- FDA issues EUA for Pfizer-BioNTech mRNA vaccine after its advisory committee vote; fact sheets published
- ACIP recommends first COVID-19 vaccine for use in U.S.; IAC summarizes guidance from December 11–12 meeting
- CDC launches V-Safe website with information to encourage vaccinee enrollment in new post-vaccination health-monitoring program
- CDC adds many more ready-to-use materials to its COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians
- CDC publishes “ACIP’s Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—U.S., 2020" in December 11 MMWR, previously issued as an MMWR Early Release on December 5
- FDA and CDC’s advisory committees prepare to review Moderna’s mRNA vaccine for Emergency Use Authorization
- CDC invites you to attend its weekly partner calls with updates on the COVID-19 response; Dr. Messonnier to be featured on December 21 call
- Reminder: NCIRD leaders Drs. Messonnier and Cohn presented a webinar on COVID-19 vaccination implementation and 3,000 attended; now you can watch the archived presentations
- First influenza-related pediatric death for 2020–21 season reported; make sure all your patients are getting vaccinated
- IAC Spotlight! On IAC’s "View All Materials" web page, you can find links to more than 300 IAC patient handouts, staff education materials, and slide sets
- One additional university requires flu vaccine to protect staff and students—the list continues to grow!
- IAC enrolls one new birthing institution into its Hepatitis B Birth Dose Honor Roll; two previously honored institutions qualify for additional years' honors
- IAC experts called on by news media
- Not-to-miss immunization articles in the news
- Round Up: CDC, FDA, and other organizations offer COVID-19 vaccination resources for healthcare personnel and the public
Journal Articles and Newsletters
On the Lighter Side
FDA issues EUA for Pfizer-BioNTech mRNA vaccine after its advisory committee vote; fact sheets published
On December 11, the Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) for a vaccine to help prevent COVID-19 caused by SARS-CoV-2 virus in people 16 years of age and older. The EUA allows the Pfizer-BioNTech COVID-19 vaccine (also known as BNT162b2) to be distributed in the United States.
FDA’s action aligns with the recommendation of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), which determined on December 10 that the totality of scientific evidence available indicates that the benefits of vaccination with the Pfizer-BioNTech COVID-19 vaccine outweigh the risks for use in people 16 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 29-page document contains 10 pages of information and product-handling graphics plus 19 pages of the product’s prescribing information.
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ACIP recommends first COVID-19 vaccine for use in U.S.; IAC summarizes guidance from December 11–12 meeting
After holding nine formal meetings since June and hearing more than 70 presentations on COVID-19 vaccine, on December 12 the Advisory Committee on Immunization Practices voted to recommend the use of the Pfizer-BioNTech COVID-19 vaccine for persons 16 years of age and older in the United States. This historic vote followed issuance of the Food and Drug Administration’s Emergency Use Authorization (EUA) for the vaccine on December 11 (see story above).
The ACIP recommendations and additional guidance for the vaccine’s use became official when adopted by CDC and published as ACIP’s Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—U.S, December 2020 in the Morbidity and Mortality Weekly Report (MMWR) Early Release issued on December 13.
While the MMWR publication should always be consulted for official guidance, additional highlights of ACIP’s clinical guidance discussed at the committee’s December 11–12 meeting are provided below:
- Administration – The Pfizer-BioNTech COVID-19 vaccine is administered intramuscularly as a 2-dose series separated by 21 days. Although the 21-day separation should be followed as closely as possible, the standard 4-day grace period (allowing a 17–20 day interval between doses) is acceptable. If more than 21 days elapse between doses, vaccine should be administered at the earliest opportunity, but doses do not need to be repeated due to a longer interval. Both doses are necessary for protection. COVID-19 vaccines are not interchangeable, and care should be taken to ensure the same vaccine is used for both doses. However, if different mRNA vaccines are inadvertently administered, no additional doses of either vaccine are recommended at this time. A minimum interval of 14 days should be maintained before or after administration of this COVID-19 vaccine with any other type of vaccine.
- Persons with a history of SARS-CoV-2 infection or exposure – Persons should be offered vaccine regardless of a prior history of infection. However, if they are currently infected, vaccination should be deferred until their recovery from acute illness. To avoid exposure to healthcare personnel, vaccination should be deferred for persons with a known SARS-CoV2 exposure until after their quarantine period has ended, with the exception of those who live in congregate settings (e.g., long-term care, correctional facilities, homeless shelters). Vaccination should be deferred for 90 days following receipt of monoclonal antibodies or convalescent plasma used as part of COVID-19 treatment.
- Special populations – Unless otherwise contraindicated, persons with underlying medical conditions or who are immunocompromised may receive COVID-19 vaccine. Pregnant or lactating women may choose to be vaccinated after discussion with their healthcare provider to assess their risk of infection, to make an informed decision. Routine testing for pregnancy before vaccination is not recommended.
- Patient vaccine counseling – All patients should be counseled about the importance of receiving both doses of vaccine, as well as expected local and systemic post-vaccination symptoms.
- Interpretation of SARS-CoV-2 test results in a vaccinated person – Prior receipt of vaccine will not affect results of viral tests. Vaccination could affect anti-spike antibody test results, but not antibody tests based on nucleocapsid.
To enable reimbursement for vaccination (including the few eligible 16- and 17-year-olds), ACIP also voted to add descriptive text and a link to current COVID-19 vaccine recommendations within the 2021 U.S. Adult Schedule and within the Child/Adolescent Immunization Schedule. These will be published in February.
CDC is updating the COVID-19 information on its web pages frequently, with several key resources listed below.
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CDC launches V-Safe website with information to encourage vaccinee enrollment in new post-vaccination health-monitoring program
CDC has launched its website for V-Safe, its new smartphone-based tool that uses text messaging and web surveys so that vaccine recipients can tell CDC if they have any symptoms after getting the COVID-19 vaccine. Based on their responses, CDC may call to get more information. V-Safe also will remind them to get any needed second COVID-19 vaccine dose.
CDC encourages COVID-19 vaccination teams to give recipients a V-Safe information sheet at the time of vaccination. Recipients are encouraged to enroll and complete the surveys when prompted. The information sheet explains V-Safe and provides step-by-step instructions on how to sign up by using their QR code or URL.
Your participation in CDC’s V–Safe will make a difference — it will help us understand COVID-19 vaccines’ safety.
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CDC adds many more ready-to-use materials to its COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians
- A guide for building vaccine confidence within health systems, medical offices, and clinics
- Turn-key slide decks for immunization coordinators, the healthcare team, and other healthcare personnel with information about COVID-19 vaccines, tips for building vaccine confidence, and tips for having effective vaccine conversations with patients
- Posters that you can download, print, and hang in your health facility
- Fact sheets and FAQs
- Social media sample messages
- Printable buttons/stickers for staff to wear once they’ve gotten their vaccine
- A video describing how ACIP makes recommendations and advises CDC on the use of vaccines in our country
View CDC’s COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians today!
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CDC publishes “ACIP’s Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—U.S., 2020" in December 11 MMWR, previously issued as an MMWR Early Release on December 5
CDC published The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020 in MMWR on December 11.
As interim guidance, the Advisory Committee on Immunization Practices (ACIP) recommends that both 1) healthcare personnel and 2) residents of long- term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program. Details are available at CDC’s COVID-19 ACIP Vaccine Recommendations web page.
Access the MMWR article in HTML format or in PDF format.
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FDA and CDC’s advisory committees prepare to review Moderna’s mRNA vaccine for Emergency Use Authorization
The Food and Drug Administration (FDA) will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 17 to discuss the request for Emergency Use Authorization (EUA) of a SARS-CoV-2 vaccine candidate from Moderna.
The VRBPAC meeting will be webcast; access details appear at FDA web pages linked below. FDA posted several documents explaining the vaccine development process and how EUA pertains to vaccines. Additional technical review documents about Moderna’s vaccine candidate have been posted at FDA websites.
Likewise, ACIP will webcast their meetings to consider Moderna’s mRNA vaccine on December 19 and 20 (tentative). The agendas (including times) will be posted soon. No registration is required to watch the live ACIP meeting or listen via telephone.
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CDC invites you to attend its weekly partner calls with updates on the COVID-19 response; Dr. Messonnier to be featured on December 21 call
Join CDC on Monday, December 21 at 3:00 p.m. ET for its weekly partner call, including new COVID-19 resources for the private sector and the general public.
Dr. Nancy Messonnier, director, NCIRD, and lead for the CDC COVID-19 Vaccine Task Force, will provide updates on the current status of COVID-19 vaccines. Michelle Putnam, deputy for partnerships and risk management, CDC COVID-19 Emergency Response, will moderate.
To submit your questions, email email@example.com by December 16 with "Partner Call 12/21" in the subject line.
Register in advance for this webinar: COVID-19 Response Vaccine Update.
Mark your calendars for these upcoming webinars:
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Reminder: NCIRD leaders Drs. Messonnier and Cohn presented a webinar on COVID-19 vaccination implementation and 3,000 attended; now you can watch the archived presentations
On December 3, two CDC leaders were featured speakers on an IAC webinar titled COVID-19 Vaccination Implementation and ‘Vaccinate with Confidence’ Strategy:
- Nancy Messonnier, MD, director, National Center for Immunization and Respiratory Diseases (NCIRD) and COVID-10 Vaccine Task Force; and
- Amanda Cohn, MD, chief medical officer, NCIRD and COVID-19 Vaccine Task Force
Specific topics included an overview of the COVID-19 vaccine distribution strategy, current state planning efforts, and the COVID-19 “Vaccinate with Confidence” strategy.
IAC's chief strategy officer, Dr. L.J Tan, moderated the webinar and the Q&A session that followed.
The webinar was full to capacity at 3,000 attendees. The entire webinar is now archived for viewing at www.immunize.org/webinars/cdc2 and the slides are available for download.
Please share the webinar link with your colleagues.
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First influenza-related pediatric death for 2020–21 season reported; make sure all your patients are getting vaccinated
While seasonal influenza activity in the U.S. remains lower than usual for this time of year, the first influenza-associated pediatric death for the 2020–21 season was reported to CDC during the week ending November 28. This death was associated with an influenza B virus. Visit the CDC’s Weekly U.S. Influenza Surveillance Report, FluView, for details.
Influenza vaccination is recommended for everyone age 6 months and older, so please continue to vaccinate all your patients in this age range. If you don’t provide influenza vaccine at your site, please strongly recommend vaccination and refer to a site that does vaccinate.
Boston Children’s Hospital, in partnership with CDC, has developed VaccineFinder, a user-friendly website to help adult and pediatric patients find flu and other vaccines. Participating providers can now update supply estimates on VaccineFinder for a more accurate reporting. For questions or more information, contact firstname.lastname@example.org.
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IAC Spotlight! On IAC’s "View All Materials" web page, you can find links to more than 300 IAC patient handouts, staff education materials, and slide sets
On the View All Materials web pages in the Handouts for Patients & Staff section of IAC's website, you can find IAC’s collection of more than 300 ready-to-print educational materials for healthcare professionals and their patients.
Visit the "View All Materials" pages to view them sorted:
You also have the choice of viewing:
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One additional university requires flu vaccine to protect staff and students—the list continues to grow!
Many colleges and universities across the nation are mandating flu vaccine for staff and students. IAC has recently become aware of one additional school that will require influenza vaccine this year: Michigan State University.
In addition, the following schools require influenza vaccine this year: Indiana University—nine campuses, University of California system—ten campuses, University of Tennessee system—four campuses, Albion College, Butler University, Claremont Colleges, Colby College, Columbia University, Cornell University, Creighton University, Denison University, Dordt University, Duke University, Elon University, Emory University, Johns Hopkins University, La Salle University, Marist College, McDaniel College, Notre Dame, Pepperdine University, Purdue University, Rochester Institute of Technology, Rosalind Franklin University, Syracuse University, The University of the South (Sewanee), University of Dayton, University of Denver, University of Kentucky, University of Miami, University of North Carolina Charlotte, University of Pennsylvania, University of Southern California, Wabash College, Wake Forest University, Washington University in St. Louis, and Wayne State University.
Under a new statewide regulation in Massachusetts, approximately 115 colleges and universities are implementing requirements for influenza vaccination this year. All colleges and universities in Los Angeles County now require flu vaccine, too.
If you know of additional colleges or universities that require influenza vaccination, please send the name of the institution, as well as a link to the relevant policy (if available) to email@example.com.
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IAC enrolls one new birthing institution into its Hepatitis B Birth Dose Honor Roll; two previously honored institutions qualify for additional years' honors
The Immunization Action Coalition (IAC) is pleased to announce that one new institution has been accepted into its Hepatitis B Birth Dose Honor Roll, for a total of 525 honorees. The birthing institutions are listed below with their reported hepatitis B birth dose coverage rates in parentheses.
- Singing River Health System, Ocean Springs, MS (95%)
Two institutions are being recognized for a second year:
- UF Health Jacksonville, Jacksonville, FL (93%)
- Lawrence General Hospital, Lawrence, MA (99%)
The Honor Roll now includes 525 birthing institutions from 44 states, Puerto Rico, Guam, and an overseas U.S. military base. One hundred twenty-one institutions have qualified for two years, 72 institutions have qualified three times, 39 institutions have qualified four times, 25 institutions have qualified five times, 18 institutions have qualified six times, seven institutions have qualified seven times, two institutions have qualified eight times and one institution has qualified nine times.
The Honor Roll is a key part of IAC’s major initiative urging the nation’s hospitals to Give Birth to the End of Hep B. Hospitals and birthing centers are recognized for attaining high coverage rates for administering hepatitis B vaccine at birth and meeting specific additional criteria. The initiative urges qualifying healthcare organizations to apply for the Hepatitis B Birth Dose Honor Roll online.
To be included in the Hepatitis B Birth Dose Honor Roll, a birthing institution must have: (1) reported a coverage rate of 90 percent or greater, over a 12-month period, for administering hepatitis B vaccine before hospital discharge to all newborns, including those whose parents refuse vaccination, and (2) implemented specific written policies, procedures, and protocols to protect all newborns from hepatitis B virus infection prior to hospital discharge.
Honorees are also awarded an 8.5" x 11" color certificate suitable for framing and their acceptance is announced to IAC Express’s approximately 52,000 readers.
Please visit the Hepatitis B Birth Dose Honor Roll web page that lists these institutions and their exceptional efforts to protect infants from perinatal hepatitis B transmission.
Related IAC Resources
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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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Round Up: CDC, FDA, and other organizations offer COVID-19 vaccination resources for healthcare personnel and the public
To prepare for implementation of COVID-19 vaccination programs, many organizations are increasing their web content on this topic. In this article, we offer a list of resources sorted by topic, for healthcare personnel or for the public, from trusted organizations such as CDC, NIH, IAC, AIM, and others.
Resources on COVID-19 Vaccines
Resources for Training or Operations
- CDC’s COVID-19 Vaccine Training: General Overview of Immunization Best Practices for Healthcare Providers web-on-demand, self-paced, 27-slide module for healthcare providers who will be administering COVID-19 vaccines
- CDC’s COVID-19 Vaccines and Immunizations gateway page
- CDC’s COVID-19 Vaccination Program Interim Playbook, version 2.0, outlines for state, tribal, territorial, and local public health programs and their partners how to plan and implement a vaccination response to COVID-19 within their respective jurisdictions
- CDC’s COVID-19 Vaccination Program Operational Guidance and State and Jurisdiction Executive Summaries
- CDC’s Guidance for Planning Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations to assist with jurisdictional planning and implementation of satellite, temporary, or off-site vaccination clinics by public and private vaccination organizations
- CDC’s Healthcare Professionals: Preparing for COVID-19 Vaccination gateway page
- AIM’s COVID-19 Updates gateway page
- AIRA’s Response to COVID-19 gateway page
- CMS's COVID-19 Vaccine Policies and Guidance gateway page
- PREP Act Indemnification Q&A page
- HRSA’s Countermeasures Injury Compensation Program gateway page
- DoD’s Immunization Healthcare gateway page
- IHS’s COVID-19 Vaccine Planning gateway page
- IAC webinar with CDC leaders Nancy Messonnier, MD and Amanda Cohn, MD: COVID-19 Vaccination Implementation and ‘Vaccinate with Confidence’ Strategy
Resources for Talking about COVID-19 Vaccines with Your Patients
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In IAC’s “Video of the Week,” JAMA Network describes the types of vaccines being developed for COVID-19 and how they might induce immunity to SARS-CoV-2 infection
Using discussion and animation, this JAMA Network video describes the types of vaccines being developed for COVID-19, including nucleic acid, viral vector, and more conventional vaccines, and how they might induce immunity to SARS-CoV-2 infection. Dr. Paul Offit reminds us that what ultimately matters is not how quickly a type of vaccine can be produced but how effective the vaccine is shown to be.
Visit the VOTW archive.
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IAC’s “Vaccination and COVID-19” gateway page offers a collection of tools from many organizations to sustain routine vaccination services during the pandemic
IAC’s Vaccination and COVID-19 gateway page assists healthcare professionals who are faced with challenges in providing routine and catch-up vaccination during the COVID-19 pandemic. At this gateway, IAC has assembled key links to help both new and experienced vaccinators deliver safe, effective vaccination to people of all ages, applicable in typical and nontraditional vaccination settings.
The site facilitates access to key pandemic resource pages from major clinical and public health organizations involved in immunization. The page will be updated frequently with new links and resources specific to catch-up vaccination, so be sure to check back regularly.
To easily locate this gateway page from anywhere on immunize.org, go to the light blue band of tabs across the top, choose the "Clinic Tools" tab, and then select "Vaccination and COVID-19” from the drop-down menu. To link directly to the site, go to www.immunize.org/vax-and-covid-19. You also can use the Guide to immunize.org at the bottom of every web page.
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Reminder: Newly updated 65+ Flu Defense website features tools and resources for healthcare professionals serving older adults
In the 2018–19 season, only 68% of adults age 65 and older were vaccinated against influenza. Confident recommendations for flu vaccine from healthcare providers are powerfully persuasive and make a significant difference in decisions your patients make about vaccination.
To assist you in maximizing protection for your patients, IAC, in collaboration with Seqirus, has updated the 65+ Flu Defense website at www.influenza-defense.org. This helpful site includes information, tools, and tips for communicating with these adults about the scope and severity of influenza, for example:
One new handout on the site, The Importance of Preventing Influenza during a Pandemic, offers responses to help guide discussions with patients on the increased importance of flu vaccination during the COVID-19 pandemic. Age increases risks associated with COVID-19 infection including hospitalization and death. Preliminary studies suggest coinfection with influenza B and SARS-CoV-2 may elevate the risk of poor outcomes.
Be sure to check out the updated 65+ Flu Defense website at www.influenza-defense.org to assist your efforts in protecting this vulnerable population.
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Great gift idea! IAC's elegantly designed "Vaccines Save Lives" black enamel pins make wonderful holiday gifts or workplace recognitions!
Several thousand sold already! IAC’s elegantly designed “Vaccines Save Lives” pins are meaningful gifts for people who care about immunization. The pin makes a refined statement in hard black enamel with gold lettering and edges, measuring 1.125" x 0.75".
The pin is a stick-through-post variety with the back end covered by a round rubber cap that holds the pin securely. A gold metal spring-lock clasp is also provided.
Wear these pins on clothing, uniforms, and white coats to show that you value vaccines! They make a meaningful gift for people who care about immunization.
Click here for "Vaccines Save Lives" pin pricing and ordering information.
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IAC's comprehensive Vaccinating Adults: A Step-by-Step Guide is available for free download either by chapter or in its entirety (142 pages)
Download IAC's free book on all aspects of adult immunization, to help train your team and refresh your leaders: Vaccinating Adults: A Step-by-Step Guide (Guide).
This up-to-date, thorough "how to" guide on adult immunization provides easy-to-use, practical information covering essential adult immunization activities. It helps vaccine providers enhance their existing adult immunization services or introduce them into any clinical setting.
In addition, the Guide is filled with hundreds of web addresses and references to help providers stay up to date on the latest immunization information, both now and in the future.
The Guide is available to download/print either by chapter or in its entirety free at www.immunize.org/guide. The downloaded version is suitable for double-sided printing. The National Vaccine Program Office and CDC both supported the development of the Guide and provided early technical review.
The Guide is a uniquely valuable resource to assist providers in increasing adult vaccination rates. Be sure to get a copy today!
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Journal Articles and Newsletters
"Number of Childhood and Adolescent Vaccinations Administered before and after the COVID-19 Outbreak in Colorado" published in JAMA Pediatrics
In the December 7 issue, JAMA Pediatrics published Number of Childhood and Adolescent Vaccinations Administered before and after the COVID-19 Outbreak in Colorado. The discussion section is reprinted below.
Since the onset of the COVID-19 pandemic, vaccination uptake in children and adolescents has shown a significant decrease in Colorado. While the clinical implications of our observation are not yet known, public health advocates should consider addressing this drop to avoid the potential for vaccine-preventable diseases. Primary care professionals should consider implementing reminders and recalls to parents, and local and state health departments should consider implementing immunization registry-based recall. Limitations of this report include its ecological nature, being limited to a single state, and the potential for missing data.
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In this sweet 2004 PSA from the New Mexico Department of Health, the former first lady of New Mexico promotes timely childhood vaccination
In this adorable public service announcement (PSA) from the New Mexico Department of Health in 2004, children dream of traveling the world with their Health Passport, while former first lady Barbara Richardson discusses the importance of childhood immunization. It is part of a PSA collection curated by vaccine expert William L. Atkinson, MD, MPH.
Previous PSAs featured in “On the Lighter Side” are available when viewing this Vimeo video.
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