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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.
Disease Issues
What is COVID-19?
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.
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.
Where can I find answers to more clinical questions about COVID-19 disease, diagnosis, treatment and care of patients?
The CDC has assembled clinical questions and answers at this site: www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html.
Vaccine Recommendations Back to top
Where can I find current COVID-19 vaccine recommendations?
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.
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.
Has CDC developed a frequently asked question (FAQ) page for COVID-19 vaccines?
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.
Who is recommended to receive COVID-19 vaccines?
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.
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.
Should people confirmed to have had SARS-CoV-2 infection in the past be vaccinated?
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.
Vaccine Products Back to top
What is an Emergency Use Authorization (EUA)?
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.
When will we have a VIS for the vaccines that have an EUA? What information am I supposed to give patients in writing?
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.
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.
The Pfizer-BioNTech COVID-19 vaccine EUA Fact Sheet for Recipients and Caregivers is available here: www.fda.gov/media/144414/download.
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.
What are mRNA vaccines?
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.
How well do the COVID-19 mRNA vaccines work?
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.
Do COVID-19 vaccines prevent infection with SARS-CoV-2?
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.
 
Where can I obtain detailed information about the Pfizer-BioNTech COVID-19 or the Moderna COVID-19 vaccine?
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.
Pfizer-BioNTech COVID-19 vaccine: www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html.
  Moderna COVID-19 vaccine: www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html.
In addition to CDC, each company has a detailed EUA Fact Sheet for Providers.
Pfizer-BioNTech COVID-19 vaccine: www.fda.gov/media/144413/download
  Moderna COVID-19 vaccine: www.fda.gov/media/144637/download
COVID-19 Vaccines for Adolescents and Adults Back to top
What ages are authorized to receive the available COVID-19 vaccines?
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.
COVID-19 Vaccines and Pregnancy Back to top
Are COVID-19 vaccines recommended during pregnancy?
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.
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.
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.
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.
Are COVID-19 vaccines recommended if the recipient is breastfeeding?
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.
Administering Vaccines Back to top
How are mRNA vaccines administered?
CDC has prepared a quick reference guide for preparation and administration of each mRNA COVID-19 vaccine:
Pfizer-BioNTech COVID-19 vaccine:
www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/prep-and-admin-summary.pdf.
  Moderna COVID-19 vaccine:
www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/prep-and-admin-summary.pdf
Scheduling Vaccines Back to top
Where can I find the latest information on scheduling COVID-19 vaccines?
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.
What is the schedule for COVID-19 mRNA vaccines?
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.
The Moderna COVID-19 vaccine is administered as a two-dose series, 28 days apart. Both doses must be the Moderna COVID-19 vaccine.
If a patient does not come back on time for the second dose, do we need to re-start the vaccine series?
No. Simply administer the second dose to complete the series.
What if the patient gets the second dose early?
Second doses administered within a grace period of 4 days or fewer from the recommended date for the second dose are considered valid; however, doses administered earlier do not need to be repeated.
If the second dose of vaccine may be given before the recommended interval because of the 4-day grace period, should we offer that option routinely?
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.
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?
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.
What should be done if a patient scheduled for vaccination is exposed to COVID-19 and quarantined or is isolated for suspected or confirmed SARS-CoV-2 infection?
In general, the people scheduled for COVID-19 vaccination who are exposed to SARS-CoV-2 virus and quarantined should reschedule vaccination after their quarantine period has ended in order to avoid the risk of exposing vaccinators to the virus.
People diagnosed with SARS-CoV-2 infection before a scheduled vaccination should defer vaccination until after recovery and the end of the isolation period to avoid the risk of exposing vaccinators to the virus.
Can COVID-19 vaccine recipients be given other vaccines at the same visit?
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.
How does the use of monoclonal antibodies to treat symptomatic COVID-19 affect the scheduling of mRNA COVID vaccination?
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.
Contraindications and Precautions Back to top
Please describe the contraindications for COVID-19 mRNA vaccination?
CDC considers a history of the following to be a contraindication to vaccination with both the Pfizer-BioNTech and Moderna COVID-19 vaccines:
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
  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])*
  Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*
* 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).
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
What are the precautions to COVID-19 mRNA vaccination?
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.
The following considerations may help in the decision about whether or not to proceed with mRNA COVID-19 vaccination in these individuals:
Risk of exposure to SARS-CoV-2
  Risk of severe disease or death due to COVID-19
  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)
  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
  Ability of the patient to be vaccinated in a setting where appropriate medical care is immediately available for anaphylaxis
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 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.
Vaccine Safety Back to top
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 COVID-19 mRNA 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 COVID-19 mRNA 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-B.
How long should patients be observed for signs of an immediate allergic reaction following vaccination with a COVID-19 mRNA 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?
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.
FDA defines serious AEs as:
Death
  A life-threatening AE
  Inpatient hospitalization or prolongation of existing hospitalization
  A persistent or significant incapacity or substantial disruption of normal life functions
  A congenital anomaly/birth defect
  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
  Cases of Multisystem Inflammatory Syndrome
  Cases of COVID-19 that result in hospitalization or death
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.
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.
Storage and Handling Back to top
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.
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.
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.
Back to top
This page was updated on January 8, 2021.
This page was reviewed on December 23, 2020.
 
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