COVID-19 Provider's Forum - Harnett Health

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COVID-19 Provider's Forum - Harnett Health
Harnett Health
  COVID-19
 Provider`s Forum
   January 26, 2021

      Presented by:
     Dr. Toks Folarin
   Harnett Health, CMO
COVID-19 Provider's Forum - Harnett Health
United States

   December 1          December 15           January 26
Coronavirus Cases:   Coronavirus Cases:   Coronavirus Cases:
   14,046,293           17,087,922           25,969,418

     Deaths:              Deaths:              Deaths:
     276,154              310,095              434,261

   Recovered:           Recovered:           Recovered:
   8,287,295            9,963,068            15,697,204
COVID-19 Provider's Forum - Harnett Health
USA
USA              Total              New          Total      New        Active
State            Cases              Cases        Deaths     Deaths     Cases
California               ,206,941       +7,046     37,639       +112    1,716,765
Texas                2,287,351         +12,046     35,610       +282     377,234

Florida              1,667,763          +9,594     25,675       +229     797,343

Illinois             1,108,430          +3,667     20,853       +109     188,242

New York             1,392,559          +9,397     42,751       +146     821,464

Ohio                     879,221        +8,393     13,482       +179     482,465

Georgia                  872,919        +4,263     10,856        +88     113,931

Pennsylvania             817,665        +4,000     20,915       +213     158,536

North Carolina           727,423        +3,978      8,776        +56      83,104
COVID-19 Provider's Forum - Harnett Health
COVID-19 HHS
           10/20/2020    11/3/2020     11/17/2020    12/1/2020   12/15/2020   1/12/2021   1/26/2021

Tested     2626          2904          2995          3313        3619         NA          NA

+ Cases    437           489           530           595         756          1045        1206

+Expired   39            44            49            50          56           72          84

In house   3             12            17            11          26           24          34
           positive      positive      positive      positive    positive     positive    positive
           7             5             6             13          7            13          0
           pending       pending       pending       pending     Pending      Pending     Pending
Employee   230           263           304           353         423          519         545
tested

Employee   28 positive   35 positive   49 positive   61          79           102         126 positive
+          0 pending     4 pending     5 pending     positive    positive     positive    5 pending
                                                     6           7 pending    4 pending
                                                     pending
COVID-19 Provider's Forum - Harnett Health
Covid surge- cases
COVID-19 Provider's Forum - Harnett Health
Covid Surge- NC
Coronavirus Vaccine Update

Approved
•  Pfizer-BioNTech (BNT162b2) Approved in several countries, EUA in USA, elsewhere

•   Moderna (mRNA-1273) Approved in Canada, EUA in USA

•   Oxford-AstraZeneca (AZD1222) EUA in UK, elsewhere
Abandoned.
  Australia’s vaccine
•   The researchers made a small change to the protein, unfortunately, the clamp is similar to
    a protein on HIV making HIV-like antibodies. Vaccine trial participants tested positive on
    HIV antibody tests, even though they were perfectly healthy.

•   Merck Weakened Measles virus, provoked a weaker response than natural infection

•   Merck a Vesicular Stomatitis virus pill vaccine, failed to trigger an immune response
Vaccine Rollout
•   The biggest vaccination campaign in history

•   More than 68.1 million doses in 56 countries have been administered
•   About 3.44 million doses a day

•   In the USA 23.5 million people have received at least one dose of a Covid-19 vaccine
    and about 3,481,921 have been fully vaccinated.
•   7.1 doses have been administered for every 100 people, and 57% of the shots distributed
    to states have been administered

•   The federal government has delivered 44,394,075 doses to states, territories and federal
    agencies.
•   2,725,830 people in nursing homes and long-term-care centers had been given first shots.

•   Most of the first vaccines have been given to front-line medical workers and nursing
    home residents along with above age 65 years
•   Every state was granted an amount of the vaccine roughly in proportion to its population.

NC.
•   Distributed dose: 41,418,325
•   Shots given: 23,461,494
•   Doses Used: 57%
•   Pct. Of people given a shot: 7.14%
HHS Vaccination
Started vaccination on Thursday December 21
HHS deep freezer arrived
        Phase 1a
        HHS Employee household 75 and older
        65 years and older
        Second doses
Multiple drives at BJRH and CHH
City of Dunn Community Center this week
HHS vaccine allocation weekly but unpredictable
Total shots given about 6500

Harnett Health compliance
      566 Employees/providers have received #1 dose
      472 have received both
COVID -19 section - Harnett Health
(myharnetthealth.org)
CDC COVID-19 Response Team
January 26 Update
Morbidity and Mortality Weekly Report MMWR

•   Allergic Reactions Including Anaphylaxis after Receipt of the First Dose of
    Moderna COVID-19 Vaccine — United States, December 21, 2020–
    January 10, 2021

•   Early safety monitoring of Moderna vaccine detected 10 cases of
    anaphylaxis after reported administration of 4,041,396 first doses of
    Moderna COVID-19 vaccine (2.5 cases per million). No anaphylaxis-
    related deaths were reported.

•   Based on this, anaphylaxis after receipt of Moderna vaccine appears to
    be a rare event.

•   A previous analysis of the Pfizer-BioNTech COVID-19 vaccine, estimated
    an initial rate of 11.1 cases per million doses administered after receipt of
    the first dose.

•   CDC and FDA will continue enhanced monitoring for anaphylaxis among
    recipients of COVID-19 vaccines and will review case reports to VAERS.
•   In nine of 10 cases of anaphylaxis after Moderna vaccine, patients had
    symptom onset within 30 minutes of vaccination, and nine anaphylaxis
    patients also had a history of allergies or allergic reactions, including
    some with previous anaphylaxis events.
CDC COVID-19 Response Team
•   All 10 anaphylaxis cases reported occurred in women.

•   A previous review of anaphylaxis reports to VAERS found that 80%
    of cases reported in adults involved females, the current finding
    could be affected by the observation that more women than men
    had received the vaccine during the analytic period (61% versus
    36%).

•   The clinical and epidemiologic characteristics of anaphylaxis
    case reports after receipt of Moderna vaccine are similar to those
    reported after receipt of the Pfizer-BioNTech vaccine.

•   For both vaccines, symptom onset after vaccination occurred
    quickly, usually within minutes.

•   A strong female predominance of anaphylaxis case reports exists
    for both vaccines.

•   Finally, many persons experiencing anaphylaxis after receiving
    either vaccine had a history of allergies or allergic reactions, with
    several having experienced an anaphylaxis episode in the past.
CDC COVID-19 Response Team
• Similar patient characteristics in case reports of
  nonanaphylaxis allergic reactions were observed among the
  two vaccines.

• CDC and FDA will continue to monitor for adverse events,
  including anaphylaxis, after administration of COVID-19
  vaccines and will regularly assess the benefits and risks of
  vaccination in the context of the evolving epidemiology of the
  pandemic.

• Persons with an immediate allergic reaction to the first dose of
  an mRNA vaccine should not receive additional doses of
  either of the two vaccines.

• In addition to screening for contraindications and precautions
  before administering vaccines, vaccine locations should have
  the necessary supplies and trained staff members available to
  manage anaphylaxis, implement postvaccination observation
  periods, immediately treat persons experiencing anaphylaxis
  signs and symptoms with intramuscular injection of
  epinephrine, and transport patients to facilities where they can
  receive advanced medical care.
International Travel Order
•   Issued On January 12, 2021

•   Requiring all air passengers arriving to the US from a foreign
    country to get tested no more than 3 days before flight departure
    and to present the negative result or documentation of having
    recovered from COVID-19 to the airline before boarding the flight.

•   Air passengers will also be required to confirm that the
    information they present is true in the form of an attestation.

•   This Order is effective as of 12:01am EST on January 26, 2021.

•   After You Travel
•   Get tested 3-5 days after travel AND stay home for 7 days after
    travel.
     o   Even if you test negative, stay home for the full 7 days.
     o   If your test is positive, isolate yourself to protect others from getting infected.​​
•   ​If you don’t get tested, it’s safest to stay home for 10 days after
     travel.​
•    Avoid being around people who are at increased risk for severe
     illness for 14 days, whether you get tested or not.
International Travel Order
• This Order applies to all air passengers, 2 years of age or older,
  traveling into the US, including US citizens and legal
  permanent residents.
•
• The Order does not apply to air passengers flying from a US
  territory or possession to a US state. (American Samoa, Guam,
  the Northern Mariana Islands, the Commonwealth of Puerto
  Rico, and the US Virgin Islands).

• The requirements of this Order only apply to air travel into the
  US.

• Testing must be performed using a viral test (NAAT or antigen),
  and negative results must be presented to the airline prior to
  boarding.

• At this time all air passengers traveling to the US, regardless of
  vaccination or antibody status, are required to provide a
  negative COVID-19 test result or documentation of recovery.
New COVID Variant
Information about the characteristics of these variants is rapidly
emerging.

Multiple COVID-19 variants are circulating globally:

In the UK, a new variant called B.1.1.7 has emerged with an
unusually large number of mutations.

• This variant spreads more easily and quickly than other
  variants. This variant is associated with increased
  transmissibility (i.e., more efficient and rapid transmission).
• Currently there is no evidence to suggest that the variant has
  any impact on the severity of disease or vaccine efficacy or
  increased risk of death.

• It has since been detected in numerous countries around the
  world, including the United States and Canada.
• About 195 cases reported in the US
New COVID Variant

• In South Africa, another variant called 1.351 has
  emerged independently of the UK variant.

• This variant, originally detected in early October, shares
  some mutations with the variant detected in the UK.

• There have been cases caused by this variant outside of
  South Africa, but it has not been detected in the US.

• Currently there is no evidence to suggest that this variant
  has any impact on disease severity.

• There is some evidence to indicate that one of the spike
  protein mutations, E484K, may affect neutralization by
  some polyclonal and monoclonal antibodies.1
New COVID Variant
In Brazil, a variant called P.1 emerged

•   This variant contains a set of additional mutations that may affect its
    ability to be recognized by antibodies. This variant has not been
    detected in the US.

•   There is evidence to suggest that some of the mutations in the P.1 variant
    may affect its transmissibility and antigenic profile, which may affect the
    ability of antibodies generated through a previous natural infection or
    through vaccination to recognize and neutralize the virus.

•   A recent study reported on a cluster of cases in Manaus brazil, in which
    the P.1 variant was identified in 42% of the specimens from late
    December In this region, it is estimated that approximately 75% of the
    population had been infected with SARS-CoV2 as of October 2020.
    However, since mid-December the region has observed a surge in cases.

•   The emergence of this variant raises concerns of a potential increase in
    transmissibility or propensity for SARS-CoV-2 re-infection of individuals.

•   This variant has not yet been identified in the United States.
Ivermectin
•   For decades, ivermectin has served as a potent drug to treat parasitic
    worms against river blindness and other diseases, while veterinarians
    give dogs a different formulation to prevent heartworm.

•   Studies on cells have suggested ivermectin might also kill viruses.
•
    In April, Australian researchers reported that the drug blocked
    coronaviruses in cell cultures, but they used a dosage that was so high it
    might have dangerous side effects in people.

•   Since then a number of clinical trials have been launched to see if a safe
    dose of ivermectin can fight Covid-19. The results reported so far have
    been mixed.

•   The N.I.H. Covid-19 treatment guidelines state that there is insufficient
    data to recommend for or against the use of ivermectin for the disease,
    except in a clinical trial.

•   Nevertheless ivermectin is being prescribed increasingly often
    especially in Latin America
Ivermectin
NIH Recommendation. Updated: January 14, 2021

The COVID-19 Treatment Guidelines Panel (the Panel) has
determined that currently there are insufficient data to
recommend either for or against the use of ivermectin for the
treatment of COVID-19. Results from adequately powered, well-
designed, and well-conducted clinical trials are needed to
provide more specific, evidence-based guidance on the role of
ivermectin for the treatment of COVID-19.

• Ivermectin is an antiparasitic drug that is approved by FDA for
  the treatment of onchocerciasis and strongyloidiasis.

• Ivermectin is not FDA-approved for the treatment of any viral
  infection.

• In general, the drug is well tolerated. It is currently being
  evaluated as a potential treatment for COVID-19.
•
                           Ivermectin
    Reports from in vitro studies suggest that ivermectin acts by inhibiting the host
    proteins, that are part of a key intracellular transport process that viruses hijack to
    enhance infection by suppressing the host antiviral response.

•   In addition, ivermectin docking in vitro may interfere with the attachment of the
    SARS-CoV-2 spike protein to the human cell membrane.

•   Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in cell culture.

•   However, pharmacokinetic and pharmacodynamic studies suggest that ivermectin
    doses up to 100-fold higher than those approved for use in humans would be
    required to achieve the plasma concentrations necessary to duplicate the drug’s
    antiviral efficacy in vitro

•   Even though ivermectin appears to accumulate in lung tissue, with the doses used
    in most clinical trials, predicted systemic plasma and lung tissue concentrations are
    much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against
    SARS-CoV-2 in vitro7

•   Ivermectin demonstrates potential anti-inflammatory properties in some in vitro
    studies properties which have been postulated to be beneficial in the treatment of
    COVID-19
Ivermectin
• Since the last revision of the Ivermectin section of the
  Guidelines, the results of several randomized trials and
  retrospective cohort studies of ivermectin use in patients with
  COVID-19 have been published in peer-reviewed journals or
  made available as preliminary, non-peer-reviewed reports.

• Some clinical studies showed no benefits or worsening of
  disease after ivermectin use,

•    whereas others reported shorter time to resolution of disease
    manifestations attributed to COVID-19, greater reduction in
    inflammatory markers, shorter time to viral clearance, or lower
    mortality rates in patients who received ivermectin than in
    patients who received comparator drugs or placebo.

• However, most of the studies reported to date had incomplete
  information and significant methodological limitations, which
  make it difficult to exclude common causes of bias.
Ivermectin
The missing information and limitations include the following:
• The sample size of most of the trials was small.

•   Various doses and schedules of ivermectin were used.

•   Some of the randomized controlled trials were open-label studies in which neither
    the participants nor the investigators were blinded to the treatment arms.

•   In addition to ivermectin or the comparator drug, patients also received various
    concomitant medications (e.g., doxycycline, hydroxychloroquine, azithromycin,
    zinc, corticosteroids), confounding assessment of the true efficacy or safety of
    ivermectin.

•   The severity of COVID-19 in the study participants was not always well described.

•   The study outcome measures were not always clearly defined.

•   Because of these limitations, the Panel cannot draw definitive conclusions about
    the clinical efficacy or safety of ivermectin for the treatment of COVID-19.

•   Results from adequately powered, well-designed, and well-conducted clinical
    trials are needed to provide more specific, evidence-based guidance on the role
    of ivermectin for the treatment of COVID-19.
Ivermectin
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