| 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
COVID-19 vaccines that have received
Emergency Use Authorization (EUA) from the
federal Food and Drug Administration (FDA).
ACIP also has issued recommendations for
prioritizing
recipients while supplies are limited 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 jurisdictions.
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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| 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 (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 mRNA vaccines were similar, demonstrating
an overall efficacy of 94–95% in preventing
symptomatic
COVID-19 illness compared to placebo
recipients. |
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| Please
describe the Janssen (Johnson & Johnson)
vaccine. |
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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 (Janssen, a
subsidiary of Johnson & Johnson). The Janssen
COVID-19 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
COVID-19 vaccine consists
of a single dose (5 × 1010 virus particles per
0.5-mL dose) administered intramuscularly. |
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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. |
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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 vaccination does reduce
the risk of asymptomatic infection with
SARS-CoV-2; however, definitive data are not
yet available. For this reason, CDC has
released detailed guidelines for vaccinated
people to follow in order to reduce the risk
of transmission of SARS-CoV-2 from an asymptomatic vaccinated person
to an unvaccinated person. These guidelines
will be 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 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 and Janssen COVID-19 vaccines are
authorized for emergency use in people age 18
years and older. Licensure 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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| Are COVID-19
vaccines safe during pregnancy? |
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| Pregnancy is not
a contraindication or precaution for Moderna,
Pfizer-BioNTech, or Janssen COVID-19 vaccines. Based on current knowledge, experts
believe that COVID-19 vaccines are unlikely to
pose a risk to the pregnant person or fetus
because the currently authorized 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 women
with non-replicating vaccines in general. |
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| There are
currently few data on the safety of COVID-19
vaccines in pregnant people. Limited data are
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. |
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| Pregnant
individuals who are vaccinated are encouraged
to enroll in CDC's voluntary COVID-19 vaccine
safety surveillance system, v-safe. A v-safe
pregnancy registry has been established to
follow outcomes among pregnant people who are
vaccinated. Based on self-reported
information, no specific
safety signals have been observed among
pregnant vaccine recipients included in the
v-safe registry. However, longitudinal
follow-up is needed to fully
evaluate pregnancy and birth outcomes. |
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| Are COVID-19
vaccines recommended during pregnancy? |
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| Pregnant people
are at increased risk of severe illness from
COVID-19 compared to non-pregnant people of
the same age and may choose to be
vaccinated with any authorized vaccine. |
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| 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. Pregnancy testing is not
recommended before vaccination and individuals
who are
trying to become pregnant do not need to avoid
pregnancy after receiving a COVID-19 vaccine. |
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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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| 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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| A person who is
lactating and part of a group recommended to
receive a COVID-19 vaccine should be offered vaccination with any available product and
may choose to be vaccinated. There are no data
on the effects of authorized COVID-19 vaccines
on the breastfed infant or milk
production/excretion.
These vaccines are not thought to be a risk to
the breastfeeding infant. |
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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, 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
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 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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| 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. |
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| If no mRNA
vaccine is obtainable for the second dose, a
single dose of the Janssen COVID-19 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. |
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| 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? |
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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 of an mRNA
COVID-19 vaccine 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 mRNA COVID-19 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. 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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| 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? |
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| 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. |
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| 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. |
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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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| No authorized
COVID-19 vaccines are live virus vaccines;
however, there currently are no data on the
safety and efficacy of any authorized COVID-19
vaccines administered with any other vaccine.
For this reason, CDC currently recommends that
COVID-19 vaccine doses should be administered
alone,
and not within 14 days before or after any
other vaccination. However, 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 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 single
dose of Janssen COVID-19 vaccine or 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 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 any 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 COVID-19 vaccination is
unknown. |
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| For additional
details on COVID-19 vaccination of patients
being evaluated for active tuberculosis, refer
to CDC clinical considerations for COVID-19
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 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 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 any COVID-19
vaccination. |
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| Please
describe the contraindications for each
COVID-19 vaccination. |
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| CDC considers a
history of the following to be a
contraindication to vaccination with COVID-19
vaccines: |
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Severe allergic reaction (e.g.,
anaphylaxis) after a previous dose or to
a component of the COVID-19 vaccine |
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Immediate allergic reaction of any
severity to a previous dose or known
(diagnosed) allergy to a component of the vaccine |
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| 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 COVID-19 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 COVID-19 vaccine
and thus, a precaution to mRNA COVID-19
vaccination. |
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| A list of
ingredients in each COVID-19 vaccine is
available here:
www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-C. |
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| 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 COVID-19 vaccination? |
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| 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. |
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| People with a
contraindication to one type of the currently
authorized 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. |
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| 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/info-by-product/clinical-considerations.html#Contraindications. |
|
| Can people who
are immunocompromised or who have autoimmune
disease be vaccinated with mRNA COVID-19
vaccines? |
|
| 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. |
|
| 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 or
gelatin. |
|
| 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 Moderna 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
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
currently recommended
because information on the impact of such use on COVID-19 vaccine-induced antibody responses
is not available at this time. |
|
| In addition,
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. |
|
|
|
|
|
| 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. |
|
| What side
effects are expected after vaccination with
Janssen viral vector vaccine? |
|
| 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%). |
|
| 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
closely monitoring reports of severe allergic
reactions following vaccination with mRNA COVID-19 vaccines and will update their
screening recommendations as new information
becomes available. Anaphylaxis following
vaccination with mRNA COVID-19 vaccines is
reported at a rate
of approximately 2 to 5 cases per million
doses administered. |
|
| 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/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 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. |
|
| 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: |
|
| • |
|
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; 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 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 each
authorized 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. |
|
| 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. |
|
| 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 
