Maine DHHS COVID-19 Vaccines Information for Clinicians - Stephen Sears MD, MPH, Maine CDC
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Maine DHHS
COVID-19 Vaccines
Information for Clinicians
Stephen Sears MD, MPH, Maine CDC
Corrie Anderson DO, Northern Light Health
Lisa M. Letourneau MD, MPH, ME DHHS
March 23, 2021
Welcome
• Introductions
• Session goals & format
• CME available (0.5 AMA PRA Cat 1 Credit/session)
If CME desired, pls email your name & session
attended to COVIDCME.DHHS@maine.gov
• Future sessions
• Current context
2
Disclosures
The planners and faculty for this activity do not
have any relevant financial relationships to
disclose with any Commercial Interests and do
not have any conflicts of interest to resolve
3
COVID-19 Vaccines – Info for Clinicians
• Context
• Science of vaccines
• Clinical trials & emerging vaccines
• Vaccine updates
• Vaccination concerns in pregnancy
• Promoting vaccine equity
• Building vaccine confidence
• Reporting & tracking adverse events
• State vaccination priorities & distribution
4
COVID Vaccines:
Key Similarities & Differences
Pfizer BioNTech Moderna J&J/Janssen
• mRNA vaccine • mRNA vaccine • Viral vector vaccine
• Trial with >44,000 • Trial with >30,000 • Trial with >43,800 in
in multp countries in US multp countries
• Efficacy 94.5% • Efficacy >94.1% • Efficacy >66.1%
• Minimal adverse • Minimal adverse overall, 72% in US
rxn’s rxn’s • Minimal adverse
• 2nd dose at 21D • 2nd dose at 28D rxn’s
• Auth’d for ≥16yo • Auth’d for ≥18yo • Single dose only
• Storage at -70C • Storage at -20C • Auth’d for ≥18yo
• Can be refridg’d • Can be refridg’d for • Storage at 2°C to
for 5D 30D 8°C (36°F to 46°F)
ser Note: COVID vaccines not interchangeable; however, if first dose of mRNA vaccine was received
but patient unable to complete with same or different mRNA vaccine, single dose of J&J COVID-19
vaccine may be administered at minimum interval of 28 days from mRNA dose 5
AstraZeneca Adenovirus Vector Vaccine
• AstraZeneca press release March 22 cites trial results
• Two doses (4wks apart) was 79% effective in preventing
symptomatic COVID-19
• 100% effective in preventing severe disease & hosp
• Trials included 32,449 participants (79% white; 20%
60+yo; 60% had high-risk comorbidities)
• Indep safety board found no increased risk of
thrombosis or events among 21,583 participants
receiving at least one vaccine dose
• Vaccine can be stored, transported at normal
refrigerated conditions (2-8C, 36-46F)
• Expect to file for EUA with US FDA “in coming wks”
www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-
6
us-vaccine-trial-met-primary-endpoint.html
COVID Vaccines & Efficacy
Company Platform Doses Number of Protection from Protection from Efficacy vs
vaccine COVID-19 severe COVID-19 (+/- milder
recipients hospitalization at hospitalized) COVID-19
28D post-dose 2 disease
Moderna mRNA 2 ~15,000 100% 100% (30 cases in 94.1%
placebo; 0 in vaccine
reported, though 1
per FDA)
Pfizer mRNA 2 ~18,600 100% 100% (9 cases in 95%
placebo arm; 0 in
vaccine)
Johnson & Non-replicating 1 ~22,000 in US, 100% 85% across 3 sites 72% US,
human Latin America, (89% in S Africa 66% Latin
Johnson adenovirus vector where nearly all
South Africa America;
were variant)
57% S Africa
AstraZeneca Non-replicating 2 ~21,500 100% 100% (15 79% overall
chimp adenovirus hospitalized in
vector placebo arm; 0 in
vaccine arm)
Novavax Spike 2 ~9700 (Phase 3 100% 100% (but only 1 89.3% UK;
protein/adjuvant UK; 2b SA) severe in placebo) 60% SA
Sputnik V Ad26/AdS 2 ~15,000 100% 100% (20 in placebo 91.6%
adenovirus vector arm; 0 vaccine arm)
7
Adapted from table courtesy of Monica Gandhi, MD, MPH, UCSF , Feb 18, 2021COVID Vaccines & Pregnancy • Symptomatic pregnant women more likely to have severe disease – ICU Admission (3-fold increased risk) – Intubation – ECMO (2.4-fold increased risk) – Death (1.7-fold increased risk) • Pregnant women with co-morbidities at increased risk • Black and Hispanic pregnant women are at increased risk • Increased risk of preterm birth and stillbirth • Vertical transmission appears to be rare
COVID Vaccines & Pregnancy • Data limited on safety of COVID-19 vaccines in pregnant women for all vaccines • Clinical trials for all three vaccines excluded pregnant women, but did include women subsequently identified as pregnant • Animal trials for all three vaccines showed no female reproduction or fetal, embryonal, or postnatal development safety concerns • Adenovirus vector platform used in J&J vaccine also used for other Janssen vaccines that included pregnant women – e.g. large-scale Ebola vaccination trial – & showed no adverse pregnancy-related or infant outcomes
COVID Vaccines & Pregnancy
• ACOG
– Vaccinating Pregnant and Lactating Patients Against COVID-
19, Practice Advisory, Update 3/4/21
• SMFM
– Provider Considerations for Engaging in COVID-19 Vaccine
Counseling with Pregnant & Lactating Patients, Update 3/3/21
• ASRM
– Patient Management and Clinical Recommendations During
Coronavirus Pandemic, Update 2/22/2021
• University of Washington OB/Gyn Voluntary Registry for
lactating and pregnant women who did receive vaccineCOVID Vaccines & Fertility • No evidence that COVID-19 vaccines reduce natural fertility • No evidence that COVID-19 vaccines harm the placenta or fetus • While COVID-19 vaccines are new, mechanisms of action of mRNA & adenovirus vaccines and existing safety data provide reassurance regarding safety of vaccines during pregnancy www.uchicagomedicine.org/forefront/coronavirus-disease-covid-19/mrna- covid-19-vaccine-pregnancy-breastfeeding
COVID Vaccines & Pregnancy Planning • Current recommendations state no reason to delay conception with getting COVID-19 vaccine • If women become pregnant after receiving first dose vaccine, should not delay getting 2nd dose as scheduled • Only possible risk currently identified vaccine is possibility of fever following 2nd dose, a side effect experienced by around 10- 15% of vaccine recipients. In animal studies, high fevers in early pregnancy have been associated with slight increase in risk of birth defects and pregnancy loss • If this is concern, current recommendation is to take pregnancy- safe fever reducer (e.g. Tylenol) if fever after getting vaccinated • If undergoing fertility treatments, current recommendation is to continue treatments and get vaccinated • Talk with your physician and/or fertility specialists to make the decision that is best for you www.uchicagomedicine.org/forefront/coronavirus-disease-covid-19/mrna- covid-19-vaccine-pregnancy-breastfeeding
COVID Vaccines & Maternal Antibodies • JAMA Peds: cohort study showed trans-placental transfer of maternal SARS-CoV-2 antibodies • IgG antibodies transferred across placenta after asymptomatic & symptomatic infection during pregnancy • IgM antibodies not detected in cord blood sera • Cord blood antibody concentrations correlated with maternal antibody concentrations and with duration between onset of infection and delivery • Findings demonstrate potential for maternally derived SARS-CoV-2 specific antibodies to provide neonatal protection from COVID-19 https://jamanetwork.com/journals/jamapediatrics/fullarticle/2775945
Breastfeeding & COVID Vaccines Risks • Any small amounts of mRNA or DNA from vaccines in body are quickly broken down • It is extremely unlikely that any vaccine material would be able to get into breast milk or into fetus through the placenta • Additionally, because this material is so easily degraded, it cannot survive acidic environment of baby’s stomach even if it were ingested www.uchicagomedicine.org/forefront/coronavirus-disease-covid-19/mrna- covid-19-vaccine-pregnancy-breastfeeding
Children and COVID-19 Vaccines • Pfizer is available for older than 16 years • Moderna and J and J are available for >18 yrs • Pfizer trial is fully enrolled for children 12
State COVID Updates: Transportation
• Maine DHHS offering free transportation to
anyone needing ride to vaccination appt
• Indiv’s must first schedule vaccine appt
• Those with vaccine appt can schedule rides by
calling tel. 1-855-608-5172 (Mon-Sat, 7A – 4P)
• Need to call at least 48hrs before vaccine appt
• Managed by ModivCare (formerly LogistiCare),
with contracts to CAPs & other agencies
• Drivers will leave pts for appt, return at 60’ or 90’
16State COVID Updates: Call Line
• Community Vaccination Line: tel. 1-888-445-4111
• Available M-F: 7A -7P, & Sat-Sun: 8A - 2P
• Can help those who…
– Do not have internet access
– Need assistance connecting to or navigating online
resources
– Require interpretation assistance
– Are home bound and need transportation
– Have other questions about resources in their area
• Will not provide faster access to clinic appts
17Ensuring Racial/Ethnic Equity
ME DHHS Equity webinar Wed, April 21, 7:30A
• Register in advance for this and additional
webinars in monthly series:
https://zoom.us/meeting/register/tJcsfuGvpj0jGda
RiW5Y15qnYa2AMVriHgaI , OR
• Log on at the time of the webinar with
following link: https://zoom.us/j/93198786932
– Meeting ID: 931 9878 6932
– Passcode: 4FrT7H
– One tap mobile:
+13126266799,,93198786932#,,,0#,,416363#
*NOTE: Clinician Info Sessn’s now being held on
2nd & 4th Tues (7:30A) & Fri (12N) each month
18Maine Plan for Vaccine Distribution*
Phase 1a
• Health Care All Other
Personnel • Current:
• Residents & staff • ≥ 60 yo1
of long-term care •School teachers & staff, child care staff
facilities
• Then…
• Public safety
• March 23: 50yo & older2
• State COVID • April 19: All other 16yo & older!
response critical
personnel
*Updates posted to Gov Mills COVID Vaccine website: www.maine.gov/covid19/vaccines
1 60+ yo: Currently being vaccinated
2 50-59yo: Anticipate starting vaccination early April
NOTE: Facilities booking appts listed at: www.maine.gov/covid19/vaccines/vaccination-sitesGov Mills Info COVID Vaccine
www.maine.gov/covid19/vaccines 20Gov Mills Info COVID Vaccine
www.maine.gov/covid19/vaccines 21Gov Mills Info COVID Vaccine
www.maine.gov/covid19/vaccines 22ME CDC COVID Vaccine Resources
ME CDC COVID-19 Vaccine Resources
(www.maine.gov/dhhs/mecdc/infectious-disease/immunization/covid-19-providers/index.shtml)
Vaccine questions? Email:
23
C19vaccine.MECDC@maine.govPresenters
• Lisa Letourneau MD, MPH
Senior Advisor, Healthcare Delivery System Change, ME DHHS
Lisa.Letourneau@maine.gov
C: 207-415-4043
• Corrie Anderson DO
OB-Gyn
canderson@northernlight.org
• Stephen Sears MD, MPH
Consulting Epidemiologist, Maine CDC
Stephen.sears@maine.gov
C: 207-458-2351
Maine Department of Health and Human Services 24COVID-19 Vaccines
Questions??
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