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..