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Daptacel Vaccine

Daptacel is an immunization against diphtheria, tetanus, and pertussis (DTaP) that is given in a 5-shot series to children.

What is Daptacel?

daptacel vaccineDaptacel® is a DTaP vaccine made by Sanofi that was approved in 2002. Daptacel is an inactivated bacterial vaccine against diphtheria, tetanus, and pertussis.

What is DTaP?

DTaP is a vaccine against diphtheria, tetanus, and pertussis (whooping cough). Daptacel contains diphtheria (D) and tetanus (T) toxoids and acellular pertussis (aP). Toxoids are modified bacterial toxins that are incapable of causing disease. Acellular pertussis contains only certain parts of the pertussis bacteria.

How many shots do I need?

Children under 7 years old should get 5 shots of Daptacel, one shot at each of the following ages:

  • 2 months
  • 4 months
  • 6 months
  • 15-20 months
  • 4-6 years old

What dose is more likely to cause side effects?

The risk of side effects varies by dose. Doses 1-3 were more likely to cause systemic reactions like fussiness/irritability, inconsolable crying, and decreased activity. Doses 4-5 were more likely to cause injection-site reactions, such as tenderness, redness, and swelling of the arm.

What are the most common side effects of Daptacel?

On average, over 50% of children had systemic reactions, over 30% had injection-site reactions, and 6-16% developed fever over 100.4° F.

Who should not get Daptacel?

Daptacel is not safe for children who had severe allergic reactions after a previous vaccine against diphtheria, tetanus, or pertussis, or any other ingredient in Daptacel (see below for a list of ingredients).

Children should not get Daptacel if they had encephalopathy (brain inflammation) within 7 days of a previous pertussis vaccine, or any progressive neurological disorder until the condition has stabilized.

Daptacel may also be risky for children who had severe side effects within 48 hours of a previous pertussis vaccine, such as:

  • Fever over 105°F
  • Hypotonic-Hyporesponsive episode (HHE) — collapse or shock-like state
  • Persistent, inconsolable crying lasting ≥3 hours

Daptacel may increase the risk of Guillain-Barré Syndrome (GBS) in children who developed this condition within 6 weeks of receiving a previous pertussis vaccine.

Premature babies who receive Daptacel have stopped breathing temporarily. This condition is called apnea. The risk should be carefully considered based on the infant’s medical status.

What are severe side effects of Daptacel?

  • Allergic reaction
  • Anaphylaxis
  • Apnea in premature infants
  • Brachial Neuritis
  • Brain inflammation
  • Coma
  • Death
  • Decreased level of consciousness
  • Encephalopathy
  • Epilepsy
  • Fainting
  • Fever over 105°F
  • Guillain-Barré Syndrome (GBS)
  • Hypersensitivity reactions
  • Hypotonic-Hyporesponsive Episode (HHE)
  • Nerve damage
  • Progressive neurologic disorder
  • Seizures

What other side effects have been reported?

Daptacel has been linked to other side effects. Some of them were reported frequently or extremely serious. It is unknown if Daptacel actually causes these side effects, but the potential risks include:

  • Abscess where the shot was given
  • Bleeding disorders
  • Cellulitis
  • Convulsions
  • Cyanosis or “Blue Baby Syndrome”
  • Diarrhea
  • Enlarged lymph nodes
  • Extensive swelling of the injected limb
  • Heart problems
  • Lymphadenopathy
  • Low oxygen in the bloodstream
  • Nausea
  • Rash
  • Screaming (psychiatric disorder)
  • Seizures
  • And more

What else is in Daptacel?

Aluminum phosphate, formaldehyde, glutaraldehyde, 2-Phenoxyethanol, Stainer-Scholte medium, modified Mueller’s growth medium, modified Mueller-Miller casamino acid medium (without beef heart infusion), dimethyl 1-beta-cyclodextrin, ammonium sulfate.

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