Changes in CDC Vaccination Guidance 2020

SUMMARY:

Changes to the CDC Adult Immunization Schedule for 2020

Influenza

• Routine annual influenza vaccination is recommended for
  • All individuals ≥6 months who do not have contraindications
  • One influenza vaccine product is not preferred over another
• LAIV (influenza vaccine, live attenuated) is an option for adults through age 49 years with the following exceptions
  • Immunocompromising conditions, including HIV infection
  • Anatomical or functional asplenia
  • Pregnancy
  • Close contact with or are caregivers of severely immunocompromised persons in a protected environment
  • Have received influenza antiviral medications in the previous 48 hours
  • Cerebrospinal fluid leak
  • Cochlear implant

Note: “Those with a history of Guillain–Barré syndrome within 6 weeks of a previous dose of influenza vaccine generally should not be vaccinated, unless vaccination benefits outweigh risks for those at higher risk for severe complications from influenza.”

Hepatitis A

• HepA vaccination is recommended for
  • All persons with HIV ≥1 year
• Clotting factor disorders recommendation has been removed from the list
• List of other higher risk population groups “has not changed significantly” and includes the following
  • Chronic liver disease
  • Travelers in countries with high or intermediate endemic hepatitis A
  • Close, personal contact with an international adoptee in the first 60 days after arrival from a country with high or intermediate endemic hepatitis A
  • Men who have sex with men
  • Persons who use injection or noninjection drugs
  • Persons experiencing homelessness
  • Persons who work with hepatitis A virus in a laboratory or nonhuman primates infected with the virus
• Expanded definition of chronic liver disease: Now includes, but is not limited to persons with
  • Hepatitis B | Hepatitis C | Cirrhosis | Fatty liver disease | Alcoholic liver disease | Autoimmune hepatitis | ALT or AST level >2x upper limit of normal
• Pregnancy: A 2-dose series HepA (or 3-dose series HepA-HepB) is recommended for pregnant women if they are at risk for Infection or severe outcome from infection during pregnancy
• HepA vaccination is recommended for persons working in settings of exposure, including
  • Those working in health care settings for injection or noninjection drug users or group homes and nonresidential day care facilities for developmentally disabled persons)

Note: Any person who is not at risk for hepatitis A virus infection but wants protection against it may be vaccinated

Hepatitis B

• The list of populations at risk for hepatitis B infection or severe hepatitis B disease has not changed
• High risk list includes persons with
  • Hepatitis B | Hepatitis C | Cirrhosis | Fatty liver disease | Alcoholic liver disease | Autoimmune hepatitis | ALT or AST level >2x upper limit of normal
  • HIV infection
  • Sexual exposure risk such as
    • Sex partners of hepatitis B surface antigen [HBsAg]–positive person | Sexually active persons not in mutually monogamous relationships | Persons seeking evaluation or treatment of a sexually transmitted infection | Men who have sex with men
  • Current or recent injection drug use
  • Percutaneous or mucosal risk for exposure to blood such as
    • Household contacts of HBsAg-positive persons | Residents and staff of facilities for developmentally disabled persons | Health care and public safety personnel with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids | Hemodialysis |Peritoneal dialysis | Home dialysis | Predialysis patients
  • Diabetes mellitus
    • < 60 years
    • ≥60 years (at the discretion of the treating clinician)
  • Incarcerated persons
  • Persons traveling in countries with high or intermediate endemic hepatitis
• Pregnancy – new ‘at risk group’
  • If at risk for infection or severe outcome from infection during pregnancy
  • Not recommended: HepB-Cpg (Heplisav-B) administration due to a lack of safety data

HPV

Catch-up HPV vaccination (not adequately vaccinated previously)

• Through age 26
  • Catch-up HPV vaccination recommended for all adults, male and female
• 27 through 45 years
  • Shared clinical decision-making is recommended

Public health benefit of HPV vaccinations for adults in this age range is minimal, yet some persons who are not adequately vaccinated might benefit. HPV vaccination does not need to be discussed with most adults older than 26 years of age, but clinicians can consider discussing HPV vaccination with persons who are most likely to benefit. HPV vaccines are not licensed for use in adults older than age 45 years.

Measles, mumps, and rubella (MMR)

• Healthcare workers: Additional language added to address and clarify indications for health care workers
  • Born ≥1957 without evidence of immunity to measles, mumps, or rubella: A 2-dose series at least 4 weeks apart and at least 1 dose of MMR “should be administered” for rubella immunity
  • Born <1957 without evidence of immunity to measles, mumps, or rubella: “Consider” a 2-dose series at least 4 weeks apart for measles or mumps immunity and at least 1 dose MMR for rubella immunity

Meningococcal B

• Persons ≥10 years with complement deficiency, complement inhibitor use, or asplenia or who are microbiologists
  • “Should receive” a MenB booster dose 1 year following completion of a MenB primary series, followed by MenB booster doses every 2–3 years thereafter, for as long as the increased risk remains
• Persons ≥10 years determined by public health officials to be at increased risk during an outbreak
  • ACIP Recommends a one-time booster dose if it has been 1 year or more since completion of a MenB primary series
  • A booster dose interval of 6 months or more may be considered by public health officials depending on the specific outbreak, vaccination strategy, and projected duration of elevated risk

Pneumococcal Vaccination

• PCV13 (pneumococcal 13-valent conjugate vaccine)
  • Offer based on shared clinical decision-making for adults ≥65 years and who have not previously received PCV13
  • Do not offer to those with an immunocompromising condition, cerebrospinal fluid leak, or cochlear implant
• PPSV23 (pneumococcal 23-valent polysaccharide vaccine
  • Recommended for all adults ≥65 years

Tetanus, Diphtheria, And Pertussis

• ACIP recommends either Td or Tdap vaccine be used for the following clinical situations where only Td vaccine is currently recommended
  • Decennial booster
  • Tetanus prophylaxis in wound management
  • Catch-up immunization schedule, including in pregnant women

Varicella

• Consider vaccination for persons with HIV without evidence of varicella immunity who have CD4 counts ≥200 cells/µL

Learn More – Primary Sources:  

Recommended Adult Immunization Schedule, United States, 2020

Shingles Vaccine: CDC/ACIP Recommendations 

SUMMARY:  

In October 2017, the FDA approved and ACIP recommended a Shingrix (RZV) vaccine for adults ≥50 years of age. Zostavax (ZVL) is no longer available for use in the United States, as of November 18, 2020.

• Herpes Zoster and Postherpetic Neuralgia
• Zoster Vaccine Recommendations
• Clinical Guidance
• Counseling and Adverse Events
• Special Populations

Herpes Zoster and Postherpetic Neuralgia 

• Herpes zoster is a localized, painful, cutaneous eruption resulting from reactivation of latent varicella zoster virus (VZV) 
• Approximately one million cases occur each year in the United States  
• Incidence increases with age 
  • 50 to 59 years of age: 5 cases per 1,000  
  • ≥80 years: 11 cases per 1,000  
• Postherpetic Neuralgia is the most common complication  
  • Defined as persistent pain for at least 90 days following the resolution of the herpes zoster rash 
  • Occurs in 10 to 13% of herpes zoster cases in persons aged >50 years and risk increases with age 

Herpes Zoster Vaccine Recommendations  

Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged ≥50 years 

• Two doses of Shingrix provides strong protection against shingles and postherpetic neuralgia (PHN), the most common complication of shingles
  • Shingles Prevention: In adults 50 to 69 years old who got two doses, Shingrix was 97% effective; among adults 70 years and older, Shingrix was 91% effective
  • Postherpetic Neuralgia: In adults 50 to 69 years old who got two doses, Shingrix was 91% effective; among adults 70 years and older, Shingrix was 89% effective
• Shingrix protection remained high (more than 85%) in people 70 years and older throughout the four years following vaccination
• Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received Zostavax or have already had herpes zoster
• There is no maximum age for Shingrix

Clinical Guidance 

• Administer 2 doses (0.5 mL each) administered intramuscularly 2 to 6 months apart 
• Shingrix may be used in adults aged ≥50 years, irrespective of prior receipt of varicella vaccine or Zostavax 
• If patient previously received Zostavax
  • Consider the patient’s age and when he or she received Zostavax to determine when to vaccinate with Shingrix | Differences in efficacy between Shingrix and Zostavax are most pronounced among older patients
  • Studies examined the safety of Shingrix vaccination five or more years after Zostavax vaccination | Shorter intervals were not studied, but there are no theoretical or data concerns to indicate that Shingrix would be less safe or effective if administered less than five years after a patient received Zostavax
• Screening for a history of chickenpox (varicella) not required  
  • Recombinant and adjuvanted vaccines, such as Shingrix, can be administered concomitantly at the same visit, at different anatomic sites, with other adult vaccines (e.g., influenza and pneumococcal vaccines) 
• Shingrix is not a treatment for herpes zoster or postherpetic neuralgia  
• Pregnancy and breastfeeding 
  • There are no available data to establish whether Shingrix is safe in pregnant or lactating women   
  • Consider delaying vaccination with Shingrix in such circumstance 

KEY POINTS:  

Counseling and Adverse Events  

• Reactions to the first dose of Shingrix did not strongly predict reactions to the second dose 
• Vaccine recipients should be encouraged to complete the series even if they experienced a grade 1 to 3 reaction to the first dose of Shingrix  
  • In studies, Grade 3 solicited symptoms were defined as “preventing normal everyday activity” (pain, headache, fatigue, gastrointestinal symptoms, myalgia, shivering) | surface diameter >100 mm (redness/swelling) | tympanic/oral/axillary temperature >39.0 °C (fever)  
  • Grade 3 unsolicited adverse events were also defined as “preventing normal, everyday activities” 

Adverse Events

• The impact of prophylactic analgesics in conjunction with Shingrix has not been studied 
• Adverse local events are relatively common and include 
  • Pain  
  • Redness  
  • Swelling  
• General adverse reactions include  
  • Myalgia  
  • Fatigue  
  • Headache  
  • Shivering  
  • Fever  
  • Gastrointestinal symptoms
• Severe (rare) events include
  •  Difficulty breathing
  • Wheezing
  • Hives
  • Pale skin
  • Fast heartbeat
  • Dizziness 
• Contraindications 
  • History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine OR after previous dose  
  • Acute episode of herpes zoster | Wait until acute episode has abated 

Special Populations 

• Persons with a history of herpes zoster 
  • Adults with a history of herpes zoster should receive Shingrix as herpes zoster can recur  
• Persons with chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, and chronic pulmonary disease) 
  • Shingrix should be used 
• Immunocompromised persons  
  • Shingrix may be used in persons taking low-dose immunosuppressive therapy (e.g., <20 mg/day of prednisone or equivalent or using inhaled or topical steroids), persons anticipating immunosuppression or who have recovered from an immunocompromising illness
  • Advisory Committee on Immunization Practices recommended 2 RZV doses for prevention of herpes zoster and related complications in immunodeficient or immunosuppressed adults aged ≥19 years
  • Second RZV dose should be given 2 to 6 months after the first | For persons who are or will be immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first
• Persons known to be VZV negative 
  • Screening for a history of varicella (either verbally or via laboratory serology) is not recommended 
  • However, in persons known to be VZV negative via serologic testing, ACIP guidelines for varicella vaccination should be followed 
    • All healthy adults should be assessed for varicella immunity, and those who do not have evidence of immunity should receive 2 doses of single-antigen varicella vaccine 4-8 weeks apart 
    • Shingrix has not been evaluated in persons who are VZV seronegative and the vaccine is not indicated for the prevention of chickenpox (varicella) 

Learn More – Primary Sources:

CDC MMWR: Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 | MMWR (cdc.gov)

CDC: Shingles (Herpes Zoster) Vaccination Information for Healthcare Providers

FDA: SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted)  

CDC Epidemiology and Prevention of Vaccine-Preventable Diseases; The Pink Book: Course Textbook – 13th Edition (2015)

Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study