Feb 28, 2024 ACIP Meeting - Chikungunya Vaccines
TLDRThe transcript discusses the licensing of the Chikungunya vaccine by Valneva in the United States in 2023 and the subsequent development of policy options for its use among various at-risk groups, including travelers, laboratory workers, and residents of areas with transmission risk. The vaccine's immunogenicity and safety profile, as well as the proposed clinical guidance for its use in pregnant and breastfeeding individuals, are also covered. The document highlights the importance of shared clinical decision-making and the need for post-licensure monitoring of vaccine safety.
Takeaways
- 📅 The Chikungunya vaccine by Valneva was licensed in the United States in November 2023, marking the first global license for a Chikungunya vaccine.
- 🌍 The Chikungunya Vaccines Work Group was formed in May 2022 to develop policy options for the use of the vaccine among US persons at risk, including travelers, laboratory workers, and residents of areas with transmission risk.
- 💡 The FDA approved the live attenuated Chikungunya vaccine, named lxchiq, for individuals at increased risk of exposure to the Chikungunya virus, with specific contraindications for immunocompromised individuals and those with severe allergic reactions.
- 🚨 The vaccine's warnings and precautions highlight the potential for severe or prolonged Chikungunya-like adverse reactions and the occurrence of vaccine viremia in the first week post-vaccination, with unknown risks regarding vertical transmission.
- 📈 The vaccine's immunogenicity was high, with a seroresponse rate of 98% at 28 days and 99% at 12 months, although the data is limited.
- 🧬 The vaccine's safety profile revealed it to be reactogenic, with common adverse events including headache, fatigue, and myalgia, and severe systemic adverse events reported in 1.9% of vaccine recipients.
- 🌐 The Chikungunya virus is primarily transmitted in tropical and subtropical regions, with periodic large outbreaks and high attack rates, affecting 1/3 to 3/4 of the population.
- 🧵 The work group proposed draft recommendations for Chikungunya vaccine use among adult travelers and laboratory workers, with considerations for shared clinical decision making for certain individuals.
- 🤰 The proposed clinical guidance for pregnant individuals suggests avoiding Chikungunya virus infection risk if possible and deferring vaccination until after delivery, with exceptions for high-risk situations.
- 🍼 For breastfeeding individuals, breastfeeding is considered a precaution for Chikungunya vaccination, and healthcare providers should discuss the benefits and risks with the individual.
- 📝 Post-licensure requirements include controlled trials to confirm the clinical benefits of the vaccine, with specific studies planned for adolescents, adults, and pragmatic randomized controlled trials.
Q & A
When was the Chikungunya vaccine by Valneva licensed in the United States?
-The Chikungunya vaccine by Valneva was licensed in the United States in November of 2023.
What is the primary mode of transmission for Chikungunya virus?
-The primary mode of transmission for Chikungunya virus is through Aedes aegypti and Aedes albopictus mosquitoes.
What are the key symptoms of Chikungunya virus infection?
-The key symptoms of Chikungunya virus infection include fever, severe joint pain, headache, rash, myalgia, and anorexia.
What is the recommended age group for the Chikungunya vaccine?
-The Chikungunya vaccine is recommended for individuals aged 18 years and older.
What is the加速批准途径 (accelerated approval pathway) and why was it used for the Chikungunya vaccine?
-The accelerated approval pathway is a route used by the FDA for serious conditions that fill an unmet medical need. It allows for products to be approved based on a surrogate endpoint that is reasonably likely to predict clinical benefits. This pathway was used for the Chikungunya vaccine because conducting an efficacy trial with a disease endpoint would be challenging due to the unpredictable nature of Chikungunya outbreaks and the lack of an established immunologic correlator of protection.
What are the two post-marketing studies required by the FDA for the Chikungunya vaccine?
-The two post-marketing studies required by the FDA include a vaccine effectiveness case control study in adolescents and adults aged 12 years and older, planned to start by March 2026 and be completed by March 2028, and a pragmatic randomized control trial for effectiveness and safety in adults in an endemic area, planned for initiation by October 2025 for completion by July 2029.
What is the short-term protection measured by the seroresponse after Chikungunya vaccination?
-The short-term protection measured by the seroresponse at 28 days after vaccination was 98% or 611 of 622 subjects when the results from two studies with data were combined.
What are the contraindications for the Chikungunya vaccine?
-The contraindications for the Chikungunya vaccine are administration to immunocompromised individuals and to individuals with a history of a severe allergic reaction to any component of lxchiq.
What is the significance of the Chikungunya vaccine's reactogenicity?
-The reactogenicity of the Chikungunya vaccine means that it can cause adverse reactions such as fever, headache, fatigue, and myalgia. While these reactions are generally mild or moderate, it is important to monitor vaccine safety post-licensure as the vaccine is used in larger populations.
What are the proposed policy options for the use of the Chikungunya vaccine among US travelers?
-The proposed policy options for the use of the Chikungunya vaccine among US travelers include recommending the vaccine for persons aged 18 years or older traveling to a country or territory where there is a Chikungunya outbreak, and considering the vaccine for persons traveling to areas without an outbreak but with evidence of Chikungunya virus transmission among humans within the last five years, especially those aged older than 65 years with underlying medical conditions or those staying for a cumulative period of six months or more.
How is the risk-benefit assessment for the Chikungunya vaccine determined?
-The risk-benefit assessment for the Chikungunya vaccine is determined based on factors such as the intensity of Chikungunya virus transmission, the individual's risk profile, the potential severity of the disease, the vaccine's efficacy, and the possibility of vaccine-associated adverse events.
What is the definition of an outbreak for the purposes of the Chikungunya vaccine recommendations?
-An outbreak, for the purposes of the Chikungunya vaccine recommendations, is defined as occurring when the CDC posts information on an outbreak on the CDC website.
Outlines
🌟 Introduction to Chikungunya Vaccine Session
The session begins with an introduction by Dr. Wilbur Chen, the work group chair, for the Chikungunya vaccine presentation. He discusses the licensing of the Chikungunya vaccine by Valneva in November 2023, the first of its kind globally. The session's agenda includes reviewing the vaccine's policy options for use among US travelers, laboratory workers, and pregnant or breastfeeding individuals. Dr. Chen also highlights the work group's previous presentations to the ACIP and introduces the next speaker, Dr. Susan Hills, who will provide an update on the licensure of the Chikungunya vaccine.
🧬 Licensure and Updates on Chikungunya Vaccine
Dr. Susan Hills provides an update on the licensure of the live attenuated Chikungunya vaccine, known as lxchiq, approved by the FDA in November of the previous year. The vaccine is licensed for individuals at increased risk of exposure to Chikungunya virus, with specific contraindications. She discusses the warnings and precautions related to the vaccine, including the potential for Chikungunya-like adverse reactions and the lack of data on vertical transmission risks. Dr. Hills also mentions the accelerated approval pathway used for the vaccine and the post-marketing studies required by the FDA to confirm clinical benefits.
💡 Proposed Policy Options for Chikungunya Vaccine Use
The presentation continues with a discussion on the proposed policy options for the use of Chikungunya vaccine among adult travelers and laboratory workers. Dr. Hills provides a detailed overview of Chikungunya virus transmission, its symptoms, and the risk factors for severe disease. She reviews the immunogenicity and safety data from the vaccine's clinical trials and discusses the work group's draft recommendations for its use. The recommendations include vaccination for travelers to areas with Chikungunya outbreaks and consideration for those traveling to areas with a history of transmission. Dr. Hills emphasizes the importance of shared clinical decision-making for certain individuals.
🌐 Chikungunya Transmission and Vaccine Recommendations
Dr. Hills elaborates on the rationale behind the proposed recommendations for Chikungunya vaccine use, focusing on the evidence of virus transmission within the last five years as a criterion. She clarifies the definition of an outbreak for the recommendations and discusses the importance of moderate exposure to mosquitoes for travelers. Dr. Hills also addresses the concerns regarding the upper age limit for vaccination and provides data on adverse events in vaccinated subjects. The discussion includes the challenges of tracking accurate information on Chikungunya transmission and the potential implications for vaccine recommendations.
📝 Motion to Approve Vaccine Recommendations
The presentation concludes with a motion to approve the draft recommendations for the use of the Chikungunya vaccine. Dr. Daley proposes the motion, and Dr. Long seconds it. The discussion includes clarifications on the recommendations' language, the need for additional discussions with healthcare providers, and considerations for special populations such as immunocompromised individuals. Dr. Kotton raises concerns about the upper age limit for vaccination, and Dr. Hills addresses these concerns with data from clinical trials. The session proceeds with a discussion on the vaccine's use in laboratory workers, with Dr. Hills providing an overview of Chikungunya among this population.
🥼 Chikungunya Vaccine for Laboratory Workers
Dr. Hills presents the proposed policy options for Chikungunya vaccine use among US laboratory workers, who are at potential risk of exposure to the Chikungunya virus in their work. She reviews the reported cases of Chikungunya infection in laboratory workers globally and in the US, emphasizing the importance of vaccination for this specific group. Dr. Hills discusses the draft recommendation, which advises vaccination for laboratory workers with potential exposure to Chikungunya virus. The recommendation is based on the benefits outweighing the risks for this small group of laboratorians working with live virus. The session concludes with a question and answer segment, where Dr. Hills addresses queries about vaccine counseling for laboratorians.
🤰 Clinical Guidance for Pregnant and Breastfeeding Individuals
Dr. Hills discusses the proposed clinical guidance for the use of the live attenuated Chikungunya vaccine in pregnant and breastfeeding individuals. She provides background information on Chikungunya disease during pregnancy and the potential risks and benefits of vaccination. Dr. Hills outlines the objectives of vaccination during pregnancy, which include protecting the pregnant person and potentially the infant through transplacental transfer of antibodies. She presents the work group's proposed guidance, which advises avoiding vaccination during the first trimester and after 36 weeks gestation due to potential concerns associated with vaccine viremia. Dr. Hills also addresses the lack of data on the vaccine's safety during pregnancy and the plans for additional studies. The session includes input from ACOG representatives and other experts, emphasizing the importance of shared clinical decision-making and the potential benefits of vaccination in high-risk situations.
Mindmap
Keywords
💡Chikungunya vaccine
💡Chikungunya virus
💡Vaccine recommendations
💡Immunogenicity
💡Reactogenicity
💡Chikungunya-like adverse reactions
💡Accelerated approval pathway
💡Post-licensure studies
💡Work group
💡Travelers
💡Laboratory workers
Highlights
Chikungunya vaccine manufactured by Valneva was licensed in the United States in November 2023, marking the first Chikungunya vaccine to be licensed globally.
There are currently no existing ACIP (Advisory Committee on Immunization Practices) Chikungunya vaccine recommendations.
The Chikungunya Vaccines Work Group was formed in May 2022 to develop policy options for ACIP's consideration regarding the use of the vaccine among US persons at risk of Chikungunya.
The work group has been focusing on travelers, laboratory workers, and residents of US territories and states with a risk of Chikungunya transmission as potential recipients of the vaccine.
The FDA-approved vaccine, named lxchiq, is administered in a single dose to individuals aged 18 years and older who are at an increased risk of exposure to Chikungunya virus.
The vaccine is contraindicated for immunocompromised individuals and those with a history of severe allergic reaction to any component of lxchiq.
Under the vaccine's warnings and precautions, it is noted that the vaccine may cause severe or prolonged Chikungunya-like adverse reactions.
There is no data on the risk of vertical transmission to the fetus or neonate due to vaccine viremia that occurs in the first week following vaccination.
The Chikungunya vaccine was licensed through an accelerated approval pathway due to the challenges in conducting efficacy trials for the vaccine.
Post-licensure requirements for controlled trials to confirm the clinical benefits of the Chikungunya vaccine include a vaccine effectiveness case control study and a pragmatic randomized control trial.
Chikungunya is a reportable disease in the United States, with approximately 100 to 200 cases reported annually, likely reflecting underdiagnosis and underreporting.
The Chikungunya virus is typically transmitted in tropical and subtropical regions, with about 120 countries and territories globally where transmission has been documented.
Clinical illness from Chikungunya is characterized by acute onset of fever and joint pain, which can be severe and debilitating, often involving multiple joints.
Persistent symptoms such as fatigue and arthralgia can continue months after acute illness, with up to half of the patients experiencing ongoing arthralgia at three months and up to a third at 12 months post-infection.
The live attenuated Chikungunya vaccine has shown high immunogenicity in clinical trials, with short-term protection measured by seroresponse at 28 days post-vaccination being 98%.
The vaccine has a reactogenic nature, with systemic adverse events reported by 50% of vaccine recipients in the pivotal Phase 3 clinical trial, commonly including headache, fatigue, and myalgia.
Chikungunya vaccine is recommended for persons aged 18 years or older traveling to a country or territory where there is a Chikungunya outbreak.
The work group also provides shared clinical decision-making recommendations for certain individuals traveling to areas with documented human cases but without an outbreak, considering factors such as age, medical conditions, and duration of stay.
Transcripts
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