Diphtheria, Tetanus, Pertussis: New Vaccine Information Materials From CDC

Legal Eagle Eye Newsletter for the Nursing Profession

October 1996

   On September 13, 1996 the CDC published new vaccine information materials to go along with a new acellular pertussis vaccine to be combined with diphtheria and tetanus toxoids, which the FDA approved on July 31, 1996 for administration to infants as young as two months of age.

   These new vaccine information materials are to be used effective immediately.

   The CDC’s new vaccine information statement for DTP/DTaP is reproduced here verbatim from the CDC’s recent announcement.

   The CDC’s vaccine information materials are not copyrighted. Subscribers to this newsletter are free to copy, reproduce and redistribute this information to patients and others.  FEDERAL REGISTER, September 13, 1996 Pages 48595 - 48597.

   On July 31, 1996, the FDA licensed Connaught's Tripedia combined diphtheria and tetanus toxoids and acellular pertussis vaccine for administration to infants as young as two months of age. This recent development requires revision of the vaccine information statement entitled, "Diphtheria, Tetanus, and Pertussis Vaccine: What you need to know before your child gets the vaccine."

(See also Polio Vaccine: CDC Proposes New Childhood Immunization Schedule and Vaccine Information Materials., Legal Eagle Eye Newsletter for the Nursing Profession, (4)12, Sep. ‘96 p.3.)

The CDC is distributing the following statement which includes the new information regarding this acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP), to replace the current diphtheria, tetanus, and pertussis statement. As soon as practicable, health-care providers should use this statement, so that individuals receiving pertussis vaccine will have accurate up-to-date information. Single copies of this statement are available from state health departments.

 

 

Diphtheria, Tetanus, and Pertussis Vaccines What You Need To Know Before Your Child Gets the Vaccines

About the Diseases

Diphtheria, tetanus (lockjaw), and pertussis (whooping cough) are serious diseases. Diphtheria and pertussis spread when germs pass from an infected person to the nose or throat of others. Tetanus is caused by a germ that enters the body through a cut or wound.

Diphtheria causes: a thick coating in the nose, throat, or airway. It can lead to:

--breathing problems

--heart failure

--paralysis

--death

Tetanus causes: serious, painful spasms of all muscles. It can lead to:

"locking" of the jaw so the patient cannot open his or her mouth or swallow

--death

Pertussis causes: coughing and choking for several weeks (makes it hard for infants to eat, drink, or breathe). It can lead to:

--pneumonia

--seizures (jerking and staring spells)

--brain damage

--death

About the Vaccines

Benefits of Vaccination

Vaccination is the best way to protect against diphtheria, tetanus,

and pertussis. Because most children get the vaccines, there are now many fewer cases of these diseases. There would be many more cases if we stopped vaccinating children.

The Vaccines

 

DTP (Diphtheria Tetanus Pertussis) DTP vaccine prevents diphtheria, tetanus, and pertussis. It has been used for many years in the United States.

DTaP (Diphtheria Tetanus acellular Pertussis) DTaP prevents diphtheria, tetanus, and pertussis. It is less likely to cause the mild and moderate problems we see after DTP.

Both DTP and DTaP are very effective for preventing all three diseases.

DT (Diphtheria Tetanus) Unlike DTP and DTaP, it does not prevent pertussis. For this reason, it is usually not recommended.

 

Schedule

 

Most children should have a total of 5 DTP or DTaP vaccinations. They should get these vaccinations at:

2 months of age

4 months of age

6 months of age

12-18 months of age

4-6 years of age

Other vaccines may be given at the same time as DTP or DTaP.

 

Who Should Get DTP or DTaP Vaccine?

 

Most doctors recommend that almost all young children get DTP or DTaP vaccine. Some children should get DT. With all vaccines there are some cautions.

Tell your doctor or nurse if the child getting the vaccine:

ever had a serious allergic reaction or other problem after getting DTP, DTaP, or DT

now has a moderate or serious illness

has ever had a seizure

has a parent, brother, or sister who has had seizures

has a brain problem that is getting worse.

If you are not sure, ask your doctor or nurse.

 

What Are the Risks From These Vaccines?

As with any medicine, there are very small risks that serious problems, even death, could occur after getting a vaccine.

The risks from the vaccines are much smaller than the risks from the diseases if people stopped using vaccine. Below is a list of problems that may occur after getting the vaccine. If your child ever had one of the moderate or severe problems listed below or any other serious problem after DTP, DTaP, or DT, discuss it with your doctor or nurse before this vaccination.

 

Mild Problems

If these problems occur, they usually start within hours to a day or two after vaccination. They usually last up to 1-2 days:

soreness, redness, or swelling where the shot was given

fever

fussiness, drowsiness, less appetite

These problems are much less likely to occur with DTaP than with DTP.

Acetaminophen or ibuprofen (not aspirin) may be used to prevent or reduce fever and soreness. This is especially important for children who have had seizures or have a parent, brother, or sister who has had seizures.

 

Moderate Problems

Once for every 100-1,000 doses of DTP (less after DTaP):

on-going crying for 3 hours or more

fever of 105 deg. or higher

an unusual, high-pitched cry

Once for 1,750 doses of DTP (less after DTaP):

a seizure (jerking and staring spell) usually caused by fever

"shock-collapse" (becomes pale, limp, and less alert)

 

Severe Problems

These problems happen very rarely:

decreased consciousness, coma, or long seizure following DTP. Some of these children may have lasting brain damage. There is disagreement about whether or not DTP causes the lasting brain damage. If it does, it is very rare. The risk of decreased consciousness, coma, or long seizure after DTaP is not yet known, but experts believe it is even less likely to occur than after DTP.

a serious allergic reaction

What to do if there is a serious reaction:

+ Call a doctor or get the person to a doctor right away.

+ Write down what happened and the date and time it happened.

+ Ask your doctor, nurse, or health department to file a Vaccine Adverse Event Report form, or you can call: (800) 822-7967 (toll-free)

The National Vaccine Injury Compensation Program gives compensation (payment) for persons thought to be injured by vaccines. For details call: (800) 338-2382 (toll-free).

If you want to learn more, ask your doctor or nurse. She/he can give you the vaccine package insert or suggest other sources of information.

 

 

FEDERAL REGISTER, September 13, 1996

Pages 48595 - 48597.