An Advanced Birthday Present- Nite Light Decor from Lampeez

 

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:

 

 https://www.facebook.com/lampeez

 

 I Love You-my Christmas gift to Carenna this year

The Yoga-My Christmas Gift to Ditas this year

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.

 

https://vimeo.com/305811635

 

 

Celebration of Life: Macrine J. Katague via her Favorite Music (Popular)-Part 12

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

Meanwhile enjoy this photo from my collection

  

 

Differences Between Emergency Use Authorization versus Standard Approval for New Drugs and Biologics

Time Differences in the Stages of Development Between Classical and Covid-19 Vaccines

Covid-19 vaccinations had started in several locations in the US yesterday.

https://abcnews.go.com/Nightline/video/inside-race-covid-19-vaccine-part-74730914. 

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.

For complete details visit:

https://agencyiq.com/the-basics-of-emergency-use-authorizations-why-an-authorization-isnt-the-same-as-approval/

 

The Current Development Status of Covid-19 Vaccines in the US and In Other Countries

There are several COVID-19 vaccines under development in the US and in other countries*. Pfizer Vaccine was authorized for emergency use the other day and distribution to all of the US 50 States started yesterday. Moderna's Vaccine will be reviewed by FDA next week. Hopefully it will be a second vaccine authorized for emergency use here in the US this year,

Here’s a list at some of the ongoing COVID-19 vaccine projects:

1. Pfizer / BioNTech / Fosun Pharma. Drugmaker Pfizer teamed up German biotech company BioNTech and Chinese drugmaker Fosun Pharma to develop a two-dose mRNA vaccine.

In mid-August, company officials said the vaccine had produced a “robust” response in a phase 1/2 clinical trial.

The company launched a phase 3 trial in late July, with a goal to recruit 30,000 people from the United States, Brazil, Argentina, and Germany. They later announced plans to increase this to 44,000 people. In October, the company said it received approval to enroll children as young as 12 years in the trial — the first American trial to include this age group.

As of late October, the trial had enrolled more than 42,000 people. At the time, the company had not yet conducted an interim analysis of the study data, which puts it behind its original goal of doing so by September. However, the company still expects to have enough data sometime in November to apply for emergency use authorization from the FDA.

On November 9, the company announced that its vaccine had been more than 90 percent effective in clinical trial participants.

A few days later, company officials announced they were applying for an emergency use authorization from the FDA for their vaccine. It was the first regulatory approval in the United States for a COVID-19 vaccine. The officials said the vaccine could be available to high-risk groups as early as mid-December.

On December 8, the FDA released documents that reported the Pfizer vaccine offers some protection after the first dose and nearly full protection after a second dose. 

*Yesterday, December 13, vaccines were distributed and transported from Michigan to all 50 US states after FDA authorization for emergency use and CDC recommendation.

2. Moderna / National Institutes of Health. The company began testing its two-dose messenger RNA (mRNA) vaccine in March in a phase 1 clinical trial, with promising results.

In late July, Moderna began phase 3 clinical trials of the vaccine.

In late August, company officials said preliminary phase 1 trial data showed that the vaccine elicited a promising immune response in 10 people between the ages of 56 and 70 as well as 10 people over age of 70.

The company announced in late October that it had finished recruiting all 30,000 participants in the phase 3 trial. This included more than 7,000 people over the age of 65 and more than 5,000 younger people with chronic conditions that increase their risk of severe COVID-19.

In early October, company officials announced their vaccine won’t be available for wide distribution until spring 2021. Later in the month, Moderna’s CEO told investors that the trial’s data and safety monitoring board could start analyzing study data in November.

In mid-November, Moderna officials reported that their vaccine had achieved an effective rate of 94 percent in initial phase 3 trial results. Experts said more testing and more information is needed.

On November 30, Moderna officials said they would apply to the FDA for its vaccine to be approved for emergency use. Company executives said the vaccine could be available by December 21 if it receives FDA approval.

3. Inovio. When COVID-19 appeared in December, drugmaker Inovio had already been working on a DNA vaccine for MERS, which is caused by another coronavirus. This allowed the company to quickly develop a potential COVID-19 vaccine.

Company officials announced at the end of April that it had enrolled 40 healthy volunteers in its phase 1 trial. In late September, the company announced that its phase 2/3 trial is on hold as the it responds to the FDA’s questions about the study.

4. Sanofi / Translate Bio. Drugmaker Sanofi announced in February that it would work with Translate Bio to develop an mRNA vaccine. Preclinical testing showed that the vaccine could elicit a strong immune response in mice and monkeys. The company expects results from its phase 2 trial in early December. After that, they will start a phase 3 study.

5. CanSino Biologics. Scientists at this Chinese company are also working on a potential vaccine that uses an adenovirus known as Ad5 to carry coronavirus proteins into cells.

In late July, they reported that participants in a phase 2 trial showed a strong immune response when given the vaccine. However, they noted older adults had a weaker response, suggesting two doses might be needed for that segment of the population.

The Chinese military approved the vaccine in June, allowing the vaccine to be given to its armed forces. In August, the company began phase 3 trials in Pakistan, Saudi Arabia, and Russia.

6. Gamaleya Research Institute. This Russian institute developedTrusted Source a vaccine that includes two adenoviruses, Ad5 and Ad26.

In August, President Vladimir Putin announced that the country’s regulatory agency had approved the vaccine, even before phase 3 trials had started. Russian officials later said the vaccine had received a “conditional registration certificate.”

Results of a phase 1/2 trial found that the vaccine elicited an immune response with mild side effects. Phase 3 trials are currently under way in Russia, Belarus, United Arab Emirates, and India.

7. Johnson & Johnson. Drugmaker Johnson & Johnson announced in late July that it had begun a phase 1/2 trial in people after their adenovirus vaccine had shown promising results when used in monkeys.

In late September, the company announced it was starting a phase 3 trial of its one-dose vaccine with 60,000 participants. In mid-October, the company announced it was pausing this trial due to an “unexplained illness” with one of the participants. The company has since received permission to restart the study.

In mid-November, Johnson & Johnson officials said they expected their vaccine to be ready for FDA approval by February.

8. AstraZeneca / University of Oxford. A phase 1 clinical trial at the University of Oxford began in late April. The vaccine is based on a chimpanzee adenovirus, which shuttles coronavirus proteins into cells.

In August, AstraZeneca began phase 3 trials in Brazil, South Africa, and the United StatesTrusted Source. These trials were halted in September when a study volunteer developed a rare spinal inflammatory disorder called transverse myelitis. The trials were restarted a week later in Brazil and the United Kingdom. In late October, the FDA authorized the U.S. trial to resume.

In mid-November, company officials said their vaccine had produced a strong immune response in a clinical trial that involved people over the age of 70.

Data released on December 8 indicated that the vaccine was safe but only about 70 percent effective.

9. Sanofi / GSK / TranslateBio. Drugmaker Sanofi is pursuing two vaccines. The company is working with drugmaker GSK on a vaccine based on proteins from the coronavirus. When combined with another compound, called an adjuvant, the proteins elicit an immune response. They expect results from a phase 2 trial in early December, after which they will begin a phase 3 study.

Sanofi is also working with biotech company Translate Bio to develop an mRNA vaccine. They expect to start clinical trials in December.

10. Novavax. This company received up to $388 million in funding this spring from the Coalition for Epidemic Preparedness Innovations (CEPI), a group that has funded COVID-19 vaccine development. The vaccine is made by attaching virus proteins to microscopic particles.

In August, Novavax launched a phase 2 trial in South Africa. A month later, the company began a phase 3 trial in the United Kingdom. It plans to start another phase 3 trial in the United States by the end of November.

11. University of Queensland in Australia / CSL. Researchers at the university developed a vaccine by growing viral proteins in cell cultures. They began preclinical testing stages in early April. The phase 1 trial in people began in early July. A phase 2/3 trial is expected to start late this year.

12. Wuhan Institute of Biological Products / Sinopharm. Chinese company Sinopharm is testing an inactivated virus vaccine developed by the Wuhan Institute of Biological Products. After a successful phase 1 trialTrusted Source, researchers launched phase 3 trials in the UAE in July and a month later in Peru and Morocco.

13. Beijing Institute of Biological Products / Sinopharm. Sinopharm is testing a second inactivated virus vaccine developed by Beijing Institute of Biological Products.

Phase 3 trials began in June in the UAE and in September in Argentina. In September, the UAE approved the vaccine for use on healthcare workers even before the results of the phase 3 trials.

14. Sinovac Biotech. This Chinese company launched phase 3 trials of its inactivated virus vaccine in Brazil in July, Indonesia in August, and Turkey in September. In August, the Chinese government issued emergency approval for the vaccine for use on high-risk groups.

15. Bharat Biotech / Indian Council of Medical Research / Indian National Institute of Virology. Indian company Bharat announced in late October that it was beginning a phase 3 trial of its inactivated virus vaccine.

 

Repurposed vaccines

Murdoch Children’s Research Institute in Australia is conducting a phase 3 trial of the bacillus Calmette-Guérin (BCG) tuberculosis vaccine to see if it also protects people from the coronavirus. This trial is being run in Australia, Brazil, the Netherlands, Spain, and the United Kingdom.

Some scientists think the polio vaccine might boost the immune system just enough to fight off the new coronavirus, although there’s no evidence yet to confirm this theory.

Two U.S. researchers also suggested that the measles, mumps, rubella (MMR) vaccine might offer protection against inflammation and sepsis in people with COVID-19. They recommend starting a clinical trial with the MMR vaccine in healthcare workers.

Antivirals

Antivirals are drugs that are used for treating viral infections. Some antivirals target specific viruses, while others work against a number of viruses.

These drugs can work in different ways such as preventing the virus from entering host cells, replicating, or releasing viral particles to infect other cells.

Here are some of antivirals being eyed as treatments for COVID-19. Many of these have been approved for other conditions or have been tested on other viruses.

Remdesivir (brand name Veklury). Developed a decade ago, remdesivir failed in clinical trials against Ebola in 2014. But it was found to be generally safe in people.

Research with MERS, a disease caused by a different coronavirus, showed that the drug blocked the virus from replicating.

In April, drugmaker Gilead Sciences announced that preliminary data from a trial of remdesivir overseen by the National Institute of Allergy and Infectious Diseases (NIAID) had “met its primary endpoint.”

Based on these results, the FDA issued an orderTrusted Source on May 1 for the emergency use of remdesivir for hospitalized patients with severe COVID-19.

In August, the agency broadenedTrusted Source the EUA to allow for use of the drug in all hospitalized COVID-19 patients, including children.

The results of a phase 3 trial published in October in the New England Journal of Medicine showed that remdesivir shortened the hospital stay of COVID-19 patients by about 5 days.

People taking remdesivir also had a lower risk of dying compared to those who had been given an inactive control substance.

On Oct. 22, the FDA approvedTrusted Source remdesivir for use as a treatment for COVID-19 in adults and children 12 years and older. The drug is the first approved by the agency as a treatment for COVID-19.

Not all clinical trials have found that remdesivir is effective.

A studyTrusted Source published in The Lancet in May reported that participants in a clinical trial who took remdesivir showed no benefits compared to people who took a placebo.

Preliminary results from a World Health Organization trial released in October found that remdesivir had little effect on how long people stayed in the hospital and no effect on their risk of dying.

For Complete Details visit:

https://www.healthline.com/health-news/heres-exactly-where-were-at-with-vaccines-and-treatments-for-covid-19#COVID-19-vaccines

 

 

Is Lame Duck President Trump Crazy? If Not, He is Certainly a Con Man

If you don't agree, then he must be a con artist raising more than $207 million for his own use. He lost the election, but I have a feeling his political ambitions is not dead! 

Articles discussing lame Duck Trump going crazy and mad because he lost the election is all over the news and in the Internet. Here are some excerpts and their authors that I can identify and agreed with their sentiments.

1.Shane Shaw( 2/15/2017): Albert Einstein is famously quoted: “The definition of insanity is doing the same thing over and over and expecting something to change.”This is not, of course, the actual definition of insanity. It also turns out Einstein never said this. It actually comes from an Alcoholics Anonymous pamphlet from the 1980s.

Which is apropos, because nearly 60,000 mental health professionals have diagnosed President Donald Trump with a type of insanity that is often compared to an alcoholic’s lack of honesty and impulse control. Sparked by Change.org petitions by a top former Johns Hopkins professor and a California congresswoman, the psychiatric community has declared that Trump suffers from “Malignant Narcissism.” or Narcissistic Personality Disorder (NPD).

2. May Bulman ( 7/4/2017): Donald Trump has a “dangerous mental illness” and is not fit to lead the US, a group of psychiatrists has warned during a conference at Yale University. Mental health experts claimed the President was “paranoid and delusional”, and said it was their “ethical responsibility” to warn the American public about the “dangers” Mr Trump’s psychological state poses to the country.

Speaking at the conference at Yale’s School of Medicine on Thursday, one of the mental health professionals, Dr John Gartner, a practising psychotherapist who advised psychiatric residents at Johns Hopkins University Medical School until 2015, said: “We have an ethical responsibility to warn the public about Donald Trump's dangerous mental illness.”

3. H.A. Adaza(11/2/2020): On the issue of madness, the most outstanding example is the President of the United States of America, Donald Trump. He occupies center stage in American and international media. Why? The man demonstrates the qualities of narcissists and strong men in our planet. Trump has one greatest love of his life – Donald Trump. Anything is sacrificed at the altar of Donald Trump, even America, in the pursuit of personal adulation. Anyone that contradicts his opinion he calls disasters and idiots, including the famous doctor, Anthony Fauci, who is a member of his task force on the corona virus.

Trump’s demonstration of madness is overwhelming. And the same is clearly shown in his words and behavior. If he were not the President of the United States of America, he would be a clown. As some individuals would have it – he looks like a clown, walks like a clown and talks like a clown, so he must be a clown. And I wholeheartedly agree with their accurate observation.

 

4. William Opfer, Jr ( Baltimore Sun): President Donald Trump’s downward spiral into total delusional behavior is not only distressing, it is extremely dangerous (”Last throes of Trump’s presidency turn ugly — even dangerous,” Dec. 2). His total fixation on the myth of election fraud, his complete abandonment of any involvement with the COVID-19 crisis, and his irrational actions to fire key governmental officials and replace them with “yes men” to do his bidding in both the departments of Defense and Homeland Security should alarm every American. His efforts to undermine, insult, demean and even threaten every person who speaks truth to the election reality is a sign of severe mental instability.

This is a man with access to the nuclear codes. This is a man who still thinks his executive power is absolute. This is a man who at this point is a menace. It is way past time for high ranking Republicans, including Vice President Mike Pence, Senate Majority Leader Mitch McConnell, Sen. Lindsey Graham and others to publicly rebuke President Trump and speak directly to the 74 million voters who supported him to say enough and stop the madness.

Donald Trump is a lame duck president who needs to be constrained from doing further damage to our nation until he leaves office on January 20. Republican leadership has the power to do so. Do they have the courage?

 Here's some of the websites discussing Trump Madness:

https://www.politico.com/news/magazine/2020/11/13/trumps-crazy-and-confoundingly-successful-conspiracy-theory-436404 

https://www.oregonlive.com/trending/2017/09/is_donald_trump_actually_crazy.html

https://www.newyorker.com/news/letter-from-trumps-washington/the-president-is-acting-crazy-so-why-are-we-shrugging-it-off

Meanwhile for a more enjoying subject: Our simple Christmas Decorations this year

David III autographed photos of Bill and Hilary-he displays it on our Fire Place Mantle during Christmas and until New Year every year.

 

Memories of our Visit to the Malacanang Palace of the Philippines

Yesterday, I posted in my blogs our  pleasant memories 25 years ago during our personal Christmas tour of the White House. Today, I am posting our visit to Malacanang Palace 22 years ago, December 11, 1998.

 

Twenty-Two Years ago today, Macrine and I were invited to an Award Ceremony for Overseas Filipinos at the Malacanang Palace in the Philippines.
 

The Reception Hall with its Crystal Chandelier

Malacañang Palace (officially "Malacañan Palace"; Filipino: Palasyo ng Malakanyang; Spanish: Palacio de Malacañán⁾ is the official residence and principal workplace of the President of the Philippines. It is located in old Manila district of San Miguel, and is commonly associated with Mendiola Street. The term "Malacañang" is often used as a metonym for the president and his advisers. The sprawling Malacañang Palace complex includes numerous mansions and office buildings designed and built largely in bahay na bato and neoclassical style.  

For history and details about this place visit: 

https://en.wikipedia.org/wiki/Malaca%C3%B1ang_Palace

Meanwhile enjoy this photo of our simple Christmas decor here in Northern California this year.