| COVID-19 |
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Guidance from CDC about COVID-19 vaccines
is evolving rapidly. To ensure access to
the most current guidance, Ask the Experts
answers often connect our readers directly
to vaccine resources provided by the
Centers for Disease Control and Prevention
(CDC).
For a comprehensive collection of COVID-19
tools and resources, visit IAC's Vaccines:
COVID-19 main page:
www.immunize.org/covid-19. For
alerts about new IAC or CDC COVID-19 resources, subscribe to our weekly
newsletter,
IAC Express. |
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| Disease Issues |
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What is COVID-19? |
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| COVID-19 is the
name given to the disease caused by infection
with the SARS-CoV-2 coronavirus. This virus
was first detected as a cause of human
illness in late 2019 in Wuhan, China, and
triggered a global pandemic that began in
2020. The virus is thought to spread mainly
from person to person
through respiratory droplets produced when an
infected person coughs, sneezes, or talks.
These droplets can land in the mouths or noses
of people who
are nearby or possibly be inhaled into the
lungs. Some people who are infected have no
symptoms of illness, while the severity of
symptomatic illness
ranges from mild to life-threatening. Adults
65 years and older and people of any age with
underlying medical conditions are at higher
risk for severe
illness. |
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| The incubation
period after exposure ranges from 2–14 days,
with an average of about 5 days. People with
COVID-19 are generally considered infectious
up to 48 hours before symptom onset through 10
days after onset, though people with severe
illness may be infectious longer. Symptoms may
include
fever or chills, cough, shortness of breath or
difficulty breathing, fatigue, muscle or body
aches, headache, new loss of taste or smell,
sore throat,
congestion or runny nose, nausea or vomiting,
and diarrhea. |
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| Where can I
find answers to more clinical questions about
COVID-19 disease, diagnosis, treatment and care of patients? |
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| The CDC has
assembled clinical questions and answers at
this site:
www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html. |
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| Where can I
find current COVID-19 vaccine recommendations? |
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| The CDC's
Advisory Committee on Immunization Practices
(ACIP) has published recommendations for all
COVID-19 vaccines that have received
Emergency Use Authorization (EUA) or licensure
from the federal Food and Drug Administration
(FDA). State and local public health officials
are
responsible for COVID-19 vaccination program implementation: consult them for details about
vaccination policies in their jurisdictions.
ACIP has updated
its recommendations frequently as new
information has emerged since the first
vaccine was authorized in December 2020. All
ACIP COVID-19 vaccine
recommendations can be accessed here:
www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html. |
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| In addition to
ACIP recommendations for the use of these
vaccines, CDC has published important interim
clinical considerations for vaccination of
eligible
recipients:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html |
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| Has CDC
developed a frequently asked question (FAQ)
page for COVID-19 vaccines? |
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| Yes. CDC has an
FAQ page about COVID-19 vaccines specifically
for healthcare providers:
www.cdc.gov/vaccines/covid-19/hcp/faq.html.
This page
includes CDC answers related to vaccination
programs, EUA, administration, storage and
handling, and safety and efficacy. |
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| Who is
recommended to receive COVID-19 vaccines? |
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| All people age 12
years and older are recommended to receive an
age-appropriate COVID-19 vaccination. |
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| Should people
who have had COVID-19 illness be vaccinated? |
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| Yes. Vaccination
should be offered to individuals regardless of
history of prior SARS-CoV-2 infection. People
who are unvaccinated have a higher risk of
reinfection than those who are fully
vaccinated following natural infection, as demonstrated in this study published in MMWR:
www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7032e1-H.pdf. |
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| Viral testing to
assess for current SARS-CoV-2 infection or
serologic testing to assess for prior
infection for the purposes of vaccine
decision-making is
not recommended. However, as with all
vaccines, vaccination should be deferred until
after recovery from moderate to severe
illness. In addition, to
minimize the risk of exposing others to SARS-CoV-2 virus, vaccination of a person
diagnosed with COVID-19 generally should be
deferred until criteria
have been met for individuals with COVID-19
illness to discontinue isolation. |
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| What is the
difference between an "additional dose" of
COVID-19 vaccine recommended for an immunocompromised person and a "booster dose"? |
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| An additional
dose of mRNA vaccine after an initial primary
series of mRNA vaccine is recommended by CDC
for people with moderate or severe
immunocompromise. In these populations, the
immune response following the primary 2-dose
series is likely to be insufficient, and the
additional dose
increases the likelihood of developing a sufficient immune response. The additional
dose of mRNA vaccine should not be delayed. It
may be given 28
days or more after the last dose of the
primary series. |
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| The term "booster
dose" applies to an additional dose of vaccine
administered only after the initial sufficient immune response to the primary series is
likely to have waned over time. The interval
between a primary series and a booster dose is
at least several months. |
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| For details about
vaccination of immunocompromised people, see
the section on special populations or CDC's interim clinical considerations for the use
of COVID-19 vaccines:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#considerations-additional-vaccine-dose. |
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| What is an
Emergency Use Authorization (EUA)? |
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| Under section 564
of the Federal Food, Drug, and Cosmetic Act
(FD&C Act), the FDA Commissioner may allow unapproved medical products or
unapproved uses of approved medical products
to be used in an emergency to diagnose, treat,
or prevent serious or life-threatening
diseases or
conditions caused by chemical, biological, radiological or nuclear threat agents when
there are no adequate, approved, and available
alternatives.
Vaccines that receive an EUA may later be
fully licensed by the FDA. |
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| What does
FDA's approval of the biologics licensure
application (BLA) for Comirnaty, the Pfizer-BioNTech
COVID-19 Vaccine, mean for my clinic? |
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| On August 23,
2021, FDA approved the BLA for Pfizer-BioNTech
COVID-19 Vaccine for individuals age 16 years and older; its trade name is Comirnaty.
The vaccine remains authorized for emergency
use for children age 12 through 15 years and
for administration of an additional dose in
immunocompromised people. For simplicity, the Ask the Experts COVID-19 section will
continue, for now, to refer to Comirnaty as
Pfizer-BioNTech
COVID-19 Vaccine. No changes have been made to
the storage, handling, or vaccine ordering
requirements as a result of licensure.
Clinicians should
continue to administer this vaccine in
accordance with current ACIP recommendations and CDC guidelines. |
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| The FDA issued an
updated Fact Sheet that reflects the new trade
name and combines information for individuals receiving the vaccine in accordance
with its licensed indication with information
for those receiving the product under the
terms of its emergency use authorization (EUA). |
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| All clinics
providing the Pfizer-BioNTech COVID-19 Vaccine
should use the updated Fact Sheet for all
recipients and caregivers:
www.fda.gov/media/144414/download. |
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| The Fact Sheet
for healthcare providers is here:
www.fda.gov/media/144413/download. |
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| The link to the
prescribing information (PI) for Comirnaty is
here:
www.fda.gov/media/151707/download. |
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| When will we
have a VIS for the vaccines that have an EUA?
What information am I supposed to give patients in writing? |
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| For each COVID-19
vaccine authorized under an Emergency Use
Authorization (EUA), the Food and Drug Administration (FDA) requires that vaccine
recipients or their caregivers are provided
with certain vaccine-specific EUA information
to help make an informed decision about
vaccination. This is
accomplished by providing an EUA Fact Sheet
for Recipients and Caregivers. The Fact Sheet
is similar in purpose and content to vaccine
information
statements (VISs) for licensed vaccines but
differs in that the EUA Fact Sheet is specific
to each authorized COVID-19 vaccine, is
developed by the
manufacturer of the vaccine, and is authorized
by the FDA. |
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| There is no VIS
for COVID-19 vaccines authorized under an EUA.
On August 23, 2021, FDA issued a revised fact sheet for the Pfizer-BioNTech vaccine
(Comirnaty) that covers both its limited
licensed indications and its broader emergency
use authorization. Once a COVID-19 VIS is
issued, the VIS and
all available translations will be posted here:
https://immunize.org/vis/. |
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| The combined Fact
Sheet for all recipients and caregivers about
Comirnaty and Pfizer-BioNTech COVID-19 Vaccine is available here:
www.fda.gov/media/144414/download. |
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| The Moderna
COVID-19 Vaccine EUA Fact Sheet for Recipients
and Caregivers is available here:
www.fda.gov/media/144638/download. |
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| The Janssen
COVID-19 Vaccine EUA Fact Sheet for Recipients
and Caregivers is available here:
www.fda.gov/media/146305/download. |
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| What are mRNA
vaccines? |
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| Both the Pfizer-BioNTech
COVID-19 (Comirnaty) Vaccine and the Moderna
COVID-19 (mRNA-1273) Vaccine are lipid nanoparticle-formulated,
nucleoside-modified mRNA vaccines encoding the
prefusion spike glycoprotein of SARS-CoV-2,
the virus that causes coronavirus disease
2019. Visit this
CDC website for more details about how mRNA
vaccines work:
www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html. |
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| How well do
the mRNA COVID-19 vaccines work? |
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| The FDA EUA was
issued based upon the short-term effectiveness
of these vaccines at preventing symptomatic illness with COVID-19. The preliminary
results of large phase 3 clinical trials for
both mRNA vaccines were similar, demonstrating
an overall efficacy of 94–95% in preventing
symptomatic
COVID-19 illness compared to placebo recipients. The Pfizer-BioNTech vaccine (Comirnaty)
was licensed by FDA with a reported vaccine
efficacy of
91.1% against symptomatic disease among
recipients age 16 years or older up to 6
months after dose 2. Observational studies of
short-term, real world
effectiveness are consistent with the clinical
trial results. In the months following EUA,
vaccine effectiveness against severe disease
and hospitalization
remains high against known variants, including
the Delta variant, even as protection against
milder illness may be reduced. |
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| Please
describe the Janssen COVID-19 Vaccine (Johnson
& Johnson). |
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| On February 27,
2021, the FDA issued an Emergency Use
Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) Vaccine (Johnson &
Johnson). The Janssen vaccine is a
recombinant, replication-incompetent (unable
to reproduce) adenovirus serotype 26 (Ad26)
vector vaccine, encoding
the stabilized prefusion spike glycoprotein of
SARS-CoV-2. Vaccination with the Janssen
vaccine consists of a single dose (5 × 1010
virus particles per
0.5-mL dose) administered intramuscularly. The
Janssen vaccine has been associated with a
rare immune-mediated blood clotting disorder;
see the
vaccine safety section for additional
information. |
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| How well does
the Janssen COVID-19 Vaccine work? |
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| A large phase 3
trial was initiated in September 2020 and
enrolled more than 43,000 individuals in
multiple countries, including the United
States, Brazil,
and South Africa. Interim results demonstrated
a 66% reduction in the risk of symptomatic
COVID-19 beginning at least 14 days following
vaccination;
efficacy against severe disease was higher.
The risk of hospitalization 14 days or more
after vaccination was reduced by 93% compared
to placebo
recipients; no hospitalizations occurred among
vaccine recipients 28 days or more after
vaccination. No deaths related to COVID-19
infection occurred
among vaccine recipients, while seven occurred
among placebo recipients. In the months
following EUA, vaccine effectiveness against
severe disease
and hospitalization remains high against known
variants, including the Delta variant, even as
protection against milder illness may be
reduced. |
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| How well do
COVID-19 vaccines work to prevent asymptomatic
infection with SARS-CoV-2? Based on that, what
can be said about what people may do
after they are fully vaccinated? |
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| A growing body of
evidence suggests that fully vaccinated people
are less likely than the unvaccinated to have asymptomatic infection or transmit SARS-CoV-2 to others; however, the degree of
protection may vary depending on the variant
of the virus to which a person is exposed and
the time since
vaccination. How long vaccine protection lasts
and to what degree vaccines protect against
emerging SARS-CoV-2 variants are under ongoing
investigation. CDC guidelines are updated as
new data become available:
www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. |
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| Where can I
obtain detailed information about the COVID-19
vaccines? |
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| CDC has developed
a "one-stop" product-specific webpage for each
COVID-19 vaccine with all of the important details immunization providers need to
know. |
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| In addition to
CDC, each company has a detailed Fact Sheet
for Providers. |
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| COVID-19
Vaccines for Adolescents and Adults |
Back to top |
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| What ages are
authorized to receive the available COVID-19
vaccines? |
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| On May 10, 2021,
FDA authorized the Pfizer-BioNTech COVID-19
vaccine for emergency use in people age 12
years and older; it is licensed for ages 16
years and older. Moderna and Janssen COVID-19
vaccines are authorized for emergency use in
people age 18 years and older. Further FDA
authorization of one or more of the vaccines
in younger age groups could occur once
sufficient data are generated to support an
application. |
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| What do we
know about the Pfizer-BioNTech COVID Vaccine
effectiveness and side effects in children and young teens in the 12- to 15-year-old age
group? |
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| Clinical trial
results demonstrated that the immune response
of young adolescents in this age group was
similar to that observed in people age 16–25
years. No symptomatic cases of COVID-19 were
detected among fully vaccinated people age
12–15 years. Among vaccine recipients age
12–15 years,
side effects during the 7 days after vaccination were commonly reported (90.9% of
vaccine recipients reported a local reaction
and 90.7% reported a
systemic reaction). Most reactions were mild
to moderate. Pain at the injection site was
the most common local reaction. One in 10
reported a side effect
that interfered with daily activities. Side
effects usually resolved after 1–2 days.
Systemic side effects (e.g., fever, fatigue,
headache, muscle pain) were
more commonly reported after the second dose
than after the first dose. No specific safety
concerns were identified among adolescent
vaccine
recipients. |
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| Are COVID-19
vaccines safe during pregnancy? |
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| A growing body of
evidence on COVID-19 vaccination during
pregnancy has not indicated any safety or effectiveness concerns for vaccination at any
stage of pregnancy; the benefits of
vaccination outweigh any known or potential
risks of COVID-19 vaccination during
pregnancy. The currently
authorized or licensed COVID-19 vaccines are
non-replicating vaccines and cannot cause
infection in either the mother or the fetus.
No evidence exists
of risk to the fetus from vaccinating pregnant
people with non-replicating vaccines in
general. |
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| No safety
concerns were found in animal developmental
and reproductive toxicity studies of animals
that received Pfizer-BioNTech, Moderna, or
Janssen
vaccines. Reassuring early safety data on mRNA
COVID-19 vaccines administered to people
during pregnancy have been published by CDC.
Data from
the Vaccine Adverse Events Reporting System
(VAERS), the v-safe surveillance system, and
the v-safe pregnancy registry have not
signaled any safety
concerns for pregnant people who were
vaccinated or their infants. The vaccine
manufacturers are following the pregnancy
outcomes of people in the
clinical trials who became pregnant.
Additional studies in pregnant people are
continuing to fully evaluate pregnancy and
birth outcomes. |
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| Pregnant
individuals should be vaccinated and are
encouraged to enroll in CDC's voluntary
COVID-19 vaccine safety surveillance system,
v-safe. The v-safe pregnancy registry follows outcomes among
pregnant people who are vaccinated. |
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| Can COVID-19
vaccination lead to fertility problems? |
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| There is
currently no evidence that any of the COVID-19
vaccines affect current or future fertility.
In fact, there is currently no evidence that
any vaccines
cause fertility problems. Many individuals
have become pregnant after receiving COVID-19
vaccine; ongoing long-term studies of
pregnancy outcomes
following vaccination are underway. |
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| Are COVID-19
vaccines recommended during pregnancy? |
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| Yes. COVID-19
vaccination is recommended for all people age
12 years and older, including people who are pregnant, lactating, trying to get pregnant
now, or planning for future pregnancy.
Pregnant people are at increased risk of
severe complications and death from COVID-19
compared to non-pregnant people of the same age. They can be
administered any authorized vaccine: ACIP does
not state a product preference. However, women
younger than age 50 years should be aware of
the rare risk of blood clots with low platelet
counts (thrombosis with thrombocytopenia
syndrome [TTS])
after receipt of the Janssen vaccine and the
availability of other FDA-authorized or
licensed COVID-19 vaccines (mRNA vaccines)
that do not have that
risk. |
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| CDC, the American
College of Obstetricians and Gynecologists (ACOG),
and the Society for Maternal-Fetal Medicine (SMFM)
all recommend vaccination
of pregnant people at any stage of pregnancy. |
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| For more details
about COVID-19 vaccination during pregnancy,
visit CDC's webpage, "COVID-19 Vaccines while Pregnant or Breastfeeding":
www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html. |
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| Are COVID-19
vaccines recommended if the recipient is
breastfeeding? |
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| Yes. COVID-19
vaccination is recommended for all people age
12 years and older, including people who are lactating. Lactating women younger than age
50 should be aware of the increased risk for
TTS with the Janssen vaccine and the
availability of other FDA-authorized or
licensed COVID-19 vaccines
(i.e., mRNA vaccines). |
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| There are limited
data on the safety of currently available
COVID-19 vaccines on the breastfed infant or
milk production/excretion. However, the
currently
available COVID-19 mRNA and non-replicating
viral vector vaccines cannot cause infection
in either the lactating person or the infant.
More data are
needed to determine if COVID-19 antibodies
present in breastmilk convey protection
against SARS-CoV-2 infection for infants. |
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| Why is an
additional dose of mRNA vaccine recommended
for some immunocompromised people? |
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| Immunocompromised
people are at increased risk for severe
COVID-19 illness. Studies have shown a reduced immune response to COVID-19 vaccines
in some people with immunocompromising
conditions or people who take immunosuppressive medications. Small studies
have shown that an additional
mRNA vaccine dose in some immunocompromised
people who had already completed the primary
mRNA vaccine series increased the proportion
of
people who showed an antibody response to
vaccination, which may mean they are better
protected from illness. Side effects were
similar to the side
effects of prior doses. |
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| Although the
benefit of the additional dose of mRNA vaccine
for a moderately or severely immunocompromised person is not precisely known, the
available evidence of potential benefit and
acceptable safety supports its use. |
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| Immunocompromised
people who receive an additional dose should
be counseled that they may still have a reduced immune response to COVID-19
vaccination, even after an additional dose.
They should be advised to continue other
recommended infection prevention measures,
such as wearing a
face mask and avoiding crowds, to limit their
risk of exposure to the SARS-CoV-2 virus. |
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| Exactly which
immunocompromised groups are recommended to
receive an additional dose of mRNA vaccine? |
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| The age groups
eligible are those already eligible for mRNA
vaccines: people age 12 years or older
(Pfizer-BioNTech) and people age 18 years or
older
(Moderna). |
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| The conditions
and treatments that may result in moderate or
severe immunocompromise in these eligible age groups include but are not limited to: |
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Active treatment for solid tumor and
hematologic malignancies |
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Receipt of solid-organ transplant and
taking immunosuppressive therapy |
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Receipt of CAR-T-cell or hematopoietic
stem cell transplant (within 2 years of
transplantation or taking immunosuppression therapy) |
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Moderate or severe primary
immunodeficiency (such as DiGeorge
syndrome or Wiskott-Aldrich syndrome) |
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Advanced or untreated HIV infection |
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Active treatment with high-dose
corticosteroids (in other words, 20 mg
or more of prednisone or equivalent per day), alkylating agents,
antimetabolites, transplant-related
immunosuppressive drugs, cancer chemotherapeutic agents classified as
severely immunosuppressive,
tumor-necrosis
factor (TNF) blockers, and other
biologic agents that are
immunosuppressive or immunomodulatory. |
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| Additional
factors to consider in assessing the general
level of immune competence in a patient
include disease severity, duration, clinical
stability,
complications, comorbidities, and any
potentially immune-suppressing treatment. A
patient's clinical care team is in the best
position to evaluate the
degree of immunocompromise and timing of
vaccination. |
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| For additional
information, please review CDC's interim
clinical considerations for COVID-19 vaccines:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#considerations-additional-vaccine-dose. |
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| Should I
conduct serologic testing or cellular immune
testing before or after offering an additional
dose of mRNA vaccine to an immunocompromised
patient? |
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| No. At this time,
serologic testing or cellular immune testing
before or after an additional dose (outside
the context of research studies) is not
recommended. |
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| Does it matter
which brand of mRNA vaccine I give to an
immunocompromised person who is recommended to
receive an additional dose? |
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| CDC recommends
that the additional dose should be the same
brand as the primary series. However, if the
same brand is unavailable, you may
administer the other mRNA vaccine. An
immunocompromised person should not receive
more than 3 mRNA vaccine doses. |
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| My patient
takes high dose steroids and received a single
dose of Janssen COVID-19 Vaccine (Johnson & Johnson) in late March 2021. He meets the
definition of moderate or severe
immunocompromise. Should I give him an
additional dose of Janssen or mRNA vaccine? |
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| At this time,
there are insufficient data to recommend an
additional dose either of mRNA vaccine or
Janssen vaccine for immunocompromised patients
who received primary COVID-19 vaccination with
Janssen vaccine. Additional guidance from FDA
and CDC is expected once data are available. |
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| My patient has
had a kidney transplant and wants to know if
he is considered fully vaccinated for public health purposes (e.g., allowed to enter a
restaurant where proof of immunization is
required) if he has received the 2-dose mRNA
primary series but has not yet had an
additional dose? |
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| Yes. CDC guidance
states that, for the purposes of public health
classification, all vaccinated individuals may
be classified as fully vaccinated beginning 2
weeks after receipt of either a single dose of
Janssen vaccine or a two-dose primary series
of mRNA vaccine. A person known to be
immunocompromised is not required to receive a
third mRNA dose to be considered fully
vaccinated. However, he should be counseled to
continue to
practice preventive measures, such as wearing
a mask and avoiding crowds, even after an
additional dose, to limit his risk of exposure to SARS-CoV-2. |
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| How are
COVID-19 vaccines administered? |
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| CDC has prepared
a quick reference guide for preparation and
administration of each COVID-19 vaccine: |
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| Has CDC
provided clinical guidance on what to do if an
error occurs while administering COVID-19 vaccinations? |
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| Yes. CDC has
published an appendix to its "Interim Clinical
Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States."
This
appendix provides resources for preventing and
reporting COVID-19 vaccine administration
errors, and a simple table outlining actions
to take after an
error has occurred:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Appendix-A. |
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| The summary table
is also available from CDC as a print-ready
document:
www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-errors-deviations.pdf. |
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| Errors addressed
include the following: |
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Incorrect route or site |
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Incorrect age |
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Incorrect dosing interval |
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Incorrect dose (high or low) |
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Administration after improper storage
conditions |
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Administration after the
expiration/beyond use date |
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Diluent errors (wrong diluent, too much
or too little) with the Pfizer-BioNTech
vaccine |
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| A dose of
COVID-19 vaccine was administered
subcutaneously instead of by the intramuscular
route. Does the dose need to be repeated? |
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| No. CDC does not
recommend repeating the dose of any COVID-19
vaccine in circumstances where the dose is administered in an incorrect route or an
incorrect site (i.e., not in the deltoid or
anterolateral thigh). |
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| During
vaccination, the needle came loose and vaccine
leaked out around it. Do we need to repeat the dose? |
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| It depends on how
much of the dose was successfully
administered. If, in your judgment, the
patient received at least half of the vaccine
dose, do not
repeat the dose. However, if you judge that
less than half the dose was administered,
revaccinate the recipient immediately (no
minimum interval) with a
full dose in the opposite arm. |
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| Where can I
find the latest information on scheduling
COVID-19 vaccines? |
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| For detailed
information on COVID-19 vaccine scheduling,
refer to the CDC's interim clinical
considerations for COVID-19 vaccination:
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html. |
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| What is the
recommended schedule for mRNA COVID-19
vaccines? |
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| The Pfizer-BioNTech
COVID-19 Vaccine (Comirnaty) primary series is
administered as a two-dose series, 21 days apart. Both doses should be the
Pfizer-BioNTech vaccine. |
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| The Moderna
COVID-19 Vaccine primary series is
administered as a two-dose series, 28 days
apart. Both doses should be the Moderna
vaccine. |
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| Second doses of
either mRNA vaccine may be scheduled routinely
up to 6 weeks after the first dose, if
desired, but should not be scheduled earlier
than
the recommended interval. |
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| Every effort
should be made to administer the same brand
for both doses. There are no data on the
effectiveness of a mixed-brand vaccination
series. In
exceptional situations in which the first-dose
vaccine product cannot be determined or is no
longer available, any available mRNA COVID-19
vaccine may
be administered at a minimum interval of 28
days between doses to complete the mRNA
COVID-19 vaccination series. If two doses of
different mRNA
COVID-19 vaccine products are administered in
these situations (or inadvertently), no
additional doses of either product are
recommended at this time. |
|
| If no mRNA
vaccine is obtainable for the second dose, a
single dose of the Janssen vaccine may be
administered at least 28 days after the mRNA
vaccine dose. The recipient should be
considered to have received a valid,
single-dose Janssen vaccination—not a mixed
vaccination series. |
|
| Individuals with
moderate or severe immunocompromise who
complete a two-dose primary series of either
mRNA vaccine are recommended to receive an
additional dose of mRNA vaccine, preferably of
the same brand, at least 28 days after
completing the primary series. |
|
| If a patient
does not come back on time for the second dose
of an mRNA COVID-19 vaccine, do we need to re-start the vaccine series? |
|
| No. Simply
administer the second dose to complete the
series. |
|
| What if the
patient gets the second dose of an mRNA
COVID-19 vaccine early? |
|
| Second doses
administered within a grace period of 4 days
or fewer from the recommended date for the
second dose are considered valid; however,
doses administered earlier do not need to be
repeated. |
|
| If the second
dose of mRNA COVID-19 vaccine may be given
before the recommended interval because of the
4-day grace period, should we offer that
option routinely? |
|
| No. People should
not be scheduled to receive dose 2 earlier
than recommended (21 days for Pfizer-BioNTech,
28 days for Moderna). Schedulers should
offer second dose appointments beginning on
the date of the recommended interval or later.
CDC guidance allows for dose 2 to be given up
to 4 days
before the recommended interval in order to
avoid missed vaccination opportunities when a
recipient unexpectedly arrives early and might
not return on
schedule. The series never needs to be
restarted due to a delay in the second dose. |
|
| If a patient
inadvertently received a different brand of
mRNA vaccine as a second dose, does it need to
be repeated with the correct brand? |
|
| If a recipient is
inadvertently given a different brand of mRNA
vaccine for the second dose, the CDC does not currently recommend that the patient
receive a repeat dose of either product. |
|
| If a patient
received a dose of mRNA COVID-19 vaccine, but
cannot obtain a second dose of the original brand of mRNA vaccine, what should we do? |
|
| Once a series is
initiated, the first choice is to complete the
mRNA COVID-19 vaccine series with the same
brand. In exceptional circumstances where
the same brand cannot be obtained, the series
may be completed with a different mRNA brand. |
|
| Only in
situations where no second dose of mRNA
COVID-19 vaccine may be given (due to
availability or contraindication), a single
dose of Janssen
COVID-19 vaccine may be considered at a
minimum interval of 28 days from the mRNA
COVID-19 vaccine dose. Patients who receive
the Janssen
COVID-19 vaccine after a dose of an mRNA
COVID-19 vaccine should be considered to have
received a valid, single-dose Janssen
vaccination—not a
mixed vaccination series. |
|
| We have a
patient who was fully vaccinated with a
COVID-19 vaccine not authorized in the U.S. Do
we need to revaccinate? |
|
| Not necessarily.
People who completed a COVID-19 vaccination
series with a vaccine that has been authorized
for emergency use by the World Health
Organization (WHO) do not need any additional
doses with an FDA-authorized COVID-19 vaccine.
People who completed or partially completed a
COVID-19 vaccine series with a vaccine that is not authorized by either FDA or WHO may be
offered an FDA-authorized COVID-19 vaccine
series. The
minimum interval between the last dose of a
non-FDA authorized vaccine and an
FDA-authorized COVID-19 vaccine is 28 days. |
|
| As of August 13,
2021, WHO has listed the following vaccines
for emergency use: |
|
| • |
|
Pfizer-BioNTech COVID-19 vaccines (also
known as Comirnaty, tozinameran) |
|
|
|
| • |
|
AstraZeneca-Oxford COVID-19 vaccines
(also known as ChAdOx1-S, Covishield,
Vaxzevria) |
|
|
|
| • |
|
Janssen (Johnson & Johnson) COVID-19
Vaccine |
|
|
|
| • |
|
Moderna COVID-19 Vaccine (also known as
Spikevax) |
|
|
|
| • |
|
Sinopharm COVID-19 Vaccine (also known
as BBIBP-CorV) |
|
|
|
| • |
|
Sinovac COVID-19 Vaccine (also known as
CoronaVac) |
|
|
| We have a
patient who was partially vaccinated with a
COVID-19 vaccine not authorized for use in the
U.S. What should we do? |
|
| People who are
partially vaccinated outside the U.S. with a
COVID-19 vaccine brand not authorized in the
U.S. may be offered a complete FDA-authorized or licensed COVID-19 vaccine
series. The minimum interval between the last dose of a non-FDA authorized vaccine and an
FDA-authorized or
licensed COVID-19 vaccine is 28 days. |
|
| What should be
done if a patient scheduled for vaccination is
exposed to COVID-19 and quarantined or is isolated for suspected or confirmed SARS-CoV-2 infection? |
|
| In general, the
people scheduled for COVID-19 vaccination who
are exposed to SARS-CoV-2 virus and
quarantined should reschedule vaccination
after
their quarantine period has ended in order to
avoid the risk of exposing vaccinators to the
virus. |
|
| People diagnosed
with SARS-CoV-2 infection before a scheduled
vaccination should defer vaccination until
after recovery and the end of the isolation
period to avoid the risk of exposing
vaccinators to the virus. |
|
| Residents or
patients with a known COVID-19 exposure in
congregate healthcare settings (e.g.,
long-term care facilities) or congregate
non-healthcare
settings (e.g., correctional facilities,
homeless shelters) may be vaccinated. In these
settings, exposure to and transmission of
SARS-CoV-2 can occur
repeatedly for long periods of time, and healthcare personnel and other staff are
already in close contact with residents.
People residing in congregate
settings (healthcare and non-healthcare) who
have had an exposure and are awaiting
SARS-CoV-2 testing results may be vaccinated
if they do not have
symptoms consistent with COVID-19. Vaccinators
should employ appropriate infection prevention
and control procedures. |
|
| Can COVID-19
vaccine recipients be given other vaccines at
the same visit? |
|
| Yes. COVID-19
vaccines and other vaccines may be
administered without regard to timing. |
|
| COVID-19 vaccines
were previously recommended to be administered
alone, with a minimum interval of 14 days before or after administration of any
other vaccines. This was out of an abundance
of caution and not due to any known safety
concerns or concerns about interference with
effectiveness.
Although data are not available for COVID-19
vaccines administered simultaneously with
other vaccines, extensive experience with
non-COVID-19
vaccines has demonstrated that the immune
response and side effects following
vaccination are generally similar when
vaccines are administered
simultaneously and when vaccines are
administered alone. |
|
| My patient is
due for a second dose of recombinant zoster
vaccine (Shingrix, GSK). However, the patient
is eligible to receive COVID-19 vaccine and
wants to be vaccinated against COVID-19 as
soon as possible. What should we advise our
patient about scheduling the second Shingrix
dose? |
|
| Your patient may
choose to receive the vaccines at the same
visit or separately, without regard to the
timing interval. It is unknown whether side
effects of
COVID-19 vaccine or other vaccines are
increased with coadministration. In general,
when deciding whether to coadminister other
vaccines with
COVID-19 vaccine, you should consider whether
the patient is behind or at risk of becoming
behind on recommended vaccines, their risk of vaccine-preventable disease (e.g., during an outbreak
or occupational exposures), and the
reactogenicity profile of the vaccines. |
|
| When multiple
vaccines are administered at a single visit,
administer each injection in a different
injection site. For adolescents and adults,
the deltoid
muscle may be used for more than one
injection, though injection sites should be at
least one inch apart. |
|
| A patient had
a routine tuberculin skin test (TST) placed
the day before the patient's appointment for a COVID-19 vaccine. Should we proceed with
vaccination or do we need to reschedule? |
|
| COVID-19
vaccination may take place on the same day or
any day after a TST is placed. A TST will not
interfere with the response to vaccination.
The
reliability of a TST is expected to be
unchanged if a TST is placed before or simultaneously with COVID-19 vaccination. The
reliability of a negative TST
or interferon gamma release assay (IGRA) soon
after COVID-19 vaccination has not been
studied. |
|
| COVID-19
vaccination should not be delayed because of
testing for tuberculosis (TB) infection. A TST
is not a vaccine. If not administered on the
same
day, CDC recommends that a TST be delayed at
least 4 weeks after completion of COVID-19
vaccination because the reliability of a
negative TST result
soon after COVID-19 vaccination is unknown. |
|
| For additional
details on COVID-19 vaccination of patients
being evaluated for active tuberculosis,
please refer to CDC clinical considerations
for
COVID-19 vaccines and laboratory testing:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#laboratory-testing. |
|
| How does the
use of monoclonal antibodies to treat
symptomatic COVID-19 affect the scheduling of
COVID-19 vaccination? |
|
| There are no data
on the effect of passive antibody therapies
for COVID-19, including monoclonal antibodies
and convalescent plasma, on the
effectiveness of vaccination with COVID-19
vaccines. As a precautionary measure, CDC
recommends waiting at least 90 days after
receipt of passive
antibody therapy for COVID-19 illness before initiating the COVID-19 vaccine series.
Individuals who develop COVID-19 illness after
the first COVID-19
vaccination and receive passive antibody
therapy should wait 90 days after antibody
therapy to receive the second dose. There is
no need to restart the
vaccination series. |
|
| Antibody
therapies not specific to COVID-19 treatment
(e.g., intravenous immunoglobulin, RhoGAM) are
unlikely to substantially impair development
of a
protective antibody response to COVID-19
vaccination. Thus, there is no recommended
minimum interval between antibody therapies
not specific to
COVID-19 treatment and any COVID-19
vaccination. |
|
|
|
|
|
| Please
describe the contraindications for each
COVID-19 vaccination. |
|
| CDC considers a
history of the following to be a
contraindication to vaccination with COVID-19
vaccines: |
|
| • |
|
Severe allergic reaction (e.g.,
anaphylaxis) after a previous dose or to
a component of the COVID-19 vaccine |
|
|
|
| • |
|
Immediate allergic reaction of any
severity to a previous dose or known
(diagnosed) allergy to a component of the vaccine |
|
|
| Polyethylene
glycol (PEG) is an ingredient in both mRNA
COVID-19 vaccines, and polysorbate 80 is an
ingredient in Janssen COVID-19 vaccine. PEG
and polysorbate are structurally related, and
cross-reactive hypersensitivity between these
compounds may occur. People with a
contraindication to one of the mRNA COVID-19
vaccines should not receive doses of either of
the mRNA vaccines (Pfizer-BioNTech or Moderna).
However, people with a contraindication to
mRNA COVID-19 vaccines may be able to receive
Janssen vaccine, and vice versa (see description of COVID-19 vaccine precautions
for details). Known polysorbate allergy is no
longer a contraindication to mRNA vaccination;
however, known polysorbate allergy is a
contraindication to Janssen vaccine and thus,
a precaution to mRNA COVID-19 vaccination. |
|
| A list of
ingredients in each COVID-19 vaccine is
available here:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Appendix-C. |
|
| CDC has provided
a chart to assist in the evaluation of
immediate reactions to vaccination:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Appendix-D. |
|
| What are the
precautions to COVID-19 vaccination? |
|
| CDC considers a
history of an immediate allergic reaction to
any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous
vaccines or therapies [excluding subcutaneous
immunotherapy for allergies, i.e., "allergy
shots"]) as a precaution but not a
contraindication to vaccination. People with a
reaction to a vaccine or injectable therapy
that contains multiple components, one of
which is a vaccine component, but in whom it
is unknown which component elicited the
immediate allergic reaction, have a precaution
to vaccination. |
|
| People with a
contraindication to one type of the currently
authorized or licensed COVID-19 vaccines
(e.g., mRNA) have a precaution to the other
(e.g., Janssen viral vector). However, because
of potential cross-reactive hypersensitivity
between ingredients in mRNA and Janssen
COVID-19 vaccines, consultation with an
allergist-immunologist should be considered to
help determine if the patient can safely
receive vaccination. Healthcare providers and
health departments may also request a
consultation from the Clinical Immunization
Safety Assessment COVIDvax project (www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html). Vaccination of these individuals should only
be undertaken in an appropriate setting under
the supervision of a health care provider
experienced in the management of severe
allergic reactions. |
|
| People with a
contraindication to mRNA COVID-19 vaccines
(including due to a known PEG allergy) may
consider vaccination with Janssen COVID-19
Vaccine. People who have received one mRNA
COVID-19 vaccine dose but for whom the second
dose is contraindicated should wait at least
28 days after the mRNA vaccine dose to receive Janssen COVID-19 Vaccine. |
|
| People with a
contraindication to Janssen COVID-19 Vaccine
(including due to a known polysorbate allergy)
may consider mRNA COVID-19 vaccination. Polysorbate allergy is no longer a
contraindication to mRNA COVID-19 vaccination,
it is a precaution. |
|
| The following
considerations can be used to conduct a risk
assessment for vaccination in individuals with
a precaution to vaccination: |
|
| • |
|
Risk of exposure to SARS-CoV-2 |
|
|
|
| • |
|
Risk of severe disease or death due to
COVID-19 |
|
|
|
| • |
|
The unknown risk of anaphylaxis
following COVID-19 vaccination in a
person with a history of an immediate allergic reaction to other vaccines or
injectable therapies |
|
|
|
| • |
|
Ability of the recipient to be
vaccinated in a setting where
appropriate medical care is immediately
available for anaphylaxis. Note, for
people with a contraindication to one
type of COVID-19 vaccine (e.g., mRNA vaccines), vaccination with another type
(e.g., Janssen viral vector vaccine)
should only be undertaken in an appropriate setting under the
supervision of a health care provider
experienced in the management of severe allergic reactions. |
|
|
| For additional
guidance about contraindications and
precautions, please refer to
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Contraindications. |
|
| Can people who
are immunocompromised or who have autoimmune
disease be vaccinated with mRNA COVID-19
vaccines? |
|
| Yes, they may be
vaccinated as long as they do not have a
contraindication to vaccination. Antibody
testing is not recommended to assess for
immunity to SARS-CoV-2 following COVID-19
vaccination. |
|
| People should be
counseled about the unknown vaccine safety
profile and effectiveness in immunocompromised populations and the potential for reduced
immune responses. Individuals with moderate or
severe immunocompromise who have received a
primary series of mRNA vaccine are recommended
to receive an additional dose of mRNA vaccine
at least 28 days after the primary series.
Please see detailed considerations about administration of an additional dose here:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#considerations-additional-vaccine-dose. |
|
| Are there any
common types of allergies that are neither
contraindications nor precautions to
vaccination? |
|
| Allergic
reactions (including severe allergic
reactions) not related to vaccines (COVID-19
or other vaccines) or injectable therapies,
such as allergic reactions related to food,
pet, venom, or environmental allergies, or
allergies to oral medications (including the
oral equivalents of injectable medications),
are not a contraindication or precaution to
COVID-19 vaccination. The vial stoppers of
COVID-19 vaccines are not made with natural
rubber latex, and there is no contraindication
or precaution to vaccination for people with a
latex allergy. COVID-19 vaccines do not
contain eggs, gelatin, or metals. |
|
| A self-limited,
delayed-onset local reaction around the
injection site has been reported by some mRNA
vaccine recipients several days after
vaccination (see next question). This type of
reaction is not a precaution or contraindication to future doses of the same
vaccine. |
|
| A vaccine
recipient reported experiencing a red, itchy,
swollen patch of skin that developed several
days after vaccination around the injection
site of her first COVID-19 vaccine dose. It
resolved after a few days. Is this a
contraindication? Should this alter our plans
for dose two? |
|
| She should
receive dose two as recommended. Individuals
with only a delayed-onset local reaction
(e.g., redness, induration, itching) around
the injection site area after the first
vaccine dose do not have a contraindication or precaution to the second dose. Some people
have reported delayed-onset local reactions,
including Moderna clinical trial participants,
beginning a few days through the second week
after the first dose. The reactions are sometimes quite large but are self-limited. It
is not known whether individuals who
experienced a delayed-onset injection site
reaction after the first dose will experience
a similar reaction after the second dose.
However, these reactions are not believed to
represent an increased risk for anaphylaxis
after a subsequent dose. Thus, individuals with such delayed injection site reactions
after the first mRNA COVID-19 vaccine dose
should receive the second dose using the same
vaccine product as the first dose and at the
recommended interval, preferably in the
opposite arm. |
|
| Patients
concerned about the risk of allergic reaction
or side effects following COVID-19 vaccination
are asking if they should take acetaminophen,
aspirin, and/or antihistamines before
receiving COVID-19 vaccination. What does CDC
advise? |
|
| Medications to
reduce fever and pain (e.g., acetaminophen,
non-steroidal anti-inflammatory drugs) may be
taken to treat post-vaccination local or
systemic symptoms, if medically appropriate.
However, routine administration of such
medications before vaccination is not
recommended because information on the impact
of such use on COVID-19 vaccine-induced
antibody responses is not available at this
time. |
|
| Administration of
antihistamines before COVID-19 vaccination to
prevent allergic reactions is not recommended. Antihistamines do not prevent anaphylaxis, and
their use might mask cutaneous symptoms, which
could delay diagnosis and management of
anaphylaxis. |
|
| It is not
recommended that people take aspirin or an
anticoagulant before vaccination with the
Janssen COVID-19 vaccine or any other
FDA-authorized COVID-19 vaccine unless they
take these medications as part of their
routine medications. |
|
| Is COVID-19
vaccination contraindicated in a patient who
has had immune-mediated thrombosis with thrombocytopenia syndrome (TTS)? |
|
| No. The rare
syndrome that combines thrombosis (blood clot)
and thrombocytopenia (low platelet count),
known as TTS, that is associated with the
Janssen COVID-19 Vaccine appears to be similar
to another rare immune-mediated syndrome,
heparin-induced thrombocytopenia (HIT). Until
more information becomes available, experts
advise that individuals with a history of an
episode of an immune-mediated TTS, such as
HIT, should be offered another FDA-authorized
or licensed COVID-19 vaccine (i.e., mRNA
vaccine) if they are within at least 90 days
after resolution of their TTS illness. After
90 days, patients may be vaccinated with any
FDA-authorized or licensed COVID-19 vaccine. |
|
| My patient has
a history of deep venous thrombosis (DVTs). Is
that a precaution or contraindication to vaccination with the Janssen COVID-19 Vaccine? |
|
| Venous
thromboembolism (VTE), defined as deep vein
thrombosis, pulmonary embolism, or both, are
common. The biologic mechanisms for VTE (as
well as arterial thrombi) differ from the
underlying immune-mediated mechanism for
thrombosis with thrombocytopenia syndrome
(TTS). Experts believe that the presence of
risk factors for VTE does not make individuals
more susceptible to TTS after vaccination with
the Janssen vaccine. These people can receive
any FDA-authorized or licensed vaccine,
including the Janssen vaccine. |
|
| Is there a
precaution or contraindication against
vaccination of children or adults who have
recovered from COVID-19 Multisystem
Inflammatory Syndrome (MIS-C or MIS-A)? |
|
| Currently, there
are no data on the safety and efficacy of
COVID-19 vaccines in people with a history of
multisystem inflammatory syndrome in children
(MIS-C) or in adults (MIS-A) after SARS-CoV-2
infection. The mechanisms of MIS-C and MIS-A
are not well understood but include a dysregulated immune response to SARS-CoV-2
infection. It is unclear if people with a
history of MIS-C or MIS-A are at risk of
recurrence of the same dysregulated immune response following reinfection with SARS-CoV-2
or in response to vaccination. |
|
| People with a
history of MIS-C or MIS-A may choose to be
vaccinated. Considerations for vaccination may
include: |
|
| • |
|
Clinical recovery from MIS-C or MIS-A,
including return to normal cardiac
function |
|
|
|
| • |
|
Personal risk of severe acute COVID-19 |
|
|
|
| • |
|
Level of COVID-19 community transmission
and personal risk of reinfection |
|
|
|
| • |
|
Lack of safety data of COVID-19 vaccines
following these illnesses |
|
|
|
| • |
|
Timing of any immunomodulatory therapies |
|
|
| Though not
required before vaccination, a conversation
between the patient, their guardian(s), and
their clinical team or a specialist may assist
with decisions about the use of a COVID-19
vaccine. |
|
| People with a
history of MIS-C or MIS-A should consider
delaying vaccination until they have recovered
from their illness and for 90 days after the
date of diagnosis of MIS-C or MIS-A, because
the risk of SARS-CoV-2 reinfection (and
benefit of vaccination) may increase with time
following initial infection. |
|
| My patient had
an episode of myocarditis 5 years ago. Is a
history of myocarditis a contraindication or precaution to vaccination with an mRNA
vaccine? |
|
| People who have a
history of myocarditis or pericarditis
unrelated to mRNA COVID-19 vaccination may
receive any currently FDA-authorized or
licensed COVID-19 vaccine after the episode of myocarditis or pericarditis has completely
resolved. This includes resolution of symptoms
attributed to myocarditis or pericarditis, as
well as no evidence of ongoing heart
inflammation or damage as determined by the
person's clinical team. |
|
| Individuals who
experience myocarditis or pericarditis after
their first mRNA vaccination are advised to
defer receiving the second dose until
additional safety data are available. If such
a person elects to receive a second dose, they
should wait until their episode of myocarditis
or pericarditis has fully resolved and make
the decision in consultation with their
clinical team. |
|
| For additional
details, see CDC's interim clinical
considerations for COVID-19 vaccination of
people with certain underlying health
conditions:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#underlying-conditions. |
|
| My patient has
a history of Guillain-Barré syndrome (GBS). Is
that a contraindication or precaution to
vaccination with any COVID-19 vaccine? |
|
| People with a
history of GBS can receive any currently
FDA-authorized or licensed COVID-19 vaccine.
However, given the possible association
between the Janssen COVID-19 Vaccine and an
increased risk of GBS, a patient with a
history of GBS and their healthcare provider
should discuss the availability of mRNA
COVID-19 vaccines to offer protection against
COVID-19. |
|
|
|
|
|
| What side
effects are expected after vaccination with
mRNA vaccines? |
|
| Recipients of
mRNA COVID-19 vaccines often experience local
(e.g., pain, swelling, redness at the
injection site, localized swollen lymph nodes
in the armpit of the vaccinated arm) or
systemic (e.g., fever, fatigue, headache, chills, body and joint aches) post-vaccination
symptoms. Depending on vaccine product
(Pfizer-BioNTech vs. Moderna), age group, and
vaccine dose, approximately 80–91% of
vaccinated people develop at least one local symptom and 55–91% develop at least one
systemic symptom following vaccination. |
|
| Most systemic
post-vaccination symptoms are mild to moderate
in severity, occur within the first three days
of vaccination, and resolve within 1–3 days of
onset. These symptoms are more frequent and
severe following the second dose and among
younger people compared to older people. |
|
| What side
effects are expected after vaccination with
Janssen COVID-19 Vaccine (Johnson & Johnson)? |
|
| Recipients of the
Janssen viral vector vaccine in the phase 3
clinical trial often experienced local or
systemic post-vaccination symptoms, though the
majority of reported symptoms were mild to
moderate in severity and resolved within 1 to
3 days after vaccination. The frequency of any
local reaction was higher in participants aged
18 to 59 years than participants age 60 years
or older (59.8% vs 35.4%). Pain at the
injection site was the most frequently reported solicited local reaction. The
frequency of systemic reactions was higher in
participants age 18–59 years than participants
60 years or older (61.5% vs 45.3%). For both
age groups, fatigue and headache were the most commonly reported systemic reactions. Fever
was more common in participants 18–59 years
(12.8%) compared to those 60 years or older
(3.1%). |
|
| What is the
thrombosis with thrombocytopenia syndrome,
called TTS, associated with the Janssen
COVID-19 Vaccine? |
|
| TTS is a rare,
immune-mediated syndrome that involves acute
venous or arterial thrombosis (blood clot) and
new onset thrombocytopenia (low platelet
count) in patients with no recent known
exposure to heparin. The onset of TTS is
typically 1 to 2 weeks following vaccination;
treatment with heparin, a common anticoagulant
used to treat blood clots, worsens the
condition. In the U.S., the majority of people
with TTS after Janssen COVID-19 vaccination
had clots located in cerebral venous sinuses;
clots occurred in other unusual locations
including in the portal vein and splenic vein,
and also included a combination of venous and
arterial thromboses. |
|
| On April 13,
2021, after 6 reports of TTS to VAERS, the FDA
and CDC recommended a pause in the use of the Janssen vaccine while a thorough safety
investigation was conducted. This pause also
allowed healthcare professionals to be
informed how to recognize, diagnose, treat,
and report suspected cases of TTS. On April
23, 2021, based on its conclusion that the
risk of severe COVID-19 disease substantially
outweighed the rare risk of TTS, ACIP
reaffirmed its interim recommendation for use
of the Janssen vaccine in all people age 18
years and older under the FDA EUA. |
|
| The highest rates
of TTS were identified by CDC in women younger
than age 50 years. At the time the pause was lifted, the rate was 7 cases per million
Janssen vaccine doses administered to women
age 18–49 years and 0.9 per million to women
age 50 years and older. |
|
| The FDA's EUA
fact sheets now include a warning that rare
TTS might occur after vaccination, primarily
among women age 18–49 years. It is critical to
ensure that women younger than age 50 years
are aware of the increased risk for TTS after
receipt of the Janssen vaccine and the
availability of other FDA-authorized or
licensed COVID-19 vaccines (i.e., mRNA
vaccines) not associated with TTS. |
|
| What are the
symptoms of TTS and where can I learn more
about treatment? |
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| TTS following
vaccination with the Janssen COVID-19 Vaccine
is rare, but the risk is increased among women younger than age 50 years. Symptom onset
typically begins 1 to 2 weeks after
vaccination. People should seek medical
attention right away if they have any of the
following symptoms after receiving the Janssen
vaccine: |
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Shortness of breath |
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Chest pain |
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Leg swelling |
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Persistent abdominal pain |
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Severe or persistent headaches or
blurred vision |
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Easy bruising or tiny blood spots under
the skin beyond the site of the
injection |
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| Treatment of TTS
is different from the treatment of typical
blood clots; heparin should be avoided in any
patient suspected of TTS until the diagnosis
can be ruled out. |
|
| For additional
clinical guidance, see the CDC Health Alert
Network Report from April 13, 2021:
emergency.cdc.gov/han/2021/han00442.asp and
treatment guidelines from the American Society
for Hematology:
www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia. |
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| Have any
COVID-19 vaccines been associated with
Guillain-Barré syndrome (GBS)? |
|
| Reports to the
Vaccine Adverse Event Reporting System (VAERS)
following use of Janssen COVID-19 Vaccine indicate an increased risk of GBS within 42
days of vaccination. Investigations to assess
whether Janssen vaccine causes GBS are
ongoing. Although the chance of GBS occurring
is low, Janssen vaccine recipients should be counseled to seek medical attention promptly
if symptoms of GBS occur, such as progressive
muscle weakness. Currently, no association has
been observed between GBS and mRNA COVID-19
vaccines. |
|
| Patients with a
history of GBS may receive Janssen COVID-19
Vaccine, but should be counseled about the
potential increased risk of GBS and the
availability of alternative vaccine options
for COVID-19 protection. |
|
| I have both
mRNA and Janssen vaccines available. Should I
avoid offering the Janssen COVID-19 Vaccine to
my younger female patients? |
|
| All who prefer
the Janssen vaccine may be offered that
option, if available. It is critical that all
women younger than age 50 be made aware of the
rare, but increased, risk of TTS following
Janssen vaccine administration and the availability of other COVID-19 vaccines not
associated with TTS. However, the ACIP has
concluded that the risks of delaying full
immunization while the virus that causes
COVID-19 is circulating widely substantially
outweigh the risk of TTS. Completing
vaccination with a single dose is an
advantage, and a priority, for some
recipients. |
|
| Can COVID-19
vaccination lead to fertility problems? |
|
| There is no
evidence that any of the COVID-19 vaccines
affect current or future fertility. |
|
| Tell me about
mRNA COVID-19 vaccines and the risk of
myocarditis and pericarditis. |
|
| Reports of
myocarditis (inflammation of the heart muscle)
and pericarditis (inflammation of the tissue
surrounding the heart) within a few days of
mRNA COVID-19 vaccination have prompted the
FDA to include information about these
conditions in the Fact Sheets for each mRNA
vaccine. There has not been a similar
reporting pattern observed after receipt of
Janssen COVID-19 Vaccine. |
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| ACIP conducted a
risk assessment and observed that the reported
risk was rare, but was most commonly reported in males age 12 through 29; reported cases
have occurred more often after dose 2 than
dose 1. In most cases, patients who were
diagnosed with myocarditis or pericarditis
after mRNA vaccination have responded well to medication and rest and had prompt improvement
of symptoms. ACIP has concluded that the
benefit of vaccination clearly outweighs the
risk of myocarditis or pericarditis. |
|
| People receiving
mRNA vaccines, especially males age 12 through
29, should be counseled about the risk of myocarditis or pericarditis and advised to
seek medical attention promptly if they
develop chest pain, shortness of breath, or
feelings of a fast, fluttering, or pounding
heartbeat. |
|
| CDC has published
additional clinical considerations for
patients with myocarditis or pericarditis
following mRNA vaccination:
www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html. |
|
| How should
patients with allergies presenting for
COVID-19 vaccination be evaluated? |
|
| Serious allergic
reactions, such as anaphylaxis, in the minutes
following vaccination are rare but are
possible with any vaccine. Every vaccination
site should have staff available who are
trained and equipped to recognize and respond
to signs of anaphylaxis in a vaccine
recipient. See this CDC website for additional
information about preparing for the management
of anaphylaxis:
www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html?anaphylaxis-management.html. |
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| Anaphylaxis
following vaccination with mRNA COVID-19
vaccines is reported at a rate of
approximately 2 to 5 cases per million doses
administered. |
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| An immediate
allergic reaction to any component or previous
dose of an mRNA COVID-19 vaccine is a contraindication to vaccination with both the
Pfizer-BioNTech and Moderna vaccines; however,
use of the Janssen viral vector vaccine may
not be contraindicated (see the COVID-19
section on contraindications and precautions
for details). Please see this CDC chart of
vaccine components designed to assist the
triage of patients with various health
conditions or allergies:
www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Appendix-C. |
|
| How long
should patients be observed for signs of an
immediate allergic reaction following
vaccination with a COVID-19 vaccine? |
|
| People with a
history of an immediate allergic reaction of
any severity to a vaccine or injectable
therapy and people with a history of
anaphylaxis due to any cause should be
observed for 30 minutes. People with a
contraindication to a different type of
COVID-19 vaccine should be observed for 30
minutes following vaccination (for example,
people with a contraindication to mRNA
COVID-19 vaccines who receive Janssen viral
vector vaccine should be observed for 30
minutes following Janssen vaccination). All
other people should be observed for 15
minutes. |
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| Where can I
find the latest information on allergic
reactions and COVID-19 vaccines? |
|
| Visit this CDC
website for the latest information:
www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html. |
|
| I have heard
that the FDA has specific reporting
requirements for healthcare providers who
administer COVID-19 vaccines under EUA. What
are they? |
|
| Adverse events
that occur in a recipient following COVID-19
vaccination should be reported to the Vaccine
Adverse Event Reporting System (VAERS).
Vaccination providers are required by the FDA
to report the following that occur after
COVID-19 vaccination under Emergency Use
Authorization: |
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Vaccine administration errors |
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Serious adverse events, including TTS |
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Cases of Multisystem Inflammatory
Syndrome |
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Cases of COVID-19 that result in
hospitalization or death |
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| Reporting is
encouraged for any other clinically
significant adverse event even if it is
uncertain whether the vaccine caused the
event. Information on how to submit a report
to VAERS is available at
https://vaers.hhs.gov
or by calling 1-800-822-7967. |
|
| How is the
safety of COVID-19 vaccines being monitored? |
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| Multiple national
surveillance systems are being used to monitor
the safety of new COVID-19 vaccines in
different ways. Please see this CDC website
for additional information on each system:
www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html. |
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| What is
v-safe? |
|
| CDC's v-safe
program is a smartphone-based tool that uses
text messaging and web surveys to provide personalized health check-ins after a person
receives a COVID-19 vaccination. It also
provides second dose reminders. Participation
is voluntary; pregnant individuals are
especially encouraged to participate in the
v-safe pregnancy registry. Vaccine recipients
may sign up for the program after receiving
the first dose. For more information, visit
www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html. |
|
| Is
compensation for an injury resulting from an
EUA COVID-19 vaccine available through the
National Vaccine Injury Compensation Program (VICP)? |
|
| No. The COVID-19
vaccines are not part of the VICP. The
COVID-19 vaccines are part of a similar
program called the Countermeasures Injury
Compensation Program (CICP). For more
information, visit this web page:
www.hrsa.gov/cicp. |
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| Where can I
find details about the storage and handling of
COVID-19 vaccines? |
|
| You may find
guidance on the storage and handling of each
authorized or licensed COVID-19 vaccine in the
CDC's Vaccine Storage and Handling Toolkit
addendum on COVID-19 vaccines:
www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. |
|
| IAC has
assembled key COVID-19 vaccine storage and
handling resources in its section on Clinic
Resources and Tools at our "Vaccines:
COVID-19" main page:
www.immunize.org/covid-19/#tools. |
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| I heard the
Pfizer-BioNTech vaccine storage requirements
changed in May 2021. Where can I get more information? |
|
| In May 2021, the
FDA authorized storage of the Pfizer-BioNTech
vaccine at refrigerated temperatures, between
2°C and 8°C (36°F and 46°F), for up to 1 month
(31 days). It is permissible to store the
vaccine in a standard freezer between -25°C
and -15°C (-13°F to 5°F) for up to 2 weeks
before storing in the refrigerator for up to
31 days. No changes to these specifications
were made at the time of licensure on August
23, 2021. Detailed storage and handling
information is available from CDC in a
printable document:
www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf. |
|
| Pfizer-BioNTech
vaccine (Comirnaty) stored in an ultra-low
temperature freezer (ULT, between -80°C and
-60°C [-112°F and -76°F]) may have its
expiration date extended as more data become
available on the vaccine's stability under
those storage conditions. Contact the
manufacturer before discarding any vaccine
past its printed expiration date to verify
that its expiration date has not been
extended. |
|
| Under what
conditions may we transport COVID-19 vaccines?
Is transport of a partial vial or predrawn
syringe ever permissible? |
|
| Although routine
transportation of vaccines to different
facilities is not generally recommended, there
are times when this is necessary. CDC
recommends transporting COVID-19 vaccine in
vials and always with a continuous temperature
monitoring device to ensure adherence to
authorized storage times and temperatures.
Because liquid mRNA COVID-19 vaccines should
not be shaken vigorously, it is preferred to
transport vials in their solid frozen state,
if possible, or to initiate transport while
they are frozen. Moderna recommends that
thawed vials of liquid be cushioned to
minimize agitation during transport. Thawed
vaccine should never be refrozen. A partially
used vial may be transported (e.g., in the
process of vaccinating homebound individuals),
but cannot be transferred from one provider to
another nor can it be transported across state
lines. Details are provided in the 2021 CDC
Vaccine Storage and Handling Toolkit addendum
on COVID-19 vaccines:
www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. |
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| There may be
instances when the only option is to transport
vaccine in a predrawn syringe. CDC refers to
the U.S. Pharmacopeia (USP) guidance for
transporting predrawn vaccine in syringes on
page 11 of the USP COVID-19 Vaccine Toolkit:
Operational Considerations for Healthcare
Practitioners. The complete document provides
detailed guidance on COVID-19 vaccine
transport and is available for download from
this site:
www.usp.org/covid-19/vaccine-handling-toolkit. |
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ACIP Recommendations
Vaccine Information Statements 
