Update on COVID-19 in Hawai‘i October 2, 2021

Lee Buenconsejo-Lum, MD, FAAFP

Associate Dean for Academic Affairs John A. Burns School of Medicine

JABSOM Liaison to HI EMA S ESF-8 and several State Vaccine Implementation Plan committees

Topics to be discussed in this session: 1. Overview of the virus that causes

COVID-19 (SARS-CoV-2) 2. Moderate to severe COVID-19 disease

and “long COVID” 3. COVID-19 vaccines and booster plans 4. Other prevention & risk reduction

measures

Key timelines in the pandemic • New virus in December 2019 • WHO declared a Global Health emergency Jan

30, 2020 • White House declares National Public Health

Emergency February 1, 2020 • WHO declares pandemic March 11, 2020 • Disruption of services in March 2020 • Hawai‘i surge in Aug-Sept 2020 • Hawai‘i starts vaccine planning Oct 2020 • First doses of vaccine December 15, 2020 • Started vaccinating kupuna in mid-January 2021 • Second surge in January 2021 • Variant strain identified in HI January 25, 2021 • Third surge started July 2021 (Delta variant 93%)

Coronavirus basics • The name comes from the crown-like

appearance • The “spikes” on the surface are the spike

proteins, which are the target of the vaccines

• This family of viruses causes many diseases in humans and animals, including the common cold

• Can cross species from bats into other animals (found in the live-animal markets) into humans and humans to other animals (rare)

Lauring AS, Malani PN. Variants of SARS-CoV-2. JAMA. Published online August 13, 2021. doi:10.1001/jama.2021.14181

Transmission of the Novel 2019 Coronavirus (SARS-CoV-2) • Person to person • Respiratory droplets & aerosols from

coughing, sneezing, talking, shouting, singing

• Contact with surfaces (low risk) • Health care workers not wearing proper

personal protective equipment (PPE) CLUSTERS • Family transmission - gatherings • Bars, carpools, break rooms, churches,

funerals, nursing home, prisons • Weekly cluster reports on the

Department of Health (DOH) website

Factors affecting distribution of aerosols indoors

• Open windows when possible • Eat on the patio/outdoors, in

small group to allow spacing • Only vaccinated people in the

home (esp. if there are immunocompromised, elderly or children under 12)

• HEPA filter plus universal masking is very effective

https://science.sciencemag.org/content/373/6558/eabd9149.full

Incubation Period and Asymptomatic Transmission • Range 2-14 days, average 5-6 days • Long pre-symptomatic period (12 days) • ⅓ to ½ of cases are asymptomatic transmission

(up to 21 days)

The time periods of infectivity are the basis for: • Contact tracing • Quarantine • Isolation

Clinical signs and symptoms • If more severe and need oxygen

hospitalization

Chest x-rays, illness day 10, hospital day 6 White areas in the lung = inflammation

Common clinical features • Loss of smell or taste (early) • In hospitalized patients

• Prolonged fever • Cough • Body aches or fatigue • Shortness of breath

Less common clinical features • Oral rash • Myocarditis (weak heart) • Blood clots and stroke • COVID toes (more common in kids) • Multisystem Inflammatory Syndrome in

Children (MIS-C) – heart, lungs, kidneys, brain, skin, eyes, GI tract

COVID-19 disease tends to be worse in elderly and those with multiple chronic conditions • Death: 60-69 years: 3.6%; 70-79 years:

8%; ≥80 years: 14.8% • Death is higher for some

• 10.5% for those with cardiovascular disease

• 7% for diabetes • 6% each for chronic respiratory

disease, hypertension, and cancer • 49% for patients who developed

respiratory failure, septic shock, or multiple organ dysfunction

• Prevention is critical!! • Treatment is mostly supportive • Recommendations are evolving • Role of monoclonal antibody in

those who test positive and are at high risk for hospitalization/death

Post-COVID conditions “Long COVID” • Difficulty breathing or shortness of breath • Tiredness or fatigue • Symptoms that get worse after physical or mental activities • Difficulty thinking or concentrating (sometimes referred to as “brain

fog”) • Cough • Chest or stomach pain • Headache • Fast-beating or pounding heart (also known as heart palpitations) • Joint or muscle pain • Pins-and-needles feeling • Diarrhea • Sleep problems • Fever • Dizziness on standing (lightheadedness) • Rash • Mood changes • Change in smell or taste • Changes in period cycles

• Multiorgan effects (severe illness or autoimmune)

• Heart, lung, kidney, skin, brain function

• Multisystem inflammatory syndrome – adults or children

• Post-Intensive Care Syndrome https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects.html

Testing is important if you have any symptoms • PCR detects presence of viral nucleic acid • Does not distinguish between living and dead virus • Presence does not necessarily imply transmissibility • Tests were designed to detect disease in symptomatic persons • Asymptomatic may test positive • Monitored self-collected swab (mid-nose) is effective as nasopharyngeal

Questions • How did we get the vaccines so quickly?

• Work on the SARS-CoV vaccine began after SARS and MERS

• $$$$, Pre-approval production • Combined phase 1/Phase 2 trials

• Are they safe? • Held to a very high (higher than usual) standard • Close monitoring and for 1-2 years

• COVID is not like the

flu! • Much worse

• Common symptoms after the vaccine are part of the normal immune response

Yeah for Vaccines!

Janssen/Johnson & Johnson • 14M doses as of 8/26/21

mRNA vaccines given in US as of 8/26/21 Pfizer-BioNTech 2 dose 92M Moderna 2 dose 65M

mRNA Vaccines • Pfizer and Moderna

• Cannot get infected from these • Similar safety profile • Efficacy: testing positive 7 days after the second dose

• 94-95%; less against Delta variant

• Effective in preventing severe COVID-19 (95%-100%) (>80% with Delta)

Questions to be answered with additional data from ongoing trials

• How long will the vaccine last (duration of protection)?

• 6-8 months (antibody) – likely longer in immunocompetent

• Will vaccination prevent asymptomatic SARS-CoV-2 infection?

• Ongoing studies • Will vaccination reduce SARS-CoV-2

transmission? • Some suggestion of this, but Delta is very

contagious (1000-1200x) • Are two vaccine doses required for protection or

can protection be achieved with a single vaccine dose?

• 2 doses for mRNA and Astra-Zeneca/Oxford • 1 dose for Janssen • Studies ongoing

• Is the vaccine safe and effective • In children 12-15 years of age – yes • In pregnant women – yes • In children 5-11 year of age – (yes) ongoing studies

• Vaccine safety follow up reported by recipients (V-Safe and VAERS)

Who should NOT get the COVID-19 vaccine? • A history of the following is considered by

CDC to be a contraindication to both the Pfizer and Moderna vaccines:

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components

• Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])*

• Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

• Persons with an immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine should not receive additional doses

Anaphylaxis • Wheezing, severe trouble

breathing • Dizzy / low blood pressure • Requires epinephrine • Often hospital / ER visit

Precautions A history of any immediate allergic reaction to any other vaccine or injectable therapy is a precaution but not a contraindication to vaccination for both the Pfizer-BioNTech and Moderna COVID-19 vaccines

• intramuscular, intravenous, or subcutaneous vaccines or

• therapies not related to a component of mRNA COVID-19 vaccines

• Should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefits of vaccination

• May defer vaccination until more information on risk of anaphylaxis is available

• Patients with these precautions or other non-severe allergies to food or drugs will be monitored for 30 minutes after vaccination

What about …. • Persons with a history of Guillain-Barre

syndrome • NO CASES of Guillain-Barré syndrome (GBS)

reported following vaccination among participants in Pfizer-BioNTech or Moderna COVID-19 vaccines clinical trials

• 1 case in Janssen and 1 in placebo • May receive COVID-19 vaccination if they have

no contraindications to vaccination • Persons with a history of Bell’s palsy

(temporary facial paralysis) • Cases of Bell’s palsy following vaccination in

both trials not found to be causally related to vaccination

• Post-authorization safety surveillance will further assess any possible causal association

• May receive COVID-19 vaccination if they have no contraindications to vaccination

• https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html

https://theconversation.com/what-is-herd-immunity-and-how-many-people-need-to-be-vaccinated-to-protect-a-community-116355

Vaccination rate thought to be needed now that the Delta variant is predominant: • Maybe around 85%

of the population vaccinated

https://www.straitstimes.com/singapore/health/those-who-refuse-covid-19-vaccine-endanger-themselves-and-others

Pfizer/BioNTech FDA Full Licensure • CDC ACIP recommends approval (unanimous) August 30,

2021 • Prevented a COVID infection with symptoms about

90%–92% of the time, at least for the first 4 months after the second shot.

• Israel and other studies indicate lower efficacy with the Delta variant (est. ~74.6%)

• Protection against hospitalization and death was 95-100%

• Data collection and new studies ongoing regarding • Waning immunity • Efficacy with Delta variant

• 11% with pain, swelling, needing to visit hospital or ER for pain, high fever, vomiting that requires IV fluid, persistent diarrhea, severe headache, or severe muscle/joint pain

• Anaphylaxis ~ 5 cases for every 1 million shots given • Myopericarditis

• After vaccine, within a week, younger men under age 30 • MILD, 1-2 day hospitalization in the great majority

• 6 – 34 x risk of moderate-to-severe myocarditis with the actual infection (prolonged hospitalizations, ICU)

Boosters?

Additional Dose in mod-severe immunocompromised • Active chemotherapy, immunosuppressive

drugs, prednisone more than 20 mg per day, those without spleens

• Patients on hemodialysis • Available now – with self-attestation • TALK TO YOUR FIRST DOCTOR IF YOU ARE ON

A CHEMOTHERAPY REGIMEN https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/09-COVID-Oliver-508.pdf

• Hospitalization in adults older than 75 – decreased efficacy but more than 80%

• Long-term care facility residents - ~ 50% effective with Delta variant • Continuing to review data – will decide in September after FDA

approval • May be: LTCF residents, HCP, adults either over 65 or over 75

Avoid the 3 Cs: Closed spaces with poor ventilation Crowds Close contact with people outside your social bubble

Questions? • Stay safe! • Live aloha!