When Tdap isn't necessary,

TdVax

HITS THE MARK

TdVax delivers what your patients
need,
and nothing they don't

According to updated ACIP guidelines, if an individual is over 11 years of age and has already received a Tdap at any time — only a Td vaccine is recommended.1

Learn more »

 

About TdVax

TdVax is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.2

ACIP guidelines recommend a dose of Tdap for pregnant women at each pregnancy.1

ACIP = Advisory Committee on Immunization Practices.

Why choose TdVax icon

Choose TdVax for tetanus and diphtheria protection


Why choose TdVax icon
  • More than 15 years of consistent supply
  • Meets FDA-approved tests to demonstrate efficacy
  • Preservative free and not made with natural rubber latex
  • 36-month shelf life

Dosage and administration


Primary immunization

TdVax may be used in people 7 years of age and older who have not been previously immunized against tetanus and diphtheria as a primary immunization series2

Table with information about dosage and administration of TdVax

TdVax may be used to complete the primary immunization series for tetanus and diphtheria, following one or two doses of whole cell DTP, DTaP, and/or DT vaccine. However, the safety and efficacy of TdVax in such regimens have not been evaluated.2

Routine booster immunization

TdVax may be used for routine booster immunization against tetanus and diphtheria in people 7 years of age and older who have completed primary immunization against tetanus and diphtheria.2


ROUTINE BOOSTER IMMUNIZATION AGAINST
TETANUS AND DIPHTHERIA IS RECOMMENDED IN:

CHILDREN 11-12 YEARS OF AGE AND EVERY 10 YEARS THEREAFTER2


Tetanus prophylaxis in wound management2

  • A preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection
  • The need for Td with or without tetanus immune globulin (TIG) depends on both the condition of the wound and the patient's vaccination history
    • TIG should be administered using a separate needle and syringe at a different anatomic site

TdVax administration2

The preferred site for administration is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. Do not administer TdVax intravenously, subcutaneously, or intradermally.

TdVax should not be combined through reconstitution or mixed with any other vaccine.

TdVax works WITHIN 2 WEEKS but is good for up to 10 years as a booster
dose for routine vaccination and postexposure prophylaxis (PEP)3

Demonstrated efficacy


Response to primary series:

Tetanus

In a study of 20 adults with less than 0.0025 units/mL of tetanus antitoxin in pre-immunization serum2

Tetanus primary series graph Tetanus primary series graph

Diphtheria

In a study of 10 adults with less than 0.001 units/mL of diphtheria antitoxin in pre-immunization serum2

Diphtheria primary series graph Diphtheria primary series graph

After 3 doses, patients received 100%
immunization to tetanus and diphtheria2

Response to booster:

Tetanus

In a study of 36 adults who had received prior tetanus immunizations2:

Tetanus response to booster Tetanus response to booster

 

Diphtheria

In a study of 140 adolescent males given a single booster dose of TdVax2:

Diphtheria response to booster Diphtheria response to booster

In clinical trials, booster doses of formulations that contain 1 Lf and 5 Lf of diphtheria toxoid both induced antitoxin levels greater than 0.01 units/mL when administered to adults with prior diphtheria immunity.

Deliver the tetanus and diphtheria
protection your patients need with TdVax

 

Understanding Tetanus

Tetanus remains a rare but life-threatening disease in the
United States. It leads to death in about 1 in 10 cases.4,5

Tetanus is a toxin produced by Clostridium tetani (C. tetani)4,6


Tetanus icon

This occurs when6,7:

  • Spores gain access into the body through a wound
  • The spores then transform to active bacteria

The tetanus vaccine is vital because:

People rarely form immunologic memory in reaction to the
C. tetani infection; the tetanus vaccine helps protect against
the disease (reducing morbidity and mortality)7,8

Tetanus is characterized by rigidity, which usually starts in the jaw and neck before becoming generalized, as well as compulsive spasms of skeletal muscles, which can last for several minutes and can continue for 3-4 weeks.6


WITH EFFECTIVE IMMUNIZATION PROGRAMS IN PLACE, TETANUS INCIDENCE HAS DECLINED, BUT IT HAS NOT BEEN ERADICATED IN THE UNITED STATES.8

Link to video about tetanus in the US WATCH A VIDEO TO LEARN MORE ABOUT TETANUS.


Tetanus-prone wounds9


Wounds that are sustained more than 6 hours before surgical treatment or at any point after injury that show one or more of the following:

  • Puncture-type wound
  • Significant devitalized tissue
  • Evidence of sepsis
  • Contamination with soil/manure that could contain tetanus organisms
  • Burns
  • Frostbite
  • High-velocity missile wounds

 

Symptoms of tetanus


Graph with the symptoms of tetanus

Between 2009 and 2015, there were 197 cases of tetanus and 16 deaths reported in the United States—over the last several years, deaths have declined, but the disease has not been completely eliminated.1,8

People who are at high risk for tetanus:


Elderly tetanus patient icon

Elderly patients

  • Most deaths due to tetanus occur in the elderly population1,4,6
  • 55% of men and 79% of women at age 70 have been shown not to have protective levels of tetanus antibodies1
Earth icon representing geographical risk of tetanus

Immigrants/visitors to the United States11

Plus icon

People who were never vaccinated or did not complete their vaccination series1,6

Needle icon

Those who have not received a booster within the last 10 years6

Bandaid icon

People who have chronic wounds, are intravenous drug users, or are immunocompromised6

Diabetes patient icon

People with diabetes8

  • Those who have diabetes accounted for 13% of reported tetanus cases and 25% of deaths from 2009 through 2015

ASK YOUR PATIENTS THE RIGHT QUESTIONS
TO DETERMINE WHICH VACCINE THEY NEED.


Tetanus in disaster-affected areas12:


  • During evacuation and flood cleanup, emergency responders, cleanup workers, volunteers, and residents may be at increased risk for wounds such as punctures, cuts, bruises, lacerations, and scrapes
  • Skin injuries can become contaminated with flood waters, human or animal waste, soil, dirt, or saliva
  • Workers and residents should make sure they are up-to-date with tetanus vaccination before starting cleanup activities

 

 

Postexposure Prophylaxis

According to the most recent CDC tetanus surveillance data, an analysis
of sufficiently complete case reports of patients with acute wounds who
sought medical care revealed that 96% did not receive recommended PEP.4

Guide to tetanus prophylaxis in routine wound management6


Chart for Health Care Professionals about tetanus in wound management

An animal bite or severe dirty wound would leave patients at risk for tetanus.6,13

*Tdap vaccine (tetanus, diphtheria, pertussis) may be substituted for Td vaccine if the person has not previously received Tdap and is 11 years of age or older.

ACIP Vaccine Guidelines and Recommendations icon The ACIP guidelines can provide you with more information on specific patients.

Td vaccine recommendations


Updated ACIP guidelines recommend only 1 dose of Tdap followed by Td vaccine every 10 years.1

Td vaccine recommendations for patients Td vaccine recommendations for patients

ACIP guidelines have found that the effectiveness of cocooning is inconclusive when evaluating the prevention of transmitting pertussis to infants. In fact, recent evidence suggests that Tdap does not provide indirect protection against the risk of exposure and transmission of pertussis.1

 

As of 2018, based on recent data, ACIP guidelines no longer support
a general recommendation for a second dose of Tdap—stating that
the recommendation of a second dose of Tdap would be limited.1

Ordering TdVax

TdVax packaging
Package of individual single-dose (0.5 mL) vial
NDC #13533-131-00
Package of 10 single-dose (0.5 mL) vials
NDC #13533-131-01

TdVax is available through:

AmerisourceBergen Drug Corporation
Besse Medical
Cardinal Health
Caribe Rx
FFF Enterprises
Henry Schein
McKesson Pharmaceutical
McKesson Medical-Surgical
Medline Industries
Metro Medical
Morris & Dickson, LLC
Seacoast Medical

Contact Grifols for more information on TdVax.

Customer Service: 1-844-GRF-VACC (473-8222)

Medical Information: 1-800-520-2807

Email:customer.service@grifols.com

Tools for your practice

Download resources for your staff and patients

These materials can help educate about tetanus, TdVax, and the updated postexposure prophylaxis guidelines.

PDF: Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States

Download the 2018
recommendations
from the ACIP

PDF: Best Practices for Tetanus Vaccination and Treatment

Learn about the best
practices for tetanus
vaccination and treatment

 

TDVAXTM (tetanus and diphtheria toxoids adsorbed) is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.

A severe allergic reaction (eg, anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

More frequent administration than described in the product insert may be associated with an increased incidence and severity of adverse reactions.

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive Td more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of TDVAX or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

Vaccination with TDVAX may not protect all individuals.

Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.

Prior to the administration of TDVAX, the vaccine recipient's current health status and health history should be reviewed, including immunization history, presence of any contraindications to immunization, and any adverse events after previous immunizations.

If TDVAX is administered to immunocompromised persons (whether from disease or treatment) the expected immune response may not be obtained.

Prior to administration of TDVAX, healthcare providers should inform patients, parents, or guardians of the benefits and risks of immunization with Td; the importance of completing the primary immunization series or receiving recommended booster doses; the potential for adverse reactions associated with TDVAX or other vaccines containing similar ingredients; and to report any suspected adverse reactions to the healthcare provider.

Patients who are on immunosuppressive therapy, including alkylating agents, antimetabolites, cytotoxic drugs, irradiation, or corticosteroids (used in greater than physiologic doses), may have a reduced immune response to vaccines.

No safety and immunogenicity data are available on the concomitant administration of TDVAX vaccine with other US licensed vaccines.

Data on adverse reactions following fluid and adsorbed preparations of TDVAX with various doses of the diphtheria and tetanus components have been reported in a series of studies.

The following adverse events have been identified during post-approval use of TDVAX and are included because of seriousness or frequency of reporting: Injection-site reactions, including pain, tenderness, erythema, induration, pruritus, swelling, and warmth; peripheral oedema; pyrexia; malaise; dizziness; headache; convulsions; myalgia; musculoskeletal stiffness or pain; arthralgia; rash; nausea; and cellulitis.

To report SUSPECTED ADVERSE REACTIONS, contact MassBiologics at 1-800-457-4626 or Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or www.vaers.hhs.gov.

Please see full Prescribing Information for TDVAX (tetanus and diphtheria toxoids adsorbed).

References:
  1. Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(2):1-44.
  2. TDVAX™ (tetanus and diphtheria toxoids adsorbed) Prescribing Information. Grifols.
  3. Porter JD, Perkin MA, Corbel MJ, Farrington CP, Watkins JT, Begg NT. Lack of early antitoxin response to tetanus booster. Vaccine. 1992;10(5):334-336.
  4. Centers for Disease Control and Prevention (CDC). Tetanus surveillance—United States, 2001-2008. MMWR Morb Mortal Wkly Rep. 2011;60(12):365-369.
  5. Centers for Disease Control and Prevention (CDC). Td (tetanus, diphtheria) vaccine information statement. CDC website. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/td.html. Updated April 11, 2017. Accessed May 9, 2019.
  6. Centers for Disease Control and Prevention (CDC). Tetanus. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. Tetanus. 13th ed. Washington, DC: Public Health Foundation; 2015:341-352. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/tetanus.pdf. Accessed May 9, 2019.
  7. Alagappan K, Poland GA. Special report: best practices for tetanus vaccination and treatment. A supplement to Infectious Disease Special Edition (IDSE) and Pharmacy Practice News. 2019.
  8. Centers for Disease Control and Prevention (CDC). VPD surveillance manual tetanus chapter 16.1: tetanus. https://www.cdc.gov/vaccines/pubs/surv-manual/chpt16-tetanus.html. Accessed May 3, 2019.
  9. World Health Organization (WHO). Prevention and management of wound infection. https://www.who.int/hac/techguidance/tools/guidelines_prevention_and_management_wound_infection.pdf. Accessed May 3, 2019.
  10. Centers for Disease Control and Prevention (CDC). Symptoms and complications. https://www.cdc.gov/tetanus/about/symptoms-complications.html. Accessed May 9, 2019.
  11. Alagappan K, McGowan J, Declaro D, NG D, Silverman RA. Tetanus antibody protection among HIV-infected US-born patients and immigrants. Int J Emerg Med. 2008;1:123-126.
  12. Centers for Disease Control and Prevention (CDC). Tetanus Clinical Information. CDC website. https://www.cdc.gov/tetanus/clinicians.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fdisasters%2Fdisease%2Ftetanus.html. Updated February 28, 2019. Accessed April 12, 2019.
  13. Baddour LM, Harper M. Patient education: animal bites (beyond the basics). UpToDate website. http://www.uptodate.com/contents/animal-bites-beyond-the-basics. Updated February 15, 2017. Accessed February 18, 2019.