| 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 new
virus was first detected as a cause of human
illness in late 2019 in Wuhan, China, and
triggered a global pandemic in 2020. The virus
is thought to spread mainly from person to
person, mainly
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. |
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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. Severity
ranges from
asymptomatic infection to severe illness.
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 mRNA COVID-19 vaccines that have received
Emergency Use Authorization (EUA) from the
federal Food and Drug Administration (FDA).
Until vaccine supplies are sufficient, the
ACIP also has issued
recommendations for prioritizing recipients
based upon either risk of serious outcomes or
risk of occupational exposure. State and local public health
officials are responsible for COVID-19
vaccination program implementation: consult
them for details about vaccination policies in
their jurisdiction. 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/info-by-product/clinical-considerations.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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| ACIP has made
recommendations about which groups should be
prioritized for vaccination while supplies are limited. Prioritization is based upon either
risk factors for serious outcomes or risk of
infection among workers in sectors considered
essential to the functioning of society. |
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| The highest
priority recipients in ACIP's Phase 1a include
all individuals who work in healthcare
settings and the staff and residents of long
term care
facilities. On December 20, 2020, ACIP
recommended that in Phase 1b, vaccine should
be offered to people age 75 years or older and
frontline essential
workers (non–health care workers), and that in
Phase 1c, people aged 65–74 years, people aged
16–64 years with high-risk medical conditions,
and
essential workers not recommended for
vaccination in Phase 1b should be offered
vaccine. All other people age 16 years and
older not included in earlier
groups are included in Phase 2. State and
local public health authorities are
responsible for implementation of vaccination
programs and their programs
may not follow these recommendations exactly.
Updated prioritization recommendations were
published on December 22, 2020:
www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm695152e2-H.pdf. |
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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. 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. |
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| As with all
vaccines, vaccination should be deferred until
after recovery from moderate to severe
COVID-19 illness. In addition, to minimize the
risk of
exposing others to SARS-CoV-2 virus,
vaccination generally should be deferred until
criteria have been met for individuals with
COVID-19 illness to
discontinue isolation. |
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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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| 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.
Instead, the FDA-issued EUA Fact Sheet for Recipients and Caregivers for each
COVID-19 vaccine must be used. |
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| The Pfizer-BioNTech
COVID-19 vaccine EUA Fact Sheet for Recipients
and Caregivers 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.modernatx.com/covid19vaccine-eua/eua-fact-sheet-recipients.pdf. |
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| What are mRNA
vaccines? |
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| Both the Pfizer-BioNTech
COVID-19 (BNT162b2) vaccine and the Moderna
COVID-19 (mRNA-1273) vaccines 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 vaccines were similar, demonstrating an
overall efficacy of 94–95% in preventing
symptomatic COVID-19
illness compared to placebo recipients. |
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| Do COVID-19
vaccines prevent infection with SARS-CoV-2? |
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| Definitive data
are not yet available to answer the question
of how well the mRNA COVID-19 vaccines prevent asymptomatic infection with the SARS-CoV-2 virus and subsequent transmission of the
virus to others. For this reason, CDC
currently recommends that vaccine recipients
continue to follow the
general recommendations to prevent the spread
of COVID-19 related to wearing masks,
practicing physical distancing, and
maintaining good hand
hygiene. |
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| Where can I
obtain detailed information about the Pfizer-BioNTech
COVID-19 or the Moderna COVID-19 vaccine? |
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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 EUA Fact
Sheet for Providers. |
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| COVID-19 Vaccines for Adolescents and Adults |
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| What ages are
authorized to receive the available COVID-19
vaccines? |
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| The Pfizer-BioNTech
COVID-19 vaccine is authorized for emergency
use in people age 16 years and older. The
Moderna COVID-19 vaccine is authorized for
emergency use in people age 18 years and
older. Both companies have announced plans to
pursue licensure of the vaccines in younger
age groups as soon as they have sufficient
data to support an application. |
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| Are COVID-19
vaccines recommended during pregnancy? |
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| Pregnancy is not
a contraindication or precaution for either
the Moderna or Pfizer-BioNTech COVID-19
vaccines. Pregnant people are at increased
risk of severe illness from COVID-19 compared
to non-pregnant people of the same age.
However, there is very limited information
available on the use of either vaccine during
pregnancy. There are currently few data on the
safety of COVID-19 vaccines, including mRNA
vaccines, in pregnant people. Limited data are
currently available from animal developmental
and reproductive toxicity studies: no safety
concerns were demonstrated in these studies.
Studies in pregnant people are underway and
the vaccine manufacturers are following
outcomes in people in the clinical trials who
became pregnant. Based on current knowledge,
experts believe that mRNA vaccines are
unlikely to pose a risk to the expectant
mother or the fetus. CDC and the American
College of Obstetricians and Gynecologists (ACOG)
recommend if pregnant people are part of a
group that is recommended to receive a
COVID-19 vaccine, they may choose to be
vaccinated. |
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| Vaccination
should not be withheld from a pregnant person
who is otherwise eligible for vaccination and
chooses to be vaccinated. |
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| There is no
recommendation for routine pregnancy testing
before receipt of a COVID-19 vaccine. Those
who are trying to become pregnant do not need
to avoid pregnancy after mRNA COVID-19
vaccination. |
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| For more details
about COVID-19 vaccination during pregnancy,
visit CDC's webpage, Vaccine Considerations
for People who are Pregnant:
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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| There are no data
on the effects of mRNA COVID-19 vaccines on
the breastfed infant or milk
production/excretion. These vaccines are not
thought to be
a risk to the breastfeeding infant. A person
who is lactating and part of a group
recommended to receive an mRNA COVID-19
vaccine should be offered
vaccination as appropriate and may choose to
be vaccinated. |
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| How are mRNA
vaccines administered? |
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| CDC has prepared
a quick reference guide for preparation and
administration of each mRNA COVID-19 vaccine: |
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| Has CDC
provided clinical guidance on what to do if an
error occurs while administering mRNA COVID-19
vaccinations? |
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| Yes. On February
10, 2021, CDC published a new appendix to its
"Interim Clinical Considerations for Use of mRNA Vaccines Currently Authorized in the
United States." This appendix provides
resources for preventing and reporting mRNA
COVID-19 vaccine administration errors, as
well as a simple table
outlining actions to take after an error has
occurred:
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-A. |
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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 mRNA
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 mRNA 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 the patient received at least
half of the authorized vaccine dose, do not
repeat the
dose. However, if 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 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 is administered as a two-dose
series, 28 days apart. Both doses should be
the Moderna vaccine. |
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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. |
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| If a patient
does not come back on time for the second
dose, do we need to re-start the vaccine
series? |
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| No. Simply
administer the second dose to complete the
series. |
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| What if the
patient gets the second dose early? |
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| 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. |
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| If the second
dose of vaccine may be given before the
recommended interval because of the 4-day
grace period, should we offer that option
routinely? |
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| No. CDC states
that 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. |
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| 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? |
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| There are no data
on the safety or efficacy of a mixed-brand
mRNA vaccine schedule. For this reason, both
doses in the series should be the same
brand. However, 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. |
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| 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? |
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| 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. |
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| 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. |
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| Can COVID-19
vaccine recipients be given other vaccines at
the same visit? |
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| There are no data
on the safety and efficacy of mRNA COVID-19
vaccines administered with any other vaccine.
For this reason, CDC currently
recommends that the mRNA COVID-19 vaccine
series should be administered alone, and not
within 14 days before or after any other
vaccination.
However, mRNA COVID-19 and other vaccines may be administered at shorter intervals if the
benefits of vaccination are judged to outweigh
any unknown
potential risks of vaccine coadministration.
Examples of such situations include tetanus
vaccination as a part of wound management,
vaccination in
response to a measles or hepatitis A outbreak,
or COVID-19 vaccination of a person in a
long-term care facility or healthcare setting
who recently
received influenza or other vaccinations (to
avoid delays or missed opportunities for
COVID-19 vaccination). If mRNA COVID-19
vaccines are
administered within 14 days of another
vaccine, doses do not need to be repeated for
either vaccine. |
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| 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? |
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| Advise your
patient to schedule the second Shingrix dose
at least 14 days after receiving the second
mRNA COVID-19 vaccination. |
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| A patient had
a routine tuberculin skin test (TST) placed
the day before the patient's appointment for a first dose of COVID-19 vaccine. Should we
proceed with vaccination or do we need to
reschedule? |
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| 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. |
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| COVID-19
vaccination should not be delayed because of
testing for tuberculosis (TB) infection. A TST
is not a vaccine and is not subject to the
general
recommendation for an interval of at least 14
days between mRNA COVID-19 vaccination and
administration of any other 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 mRNA COVID-19
vaccination is unknown. |
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| For additional
details on mRNA COVID-19 vaccination of
patients being evaluated for active
tuberculosis, refer to CDC clinical
considerations for mRNA
vaccines and laboratory testing:
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#laboratory-testing. |
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| How does the
use of monoclonal antibodies to treat
symptomatic COVID-19 affect the scheduling of
mRNA COVID-19 vaccination? |
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| 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 mRNA
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. |
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| 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 mRNA COVID-19
vaccination. |
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| Please
describe the contraindications for mRNA
COVID-19 vaccination. |
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| CDC considers a
history of the following to be a
contraindication to vaccination with both the
Pfizer-BioNTech and Moderna COVID-19 vaccines: |
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Severe allergic reaction (e.g.,
anaphylaxis) after a previous dose of an
mRNA COVID-19 vaccine or any of its components |
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Immediate allergic reaction of any
severity to a previous dose of an mRNA
COVID-19 vaccine or any of its components (including polyethylene
glycol [PEG])* |
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Immediate allergic reaction of any
severity to polysorbate (due to
potential cross-reactive
hypersensitivity with the vaccine
ingredient PEG)* |
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| * These people
should not receive mRNA COVID-19 vaccination
at this time unless they have been evaluated
by an allergist-immunologist and it is
determined that they can safely receive the
vaccine (e.g., under observation, in a setting
with advanced medical care available). |
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| CDC has published
a table with additional details about the
components of both mRNA COVID-19 vaccines:
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-C. |
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| People with an
immediate allergic reaction to the first dose
of an mRNA COVID-19 vaccine should not receive additional doses of either of the mRNA
COVID-19 vaccines. CDC has provided a chart to
assist in the evaluation of immediate
reactions to vaccination:
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-D. |
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| What are the
precautions to mRNA COVID-19 vaccination? |
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| CDC considers a
history of any immediate allergic reaction to
any other vaccine or injectable therapy
(defined as intramuscular, intravenous, or
subcutaneous vaccines or therapies [excluding
subcutaneous immunotherapy for allergies,
known as "allergy shots"] not related to a
component of mRNA
COVID-19 vaccines or polysorbate) as a precaution but not a contraindication to
vaccination for both the Pfizer-BioNTech and
Moderna COVID-19
vaccines. These precautions based on history,
as defined, include people with a reaction to
a vaccine or injectable therapy that contains
multiple
components, one of which is PEG, another
vaccine component, or polysorbate, but in whom
it is unknown which component caused the
immediate
allergic reaction. |
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| Individuals with
a precaution to vaccination should be
counseled about the unknown risks of
experiencing a severe allergic reaction and
balance these
risks against the benefits of vaccination.
Deferral of vaccination and/or consultation
with an allergist-immunologist may be
considered until further
information on the risk of anaphylaxis is
available. |
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| The following
considerations can be used to help assess the
risk for mRNA COVID-19 vaccination in these individuals: |
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Risk of exposure to SARS-CoV-2 |
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Risk of severe disease or death due to
COVID-19 |
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Whether the patient has previously been
infected with SARS-CoV-2 and, if so, how
long ago; because reinfection is
uncommon in the months
following infection, a person with a
precaution to vaccination and recent COVID-19 illness may choose to delay
vaccination until further information is
known about the risk of anaphylaxis
following vaccination |
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The unknown risk of anaphylaxis
following mRNA COVID-19 vaccination in a
person with a history of an immediate
allergic reaction to other
vaccines or injectable therapies |
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Ability of the patient to be vaccinated
in a setting where appropriate medical
care is immediately available for anaphylaxis |
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| For additional
guidance about contraindications and
precautions, please refer to
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Contraindications. |
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| Can people who
are immunocompromised or who have autoimmune
disease be vaccinated with mRNA COVID-19
vaccines? |
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| Yes, they may
choose to be vaccinated as long as they do not
have a contraindication to vaccination. Please
see detailed considerations about
vaccination of people with underlying medical
conditions here:
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#underlying-conditions. |
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| Are there any
common types of allergies that are neither
contraindications nor precautions to vaccination? |
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| Allergic
reactions (including severe allergic reactions
such as anaphylaxis) that are not related to
vaccines, injectable therapies, components of
mRNA
COVID-19 vaccines (including PEG), or
polysorbates are not a contraindication or
precaution to vaccination with either mRNA
COVID-19 vaccine.
Examples of other allergies that are not a
contraindication or precaution include other
food, pet, venom, or environmental allergies,
or allergies to oral
medications (including the oral equivalents of
injectable medications). The vial stoppers of
these mRNA vaccines are not made with natural
rubber latex, so
there is no contraindication or precaution to
vaccination for persons with a latex allergy.
In addition, mRNA COVID-19 vaccines do not
contain eggs or
gelatin. |
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| 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 Moderna vaccine dose. It resolved after
a few days. Is this a contraindication? Should
this alter our plans for dose two? |
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| 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. |
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| Patients
concerned about the risk of allergic reaction
or side effects following COVID-19 vaccination
are asking if they should take acetaminophen
and/or
antihistamines before receiving mRNA COVID-19 vaccination. What does CDC advise? |
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| 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
currently recommended
because information on the impact of such use on mRNA COVID-19 vaccine-induced antibody
responses is not available at this time. |
|
| In addition,
administration of antihistamines before mRNA
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. |
|
|
|
|
|
| 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 80–89%
of vaccinated people develop at least one
local symptom
and 55–83% 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. |
|
| I have heard
of people who have experienced anaphylaxis or
other allergic-type reactions following vaccination with the mRNA COVID-19 vaccines.
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/info-by-product/pfizer/anaphylaxis-management.html. |
|
| CDC and FDA are
investigating reports of allergic reactions
following vaccination with mRNA COVID-19
vaccines and are updating their screening
recommendations as new information becomes
available. |
|
| 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. 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/info-by-product/clinical-considerations.html#Appendix-C. |
|
| How long
should patients be observed for signs of an
immediate allergic reaction following
vaccination with a mRNA 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.
All other people should be observed for 15
minutes. |
|
| 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 mRNA
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 mRNA COVID-19 vaccination under
Emergency Use
Authorization: |
|
| • |
|
Vaccine administration errors |
|
|
|
| • |
|
Serious adverse events |
|
|
|
| • |
|
Cases of Multisystem Inflammatory
Syndrome |
|
|
|
| • |
|
Cases of COVID-19 that result in
hospitalization or death |
|
|
| 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? |
|
| 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. |
|
| 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. 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 EUA
COVID-19 vaccines are not part of the VICP.
The EUA 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. |
|
|
|
|
|
| Where can I
find details about the storage and handling of
COVID-19 vaccines? |
|
| You may find
guidance on the storage and handling of
COVID-19 vaccines 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. |
|
| Under what
conditions may we transport mRNA 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 mRNA 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 mRNA
COVID-19 vaccines:
www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. |
|
| 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 mRNA 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 
