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Issue 1,553: March 3, 2021
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IAC Handouts
World News
Featured Resources
Journal Articles and Newsletters
Education and Training
From the Archives
Top Stories
FDA issues EUA for Janssen
COVID-19 Vaccine after advisory committee review
On February 27, the FDA issued an
Emergency Use Authorization (EUA) for the
Janssen COVID-19 Vaccine (also known as Ad26.COV.2) to help prevent disease caused by SARS-CoV-2 virus in people 18 years of age and older. Janssen is the
pharmaceutical division of Johnson & Johnson.
FDA’s action follows the unanimous recommendation of its
Vaccines and Related Biological Products Advisory Committee (VRBPAC), which
determined on February 26 that the totality of scientific evidence available indicates that the benefits of vaccination with the Janssen COVID-19 Vaccine
outweigh the risks for use in people age 18 years or older.
Below appear links to technical and supportive documents related to this vaccine and the EUA. Most relevant to vaccinators are the
Fact Sheet for Potential Recipients and Caregivers and the
Fact Sheet for Healthcare Providers. That second 23-page document includes the product’s
prescribing information.
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ACIP recommends third COVID- 19 vaccine for use in U.S.; IAC
summarizes February 28 – March 1 meeting and highlights clinical considerations for use of Janssen vaccine
On February 28, the Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the Janssen COVID-19 Vaccine for
persons 18 years of age and older in the United States. Janssen is the pharmaceutical division of Johnson & Johnson. This vote followed FDA issuance of an
Emergency Use Authorization (EUA) for the vaccine on February 27 (see story above). The ACIP meeting continued on March 1 with a discussion of the
clinical considerations for use of the adenovirus-vectored vaccine from Janssen, as well as the previously recommended mRNA COVID-19 vaccines
(Pfizer-BioNTech and Moderna), and updates on COVID-19 vaccine safety data and the potential impact of SARS-CoV-2 variants on vaccines.
Before the vote, ACIP received an overview of the Janssen COVID-19 Vaccine from company scientists. The Committee also reviewed its Grading of
Recommendations, Assessment, Development, and Evaluation (GRADE) approach and assessed available vaccine information using its Evidence to
Recommendation (EtR) framework.
ACIP’s recommendation to add Janssen COVID-19 Vaccine to the available vaccines in the United States offers two practical benefits; the vaccine
is administered as a one-dose regimen, and it is stored at refrigerated temperatures. The FDA Fact Sheet for Healthcare Providers and the CDC and Janssen COVID-19 Vaccine websites should be consulted for a rapidly expanding list of resources on the
vaccine’s use. Basic information on the Janssen vaccine follows.
Authorized age group: The Janssen COVID-19 Vaccine is authorized for use in persons 18 years of age and older.
Platform: The Janssen COVID-19 Vaccine is a recombinant “replication-incompetent” vaccine, meaning it is incapable of
replicating within the human body and is not considered a live virus vaccine. Unlike the mRNA approach used by the Pfizer-BioNTech and Moderna
COVID-19 vaccines, the Janssen vaccine uses adenoviruses that contain a DNA gene segment that causes human cells to manufacture COVID-19 spike
proteins, triggering a strong immune response and the development of antibodies to COVID-19. This adenovirus type 26 (Ad26) platform has been
previously used for an Ebola vaccine licensed in Europe. The vaccine does not contain adjuvants, antibiotics, or preservatives.
Packaging: The Janssen COVID-19 Vaccine is provided in a multidose vial, with five 0.5 mL doses per vial. Each carton contains 10
vials of vaccine and is approximately 3.7” x 3.7” x 2.1”. The minimum shipment size is 2 cartons (20 vials/100 doses), although there
can be as many as 48 cartons (480 vials/2,400 doses) per shipper.
Storage and Handling: Unpunctured multi-dose vials of the Janssen COVID-19 Vaccine are shipped frozen from the manufacturer.
Upon arrival, they are stored at normal refrigerator temperatures (2° C to 8° C, 36° F to 46° F) for up to 3 months.
The vaccine should not be refrozen. Unpunctured vials may be stored at room temperature (9° C to 25° C, 47° F to
77° F) for up to 12 hours. After the vaccine vial has been punctured, it may be maintained at refrigerated temperatures (2° C to
8° C, 36° F to 46° F) for up to 6 hours or at room temperature (maximum 25° C, 77° F) for up to
2 hours. If not used within these intervals, discard the vaccine.
Preparation and Administration: The Janssen COVID-19 Vaccine is administered as a single 0.5 mL IM dose. No dilution is
required.
Use in Pregnancy: There are currently few data on the safety of COVID-19 vaccines in
pregnant
people. If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., healthcare personnel), they may choose to
be vaccinated.
Use with Other Vaccines: There are no data available on the use of the Janssen COVID-19 Vaccine to complete a series started with
another COVID-19 vaccine. There also are no data on use of the Janssen COVID-19 Vaccine with other vaccines, such as influenza. Per CDC’s
clinical use guidance, providers should allow at least 14 days between administration of COVID-19 vaccine and any other vaccine.
Vaccine Efficacy: Over 44,000 persons were included in the vaccine’s Phase 3 clinical trial, which was conducted in areas
(e.g., United States, South Africa, Brazil) where COVID-19 incidence was highest and where variants were emerging. In the United States portion of the
trial, vaccine efficacy (VE) was 72% against moderate to severe/critical disease 14 days after receipt of a single dose. Across all countries, this VE was
66%. Importantly, beyond 28 days after vaccination, the vaccine was highly effective (85%) against severe COVID-19 disease, with no COVID-19-related
hospitalizations or deaths reported among recipients. Efficacy in preventing severe disease was consistent across races, ethnicities, and age groups
studied, including among adults 60 years of age and older, and those infected with an emerging viral variant. Of note, the Phase 3 trials of the Janssen
COVID-19 vaccine and those of the previously authorized mRNA vaccines should not be compared head-to-head, as they were conducted at different
times and across different geographic areas, and they were tested against different circulating variants.
Vaccine Safety: The Janssen COVID-19 Vaccine was well-tolerated by all participants, including adults age 60 years and older
and those with underlying health conditions. Most adverse events (AEs) following vaccination occurred within 1 to 2 days of vaccination and were mild or
moderate. Approximately one-half (49%) of vaccine recipients reported injection-site pain, with headache (39%), fatigue (38%), and muscle ache (33%)
being the next most frequently reported AEs. Reported AEs were less common among persons 60 years of age or older. No anaphylaxis was observed
during the Phase 3 clinical trial, although one hypersensitivity reaction (not classified as anaphylaxis) was likely related to the vaccine. The adenovirus
vector does not replicate and is not integrated into cellular DNA.
Vaccine Expiration: Currently Janssen COVID-19 Vaccine has a shelf life of 3 months. Because it is possible an extended interval may
receive FDA authorization in the future, the company established an expiry checker page. Providers can enter the lot number found on the product carton or vial to obtain the product’s
expiration date.
ACIP’s recommendation on use of the Janssen COVID-19 Vaccine was approved by the CDC Director on February 28 and was published in the
Morbidity and Mortality Weekly Report (MMWR) on March 2.
COVID-19 Vaccination Program Review: On the second day of the meeting, ACIP members discussed multiple challenges to COVID-
19 vaccine implementation in the United States and informally agreed on several concepts for inclusion in updated clinical considerations for use of
COVID-19 vaccines. The group stated no preference for any of the three authorized COVID-19 vaccines and agreed that the Janssen COVID-19 Vaccine
should be offered within the currently established allocation and eligibility recommendations. ACIP members also agreed that no changes should be made
to the current two-dose mRNA vaccine schedule or dosing intervals. Members discussed the challenges of implementing vaccine prioritization
recommendations and expressed the importance of equity in vaccine access among high risk-groups, but did not suggest specific changes to their
existing recommendations.
Vaccine Safety Data: CDC provided an overview of the extensive safety data being collected on COVID-19 vaccination through various
reporting mechanisms, including v-safe, the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), and the Clinical
Immunizations Safety Assessment (CISA) Project. Reported side effects have been consistent with those observed in clinical trials, and no safety signals
of concern have been observed to date. Specific details are available in the
slide
presentation.
SARS-CoV-2 Variants: The meeting concluded with an update on SARS-CoV-2 variants circulating around the world. CDC presented a
summary of published and unpublished studies on the vaccine efficacy of individual vaccines against the variants. Specific details are available in the slide presentation. In general, current prevention efforts and authorized vaccines offer
protection against SARS-CoV-2 variants, but ongoing monitoring of variants will be essential.
CDC is updating the COVID-19 information on its web pages frequently, with several key resources listed below.
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IAC summarizes February 2021 routine ACIP virtual
meeting
The Advisory Committee on Immunization Practices (ACIP) conducted its scheduled 2-day virtual meeting on
February 24–25, 2021.
Presentation slides from the meeting are available online.
The Committee reviewed information on the epidemiology of tick-borne encephalitis (TBE) in Europe and Asia and a TBE vaccine licensed in Europe that
is being evaluated for licensure as a travel vaccine by the FDA. Additionally, the ACIP heard presentations intended to inform future refinements in
recommendations for the use of vaccines against dengue, Ebola, hepatitis B, pneumococcal disease, zoster, influenza, cholera, and orthopoxviruses.
ACIP took two votes related to use of rabies vaccine for pre-exposure prophylaxis (PrEP).
Rabies Vaccine for PrEP
The Committee recommended a 2-dose (days 0 and 7) intramuscular rabies vaccination series in immunocompetent persons at least 18 years of age for
whom rabies vaccine PrEP is indicated. The need for PrEP is based on a person’s occupation or activities, the frequency and location of their
encounters with specific animal species, and their access to medical care if exposed. The new 2-dose recommendation replaces a recommendation for
three doses of vaccine (days 0, 7, and 21/28). Extensive information presented during the meeting indicates two doses are sufficient for protection. The
2-dose schedule is consistent with existing recommendations from the World Health Organization.
The Committee also unanimously recommended that the category of immunocompetent people at least 18 years of age who have had a 2-dose PrEP
series and who are expected to have a sustained, elevated risk for recognized rabies exposures for more than 3 years should have either an
intramuscular booster dose of rabies vaccine (21 days to 3 years after initiating the series) or a titer check 1 to 3 years after vaccination. Individuals at
the highest risk of unrecognized exposures, laboratory workers exposed to rabies virus and bat biologists, have different titer recommendations that were
unchanged.
ACIP extensively discussed appropriate categorization of persons according to their potential risk of exposure and likelihood that an exposure would be
recognized. The final groupings will be clarified upon publication of the updated rabies vaccine official recommendations in the MMWR. The
American Academy of Pediatrics (AAP) will consider whether to adjust pediatric recommendations in a similar manner, and the ACIP will address the
question of expanding its 2-dose PrEP recommendation to include children following AAP evaluation.
The next regularly scheduled ACIP meeting will be held June 23–24, 2021. However, in the interim, ACIP will call emergency meetings to address
recommendations for use of any FDA-authorized COVID-19 vaccine(s). Information about past and future ACIP
meetings may be found on the ACIP website.
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Attend today (March 3): CDC’s “Current Issues in Immunization
Webinar” on the 2021 child/adolescent and adult immunization schedules
Tune in today! CDC's Current Issues in Immunization Webinar will review the 2021 child/adolescent and adult
immunization schedules, today, March 3, from 12:00–1:00 p.m. (ET).
Attendance for the live webinar is limited to 1,500 registrants, so log in early to secure a "seat." If you miss the live event, you can watch the
archived version once it is posted on CDC’s website.
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Last chance to register for IAC’s March 4 webinar! CDC's Dr.
Shimabukuro and Janine Cory will present “Updates on CDC’s Safety Monitoring and Communications for COVID-19
Vaccines”
IAC will host a webinar, Updates on CDC’s Safety Monitoring and Communications for COVID-19 Vaccines, tomorrow, March
4, from 1:00–2:00 p.m. (ET). Topics will include COVID-19 vaccine safety monitoring systems (e.g., the Vaccine Adverse Events Reporting
System [VAERS], v-safe), as well as CDC’s COVID-19 vaccine communication products, and their Vaccinate with Confidence framework.
These important and timely topics will be addressed by speakers from the CDC Immunization Safety Office and CDC’s Vaccine Task
Force.
- Tom Shimabukuro, MD, MPH, MBA, deputy director, Immunization Safety Office
- Janine Cory, MPH, associate director for communications, Vaccine Task Force
Kelly L. Moore, MD, MPH, IAC deputy director, will moderate the webinar. Speakers will answer audience questions at the conclusion of the
presentations. You are welcome to submit your questions to eocevent545@cdc.gov in advance of the webinar.
Register now to be sure you don’t miss this informative session. Attendance for the live webinar is limited to 3,000 registrants,
so register early to secure a "seat." If you miss the live event, you can watch the archived version once it is posted on the immunize.org
home page.
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FDA announces more flexible storage and transportation conditions for Pfizer-
BioNTech COVID-19 vaccine
On February 25, FDA issued a press release titled
Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for
Pfizer-BioNTech COVID-19 Vaccine. The first paragraph of the press release appears below.
Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be
transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an
alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -
76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).
The Ad Council launches COVID-19 vaccine campaign to help people make
an informed choice to get vaccinated
On February 25, The Ad
Council launched their COVID-19 vaccination campaign It's Up to You to encourage people to get the latest vaccine information,
knowing that personal education is the first step in building vaccine confidence. The campaign is designed to reach a variety of audiences, including
communities of color who have been disproportionately affected by COVID-19. The Ad council aims to expand trust in vaccines by ensuring that
Americans have accurate and timely information to address their concerns about vaccine side effects, efficacy, and clinical trials.
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Pre-order IAC's laminated versions of CDC’s 2021 immunization
schedules today!
IAC's laminated versions of the 2021 U.S. child and adolescent immunization schedule and the 2021 U.S. adult immunization schedule are available for pre-order and will ship in mid-March.
These schedules are ideal for use in any busy healthcare setting where vaccinations are given. Their tough coating can be wiped down, and
they’re durable enough to stand up to a year's worth of use.
The child/adolescent schedule is eight pages (i.e., four double-sided pages) and the adult schedule is six pages (i.e., three double-sided pages), but both
schedules fold down to a convenient 8.5" x 11" size.
 
With color coding for easy reading, our laminated schedules replicate the original CDC formatting, including the essential tables and notes.
PRICING
1–4 copies: $7.50 each
5–19 copies: $5.50 each
20–99 copies: $4.50 each
100–499 copies: $4.00 each
500–999 copies: $3.50 each
For quotes on customizing or placing orders of 1,000 copies or more, call 651-647-9009 or email admininfo@immunize.org.
Visit the Shop IAC: Laminated Schedules web page for more information on the schedules, to view images of all the pages, to download the
order form, and to pre-order today!
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IAC Spotlight! These updated IAC educational materials and web pages were
released during January and February
IAC Express regularly provides readers with information about IAC’s new and updated educational materials for healthcare
professionals and handouts for patients. All IAC materials are free to download, print, and distribute. Important web page updates and VIS translations are
announced as well.
In case you missed them during recent weeks, these helpful materials were announced:
Updated Materials for Clinicians
New and Updated COVID-19 Web Pages
Other Updated Web Pages
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Vaccinate Your Family issues special report on the state of our nation's
"ImmUnion," highlighting 2021 vaccine priorities
Vaccinate Your Family released their annual report titled 2021 State of
the ImmUnion: A Report on Vaccine-Preventable Diseases in the U.S. on Tuesday, February 23.
The report presents an overview of the current state of vaccine-preventable diseases in the U.S. and offers members of Congress ways to help ensure our
country is stronger and more resilient in the face of emerging health threats.
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IAC experts called on by news
media
With vaccines in the news so much lately, journalists have sought out IAC experts to communicate the intricacies of running a quality vaccination
program. Our insights have helped explain vaccines to the public and policy makers. We want to help them understand the complex work vaccinators do.
We've reached mass markets and local stations, across the U.S. and overseas, via print, radio, television, blogs, and more. Here is a selection of
our recent citations:
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Not-to-miss immunization articles in the news
These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
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IAC Handouts
IAC updates its popular document for healthcare personnel titled “Skills Checklist for Vaccine
Administration”
IAC recently revised its popular document for healthcare personnel titled Skills Checklist for Vaccine Administration. Revisions include adding an online
vaccination administration video, reporting adverse events to the Vaccine Adverse Events Reporting System, following manufacturer instructions
when preparing vaccine for administration, and verification of patient identity.
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IAC updates “Meningococcal
ACWY Vaccine Recommendations by Age and Risk Factor”
IAC recently revised Meningococcal ACWY Vaccine Recommendations by Age and Risk Factor to add a column in the routine recommendations table that more
clearly displays doses needed and spacing based on the potential vaccinee's previous history of MenACWY vaccination. No technical changes were
made.
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IAC updates helpful office documents:
“Tips for Locating Old Immunization Records” and “Record of Vaccine Declination in the Medical Office”
IAC recently revised its helpful office documents titled Tips for Locating Old Immunization Records and Record of Vaccine
Declination in the Medical Office.
Tips for Locating
Old Immunization Records: This was revised to remove a suggestion for the individual (e.g., parent) to consolidate old vaccination records on to a
personal record card. IAC recommends that only a healthcare provider review old records and complete an immunization record card.
Record of
Vaccine Declination in the Medical Office: Revisions include a title change to clarify that this form is intended to be used in a medical office only and
not as an exemption form that can be submitted to meet childcare or school immunization requirements. Minor text edits were made on the form
itself.
 
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World News
“BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting” published in New England Journal of
Medicine
In the February 24 issue, New England Journal of Medicine published BNT162b2
mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting, demonstrating real world effectiveness of this vaccine in a large population
consistent with the preliminary results of the phase 3 clinical trial. A portion of the background and results appear below.
Background
In this study, data from Israel’s largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine.
Results
Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes...at 7 or more days after the second dose was as
follows: for documented infection...92% (95% CI, 88 to 95); for symptomatic Covid-19...94% (95% CI, 87 to 98); for hospitalization...87% (95% CI, 55 to
100); and for severe disease...92% (95% CI, 75 to 100)....
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Featured Resources
In
IAC’s “Video of the Week,” Alice Benjamin describes the "The Fauci Effect” and recent increases in nursing school
applications
In this Nurse News Now video, Alice Benjamin, known as "Nurse Alice," asks Dr. Fauci whether recent increased interest in
nursing and medical careers is due to "The Fauci Effect." Dr. Fauci attributes the rise to the actions of nurses and other medical professionals
during the pandemic that inspires others to consider careers in healthcare. (Source: Nurse.Org)
Visit the whole collection at
the VOTW archive.
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Check out the www.Give2MenACWY.org website to
enhance your efforts at increasing rates of MenACWY booster and other adolescent vaccinations
The website www.Give2MenACWY.org promotes the importance of adolescent vaccination and administering a booster dose of MenACWY vaccine at
age 16.
Designed for healthcare professionals, the site incorporates materials and highlights the importance of all recommended vaccines for 16-year-olds.
A simplified navigation structure makes locating information a breeze.
The colorful
Give2MenACWY.org website is divided into five easy-to-access sections:
The
site’s design categorizes materials according to whether they are primarily of interest to providers or to teens or their parents.
Visit
Give2MenACWY.org and enjoy browsing (and deploying) its bountiful resources, brought to you by IAC's collaboration with Sanofi
Pasteur.
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Journal Articles and Newsletters
“Vaccines for Older Adults” (State of the Art Review) published in the British Medical Journal
In the February 22 issue, British Medical Journal published Vaccines for Older Adults in its State of the Art Review section. The abstract
appears below.
The proportion of the global population aged 65 and older is rapidly increasing. Infections in this age group, most recently with SARS-CoV-2,
cause substantial morbidity and mortality. Major improvements have been made in vaccines for older people, either through the addition of novel
adjuvants—as in the new recombinant zoster vaccine and an adjuvanted influenza vaccine—or by increasing antigen concentration, as in
influenza vaccines. In this article we review improvements in immunization for the three most important vaccine preventable diseases of aging. The
recombinant zoster vaccine has an efficacy of 90% that is minimally affected by the age of the person being vaccinated and persists for more than four
years. Increasing antigen dose or inclusion of adjuvant has improved the immunogenicity of influenza vaccines in older adults, although the relative
effectiveness of the enhanced influenza vaccines and the durability of the immune response are the focus of ongoing clinical trials. Conjugate and
polysaccharide pneumococcal vaccines have similar efficacy against invasive pneumococcal disease and pneumococcal pneumonia caused by vaccine
serotypes in older adults. Their relative value varies by setting, depending on the prevalence of vaccine serotypes, largely related to conjugate vaccine
coverage in children. Improved efficacy will increase public confidence and uptake of these vaccines. Co-administration of these vaccines is feasible and
important for maximal uptake in older people. Development of new vaccine platforms has accelerated following the arrival of SARS-CoV-2, and will likely
result in new vaccines against other pathogens in the future.
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“Estimated Medicaid Costs
Associated with Hepatitis A During an Outbreak—West Virginia, 2018–2019” published in MMWR
CDC published Estimated Medicaid Costs Associated with Hepatitis A During an Outbreak—West Virginia,
2018–2019 in MMWR on February 26. This article illustrates the medical costs associated
with large outbreaks that can result from not following ACIP recommendations to vaccinate adults at risk of hepatitis A. A portion of the summary appears
below.
...During January 1, 2018–July 31, 2019, hepatitis A–related clinical costs among West Virginia Medicaid beneficiaries ranged
from $1.4 million to $5.6 million. Among those with a substance use disorder diagnosis, costs ranged from $1.0 million to $4.4 million....
Access the MMWR article in HTML format or in PDF format.
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Education and Training
Immunization partners offer Zoom event on COVID-19 questions and answers featuring FDA and CDC leaders on March 5
Vaccinate Your Family (VYF), the Association of Immunization Managers (AIM), the National Association of City and County Health Officials (NACCHO),
and Trust for America’s Health (TFAH) will host a Zoom event on Friday, March 5, 2021 at 11:00 a.m. (ET). Speakers include Janet Woodcock,
acting commissioner, FDA; Dr. Peter Marks, director, Center for Biologics Evaluation and Research (CBER); and CDC leadership. Topics for this webinar
include:
- COVID-19 vaccine
- Emerging COVID-19 variants
- Emergency Use Authorization of the Janssen COVID-19 Vaccine
To register, send an RSVP to
info@vaccinateyourfamily.org. Please include any questions you have in the RSVP email.
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In Vaccine Education Center’s Current Issues in Vaccines webinar on
March 24, Dr. Paul Offit will discuss SARS-CoV-2 vaccines; CE available
The Vaccine Education Center (VEC) at Children's Hospital of Philadelphia will present a 1-hour webinar, beginning at 12:00 p.m. (ET) on March 24.
Part of its
Current Issues in Vaccines series, the webinar will feature Paul Offit, MD, director of VEC. Dr.
Offit's topics for this webinar will be:
- Interpret and employ new or updated vaccine information
- Discuss vaccine-related information with patients and their families
- Provide science-based resources to patients and their families who are seeking additional information
- Describe the status of COVID-19 vaccines
Free continuing-education credits (CME, CEU, and CPE) will be available for both the live and archived events.
Register for the webinar.
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From the Archives
In this catchy 1975 PSA, Dr. John Witte encourages parents to immunize “at Romper Room
size”
In this catchy
1975 public service announcement from the U.S. Department of Health, Education, and Welfare, Dr. John Witte (former head of CDC’s
immunization program) and Do-Bee promote Immunization Action Month by encouraging parents to immunize their children. This PSA is part of a
collection curated by vaccine expert William L. Atkinson, MD, MPH.
Previous PSAs featured in “From the Archives” are available when viewing this Vimeo video.
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