COVID-19 Vaccine Safety Webinar

COVID-19 Vaccine Safety WebinarDecember 17, 2020

Before We Start All participants will be muted for the presentation. The webinar will be recorded. You may ask questions using the questions pane of the GoToWebinar panel. We may be able toanswer questions at the end of the presentation. You can download the slides using the GoToWebinar panel. Continuing education credit is available for nurses, medical assistants, pharmacists, andphysicians attending the webinar or watching the recording. If you’re watching in a group settingand wish to claim CE credit, please make sure you register for the webinar as an individual andcomplete the evaluation separately. You can find more information on our ccineSafetyWebinarWashington State Department of Health 2

PresentersMichelle Holshue, MPH, BSN, RNLCDR, US Public Health Service Commissioned CorpsCDC Career Epidemiology Field Officer (CEFO), assigned toWashington State Department of HealthJohn Dunn, MD, MPH, FAAPMedical Director of Preventive CareKaiser PermanenteKathy Bay, RN, CENPDoctorate of Nursing PracticeClinical, Quality, Epidemiology, & School Section ManagerWashington State Department of HealthWashington State Department of Health 3

Continuing Education Disclosure The planners and speakers of this activity have no relevant financialrelationships with any commercial interests pertaining to this activity Information about obtaining CE credit will be available at the end of thiswebinarWA State DOH 4

Continuing Education This continuing nursing education activity was approved by the Montana Nurses Association, an accredited approverwith distinction by the American Nurses Credentialing Center’s Commission on Accreditation. Upon successfulcompletion of this activity, 1.0 contact hours will be awarded. This program has been granted prior approval by the American Association of Medical assistants (AAMA) for 1.0administrative continuing education unit. This training was approved by the Washington State Pharmacy Quality Assurance Commission (PQAC) for pharmacisteducation. Upon successful completion of this activity, 1.0 credit hour of continuing education will be awarded. This activity has been planned and implemented in accordance with the accreditation requirements and policies ofthe Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Federationof State Medical Boards, the Washington Medical Commission and the Washington State Department of Health. TheFederation of State Medical Boards is accredited by the ACCME to provide continuing medical education forphysicians. The Federation of State Medical Boards designates this live activity for a maximum of 1.0 AMA PRA Category 1Credit . Physicians should claim only the credit commensurate with the extent of their participation in the activity.WA State DOH 5

Continuing Medical Education Disclosure This webinar is not funded by any commercial entity. As an organization accredited by the ACCME, the Federation of State Medical Boards (FSMB) requires that the content of CME activities andrelated materials provide balance, independence, objectivity, and scientific rigor. Planning must be free of the influence or control of acommercial entity and promote improvements or quality in healthcare. All persons in the position to control the content of an educationactivity are required to disclose all relevant financial relationships in any amount occurring within the past 12 months with any entityproducing, marketing, re-selling, or distributing health care goods or services consumed by, or used on patients. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that create aconflict of interest. The FSMB has implemented a mechanism to identify and resolve all conflicts of interest prior to the activity. The intent ofthis policy is to identify potential conflicts of interest so participants can form their own judgments with full disclosure of the facts. Participantswill be asked to evaluate whether the speaker’s outside interests reflect a possible bias in the planning or presentation of the activity. The speakers, course director and planners at the Federation of State Medical Boards, Washington Medical Commission and the WashingtonState Department of Health have nothing to disclose. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food andDrug Administration. For additional information about approved uses, including approved indications, contraindications, and warnings, pleaserefer to the prescribing information for each product, or consult the Physicians’ Desk Reference. No speakers or persons in control of content reported intent to reference unlabeled/unapproved uses of drugs or products.WA State DOH 6

Topics to be Covered Epidemiology of COVID-19 in WashingtonAvailable COVID vaccinesPre-clinical trials and phases, FDA approval process, post-licensure monitoringPrevention of vaccine adverse eventsProvider-based approaches to review vaccine adverse event with patient orparent Vaccine adverse events reporting Vaccine safety resourcesWA State DOH 7

COVID-19 EpidemiologyMICHELLE HOLSHUE, MPH, BSN, RN

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Since January, Washington has confirmed morethan 200,000 cases of COVID-19203,797 Confirmed Cases of COVID-19 in Washington by Illness Onset Date, as of 12/13/2020Washington State Department of Health 10

Since January, Washington has confirmedalmost 3,000 Deaths from COVID-192,857 Confirmed Deaths from COVID-19 in Washington by Illness Onset Date, as of 12/13/2020Washington State Department of Health 11

The U.S. has had more than 16 Million COVID-19 casesand 300,000 deaths in 2020.Washington State Department of Health 12

The U.S. has more new cases per population than anyother country.Washington State Department of Health 13

COVID-19 VaccinesJOHN DUNN, MD, MPH

COVID-19Vaccines

What’s in the pipeline COVID-19Vaccines

What’s in the pipeline COVID-19Vaccines Use authorized under EUA Pfizer-BioNTech

What’s in the pipeline COVID-19Vaccines Use authorized under EUA Pfizer-BioNTech Authorization pending Moderna

What’s in the pipeline COVID-19Vaccines Use authorized under EUA Pfizer-BioNTech Authorization pending Moderna Phase 3 trials Others

Process:COVID-19Vaccines Streamlined but no stepsomitted

Process:COVID-19Vaccines Streamlined but no stepsomitted Pre-clinical trials and phases FDA approval process CDC guidance Post-licensure monitoring

FROM CENTERS FOR DISEASE CONTROL: istory/index.html#anchor 1593624850886

COVID-19Vaccines FDA authorization

COVID-19Vaccines FDA authorization The FDA’s role

COVID-19Vaccines FDA authorization The FDA’s role “VRBPAC”

COVID-19Vaccines FDA authorization The FDA’s role “VRBPAC” Emergency Use Authorization

COVID-19Vaccines FDA authorization The FDA’s role “VRBPAC” Emergency Use Authorization Process for approval

COVID-19Vaccines CDC Recommendations

COVID-19Vaccines CDC Recommendations The CDC’s role

COVID-19Vaccines CDC Recommendations The CDC’s role “ACIP”

COVID-19Vaccines CDC Recommendations The CDC’s role “ACIP” Publication in MMWR

AdverseEvents

Pfizer vaccineAdverseEvents

Pfizer vaccineAdverseEvents Over 37,000 participants receivedtwo doses

Pfizer vaccineAdverseEvents Over 37,000 participants receivedtwo doses Half got vaccine, half placebo Followed for two months afterdose #2 Additional data from almost6000 additional participants

Pfizer vaccineAdverseEvents Local site reactions & systemicsolicited events were

Pfizer vaccineAdverseEvents Local site reactions & systemicsolicited events were Frequent Mostly mild to moderate. More common in those55-and-under than inthose over age 55

Pfizer vaccine Most common reactions AdverseEvents

Pfizer vaccine Most common reactions AdverseEvents injection site reactions (84.1%),fatigue (62.9%),headache (55.1%),muscle pain (38.3%),chills (31.9%),joint pain (23.6%),fever (14.2%)

Pfizer vaccine Severe adverse reactions AdverseEvents

Pfizer vaccineAdverseEvents Severe adverse reactions Occurred in 0.0% to 4.6% ofparticipants More frequent after Dose 2than after Dose 1 Less frequent in older adultsthan in younger participants

Pfizer vaccine What about AdverseEvents

Pfizer vaccineAdverseEvents What about Lymphadenopathy?

Pfizer vaccineAdverseEvents What about Lymphadenopathy? Bell’s Palsy?

Pfizer vaccineAdverseEvents What about Lymphadenopathy? Bell’s Palsy? Immediate reactions(within 30 minutes of dose)?

Pfizer vaccineAdverseEvents What about Lymphadenopathy? Bell’s Palsy? Immediate reactions(within 30 minutes of dose)? Serious or life-threateningadverse events?

Moderna vaccineAdverseEvents Data just being released FDA meeting as we speak toreview this Similar safety profile

Treatment considerationsAdverseEvents Symptomatic care andtincture-of-time Symptoms generally selflimited May last a few days Some overlap with symptomsof COVID-19

Discussion with patientsand families AdverseEvents

Discussion with patientsand families AdverseEvents Awareness!

Discussion with patientsand families AdverseEvents Awareness! Setting expectations

Discussion with patientsand families AdverseEvents Awareness! Setting expectations Reassurance about benignnature of known side effects

Discussion with patientsand families AdverseEvents Awareness! Setting expectations Reassurance about benignnature of known side effects Reassurance about absence ofsevere side effects in studies

Discussion with patientsand families AdverseEvents Handling questions

Discussion with patientsand families AdverseEvents Handling questions On duration of follow-up datafor study participants

Discussion with patientsand families AdverseEvents Handling questions On duration of follow-up datafor study participants On need for a second dose

Discussion with patientsand families AdverseEvents Handling questions On duration of follow-up datafor study participants On need for a second dose On what they hear in the newsor online

Vaccine Safety MeasuresKATHY BAY DNP, RN, CENP

Vaccine Safety & WADOH anning-progress-inWashington-State.“DOH is committed to science and the needto critically evaluate these new vaccines fortheir safety and efficacy in an unbiased waybefore their use,” said Dr. Kathy Lofy, StateHealth Officer. “We will be watching the FDAapproval process closely to make sure it isthorough and transparent.”Washington State Department of Health 59

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Obtaining Continuing Education Continuing education credit is available for nurses, physicians, medical assistants, and pharmacists Successful completion of this continuing education activity includes the following: Attending the entire live webinar or watching the webinar recording Completing the evaluation available after the webinar or webinar recording Expiration date is 12/17/21 After completing the evaluation, send an email to trang.kuss@doh.wa.gov to request a certificate Due to limited staff availability with COVID-19 priorities, certificates may be slightly delayed If you have any questions about CE credit, contact Trang Kuss at trang.kuss@doh.wa.govWA State DOH 71

Questions?