Supplemental Evidence and Data Request on Safety of Vaccines Used for Routine Immunization in the United States, 21855-21858 [2020-08331]

Download as PDF Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices information pursuant to section 54.804(a) of the Commission’s rules, replacing section 54.315(a) of the Commission’s rules. 47 CFR 54.315(a), 54.804(a). The Commission also intends to make several revisions to FCC Form 183, including text changes to reflect the Rural Digital Opportunity Fund auction. Based on the Commission’s experience with auctions and consistent with the record, this two-stage collection of information balances the need to collect information essential to conduct a successful auction with administrative efficiency. Under this information collection, the Commission will collect information that will be used to determine whether an applicant is legally qualified to participate in an auction for Rural Digital Opportunity Fund support. To aid in collecting this information, the Commission will use FCC Form 183, which the public will use to provide the necessary information and certifications. Commission staff will review the information collected on FCC Form 183 as part of the pre-auction process, prior to the start of the auction, and determine whether each applicant satisfies the Commission’s requirements to participate in an auction for Rural Digital Opportunity Fund support. Without the information collected on FCC Form 183, the Commission will not be able to determine if an applicant is legally qualified to participate in the auction and has complied with the various applicable regulatory and statutory auction requirements for such participation. This approach is an appropriate assessment of providers for ensuring serious participation without being unduly burdensome. Federal Communications Commission. Cecilia Sigmund, Federal Register Liaison Officer. [FR Doc. 2020–07839 Filed 4–17–20; 8:45 am] BILLING CODE 6712–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality jbell on DSKJLSW7X2PROD with NOTICES Supplemental Evidence and Data Request on Safety of Vaccines Used for Routine Immunization in the United States Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submissions AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking SUMMARY: VerDate Sep<11>2014 18:34 Apr 17, 2020 Jkt 250001 scientific information submissions from the public. Scientific information is being solicited to inform our review on Safety of Vaccines Used for Routine Immunization in the United States, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before 30 days after the date of this publication in the Federal Register. ADDRESSES: Email Submissions: epc@ ahrq.hhs.gov. Print Submissions: Mailing Address: Center for Evidence and Practice Improvement; Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement; Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301–427–1496 or Email: epc@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Safety of Vaccines Used for Routine Immunization in the United States. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Safety of Vaccines Used for Routine Immunization in the United States, including those that describe adverse events. The entire research protocol is available online at: https:// effectivehealthcare.ahrq.gov/products/ safety-vaccines/protocol. This is to notify the public that the EPC Program would find the following information on Safety of Vaccines Used for Routine Immunization in the United States helpful: D A list of completed studies that your organization has sponsored for this PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 21855 indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. D For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results. D A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. D Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ’s EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare. ahrq.gov/email-updates. The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. Key Questions (KQ) KQ 1: What is the evidence that vaccines included in the immunization schedule recommended for adults in the United States (https://www.cdc.gov/ vaccines/schedules/hcp/imz/adult.html) are safe in the short term (within 42 days following immunization) or long term (>42 days after immunization)? E:\FR\FM\20APN1.SGM 20APN1 21856 Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices KQ1a. What adverse events (AEs) are collected in clinical studies (Phases I– IV) and in observational studies containing a control/comparison group? KQ1b. What AEs are reported in clinical studies (Phases I–IV) and in observational studies containing a control/comparison group? KQ1c. What AEs are associated with these vaccines? 1. For each AE associated with a particular vaccine, what is the average severity and frequency? 2. For AEs without statistically significant associations with a particular vaccine, what is the range of possible effects? 3. For each AE associated with a particular vaccine, what are the risk factors for the AE (including age, sex, race/ethnicity, genotype, underlying medical condition, whether a vaccine is administered individually or in a combination vaccine product, schedule of vaccine administration, adjuvants, and medications administered concomitantly)? KQ 2: What is the evidence that vaccines included in the immunization schedules recommended for children and adolescents in the United States (https://www.cdc.gov/vaccines/ schedules/hcp/imz/childadolescent.html) are safe in the short term (within 42 days following immunization) or long term (>42 days after immunization)? KQ2a. What AEs are collected in clinical studies (Phases I–IV) and in observational studies containing a control/comparison group? KQ2b. What AEs are reported in clinical studies (Phases I–IV) and in observational studies containing a control/comparison group? KQ2c. What AEs are associated with these vaccines? 1. For each AE associated with a particular vaccine, what is the average severity and frequency? 2. For AEs without statistically significant associations with a particular vaccine, what is the range of possible effects? 3. For each AE associated with a particular vaccine, what are the risk factors for the AE (including age, sex, race/ethnicity, genotype, underlying medical condition, whether a vaccine is administered individually or in a combination vaccine product, schedule of vaccine administration, adjuvants, and medications administered concomitantly)? KQ 3: What is the evidence that vaccines recommended for pregnant women in the United States are safe in the short term (within 42 days following immunization) or long term (>42 days after immunization) for both the woman and her fetus/infant? KQ3a. What AEs are collected in clinical studies (Phases I–IV) and in observational studies containing a control/comparison group? KQ3b. What AEs are reported in clinical studies (Phases I–IV) and in observational studies containing a control/comparison group? KQ3c. What AEs are associated with these vaccines? 1. For each AE associated with a particular vaccine, what is the average severity and frequency? 2. For AEs without statistically significant associations with a particular vaccine, what is the range of possible effects? 3. For each AE associated with a particular vaccine, what are the risk factors for the AE (including age, sex, race/ethnicity, genotype, underlying medical condition, whether the vaccine is administered individually or in a combination vaccine product, the schedule of vaccine administration, adjuvants, and medications administered concomitantly)? KQ3d. What AEs are associated with these vaccines in the fetus/infant? 1. For each AE associated with a particular vaccine, what is the average severity and frequency? 2. For AEs without statistically significant associations with a particular vaccine, what is the level of certainty? 3. For each AE associated with a particular vaccine, what are risk factors for the AE (including age, gender, race/ ethnicity, genotype, underlying medical condition, whether vaccine administered individually or in a combination vaccine product, vaccine schedule of administration, adjuvants, medications administered concomitantly)? jbell on DSKJLSW7X2PROD with NOTICES PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) Domain Inclusion Exclusion Population ............... • Human participants of all ages for whom the vaccines are recommended in the United States. Interventions ........... All KQs ................................................................................... • Individual vaccines included in the immunization schedule recommended for adults, children and adolescents, and pregnant women, as well as combination vaccines available in the United States.. Vaccines for adults (KQ1). • Studies in animals or mechanistic/in vitro studies. • Studies exclusively in populations for whom the vaccine is not approved or is contraindicated. • Studies of vaccines not on the United States recommended schedules, including brands/formulations not available in the United States, or no longer used. VerDate Sep<11>2014 18:34 Apr 17, 2020 Jkt 250001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1 Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices 21857 PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS)—Continued Domain Inclusion Comparators ........... Outcomes ............... Timing ..................... jbell on DSKJLSW7X2PROD with NOTICES Setting(s) ................ Study design ........... Other limiters .......... Exclusion • Hepatitis A (HepA; Havrix, Vaqta); hepatitis B (HepB; Engerix-B, Recombivax HB, HEPLISAV–B); HepAHep B (Twinrix); Haemophilus influenzae type b (Hib; PedvaxHIB, ActHIB, Hiberix); human papillomavirus (HPV, HPV9; Gardasil 9); inactivated influenza (IIV; Afluria Quadrivalent, Flucelvax Quadrivalent, Fluarix Quadrivalent, Flulaval Quadrivalent, Fluzone High Dose, Fluzone Quadrivalent, Fluad); live attenuated influenza (LAIV; FluMist Quadrivalent); recombinant influenza (RIV; Flublok Quadrivalent); measles, mumps, rubella (MMR; M–M–R II); meningococcal (Menactra [MenACWY–D], Menveo [MenACWY– CRM]); Meningococcal B (MenB; Bexsero [MenB– 4C], Trumenba [MenB–FHbp]); pneumococcal conjugate vaccine (PCV13; Prevnar 13); pneumococcal polysaccharide vaccine (PPSV23; Pneumovax); tetanus, diphtheria, & acellular pertussis (Tdap; Adacel, Boostrix); tetanus, diphtheria (Td; TDVAX, Tenivac); varicella (VAR; Varivax); zoster (recombinant, RZV; live, ZVL; Shingrix, Zostavax). Children and Adolescents (KQ 2). • Vaccines for children and adolescents will include diphtheria, tetanus, & acellular pertussis (DTaP; Daptacel, Infanrix); hepatitis A (HepA; Havrix, Vaqta); hepatitis B (HepB; Engerix-B, Recombivax HB); Haemophilus influenzae type b (Hib; PedvaxHIB, ActHIB, Hiberix); human papillomavirus (HPV, HPV9; Gardasil 9); inactivated polio vaccine (IPV; IPOL); inactivated influenza (IIV; Afluria Quadrivalent, Fluarix Quadrivalent, Flulaval Quadrivalent, Fluzone Quadrivalent, Flucelvax Quadrivalent); live attenuated influenza (LAIV; FluMist Quadrivalent); measles, mumps, rubella (MMR; M–M–R II); meningococcal (MenACWY–D, Men-ACWY–CRM; Menactra [MenACWY–D], Menveo [MenACWY–CRM]); meningococcal B (MenB; Bexsero [MenB–4C], Trumenba [MenB–FHbp]); pneumococcal conjugate vaccine (PCV13; Prevnar 13); pneumococcal polysaccharide vaccine (PPSV23; Pneumovax); rotavirus (RV; Rotarix, RotaTeq); tetanus, diphtheria, & acellular pertussis (Tdap; Adacel, Boostrix); varicella (VAR; Varivax); DTaP-HepB–IPV (Pediarix); DTaP– IPV/Hib (Pentacel); DTaP–IPV (Kinrix, Quadracel); MMR–V (ProQuad); DTaP–IPV-Hib-HepB (Vaxelis). Vaccines for pregnant women (KQ3). • Hepatitis B (HepB; Engerix-B, Recombivax HB, HEPLISAV–B); inactivated influenza (IIV; Afluria Quadrivalent, Flucelvax Quadrivalent, Fluarix Quadrivalent, Flulaval Quadrivalent, Fluzone Quadrivalent); recombinant influenza (RIV; Flublok Quadrivalent); tetanus, diphtheria, & acellular pertussis (Tdap; Adacel, Boostrix). • Active comparators (e.g., other vaccines or other vaccination schedules) and inactive comparators (e.g., no vaccine). • Adverse events identified in participants, and, in the case of pregnant women, in their fetuses/infants (including the presence and the absence of harms, toxicities, transient side effects, and unintended adverse health effects). • Short term (within 30–42 days following immunization) as well as long term (>42 days after immunization) effects. • No restrictions with regard to settings. • Controlled studies (randomized and non-randomized controlled clinical trials, cohort studies comparing two or more cohorts, case-control studies, self-controlled case series). • English language scientific journal publications and trial records with published results. • Studies without intervention comparator. • Studies reporting only on effectiveness outcomes. • No exclusions apply. • Studies without comparator (e.g., case studies *). • Studies published in abbreviated form only (e.g., letters, conference abstracts). • Studies reported only in non-English publications. * Case studies are outside the scope of the review because they do not include unvaccinated individuals for comparison. VerDate Sep<11>2014 18:34 Apr 17, 2020 Jkt 250001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1 21858 Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices Dated: April 15, 2020. Virginia Mackay-Smith, Associate Director, Office of the Director, AHRQ. items are subject to change as priorities dictate. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. [FR Doc. 2020–08331 Filed 4–17–20; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS) Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public limited only by the audio (via teleconference) lines available. The public is welcome to listen to the meeting, please use the following URL https://www.cdc.gov/nchs/about/bsc/ bsc_meetings.htm that points to the BSC homepage. Further information and meeting agenda will be available on the BSC website including instructions for accessing the live meeting broadcast. DATES: The meeting will be held on May 5, 2020, 11:00 a.m.–1:30 p.m., EDT. ADDRESSES: The teleconference access is https://www.cdc.gov/nchs/about/bsc/ bsc_meetings.htm. FOR FURTHER INFORMATION CONTACT: Sayeedha Uddin, M.D., M.P.H., Executive Secretary, NCHS/CDC, Board of Scientific Counselors, 3311 Toledo Road, Room 2627, Hyattsville, Maryland 20782, telephone (301) 458–4303, isx9@ cdc.gov. SUPPLEMENTARY INFORMATION: Purpose: This committee is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the scientific and technical program goals and objectives, strategies, and priorities of NCHS. Matters to be Considered: The agenda will include discussion on items per the scope of the Charter. The meeting agenda includes welcome remarks and a Center update by NCHS leadership; update on Patient Centered Outcomes Research Trust Fund Projects. Agenda jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:34 Apr 17, 2020 Jkt 250001 Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–08213 Filed 4–17–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) GH20–001, Develop, Implement, and Evaluate Evidence-Based, Innovative Approaches To Prevent, Find, and Cure Tuberculosis in High-Burden Settings; GH20–002, Malaria Operations Research To Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya; GH20– 003, Conducting Public Health Research in Colombia; GH20–004, Conducting Public Health Research in Georgia; and GH20–005, Conducting Public Health Research in South America; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)—GH20– 001, Develop, Implement, and Evaluate Evidence-based, Innovative Approaches to Prevent, Find, and Cure Tuberculosis in High-Burden Settings; GH20–002, Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya; GH20– 003, Conducting Public Health Research in Colombia; GH20–004, Conducting Public Health Research in Georgia; and GH20–005, Conducting Public Health Research in South America; April 14– 16, 2020, 9:00 a.m.– 2:00 p.m., EDT, in the amended FRN. The teleconference, which was published in the Federal Register on April 1, 2020, Vol. 85, No. 63, page 18243, is being amended to change the meeting dates and times to: April 14–15, PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 2020, from 9:00 a.m.–2:00 p.m., EDT. The meeting is closed to the public. FOR FURTHER INFORMATION CONTACT: Hylan Shoob, Ph.D., Scientific Review Officer, Center for Global Health, CDC, 1600 Clifton Road NE, Atlanta, Georgia 30329–4027, Telephone (404) 639–4796; HShoob@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–08214 Filed 4–17–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–P–0015A] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. 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[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21855-21858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Safety of Vaccines Used 
for Routine Immunization in the United States

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Supplemental Evidence and Data Submissions

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Safety of 
Vaccines Used for Routine Immunization in the United States, which is 
currently being conducted by the AHRQ's Evidence-based Practice Centers 
(EPC) Program. Access to published and unpublished pertinent scientific 
information will improve the quality of this review.

DATES: Submission Deadline on or before 30 days after the date of this 
publication in the Federal Register.

ADDRESSES: 
    Email Submissions: [email protected].
    Print Submissions:
    Mailing Address: Center for Evidence and Practice Improvement; 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement; Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Safety of Vaccines 
Used for Routine Immunization in the United States. AHRQ is conducting 
this systematic review pursuant to Section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Safety of Vaccines Used for Routine Immunization in the 
United States, including those that describe adverse events. The entire 
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/safety-vaccines/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Safety of Vaccines Used for Routine 
Immunization in the United States helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements: study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on indications not 
included in the review cannot be used by the EPC Program. This is a 
voluntary request for information, and all costs for complying with 
this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

Key Questions (KQ)

    KQ 1: What is the evidence that vaccines included in the 
immunization schedule recommended for adults in the United States 
(https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html) are safe in 
the short term (within 42 days following immunization) or long term 
(>42 days after immunization)?

[[Page 21856]]

    KQ1a. What adverse events (AEs) are collected in clinical studies 
(Phases I-IV) and in observational studies containing a control/
comparison group?
    KQ1b. What AEs are reported in clinical studies (Phases I-IV) and 
in observational studies containing a control/comparison group?
    KQ1c. What AEs are associated with these vaccines?
    1. For each AE associated with a particular vaccine, what is the 
average severity and frequency?
    2. For AEs without statistically significant associations with a 
particular vaccine, what is the range of possible effects?
    3. For each AE associated with a particular vaccine, what are the 
risk factors for the AE (including age, sex, race/ethnicity, genotype, 
underlying medical condition, whether a vaccine is administered 
individually or in a combination vaccine product, schedule of vaccine 
administration, adjuvants, and medications administered concomitantly)?
    KQ 2: What is the evidence that vaccines included in the 
immunization schedules recommended for children and adolescents in the 
United States (https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html) are safe in the short term (within 42 days following 
immunization) or long term (>42 days after immunization)?
    KQ2a. What AEs are collected in clinical studies (Phases I-IV) and 
in observational studies containing a control/comparison group?
    KQ2b. What AEs are reported in clinical studies (Phases I-IV) and 
in observational studies containing a control/comparison group?
    KQ2c. What AEs are associated with these vaccines?
    1. For each AE associated with a particular vaccine, what is the 
average severity and frequency?
    2. For AEs without statistically significant associations with a 
particular vaccine, what is the range of possible effects?
    3. For each AE associated with a particular vaccine, what are the 
risk factors for the AE (including age, sex, race/ethnicity, genotype, 
underlying medical condition, whether a vaccine is administered 
individually or in a combination vaccine product, schedule of vaccine 
administration, adjuvants, and medications administered concomitantly)?
    KQ 3: What is the evidence that vaccines recommended for pregnant 
women in the United States are safe in the short term (within 42 days 
following immunization) or long term (>42 days after immunization) for 
both the woman and her fetus/infant?
    KQ3a. What AEs are collected in clinical studies (Phases I-IV) and 
in observational studies containing a control/comparison group?
    KQ3b. What AEs are reported in clinical studies (Phases I-IV) and 
in observational studies containing a control/comparison group?
    KQ3c. What AEs are associated with these vaccines?
    1. For each AE associated with a particular vaccine, what is the 
average severity and frequency?
    2. For AEs without statistically significant associations with a 
particular vaccine, what is the range of possible effects?
    3. For each AE associated with a particular vaccine, what are the 
risk factors for the AE (including age, sex, race/ethnicity, genotype, 
underlying medical condition, whether the vaccine is administered 
individually or in a combination vaccine product, the schedule of 
vaccine administration, adjuvants, and medications administered 
concomitantly)?
    KQ3d. What AEs are associated with these vaccines in the fetus/
infant?
    1. For each AE associated with a particular vaccine, what is the 
average severity and frequency?
    2. For AEs without statistically significant associations with a 
particular vaccine, what is the level of certainty?
    3. For each AE associated with a particular vaccine, what are risk 
factors for the AE (including age, gender, race/ethnicity, genotype, 
underlying medical condition, whether vaccine administered individually 
or in a combination vaccine product, vaccine schedule of 
administration, adjuvants, medications administered concomitantly)?

                  PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings)
----------------------------------------------------------------------------------------------------------------
               Domain                              Inclusion                              Exclusion
----------------------------------------------------------------------------------------------------------------
Population.........................   Human participants of all      Studies in animals or
                                      ages for whom the vaccines are         mechanistic/in vitro studies.
                                      recommended in the United States.      Studies exclusively in
                                                                             populations for whom the vaccine is
                                                                             not approved or is contraindicated.
Interventions......................  All KQs..............................   Studies of vaccines not on
                                      Individual vaccines included   the United States recommended
                                      in the immunization schedule           schedules, including brands/
                                      recommended for adults, children and   formulations not available in the
                                      adolescents, and pregnant women, as    United States, or no longer used.
                                      well as combination vaccines
                                      available in the United States..
                                     Vaccines for adults (KQ1)............

[[Page 21857]]

 
                                         Hepatitis A (HepA;
                                         Havrix, Vaqta); hepatitis B
                                         (HepB; Engerix-B, Recombivax HB,
                                         HEPLISAV-B); HepA-Hep B
                                         (Twinrix); Haemophilus influenzae
                                         type b (Hib; PedvaxHIB, ActHIB,
                                         Hiberix); human papillomavirus
                                         (HPV, HPV9; Gardasil 9);
                                         inactivated influenza (IIV;
                                         Afluria Quadrivalent, Flucelvax
                                         Quadrivalent, Fluarix
                                         Quadrivalent, Flulaval
                                         Quadrivalent, Fluzone High Dose,
                                         Fluzone Quadrivalent, Fluad);
                                         live attenuated influenza (LAIV;
                                         FluMist Quadrivalent);
                                         recombinant influenza (RIV;
                                         Flublok Quadrivalent); measles,
                                         mumps, rubella (MMR; M-M-R II);
                                         meningococcal (Menactra [MenACWY-
                                         D], Menveo [MenACWY-CRM]);
                                         Meningococcal B (MenB; Bexsero
                                         [MenB-4C], Trumenba [MenB-FHbp]);
                                         pneumococcal conjugate vaccine
                                         (PCV13; Prevnar 13); pneumococcal
                                         polysaccharide vaccine (PPSV23;
                                         Pneumovax); tetanus, diphtheria,
                                         & acellular pertussis (Tdap;
                                         Adacel, Boostrix); tetanus,
                                         diphtheria (Td; TDVAX, Tenivac);
                                         varicella (VAR; Varivax); zoster
                                         (recombinant, RZV; live, ZVL;
                                         Shingrix, Zostavax).
                                     Children and Adolescents (KQ 2)......
                                         Vaccines for children and
                                         adolescents will include
                                         diphtheria, tetanus, & acellular
                                         pertussis (DTaP; Daptacel,
                                         Infanrix); hepatitis A (HepA;
                                         Havrix, Vaqta); hepatitis B
                                         (HepB; Engerix-B, Recombivax HB);
                                         Haemophilus influenzae type b
                                         (Hib; PedvaxHIB, ActHIB,
                                         Hiberix); human papillomavirus
                                         (HPV, HPV9; Gardasil 9);
                                         inactivated polio vaccine (IPV;
                                         IPOL); inactivated influenza
                                         (IIV; Afluria Quadrivalent,
                                         Fluarix Quadrivalent, Flulaval
                                         Quadrivalent, Fluzone
                                         Quadrivalent, Flucelvax
                                         Quadrivalent); live attenuated
                                         influenza (LAIV; FluMist
                                         Quadrivalent); measles, mumps,
                                         rubella (MMR; M-M-R II);
                                         meningococcal (MenACWY-D, Men-
                                         ACWY-CRM; Menactra [MenACWY-D],
                                         Menveo [MenACWY-CRM]);
                                         meningococcal B (MenB; Bexsero
                                         [MenB-4C], Trumenba [MenB-FHbp]);
                                         pneumococcal conjugate vaccine
                                         (PCV13; Prevnar 13); pneumococcal
                                         polysaccharide vaccine (PPSV23;
                                         Pneumovax); rotavirus (RV;
                                         Rotarix, RotaTeq); tetanus,
                                         diphtheria, & acellular pertussis
                                         (Tdap; Adacel, Boostrix);
                                         varicella (VAR; Varivax); DTaP-
                                         HepB-IPV (Pediarix); DTaP-IPV/Hib
                                         (Pentacel); DTaP-IPV (Kinrix,
                                         Quadracel); MMR-V (ProQuad); DTaP-
                                         IPV-Hib-HepB (Vaxelis).
                                     Vaccines for pregnant women (KQ3)....
                                         Hepatitis B (HepB;
                                         Engerix-B, Recombivax HB,
                                         HEPLISAV-B); inactivated
                                         influenza (IIV; Afluria
                                         Quadrivalent, Flucelvax
                                         Quadrivalent, Fluarix
                                         Quadrivalent, Flulaval
                                         Quadrivalent, Fluzone
                                         Quadrivalent); recombinant
                                         influenza (RIV; Flublok
                                         Quadrivalent); tetanus,
                                         diphtheria, & acellular pertussis
                                         (Tdap; Adacel, Boostrix).
Comparators........................   Active comparators (e.g.,      Studies without
                                      other vaccines or other vaccination    intervention comparator.
                                      schedules) and inactive comparators
                                      (e.g., no vaccine).
Outcomes...........................   Adverse events identified in   Studies reporting only on
                                      participants, and, in the case of      effectiveness outcomes.
                                      pregnant women, in their fetuses/
                                      infants (including the presence and
                                      the absence of harms, toxicities,
                                      transient side effects, and
                                      unintended adverse health effects).
Timing.............................   Short term (within 30-42       No exclusions apply.
                                      days following immunization) as well
                                      as long term (>42 days after
                                      immunization) effects.
Setting(s).........................   No restrictions with regard
                                      to settings.
Study design.......................   Controlled studies             Studies without comparator
                                      (randomized and non-randomized         (e.g., case studies *).
                                      controlled clinical trials, cohort
                                      studies comparing two or more
                                      cohorts, case-control studies, self-
                                      controlled case series).
Other limiters.....................   English language scientific    Studies published in
                                      journal publications and trial         abbreviated form only (e.g.,
                                      records with published results.        letters, conference abstracts).
                                                                             Studies reported only in
                                                                             non-English publications.
----------------------------------------------------------------------------------------------------------------
* Case studies are outside the scope of the review because they do not include unvaccinated individuals for
  comparison.



[[Page 21858]]

    Dated: April 15, 2020.
Virginia Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-08331 Filed 4-17-20; 8:45 am]
BILLING CODE 4160-90-P