| 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 connect our
readers directly to vaccine resources provided by the Centers for Disease Control and Prevention (CDC). 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. 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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| The 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 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 these recommendations and
may sub-prioritize
within these groups while vaccine supplies are
insufficient to meet demand. 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
confirmed to have had SARS-CoV-2 infection in
the past be vaccinated? |
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| Yes. People who
have recovered from SARS-CoV-2 infection are
expected to benefit from vaccination. Although they may be vaccinated at any time after
recovery, it is rare to be reinfected within
90 days of a previous infection. If supplies
are scarce, recently recovered individuals
prioritized for vaccination
may choose to defer until closer to three
months after recovery. |
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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 COVID-19 mRNA 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 for either the Moderna or
Pfizer-BioNTech COVID-19 vaccines. 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
planned 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. |
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| CDC recommends 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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| 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 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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| 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
schedule for COVID-19 mRNA vaccines? |
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| The Pfizer-BioNTech
COVID-19 vaccine is administered as a two-dose
series, 21 days apart. Both doses must be the
Pfizer-BioNTech COVID-19 vaccine. |
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| The Moderna
COVID-19 vaccine is administered as a two-dose
series, 28 days apart. Both doses must be the Moderna COVID-19 vaccine. |
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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. There is no maximum
interval and 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.
CDC recommends that the vaccine series should
routinely 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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| How does the
use of monoclonal antibodies to treat
symptomatic COVID-19 affect the scheduling of
mRNA COVID vaccination? |
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| There are no data
on the effect of passive antibody therapies,
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 dose 2.
There is no maximum interval between vaccine
doses and there is no need to restart the
vaccination series. |
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| Please
describe the contraindications for COVID-19
mRNA 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 the person can safely receive
the vaccine (e.g., under observation, in a
setting with advanced medical care available). |
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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-C |
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| What are the
precautions to COVID-19 mRNA vaccination? |
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| CDC considers a
history of any immediate allergic reaction to
any other vaccine or injectable therapy (in
other words, intramuscular, intravenous, or
subcutaneous vaccines or therapies 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.
People with such a history should be counseled
about the unknown risks of developing a severe
allergic reaction and balance these risks
against the benefits of vaccination. Deferring
vaccination and/or consulting with an
allergist-immunologist may be considered until
further information on the risk of anaphylaxis
is available. |
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| The following
considerations may help in the decision about
whether or not to proceed with 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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History of previous infection with
SARS-CoV-2 and, if so, how long ago (a
person is unlikely to be reinfected within 3
months of a previous infection and a person
with recent infection may choose to defer
vaccination until more is known about the
risk of allergic reactions) |
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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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| What side
effects are expected after vaccination with
mRNA vaccines? |
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| 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. |
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| 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. |
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| I have heard
of people who have experienced anaphylaxis or
other allergic-type reactions following
vaccination with the COVID-19 mRNA vaccines.
How should patients with allergies presenting
for COVID-19 vaccination be evaluated? |
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| 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 |
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| CDC and FDA are
investigating reports of allergic reactions
following vaccination with COVID-19 mRNA
vaccines and are updating their screening
recommendations as new information becomes
available. |
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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. 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-B. |
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| How long
should patients be observed for signs of an
immediate allergic reaction following
vaccination with a COVID-19 mRNA vaccine? |
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| 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. |
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| Where can I
find the latest information on allergic
reactions and COVID-19 vaccines? |
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| Visit this CDC
website for the latest information:
www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/allergic-reaction.html. |
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| I have heard
that the FDA has specific reporting
requirements for healthcare providers who
administer COVID-19 vaccines under EUA. What
are they? |
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| Healthcare
providers are required to report to VAERS all
vaccine administration errors, whether or not
associated with an adverse event (AE) and all
serious AEs following COVID-19 vaccination
regardless of whether they are thought to be
caused by the vaccine. |
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| FDA defines
serious AEs as: |
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Death |
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A
life-threatening AE |
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Inpatient
hospitalization or prolongation of existing
hospitalization |
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A persistent or
significant incapacity or substantial
disruption of normal life functions |
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A congenital
anomaly/birth defect |
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An important
medical event that based on appropriate
medical judgement may jeopardize the
individual and may require medical or
surgical intervention to prevent one of the
outcomes listed above |
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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 of
other adverse events may be required later if
revised by CDC or FDA. As always, healthcare
providers are encouraged to report to VAERS
any clinically significant adverse event
following vaccination, even if unsure if
vaccination caused the event. |
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| 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? |
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| 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. |
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| Is
compensation for an injury resulting from an
EUA COVID-19 vaccine available through the
National Vaccine Injury Compensation Program (VICP)? |
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| 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. |
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| Where can I
find details about the storage and handling of
COVID-19 vaccines? |
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| 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. |
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| CDC has produced
a brief Pfizer-BioNTech COVID-19 vaccine
storage summary available here:
www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf. |
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| CDC has produced
a brief Moderna COVID-19 vaccine storage
summary available here:
www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/storage-summary.pdf. |
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| Back to top |
ACIP Recommendations
Vaccine Information Statements 
