IMMUNIZE WISE:
2021 IMMUNIZATION
UPDATE
AMY BACHYRYCZ, PHARMD
CAROL CUMMINS, PHARMD
OBJECTIVES
•1) Identify how recent HHS, NMBOP, and ACIP recommended changes may impact pharmacy practice.
•2) Explain the reasons the ACIP recommendation was made, including changes in epidemiology of disease, data from clinical trials, newly available vaccines, or safety issues discovered.
•3) Discuss newly available information regarding existing and emerging vaccines, shortages and availability of vaccines, safety concerns, outbreaks of vaccine preventable diseases, and federal level guidelines.
HHS UPDATE
HTTPS://WWW.HHS.GOV/SITES/DEFAULT/FILES/PREP-ACT-GUIDANCE.PDF
•The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians and the vaccine must be FDA-authorized or FDA-licensed.
•In the case of a COVID-19 vaccine, the vaccination must be ordered and
administered according to ACIP’s COVID-19 vaccine recommendation(s).
•In the case of a childhood vaccine, the vaccination must be ordered and
administered according to ACIP’s standard immunization schedule. •The qualified pharmacy technician or state-authorized pharmacy intern must
complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
HHS UPDATE CONT.
•The qualified pharmacy technician or State-authorized pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
•The qualified pharmacy technician must complete a minimum of two hours of ACPE- approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
NOTE: THE HHS INFORMATION IN THIS PRESENTATION IS NOT COMPLETE, PLEASE CLICK THE HHS LINK ABOVE FOR FULL FEDERAL GUIDANCE.
NM BOP UPDATE
•HTTP://WWW.RLD.STATE.NM.US/UPLOADS/FILELINKS/AD6770C244F74BD AAEAA53842023B4C7/TECHNICIAN_VACCINE_ADMINISTRATION_AND_C OVID_TESTING_II.PDF
ADVISORY COUNCIL ON IMMUNIZATION
PRACTICES (ACIP) UPDATE PROCESS
•The ACIP holds three meetings each year at the CDC in Atlanta, to review scientific data and vote on vaccine recommendations.
•Meetings are open to the public and available online via live webcast.
•An interested person who wishes to make an oral public comment during an ACIP meeting should submit a request with the CDC before the meeting.
•Largely a formality, the ACIP is required to vote on all changes made to the adult and child immunization schedule since October 2019, prior to publication in the Morbidity and Mortality Weekly Report (MMWR) in February 2021.
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SHARED CLINICAL DECISION MAKING
•HTTPS://WWW.CDC.GOV/VACCINES/ACIP/ACIP-SCDM-FAQS.HTML
ACIP UPDATE
•PREVNAR 13 (PCV 13)
•WHAT: In 2020 for 65+, this went from required (yellow bar on ACIP schedule) to shared clinical decision making (blue bar on ACIP schedule).
•WHY: PCV 13 vaccine in 65+ has not shown a relevant reduction in the incidence of Community Acquired Pneumonia (CAP), Lower Respiratory Tract Infections (LRTI), or antibiotic use in primary care.
• ACIP determined the cost and disease burden of CAP and LRTI is relatively low.
• Researchers advised the prevention of CAP and LRTI in primary care does not drive the societal value of PCV 13 vaccine in 65+.
•2021: Shared Clinical Decision Making will remain on the ACIP schedule for Prevnar13 in 65+ the population.
CONJUGATE VACCINES
•Remember, this type of vaccine is created by joining an antigen to a protein molecule (polysaccharide antigen with carrier protein).
•It is used to vaccinate babies and infants again bacteria that have polysaccharide capsules.
•The immature immune systems of these patients have difficult recognizing certain antigens, so the combination of the antigen with the carrier protein creates a substance that is more easily recognized to the WBCs in the blood, resulting in stronger immune response/protection.
SCHEDULE
PCV13 SHARED CLINICAL DECISION
MAKING GUIDANCE FOR 65+
HTTPS://WWW.CDC.GOV/MMWR/VOLUMES/68/WR/MM6846A5.HTM#B1_DOWN
• Grading of Recommendations Assessment, Development and Evaluation (GRADE) for use of PCV13 among adults ≥65 years old persons:
•Residing in nursing homes or other long-term care facilities
•Residing in settings with low pediatric PCV13 uptake
•Traveling to settings with no pediatric PCV13 program
•With chronic heart, lung, liver disease, or diabetes
•With alcoholism
•Who smoke cigarettes
•Who have more than one chronic medical condition
ACIP UPDATE
•MENQUADFI (MENACWY-TT )
•WHAT: New vaccine added as an option to prevent disease from meningococcal serogroups A, C, W, and Y. The FDA approved MenQuadfi in April 2020 for use in people ages 2 and older.
•WHY: MenQuadfi was designed to elicit and demonstrate a high immune response across all four serogroups of meningococcal for multiple ages with good tolerability. MenQuadfi is intended to protect an expanded age group and is the only meningococcal vaccine in the US that uses tetanus toxoid as a protein carrier. It will be available in a ready-to-use liquid formulation allowing healthcare providers to avoid vaccine reconstitution.
•NOW:
• MENVEO (AGE 2 MONTHS TO 55 YRS OF AGE) • MENACTRA (AGE 9 MONTHS TO 55 YRS OF AGE)
• MENQUADFI (AGE 2 YRS TO 56 YRS OF AGE) PHASE 3 YOUNGER STUDIES ONGOING
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ACIP UPDATE
•Shingrix (RZV)
•WHAT: Since Shingrix was added to the ACIP schedule, in immunocompromised patients, there is currently no data (grey bar on ACIP schedule).
•WHY: Principles of vaccines and clinical trial data suggests acceptable safety and efficacy in immunocompromised patients, however, FDA or ACIP recommendations have not been updated.
• Researchers advised longer follow-up studies are warranted to asses duration of RZV immunity in immunocompromised patients.
•NOW: Zoster vaccine live (Zostavax), or ZVL, will be removed from the adult immunization schedule, it is no longer sold in the US after 6/1/2020. There is no evidence the grey bar on the ACIP schedule by medical condition will be changed to purple or yellow for immunocompromised patients on the 2021 schedule.
SCHEDULE
ACIP UPDATE
•HEP B
•WHAT: ACIP voted that Shared Clinical Decision making between patients and clinicians should be used when considering hepatitis B vaccine for individuals with diabetes who are 60 and older.
•WHY: Initially this recommendation from ACIP came to cover those patients that shared glucose meters or may share diabetic equipment.
•NOW: The ACIP schedule by medical condition will turn to blue for patients who have diabetes.
SCHEDULE
ACIP UPDATE
• MMR-II (MMR)
• WHAT: ACIP continues to emphasize the importance of the measles vaccine for those without documented immunity and those traveling internationally without documentation of 2 doses before departure.
• ACIP now recognizes that some born before 1957 may still need an MMR vaccination(s) booster dose(s) despite previous exceptions.
• WHY: Previously ACIP stated that all those born before 1957 did not need to be given an MMR vaccination(s) booster dose(s) due to regular exposures before 1957. The ACIP recommendation is important because a review of measles cases internationally imported into the U.S. during 2001–2016 found 20 of 553 (4%) of the cases occurred in people born before 1957.
• NOW: Most likely, the footnotes will contain language pertaining to this change.
SCHEDULE
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ACIP UPDATE
•LAIV4 (FLUMIST)
•WHAT: Quadrivalent LAIV should not be used in children younger than 2 years, or in patients that have received any influenza antivirals; oseltamivir or zanamivir, within the previous 48 hours, peramivir within the previous 5 days, or baloxavir within the previous 17 days. For patients who show an egg allergy with symptoms other than hives (e.g., angioedema, respiratory distress, or need for emergency medical services or epinephrine), any influenza vaccine other than Flublok or Flucelvax should be administered in a medical setting.
•WHY: Reminder that severe allergic reactions can always occur and CPR is needed.
•NOW: Most likely, the footnotes will contain language pertaining to this change.
SCHEDULE
ACIP UPDATE
•TWINRIX
•WHAT: a vaccine against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus, may be administered on an accelerated schedule of three doses at 0, 7, and 21-30 days, followed by a booster at 12 months, to individuals traveling to countries that have high or intermediate rates of hepatitis A.
•WHY: for protection of disease transmission among varying countries in the world.
•NOW: Most likely, the footnotes will contain language pertaining to this change.
SCHEDULE
COVID VACCINES FAQS
•Pregnancy and Breastfeeding?
•Benefits outweigh risks, long term safety data needed.
•American College of OB GYNS (ACOG)
•Immunocompromised patients?
•Benefits outweigh risks, long term safety data needed.
•The Center for Biosimilars
•Allergies contraindicated?
•EUA of each vaccine should be evaluated.
•Efficacy if late for second dose?
•CDC: Only data available look at how well the vaccines worked when given either 21 days apart for Pfizer, and 28 days apart for Moderna.
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INGREDIENTS COMPARISON
•Moderna: mRNA, lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate.
•Pfizer: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
COVID VACCINES FAQS
•Patient requirements •EUA (VIS once available)
•V-safe (VAERS should also be completed)
•Covid vaccine record card
•Concurrent with other vaccines?
•CDC: Wait 14 days pre and post other vaccines.
•Concurrent with TST (Tb testing)?
•CDC: May cause false positive due to initiation of an immune response.
•Waiting period post-COVID infection?
•CDC: Given the limited vaccine supply and your natural immunity following your COVID infection, you may wish to wait up to 90 days for the vaccine (so that others –who have no immunity –can receive their vaccine now). However, you are not required to wait 90 days.
•Wait until asymptomatic or (if MAB) for 90 days.
DEALING WITH VACCINE HESITANCY
MOTIVATIONAL INTERVIEWING
Ethical Principle Health Care Personnel Patients
Maximize benefits and minimize harm
Multiplier effect, protection and preservation of health care capacity
Especially elderly, are at high risk for infection, severe disease, and even death. Prevention may reduce hospitalizations. Promotes justice Provides care in high risk
settings and is essential for assisting in vaccine distribution.
Federal facility partnerships will facilitate equal access to vaccines. Mitigate health inequities Include broad range of
occupations , includes racial and minority groups.
Increased risk in various socioeconomic status in NM.
SAFETY DATA STUDY RESULTS (POLACK,
ET AL. NEJM, 2020.) = PFIZER
• Many patients have been asking, is this vaccine safe?
• This study identified a total of 43,548 participants that underwent randomization, of whom 43,448 received injections: 21,720 with mRNA vaccines and 21,728 with placebo.
• There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive the vaccine and 162 cases among those assigned to receive placebo. • The vaccine was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). • Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex,
race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. • Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients
and 1 in a vaccine recipient.
• The safety profile was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
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SAFETY DATA (NIH REPORT DEC. 30,
2020) = MODERNA
• The trial began on July 27, 2020, and enrolled 30,420 adult volunteers at clinical research sites across the United States. Volunteers were randomly assigned 1:1 to receive either two 100 microgram (mcg) doses of the investigational vaccine or two shots of saline placebo 28 days apart.
• From the start of the trial through Nov. 25, 2020, investigators recorded 196 cases of symptomatic COVID-19 occurring among participants at least 14 days after they received their second shot. • One hundred and eighty-five cases (30 of which were classified as severe COVID-19) occurred in the
placebo group and 11 cases (0 of which were classified as severe COVID-19) occurred in the group receiving vaccine.
• The incidence of symptomatic COVID-19 was 94.1% lower in those participants who received vaccine as compared to those receiving placebo.
• Investigators observed 236 cases of symptomatic COVID-19 among participants at least 14 days after they received their first shot, with 225 cases in the placebo group and 11 cases in the group receiving vaccine. The vaccine efficacy was 95.2% for this secondary analysis.
• There were no concerning safety issues with vaccination, according to the authors. Local reactions to the vaccine were generally mild. About 50% of participants receiving vaccine experienced moderate-to-severe side effects —such as fatigue, muscle aches, joint pain and headache —after the second dose, which resolved in most volunteers within two days.
COUNTRIES WITH HIB VACCINE IN THE
NATIONAL IMMUNIZATION PROGRAM
COUNTRIES WITH PNEUMOCOCCAL
CONJUGATE VACCINE IN THE NATIONAL
IMMUNIZATION PROGRAM
COUNTRIES WITH ROTAVIRUS VACCINE IN
THE NATIONAL IMMUNIZATION PROGRAM
COUNTRIES WITH HPV VACCINE IN THE
NATIONAL IMMUNIZATION PROGRAM
COUNTRIES WITH MEASLES SECOND
DOSE VACCINE IN THE NATIONAL
IMMUNIZATION PROGRAM
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COUNTRIES WITH RUBELLA CONTAINING
VACCINE IN THE NATIONAL IMMUNIZATION
PROGRAM
HEPATITIS B BIRTH DOSE VACCINATION
STRATEGIES IN THE NATIONAL
IMMUNIZATION PROGRAM
COUNTRIES WITH MUMPS CONTAINING
VACCINE IN THE NATIONAL IMMUNIZATION
PROGRAM
COUNTRIES WITH VARICELLA CONTAINING
VACCINE IN THE NATIONAL IMMUNIZATION
PROGRAM
COUNTRIES AND TERRITORIES USING
YELLOW FEVER* VACCINE TO DATE
COUNTRIES AND TERRITORIES USING JE
VACCINE TO DATE
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SUMMARY
•It is important to stay up to date (legally and clinically) on all vaccine information as immunizers.
•Telling patient’s misinformation can occur if you are not following vaccine schedules, new cinical info, etc.
•Patient’s rely on pharmacists for vaccine information.
•Globally, vaccines are a significant part of world health and we must continue to immunize/protect travelers as they leave and enter the United States.
