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.
 SHARED CLINICAL DECISION
MAKING
• HTTPS://WWW.CDC.GOV/VACCINES/ACIP/ACIP-SCDM-FAQS.H
TML
 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
Prevnar 13 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
 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

• HEPATITIS 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 (currently yellow bar on ACIP schedule).
• 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 (may change
from grey bar to purple).
SCHEDULE
 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 (HEPATITIS A AND HEPATITIS B)

• WHAT: A vaccine against disease caused by hepatitis A virus and 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.
• CDC: https://www.medpagetoday.com/infectiousdisease/covid19/90556

• Efficacy if late for second dose?

• CDC: Only data available looks at how well the vaccines worked when given either 21 days apart
for Pfizer, and 28 days apart for Moderna.
 INGREDIENTS COMPARISON

• Moderna: mRNA, lipids, polyethylene glycol [PEG] 2000, cholesterol,

1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC], tromethamine,
tromethamine hydrochloride, acetic acid, sodium acetate.
• Pfizer: mRNA, lipids, polyethylene glycol [PEG] 2000, N-
ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and
cholesterol [DSPC], potassium chloride, monobasic potassium
phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and
sucrose.
 COVID VACCINES FAQS
• Patient requirements (things to provide patient):
• 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 positives due to initiation of an immune response.

• Waiting period post-COVID infection (no infusion treatment) ?

• 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.
VACCINE UPDATE – OUT!
DEALING WITH VACCINE
HESITANCY
 MOTIVATIONAL INTERVIEWING
Ethical Principle Health Care Personnel Patients
Maximize benefits and Multiplier effect, Especially elderly, are at
minimize harm protection and high risk for infection,
preservation of health severe disease, and even
care capacity death. Prevention may
reduce hospitalizations.
Promotes justice Provides care in high risk Federal facility
settings and is essential partnerships will facilitate
for assisting in vaccine equal access to vaccines.
distribution.
Mitigate health inequities Include broad range of Increased risk in various
occupations , includes socioeconomic status in
racial and minority NM.
groups.
 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.
 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
 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
 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.