Coronavirus COVID-19 *Global Health Emergency* #9

DNA Solves
DNA Solves
DNA Solves

New Posts

Status
Not open for further replies.
Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

(Not BBM’d by me, was already bolded)

For Immediate Release:
February 29, 2020
Today, as part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.

“We believe this policy strikes the right balance during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China and which has now been detected in 50 locations internationally, including cases in the United States. The virus has been named “SARS-CoV2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on health care systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the U.S. To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care.

The new policy is for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed review of their Emergency Use Authorization(EUA) requests. The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products’ emergency use.

On Feb. 4, 2020, the Secretary of HHS determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the COVID-19 outbreak. Rapid detection of COVID-19 cases in the U.S. requires wide availability of diagnostic testing to control the emergence of a rapidly spreading, severe illness. The FDA has authorized one EUA for COVID-19 that is in use by the U.S. Centers for Disease Control and Prevention (CDC) and some public health labs across the country.

The guidance issued today describes a policy enabling laboratories to immediately use tests they developed and validated in order to achieve more rapid testing capacity in the U.S.

“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” said Nancy Messonnier, M.D., director of the CDC’s Center for the National Center for Immunization and Respiratory Diseases (NCIRD).

The immediately in effect guidance issued today describes the circumstances where the FDA does not intend to object to the use of these tests for clinical testing while the laboratories are pursuing an EUA with the FDA. Importantly, this policy only applies to laboratories that are certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments.

“We applaud the FDA’s approach to speed the path toward emergency use authorization for COVID-19 diagnostics. This step may reduce development costs, speed the process for availability at more testing sites, incentivize private development and, ultimately, help save lives,” said Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. “At BARDA, we are identifying industry partners to develop rapid diagnostics that can be used in commercial and hospital labs or even doctors’ offices so that medical professionals and their patients have the information they need to take action.”

The FDA guidance provides recommendations for test developers, including information regarding test validation, FDA notification and interim confirmatory clinical testing.

Following the completion of their test validation, laboratories should communicate with the FDA, via email, in order to notify the agency that the test has been validated. Laboratories should submit a completed EUA request within 15 business days of notification.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation. We are dedicating all available resources to expediting the review of medical products, including diagnostics, to prevent the spread of this outbreak.”
 
firebird said:
There are two people who died. They both are extremely recent. I believe the first was the woman last night, and the second was the man this morning. Obviously, they prepared for the presser without knowing about the second death. Not too bizarre imo.
Click to expand...
I think they probably knew about the second death but refrained from announcing it until locals were able to reach out to family/friends of the young man. JMO.
 
New York State to Start COVID-19 Testing, Gov. Cuomo Says
Gov. Andrew Cuomo on Saturday morning tweeted that his office "just received word that our test has been approved by the FDA"
Published 3 hours ago • Updated 2 hours ago

New York State is ready to start testing for potential cases of the novel coronavirus, joining New Jersey and Connecticut, Gov. Andrew Cuomo said Saturday.

As of Friday, New York still didn't have permission from the Centers for Disease Control to begin testing, but Cuomo on Saturday morning said his office "just received word that our test has been approved by the FDA."


[...]

A New York City resident who recently came back from a trip to Italy is currently being tested for COVID-19, according to officials. After a sample was sent to Atlanta for testing on Thursday, it could be until well into the weekend before the city learns if it has its first confirmed case of the virus that the CDC says has killed more than 2,800 people worldwide.

The patient began exhibiting symptoms shortly after returning from a trip to Italy, where NBC News confirmed there are nearly 900 people infected, in addition to 21 deaths. Symptoms — which include fever, coughing and shortness of breath — are likely to appear as soon as two days after exposure, or up to two weeks later, according to the CDC.“
 
mickey2942 said:
Not any more. Maybe a transgender. :)

I wish that people would be more respectful to our president and vice president. INMO, at least there is some leadership being demonstrated. American people need some reassurance.
Click to expand...

I certainly appreciate the promise of transparency and reassurance that pros will not be censored. Here’s hoping.
 
I watched the news conference and have breathed a huge sigh of relief :) After listening to the President, Vice President, and medical professionals who spoke during the presser, I feel confident that our government agencies are doing everything they can to curtail the spread of COVID-19. I'm not an alarmist by nature and didn't want to put my life on hold due to fear about possibly contracting the virus. At 70, I am a very healthy with no underlying medical issues other than mild allergic asthma that is under control with medication. In fact, I have not had an active asthma episode for almost two years! I will continue to observe recommended preventative measures like frequent hand washing, not touching face, avoiding contact with those who are symptomatic, etc., but I am not going to go into panic mode. I maintain a healthy diet, get plenty of rest, exercise regularly, and as previously mentioned, spend the majority of my time in my own home. I think the majority of Americans will be fine if they take common sense precautions to keep themselves healthy.
 
Betty P said:
CDC director says Americans are safe, no problems. No need for domestic travel restrictions at this time. Answer was in response to reporter's question about whether travel to west coast/northern Cal should be restricted.

Looks like Redfield has some controversy in his past, some due to concerns about profiteering.

Robert R. Redfield - Wikipedia
Click to expand...
Our grandson is graduating from high school in May. We planned on flying out of Sea-Tac international airport and arriving into Nashville TN international airport then getting a car rental and driving down to Memphis TN. At this point my husband feels it’s better if we just drive instead of flying.
 
SAMS said:
BNO Newsroom on Twitter

LISTEN LIVE: U.S. CDC provides update on coronavirus
Click to expand...

U.S. CDC provides update on coronavirus outbreak

(Video not working?)

—-

“Two patients with acute respiratory symptoms tested positive for the coronavirus Friday night at EvergreenHealth Medical Center in Kirkland, Washington, a suburb of Seattle. One of the patients has since died, and the other is in isolation. The state's health department has not confirmed details of the death, or whether the CDC confirmed the coronavirus screening test, but plans to announce more at a press conference Saturday afternoon.”

NPR:
First Person Dies Of Coronavirus In U.S.
February 29, 20201:06 PM ET

—-

“Vice President Mike Pence, who was appointed by Trump to lead the response to the coronavirus, said Saturday that the US would be imposing travel restrictions because of the spread of the virus, including banning any foreign national who has visited the country in the past 14 days.

The US will also enact travel warnings to Italy and South Korea.

"We are urging Americans to not travel to the areas in Italy and the areas South Korea," he said.”

Officials Have Confirmed The First Death From Coronavirus In The US

—-

“We are dealing with an emergency evolving situation,” Amy Reynolds of the Washington state health department told the Associated Press.

[...]

““I want to assure this family that they are in the hearts of every American,” Vice President Mike Pence, who was named as czar of the president’s coronavirus task force, said at the White House briefing.”

https://www.thenewstribune.com/news/state/washington/article240761641.html

—-

BetteDavisEyes said:
I watched the news conference and have breathed a huge sigh of relief :) After listening to the President, Vice President, and medical professionals who spoke during the presser, I feel confident that our government agencies are doing everything they can to curtail the spread of COVID-19. I'm not an alarmist by nature and didn't want to put my life on hold due to fear about possibly contracting the virus. At 70, I am a very healthy with no underlying medical issues other than mild allergic asthma that is under control with medication. In fact, I have not had an active asthma episode for almost two years! I will continue to observe recommended preventative measures like frequent hand washing, not touching face, avoiding contact with those who are symptomatic, etc., but I am not going to go into panic mode. I maintain a healthy diet, get plenty of rest, exercise regularly, and as previously mentioned, spend the majority of my time in my own home. I think the majority of Americans will be fine if they take common sense precautions to keep themselves healthy.
Click to expand...

:)
 
Last edited:
Betty P said:
CDC is supposed to be leading the way and setting standards and guidelines for this. It's a shame they're not getting this done.

ETA: CDC chief says deceased US patient may have contacted virus from "community spread" not travel.

BBM
Click to expand...
Dr Fauci has been told that he can no longer talk to the press and anything that does go out goes through the government administration. The pandemic response team had been let go in 2018. So I'm sure they all have jobs elsewhere by now.
I don't know if anyone has seen the 1918 Pandemic films. We had to watch them in Microbiology. 675,000 Americans died, 50 million worldwide. And it should be noted that the Spanish flu of 1918 had a similar mortality rate as the corona virus (2.3%). There were slip ups along the way with our troops becoming infected among other things which have been studied and led to new procedures and protocols. During the Spanish flu "Mortality was high in people younger than 5 years old, 20-40 years old, and 65 years and older. The high mortality in healthy people, including those in the 20-40 year age group, was a unique feature of this pandemic."
Dr Fauci says that vaccine is approximately a year out. Other reports say that a vaccine will be available in April and that the cost will be exorbitant.

"The Harvard epidemiology professor Marc Lipsitch is exacting in his diction, even for an epidemiologist. Twice in our conversation he started to say something, then paused and said, “Actually, let me start again.” So it’s striking when one of the points he wanted to get exactly right was this: “I think the likely outcome is that it will ultimately not be containable.”

Hopefully, this will be overblown. I'm sure we would all be ecstatic, but it is probably a good thing to prepare. Have prescriptions filled and enough essentials like food for at least 2 weeks. Stay healthy everyone.

You’re Likely to Get the Coronavirus
Why it’s too early to compare COVID-19 with the flu
1918 Influenza: the Mother of All Pandemics
1918 Pandemic (H1N1 virus) | Pandemic Influenza (Flu) | CDC
Did Trump Fire the US Pandemic Response Team?
 
margarita25 said:
New York State to Start COVID-19 Testing, Gov. Cuomo Says
Gov. Andrew Cuomo on Saturday morning tweeted that his office "just received word that our test has been approved by the FDA"
Published 3 hours ago • Updated 2 hours ago

New York State is ready to start testing for potential cases of the novel coronavirus, joining New Jersey and Connecticut, Gov. Andrew Cuomo said Saturday.

As of Friday, New York still didn't have permission from the Centers for Disease Control to begin testing, but Cuomo on Saturday morning said his office "just received word that our test has been approved by the FDA."


[...]

A New York City resident who recently came back from a trip to Italy is currently being tested for COVID-19, according to officials. After a sample was sent to Atlanta for testing on Thursday, it could be until well into the weekend before the city learns if it has its first confirmed case of the virus that the CDC says has killed more than 2,800 people worldwide.

The patient began exhibiting symptoms shortly after returning from a trip to Italy, where NBC News confirmed there are nearly 900 people infected, in addition to 21 deaths. Symptoms — which include fever, coughing and shortness of breath — are likely to appear as soon as two days after exposure, or up to two weeks later, according to the CDC.“
Click to expand...
I dreaded NYC news. My kids are there. Also most people use the subway or the bus. And trains in and out. It will surely spread. :(
 
Last edited:
CNN reporter saying 3 people who have coronavirus with no known origin. One is a 70 yo woman in a nursing home.

Agree w/ experts we need to be testing more. That's how we know who has it, how its being spread. Duh.
 
The silly “tips” emails are starting. An elderly friend forwarded this to me this morning. I googled and found nothing except a Greek news source discussing it as a rumor. Needless to say, I let her know this and cautioned her about spreading unverified information.

Unsourced email tips:

The new NCP coronavirus may not show sign of infection for many days, how can one know if he/she is infected. By the time they have fever and/or cough and goes to the hospital, the lungs is usually 50 % Fibrosis and it's too late!

Taiwan experts provide a simple self-check that we can do every morning:

Take a deep breath and hold your breath for more than 10 seconds. If you complete it successfully without coughing, without discomfort, stuffiness or tightness, etc.,it proves there is no fibrosis in the lungs, basically indicating no infection.

In critical times, please self-check every morning in an environment with clean air.

SERIOUS EXCELLENT ADVICE by Japanese Doctors treating COVID-19 cases:
Everyone should ensure your mouth & throat is moist, never DRY. Take a few sips of water every 15 mins at least. WHY? Even if the virus gets into your mouth...drinking water or other liquids will WASH them down through your oesophagus into the stomach. Once there in tummy...your stomach ACID will kill all the virus. If you don't drink enough water more regularly...the virus can enter your windpipes and into the LUNGS. That's very dangerous.

You may want to send and share with family, friends and everyone.
 
Status
Not open for further replies.

DNASolves

Who is DeKalb County John Doe (2022)?

Members online

... and 43 more.
Total: 2,092 (members: 44, guests: 2,048)

Online statistics

Members online
44
Guests online
2,048
Total visitors
2,092
Totals may include hidden visitors.

Forum statistics

Threads
602,245
Messages
18,137,448
Members
231,281
Latest member
omnia
Back
Top