Nonetheless No Solutions: Observe-up to Advocate Vaccine Assembly Hosted by CDC

Nonetheless No Solutions: Observe-up to Advocate Vaccine Assembly Hosted by CDC

Table of Contents


On March 7, 2024 a gathering was hosted by the CDC that consisted of a small group of expert-advocates to develop the CDC’s understanding of the lived expertise of Lyme disease. The aim of this assembly was to compile an inventory of particular person questions to grasp extra a couple of future Lyme disease vaccine, and the VLA15 vaccine particularly, given it was the one vaccine candidate being evaluated in section 3 medical trials as of the date of this assembly. Pat Smith reported on this assembly within the President’s Blog – In-depth Synopsis of Advocate Vaccine Meeting Hosted by CDC. The next is an inventory of all of the questions contributed by the contributors of the assembly. These questions have been shared with a Pfizer consultant by the CDC on March 8, 2024. As of April 30, 2024, there was no response by Pfizer. 


Lyme Illness Vaccine Technical Session, March 7-8, 2024
Assembly Product

Background

On March 7, 2024 a small group of expert-advocates have been convened to compile an inventory of particular person
questions that they’ve a couple of future Lyme disease vaccine, and the VLA15 vaccine particularly, given
it was the one vaccine candidate being evaluated in section 3 medical trials as of the date of this assembly.
The next is an inventory of all of the questions contributed by the contributors. These questions have been shared
with a Pfizer consultant on March 8, 2024.

Questions for Pfizer

Basic Questions

  • Why didn’t Pfizer have interaction the Lyme disease group sooner within the vaccine growth course of?
  • Are you able to inform us why a presentation about VLA15 wasn’t supplied by Pfizer for this assembly?
  • Is there a option to have entry to shows beforehand given at scientific conferences (e.g., the Gordon Convention)?
  • Would Pfizer be capable to make a presentation about VLA15 and the outcomes of the medical trials at a gathering convened by CDC with a broad group of researchers and non-researchers from the Lyme group?

Questions About Vaccine Improvement

  • Which OspA fragments have been utilized in VLA15?
  • Does the ST1-OspA that was used cowl the strains in California?
  • How was OspA modified to forestall autoimmune reactivity to HLA/LFA?
  • What are the vaccine know-how and elements? (Background be aware: there are considerations in regards to the hazard of these with alpha-gal receiving mammalian merchandise through healthcare merchandise.)
  • Why was OspA chosen because the goal, given the LYMERix® considerations?
  • How is that this vaccine comparable and different than LYMERix®?
  • Specifically, how have the vaccine’s builders edited out the putative mimic of hLFA-1? Is there any knowledge to confirm that extra epitopes will not be problematic, if the mimic of hLFA-1 shouldn’t be the one one which brought about an autoimmune response in LymeRix? What knowledge satisfied you that VLA15 can be safer than LYMERix®?
  • Did Pfizer examine any of the peer-reviewed articles on the issues that have been thought to have affected those that took LYMERix® (for instance, these associated to HLA or demyelination)?
    • If that’s the case, please present a If not, why?
  • What occurred to the Baxter Lyme disease vaccine?
    • Did Pfizer look into this vaccine?
    • Did Pfizer purchase any portion of the Baxter Lyme disease vaccine division?
  • What occurred to the Connaught ImmuLyme vaccine?
    • Did Pfizer look into this vaccine?
  • How does VLA15 stop Lyme disease?
  • How lengthy does it take for human antibodies to develop after the OspA vaccine?
    • How lengthy does this response proceed?
  • How lengthy does it take for the antibodies within the human blood to deactivate the Borrelia within the tick (minutes, hours, days)?
  • What are the transmission assumptions used within the growth of VLA15?
  • Do you could have plans for different tickborne illness vaccines (e.g., babesiosis, bartonella, relapsing fever species)?
  • Do you retain a repository of trial samples to be used in future analysis?
    • If that’s the case, who can entry them?
  • What are the best challenges Pfizer has confronted in creating this vaccine?
    • What challenges do you anticipate dealing with sooner or later?
  • Is there something you may inform us that wasn’t within the press releases?

Questions In regards to the VLA15 Trials

  • On the April 2022 press launch, are you able to please make clear whether or not the pediatric immunogenicity response was comparable or different for two or 3 dose schedule?
  • Who conducts Part 4 research?
    • Does Pfizer intend to conduct Part 4 research?
  • One of many press releases references “observer blind”. Is “observer blind” different from “double blind”?
  • Are you able to please make clear the calculus of going from 6,000 goal contributors to the final recruited whole of 9,437 contributors?
  • Had been knowledge from the three,000 discontinued VALOR contributors retained?
    • If that’s the case, how will they be analyzed?
  • Does the VLA15 collection want to start out at a specific time of 12 months to optimize immunological response?
  • On what knowledge did Pfizer base the timing of a 12-month booster? If you’ll goal boosters earlier than “peak season” (as referenced within the 12/4/23 press launch), how will “peak season” be defined?
  • Within the 2/4/22 press launch, how was the “subset” of section 2 contributors chosen for the booster examine?
  • How lots of the 9,437 contributors have been enrolled from the US?
    • Europe?
    • Canada?
  • How do we all know that one booster is ample when the preliminary collection required 3 vaccines?
  • What have been the participant incentives?
  • Would you conduct subgroup analyses of those that contracted COVID-19 throughout the examine?
  • Within the medical trials, contributors have been both “Lyme naïve” or had “cleared previous an infection”. What diagnostic technique was used to find out an individual’s Lyme standing?
    • Did you check for different infections?
    • What diagnostics have been run total, throughout time?
  • What Lyme disease testing technique is getting used to confirm vaccine efficacy?
  • Do you could have knowledge on the protection and efficacy of this vaccine in people who find themselves pregnant?
    • Do you could have knowledge on individuals who turned pregnant throughout the trial? If that’s the case, what did the information present?
    • If there are ensuing pregnancies, will these pregnancies be adopted, and can any offspring born be adopted over time particularly for any Lyme instances (e.g., vaccine failures)? Will specimens be collected?
  • Did you enroll individuals who have been identified to have non-Lyme tickborne ailments?
    • If that’s the case, are you able to do subgroup analyses of them?
  • Have you ever evaluated the protection and efficacy of VLA15 in immunocompromised sufferers? If not, will you? How did you define “immunocompromised”?
  • Did you enroll folks with non-communicable ailments that weren’t a part of the exclusion standards?
    • Do you plan to do subgroup analyses of this inhabitants?
  • What’s the threshold to find out safety and the way is that this threshold decided?
    • How lengthy does safety final?
  • How lengthy after getting the third dose does it take to be absolutely protected?
  • Are you partially protected after one or two doses?
    • If that’s the case, how a lot?
  • How lengthy are medical trial contributors being monitored?
    • If that’s the case, how?
  • Are there any sex-based differences within the immunological response?
  • Is there any therapeutic worth to VLA15?
  • Are you able to present the GCP tips that have been violated by Care Entry, resulting in the removing of this contractor?

Questions About Antagonistic Occasions and Facet Results

  • Are you able to assess the protection and efficacy of VLA15 in those that have tickborne ailments?
    • Do you could have plans to conduct subgroup analyses?
  • What’s the security profile and what are the facet effects of VLA15?
    • What have been the worst facet effects?
  • Do you could have any plans to judge the protection and efficacy of VLA15 in sufferers with persistent Lyme disease?
  • Are you able to get VLA15 in case you’re sick (e.g., have chilly signs, )?
  • Can this vaccine be co-administered with different vaccines?
    • If not, what’s the wait time?
  • Is there a plan to co-administer the Lyme vaccine with the autumn vaccines (e.g., COVID, flu, ) as a way to optimize timing of efficacy?

Questions About Submit-Licensure

  • Are there future research deliberate if VLA15 if licensed within the S, post-licensure (e.g., with these excluded from VALOR: pregnant folks, breastfeeding folks, aged folks)?
  • Are there plans to broaden medical trials to different areas of the world?
  • The place is/will VLA15 be manufactured?
  • What’s going to the price be?
    • Will or not it’s lined by insurance coverage?
    • If that’s the case, beneath what circumstances?
  • If suggestions from ACIP are restrictive to geography, will Pfizer conduct extra research or trials to ascertain use in different geographic areas to assist broader uptake?
  • What are the logistics round vaccine implementation (shelf life, storage necessities, )?
  • Are there anticipated impacts of VLA15 on subsequent diagnostic testing for future infections (e.g., false positives for Lyme disease, and many others.)?
  • Will Pfizer enlist affected person entry applications to assist uptake and accessibility to the vaccine?

Questions on Communications and Rollout

  • When can the general public have entry to the advertising and marketing plan described in one of many VLA15 press releases?
  • How will Pfizer make sure that the general public understands the scope of safety from VLA15, and specifically that it’s going to not shield the general public from tickborne ailments apart from Lyme disease?

Questions for CDC

Basic Questions

  • Would Pfizer be capable to convene a gathering at which the VLA medical trial findings may very well be introduced to the broad analysis and non-research Lyme group?

Questions About Antagonistic Occasions and Facet Results

  • When an individual studies to VAERS, is their report/symptom positioned right into a coding system (utilized by the FDA or others), or are their signs investigated and analyzed at face worth?
  • What’s the reporting and investigation technique of VAERS?
  • Will we at present (throughout the section 3 medical trial) have public entry to hostile occasion knowledge from the medical trials (via VAERS or in any other case)?
    • Does VAERS obtain studies pre-licensure?
    • If that’s the case, how are VAERS studies thought-about by FDA for licensure?

Questions About Submit-Licensure

  • What might be shared publicly in regards to the ACIP member vetting course of?
    • What’s the conflict of curiosity course of for vetting ACIP members?
      • If an individual is proven to have a conflict of curiosity, is there a course of to take away them?
      • Is that this info disclosed?
    • Will VLA15 be thought-about for the Vaccines for Kids program?
    • Would particular populations get suggestions sooner or later, even when they weren’t included within the medical trials?
    • Do states have an unbiased position in figuring out if a vaccine is included within the Vaccines for Kids program?

Questions on Communications and Rollout

  • What are CDC’s plans for vaccine rollout, together with web site content material?
  • How will CDC incorporate details about vaccine security monitoring programs in its vaccine rollout?

Questions for FDA

Questions In regards to the VLA15 Trial

  • Does FDA have an announcement on why Pfizer discontinued numerous contributors of their US VALOR examine?
  • Why did FDA clear Care Entry (contractor)?
    • Why have been FDA’s findings different than Pfizer’s?
  • If VAERS receives studies pre-licensure, how are these studies thought-about by FDA for licensure?

Questions for DoD

Questions About Submit-Licensure

What’s the vaccine suggestion course of for DoD?


For Extra Info: 

Read Pat Smith’s President’s Blog on Advocate’s Vaccine Meeting

Read More LDA Articles on Pfizer Vaccine

Read Lyme Vaccine Meeting Article from Lymedisease.org

Read More from CDC on Lyme Vaccine

The publish Still No Answers: Follow-up to Advocate Vaccine Meeting Hosted by CDC appeared first on Lyme Disease Association.



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