FRONT YARD OF THE MAIN HOUSE WITH SERVANT QUARTERS BY THE SIDE AT THE END OF THE LONG DRIVEWAY. SOME PHOTOS AND VIDEOS ON THIS SITE, I DO NOT OWN. HOWEVER, I HAVE NO INTENTION IN INFRINGING ON YOUR COPYRIGHTS.
FRONT YARD OF THE MAIN HOUSE WITH SERVANT QUARTERS BY THE SIDE AT THE END OF THE LONG DRIVEWAY. SOME PHOTOS AND VIDEOS ON THIS SITE, I DO NOT OWN. HOWEVER, I HAVE NO INTENTION IN INFRINGING ON YOUR COPYRIGHTS.
Today, 4th Sunday of Advent, my 86th Birthday, I attended Catholic
Mass on line, that is On TV sponsored by Heart of the Nation.org.
Today's mass reminded me that a momentous event in US history has
occurred. This event is the election Of Joe Biden the second Roman
Catholic ever elected in the US. In case you have forgotten, the first
one was John Kennedy.
For the last year couple of years,
Macrine (RIP) and I had been attending Catholic Mass on TV. Two reasons:
Macrine's poor health since 2016 and the Covid-19 Lockdown in March
2020. Heart of the Nation broadcast on Television is my favorite
Channel. Here's today's mass.
Last week homily during mass discussed that year 2020 is called Annus Horribilis ( Horrible Year) and the coming year 2021 will be hopefully Annus Gratia ( Year of Favor( Grace).
I
really identified with the above homily, so it inspired me to search
for major events in 2020 that I considered horrible as follows:
1. The mishandling of covid-19 Pandemic by Trump
2. The Impeachment Hearings of Trump
3. Black Lives Matter Protest
4. The Beirut Explosion
5. Trump Tests Positive for Covid-19
For the Good news:
1. Joe Biden became the 46th president
of the United States on Nov. 7, defeating President Trump( with over 7 million popular votes) and with a
critical assist from his birth state, Pennsylvania, which delivered the
votes to propel him to victory and end one of the most contentious
elections in recent memory.
The
Pfizer/BioNTech Covid-19 vaccine can now be administered in the US,
Centers for Disease Control and Prevention Director Dr. Robert Redfield
said Sunday.
The loading process of the first shipment of the
Pfizer vaccine has begun in the United States, with vaccines heading to
all 50 states.
Health experts are warning it's likely the US
won't see any meaningful, widespread impacts from vaccinations until
well into 2021.
In Asia, Japan and South Korea both reported their highest yet single-day rise in cases since the pandemic began.
Tomorrow, December 20 will be my 86th birthday. I Thank the
Lord for all His Blessings all these years! There will be no Party or
Family Get Together due to Covid-19. David and I will just order Lobster Dinner via Doordash*
My 80th Birthday Celebration and Family Get Together-Six Years Ago
I will be 86 years
old tomorrow, December 20. This is the season of winter and sunset of my life.
There will be no big celebration because we are still in the LOCKDOWN
mode due to Covid-19. However there will be recollections of my life
( see sites listed below for details). Here's a video ( poem) that I
can identify about the winter of my life.
This time of my life I will also call the Sunset of My Life. Here's another video about Sunsets that reminds me of my eight decades and six years of my life.
Here's one of my favorite poems on aging by Samuel Taylor Coleridge, ‘Youth and Age’.
When I was young?—Ah, woful When!
Ah! for the change ’twixt Now and Then!
This breathing house not built with hands,
This body that does me grievous wrong,
O’er aery cliffs and glittering sands,
How lightly then it flashed along:—
Like those trim skiffs, unknown of yore,
On winding lakes and rivers wide,
That ask no aid of sail or oar,
That fear no spite of wind or tide!
Nought cared this body for wind or weather
When Youth and I lived in’t together …
‘You’re only as old as you feel’ might be a rough paraphrase of the
main sentiment driving this poem, by one of English literature’s leading
Romantic poets.
Here's a short article on the Afterglows of the Sunset of our Lives
I
gave myself an advance birthday gift today. I purchase on line two
decorative nite lights( a Cross) and small Christmas tree from Lampeez. I
am enjoying these two purchases very, very much. I also purchased
Lampeez lights as my Christmas Gifts for Carenna, Ditas, Dodie and Dinah
as listed in the bottom page of this article.
Lampeez
is the pioneer of 3D LED Lamp with best quality & largest
collection of optical illusion lamps. Use it as a night light or home
decor, your choice!
Lampeez
is a combination of art and technology that creates an optical illusion
and plays tricks on the eyes by creating a 3D effect hence called the
LED Illusion Lamp
The Cross 3D LED Illusion Lamp is a combination of art and technology
that creates an optical 3D illusion and plays tricks on the eyes. From
afar, you will see the design, but as you get up close, you see a thin
acrylic glass sheet that's completely flat. It's bound to dazzle and
impress your guests while always lighting up the room and your lives.
This playful product combines man made fibers with natural materials
and produced using both machines and artisan handwork. Perfect for
displaying in your bedroom, living room, office, as a night lamp or any
way you want to use it.
Features
8 Changeable color modes including Cyan, Blue, Green, Red, White,
Yellow and Purple as well as a flashing mode that displays all colors
Touch button to easily change color mode
Energy efficient long life LED bulbs
Safe to touch. Does not overheat
For other products see the following site in Facebook:
The 3D Head of a Cat-My Christmas Gift to Dinah this year
This guitar is my Christmas gift to Dodie this year
There
are numerous selections from arts, animals or landmarks. The cost
varied from $39.99 to $59.99 depending on the size. It is a good
Christmas gift to someone who has everything.
Meanwhile enjoy these two original songs that Carenna wrote in 2018 for Vision 2020, California when she was only 15 years old.
This is Part 12 out of 14 on the Series Macrine J. Katague, Celebration of Life.
Macrine
also loved popular songs besides the classical piano music of her
teenaged and childhood years. Three of her favorite popular songs are Moon River, Sound of Silence and the Prayer.
Moon River is one song Macrine's memorized, so when we attend parties and someone ask her to sing-Moon River is the song of Choice
Simon and Garfunkel was her favorite duo, but I found this arrangement of the Sound of Silence by Pentatonix excellent
The Prayer- Lea Salonga and Josh Groban Duet-Asia Mall, Manila
Another version of Moon River -Choral
and last but not least is an instrumental arrangement of I'll be Seeing You
However,
the latest survey indicated that only about 65% of the US populations
are willing to be vaccinated once the supply is available. The rest do
not want the vaccine for some reasons or another, but particularly its
safety and unknown long term side effects. As a previous FDA
employee ( retired Chemistry Team Leader, Center of New Drugs), I have
no hesitation in being vaccinated when my turn in the priority list
comes.
Please note that the Pfizer vaccine was granted by FDA an Emergency Use Authorization (EUA) and not the Standard Approval for New Drugs. Do you know the differences between an EUA versus the standard/normal Approval? Here's a summary for your information.
EUAs and normal drug approvals may both result in new medical
products entering the market. However, these two
pathways serve very distinct goals and are based in distinct and different legal
authorities.
Standard Approval for Marketing
Approval of a new drug or biologic is a long and rigorous process
intended to ensure that a product is safe, effective and made to
appropriate quality standards. A typical process for approval takes
years, and involves pre-clinical testing to ensure that a product is
safe for use in humans and is unlikely to cause any adverse effects.
This testing may take place using acceptable in silico models
or testing in animals. After pre-clinical testing is complete, a company
typically initiatives clinical testing in humans by filing an
Investigational New Drug (IND) application.
Different phases of clinical
trials generally seek to generate evidence that a product is generally
safe (Phase 1), that it is safe and effective in a larger population of
patients (Phase 2), and that it provides evidence that it is safe and
effective in a sufficient amount of patients to support approval (Phase
3). Phase 3 trials are sometimes known as “pivotal” trials, since their
success or failure is pivotal to the success (or failure) of a product.
The FDA requires that products show “substantial evidence” of their
safety and efficacy, though it often approves drugs using evidence from
small numbers of patients as well.
EUA Issuance
In contrast, EUAs typically rely on a much lower standard of evidence
to support authorization. They are also not used outside of declared
emergency situations
The triggering mechanism to use an EUA is the declaration of a public
health emergency by the Secretary of Health and Human Services under
the Public Health Service Act (42 U.S.C. 247(d)). The Secretary must then separately determine that the circumstances justifying an EUA exists. A recent amendment under the Pandemic and All Hazards Preparedness Reauthorization Act (PAHPRA)
expanded and streamlined the Secretary’s authority to enable EUAs on
the basis of a potential public health emergency that poses a risk to
national security. Once these conditions have been met, the FDA then has
the ability to enact EUAs under the Federal Food, Drug and Cosmetics
Act (21 U.S.C. 360bbb-3).
Once an authorization request has been prepared, a product sponsor
will then officially request authorization for the use of their
unapproved product. The FDA will consider all the available evidence and
make a determination based on the circumstances that the product “may
be effective” in the treatment, prevention, or diagnosis of the
condition—a significantly lower standard than marketing approval (i.e.,
“substantial evidence of safety and effectiveness”).
What are the benefits of an EUA?
Although an EUA is only in effect during the public health emergency, they are powerful tools to help meet emergency needs.
One of the primary benefits of an EUA—and one that does not apply
under the traditional approvals process—is a liability shield. To
incentivize private sector manufacturers of drugs and devices to act
under EUAs when an emergency has been declared, PAHPRA also added EUAs
to the definition of medical countermeasures. This amendment extended
the immunity from liability under the Public Readiness and Emergency
Preparedness (PREP) Act to EUAs.
Critically, an EUA can facilitate access to products on a
highly-accelerated basis, while also restricting its use outside of that
emergency situation. Review of EUAs generally only take weeks (and
sometimes less than that), as compared to the ordinary review timeline
which may take months or longer. During a global pandemic, time is of
the essence.
Finally, EUAs can be revoked at the discretion of the Secretary,
either because a product fails to meet the statutory criteria, or
because the circumstances of its authorization are no longer reasonable.
For example, a public health emergency may have concluded, or another
product may have been approved that is safer and more effective. In such
cases, the FDA may revoke the authorization, or may modify it (such as
to limit it for a smaller population of patients).
Where are EUAs being used?
No recent epidemic has generated a greater need for emergency
authorizations, nor the pressure for fast-tracking FDA approvals, like
COVID-19.
So far, more than 39 EUAs have been granted, with more than 30 of
those for diagnostic products. The fundamental challenges with
manufacturing and distribution of diagnostics has driven an unmatched
issuance of EUAs for a variety of tests, following FDA guidance that
allowed states to validate their own diagnostics.
While the law allows for a drug or biologic to be authorized under an
EUA, historical data demonstrates that this remains rare in practice.
There are several potential reasons for this, including manufacturer use
of Expanded Access and the time it takes to develop new drugs or
biologics. In many cases, an outbreak of a disease may be over by the
time a company’s product has sufficient evidence to support
authorization.
Hydroxychloroquine and chloroquine phosphate have already been authorized for Emergency Use under the COVID-19 emergency, but only in a limited capacity.
What is the impact of the use of EUA on COVID-19?
The FDA’s unmatched use of EUA in the COVID-19 pandemic has been a
vital stop gap measure to accelerate testing. Between March 12 and April
8, the FDA issued 28 EUAs for diagnostic products—a rate of more than
one per day on average, and more than the combined EUAs issued for the
Zika, Ebola and MERS-CoV public health emergencies.
The incidence and prevalence of COVID-19, as well as the rate of
spread, are some of the most important pieces of information needed to
inform the allocation of fiscal, human and material resources.
Authorizing diagnostics for emergency use has allowed for wider
availability of testing with faster turnaround time. By dramatically
reducing the time from sample collection to results (a window that could
originally last up to 5 days when samples were being mailed to the
CDC), products authorized for distribution under EUAs have helped public
health authorities and providers respond more quickly to the virus.
