Feb 28, 2024 ACIP Meeting - DT Vaccine

Centers for Disease Control and Prevention (CDC)
5 Mar 202417:25
EducationalLearning
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TLDRThe Advisory Committee on Immunization Practices (ACIP) reconvened to discuss updates on vaccination guidance, specifically focusing on diphtheria and tetanus toxoids. Dr. Hughes and Dr. Santoli provided an overview of the changes due to the discontinuation of the DT vaccine in the U.S., which previously served as an alternative for children with contraindications to pertussis-containing vaccines. With the DT vaccine no longer available, the CDC has updated its guidance to recommend Td vaccines for young children with such contraindications. However, Td is off-label for children under 7 years old and has a lower dose of diphtheria toxoid, which may impact its effectiveness. The presentation also addressed the supply constraints of Td vaccines and proposed updates to the Vaccines for Children (VFC) program to include Td for eligible children. The committee discussed the potential need for clearer communication in vaccination tables and the challenges of waning immunity for pertussis, considering the shortage of Td vaccines. The meeting concluded with a motion to vote on the inclusion of Td in the VFC program.

Takeaways
  • 📅 The meeting reconvened at 1:30 pm to discuss diphtheria and tetanus toxoids.
  • 🔄 Dr. Hughes and Dr. Santoli provided an update on CDC's guidance for Td vaccines in young children.
  • 🚫 The DT vaccine, previously recommended for children with contraindications to pertussis, is no longer available in the U.S. after April 2023.
  • 💉 CDC now recommends DTaP as the first dose for the childhood vaccination series, with Td as an alternative if a contraindication to pertussis develops.
  • 🚨 Td is an off-label use for children under 7, as it is licensed for ages 7 and older, and its effectiveness against diphtheria in young children is uncertain.
  • 📉 MassBiologics has discontinued production of Td vaccine, and supply constraints are expected in the U.S. market during 2024.
  • 📦 Grifols, the distributor of TdVax, expects to have supplies available only until June of the current year.
  • 📈 Sanofi Pasteur is working to increase the supply of Tenivac, another Td vaccine, to address the supply shortage.
  • 🔗 CDC has posted updated vaccination guidance on its website, including information for children with contraindications to pertussis-containing vaccines.
  • 📝 A minor update to the Vaccines for Children (VFC) program is needed to cover Td for children under 7 years of age.
  • ⏸ There is a proposal to add Td to the VFC program, and a vote on the proposed language is expected to take place later in the meeting.
Q & A

  • What is the topic of discussion at the reconvened Advisory Committee on Immunization Practices meeting?

    -The topic of discussion is diphtheria and tetanus toxoids, specifically focusing on the CDC's guidance for Td vaccines for young children.

  • What change has occurred with the DT vaccine in the U.S.?

    -The sole DT vaccine manufacturer in the U.S. discontinued DT production, and the last available lot expired in April 2023, making the DT vaccine no longer available in the United States.

  • What is the only contraindication specific to the pertussis component in DTAP?

    -The only contraindication specific to the pertussis component in DTAP is encephalopathy within seven days of vaccination, which is not attributed to another cause.

  • What is the CDC's updated guidance for young children with a contraindication to pertussis-containing vaccines?

    -For young children who develop a contraindication to pertussis-containing vaccines, vaccine providers may administer TD for all recommended remaining doses in place of DTaP.

  • Why is the use of Td in young children considered off-label?

    -The use of Td in young children is considered off-label because Td is only licensed for ages 7 and older.

  • What is the impact of using Td instead of DTaP on children's protection against diphtheria and pertussis?

    -Children may have less protection against diphtheria and no additional protection against pertussis if they receive Td instead of DTaP due to the lower dose of diphtheria toxoid in Td.

  • What is the status of Td vaccine supply in the U.S.?

    -The supply of Td vaccine in the U.S. is anticipated to be constrained during 2024, with MassBiologics discontinuing production of TdVax and Sanofi Pasteur taking steps to augment their supply of Tenivac.

  • What is the current recommendation for a booster dose of Tdap for individuals aged 11 to 18 years?

    -Persons aged 11 to 18 years should receive a single booster dose of Tdap, preferably at preventive care visits at ages 11 to 12 years. The booster dose is not necessary if the Tdap dose was given after the ninth birthday.

  • What is the proposed update to the Vaccines for Children (VFC) program regarding Td vaccine?

    -The proposal is to add Td vaccine to the VFC program for children less than 7 years of age for whom receipt of the pertussis component is contraindicated.

  • What is the current recommendation for boosters for Td or Tdap?

    -Td or Tdap are recommended for boosters every 10 years. With the most recent ACIP recommendation, Tdap can be used in lieu of DTaP.

  • What is the concern raised by Dr. Cineas regarding the clarity of the table indicating when Td should be used instead of DTaP?

    -Dr. Cineas is concerned that the table may not clearly indicate that Td should only be used if a child had already received a DTaP dose and experienced encephalopathy within seven days of that dose.

  • Why is there no additional booster recommended for pertussis after the 11-year-old booster, despite waning immunity?

    -The priority for boosting pertussis every 10 years is not as high as for the tetanus and diphtheria component due to the short longevity of protection from Tdap and the cost-effectiveness not supporting more frequent administration.

Outlines
00:00
📋 Advisory Committee Meeting on Vaccines: DTaP and Td Update

The meeting reconvenes to discuss diphtheria and tetanus toxoids. Dr. Hughes and Dr. Santoli provide an update on CDC's guidance for Td vaccines in young children. The DT vaccine, previously recommended for children with contraindications to pertussis-containing vaccines, is no longer available in the U.S. as the manufacturer has discontinued production. CDC has updated its vaccination guidance, suggesting the use of Td vaccine for children with contraindications to pertussis, noting it would be an off-label use. The presentation also addresses the supply situation for Td and Tdap vaccines, with a temporary constraint on Td supply anticipated in 2024.

05:01
📝 Updates to Vaccine Resolution and Considerations for Td Vaccine Supply

The presentation continues with updates to the current resolution for vaccines to prevent diphtheria, tetanus, and pertussis. Changes include adding Td vaccine for children under 7 with contraindications to pertussis and updating the Tdap booster language. The supply of Tdap vaccine is not constrained, but Td supply will be limited in 2024. The resolution's recommended schedule is updated to include Td vaccine for certain age groups, with new table notes to clarify usage in cases of contraindications. A question about the future availability of Grifols' Td vaccine after June is addressed, indicating that the vaccine may be removed from the tables if it becomes unavailable.

10:03
🤔 Discussion on Tdap Usage and Clarification on Vaccine Recommendations

Dr. Long confirms that Tdap is covered by the resolution for ages above 7 and that the previous ACIP recommendation for Tdap as an alternative to Td remains valid. There is a discussion about the availability of Td vaccines in emergency rooms and the potential need for clearer guidelines. A question is raised about the clarity of the Td vaccine usage criteria in the provided table, prompting a suggestion to enhance the accompanying table note for better understanding. The issue of waning immunity for pertussis and the rationale behind the 10-year booster recommendation is also discussed, with a mention of the need for a more effective vaccine.

15:05
🗳️ Voting on VFC Program Inclusion of Td Vaccine and Break for Public Comment

A motion is made to accept the proposed wording for a vote to include Td vaccine in the Vaccines for Children (VFC) program. The motion is seconded, and a vote is scheduled. There is a brief discussion about the duration of immunity provided by Tdap and the economic considerations that influenced the decision for its administration frequency. The meeting is then adjourned for a short break to prepare for public comment speakers.

Mindmap
Keywords
💡Advisory Committee on Immunization Practices
The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on the use of vaccines in the civilian population of the United States. In the script, they are reconvening to discuss updates on vaccine guidance, which is central to their role in shaping public health policy.
💡Diphtheria and Tetanus Toxoids
Diphtheria and tetanus toxoids are components of certain vaccines that provide immunity against diphtheria and tetanus, respectively. The script discusses the discontinuation of the DT vaccine and the implications for vaccination schedules, highlighting the importance of these toxoids in preventing disease.
💡DTaP Vaccine
DTaP is a pediatric vaccine that protects against three diseases: diphtheria, tetanus, and pertussis (whooping cough). The script mentions that CDC recommends a primary series of DTaP as part of the routine vaccination schedule for children, indicating its significance in childhood immunization.
💡Contraindication
A contraindication is a circumstance in which the potential risks of using a medical treatment or intervention, such as a vaccine, outweigh the potential benefits. The script discusses a contraindication to pertussis-containing vaccines, which leads to the use of an alternative vaccine (DT), emphasizing the need for individualized medical decisions.
💡Td Vaccine
The Td vaccine is a combination vaccine that protects against tetanus and diphtheria but does not contain the pertussis component. The script mentions that due to the discontinuation of DT vaccine production, Td may be administered to young children with a contraindication to pertussis, which is a significant change in vaccination guidance.
💡Vaccine Supply
Vaccine supply refers to the availability of vaccines to meet demand. The script discusses the discontinuation of production of Td vaccine by MassBiologics and the constrained supply of Td vaccine in the U.S. market, which is a critical issue affecting vaccination programs and public health.
💡Vaccine Effectiveness
Vaccine effectiveness is a measure of how well a vaccine works in real-world conditions. The script notes that there are no available data evaluating the effectiveness of Td against diphtheria when used in young children, which underscores the importance of ongoing research and surveillance in vaccine programs.
💡Vaccine Recommendations
Vaccine recommendations are guidelines provided by health authorities on which vaccines should be given and when. The script details the CDC's updated recommendations for the use of Td in young children with contraindications to pertussis-containing vaccines, demonstrating the dynamic nature of vaccine guidelines based on new evidence and circumstances.
💡Vaccine Adverse Reaction
An adverse reaction is an unwanted or harmful effect that occurs after the use of a medical product, such as a vaccine. The script mentions encephalopathy within seven days of vaccination as a specific contraindication to the pertussis component in DTaP, highlighting the importance of monitoring for and understanding potential vaccine side effects.
💡Vaccine Schedule
A vaccine schedule is a timetable for when specific vaccines should be administered. The script includes a discussion of the recommended vaccination schedule and intervals for children, which is a fundamental aspect of ensuring timely and appropriate vaccination coverage.
💡Vaccine Financing
Vaccine financing refers to the mechanisms by which vaccines are funded and made available to the public. The script discusses the Vaccines for Children (VFC) program and the proposal to include Td vaccine in the program, which is a key aspect of ensuring accessibility and affordability of vaccines for eligible children.
Highlights

CDC updates vaccination guidance due to the discontinuation of the pediatric diphtheria and tetanus toxoid (DT) vaccine in the U.S.

Introduction of new vaccination guidelines for young children with contraindications to pertussis-containing vaccines, recommending Td in certain scenarios.

CDC recommends DTaP as the first dose in the diphtheria, tetanus, and pertussis childhood vaccination series, emphasizing the rarity of encephalopathy as a contraindication.

Discussion on the implications of using Td (tetanus and diphtheria toxoid-only formulation) off-label for children under 7, due to lower diphtheria toxoid dosage.

Challenges in the U.S. market highlighted by the constrained supply of Td vaccine and the steps being taken by manufacturers to address this issue.

Introduction of VFC program updates to include Td vaccine for children under 7 with specific contraindications to pertussis-containing vaccines.

Overview of the recommended vaccine schedule changes, including the new allowances for Td use in children under 7 years old.

Reiteration that Tdap can be used instead of Td for individuals under 7 years in emergency situations, as indicated in the resolution.

Concerns addressed regarding the clarity of guidelines for Td vaccine usage following a contraindication event after DTaP administration.

Discussion on the waning immunity of pertussis and considerations for future booster doses to enhance vaccine effectiveness.

Motion proposed and seconded for adding Td to the VFC program to expand coverage for children under 7 years old.

Planned vote on the inclusion of Td in the VFC program reflecting updates to ACIP recommendations.

Acknowledgment of the potential impact of discontinuing Grifols' TdVax vaccine on vaccination schedules and public health policy.

Transcripts

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VaccinationCDCTd VaccineDT VaccinePertussisDiphtheriaTetanusImmunizationHealth AdvisorySupply UpdateVFC Program