Arizona News Karen Lewis, M.D. Medical Director Arizona Program Office July 30, 2021 Douglas A. Ducey | Governor Cara M. Christ | MD, MS, Director ______150 North 18th Avenue, Suite 120, Phoenix, AZ 85007-3247 P | 602-364-3630 F | 602-364-3285 W | azdhs.gov Health and Wellness for all Arizonans

Newsletter Topics

COVID-19 • COVID-19 Breakthrough in Fully Immunized People • Vaccine Effectiveness of mRNA COVID-19 Vaccines in Health Care Personnel • Effectiveness of mRNA COVID-19 Vaccines in Preventing Hospitalization of the Elderly • Effectiveness of Pfizer-BioNTech COVID-19 Vaccine Against Variants in Qatar • Effectiveness of Pfizer-BioNTech COVID-19 Vaccine in Israel • Vaccine Lowers COVID-19 Cases, ED Visits, Hospitalizations and Deaths in the Elderly • mRNA COVID-19 Vaccines Attenuate SARS-CoV-2 Symptoms in Breakthrough Cases • COVID-19 Vaccine Effectiveness Against Delta and Alpha Variants • SARS-CoV-2 Are Found in Breastmilk • Joint CDC and FDA Statement on COVID-19 Vaccine Boosters • Considerations for Janssen COVID-19 Vaccine Use in Light of TTS • Use of mRNA COVID-19 Vaccines After Myocarditis in COVID-19 Vaccine Recipients • FDA Amends Janssen Vaccine’s EUA to Include Guillain-Barré Syndrome Risk • COVID-19 Does Not Mean Anti-Vaccine

VACCINES AND VACCINE-PREVENTABLE DISEASES • Record Pediatric Influenza Deaths in the 2019-2020 Influenza Season in the U.S. • in Pregnancy Is Not Associated with Adverse Outcomes in Mothers or Babies • Inadvertent HPV Vaccine During Pregnancy Shows No Increased Risks • Recent Stagnation in Increases of HPV Vaccine Series Initiation and Completion • CDC Issues Measles Travel Advisory Level 1 for Travel to Africa

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DO YOU KNOW? • Can Vaxelis® be given outside of infancy for children behind on their vaccines?

RESOURCES • Guidance on COVID-19 Vaccines for People Immunized Outside of the United States • Clinical Considerations for Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults • American Society of Hematology Guidance on TTS After Janssen Vaccine • American College of Rheumatology Guidance for COVID-19 • Required VAERS Reporting of Adverse Events After COVID-19 Vaccines • CDC COVID-19 Vaccines Training Modules with CME Credit

COVID-19 VACCINES COVID-19 Breakthrough Infections in Fully Immunized People • About 101 million people in the U.S. had been fully vaccinated against COVID-19 by the end of April 2021. o Of these, there were 10,262 SARS-CoV-2 vaccine breakthrough infections. . 25% were asymptomatic, 10% were hospitalized, and 2% died. . Median age of breakthrough cases was 58-years-old. . Median age of breakthrough cases who died was 82-years-old. . Of the viruses that were sequenced, 64% were SARS-CoV-2 variants of concern. • The breakthrough COVID-19 cases represented about 1% of fully vaccinated people. See Morbidity and Mortality Weekly Report (MMWR), May 28, 2021

Vaccine Effectiveness of mRNA COVID-19 Vaccines in Health Care Personnel • The effectiveness of Pfizer-BioNTech and Moderna vaccines for preventing COVID-19 in U.S. healthcare providers was measured between January-March 2021. st o Fourteen days after the 1 dose, protection was 82%. nd o Seven days after the 2 dose, protection was 94%. See MMWR, May 21, 2021.

Effectiveness of mRNA COVID-19 Vaccines in Preventing Hospitalization of the Elderly • In a case-control study of mRNA COVID-19 vaccines in hospitalized adults > 65-years-old: o One dose was 64% effective in preventing hospitalization. o Two doses were 94% effective in preventing hospitalization. See MMWR, May 7, 2021.

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Effectiveness of Pfizer-BioNTech COVID-19 Vaccine Against Variants in Qatar • In Qatar, more than 265,000 people had received two doses of the Pfizer-BioNTech mRNA COVID-19 vaccine as of March 31, 2021. • 50.0% of infections were caused by the Beta variant (B.1.351) and 44.5% by the Alpha variant (B.1.1.7). • Vaccine effectiveness was 89.5% against the Alpha variant and 75.0% against the Beta variant. • Effectiveness against severe, critical, or fatal disease was 97.4% against both variants. See the New England Journal of Medicine (NEJM), May 5, 2021.

Effectiveness of Pfizer-BioNTech COVID-19 Vaccine in Israel • Israel used Pfizer-BioNTech COVID-19 vaccine in their country, giving more than 10 million doses to over 5.2 million people, about 80% of their population. • They assessed vaccine effectiveness for protection against: o Asymptomatic SARS-CoV-2 = 91.5% o Symptomatic COVID-19 = 97.0% o COVID-19 hospitalization = 97.2% o Severe or critical hospitalization = 97.5% o Death = 96.7% See , May 5, 2021.

Vaccine Decreases COVID-19 Cases, ED Visits, Hospitalizations and Deaths in Elderly Adults • By May 1, 2021, 82%, 63%, and 42% of U.S. adults ages ≥65, 50–64, and 18–49 years old, respectively, had received at least 1 dose of COVID-19 vaccine. • Between November 29–May 1, 2021, when comparing COVID-19 infections in elderly adults to adults ages 18-49 years old, there was the following comparative decline: o 40% fewer COVID-19 cases. o 59% fewer emergency room visits for COVID-19. o 65% fewer hospitalizations due to COVID-19. o 66% fewer deaths from COVID-19. See MMWR, June 11, 2021. mRNA COVID-19 Vaccines Attenuate SARS-CoV-2 Symptoms in Breakthrough Cases • In a prospective cohort study involving 3,975 health care personnel (HCP), the vaccine effectiveness of mRNA vaccines in preventing symptomatic and asymptomatic SARS-CoV-2 infection was: o 91% if fully vaccinated. o 81% if partially vaccinated. • Among study subjects with SARS-CoV-2 infection: o The mean viral RNA load was 40% lower in partially or fully vaccinated HCP. o Vaccinated HCP had 58% less symptoms and a shorter duration of illness, with 2.3 fewer days spent sick in bed compared to unvaccinated HCP. See NEJM, July 22, 2021. 3

COVID-19 Vaccine Effectiveness Against Delta and Alpha Variants • In England, a study compared the effectiveness of COVID-19 against the predominant Alpha variant (B.1.1.7) and the new Delta variant (B.617.2). o Effectiveness after one dose of COVID-19 vaccine was lower among persons with the Delta variant (30.7%) than among those with the Alpha variant (48.7%) for both Pfizer- BioNTech and Oxford-AstraZeneca COVID-19 vaccines. nd o After the 2 dose of the Pfizer-BioNTech COVID-19 vaccine, effectiveness was 93.7% against the Alpha variant and 88.0% against the Delta variant. nd o After the 2 dose of the Oxford-AstraZeneca COVID-19 vaccine, the effectiveness was 74.5% against the Alpha variant and 67.0% against the Delta variant. • Vaccine effectiveness was optimized when both doses of COVID-19 vaccine were given. See NEJM, July 21, 2021.

SARS-CoV-2 Antibodies Are Found in Breastmilk • SARS-CoV-2 specific IgA and IgG levels in breast milk were measured after the 1st and 2nd doses of Pfizer-BioNTech vaccine. st o By 2 weeks after the 1 dose, 61.8% of samples had high anti–SARS-CoV-2- specific IgA antibodies, and by 1 week after the 2nd dose, 86.1% tested positive. o Anti–SARS-CoV-2-specific IgG antibodies remained low for the first 3 weeks, but by the 4th week, 91.7% of samples were positive, and by the 6th week, 97% of samples were positive. JAMA, April 12, 2021.

Joint CDC and FDA Statement on COVID-19 Vaccine Boosters • People who have been fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the U.S. (such as the Delta variant). • Almost all COVID-19 hospitalizations and deaths are among the unvaccinated. • Americans who have been fully vaccinated do not need a booster shot at this time. • Boosters may be recommended in the future if scientific data indicates the need. See the full joint news release from July 8, 2021.

Considerations for Janssen COVID-19 Vaccine Use in Light of TTS • As of April 21, 2021, the Reporting System (VAERS) had received 15 reports of Thrombosis with Thrombocytopenia Syndrome (TTS) after Janssen vaccine, a syndrome where clots develop along with low platelets. o Clots were located in the cerebral venous sinuses and other unusual locations. o The risk of TTS was higher for women under 50-years-old. • If the Janssen COVID-19 vaccine were no longer available to use in the U.S., excess COVID-19 cases and deaths could occur. • The CDC continues to recommend the continued use of the Janssen COVID-19 vaccine in all persons aged 18 years and older. For more details on the risk-benefit discussion, see MMWR, April 30, 2021.

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Use of mRNA COVID-19 Vaccines After Reports of Myocarditis in COVID-19 Vaccine Recipients • There have been VAERS reports of myocarditis and pericarditis after mRNA COVID-19 vaccines, predominantly in younger males and more commonly after the 2nd dose. • The Advisory Committee on Immunization Practices (ACIP) determined that the benefits of using mRNA COVID-19 vaccines under the FDA’s Emergency Use Authorization (EUA) clearly outweigh the risks in all age groups, including adolescents and young adults. nd o It is estimated that for every million 2 doses of mRNA COVID-19 vaccine administered to males aged 12–29 years, vaccination would prevent 11,000 COVID-19 cases, 560 hospitalizations, 138 ICU admissions, and six deaths due to COVID-19. This is in comparison to an expected 39–47 myocarditis cases. For more details, see MMWR, July 9, 2021.

FDA Amends Janssen Vaccine’s EUA to Include Guillain-Barré Syndrome Risk • There have been 100 preliminary reports of Guillain-Barré Syndrome (GBS) in the U.S. following approximately 12.5 million doses of the Janssen COVID-19 vaccine (about 1 per 125,000 doses). o 95 people with GBS required hospitalization. One person died. • No such signal has been seen with Moderna or Pfizer-BioNTech COVID-19 vaccines. • GBS syndrome occurring after Janssen COVID-19 vaccine has been added to the vaccine’s EUA documents. o “Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.” • An estimated 3,000-6,000 people develop GBS unrelated to COVID-19 vaccines each year in the U.S. See the FDA News Release from July 13, 2021.

COVID-19 Vaccine Hesitancy Does Not Mean Anti-Vaccine • Vaccine-hesitant individuals can be vulnerable to manipulation by anti-vaccine messages as they search for information. o Three key messages are used by organized anti-vaccine groups: COVID-19 is not dangerous, the vaccine is dangerous, and vaccine advocates cannot be trusted. • Vaccine-hesitant people are at risk of being judged or labeled “anti-vaxx” by the very health care professionals who are best situated to encourage vaccination. • Showing empathy, building trust, and giving education are important ways to reach vaccine-hesitant people. See the editorial in Science, March 26, 2021.

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VACCINES AGAINST VACCINE-PREVENTABLE DISEASES Record Number of Pediatric Influenza Deaths in the 2019-2020 Influenza Season in the U.S. • Only 22% of children eligible for influenza vaccine in the U.S. were fully vaccinated against influenza in the 2019-2020 season. • One hundred and ninety-nine children died from influenza in the 2019-2020 influenza season—the most ever reported in one influenza season in the U.S. o 56% of deaths were in 5-17 year old children. o 44% of deaths were in children younger than 5 years old. . 12 deaths occurred in children younger than 6 months old. o Less than half of these children had a pre-existing medical condition. See the CDC report for more details.

Influenza Vaccine in Pregnancy Not Associated with Adverse Outcomes in Mothers or Babies • Maternal influenza vaccination during pregnancy showed: o No increased maternal risk of asthma, infections, , sensory impairment, emergency department visits or hospitalizations. o No increased childhood adverse health outcomes in infants whose mothers were vaccinated: . No increase in childhood asthma, neoplasms, sensory impairment, or early childhood infections. See JAMA, June 8, 2021.

Inadvertent HPV Vaccine During Pregnancy Shows No Increased Risks • The 9vHPV vaccine given during pregnancy was not associated with an increased risk for spontaneous abortion, preterm birth, or small for gestational age birth. See JAMA Network Open, April 5, 2021.

Recent Stagnation in Increases of HPV Vaccine Series Initiation and Completion • HPV vaccination between ages 9 to 12 years increased between 2008 to 2018 in the U.S. o HPV vaccine initiation rates rose from 17.3% in 2008 to 62.8% in 2018. o Up-to-date status (HPV-UTD) rose from 13.5% in 2011 to 32.8% in 2018. • For most of this period, non-Hispanic Black and Hispanic individuals had higher rates of initiation and HPV-UTD than non-Hispanic white individuals. • HPV-UTD rates in most US states have been less than 50%. For more details, graphs, and state-specific coverage, see Pediatrics, June 2021.

CDC Issues Measles Travel Advisory Level 1 for Travel to Africa • Measles is still common in the world, including Europe, the Middle East, Asia, and Africa. • Each year, an estimated 142,000 people die from measles. • People should be fully immunized against measles before international travel starting at age 6 months and above. 6

DID YOU KNOW? Vaxelis® can be given outside of infancy for children behind on their vaccines • Vaxelis® (DTaP-IPV-hepatitis B-Hib) is approved for a three dose 2-, 4-, and 6-month primary series. o It may be used for children under 5 years old needing catch-up on doses for the primary series. o Vaxelis® is not approved for booster doses (dose 4 or 5 of DTaP, dose 4 of IPV, or dose 4 of Hib). • However, if Vaxelis® is inadvertently given as a booster dose, the vaccine is considered valid and does not need to be repeated.

RESOURCES CDC Guidance on COVID-19 Vaccination for People Immunized Outside of the United States • People vaccinated outside the U.S. with an FDA-authorized COVID-19 vaccine and who have received all the recommended doses do not need any additional doses. • People who received the 1st dose of an FDA-authorized COVID-19 vaccine that requires two doses do not need to restart the vaccine series in the U.S. but should receive the 2nd dose as close to the recommended time as possible. • In some circumstances people who received a COVID-19 vaccine not currently authorized in the U.S. may be offered revaccination with an FDA-authorized vaccine. o This guidance varies as to whether the non-FDA authorized vaccine is listed for emergency use by the World Health Organization. See the “Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved in the United States” for more guidance.

Clinical Considerations for Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults • Consider myocarditis and pericarditis in adolescents or young adults with acute chest pain, shortness of breath, or palpitations a few days after receiving an mRNA COVID-19 vaccine. • CDC provides clinical care recommendations for suspected or documented cases of myocarditis and pericarditis.

American Society of Hematology (ASH) Guidance on Responding to TTS After Janssen Vaccine • ASH gives guidance as to how to diagnose and manage Thrombosis with Thrombocytopenia Syndrome (TTS) that has been described to occur rarely after adenoviral vector COVID-19 vaccines such as Janssen and Oxford-AstraZeneca. • ASH strongly agrees with the CDC that the risk of COVID-19 disease, including thrombosis, far outweighs the extremely rare risk of TTS associated with highly efficacious vaccines.

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American College of Rheumatology (ACR) Guidance for COVID-19 Vaccinations • Although patients on immunosuppressive medicines may not have as robust of an immune response as normal, ACR believes that the benefits of COVID-19 vaccination outweigh the risks. • ACR gives guidance for how long to hold off immunosuppressive therapy after receipt of COVID-19 vaccines. See Arthritis and Rheumatology, June 15, 2021.

Required VAERS Reporting of Adverse Events After COVID-19 Vaccines • Healthcare providers are required to report the following adverse events after COVID-19 vaccines to VAERS, in accordance with the EUA for COVID-19 vaccines: o Vaccine administration errors, whether associated with an adverse event or not o Serious adverse events, regardless of causality, including: . Death. . A life-threatening event. . Inpatient hospitalization or prolongation of existing hospitalization. . Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. . Congenital anomaly or birth defect. . An important medical event that, based on appropriate medical. judgement, may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above. o Cases of Multisystem Inflammatory Syndrome (MIS). o Cases of COVID-19 that result in hospitalization or death.

CDC COVID-19 Vaccines Training Modules with CME Credit • Training modules cover 1) General COVID-19 Vaccine Overview, 2) Pfizer vaccine, 3) Moderna vaccine, and 4) Janssen vaccine. • CDC continuing medical education (CME) is available for each module.

 Please feel free to distribute ADHS’ Arizona Vaccine News to any of your partners who may be interested. • If you wish to subscribe or unsubscribe, email [email protected]. • Past issues of Arizona Vaccine News are found at https://www.azdhs.gov/preparedness/epidemiology-disease- control/immunization/index.php#news.

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