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Issue 1,853: January 15, 2026
Ask the Experts: Immunize​.org Answers Questions About 2025–26 Season COVID-19 Vaccination

As an additional service to IZ Express readers, we periodically publish special editions such as this one, providing you with Ask the Experts questions and answers from Immunize​.org experts. This issue includes 13 Q&As about immunization for COVID-19. The primary source of information for this set of questions is the November 4, 2025, update of the web page entitled CDC Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States ([link removed]) . Recommendations or information from manufacturers or professional medical societies are also included and sources are linked where needed.

To find the full set of Immunize​.org's Ask the Experts Q&As related to COVID-19, visit www.immunize.org/ask-experts/topic/covid-19.

You can find all of these questions and answers, plus more than 1,300 others about vaccines and vaccine administration, on our "Ask the Experts" main page at www.immunize.org/ask-experts.

Immunize​.org’s team of experts includes Kelly L. Moore, MD, MPH (team lead); Carolyn B. Bridges, MD, FACP; Iyabode Beysolow, MD, MPH; and Jane R. Zucker, MD, MSc.
COVID-19 Vaccination
* Q: Who is recommended by CDC to receive COVID-19 vaccines? (#IZX1)
* Q: What are CDC and professional medical societies’ 2025–26 season COVID-19 vaccination recommendations for people age 6 months and older? (#IZX2)
* Q: What is the difference between Spikevax and mNexspike by Moderna? (#IZX3)
* Q: What is the Nuvaxovid (Sanofi-Novavax) COVID-19 Vaccine? (#IZX4)
* Q: What are the differences between the 2025–26 season recommendations for COVID-19 vaccination of children from CDC and from the American Academy of Pediatrics (AAP)? (#IZX5)
* Q: Should adults age 65 years and older who are vaccinated against COVID-19 in the 2025–26 season receive one or two doses of COVID-19 vaccine during the season? (#IZX6)
* Q: My patient turns 12 years old next week and has never had a COVID-19 vaccination. His parents want to vaccinate him. What options are available? (#IZX7)
* Q: Are COVID-19 vaccines safe during pregnancy? (#IZX8)
* Q: What proof do I need before giving COVID-19 vaccine to a patient who says he has a high-risk condition? (#IZX9)
* Q: May different brands of 2025–2026 Formula COVID-19 vaccine be used for immunocompromised people who require multiple doses over time? (#IZX10)
* Q: When giving COVID-19 vaccine, is use of a Vaccine Information Statement (VIS) required? (#IZX11)
* Q: If a patient reports an anaphylactic reaction to an mRNA COVID-19 vaccine two years ago, can they ever be vaccinated against COVID-19? (#IZX12)
* Q: Tell me about mRNA COVID-19 vaccines and the risk of myocarditis and pericarditis. (#IZX13)

Editorial Information (#Editorial)
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COVID-19 Vaccination
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Q: Who is recommended by CDC to receive COVID-19 vaccines?

A: The ACIP recommended on September 18, 2025, that all people age 6 months and older in the United States may receive one or more doses of an age-appropriate 2025–2026 Formula COVID-19 vaccination based on individual decision-making, following shared clinical decision-making discussion with a healthcare professional (e.g., a nurse, doctor, or pharmacist). The decision to vaccinate may be influenced by the presence of conditions that increase the risk of severe COVID-19 illness.

Product options include three FDA-licensed mRNA vaccines: Comirnaty (Pfizer-BioNTech, ages 5 years and older); Spikevax (Moderna, ages 6 months and older); mNexspike (Moderna, ages 12 years and older). There is one FDA-licensed adjuvanted protein subunit vaccine: Nuvaxovid (Sanofi-Novavax, ages 12 years and older). Schedules vary by age and immunocompromised status.

Although the FDA licenses limit use of COVID-19 vaccines among recipients younger than age 64 to those with one or more conditions that increases the risk of severe COVID-19, the fact that ACIP did not include any restrictions in its shared clinical decision-making recommendation means that it is an acceptable standard of care for people younger than age 65 without a high risk condition to be vaccinated when desired.
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Q: What are CDC and professional medical societies’ 2025–26 season COVID-19 vaccination recommendations for people age 6 months and older?

A: CDC recommends individual decision-making (also known as shared clinical decision-making) for COVID-19 vaccination of all people age 6 months and older. Among people age 6 months through 64 years, ACIP emphasizes that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk. Details of the vaccination schedule are available here: www.cdc.gov/covid/hcp/vaccine-considerations/routine-guidance.html.

Of note, among previously unvaccinated people who are not moderately or severely immunocompromised, an initial vaccination series is recommended only for young children age 6 through 23 months. All others younger than age 65 years are recommended to receive a single dose of an age-appropriate 2025–2026 formula COVID-19 vaccine. People age 65 years and older are recommended to receive a second 2025–2026 formula COVID-19 vaccine dose 6 months later (minimum interval 2 months if using Comirnaty, Spikevax, or Nuvaxovid; minimum interval 3 months if using mNexspike).

Major U.S. professional medical societies have issued their own recommendations for the 2025–26 COVID-19 season that differ from CDC, primarily in their stronger, routine recommendations for vaccination of people at risk of severe COVID-19 illness:
* American Academy of Pediatrics (AAP) for children: [link removed]
* American Academy of Family Physicians (AAFP) for healthy adults and elderly people: www.aafp.org/family-physician/patient-care/public-health-emergencies/recent-outbreaks/covid-19/covid-19-vaccine.html
* American College of Obstetricians and Gynecologists (ACOG) for pregnancy: www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care
* Infectious Diseases Society of America (IDSA) for immunocompromised people and their close contacts: www.idsociety.org/Seasonal-RTI-Vaccinations-in-Immunocompromised-Patients/

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Q: What is the difference between Spikevax and mNexspike by Moderna?

A: Spikevax and mNexspike are both mRNA vaccines targeting the same strain of COVID-19. Spikevax is the original vaccine now licensed down to age 6 months. The mNexspike product is a newer mRNA vaccine licensed for ages 12 years and older with an advanced design that achieves the same or slightly better immune response with less mRNA in each dose (10 mcg in mNexspike compared to 50 mcg in adult doses of Spikevax). The two products may be used interchangeably when age appropriate.

In adults 65 years and older (and moderately or severely immunocompromised adults) who are recommended to receive a second dose 6 months after their first 2025–2026 formula dose, the minimum interval between the two recommended 2025–26 season doses is 3 months for mNexspike, but only 2 months for the other COVID-19 vaccine products. If mNexspike is inadvertently administered after only 2 months, the dose counts as valid and does not need to be repeated.
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Q: What is the Nuvaxovid (Sanofi-Novavax) COVID-19 Vaccine?

A: Nuvaxovid is the brand name of the adjuvanted protein subunit COVID-19 vaccine developed by Novavax and commercialized by Sanofi beginning in the 2025–26 season. It contains the Omicron JN.1 subvariant SARS-CoV-2 spike protein and Matrix-M adjuvant. The saponin-based adjuvant is made from extracts of the bark of the Soapbark tree native to Chile. It is added to enhance the immune response of the vaccine recipient. The spike protein is produced in insect cells.

The 2025–2026 formulation of Nuvaxovid is FDA-licensed for use in people age 12 years or older. It is recommended as a single dose for people age 12 years through 64 years, given at least 8 weeks after the most recent dose of COVID-19 vaccine, regardless of the recipient’s vaccination history. People age 65 years or older and those age 12 years and older who are moderately or severely immunocompromised are recommended to receive 2 doses of 2025–2026 Formula COVID-19 vaccines, 6 months apart (with a minimum interval of 2 months between doses if using Nuvaxovid for both doses).

A 2-dose initial series is recommended for previously unvaccinated recipients who are moderately or severely immunocompromised, with the doses given at least 3 weeks apart. A third dose of any COVID-19 vaccine is recommended 6 months after the initial series is completed (with a minimum interval of 2 months between doses if using Nuvaxovid).
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Q: What are the differences between the 2025–26 season recommendations for COVID-19 vaccination of children from CDC and from the American Academy of Pediatrics (AAP)?

A: CDC and ACIP recommend vaccination of all people age 6 months through 64 years based on individual decision-making (also known as shared clinical decision-making), with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors. Refer to CDC’s interim clinical considerations for COVID-19 vaccination for the specific dosing schedule: www.cdc.gov/covid/hcp/vaccine-considerations/routine-guidance.html#cdc_clinical_guidance_recomm_key-table-1-2025–2026-covid-19-vaccination-schedule-november-4-2025 ([link removed]) .

The American Academy of Pediatrics (AAP) has issued separate COVID-19 vaccination recommendations for children during the 2025–26 season. Refer to the full statement for details of their recommendations: [link removed]. In summary, AAP recommends age-appropriate COVID-19 vaccination of the following groups of children:
* All children age 6 months through 23 months
* Residents of long-term care facilities or other congregate settings
* Children who have never been vaccinated against COVID-19
* Infants and children with household contacts who are at high risk for severe COVID-19
* All children who are at risk of severe COVID-19 due to underlying conditions or treatments, including: chronic pulmonary disease, cardiovascular disease, gastrointestinal disorders, hepatic disease, hematologic disease, metabolic disorders, obesity, neurologic and neurodevelopmental conditions, immunosuppressive conditions, and rheumatologic or autoimmune disease
* Children age 2 through 18 years not in the above categories whose parent or guardian desires their protection from COVID-19

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Q: Should adults age 65 years and older who are vaccinated against COVID-19 in the 2025–26 season receive one or two doses of COVID-19 vaccine during the season?

A: Adults age 65 years and older have the highest rates of hospitalization and death from COVID-19 illness. Protection against severe COVID-19 disease wanes after a few months. Disease surveillance data from the United States shows that SARS-CoV-2 viruses circulate and cause illness at varying levels year-round, with waves of activity observed historically in winter and late summer. It is not known whether this pattern will continue. This pattern is not like influenza, which usually causes a single epidemic wave (sometimes with more than one peak) each winter.

The 2025 CDC adult immunization schedule shows that adults age 65 years and older who are vaccinated against COVID-19 are recommended to receive a second dose of any 2025–2026 Formula COVID-19 vaccine 6 months after their first 2025–2026 Formula COVID-19 vaccine dose (minimum interval of 2 months for Comirnaty, Spikevax, and Nuvaxovid; minimum interval of 3 months for mNexspike). The second dose does not have to be the same brand as the first.
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Q: My patient turns 12 years old next week and has never had a COVID-19 vaccination. His parents want to vaccinate him. What options are available?

A: This child should receive one dose recommended for his age at the time of the vaccination visit. At age 11 years, an age-appropriate single dose of either Comirnaty (Pfizer-BioNTech) or Spikevax (Moderna) mRNA vaccine is recommended. If the patient arrives in your clinic after turning 12 years old, the 2025–2026 Formula Nuvaxovid (Sanofi-Novavax) protein subunit vaccine and the mNexspike (Moderna) mRNA vaccine are also options.
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Q: Are COVID-19 vaccines safe during pregnancy?

A: Yes. Evidence continues to demonstrate that COVID-19 vaccination is safe and effective during any stage of pregnancy; the benefits of vaccination clearly outweigh any known or potential risks of COVID-19 vaccination during pregnancy. The currently licensed COVID-19 vaccines are nonreplicating vaccines and cannot cause infection in either the mother or the fetus. No evidence exists of risk to the fetus from vaccinating during pregnancy with nonreplicating vaccines in general.

Data from the Vaccine Adverse Events Reporting System (VAERS), the V-safe surveillance system, and the V-safe pregnancy registry have not signaled any safety concerns related to vaccination during pregnancy for mother or infant.

Pregnant women have historically been at an increased risk of severe disease, adverse pregnancy outcomes, and maternal death from COVID-19 infections. ACIP recommends the use of 2025–2026 COVID-19 vaccine during pregnancy based upon individual decision-making (i.e., shared clinical decision-making).

The American College of Obstetricians and Gynecologists (ACOG) recommends all pregnant women receive any age-appropriate 2025–2026 Formula COVID-19 vaccine if they have not already received one. Current ACOG recommendations are available here: www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care.
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Q: What proof do I need before giving COVID-19 vaccine to a patient who says he has a high-risk condition?

A: CDC states that no additional medical documentation is required before administering COVID-19 vaccine. The patient’s self-attestation of a high-risk condition, including moderate or severe immunocompromise, is sufficient. Those who report moderate or severe immunocompromise should be offered the modified schedule for people with moderate or severe immunocompromise. Vaccinators should not deny COVID-19 vaccination to a person due to lack of documentation of a self-reported high-risk condition.
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Q: May different brands of 2025–2026 Formula COVID-19 vaccine be used for immunocompromised people who require multiple doses over time?

A: Immunocompromised people who need an initial series of 3 doses of mRNA COVID-19 vaccine or two doses of Nuvaxovid (Sanofi-Novavax) adjuvanted protein COVID-19 vaccine should receive the initial series using COVID-19 vaccines from the same manufacturer, unless it is not feasible. If the same manufacturer cannot be used for all primary series doses (e.g., the brand is unavailable at the time of the vaccination visit, the previous brand is unknown, or the patient would not be vaccinated with the previous brand due to a contraindication or other reason), then administer another age-appropriate brand. Spikevax (Moderna) is the only licensed 2025–2026 Formula COVID-19 vaccine option for children younger than age 5 years. If the immunocompromised recipient is age 5 years or older, once the initial series is complete, any appropriate brand may be used for all subsequent doses. Spikevax and mNexspike are interchangeable: both vaccines are made by Moderna.
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Q: When giving COVID-19 vaccine, is use of a Vaccine Information Statement (VIS) required?

A: Providing a vaccine recipient with a COVID-19 vaccine VIS is recommended by CDC but not required. The requirement to provide the VIS to a patient is present only when a vaccine is included in the federal Vaccine Injury Compensation Program (VICP). COVID-19 vaccines are not included in the VICP at this time. The current official VIS and all available translations are available from Immunize​.org: www.immunize.org/vaccines/vis/covid-19 ([link removed]) .
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Q: If a patient reports an anaphylactic reaction to an mRNA COVID-19 vaccine two years ago, can they ever be vaccinated against COVID-19?

A: Anaphylaxis occurs at a rate of approximately 5 cases per 1 million mRNA COVID-19 vaccinations administered. History of an anaphylactic reaction to a dose of mRNA COVID-19 vaccine is a contraindication to receipt of further doses of mRNA-type COVID-19 vaccines. However, a person with a contraindication to one type of COVID-19 vaccine (mRNA) may receive the alternative COVID-19 vaccine type (in this case, the adjuvanted protein subunit vaccine, Nuvaxovid) in the usual vaccination setting.

CDC offers additional considerations for patients with a history of allergic reactions in its interim clinical considerations: www.cdc.gov/covid/hcp/vaccine-considerations/contraindications-precautions.html#cdc_vaccine_special_topics_research-considerations-for-people-with-a-history-of-allergies-or-allergic-reactions.

CDC’s Clinical Immunization Safety Assessment (CISA) Project (www.cdc.gov/vaccine-safety-systems/hcp/cisa/) may be an option for a complex COVID-19 vaccine safety question not readily addressed by CDC guidance.
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Q: Tell me about mRNA COVID-19 vaccines and the risk of myocarditis and pericarditis.

A: There is a rare risk of myocarditis (inflammation of the heart muscle) and/or pericarditis (inflammation of the tissue surrounding the heart) following receipt of any COVID-19 vaccine. This rare risk is greatest in biological males age 12 through 39 years. Despite this risk, evaluation conducted in past seasons demonstrated that the benefits of vaccination clearly outweigh the risks in all age groups. SARS-CoV-2 virus infection poses a substantially higher risk of myocarditis or pericarditis than COVID-19 vaccination.

The risk after vaccination appears related to age (12 through 39 years), biological sex (male), and the short (3- to 4-week) interval between initial series doses. For the 2025–2026 formulations, an initial series is no longer recommended except in infants and toddlers younger than age 2 years or in people with moderate or severe immunocompromise. These groups have not historically been associated with an increased risk of pericarditis or myocarditis following COVID-19 vaccination. Extending the interval between doses to 8 weeks in infants and toddlers may reduce the rare risk of myocarditis following the second dose; however, this is not recommended if delaying vaccination poses an unacceptable risk of severe COVID-19 illness.

Most patients diagnosed with myocarditis after mRNA COVID-19 vaccination have been hospitalized for short periods, with most completely recovering from their acute symptoms. Post-vaccination myocarditis is milder than myocarditis following viral infection. CDC continues to assess long-term outcomes in people with myocarditis after mRNA COVID-19 vaccination.

People who receive COVID-19 vaccines, especially males age 12 through 39, should be counseled about the risk of myocarditis or pericarditis and advised to seek medical attention promptly if they develop chest pain, shortness of breath, or feelings of a fast, fluttering, or pounding heartbeat.

Cases of myocarditis and pericarditis were identified in clinical trials of the adjuvanted protein subunit COVID-19 vaccine (now with brand-name Nuvaxovid) and have also been reported during post-authorization use outside the United States.

CDC’s complete interim clinical considerations for COVID-19 vaccination and myocarditis or pericarditis are available here: www.cdc.gov/covid/hcp/vaccine-considerations/safety-considerations.html#cdc_vaccine_special_topics_research-covid-19-vaccination-and-myocarditis-and-pericarditis.

CDC also has published additional clinical considerations for the evaluation and care of patients with myocarditis or pericarditis following mRNA vaccination: www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html.
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Editorial Information
Editor-in-Chief
Kelly L. Moore, MD, MPH
Managing Editor
John D. Gr
äbenstein, RPh, PhD
Associate Editor
Sharon G. Humiston, MD, MPH
Writer/Publication Coordinator
Taryn Chapman, MS
Courtnay Londo, MA
Style and Copy Editor
Marian Deegan, JD
Web Edition Managers
Arkady Shakhnovich
Jermaine Royes
Technical Reviewer
Kayla Ohlde

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IZ Express is supported in part by Grant No. 1NH23IP922654 from the National Center for Immunization and Respiratory Diseases, CDC. Its contents are solely the responsibility of Immunize​.org and do not necessarily represent the official views of CDC.

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