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Aug 13, 2021 · The CDC is officially recommending a third dose of the Pfizer or Moderna vaccine for people with weakened immune systems. It follows the FDA authorization a day earlier.
- Joe Neel
- Overview
- Overview of COVID-19 vaccination
- COVID-19 vaccination guidance for people who are not moderately or severely immunocompromised
- COVID-19 vaccination guidance for people who are moderately or severely immunocompromised
- Timing, spacing, age transitions, and simultaneous administration
- Interchangeability of COVID-19 vaccines
- Vaccination and SARS-CoV-2 laboratory testing
- Patient counseling
- Contraindications and precautions
- Reporting of vaccine adverse events
•Post-vaccination reaction information updated in sections on pre-vaccination counseling and safety considerations for mRNA and Novavax vaccines to better align with EUA fact sheets for health care providers and package inserts.
•Information on the availability of the V-safe safety monitoring system for updated (2023–2024 Formula) Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines added to the section on reporting of vaccine adverse events.
•COVID-19 Vaccine Product Information •FAQs for the Interim Clinical Considerations •COVID-19 Vaccination Recommendations Infographic •COVID-19 Vaccination Recommendations Infographic (Immunocompromised)
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These clinical considerations provide information to healthcare professionals and public health officials on use of COVID-19 vaccines. They are informed by:
•Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC)
•COVID-19 vaccine approval (licensure) under a Biologics License Application (BLA) or authorization under an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)
•CDC’s Emergency Use Instructions (EUI) for FDA-approved vaccines
•Emergency Use Listing (EUL) of COVID-19 vaccines by the World Health Organization (WHO)
•ACIP’s General Best Practice Guidelines for Immunization
The COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised is detailed in Table 1. The recommended vaccine type and number of updated (2023–2024 Formula) COVID-19 vaccine doses are based on age and vaccination history.
Ages 6 months–4 years
•Unvaccinated: 2 or 3 homologous (i.e., from the same manufacturer) updated (2023–2024 Formula) mRNA vaccine doses, depending on vaccine manufacturer (i.e., Moderna, Pfizer-BioNTech).
•Previously received an incomplete series of Original monovalent or bivalent mRNA vaccine doses: Complete the vaccination series with 1 or 2 homologous updated (2023–2024 Formula) mRNA vaccine doses, depending on vaccine manufacturer and the number of previous vaccine doses.
•Previously received all doses in the initial vaccination series with Original monovalent or bivalent mRNA vaccine: 1 homologous updated (2023–2024 Formula) mRNA vaccine dose.
Special situations for children ages 6 months–4 years: For information on circumstances in which heterologous dosing may be considered when doses from the same manufacturer are recommended, and guidance on completing the initial vaccination series if children in this age group receive 1 dose of Moderna and 1 dose of Pfizer-BioNTech, see the section on Interchangeability.
The COVID-19 vaccination schedule for people who are moderately or severely immunocompromised is detailed in Table 2. The recommended vaccine type and number of updated (2023–2024 Formula) COVID-19 vaccine doses are based on age and vaccination history.
Ages 6 months–4 years
•Unvaccinated: 3 homologous (i.e., from the same manufacturer) updated (2023–2024 Formula) mRNA vaccine doses (i.e., Moderna, Pfizer-BioNTech).
•Previously received 1 or 2 Original monovalent or bivalent mRNA vaccine doses: Complete the 3-dose series with 2 or 1 homologous updated (2023–2024 Formula) mRNA vaccine doses, respectively.
•Previously received a combined total of 3 or more Original monovalent or bivalent mRNA vaccine doses: 1 dose of homologous updated (2023–2024 Formula) mRNA vaccine.
•Additional doses: May receive 1 or more additional homologous updated (2023–2024 Formula) mRNA vaccine doses.
4-Day grace periodTransitioning from a younger to older age groupSimultaneous administration of COVID-19 vaccines with other vaccinesmRNA COVID-19 vaccines
Children ages 6 months–4 years should receive all doses of an mRNA COVID-19 vaccine from the same manufacturer (i.e., homologous dosing); this includes children who are moderately or severely immunocompromised and those who are not. People ages 5 years and older who are moderately or severely immunocompromised should receive a 3-dose initial mRNA vaccination series using vaccines from the same manufacturer.
For people who receive 1 Moderna and 1 Pfizer-BioNTech vaccine dose, complete the initial vaccination series as follows:
•Children ages 6 months–4 years who are not moderately or severely immunocompromised should follow a 3-dose schedule. A third dose of either updated (2023–2024 Formula) Moderna vaccine or updated (2023–2024 Formula) Pfizer-BioNTech vaccine should be administered at least 8 weeks after the second dose.
•People ages 6 months and older who are moderately or severely immunocompromised should follow the recommended 3-dose schedule. A third dose of either updated (2023–2024 Formula) Moderna vaccine or updated (2023–2024 Formula) Pfizer-BioNTech vaccine should be administered as follows:
•Ages 6 months–4 years: at least 8 weeks after the second dose
Pre-vaccination testing
Antibody testing is not currently recommended to assess the need for vaccination in an unvaccinated person or to assess immunity to SARS-CoV-2 following COVID-19 vaccination. If antibody testing is done, vaccination should be completed as recommended regardless of the antibody test result.
Interpretation of SARS-CoV-2 test results in vaccinated people
Prior receipt of a COVID-19 vaccine will not affect the results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests).
See also CDC COVID-19 health care professional, CDC COVID-19 laboratory, and FDA SARS-CoV-2 laboratory testing Web pages.
Table of Contents
Pre-vaccination counselingPost-vaccination observation periodCDC considers the conditions listed in Table 3 to be COVID-19 vaccination contraindications and precautions.
Table 3. Contraindications and precautions to COVID-19 vaccination
Abbreviations: MIS-C = multisystem inflammatory syndrome in children; MIS-A = multisystem inflammatory syndrome in adults
*Allergic reactions in Table 3 are defined as follows:
Severe allergic reactions include: known or possible anaphylaxis, a progressive life-threatening reaction that typically includes urticaria (hives) but also with other symptoms such as wheezing, difficulty breathing, or low blood pressure; angioedema (visible swelling) affecting the airway (i.e., tongue, uvula, or larynx); diffuse rash which also involves mucosal surfaces (e.g., Stevens-Johnson Syndrome).
Non-severe allergic reactions include but are not limited to: urticaria beyond the injection site; angioedema involving lips, facial skin, or skin in other locations. NOTE: Any angioedema affecting the airway (i.e., tongue, uvula, or larynx) is considered a severe allergic reaction.
Adverse events that occur in a recipient following administration of any licensed or authorized COVID-19 vaccine should be reported to VAERS including:
•Vaccine administration errors whether or not associated with an adverse event
•Serious adverse events, irrespective of attribution to vaccination
•Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
•Cases of myocarditis
•Cases of pericarditis
Jan 27, 2022 · The booster dose for Moderna (0.25 mL) is one half the dose used for the primary series (0.5 mL). The third dose to complete a primary series in persons with immunocompromising conditions is the same as the first 2 doses (0.5 mL).
After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” said Acting FDA...
Aug 13, 2021 · CAMBRIDGE, Mass. -- (BUSINESS WIRE)--Aug. 13, 2021-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorization for the Moderna COVID-19 vaccine (mRNA-1273) to include a t...
Oct 19, 2021 · In October 2021, the FDA amended its Emergency Use Authorization (EUA) on COVID-19 vaccines to include booster shots of all three vaccines (Pfizer, Moderna and Johnson & Johnson). For Pfizer and Moderna, the parameters are patients: Age 65 and older. Age 18 through 64 at high risk of severe COVID-19.
• a third primary series dose to individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise; • a single booster dose to individuals 18 years of...
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related to: moderna third doseRead the Latest on COVID-19 Vaccines and Booster Shots. Learn More Today. Questions Continue as Millions of Americans Get Immunized. Here Are Some Qs Answered.
