Supplemental Evidence and Data Request on Safety of Vaccines Used for Routine Immunization in the United States, 21855-21858 [2020-08331]
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[FR Doc. 2020–07839 Filed 4–17–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
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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:
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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published and unpublished pertinent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
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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)?
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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)?
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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.
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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 .....................
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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.
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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.
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dictate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
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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
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[FR Doc. 2020–08331 Filed 4–17–20; 8:45 am]
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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
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ACTION: Notice of meeting.
AGENCY:
In accordance with the
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bsc_meetings.htm that points to the BSC
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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
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SUMMARY:
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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]
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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–
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Conducting Public Health Research in
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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,
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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.
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SUMMARY:
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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)............
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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
