COVID-19 Provider's Forum - Harnett Health
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Harnett Health
COVID-19
Provider`s Forum
March 09, 2021
Presented by:
Dr. Toks Folarin
Harnett Health, CMO
United States
December 15 February 23 March 09
Coronavirus Cases: Coronavirus Cases: Coronavirus Cases:
17,087,922 28,867,820 29,762,321
Deaths: Deaths: Deaths:
310,095 513,986 539,409
Recovered: Recovered: Recovered:
9,963,068 19,167,204 20,478,209
USA USA Total New Total New Active State Cases Cases Deaths Deaths Cases California 3,604,208 54,394 1,661,239 Texas 2,703,597 45,640 131,907 Florida 1,952,733 +4,426 31,926 696,875 New York 1,738,812 48,643 860,345 Illinois 1,201,027 +1,510 23,039 69,270 Georgia 1,024,931 17,948 475,109 Ohio 981,618 +1,893 17,662 34,542 Pennsylvania 957,870 +2,520 24,499 71,615 North Carolina 874,906 11,535 25,547
COVID-19 HHS
12/1/2020 12/15/2020 1/12/2021 1/26/2021 2/09/2021 2/22/2021 3/9/2021
+ Cases 595 756 1045 1206 1275 1354 1439
+Expired 50 56 72 84 95 100 106
In house 11 26 24 34 27 24 7
positive positive positive positive positive positive positive
13 7 13 0 2 1 no
pending Pending Pending Pending Pending Pending Pending
Employee 353 423 519 545 572 597 613
tested
Employee 61 positive 79 positive 102 126 130 132 137
+ 6 pending 7 pending positive positive positive positive positive
4 pending 5 5 pending 3 pending 2 pending
pending
COVID-19 HHS
ICU DAYS
1st QTR 2nd QTR 3RD QTR 4th QTR 1st QTR
2021 TD
COVID 21 216 369 603 477
ICU
days
COVID 17 74 49 214 180
VENTS
Covid - 411 In the United States cases were down 12%, deaths are down 10%, and hospitalizations down 34% over 14 days. The 7-day average of new cases has been trending down since February 26. There are now 8,756,390 active cases . top 5 states by active cases: California, NY, FL, Georgia, and Md. NC #9 There have been 525,750 deaths, national fatality rate of 1.82%. the states with the most new deaths: California 171. Virginia 87. Florida 83. Texas 69. New York 64. Georgia 42. North Carolina 33. Arkansas 24. Washington 22. Connecticut 21. Globally, cases were up 7% and deaths down 8% over 14 days, with the 7-day average trending up since March 4. There are now 21,712,353 active cases around the world The five countries with most new cases: US 45,116. Brazil 36,136. India 15,353. Italy 13,902. Turkey 13,215. There have now been 2,599,596 deaths reported as Covid-related worldwide.
Covid - 411
Vaccination
• More than 313 million doses across 118 countries
• Rate of 8.14 million doses per day
US Vaccination
• Doses distributed to state: 123,232,775
Doses administered: 93,692,598
• 2.15 million doses a day
• At this rate estimated 6 months to cover 75% of population with two doses
Percentage of distributed vaccines that have been administered: 76
• Percentage of people with one shot: 18 (9.7%)
• The top 3 vaccinating states by percentage of at least one dose, Alaska at 24.7%
(16%), New Mexico at 24.6%(15%), and Connecticut 24.1% (9.7%).
• The bottom 3 states are Georgia 13.4% (8.6%), Alabama 14.5%(8.6%), Tennessee
16% (8.4%).
•
• North Carolina
Doses distributed to state: 3,719,845
Doses administered: 2,909,142
Percentage of distributed vaccines that have been administered: 78
• Percentage of people with one shot: 18 (9.7%)
Covid - 411
A new NEJM publication: Neutralizing Activity of BNT162b2-Elicited
Serum
• Pfizer vaccine effectively neutralizes P.1/Brazilian and B.1.
351/South African variant.
• The paper looked at 20 serum samples obtained from 15
participants 2 or 4 weeks after receiving their second dose of the
Pfizer vaccine.
• The neutralizing titer against the South African and Brazilian
variants were essentially the same as against the original US strain.
• So while neutralizing antibody is one of at least 4 components of
the adaptive immune response, it does appear to be a predictor
of real world immunity.
• First-stage testing of the experimental COVID-19 pill Molnupiravir,
by Merck, showed promising effectiveness.
• It would be an at-home, five-day treatment, similar to Tamiflu,
and could be on the market in four to five months.
HHS Vaccination Started vaccination on Thursday December 21 -Phase 1a -65 years and older -K-12 educators/ staff -All daycare staff -All essential workers -16+ with disability -Second doses Multiple clinics at BJRH/CHH HHS Clinics City of Dunn Community Center Western Harnett High School Pfizer/ Moderna / J&J Allocation weekly but unpredictable Total shots given 15152 Harnett Health compliance likely low especially with non-physician group
Janssen COVID-19 vaccine
Vaccine Efficacy
• The clinical trial demonstrated efficacy against symptomatic, laboratory-confirmed
COVID-19. The overall efficacy was 66.3%.
• For COVID-19 associated hospitalization, 31 events occurred, 29 in placebo, 2 in
vaccine group. Vaccine efficacy against hospitalization was 93%.
• For all-cause deaths, 5 in vaccine group and 20 in placebo. Vaccine efficacy
against all-cause death was 75%
• Analysis was based on detection of N-binding antibody among asymptomatic
participants and with no positive SARS-CoV-2 PCR at any time in the study.
• Between four and ten weeks after vaccination, 10/1346 participants (0.7%)
seroconverted, compared to 37/1304 (2.8%) of placebo. VE against seroconversion
was 74%.
• Efficacy estimates for severe outcomes assessed ≥28 days post vaccination were
higher: 83.5% for severe disease, 100% for hospitalization
• Efficacy against severe disease remained high across world regions (73-82%),
suggesting protection against severe illness with variant strains
• Similar efficacy for across age, sex, race, and ethnicity categories, and those with
underlying medical conditions at ≥14 days post-vaccinationJanssen COVID-19 vaccine
Safety and Reactogenicity
• Serious adverse events were reported in a similar proportion among vaccine and
placebo (0.4% vs 0.4%).
• Severe reactions were more common in vaccine recipients; 2.5% of vaccinated
versus 0.7% of placebo.
Local reactions within 7 days occurred in ~50% vaccine recipients
– Pain at the injection site most common
Systemic reactions within 7 days occurred in ~55% vaccine recipients
– Headache, fatigue, and myalgia most common
Most symptoms resolved after 1-2 days
Adverse event imbalances of note:
-Urticaria events: vaccine n=5; placebo n=1
Possibly related to the vaccine
-Tinnitus: vaccine n=6; placebo n=0
Insufficient data to determine causal relationship
-Thromboembolic events: vaccine n=15; placebo n=10
Many of the participants had predisposing conditions.
FDA determined contributory effect of vaccine not excluded, insufficient data to
determine causal relationship
FDA recommends surveillance for further evaluation of thromboembolic eventsJanssen COVID-19 vaccine All authorized COVID-19 vaccines No trials compared efficacy between vaccines in the same study at the same time – All Phase 3 trials differed by calendar time and geography – Vaccines were tested against different circulating variants and in settings with different background incidence All authorized vaccines demonstrated efficacy (range 65 to 95%) against symptomatic COVID-19 All authorized COVID-19 vaccines demonstrated high efficacy (≥89%) against COVID- 19 hospitalization In the vaccine trials, no participants who received a vaccine died from COVID-19 – The Moderna and Janssen trials each had COVID-19 deaths in the placebo arm Interchangeability of COVID-19 vaccine products Any COVID-19 vaccine can be used when indicated; no product preference COVID-19 vaccines are not interchangeable, – Safety and efficacy of a mixed series has not been evaluated If first dose of mRNA vaccine was received but patient unable to complete series – Single dose of Janssen vaccine may be administered at minimum interval of 28 days – Considered to have received valid, single-dose Janssen vaccination, not mixed vaccination
Janssen COVID-19 vaccine
Coadministration of COVID-19 vaccines with other vaccines
Currently authorized COVID-19 vaccines are all inactivated vaccines
• COVID vaccine should be administered alone with minimum
interval of 14 days before or after administration of other
vaccines
• A shorter interval may be used in situations where the benefits of
vaccination are deemed to outweigh the potential unknown risks
(e.g., tetanus toxoid vaccine for wound management, etc.) or to
avoid barriers or delays to vaccination
• Any currently authorized COVID vaccine can be administered to
persons with underlying medical conditions who have no
contraindications to vaccination, including:
• – Immunocompromised persons
• – People with autoimmune conditions
• – People with history of Guillain-Barré syndrome, Bell's palsyJanssen COVID-19 vaccine Authorized for persons aged ≥18 years IM injection shipment and storage (3 months) at refrigerator temperatures (2-8oC) Single-dose No diluent required Where: • Mobile/pop-up clinics • Newly established vaccine administration sites • Sites that do not have freezer capacity (e.g. adult HCP offices) • Pharmacies and urgent care clinics for people who don’t have a regular doctor • Slash costs for staffing and operations related to the second doses: Who: • People who want to be fully vaccinated quickly • People who don’t want to return or can’t return for a second dose • Mobile populations or homebound populations • Meatpacking, farm and grocery workers. • Homeless or people on the verge of release from prison or NH
Janssen COVID-19 vaccine Older Americans are much more likely to have a preference. Younger Americans are more likely to have no preference. (Likely don’t have plans to get the vaccine at all) Ages 45 to 64 are the most keen on the J & J . Women are more likely to have already received a dose so far. Females are also more likely to be preferential to the J&J, while men are slightly more likely to prefer Pfizer’s.
Recommendations for Fully Vaccinated People
CDC Mar. 8, 2021.
People are considered fully vaccinated ≥2 weeks after they have received the second
dose in a 2-dose series, or ≥2 weeks after a single-dose vaccine J&J
Visit with other fully vaccinated people indoors without wearing masks or physical
distancing
Visit with unvaccinated people from a single household who are at low risk for severe
COVID indoors without wearing masks or physical distancing. (Fully vaccinated
grandparents can visit indoors with their unvaccinated healthy daughter and her
healthy children without wearing masks or physical distancing, provided none of the
unvaccinated family members are at risk of severe COVID-19)
Refrain from quarantine and testing following a known exposure if asymptomatic
For now should continue to:
• Take precautions in public like wearing a well-fitted mask and physical distancing
• Wear masks, practice physical distancing, and adhere to other prevention
measures when visiting with unvaccinated people who are at increased risk for
severe covid disease or who have an unvaccinated household member who is at
increased risk for severe COVID-19 disease
• Wear masks, maintain physical distance, and practice other prevention measures
when visiting with unvaccinated people from multiple households
• Avoid medium- and large-sized in-person gatherings
• Get tested if experiencing covid symptoms
• Follow guidance issued by individual employers
• Follow CDC and health department travel requirements and recommendationsRecommendations for Fully Vaccinated People Fully vaccinated people should still watch for symptoms of covid, especially following an exposure to someone suspected or confirmed COVID If symptoms develop, all people – regardless of vaccination status – should isolate and be clinically evaluated for COVID-19. All people, regardless of vaccination status, should adhere to current guidance to avoid medium or large sized in-person gathering and to follow any applicable local guidance restricting the size of gatherings. Fully vaccinated people with no COVID-like symptoms do not need to quarantine or be tested following an exposure to someone with suspected or confirmed COVID-19, as their risk of infection is low, but should still monitor for symptoms for 14 days following an exposure. Fully vaccinated residents of non-healthcare congregate settings (e.g., correctional and detention facilities, group homes) should continue to quarantine for 14 days and be tested following an exposure. This is because residential congregate settings may face high turnover of residents, a higher risk of transmission, and challenges in maintaining recommended physical distancing. Fully vaccinated employees of non-healthcare congregate settings and other high- density workplaces (e.g., meat and poultry processing and manufacturing plants) with no symptoms do not need to quarantine following an exposure; however testing following an exposure and through routine workplace screening programs (if present) is still recommended.
Recommendations for Fully Vaccinated People Interpretation of SARS-CoV-2 test results in vaccinated people Prior receipt of a COVID-19 vaccine will not affect the results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests). Currently available antibody tests assess IgM and/or IgG to one of two viral proteins: spike or nucleocapsid. COVID vaccines are constructed to encode the spike protein, a positive test for spike protein could indicate prior infection and/or vaccination. To evaluate for evidence of prior infection in a vaccinated individual, a test that specifically evaluates IgM/IgG to the nucleocapsid protein should be used. Antibody testing is not currently recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. Antibody tests have variable sensitivity, specificity, as well as positive and negative predictive values, and are not authorized for the assessment of immune response in vaccinated people. Furthermore, does not evaluate the cellular immune response, which may also play a role in vaccine-mediated protection.
Long COVID
• Long COVID often presents as reported persistent severe fatigue, headaches, and
brain fog (mild subjective cognitive impairment) >4 weeks after acute illness and
may be independent of acute illness severity.
• One in five patients not requiring supplemental oxygen during hospitalization had
decreased lung function after 6 months.
• Prolonged symptoms are common among patients with mild COVID-19 disease not
requiring hospitalization.
Survey of patients in a post-COVID 19 clinic in France, Faroe islands and Switzerland
• – 35-54% of patients with mild acute COVID-19 had persistent symptoms after 2-4
months
• – 50-76% of patients reported new symptoms not present in their acute COVID-19
illness or symptoms that resolved and reappeared
• – 9% reported prolonged symptoms as severe
• More than one quarter of patients developed new neurological symptoms after
their acute COVID-19 illness.
• New or persistent symptoms (lasting >4-6 months) may occur among patients with
COVID-19 regardless of acute episode severity.
• There is still a lot we do not understand, and empathy toward patients
experiencing long COVID is fundamental.Long COVID
Long COVID
Long COVID Neurological Symptoms --Brain Fog Most common neurological symptom Issues with short-term memory, concentration and word-finding/speech difficulty No clear correlation with severity of COVID infection, age or comorbidities Symptoms often fluctuate, “good and bad days” Fluctuations often correlate with other symptoms like fatigue and dysautonomia Impact on life varies: some able to still work, others on disability Sleep: many patients with poor sleep Mood: many patients experiencing depression, anxiety and/or PTSD --Headaches, Paresthesias and Dysautonomia Headaches– Often describes as constant pressure that can fluctuate in severity, May have migraine symptoms, Many don’t have a history of headaches Paresthesias– Tingling, numbness and/or burning sensation, May be focal, diffuse, alternating in locations, Sometimes more in distal extremities (stocking-glove distribution) Dysautonomia– Fluctuating blood pressure and heart rate, Lightheadedness, palpitations, GI disturbances Most patients have multiple chief complaints. Treatment: mostly symptomatic and supportive
SCCM Surviving Sepsis Campaign Guideline COVID-19 Update The panel includes 43 experts from 14 countries In this update, the panel addressed nine questions relevant to managing severe or critical COVID in the ICU The team searched the literature for relevant evidence, to identify systematic reviews and clinical trials, assessed the quality of the evidence, then used the evidence-to-decision framework to generate recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. This update • Focus on therapeutics • 9 topics updated: – 3 new recommendations, – 6 updated recommendations Severe COVID-19 • Clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) and one of the following: RR >30, - Severe respiratory distress, -SpO2
SCCM Surviving Sepsis Campaign Guideline COVID-19 Update Awake Prone Positioning There is insufficient evidence to issue a recommendation on the use of awake prone positioning in non-intubated adults with severe COVID-19 Corticosteroids For adults with severe or critical COVID-19, we recommend using a shortcourse of systemic corticosteroids, over not using corticosteroids – Strong Recommendation, moderate quality evidence For adults with severe or critical COVID-19 who are considered for systemic corticosteroids, we suggest using dexamethasone over other corticosteroids – Weak recommendation, very low quality evidence Remark: If dexamethasone is not available, may use other corticosteroids in doses equivalent to 6 mg daily of dexamethasone for up to 10 days. Hydroxychloroquine For adults with severe or critical COVID-19, we recommend against using hydroxychloroquine – Strong recommendation, moderate quality evidence Convalescent Plasma For adults with severe or critical COVID-19, we suggest against the use of convalescent plasma outside clinical trials – Weak recommendation, low quality evidence Note: 88% agreed with this recommendation, 12% thought we should issue no recommendation due to insufficient evidence
SCCM Surviving Sepsis Campaign GuidelineCOVID-19 Update Remdesivir (severe COVID-19) For adults with severe COVID-19 who do not require mechanical ventilation, we suggest using remdesivir, over not using it – Weak recommendation, moderate quality evidence Remark: Remdesivir should ideally be started within 72 hours of a positive testing
SCCM Surviving Sepsis Campaign GuidelineCOVID-19 Update Remdesivir (critical COVID-19) For adults undergoing mechanical ventilation for critical COVID-19, we suggest against starting remdesivir – Weak recommendation, low quality evidence Note: A majority of the panel (97.6%) agreed with this recommendation, one panel member preferred to issue a neutral recommendation
Surviving Sepsis Update… VTE Prophylaxis For adults with severe or critical COVID-19, we recommend using pharmacologic VTE prophylaxis over not using prophylaxis. – Strong recommendation, moderate quality evidence NIH Press Release Three clinical trial platforms working together to test effects of full doses of anticoagulants [blood thinners] in Covid 19 patients have paused enrollment for one for patients. Among critically ill Covid 19 patients requiring intensive care unit ICU support, therapeutic anticoagulation drugs did not reduce the need for organ support. Anticoagulation For adults with severe or critical COVID-19 and no evidence of VTE, we suggest against the routine use of therapeutic anticoagulation outside of clinical trials. – Weak recommendation, very low quality evidence • g
Surviving Sepsis Update…
Surviving Sepsis Update…
Surviving Sepsis Update…
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