,000 doses shipped to Yuma, Arizona. 11,000 doses shipped to San Luis, r-lexico. Paralytic Poliomyelitis With Onset Since April 1, 1962 by lileek of Onset (Cases reported through Week ending July 28, 1962)

United States Vaccinee and Week United Type I (excluding Texas Vaccinee End in~ States Texas Cases and Type I) Contacts***

April 7 5 2 0 3 0 14 3 1 0 2 0 21 4 2 0 2 0 28 7 4 0 3 0

May 5 8 7 0 1 1 12 5 3 0 2 0 19 9 5 0 4 0 26 11 8 1 2 2

June 2 11 9 1 1 0 9 12 10 1 1 1 16 14 6 4 4 1* 23 11 8 1 2 1 30 15 8 0 7 2

July 7 9 4 0 5 0 14 4 2 0 2 0 21 3 2 0 1 2~':,':

Unk. Onset 25 18 1 6 0

Total 156 99 9 48 10***

* Denotes case not yet officially reported by telegram. Current Paralytic Cases* by Age Group

Cases Associated Non-associated Age with Type III Feeding Cases

0-4 1 18 5-9 2 5 10-19 0 5 20-29 1 5 30-39 2 2 40+ 4 1

Unk. 5 41

Current Paralytic Cases* by State

State

Hassachusetts () 0 Connecticut 0 1

New York 1 4

Ohio (i)(l 2 Indiana o- 1 Illinois 0 1 Michigan 1 0

Missouri 0 2

Virginia 0 2 Hest Virginia 0 3 South Carolina 0 1 Georgia 0 1

Kentucky 0 1 Tennessee 0 1 Alabama 0 2 Mississippi 0 1

Louisiana 0 3

Washington 0 Oregon 0' 1 California 0 14

lo*:'; 41

* Paralytic cases with onset since April l, excluding Type I cases and those from Texas. ** Includes 3 cases not yet officially reported by telegram. l ~ . ~ _,_1 J rP~A fj~~Y7 CASE 10 - !'1AS~ACHUSETTS Contact Fed Virus Manufacturer and Age Race Sex IPV Onset Type III Interval Isolated Lot Number

F 4 23 Lederle

This mother of two, wife of an engineer, became ill on with a fever of 101° F. When seen by her phys ician she had pain on neck flexion and normal reflexes.

For the following 36 hours she was afebrile and active. On , she became , prostrate with fever (102°) and e~treme weakne~. In addition, she complained of myalgia and headache. These persisted for 13 days. The marked accompanying eneralized weakness persisted for two weeks w~t h l!l.QJ"..§. "weakness" in the right an eg.

This patient had received 4 oos-es-·of inactiva e va c~ne Her two children received Type I oral polio vaccine n lyeth) during the first week in and Type III vaccine (Lederle) in . The patient did not receive either type of vaccine.

Because of the "typical" clinical picture of poliomyelitis, she was so diagnosed and no further laboratory studies were performed. She was treated symptoma tically and allowed to recover at home. She was febrile until Weak ness in the right arm and leg and generalized easy fatiguability persisted until mid- . On re-examination on she had an absent_pight knee and ankle jerk; however, there was riO weakness or muscle wasting. ~ The Massachusetts Department of Health was notified in late . Specimens are being obtained for viral studies.

Physicians - Dr. Barton Smith Dr. Augustus Crocker !1assachusetts and Age Race Sex IPV Interval

0 33 days III Pf. 1148

This P'rnale was admitted to , Ohio, on because of fever of one' day's duration. The child was well until o~rior ~ when he developed d~ A "mycin" antibiotic was bBgtin: tie was noted to have a temperature of 102.4°F.

The patient ~~ceived neither· inactivated nor oral polio vaccine. The children in the adjacent apartment received Type III oral vaccine on These children had intimate contact with both the patient and his family. The patient's siblings all experienced an enteritis at the time he had diarrhea.

On admission, the temperature was 101. 8°, pulse 160, and respirations 2.4. The child was listless and lethargic but became quite irritable when stimulated. The deep tendon reflexes were absent in the right leg, but were normal in the other extremities. There was a flaccid paralysis of the right leg.

Laboratory

CSF: - Clear, protein 75 mg.%, 315 cells (75% polys, 25% mononuclears). Smear and culture - Negative for bacteria.

- Clear, protein 102 mg.%, 75 cells (all mononuclear). Smear and culture - Negative for bacteria.

Poliovirus Type III was isolated from the stool (Dr. Albert Sabin's laboratory).

Summary of Laboratory Data on Family

Prior Vaccination Status Age IPV OPV Stool

Father 0 0 0 Mother ,4-(1959 t 0 0 Sib. F 3 (1957) j. /1')1 ~ III ) Sib. M 3 (1960) :1. {If I III Sib. F 0 I (1961) III Date Fed Virus Manufacturer and Age Race Sex IPV Onset Type III Interval Isolated Lot Number

M 0 27 days III Pfizer 1148

This male, son of a was in good health until when he fell, striking the back of his head and sustaining a superficial laceration. On 5, he experienced headache and had ' ~ma~ keg muscular ri idity in the backL of the neck." He also had a fever up to 102° and was admitte on . -

At age , he was diagnosed as having had H. influenza meningitis. At that time he had 3 right sided convulsions but recovered completely and has been active and normal child on no medication. One of four siblings, he had received OPT and smallpox immunization in the past but no inactivated polio vaccine. The entire family received Type I oral poliovaccine on and Type III vaccine on The mother gave a history of each member of the family having an afebrile diarrhea starting ~9ne daY after each feeding and lasting 48 hours.

During his first admission, the highest temperature recorded was 100.6° during the first 24 hours. It was normal thereafter. Laboratory work was as follows:

CSF 80 Cells 50 RBC, 30 WBC; 11% polys, 89% lymphs.); Protein 44mg.o; Culture, negative.

The skull X-ray was normal.

Because of his normal clinical condition, he was Jiischarged b~t , on returning home, he complained of severe pain in the arms and legs on exertion and was re-admitted the same day. At that time, the examiner noted marked nuchal rigidity and a depressed right patellar reflex. This finding was confirmed by a neurologic cons~nt who -considered the right knee jerk absent and the right Achilles reflex normal. The child exhibited weakness of the right ham- strings and right hip abductor m~cles. · .__,__-"" • •r • Laboratory studies included: .~~-~ --- CSF Cells 147 ~)\ 12% polys, 88% lymphs.); The only temperature elevation this admission was on June 6 when 100.6°F. was noted.

Since discharge from the hospital in , the patient has had "cramps" and "shooting pain" in the thigh _smd lower leg which are gradually diminishing. Physical examination on showed no sensory deficit; no muscle tenderness, tightness, or contractu o motor impairment could be demonstrated. The - 2 - right knee jerk was diminished when compared to the left. The right leg two inches below the tibial tuberosity measured one-half inch less in circum ference than the left leg. The same difference could be found in the thigh two inches above the upper border of the patella.

Hospital:

Physicians: Dr. Willis J. Irvine Dr. V. L. Summers Dr. C. C. Carter

Examined by Dr. James Bryan 1962