‘Red Book’ Update

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PEDIATRICS (ISSN 0031 4005). Copyright © 1982 by the

American Academy of Pediatrics.

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Committee on Infectious Diseases

‘Red

Book’

Update

As before, we suggest you clip this update and

insert it into your copy of the “Red Book.”

ERRATA

Please note the following errata in the 1982 Red

Book, and correct your copy:

Pages 26-27. The bottom line of page 26 and the

top two lines of page 27 are duplications. Cross

them out.

Page 277. Lines 7-9 are duplications. Cross them out.

Page 188. The 8th line under “Treatment” should

read “not to exceed 4 gm per day” NOT “not to

exceed 4 mg per day.”

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UPDATE

The Red Book Committee met on May 10, 1982

and considered a number of issues, including:

1. The 1982 edition (19th) of the Red Book has

been distributed beginning on June 4, 1982. We

welcome comments and suggestions for the 20th

edition.

2. IMPORTANT REVISION IN RED BOOK

RECOMMENDATIONS: After the Committee

meeting it came to our attention that three children

who had anaphylactoid reactions to egg ingestion

experienced immediate allergic reactions to

chick-embryo-grown live measles virus vaccine; two had

difficulty breathing and one had hypotension.

Per-sons who are egg-allergic but do not have a history

of anaphylactoid reactions appear to be at little or

no risk from live measles virus (LMV) vaccine (See

Morbidity Mortality Weekly Rep 31:217-231, May

7, 1982). Because previous experience indicated no

adverse reactions in egg-allergic children given

vac-cine prepared in chick embryo tissue culture, the

1982 Red Book contains the following statement:

The vaccine currently used in the United States is pre-pared in chick embryo tissue culture by inoculation with

a further attenuated passage of the Edmonston B strain of measles virus. This preparation is virtually devoid of allergenic substances derived from the chick embryo cell cultures used for growth of the live vaccine viruses. How-ever, there is a remote potential risk of hypersensitivity reactions in patients allergic to eggs, chicken, or chicken feathers; large scale use of the vaccine for more than a decade has resulted in only rare, isolated reports of minor allergic reactions. In a study in which children known to be allergic to eggs, chicken, or chicken feathers were vaccinated with a chick embryo cell culture-derived vac-cine, no allergic reactions were observed. The Committee does not believe that egg sensitivity contradicts the use ofchick embryo tissue culture vaccines (live measles virus or live mumps virus vaccine).

In view of these very recent reports, this

state-ment is too liberal. If a child has experienced an

anaphylactoid reaction to egg ingestion we

recom-mend either: (a) deferment of LMV (or live mumps

vaccine) until measures are reported that indicate

a safer method of administration of chick embryo

vaccines; one unreported method uses a

“desensitization” procedure, detais of which are

currently not in print; or (b) very cautious

admin-istration of LMV (or live mumps virus vaccine also

prepared in chick embryo tissue culture) in a setting

where an immediate allergic reaction can be

de-tected and treated.

The Committee reminds pediatricians that

influ-enza vaccine is prepared in eggs and should not be

given to egg-allergic persons. On the other hand,

live rubella virus vaccine and oral polio vaccine are prepared in nonavian systems and egg-allergy is not a contraindication.

3. The Committee reaffirmed its conclusions and

recommendations concerning the treatment of fever

with antipyretics, especially salicylates. An exten-sive review is to be found in the June issue (Pedi-atrics 69:810, 1982).

4. Dr Roger Barkin presented data on 40 children

immunized with a 0.25-mi dose of DTP in contrast

with those receiving the standard 0.5 ml. These as

yet unreported results suggest no loss in the capac-ity to induce agglutinating antibody to pertussis

and a reduction in side-effects. (Barkin RM,

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820 PEDIATRICS Vol. 70 No. 5 November 1982

vaccine: Reactions and protection from a half-dose schedule. Pediatr Res 16:235A, 1982).

In the 1982 Red Book the Committee states, “At

one time, it was common to split vaccine doses to

reduce reaction rates. There is no convincing

evi-dence this practice is warranted. The Committee

does not recommend splitting doses ofany vaccine.”

The Committee was reluctant to modify that

statement on the basis of experience in only 40

children and given the uncertainty of the aggluti-nation response as an accurate measure of efficacy.

We encourage Dr Barkin and others to extend these

observations to provide data against which our

recommendations can be reassessed. For the

pres-ent we believe it is unwise to deviate from the 0.5-ml dosage as all studies of efficacy to date are based upon this unit dose and full immunization.

5. We reaffirmed our support for the need for

and implementation of a Vaccine Compensation

System. The American Academy of Pediatrics has

presented and endorsed such a plan to compensate

those persons inadvertently injured as a result of

intrinsic risks from vaccines. The Committee

be-lieves that the tort-liability system is not the

appro-priate arena to decide upon (a) whether injury

actually occurred, and (b) if injury did occur, the degree of compensation. We believe that prevention

of communicable and infectious diseases is a

na-tional societal priority that benefits all of us, and that a national system should be developed to

iden-tify and compensate individuals inadvertently

in-jured as a result of vaccine-preventive measures.

6. The Committee decried the biased, superficial

and inaccurate portrayal of the adverse effects of

pertussis vaccine in the NBC program

“DPT-Vac-cine Roulette,” aired by station WRC-TV, an NBC

affiliate in Washington, DC on April 19, 1982.

Ex-cerpts were shown nationally on April 20th on the

NBC “Today Show” and throughout the week. The

programs failed to balance the risks from vaccine

with the real and overwhelming risks from the

disease, and contained many inaccuracies. The

Academy notified its members of more accurate

statistics, protested the program to NBC directly

and testified before the Senate Subcommittee on

Oversight in relation to the program’s potential and actual deleterious effects.

7.

The Committee reaffirmed its support for

school immunization laws in all 50 states and

em-phasized their success. We urge our members to

support actively local efforts to reach maximal

im-munization levels and to continue their excellent efforts in their own practices.

8. The Committee reaffirmed its commitment to

the need to inform parents of the benefits of

vac-cines and the risks from disease and vaccine. The

new Red Book contains recommendations for

ac-complishing this responsible goal. We emphasize

that these are recommendations and do not carry

legal weight, nor are they carved in stone. The issue of informed consent is not settled in our legal and

societal circles and no single method is “right” or

“legal.” Recent court experience in suits alleging

injury from oral polio vaccine have emphasized the

attention given by judges and juries to the actual

procedure and language used at the time of

immu-nization by physicians and their surrogates. In some jurisdictions it has been decided in specific cases

that a warning about vaccine risks is important in

deciding liability. The Committee does believe that

information should be provided to patients

(par-ents) at each vaccine encounter.

9. Recommendations for the use of hepatitis B

vaccine in children were discussed and our ideas

were transmitted to the Surgeon General’s Advisory

Committee on Immunization Practices (ACIP)

which is developing guidelines for use of this

vac-cine. Final recommendations have appeared in

Morbidity and Mortality Weekly Reports.

10. The Committee reviewed current studies

un-derway to investigate the efficacy and safety of the live varicella virus vaccine, cytomegalovirus (CMV)

vaccine, and other members of the herpes virus

group. We are indebted to Dr Stan Plotkin, who

joined us to assist in this effort. These vaccines are in various stages of clinical trials in the United

States and abroad and are still experimental but

show great promise. We will keep the membership informed as these studies near completion.

11. The Committee reviewed its

recommenda-tion concerning rifampin prophylaxis of contacts of

patients with Haemophilus influenzae type b

infec-tions (News & Comment, March 1982). We have

received a large number of inquiries concerning the desirability and practicality of this

recommenda-tion. After thorough discussion we reaffirmed the

recommendation considering all of the following:

(a) The clear-cut risk of additional cases occurring

A!:i both household and day care settings where

children less than 4 years old (less than 48 months)

were among the contacts. This risk is 500 times or

more the risk in the general population. ‘ ‘Children less than two years old have the highest risk; those

two years to 47 months old the next highest, and

those four years old and older have a risk

compa-rable to the general population. ‘‘ ( b) The

know!-edge that rifampin prophylaxis reduces carriage by

approximately 95% and minimizes the risk of

dis-ease. (c) The complicating practical considerations, including: (1) the cost of the drug,4 (2) the difficulty

in organizing and implementing day care center

prophylaxis, (3) the alleged unavailability of

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pin, (4) the theoretic possibility that resistance will rapidly develop to rifampin or to other effective

antibiotics, (5) the pharmaceutical difficulties in

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dosage and administration, given the only available

capsule form, and (6) the lack of evidence of safety

during pregnancy. (d) In addition, some experts

advised us that two cases of invasive disease

occur-ring in a day care setting, rather than just one,

should be the stimulus for prophylaxis (R. S. Daum

and D. Granoff, personal communication, 1982).

Clearly, we believe the risk data and the rifampin efficacy data outweigh the practical difficulties. Further, each of the latter is susceptible to solution, as follows: (a) The cost of rifampin for any individ-ual family must be weighed against the intolerable cost, including fiscal, emotional, and in family en-ergy, that would be spent for the secondary cases of

invasive disease. The Committee found no way to

evaluate the total cost of meningitis for the affected

children and families even though estimates are

available for the dollar amounts (>$lO,000/case

based on an average 14-day hospital stay).”4 More

important are death and high rates of permanent

brain damage. (b) Organization of day care center

prophylaxis is difficult, but not impossible. In some jurisdictions local or regional health departments voluntarily accept, or may be persuaded to accept,

overall responsibility. In some centers there is a

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medical advisor already in place or recruited if

nursery-spread disease appears. In yet others,

en-ergetic pediatricians or local professional societies take it on themselves to act as the overall

supervi-sors. Further, medical care for endemic and

epi-demic problems is not limited to Haemophilus

in-fections (eg, endemic hepatitis, giardiasis, and Cam-pylobacter enteritis treatment also requires

coor-dination and individual assessment). (c) We have

not found rifampin to be unavailable. In some

lo-cations one may have to ask the local pharmacist to track it down or obtain it from wholesalers. (d)

Some strains of

H

influenzae do become resistant

to rifampin, but thus far this is at a low level.5 No one can predict that it will necessarily increase; for

the meningococcus, rifampin resistance also

oc-curred and remained at very low 1evels.’8 Thus far

we are unaware that resistance to ampicillin and

chloramphenicol has increased secondary to

rifam-pin use anywhere in the United States. If either

type of resistance develops to an unacceptable

de-gree, then the recommendation must and will be

reconsidered. (e) The difficulties in dosage are

rather easily overcome by competent

pharmaceu-tical advice and help, in the experience of members

of the Committee. Further, a powder form of the

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drug is being marketed to facilitate mixing with

simple syrup.9

(f)

There is no current solution to

the pregnancy issue which, we hope, will affect few

and not mar most attempts at successful

prophy-laxis.

On May 10, 1982 the Committee reconsidered all

of these issues and reaffirmed the decision made

and published earlier to encourage the use of

rifam-pin prophylaxis in susceptible contacts in

house-holds and day care centers with children less than

4 years old. We recognize each of the practical

problems listed above; in some settings it may not

be possible to carry out the recommendations

ef-fectively. In our view, this does not mean we should

not state what we believe to be the preferable

management. Our recommendations are not meant

to be equivalent to Moses’ tablets, they are simply the best informed judgment of a group of pediatri-cians with knowledge and experience in infectious diseases. The practitioner must consider this opin-ion and apply it to his/her practice and community

setting and reach his/her own informed judgment

as to the best course of action.

We also agree with others that an effective active

immunization will help control invasive

H

influ-enzae type b diseases.3’5

12. Data are not yet available to determine the

role of tuberculin screening tests in practice. When

the results of a recently conducted study are

ana-lyzed, the Committee will offer its recommendation.

13. The Committee expressed its disagreement

with the views concerning immunization expressed

by Dr Robert Mendelsohn in his column “Peoples

Doctor” and in publications sold privately by him.

We believe Dr Mendelsohn’s views are counter to

scientific evidence and clearly they do not reflect

Academy policy or recommendations. A number of

members have telephoned or written letters of

pro-test to the Committee concerning his statements.

One Academy chapter informed the Committee

that it was successful in supplanting his column in

their local paper. The Committee believes Dr

Men-delsohn’s views are unscientific and potentially det-rimental to personal and public health, if heeded.

14. The Committee took note of the Food aii

Drug Administration caution concerning the

dh-covery of Clostridium botulinum spores in a few

samples of corn syrup used in infant feeding. The

previous information concerning honey as a

poten-tial source of infant botulism is well known and we

believe honey should not be used as a nutrient for

infants. There are insufficient data to make a

judg-ment on corn syrup. Dr James Chin informed the

Committee that he is unaware of any case of infant

botulism attributable to ingestion of syrup. The

Committee takes no position on syrup as an infant

formula supplement or as a sweetener for water fed

COMMITTEE ON INFECTIOUS DISEASES 1982-1983

Vincent A. Fulginiti, MD, Chair Philip A. Brunell, MD

James D. Cherry, MD

Walton L. Ector, MD

Anne A. Gershon, MD

Samuel P. Gotoff, MD (1981-1982) Walter T. Hughes, Jr, MD (1981-1982)

Edward A. Mortimer, Jr, MD

Georges Peter, MD

Stanley A. Plotkin, MD

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822 PEDIATRICS Vol. 70 No. 5 November 1982

REFERENCES

1. Band JD, Fraser DW: Prevention of Hemophilus influenzae

type b disease by rifampin prophylaxis (a CDC study to be

published shortly). 21st Interscience Conference on

Antimi-crobial Drugs and Chemotherapy, November 1981. Amen-can Society for Microbiology, 1981, abstract 17

2. Ward JI, Fraser DW, Baraff U, et al: Haemophilu.s

influ-enzae meningitis: A national study of secondary spread in

household contacts. N Engl JMed 301:122, 1979 3. Glode MR, Daum RS, Goldbman DA, et al: Haemophilus

influenzae type b meningitis: A contagious disease of

chil-dren. Br Med J 280:899, 1981

4. Glode MR: Commentary: What price orange urine? J

Pe-diatr Infect Dis 1:140, 1982

5. Shapiro ED: Prophylaxis for contacts of patients with men-ingococcal or Haemophilus influenzae type b disease. J Pediatr Infect Dis 1:132, 1982

6. Deal WB, Sanders E: Efficacy of nifampin in treatment of

meningococcal carriers. N EngI J Med 281:641, 1969 7. Eickhoff TC: In vitro and in vivo studies of resistance to

nifampin in meningococci. J Infect Dis 123:414, 1971 8. Weidmer CE, Dunkel TB, Pettyjohn FS, et al: Effectiveness

of rifampin in eradicating the meningococcal carrier state: Emergence of resistant strains. J Infect Dis 24:172, 1971

9. Rifadin#{174}(nifampin) in simple syrup (1%, 10 mg of nifampin

per milliliter) supplied in 150-mg capsules. Dow Pharmaceu-ticaLs, Indianapolis, 1982

IRS VS HEALTH

Expenditures that are merely beneficial to general health normally aren’t

deductible, but costs of treating a specific disease or illness are. The IRS recently

told one taxpayer with a family history of heart disease he couldn’t deduct the

cost of an exercise treadmill as a medical expense. But it allowed another

taxpayer to deduct the cost of repairing an air conditioner for a man with a lung condition.

Wall Street Journal, June 11, 1980.

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1982;70;819

Pediatrics

and Stanley A. Plotkin

Gershon, Samuel P. Gotoff, Walter T. Hughes, Jr, Edward A. Mortimer, Jr, Georges Peter

Vincent A. Fulginiti, Philip A. Brunell, James D. Cherry, Walton L. Ector, Anne A.

'Red Book' Update

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1982;70;819

Pediatrics

and Stanley A. Plotkin

Gershon, Samuel P. Gotoff, Walter T. Hughes, Jr, Edward A. Mortimer, Jr, Georges Peter

Vincent A. Fulginiti, Philip A. Brunell, James D. Cherry, Walton L. Ector, Anne A.

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