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We're Not Out of the Pandemic Woods Yet
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Michael Ejercito
Jun 14, 2022, 11:50:50 PM6/14/22
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http://www.medpagetoday.com/opinion/second-opinions/99225?xid=nl_secondopinion_2022-06-14&eun=g1662251d0r
We're Not Out of the Pandemic Woods Yet
— The end of the COVID emergency phase may be nearing, but we must
remain vigilant
by Monica Gandhi, MD, MPH, and Michael Daignault, MD June 14, 2022
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A computer rendering of a COVID virus colored as the Earth.
The emergency phase of the pandemic may be fading per the World Health
Organization, the European CDC, and U.S. public health officials. But
the pandemic is not over. We have the tools at our disposal to continue
to save lives and keep the burden on our hospitals low. This is what we
need to do next.
Better Hospitalization Tracking Metrics
We need better tracking of COVID-19 in hospitals. We previously proposed
delineating hospitalizations by "for COVID" rather than "with COVID,"
but disease progression is dynamic during a hospital admission. A better
metric, as is being looked at in Massachusetts, is to track use of the
steroid dexamethasone as a surrogate for hospitalized patients with
severe COVID-19 illness. Another possibility is to directly track which
patients require oxygen.
In the emergency department (ED), the presence of hypoxia is the primary
determinant of whether a COVID-19 patient needs hospitalization. These
patients are treated with dexamethasone and require a higher level of
care, including pulmonary, infectious disease, and respiratory therapist
consultations. Delineating hospitalizations for COVID-19 by use of
dexamethasone or supplemental oxygen would give us a more accurate,
bird's-eye view of hospital resource use and help public health
officials understand when hospitals are being overwhelmed with severely
ill patients.
Link Home Rapid Tests With Reporting Mechanism and Expand Wastewater Sites
The U.S. government recently provided a third round of free at-home
rapid tests through its centralized covid.gov hub. This has been a great
resource for Americans to safely test at home and quickly begin
isolating if COVID-positive.
However, home testing has led to significant underreporting of COVID-19
cases. We need greater effort from government and testing companies to
encourage and incentivize people to report the results of their home
tests, as is being done in the U.K. through the National Health Service.
Many kits already include a way to report results through their mobile
apps, and the government should launch public awareness campaigns to
facilitate this reporting. Testing companies must then share results
with local county health departments.
Expansion of COVID-19 wastewater surveillance sites is also critical.
Increased incidence of COVID-19 here can precede officially recorded
cases by a matter of weeks, allowing time for health systems to prepare
for a possible surge in patients and for public officials to consider
re-implementing stricter public health measures.
Continue the Push for Vaccines
Vaccines targeting the wild type spike have continued to hold up well in
preventing severe disease and hospitalization by the more immune-evasive
Omicron and its subvariants. The reason: T cells and memory B cells
continue to work against variants, even Omicron.
However, some groups remain vulnerable: we must double down on boosters
for the elderly. A large Veterans Affairs study of patients with a
median age of 71 during the Omicron surge showed those with three doses
had a lower rate of hospitalization and need for ICU level of care than
those with only two doses. Despite the apparent less intrinsically
severe nature of Omicron, almost as many Americans over 65 died during
the winter surge as died from last year's Delta variant surge. A second
booster is now available for those over 50 in the U.S., although most
other countries have decided on an older age cut-off for this dose. This
second booster unfortunately wanes faster than the first booster in
terms of antibodies, but each booster (or exposure) diversifies and
broadens T-cell responses to the virus and expands the potency of B
cells. Therefore, boosters are important for those at high risk for
severe COVID-19.
The next step for the FDA is to expand our vaccine arsenal.
Most urgent is the need to authorize vaccines (from both Moderna and
Pfizer) for kids under 5. Once authorized, we need additional research
to determine the most effective dosing schedule. For older age groups,
an extended 8-week or longer interval schedule has been shown to
maximize immunogenicity and effectiveness. We'll need to determine the
best approach for young kids under 5 too, and investigate how previous
COVID infection factors into this.
Considering alternative vaccine technologies is also a priority. The
Novavax vaccine, which involves the spike protein combined with an
adjuvant, was recommended by an FDA advisory committee earlier this
month and now awaits FDA authorization, pending a manufacturing review.
Perhaps a more familiar vaccine technology will sway some who remain
hesitant about mRNA vaccines. FDA should also consider nasal vaccines an
important next step in our armamentarium. These vaccines induce faster
mobilization of antibodies to our throats and nasal passages, which,
beyond just preventing severe COVID-19, may better protect people from
getting infected in the first place.
Finally, the FDA needs to determine the makeup for the next generation
of vaccines due this fall. There are several contenders: the Omicron
bivalent vaccine booster by Moderna increases neutralizing antibodies
more than a booster directed against the old strain, although studies in
primates previously performed by the NIH did not demonstrate superior
protection against disease by the Omicron-specific vaccine. The Covaxin
vaccine is an inactivated whole virus vaccine that is effective against
all of the emerging variants, with a recent study showing strong
cellular immune responses against Omicron. FDA will need to thoroughly
assess which options offer the most safety and efficacy.
Ensure Access to Therapeutics
With a non-eradicable virus like SARS-CoV-2, therapeutics are essential
to keeping our rates of severe disease low among older and high-risk
patients.
Real-world data show a clear benefit of nirmatrelvir-ritonavir
(Paxlovid) in those high-risk for severe COVID-19, whether vaccinated or
not (the original clinical trial studied the drug only among
unvaccinated individuals). Even against the more immune-evasive Omicron
variant, in those age 65 and above there was an 81% reduction in death
and 67% reduction in hospitalization. There was no benefit for
nirmatrelvir-ritonavir in those 40 to 64 years for protecting against
severe disease. Molnupiravir, another oral antiviral, has fewer
drug-drug interactions than nirmatrelvir-ritonavir, since it does not
require a ritonavir booster. In a recent subset analysis from the
MOVe-OUT study, molnupiravir demonstrated an 89% reduction in
hospitalization or death among immune-compromised participants.
These therapeutics are in robust supply. At the end of May, only around
30% of nirmatrelvir-ritonavir doses ordered by the government had been
used. After a White House initiative to transform testing sites into
federally funded "test to treat" locations, more than 182,000
prescriptions for oral antivirals were filled during the last week of
May, and 40,000 pharmacies and other locations now have antiviral pills
in stock. We need to ensure continued -- and equal -- access among all
high-risk Americans.
Monoclonal antibodies also remain in our treatment and prevention
arsenal. Bebtelovimab remains a powerful option to prevent severe
disease and hospitalization in high-risk patients, with persistent
activity against BA.2.12.1. As EDs across the country return to peak
pre-pandemic patient volume for other medical conditions, bebtelovimab
is a great one-and-done option since it's given as an intravenous dose
pushed over 30 seconds. For certain immunocompromised patients who are
unable to mount a significant protective response from vaccines, a
long-acting dual-monoclonal antibody can help. Tixagevimab co-packaged
with cilgavimab (Evusheld) given as preexposure prophylaxis demonstrated
an impressive 82.8% relative risk reduction for all COVID-19 symptoms at
6 months, with retained activity against subvariants BA.4 and BA.5.
What about treatment for long COVID? While an exact etiology remains
elusive, one of its proposed mechanisms is a high viral load.
Vaccination is highly protective against long COVID. For those with
residual symptoms, some case studies have offered evidence that oral
antivirals could reduce symptoms, so this must be studied further.
On to the Next Phase
We are certainly in a much stronger position against SARS-COV-2 than we
have ever been. Vaccines continue to provide robust protection against
severe illness and death. Therapeutics can keep high-risk patients out
of the hospital. The emergency phase of the pandemic may be fading. We
now need to avoid backsliding and instead look toward better future
COVID management.
The next phase will require increasing trust in our public health
system, updating vaccines for all, continued ease-of-access of
therapeutics, new whole virus vaccines in the future, novel therapeutics
currently in development, and nasal vaccines. Let's remain vigilant and
continue to move ahead.
Monica Gandhi, MD, MPH, is a professor of medicine in the school of
medicine at University of California San Francisco. Michael Daignault,
MD, is an emergency physician at Providence Saint Joseph Medical Center
in Burbank, California.
--
This email has been checked for viruses by AVG.
https://www.avg.com
We're Not Out of the Pandemic Woods Yet
— The end of the COVID emergency phase may be nearing, but we must
remain vigilant
by Monica Gandhi, MD, MPH, and Michael Daignault, MD June 14, 2022
share to facebook
share to twitter
share to linkedin
email article
A computer rendering of a COVID virus colored as the Earth.
The emergency phase of the pandemic may be fading per the World Health
Organization, the European CDC, and U.S. public health officials. But
the pandemic is not over. We have the tools at our disposal to continue
to save lives and keep the burden on our hospitals low. This is what we
need to do next.
Better Hospitalization Tracking Metrics
We need better tracking of COVID-19 in hospitals. We previously proposed
delineating hospitalizations by "for COVID" rather than "with COVID,"
but disease progression is dynamic during a hospital admission. A better
metric, as is being looked at in Massachusetts, is to track use of the
steroid dexamethasone as a surrogate for hospitalized patients with
severe COVID-19 illness. Another possibility is to directly track which
patients require oxygen.
In the emergency department (ED), the presence of hypoxia is the primary
determinant of whether a COVID-19 patient needs hospitalization. These
patients are treated with dexamethasone and require a higher level of
care, including pulmonary, infectious disease, and respiratory therapist
consultations. Delineating hospitalizations for COVID-19 by use of
dexamethasone or supplemental oxygen would give us a more accurate,
bird's-eye view of hospital resource use and help public health
officials understand when hospitals are being overwhelmed with severely
ill patients.
Link Home Rapid Tests With Reporting Mechanism and Expand Wastewater Sites
The U.S. government recently provided a third round of free at-home
rapid tests through its centralized covid.gov hub. This has been a great
resource for Americans to safely test at home and quickly begin
isolating if COVID-positive.
However, home testing has led to significant underreporting of COVID-19
cases. We need greater effort from government and testing companies to
encourage and incentivize people to report the results of their home
tests, as is being done in the U.K. through the National Health Service.
Many kits already include a way to report results through their mobile
apps, and the government should launch public awareness campaigns to
facilitate this reporting. Testing companies must then share results
with local county health departments.
Expansion of COVID-19 wastewater surveillance sites is also critical.
Increased incidence of COVID-19 here can precede officially recorded
cases by a matter of weeks, allowing time for health systems to prepare
for a possible surge in patients and for public officials to consider
re-implementing stricter public health measures.
Continue the Push for Vaccines
Vaccines targeting the wild type spike have continued to hold up well in
preventing severe disease and hospitalization by the more immune-evasive
Omicron and its subvariants. The reason: T cells and memory B cells
continue to work against variants, even Omicron.
However, some groups remain vulnerable: we must double down on boosters
for the elderly. A large Veterans Affairs study of patients with a
median age of 71 during the Omicron surge showed those with three doses
had a lower rate of hospitalization and need for ICU level of care than
those with only two doses. Despite the apparent less intrinsically
severe nature of Omicron, almost as many Americans over 65 died during
the winter surge as died from last year's Delta variant surge. A second
booster is now available for those over 50 in the U.S., although most
other countries have decided on an older age cut-off for this dose. This
second booster unfortunately wanes faster than the first booster in
terms of antibodies, but each booster (or exposure) diversifies and
broadens T-cell responses to the virus and expands the potency of B
cells. Therefore, boosters are important for those at high risk for
severe COVID-19.
The next step for the FDA is to expand our vaccine arsenal.
Most urgent is the need to authorize vaccines (from both Moderna and
Pfizer) for kids under 5. Once authorized, we need additional research
to determine the most effective dosing schedule. For older age groups,
an extended 8-week or longer interval schedule has been shown to
maximize immunogenicity and effectiveness. We'll need to determine the
best approach for young kids under 5 too, and investigate how previous
COVID infection factors into this.
Considering alternative vaccine technologies is also a priority. The
Novavax vaccine, which involves the spike protein combined with an
adjuvant, was recommended by an FDA advisory committee earlier this
month and now awaits FDA authorization, pending a manufacturing review.
Perhaps a more familiar vaccine technology will sway some who remain
hesitant about mRNA vaccines. FDA should also consider nasal vaccines an
important next step in our armamentarium. These vaccines induce faster
mobilization of antibodies to our throats and nasal passages, which,
beyond just preventing severe COVID-19, may better protect people from
getting infected in the first place.
Finally, the FDA needs to determine the makeup for the next generation
of vaccines due this fall. There are several contenders: the Omicron
bivalent vaccine booster by Moderna increases neutralizing antibodies
more than a booster directed against the old strain, although studies in
primates previously performed by the NIH did not demonstrate superior
protection against disease by the Omicron-specific vaccine. The Covaxin
vaccine is an inactivated whole virus vaccine that is effective against
all of the emerging variants, with a recent study showing strong
cellular immune responses against Omicron. FDA will need to thoroughly
assess which options offer the most safety and efficacy.
Ensure Access to Therapeutics
With a non-eradicable virus like SARS-CoV-2, therapeutics are essential
to keeping our rates of severe disease low among older and high-risk
patients.
Real-world data show a clear benefit of nirmatrelvir-ritonavir
(Paxlovid) in those high-risk for severe COVID-19, whether vaccinated or
not (the original clinical trial studied the drug only among
unvaccinated individuals). Even against the more immune-evasive Omicron
variant, in those age 65 and above there was an 81% reduction in death
and 67% reduction in hospitalization. There was no benefit for
nirmatrelvir-ritonavir in those 40 to 64 years for protecting against
severe disease. Molnupiravir, another oral antiviral, has fewer
drug-drug interactions than nirmatrelvir-ritonavir, since it does not
require a ritonavir booster. In a recent subset analysis from the
MOVe-OUT study, molnupiravir demonstrated an 89% reduction in
hospitalization or death among immune-compromised participants.
These therapeutics are in robust supply. At the end of May, only around
30% of nirmatrelvir-ritonavir doses ordered by the government had been
used. After a White House initiative to transform testing sites into
federally funded "test to treat" locations, more than 182,000
prescriptions for oral antivirals were filled during the last week of
May, and 40,000 pharmacies and other locations now have antiviral pills
in stock. We need to ensure continued -- and equal -- access among all
high-risk Americans.
Monoclonal antibodies also remain in our treatment and prevention
arsenal. Bebtelovimab remains a powerful option to prevent severe
disease and hospitalization in high-risk patients, with persistent
activity against BA.2.12.1. As EDs across the country return to peak
pre-pandemic patient volume for other medical conditions, bebtelovimab
is a great one-and-done option since it's given as an intravenous dose
pushed over 30 seconds. For certain immunocompromised patients who are
unable to mount a significant protective response from vaccines, a
long-acting dual-monoclonal antibody can help. Tixagevimab co-packaged
with cilgavimab (Evusheld) given as preexposure prophylaxis demonstrated
an impressive 82.8% relative risk reduction for all COVID-19 symptoms at
6 months, with retained activity against subvariants BA.4 and BA.5.
What about treatment for long COVID? While an exact etiology remains
elusive, one of its proposed mechanisms is a high viral load.
Vaccination is highly protective against long COVID. For those with
residual symptoms, some case studies have offered evidence that oral
antivirals could reduce symptoms, so this must be studied further.
On to the Next Phase
We are certainly in a much stronger position against SARS-COV-2 than we
have ever been. Vaccines continue to provide robust protection against
severe illness and death. Therapeutics can keep high-risk patients out
of the hospital. The emergency phase of the pandemic may be fading. We
now need to avoid backsliding and instead look toward better future
COVID management.
The next phase will require increasing trust in our public health
system, updating vaccines for all, continued ease-of-access of
therapeutics, new whole virus vaccines in the future, novel therapeutics
currently in development, and nasal vaccines. Let's remain vigilant and
continue to move ahead.
Monica Gandhi, MD, MPH, is a professor of medicine in the school of
medicine at University of California San Francisco. Michael Daignault,
MD, is an emergency physician at Providence Saint Joseph Medical Center
in Burbank, California.
--
This email has been checked for viruses by AVG.
https://www.avg.com
HeartDoc Andrew
Jun 15, 2022, 12:01:49 AM6/15/22
to
the U.S. & elsewhere is by rapidly ( http://bit.ly/RapidTestCOVID-19 )
finding out at any given moment, including even while on-line, who
among us are unwittingly contagious (i.e pre-symptomatic or
asymptomatic) in order to http://tinyurl.com/ConvinceItForward (John
15:12) for them to call their doctor and self-quarantine per their
doctor in hopes of stopping this pandemic. Thus, we're hoping for the
best while preparing for the worse-case scenario of the Alpha lineage
mutations and others like the Omicron, Gamma, Beta, Epsilon, Iota,
Lambda, Mu & Delta lineage mutations combining via
slip-RNA-replication to form hybrids like
http://tinyurl.com/Deltamicron that may render current COVID
vaccines/monoclonals/medicines/pills no longer effective.
Indeed, I am wonderfully hungry ( http://tinyurl.com/RapidOmicronTest
) and hope you, Michael, also have a healthy appetite too.
So how are you ?
...because we mindfully choose to openly care with our heart,
HeartDoc Andrew <><
--
Andrew B. Chung, MD/PhD
Cardiologist with an http://bit.ly/EternalMedicalLicense
2024 & upwards non-partisan candidate for U.S. President:
http://WonderfullyHungry.org
and author of the 2PD-OMER Approach:
http://bit.ly/HeartDocAndrewCare
which is the only **healthy** cure for the U.S. healthcare crisis
Michael Ejercito
Jun 15, 2022, 12:13:29 AM6/15/22
to
Michael
HeartDoc Andrew
Jun 15, 2022, 12:32:13 AM6/15/22
to
Michael Ejercito wrote:
While wonderfully hungry in the Holy Spirit, Who causes (Deuteronomy
8:3) us to hunger, I note that you, Michael, are rapture ready (Luke
17:37 means no COVID just as circling eagles don't have COVID) and
pray (2 Chronicles 7:14) that our Everlasting (Isaiah 9:6) Father in
Heaven continues to give us "much more" (Luke 11:13) Holy Spirit
(Galatians 5:22-23) so that we'd have much more of His Help to always
say/write that we're "wonderfully hungry" in **all** ways including
especially caring to http://tinyurl.com/ConvinceItForward (John 15:12
as shown by http://tinyurl.com/RapidOmicronTest ) with all glory (
http://bit.ly/Psalm112_1 ) to GOD (aka HaShem, Elohim, Abba, DEO), in
the name (John 16:23) of LORD Jesus Christ of Nazareth. Amen.
Laus DEO !
Suggested further reading:
https://groups.google.com/g/sci.med.cardiology/c/5EWtT4CwCOg/m/QjNF57xRBAAJ
Shorter link:
http://bit.ly/StatCOVID-19Test
Be hungrier, which really is wonderfully healthier especially for
diabetics and other heart disease patients:
http://bit.ly/HeartDocAndrew touts hunger (Luke 6:21a) with all glory
( http://bit.ly/Psalm112_1 ) to GOD, Who causes us to hunger
(Deuteronomy 8:3) when He blesses us right now (Luke 6:21a) thereby
removing the http://tinyurl.com/HeartVAT from around the heart
8:3) us to hunger, I note that you, Michael, are rapture ready (Luke
17:37 means no COVID just as circling eagles don't have COVID) and
pray (2 Chronicles 7:14) that our Everlasting (Isaiah 9:6) Father in
Heaven continues to give us "much more" (Luke 11:13) Holy Spirit
(Galatians 5:22-23) so that we'd have much more of His Help to always
say/write that we're "wonderfully hungry" in **all** ways including
especially caring to http://tinyurl.com/ConvinceItForward (John 15:12
as shown by http://tinyurl.com/RapidOmicronTest ) with all glory (
http://bit.ly/Psalm112_1 ) to GOD (aka HaShem, Elohim, Abba, DEO), in
the name (John 16:23) of LORD Jesus Christ of Nazareth. Amen.
Laus DEO !
Suggested further reading:
https://groups.google.com/g/sci.med.cardiology/c/5EWtT4CwCOg/m/QjNF57xRBAAJ
Shorter link:
http://bit.ly/StatCOVID-19Test
Be hungrier, which really is wonderfully healthier especially for
diabetics and other heart disease patients:
http://bit.ly/HeartDocAndrew touts hunger (Luke 6:21a) with all glory
( http://bit.ly/Psalm112_1 ) to GOD, Who causes us to hunger
(Deuteronomy 8:3) when He blesses us right now (Luke 6:21a) thereby
removing the http://tinyurl.com/HeartVAT from around the heart
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