COVID-19 Vaccine Implementation

Dr. Amanda Cohn

January 11, 2021

For more information: www.cdc.gov/COVID19 ACIP: COVID-19 Vaccine Guiding Principles

Efficient Distribution. During a pandemic, efficient, expeditious E and equitable distribution and administration of authorized vaccine Q is critical U I T Y Flexibility. Within national guidelines, state and local jurisdictions should have flexibility to administer vaccine based on local epidemiology and demand

12/21/20 COVID-19 Vaccine Distribution and Initiation As of January 4, 2021

Available: https://covid.cdc.gov/covid-data-tracker Total Doses Distributed 15,418,500 Total Number of People Initiating Vaccination (1st Dose Received) 4,563,260

Updated: Jan 4, 2021 as of 9:00am ET

1/4/21 COVID-19 vaccination phases

12/21/20 Vaccination of Special Populations Persons with underlying medical conditions . Vaccine may be administered to persons with underlying medical conditions who have no contraindications to vaccination

. Clinical trials demonstrate similar safety and efficacy profiles in persons with underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to persons without comorbidities

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html 12/21/20 Immunocompromised persons

. Persons with HIV infection, other immunocompromising conditions, or who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19

. Data not currently available to establish safety and efficacy of vaccine in these groups

. These individuals may still receive COVID-19 vaccine unless otherwise contraindicated

. Individuals should be counseled about: – Unknown vaccine safety and efficacy profiles in immunocompromised persons – Potential for reduced immune responses – Need to continue to follow all current guidance to protect themselves against COVID-19 https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html 12/21/20 Pregnant women . COVID-19 and pregnancy – Increased risk of severe illness (ICU admission, mechanical ventilation and death) – Might be an increased risk of adverse pregnancy outcomes, such as preterm birth

. There are few data on the safety of COVID-19 vaccines in pregnant women – Limited animal developmental and reproductive toxicity (DART) data – Studies in humans are ongoing and more planned

. If a woman is part of a group (e.g., healthcare personnel) who is recommended to receive a COVID-19 vaccine and is pregnant, she may choose to be vaccinated.

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnancy-breastfeeding.html 12/21/20 Pregnant women . Considerations for vaccination: – level of COVID-19 community transmission (risk of acquisition) – her personal risk of contracting COVID-19 (by occupation or other activities) – the risks of COVID-19 to her and potential risks to the fetus – the efficacy of the vaccine – the known side effects of the vaccine – the lack of data about the vaccine during pregnancy

12/21/20 Contraindications and Precautions Contraindications to vaccination . Prescribing information for both Pfizer-BioNTech and Moderna COVID-19 vaccines: – Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine is a contraindication to vaccination – Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine

12/21/20 Anaphylaxis in persons following Pfizer-BioNTech COVID-19 vaccination . Cases of anaphylaxis have been reported following Pfizer-BioNTech COVID-19 vaccination – 2 cases in United Kingdom – 6 cases* in United States (~272K doses administered)†

. US cases: – Rapid onset following vaccination – One person had prior history of anaphylaxis (to rabies vaccine)

* 6 confirmed cases meeting Brighton Collaboration criteria 1 or 2, through December 18, 2020 at 2300 hrs EST † as of December 19, 2020 at 0945 hrsEST 12/21/20 Precautions to vaccination: Pfizer-BioNTech and Moderna COVID-19 vaccines . History of severe allergic reaction (e.g., anaphylaxis) to any other vaccine or injectable therapy (e.g., intramuscular, intravenous, or subcutaneous) – Risk assessment should be conducted in persons who report history of severe allergic reaction (e.g., whether reaction required use of epinephrine [EpiPen®, etc.], resulted in hospitalization)

. These persons may still receive vaccination, but should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefits of vaccination

12/21/20 Observation period following vaccination

. Vaccine providers should observe patients after vaccination to monitor for the occurrence of immediate adverse reactions:

Persons with a history of All other persons anaphylaxis (due to any cause)

30 minutes 15 minutes 12/21/20 Additional tools to identify persons with contraindications and precautions to vaccination

Interim considerations:

Preparing for the potential management of anaphylaxis at COVID-19 vaccination sites

https://www.cdc.gov/vaccines/covid-19/downloads/pre-vaccination-screening-form.pdf https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html 12/21/20 Key messages Preparing for the potential management of anaphylaxis at COVID-19 vaccination sites

Early recognition of Prompt treatment with Activation of emergency anaphylaxis symptoms epinephrine medical services

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html 12/21/20 Vaccine Safety Monitoring COVID-19 Vaccine Safety Strategy

1. Use established systems to implement heightened safety monitoring for COVID-19 vaccines

2. Develop new platforms and leverage other federal data sources to complement existing systems

3. Communicate clearly on the vaccine safety process and systems now; provide COVID-19 vaccine safety data and monitoring results once available

12/2/20 1. text message check-ins from CDC (daily 1st week; weekly thru 6 weeks; then 3, 6, and 12 mo.) vaccine recipient completes web survey

2. clinically  missed work This Photo by Unknown Author is licensed under CC BY-SA Vaccine recipient important  unable to do normal event(s) daily activities reported  received medical care

Call center 3. a VAERS customer service representative conducts active telephone follow-up on a clinically important event and takes a report This Photo by Unknown Author is licensed under CC BY-SA if appropriate

11/23/20 Your role COVID-19 vaccine safety gets stronger with your participation

Public health partners Healthcare providers . Promote participation in v-safe . Encourage patient participation in v-safe . Promote reporting to VAERS . Report adverse events to VAERS . Communicate with your partners . Communicate with patients on vaccine safety on vaccine safety COVID-19 Vaccine Implementation

. This is an exciting and historic time, but the work is far from over. . There will be unanticipated challenges, but CDC will continue to work closely with you, our partners, to find solutions and overcome obstacles. . Vaccines are an important tool to control the pandemic, but we need to continue to message the importance of masks, social distancing, and hand washing. . Community engagement is critical to vaccination implementation success – Engage in conversations in your community, choose to get vaccinated when it’s your turn, share CDC resources and toolkits

12/21/20 Clinical Resources COVID-19 vaccine communication resources

• Engaging in Effective COVID-19 Vaccine Conversations – https://www.cdc.gov/vaccines/covid- 19/hcp/engaging-patients.htm • Toolkit for Medical Centers, Clinics, and Clinicians – https://www.cdc.gov/vaccines/covid-19/health- systems-communication-toolkit.html • More toolkits coming soon – Long-term care facilities – Health departments – Community-based organizations – Employers of essential workers 23 Thank you

For more information, contact CDC 1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.