York County Medicine Winter 2020 - 26

How a new vaccine is developed,
approved and manufactured

YO R K C O M E D S O C . O R G

The Food and Drug Administration (FDA) sets rules for the three phases of clinical trials
to ensure the safety of the volunteers. Researchers test vaccines with adults first.

PHASE 1

IN THE NEWS:

PHASE 2

PHASE 3

20-100
healthy volunteers

The Journey of
Your Child's Vaccine
ƒ Is this vaccine safe?

ƒ Does this vaccine seem to work?
ƒ Are there any serious side
effects?

ƒ How is the size of the dose
related to side effects?

ƒ How do people who get the
vaccine and people who do not
get the vaccine compare?

ƒ What are the most common
short-term side effects?

ƒ Is the vaccine safe?
ƒ Is the vaccine effective?

ƒ How are the volunteers'
immune systems responding
to the vaccine?

FDA licenses the vaccine only if:

Vaccines are
made in batches
called lots.

hundreds or thousands
of volunteers

several hundred
volunteers

ƒ What are the most common
side effects?

ƒIt's safe and effective
ƒBenefits outweigh risks

Manufacturers must test all lots
to make sure they are safe, pure
and potent. The lots can only be
released once FDA reviews their
safety and quality.

The FDA inspects
manufacturing facilities
regularly to ensure
quality and safety.

FOR MORE INFORMATION, VISIT HTTPS://WWW.FDA.GOV/CBER

Before a new vaccine is ever given to people, extensive
lab atesting
ismaydone
that
take immunization
severalschedule.
If the FDA licenses
vaccine, experts
consider adding
it to can
the recommended
years. Once testing in people begins, it can take several
years
before clinical
How a more
vaccine
is added
to the studies
U.S. are
Recommended
complete
and the vaccine
is licensed. Immunization Schedule
The Journey of Your Child's
Vaccine
Before a new vaccine is ever given to people, extensive lab testing is done that can take several years. Once testing
in people begins, it can take several more years before clinical studies are complete and the vaccine is licensed.

How a new vaccine is developed,
approved and manufactured
The Food and Drug Administration (FDA) sets rules for the three phases of clinical trials
to ensure the safety of the volunteers. Researchers test vaccines with adults first.

ACIP

The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts.
Members of the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) are
among some of the groups that also bring related immunization expertise to the committee. This group carefully
reviews all available data about the vaccine from clinical trials and other studies to develop recommendations for
vaccine use. The ACIP continues to monitor vaccine safety and effectiveness data even after the vaccine's routine
use and may change or update recommendations based on that data.

When making recommendations, ACIP considers:
PHASE 1

PHASE 2

PHASE 3

ACIP recommendations are not
official until the CDC Director
reviews and approves them
and they are published. These
recommendations then become
part of the United States official
childhood immunization schedule.

ƒ How safe is the vaccine when given at specific ages?
ƒ How well does the vaccine work at specific ages?
ƒ How serious is the disease this vaccine prevents?

20-100
healthy volunteers

ƒ Is this vaccine safe?
ƒ Does this vaccine seem to work?
ƒ Are there any serious side
effects?
ƒ How is the size of the dose
related to side effects?

several hundred
volunteers

ƒ How do people who get the
vaccine and people who do not
get the vaccine compare?

ƒ What are the most common
short-term side effects?

ƒ Is the vaccine safe?
ƒ Is the vaccine effective?

ƒ How are the volunteers'
immune systems responding
to the vaccine?

FDA licenses the vaccine only if:
Vaccines are
made in batches
called lots.

hundreds or thousands
of volunteers

Manufacturers must test all lots
to make sure they are safe, pure
and potent. The lots can only be
released once FDA reviews their
safety and quality.

ƒ How serious is the disease this vaccine prevents?
ƒ How many children would get the disease the vaccine
prevents if we didn't have the vaccine?

New vaccine to protect your child against
a disease is added to the schedule.

2

1

month

†

months

4

6

months

months

RV

RV

HepB
DTaP

Is your family
growing? To protect
your new baby and
yourself against whooping
cough, get a Tdap vaccine.
The recommended time is
the 27th through 36th week
of pregnancy. Talk to your
doctor for more details.

15

months

18

months

19-23
months

2-3

years

Hib

15

months

18

months

19-23
months

2-3

years

DTaP

4-6

years

DTaP

Hib
PCV13
IPV

IPV
Influenza (Yearly)*
MMR

MMR

Varicella

Varicella
HepA§

FOOTNOTES:

* Two doses given at least four weeks apart are recommended for children aged 6 months through 8 years of age who are getting an
influenza (flu) vaccine for the first time and for some other children in this age group.
§

Two doses of HepA vaccine are needed for lasting protection. The first dose of HepA vaccine should be given between 12 months and
23 months of age. The second dose should be given 6 to 18 months later. HepA vaccination may be given to any child 12 months and
older to protect against HepA. Children and adolescents who did not receive the HepA vaccine and are at high-risk, should be
vaccinated against HepA.
If your child has any medical conditions that put him at risk for infection or is traveling outside the United States, talk to your
child's doctor about additional vaccines that he may need.

See back page
for more
information on
vaccinepreventable
diseases and the
vaccines that
prevent them.

For more information, call toll free
1-800-CDC-INFO (1-800-232-4636)
or visit
www.cdc.gov/vaccines/parents

RISK
BENEFIT

FDA and CDC closely monitor vaccine safety
after the public begins using the vaccine.

Vaccine Safety Datalink (VSD) and
Post-Licensure Rapid Immunization Safety Monitoring (PRISM)
Two networks of healthcare organizations across the U.S.
ƒ VSD can analyze
healthcare information from
over 24 million people.

ƒ PRISM can analyze
healthcare information from
over 190 million people.

Scientists use these systems to actively monitor vaccine safety.

Clinical Immunization Safety Assessment Project (CISA)
CISA is a collaboration between CDC and 7 medical research centers.
ƒ Vaccine safety experts assist U.S.
healthcare providers with complex
vaccine safety questions about their
patients.

ƒ CISA conducts clinical research studies
to better understand vaccine safety and
identify prevention strategies for adverse
events following immunization.

4-6

years

HepB
RV

months through 18 years)*

12

months

12

months

RV
DTaP
PCV13

IPV

Vaccine recommendations may change if safety monitoring reveals new
information on vaccine risks (like if scientists detect a new serious side effect).

2018 Recommended Immunizations for Children from Birth Through 6 Years Old

Birth

6

months

Hib
PCV13

IPV

Shaded boxes indicate the
vaccine can be given during
shown age range.

NOTE:

If your child misses a shot,
you don't need to start over, just go
back to your child's
doctor for the next shot.
Talk with your child's doctor
if you have questions
about vaccines.

RV
DTaP

Hib

Vaccine Adverse Event Reporting System (VAERS)

ACIP recommendations are not
official until the CDC Director
reviews and approves them
and they are published. These
recommendations then become
part of the United States official
childhood immunization schedule.

ƒ How well does the vaccine work at specific ages?

4

months

HepB
RV

DTaP
PCV13

VAERS collects and analyzes reports of adverse events that happen after vaccination.
Anyone can submit a report, including parents, patients and healthcare professionals.

ACIP

ƒ How safe is the vaccine when given at specific ages?

months

HepB

your new baby and
yourself against whooping
cough, get a Tdap vaccine.
The recommended time is
the 27th through 36th week
of pregnancy. Talk to your
doctor for more details.

The purpose of monitoring is to watch for adverse events (possible side effects). Monitoring a vaccine
after it is licensed helps ensure that possible risks associated with the vaccine are identified.

The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts.
Members of the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) are
among some of the groups that also bring related immunization expertise to the committee. This group carefully
reviews all available data about the vaccine from clinical trials and other studies to develop recommendations for
vaccine use. The ACIP continues to monitor vaccine safety and effectiveness data even after the vaccine's routine
use and may change or update recommendations based on that data.

When making recommendations, ACIP considers:

2

1

month

†

Is your family
growing? To protect

How a vaccine's safety continues
to be monitored

The FDA inspects
manufacturing facilities
regularly to ensure
quality and safety.

How a vaccine is added to the U.S.
Recommended Immunization Schedule

HepB

Birth

HepB

New vaccine to protect your child against
a disease is added to the schedule.

months through 18 years)*

After being added to the U.S. Recommended Immunization Schedule, health
experts continue to monitor the vaccine's safety and effectiveness.

FOR MORE INFORMATION, VISIT HTTPS://WWW.FDA.GOV/CBER

At 1 month of age, HepB (1-2
months),
At 2 months of age, HepB (1-2
months), DTaP, PCV, Hib, Polio,
and RV
At 4 months of age, DTaP, PCV,
Hib, Polio, and RV
At 6 months of age, HepB (6-18
months), DTaP, PCV, Hib, Polio
(6-18 months), RV, and Influenza
(yearly, 6 months through 18
years)*
At 12 months of age, MMR (12-15

2018 Recommended Immunizations for Children from Birth Through 6 Years Old

months), PCV (12-15 months) ,
Hib (12-15 months), Varicella
(12-15 months), HepA (12-23
months)§, and Influenza (yearly, 6
months through 18 years)*
At 4-6 years, DTaP, IPV, MMR,
Varicella, and Influenza (yearly, 6

FOR MORE INFORMATION, VISIT HTTPS://WWW.CDC.GOV/VACCINES

If the FDA licenses a vaccine, experts may consider adding it to the recommended immunization schedule.

months), PCV (12-15 months) ,
Hib (12-15 months), Varicella

At 1 month of age, HepB (1-2
months),
At 2 months of age, HepB (1-2
months), DTaP, PCV, Hib, Polio,
and RV
At 4 months of age, DTaP, PCV,
Hib, Polio, and RV
At 6 months of age, HepB (6-18
months), DTaP, PCV, Hib, Polio
(6-18 months), RV, and Influenza
(yearly, 6 months through 18
years)*
At 12 months of age, MMR (12-15

ƒ What are the most common
side effects?

ƒIt's safe and effective
ƒBenefits outweigh risks

(12-15 months), HepA (12-23
months)§, and Influenza (yearly, 6
months through 18 years)*
At 4-6 years, DTaP, IPV, MMR,
Varicella, and Influenza (yearly, 6

ƒ How many children would get the disease the vaccine
prevents if we didn't have the vaccine?

DTaP

DTaP

Hib

Hib

Hib

PCV13

PCV13

PCV13

IPV

IPV

DTaP

DTaP

FOR MORE INFORMATION, VISIT HTTPS://WWW.CDC.GOV/VACCINESAFETY

Hib
PCV13
IPV

IPV
Influenza (Yearly)*

MMR

MMR
Varicella

Shaded boxes indicate the
vaccine can be given during
shown age range.

Varicella
HepA§

NOTE:

FOOTNOTES:

If your child misses a shot,
you don't need to start over, just go
back to your child's
doctor for the next shot.
Talk with your child's doctor
if you have questions
about vaccines.

* Two doses given at least four weeks apart are recommended for children aged 6 months through 8 years of age who are getting an
influenza (flu) vaccine for the first time and for some other children in this age group.
§

Two doses of HepA vaccine are needed for lasting protection. The first dose of HepA vaccine should be given between 12 months and
23 months of age. The second dose should be given 6 to 18 months later. HepA vaccination may be given to any child 12 months and
older to protect against HepA. Children and adolescents who did not receive the HepA vaccine and are at high-risk, should be
vaccinated against HepA.
If your child has any medical conditions that put him at risk for infection or is traveling outside the United States, talk to your
child's doctor about additional vaccines that he may need.

See back page
for more
information on
vaccinepreventable
diseases and the
vaccines that
prevent them.

The United States currently has the safest vaccine supply in its history.
These vaccines keep children, families and communities protected from
serious diseases.

For more information, call toll free
1-800-CDC-INFO (1-800-232-4636)
or visit
www.cdc.gov/vaccines/parents

FOR MORE INFORMATION, VISIT HTTPS://WWW.CDC.GOV/VACCINES

NCIRDig706 | 07/30/18

After being added to the U.S. Recommended Immunization Schedule, health
experts continue to monitor the vaccine's safety and effectiveness.

How a vaccine's safety continues
County Medicine | W I N T E R 2020/2021
to2 6beYorkmonitored
FDA and CDC closely monitor vaccine safety

RISK
BENEFIT

U.S. Department of
Health and Human Services
Centers for Disease
Control and Prevention


http://www.YORKCOMEDSOC.ORG http://www.cdc.gov/vaccines/parents HTTPS://WWW.CDC.GOV/VACCINES HTTPS://WWW.FDA.GOV/CBER HTTPS://WWW.CDC.GOV/VACCINESAFETY http://www.cdc.gov/vaccines/parents HTTPS://WWW.CDC.GOV/VACCINES

York County Medicine Winter 2020

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