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-Issue 1,571: June 8, 2021-

-Ask the Experts: IAC Answers More Questions about COVID-19 Vaccines-

As an additional service to IAC Express readers, we periodically publish special editions such as this one, providing you with new and updated Ask the Experts questions and answers from IAC experts. This issue includes selected Q&As about recent updates to CDC recommendations for the use of COVID-19 vaccines.

You can find all of these questions and answers, plus more than a thousand others about vaccines and vaccine administration, on our “Ask the Experts” gateway page at www.immunize.org/askexperts.

IAC's team of experts includes Kelly L. Moore, MD, MPH (team lead); Carolyn B. Bridges, MD, FACP; William L. Atkinson, MD, MPH; and Deborah L. Wexler, MD.

More Questions about COVID-19 Vaccines
* Q. Where can I find current COVID-19 vaccine recommendations?
* Q. What do we know about the Pfizer-BioNTech COVID vaccine effectiveness and side effects in children and young teens in the 12- to 15-year-old age group?
* Q. Can COVID-19 vaccination lead to fertility problems?
* Q. Has CDC provided clinical guidance on what to do if an error occurs while administering COVID-19 vaccinations?
* Q. We have a patient who was fully vaccinated with a COVID-19 vaccine not authorized in the U.S. Do we need to revaccinate?
* Q. We have a patient who was partially vaccinated with a COVID-19 vaccine not authorized for use in the U.S. What should we do?
* Q. Can COVID-19 vaccine recipients be given other vaccines at the same visit?
* Q. 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 COVID-19 vaccine dose. It resolved after a few days. Is this a contraindication? Should this alter our plans for dose two?
* Q. Patients concerned about the risk of allergic reaction or side effects following COVID-19 vaccination are asking if they should take acetaminophen, aspirin, and/or antihistamines before receiving COVID-19 vaccination. What does CDC advise?
* Q. What is the thrombosis with thrombocytopenia syndrome, called TTS, associated with the Janssen COVID-19 Vaccine (Johnson & Johnson)?
* Q. What are the symptoms of TTS and where can I learn more about treatment?
* Q. My patient has a history of deep venous thrombosis (DVTs). Is that a precaution or contraindication to vaccination with the Janssen COVID-19 Vaccine?
* Q. I have both mRNA and Janssen vaccines available. Should I avoid offering the Janssen COVID-19 Vaccine to my younger female patients?
* Q. Where can I find details about the storage and handling of COVID-19 vaccines?
* Q: I heard the Pfizer-BioNTech vaccine storage requirements changed in May 2021. Where can I get more information?

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More Questions about COVID-19 Vaccines
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Q. WHERE CAN I FIND CURRENT COVID-19 VACCINE RECOMMENDATIONS?

A: The CDC’s Advisory Committee on Immunization Practices (ACIP) has published recommendations for all COVID-19 vaccines that have received Emergency Use Authorization (EUA) from the federal Food and Drug Administration (FDA). ACIP has also issued recommendations for prioritizing recipients if supplies are limited. 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.

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/clinical-considerations/covid-19-vaccines-us.html

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Q. WHAT DO WE KNOW ABOUT THE PFIZER-BIONTECH COVID VACCINE EFFECTIVENESS AND SIDE EFFECTS IN CHILDREN AND YOUNG TEENS IN THE 12- TO 15-YEAR-OLD AGE GROUP?

A: Clinical trial results demonstrated that the immune response of young adolescents in this age group was similar to that observed in people age 16–25 years. No symptomatic cases of COVID-19 were detected among fully vaccinated people age 12–15 years. Among vaccine recipients age 12–15 years, side effects during the 7 days after vaccination were commonly reported (90.9% of vaccine recipients reported a local reaction and 90.7% reported a systemic reaction). Most reactions were mild to moderate. Pain at the injection site was the most common local reaction. One in 10 reported a side effect that interfered with daily activities. Side effects usually resolved after 1–2 days. Systemic side effects (e.g., fever, fatigue, headache, muscle pain) were more commonly reported after the second dose than after the first dose. No specific safety concerns were identified among adolescent vaccine recipients.

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Q. CAN COVID-19 VACCINATION LEAD TO FERTILITY PROBLEMS?

A: There is no evidence that any of the COVID-19 vaccines affect future fertility.

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Q. HAS CDC PROVIDED CLINICAL GUIDANCE ON WHAT TO DO IF AN ERROR OCCURS WHILE ADMINISTERING COVID-19 VACCINATIONS?

A: 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, and a simple table outlining actions to take after an error has occurred: www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Appendix-A.

The summary table is also available from CDC as a print-ready document: www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-errors-deviations.pdf.

Errors addressed include the following:
* Incorrect route or site
* Incorrect age
* Incorrect dosing interval
* Incorrect dose (high or low)
* Administration after improper storage conditions
* Administration after the expiration/beyond use date
* Diluent errors (wrong diluent, too much or too little) with the Pfizer-BioNTech vaccine

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Q. WE HAVE A PATIENT WHO WAS FULLY VACCINATED WITH A COVID-19 VACCINE NOT AUTHORIZED IN THE U.S. DO WE NEED TO REVACCINATE?

A: Not necessarily. People who completed a COVID-19 vaccination series with a vaccine that has been authorized for emergency use by the World Health Organization (WHO) do not need any additional doses with an FDA-authorized COVID-19 vaccine. People who completed or partially completed a COVID-19 vaccine series with a vaccine that is not authorized by either FDA or WHO may be offered an FDA-authorized COVID-19 vaccine series. The minimum interval between the last dose of a non-FDA authorized vaccine and an FDA-authorized COVID-19 vaccine is 28 days.

Current information about which COVID-19 vaccines are authorized by WHO for emergency use is available here: www.who.int/teams/regulation-prequalification/eul/covid-19.

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Q. WE HAVE A PATIENT WHO WAS PARTIALLY VACCINATED WITH A COVID-19 VACCINE NOT AUTHORIZED FOR USE IN THE U.S. WHAT SHOULD WE DO?

A: People who are partially vaccinated outside the U.S. with a COVID-19 vaccine brand not authorized in the U.S. may be offered a complete FDA-authorized COVID-19 vaccine series. The minimum interval between the last dose of a non-FDA authorized vaccine and an FDA-authorized COVID-19 vaccine is 28 days.

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Q. CAN COVID-19 VACCINE RECIPIENTS BE GIVEN OTHER VACCINES AT THE SAME VISIT?

A: Yes. COVID-19 vaccines and other vaccines may be administered without regard to timing.

COVID-19 vaccines were previously recommended to be administered alone, with a minimum interval of 14 days before or after administration of any other vaccines. This was out of an abundance of caution and not due to any known safety concerns or concerns about interference with effectiveness. Although data are not available for COVID-19 vaccines administered simultaneously with other vaccines, extensive experience with non-COVID-19 vaccines has demonstrated that the immune response and side effects following vaccination are generally similar when vaccines are administered simultaneously and when vaccines are administered alone.

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Q. 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 COVID-19 VACCINE DOSE. IT RESOLVED AFTER A FEW DAYS. IS THIS A CONTRAINDICATION? SHOULD THIS ALTER OUR PLANS FOR DOSE TWO?

A: 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.

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Q. PATIENTS CONCERNED ABOUT THE RISK OF ALLERGIC REACTION OR SIDE EFFECTS FOLLOWING COVID-19 VACCINATION ARE ASKING IF THEY SHOULD TAKE ACETAMINOPHEN, ASPIRIN, AND/OR ANTIHISTAMINES BEFORE RECEIVING COVID-19 VACCINATION. WHAT DOES CDC ADVISE?

A: 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 recommended because information on the impact of such use on COVID-19 vaccine-induced antibody responses is not available at this time.

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.

It is not recommended that people take aspirin or an anticoagulant before vaccination with the Janssen COVID-19 vaccine or any other FDA-authorized COVID-19 vaccine unless they take these medications as part of their routine medications.

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Q. WHAT IS THE THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME, CALLED TTS, ASSOCIATED WITH THE JANSSEN COVID-19 VACCINE (JOHNSON & JOHNSON)?

A: TTS is a rare, immune-mediated syndrome that involves acute venous or arterial thrombosis (blood clot) and new onset thrombocytopenia (low platelet count) in patients with no recent known exposure to heparin. The onset of TTS is typically 1 to 2 weeks following vaccination; treatment with heparin, a common anticoagulant used to treat blood clots, worsens the condition. In the U.S., the majority of people with TTS after Janssen COVID-19 vaccination had clots located in cerebral venous sinuses; clots occurred in other unusual locations including in the portal vein and splenic vein, and also included a combination of venous and arterial thromboses.

On April 13, 2021, after 6 reports of TTS to VAERS, the FDA and CDC recommended a pause in the use of the Janssen vaccine while a thorough safety investigation was conducted. This pause also allowed healthcare professionals to be informed how to recognize, diagnose, treat, and report suspected cases of TTS. On April 23, 2021, based on its conclusion that the risk of severe COVID-19 disease substantially outweighed the rare risk of TTS, ACIP reaffirmed its interim recommendation for use of the Janssen vaccine in all people age 18 years and older under the FDA EUA.

The highest rates of TTS were identified by CDC in women younger than age 50 years. At the time the pause was lifted, the rate was 7 cases per million Janssen vaccine doses administered to women age 18–49 years and 0.9 per million to women age 50 years and older.

The FDA’s EUA fact sheets now include a warning that rare TTS might occur after vaccination, primarily among women age 18–49 years. It is critical to ensure that women younger than age 50 years are aware of the increased risk for TTS after receipt of the Janssen vaccine and the availability of other FDA-authorized COVID-19 vaccines (i.e., mRNA vaccines) not associated with TTS.

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Q. WHAT ARE THE SYMPTOMS OF TTS AND WHERE CAN I LEARN MORE ABOUT TREATMENT?

A: TTS following vaccination with the Janssen COVID-19 Vaccine (Johnson & Johnson) is rare, but the risk is increased among women younger than age 50 years. Symptom onset typically begins 1 to 2 weeks after vaccination. People should seek medical attention right away if they have any of the following symptoms after receiving the Janssen vaccine:
* Shortness of breath
* Chest pain
* Leg swelling
* Persistent abdominal pain
* Severe or persistent headaches or blurred vision
* Easy bruising or tiny blood spots under the skin beyond the site of the injection

Treatment of TTS is different from the treatment of typical blood clots; heparin should be avoided in any patient suspected of TTS until the diagnosis can be ruled out.

For additional clinical guidance, see the CDC Health Alert Network Report from April 13, 2021: emergency.cdc.gov/han/2021/han00442.asp and treatment guidelines from the American Society for Hematology: www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia.

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Q. MY PATIENT HAS A HISTORY OF DEEP VENOUS THROMBOSIS (DVTS). IS THAT A PRECAUTION OR CONTRAINDICATION TO VACCINATION WITH THE JANSSEN COVID-19 VACCINE?

A: Venous thromboembolism (VTE), defined as deep vein thrombosis, pulmonary embolism, or both, are common. The biologic mechanisms for VTE (as well as arterial thrombi) differ from the underlying immune-mediated mechanism for thrombosis with thrombocytopenia syndrome (TTS). Experts believe that the presence of risk factors for VTE does not make individuals more susceptible to TTS after vaccination with the Janssen vaccine. These people can receive any FDA-authorized vaccine, including the Janssen vaccine.

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Q. I HAVE BOTH MRNA AND JANSSEN VACCINES AVAILABLE. SHOULD I AVOID OFFERING THE JANSSEN COVID-19 VACCINE TO MY YOUNGER FEMALE PATIENTS?

A: All who prefer the Janssen vaccine may be offered that option, if available. It is critical that all women younger than age 50 be made aware of the rare, but increased, risk of TTS following Janssen vaccine administration and the availability of other COVID-19 vaccines not associated with TTS. However, the ACIP has concluded that the risks of delaying full immunization while the virus that causes COVID-19 is circulating widely substantially outweigh the risk of TTS. Completing vaccination with a single dose is an advantage, and a priority, for some recipients.

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Q. WHERE CAN I FIND DETAILS ABOUT THE STORAGE AND HANDLING OF COVID-19 VACCINES?

A: 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.

CDC also has produced a printable quick reference guide summarizing the storage and handling requirements for each authorized COVID-19 vaccine: www.cdc.gov/vaccines/covid-19/downloads/covid19-vaccine-quick-reference-guide-2pages.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.

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Q: I HEARD THE PFIZER-BIONTECH VACCINE STORAGE REQUIREMENTS CHANGED IN MAY 2021. WHERE CAN I GET MORE INFORMATION?

A: In May 2021, the FDA authorized storage of the Pfizer-BioNTech vaccine at refrigerated temperatures, between 2°C and 8°C (36°F and 46°F), for up to 1 month (31 days). Details of this change and other information is available from CDC in a printable storage and handling document: www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf.

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Editorial Information
Editor-in-Chief
Kelly L. Moore, MD, MPH (mailto:[email protected])
Managing Editor
John Grabenstein, RPh, PhD (mailto:[email protected])
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Courtnay Londo, MA (mailto:[email protected])
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