Adult Immunization Update Disclosures

5/20/2021

Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Adult Immunization Update

Andrew Kroger M.D., M.P.H. Medical Officer Immunization Services Division

18 Annual Immunize Nebraska Conference May 21, 2021

Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.

Disclosures

. Andrew Kroger is a federal government employee with no financial interest or conflict with the manufacturer of any product named in this presentation. . Andrew Kroger will discuss the off-label use of live-attenuated measles-mumps- rubella (MMR) vaccine, live-attenuated varicella (Var) vaccine, tetanus-reduced- diphtheria-reduced-acellular-pertussis (Tdap) vaccine, and hepatitis A (HepA) vaccine. . Andrew Kroger will discuss COVID-19 vaccine, currently authorized but not licensed by FDA. . The use of trade names is for identification purposes only and does not imply endorsement by the ACIP or CDC.

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Overview

. Adult Schedule overview . Pregnancy and vaccination (MMR, Var, HPV) . Tdap (or Td) recommendations . Hepatitis A recommendations . COVID-19 vaccine

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RECENT ACIP—VACCINE SPECIFIC RECOMMENDATIONS

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Pregnancy and Vaccination

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Vaccinate After Pregnancy

. MMR vaccine – vaccinate after pregnancy – pregnancy a contraindication to MMR vaccine . Varicella vaccine – vaccinate after pregnancy – pregnancy a contraindication to Var vaccine . HPV Vaccine – vaccinate after pregnancy – pregnancy NOT a contraindication to HPV vaccine – red color indicates “not recommended” . Other vaccines either contraindicated or not recommended which lack the pregnancy guidance – LAIV vaccine (contraindicated) – alternative vaccine is available for vaccination during pregnancy.

Tetanus-reduced-diphtheria-reduced-acellular- pertussis Vaccine (Tdap)

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Tetanus-reduced-diphtheria Acellular Pertussis Vaccine (Tdap) - Changes

. For tetanus and/or diphtheria component catch-up, after the first dose is administered as Tdap, future doses can be administered as EITHER Tdap or Td. . Doses administered for wounds can be either Tdap or Td. . Doses administered in every current pregnancy should be Tdap ONLY.

Tdap Recommendations: Pregnant Women

. Administer a dose of Tdap during each pregnancy, regardless of the patient's prior history of receiving the vaccine. . Tdap should be administered between 27 and 36 weeks’ gestation, although it may be given at any time during pregnancy. – currently available data suggest that vaccinating earlier in the 27- through 36-week time period will maximize passive antibody transfer to the infant.

*Off-label ACIP recommendation MMWR 67(2):1–44

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Tdap and Pregnant Women

. Vaccination coverage for pregnant women: - 2010 and earlier <1% - 2013 28% - 2015 53%

. 96% of Tdap vaccinations were administered in physicians’ offices or clinics.

MMWR 66(41):1105–1108

Maternal Tdap Vaccination Is Very Effective in Prevention of Infant Pertussis Infection Definitions Vaccine effectiveness Infant age at Mother gestational age (95% confidence intervals) pertussis onset received Tdap United Kingdom Observational,1 91% (83–95%) Younger than At least 28 days before birth* screening method 3 months Case-Control,2 91% (77–97%), unadjusted Younger than 2 Cases: 31.5 weeks (range, 28–38) retrospective 93% (81–97%), adjusted¶ months Controls: 33 weeks (range, 26–38) United States Cohort,3 85% (33–98%) Younger than 27–36 weeks retrospective 2 months Case-Control,4 78% (44–91%) Younger than 27–36 weeks retrospective 2 months

*2012 UK recommendation: Tdap between 28 and 38 weeks ¶Adjusted for sex, geographical area, and birth period 1Amirthalingam G, et al. 2014; 2Dabrera G, et al. 2015; 3Winter K, et al. 2016; 4CDC, unpublished

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ACIP Conclusions: Safety of Tdap for Every Pregnancy

. Data reassuring on 2 doses of Tdap

. Data and experience with tetanus toxoid vaccine suggest no excess risk of adverse events. • ~5% of women would receive 4 or more doses

. CDC provides ongoing monitoring to address concerns about the safety of Tdap given during subsequent pregnancies.

Postpartum Women and Close Contacts of Infants

. Previously unvaccinated or vaccination status unknown–administer Tdap

. Previously vaccinated persons–Tdap is NOT indicated – including mothers, fathers, siblings, and grandparents – any previous, documented dose counts.

8 5/20/2021

Hepatitis A

Adult Hepatitis A Vaccination Recommendations . Travelers to areas with moderate or high incidence of hepatitis A . HIV infection . Homeless persons . Men who have sex with men . Illegal drug users . Persons with occupational risk . Persons with chronic liver disease, including hepatitis C . Household contacts of international adoptees within 60 days of the adoptee’s arrival in U.S. . Patients in settings in which high-risk patients are seen

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Hepatitis A Vaccine – New CDC Guidance

. For patients who are HIV positive . HepA vaccine is recommended (not new) . Post vaccination serology is recommended – revaccination can be considered if negative

COVID-19 Vaccination Clinical Considerations

For more information: www.cdc.gov/COVID19

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COVID-19: Emergence . Identified in Wuhan, China in December 2019 . Caused by the virus SARS-CoV-2 . Early on, many patients were reported to have a link to a large seafood and live animal market. . Later patients did not have exposure to animal markets. – indicated person-to-person spread . Travel-related exportation of cases reported – first U.S. case: January 20, 2020 https://www.cdc.gov/mmwr/volumes/69/wr/mm6924e2.htm?s_cid=mm6924e2_w . CDC is reporting confirmed COVID-19 cases in the U.S. online. at www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html

COVID-19: Epidemiology . https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases (May 10, 2021)

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COVID-19: Epidemiology . https://covid.cdc.gov/covid-data-tracker/#global-counts-rates (May 11, 2021)

Clinical Considerations for COVID-19 Vaccines

. Recommendations apply to both Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines

. Guidance may change as further information becomes available.

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html 24

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Dosing and Administration

Pfizer-BioNTech Moderna Janssen

Authorized age groups ≥ 12 years ≥ 18 years ≥ 18 years

Number of doses in series 2 doses 2 doses 1 dose

Interval between 1st and 3 weeks 1 month NA 2nd doses* Dose volume 0.3 ml 0.5 ml 0.5 ml

Route Intramuscular Intramuscular Intramuscular

*If it is not feasible to adhere to the recommended interval, the second dose may be administered up to 6 weeks (42 days) after the first dose. 25

Strategies to Improve 2nd Dose Compliance for mRNA COVID-19 Vaccines . Providing COVID-19 vaccination record cards to vaccine recipients, asking recipients to bring their card to their appointment for the second dose, and encouraging recipients to make a backup copy

. Encouraging vaccine recipients to enroll in VaxTextSM, a free text message-based platform to receive COVID-19 vaccination second-dose reminders

. Recording each recipient’s vaccination in the immunization information system (IIS)

. Recording vaccine administration information in the patient’s medical record

. Making an appointment for the second dose before the vaccine recipient leaves

https://www.cdc.gov/vaccines/covid-19/reporting/vaxtext/index.html

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Post-Vaccination Symptoms

. Before vaccination, providers should counsel vaccine recipients about expected local and systemic post-vaccination symptoms . Depending on vaccine product, age group, and dose: – 35-91% of clinical trial participants reported ≥1 local reaction (e.g., pain or swelling at injection site; swollen lymph nodes on same side as vaccinated arm) – 45-83% of clinical trial participants reported ≥1 systemic reaction (e.g., fever, fatigue, muscle aches, headache, chills) – most are mild-moderate in severity, occur within first 3 days of vaccination, and resolve within 1-2 days of onset – more frequent and severe following the second dose and among younger age groups

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/reactogenicity.html 27

Persons with a History of SARS-CoV-2 Infection

. Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection.

. Vaccination should be deferred until recovery from acute illness (if person had symptoms) and criteria have been met to discontinue isolation. – no minimum interval between infection and vaccination – Current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, may increase with time following initial infection.

. Viral or serologic testing for acute or prior infection, respectively, is not recommended for the purpose of vaccine decision-making. 28

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Persons who Previously Received Passive Antibody Therapy for COVID-19 . Currently no data on safety or efficacy of COVID-19 vaccination in persons who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment

. Vaccination should be deferred for at least 90 days to avoid interference of the treatment with vaccine-induced immune responses. – recommendation also applies to persons who receive passive antibody therapy after receiving first mRNA COVID-19 vaccine dose

Persons with a Known SARS-CoV-2 Exposure

. Community or outpatient setting: – Defer vaccination until quarantine period has ended to avoid exposing healthcare personnel (HCP) or other persons during vaccination visit

. Residents of congregate healthcare settings (e.g., long-term care facilities): – May be vaccinated, as likely would not result in additional exposures. – HCP are already in close contact with residents and should employ appropriate infection prevention and control procedures

. Residents of congregate settings (e.g., correctional facilities, homeless shelters) – May be vaccinated, in order to avoid delays and missed opportunities for vaccination – Where feasible, precautions should be taken to limit mixing of these individuals with other residents or non-essential staff

https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html

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Contraindications to COVID-19 Vaccination Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines

. Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine

. Immediate allergic reaction* of any severity to a previous dose or known (diagnosed) allergy to a component of the vaccine

. Note: People with a contraindication to one of the mRNA COVID-19 vaccines should not receive doses of either of the mRNA vaccines (Pfizer-BioNTech or Moderna)

Precautions to COVID-19 Vaccines Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines

. Severe or moderate acute illness . Any immediate allergic reaction to any other vaccine or injectable therapy

– unknown risks of developing a severe allergic reaction should be balanced against the benefits of vaccination

– deferral of vaccination and/or consultation with an allergist-immunologist may be considered

. Note: Persons with a contraindication to mRNA COVID-19 vaccines have a precaution to Janssen COVID-19 vaccine, and vice versa

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Potential Cross-reactivity Between COVID-19 Vaccines: Polyethylene Glycol (PEG) and Polysorbate

. Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines

. Polysorbate 80 is an ingredient in Janssen COVID-19 vaccine

. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds may occur

Potential Cross-reactivity Between COVID-19 Vaccines

. People with a contraindication to one of the mRNA COVID-19 vaccines (including due to known PEG allergy) – should not receive doses of either of the mRNA vaccines (Pfizer-BioNTech or Moderna) – have a precaution to Janssen COVID-19 vaccine

. People with a contraindication to Janssen COVID-19 vaccine (including due to a known allergy to polysorbate) – have a precaution to mRNA COVID-19 vaccines

. For people with these precautions for either of these reasons – referral to an allergist-immunologist should be considered. – vaccination should only be undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions.

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Observation Period Following Vaccination

Persons with a precaution to vaccination or a history of anaphylaxis All other persons (due to any cause)

30 minutes 15 minutes 35

Triage of Persons Presenting for COVID-19 Vaccination CONTRAINDICATION TO VACCINATION PRECAUTION TO VACCINATION MAY PROCEED WITH VACCINATION

ALLERGIES ALLERGIES ALLERGIES History of the following: Among people without a contraindication, a history Among persons without a contraindication or • Severe allergic reaction (e.g., anaphylaxis) after a of: precaution, a history of: previous dose or to component of the vaccine • Any immediate allergic reaction* to other • Allergy to oral medications (including the oral vaccines or injectable therapies‡ equivalent of an injectable medication) • Immediate allergic reaction* of any severity after • History of food, pet, insect, venom, a previous dose or known (diagnosed) allergy to a Note: people with a contraindication to mRNA environmental, latex, etc., allergies component of the vaccine COVID-19 vaccines have a precaution to Janssen • Family history of allergies COVID-19 vaccine, and vice versa. See footnote for additional information on additional measures to take in these people.#

ACTIONS ACTIONS • Risk assessment ACTIONS • Do not vaccinate. • Consider referral to allergist-immunologist • 30-minute observation period: Persons with a • Consider referral to allergist-immunologist. • 30-minute observation period if vaccinated history of anaphylaxis (due to any cause) • Consider other vaccine alternative. • 15-minute observation period: All other persons SEVERE OR MODERATE ACUTE ILLNESS

* Immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration. ‡Includes people with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is a vaccine component, but in whom it is unknown which component elicited the immediate allergic reaction. #Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Janssen COVID-19 vaccine. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity between these compounds may occur. People with a contraindication to mRNA COVID-19 vaccines (including due to a known allergy to PEG) have a precaution to Janssen COVID-19 vaccine. Among people who received one mRNA COVID-19 dose but for whom the second dose is contraindicated, consideration may be given to vaccination with Janssen COVID-19 vaccine (administered at least 28 days after the mRNA COVID-19 dose). People with a contraindication to Janssen COVID-19 vaccine (including due to a known allergy to polysorbate) have a precaution to mRNA COVID-19 vaccines. In patients with these precautions, vaccination should only be undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions.

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Post-Vaccination Symptoms – Adverse Reactions

https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/reactogenicity.html https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html 37

Reporting Adverse Events

. Adverse events, whether or not they are adverse reactions or not, should be reported if concerning . Report to Vaccine Adverse Event Reporting System www.vaers.hhs.gov . V-safe is an active surveillance system – related to VAERS

. Clinical Immunization Safety Assessment (provider reporting) https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html

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Active Safety Monitoring for COVID-19 Vaccines

. V-safe is a new CDC smart-phone based monitoring program for COVID-19 vaccine safety. ―uses text messaging and web surveys to check-in with vaccine recipients after vaccination ―parcipants can report any side eﬀects or health problems aer COVID-19 vaccination ―includes acve telephone follow-up by CDC for reports of significant health impact

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/v-safe.html 40

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Post-Vaccination Symptoms – v-safe Data – December 14, 2021 through January 13, 2021 mRNA Vaccines Only Symptom % in v-safe Injection Site Pain 70.9 Fatigue 33.5 Headache 29.5 Myalgia 22.9 Chills 11.6 Fever 11.4 Injection Site Swelling 10.8 Joint Pain 10.4 Nausea 8.9

https://www.cdc.gov/mmwr/volumes/70/wr/mm7008e3.htm?s_cid=mm7008e3_w 41

42 https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7017e4-H.pdf

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Thrombosis*

. Thrombosis occurs when blood clots block blood vessels – thromboses can be venous or arterial. – complications include heart attack, stroke – symptoms may include: • pain and swelling in an extremity, chest pain, numbness or weakness on one side of the body, sudden change in mental status – causes and risk factors include: • trauma, immobility, inherited disorders (genetic), autoimmune disease, obesity, hormone therapy or birth control pills, pregnancy, smoking, cancer, older age . Diagnosed mainly through imaging (e.g., CT, MRI, ultrasound) and blood tests (d-dimer) * Source: https://www.hopkinsmedicine.org/health/conditions-and-diseases/thrombosis

Platelets and Thrombocytopenia (Low Platelets)*

. Platelets (thrombocytes) are colorless blood cells that help blood clot; normal platelet count is 150,000–450,000 per microliter. . Platelets stop bleeding by clumping and forming plugs in blood vessel injuries. . Thrombocytopenia is a condition in which you have a low blood platelet count (<150,000 per microliter). . Dangerous internal bleeding can occur when your platelet count falls below 10,000 per microliter. . Though rare, severe thrombocytopenia can cause bleeding into the brain, which can be fatal.

* Source: https://www.mayoclinic.org/diseases-conditions/thrombocytopenia/symptoms-causes/syc-20378293

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Reporting Rates of TTS After Janssen COVID-19 Vaccine

8.73 million total Janssen COVID-19 vaccine doses administered* Females Males TTS Doses Reporting rate† TTS Doses Reporting rate† Age group cases admin (per million) cases admin (per million) 18-29 yrs. old 3 641,510 4.7 2 714,458 2.8 30-39 yrs. old 8 642,745 12.4 1 728,699 1.4 40-49 yrs. old 7 743,256 9.4 1 775,390 1.3 50-64 yrs. old 4 1,463,416 2.7 2 1,505,505 1.3 65+ yrs. old 0 814,947 0 0 697,925 0

45 * Source of doses administered: https://covid.cdc.gov/covid-data-tracker/#vaccinations; † Reporting rate = TTS cases per 1 million Janssen COVID-19 vaccine doses administered 45

Summary . The clinical features of TTS following Janssen COVID-19 vaccine appear similar to what is being observed following AstraZeneca COVID-19 vaccination in Europe. . It is important to recognize TTS early and initiate appropriate treatment ‒ Do not treat thrombosis with thrombocytopenia cases with heparin unless heparin-PF4 ELISA HIT antibody testing is negative . TTS does not appear to be associated with mRNA COVID-19 vaccines. . The U.S. vaccine safety monitoring system is able to rapidly detect rare adverse events following immunization and quickly assess safety signals. . Safety surveillance and research on TTS continues

23 5/20/2021

Questions?