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Not long ago, a poster told us how wrong it would have been to 'mooch' (a word which is, I believe, applied to beggars asking for money) COVID-19 test kits that were being freely offered to the US by the WHO, at a time when they would have been really helpful in locating infected people and hence slowing the spread of the disease.

When it came to vaccines (which are for all practical purposes a year to 18 months away from being available for practical use), I was confident (no doubt like most Americans) that the US bioscience establishment was at least as well able as scientists in other countries to develop such a vaccine in due course.

However, it does not seem that the President shares this confidence, but instead thinks the US would be better advised to seize control of research under development by a German company for the exclusive use of the US. See below.

Can this be true? If the President does not think that US bioscience companies are up to their jobs, I can understand why he might want to buy licenses to produce a vaccine delivered elsewhere, but what it the point of trying to buy 'exclusive rights', thereby preventing any other countries being able to use it?

Judging by the fact that news that the CEO of the German company concerned, "the US citizen Daniel Menichella, was unexpectedly leaving the firm and would be replaced by the company’s founder, Ingmar Hoerr", it does not seem as though the German Federal government is inclined to take this smash-and-grab raid lying down.

Trump offers 'large sums' for exclusive access to coronavirus vaccine

German government tries to fight off aggressive takeover bid by US, say reports

The Trump administration has offered a German medical company “large sums of money” for exclusive access to a Covid-19 vaccine, German media have reported.

The German government is trying to fight off what it sees as an aggressive takeover bid by the US, the broadsheet Die Welt reports, citing German government circles.

The US president had offered the Tübingen-based biopharmaceutical company CureVac “large sums of money” to gain exclusive access to their work, wrote Die Welt.

Trump was doing everything to secure a vaccine against the coronavirus for the US, the newspaper quoted an anonymous source, “but for the US only”.

The German government was reportedly offering its own financial incentives for the vaccine to stay in the country.

When approached about the report by the Guardian, the German health ministry would only confirm the accuracy of the quotes attributed to one of its spokespersons in the article.

“The federal government is very interested in vaccines and antiviral agents against the novel coronavirus being developed in Germany and Europe,” the spokesperson quoted in the article said. “In this regard the government is in an intensive exchange with the company CureVac.”

The German health ministry spokesperson declined the opportunity to correct any inaccuracies in Die Welt’s account.

With its headquarters in the south-western German city of Tübingen, CureVac also has sites in Frankfurt and Boston in the US. Linked with the German health ministry, it works closely with the Paul Ehrlich Institute, a research institution and medical regulatory body that is subordinate to the German health ministry.

On 11 March, CureVac released a statement that its CEO, the US citizen Daniel Menichella, was unexpectedly leaving the firm and would be replaced by the company’s founder, Ingmar Hoerr.

At the start of the month, Menichella was invited to the White House in Washington to discuss strategy for the rapid development and production of a coronavirus vaccine with Trump, the vice-president, Mike Pence, and members of the White House coronavirus task force.

The White House has been contacted for comment.

Delete.

https://www.theguardian.com/us-news/202 ... us-vaccine

It would help his re-election I am sure. Do you think he has altruistic motives.?

Wasn't he the one that turned down free German developed test kits offered early on by the WHO or is that just rumor?

I'm guessing that German media isn't going to cover this as, "Donald Trump takes unorthodox steps to provide Americans with protection against COVID-19" to prove how fair they are to Republicans.

Chap wrote:Not long ago, a poster told us how wrong it would have been to 'mooch' (a word which is, I believe, applied to beggars asking for money) COVID-19 test kits that were being freely offered to the US by the WHO, at a time when they would have been really helpful in locating infected people and hence slowing the spread of the disease.

Chap, did I pee in your cheerios at some point? Why lift something I said out of context for the sole purpose of taking a cheap shot. At the time, I was defending the CDC's decision to make its own test rather than use "WHO's free test."

What WHO actually does and the unfolding of testing of COVID-19 is fully accessible on WHO's website, but you have to be willing to sit down and read it. Here are the relevant events:

In it's first situation report on January 21, WHO stated that China announced discovery of the novel coronavirus that was eventually named SARS-CoV-2 on January 7. On January 12, it published the virus's genome. From that genome, PCR test kits could ultimately be made. https://www.who.int/docs/default-source ... 20a99c10_4

Who also posted a summary of the steps it had taken in response to discovery of the novel coronavirus. With regard to testing, WHO said:

WHO is working with our networks of researchers and other experts to coordinate global work on surveillance, epidemiology, modelling, diagnostics, clinical care and treatment, and other ways to identify, manage the disease and limit onward transmission. WHO has issued interim guidance for countries, updated to take into account the current situation.

WHO stockpiles equipment and supplies commonly needed to fight epidemics. But it can't stock PCR test kits, because a test kit for one virus isn't likely to work for another. WHO does not invent the tests. WHO does not make test kits. WHO does not make the reagents for the kits. (test kits are like your car; reagents are like the fuel that powers it. At test kit without reagents is essentially a paperweight.) Instead, WHO has a worldwide network of partners that make the materials for testing and do the necessary lab work for processing the tests. That network is called GOARN. The CDC is a member, as are many laboratories and institutions around the world. https://www.who.int/ihr/alert_and_respo ... etwork/en/ The WHO issues guidance and coordinates those efforts, making sure that things that are needed in member nations get where they are needed.

Many institutions in several countries around the world began to immediately work on designing tests. Those in seven countries published their test designs: China, Germany, Hong Kong, Japan, Thailand, France, and the US (CDC). Each protocol targeted a different part of the genome. This strategy makes sense to me, as the more test protocols there are, the lesser the change that they will all fail and the entire world won't be competing for the same reagents needed for the the same test. So, at the time it decided to design it own test, the US was doing exactly the same thing as the other six countries. https://www.who.int/emergencies/disease ... y-guidance

On January 21, the CDC announced the first confirmed case of the novel coronavirus in the U.S. It had tested the case with its own PCR test. Among the steps the CDC had taken were:

Developing a diagnostic test to detect this virus in clinical specimens, accelerating the time it takes to detect infection. Currently, testing for this virus must take place at CDC, but in the coming days and weeks, CDC will share these tests with domestic and international partners

So, as early as January 21, the CDC had a working PCR test and was testing samples at its lab.https://www.cdc.gov/media/releases/2020 ... -case.html The other six countries also developed working tests and published the results between January 17 and March 2. https://www.who.int/emergencies/disease ... y-guidance

On January 26, WHO's situation report added a link to a "Prepared disease commodity package for supplies necessary in identification and management
of confirmed patients." https://www.who.int/docs/default-source ... beaeee0c_4 You can download the package here: https://www.who.int/internal-publicatio ... irus-(ncov) As far as testing, the package said: "Laboratory confirmation of a COVID-19 case will trigger an thorough investigation. Because there currently is not a PCR test available testing may take several days or longer, WHO's recommended strategy is to begin an investigation immediately, thus requiring immediate operational support and supplies."

In other words, no WHO test.

On January 30, WHO declared the novel coronavirus to be a health emergency of international concern. It also described its efforts in regards to testing:

WHO has taken a three-pronged approach to enhance diagnostic capacity for 2019-nCoV:

1) Forming a network of specialized referral laboratories with demonstrated expertise in the molecular
detection of coronaviruses. These international labs can support national labs to confirm 2019-nCoV
cases and troubleshoot their molecular assays;

2) Strengthening national capacity for detection of 2019-nCoV so that diagnostic testing can be performed
rapidly without the need for overseas shipping. One way this has been achieved is through working with existing global networks for detection of respiratory pathogens such as, notably, the National Influenza Centers that support the Global Influenza Surveillance and Response System;

3) Ensuring test availability. This has involved a) screening of 2019-nCoV PCR protocols from academic laboratories for validation data (e.g. limits of detection, specificity), b) looking for sequence alignment of established commercial coronavirus assays (e.g. SARS) to see if any were likely to be able to detect 2019- nCoV with high sensitivity, and c) working with commercial and non-commercial agencies with capacity to manufacture and distribute newly-developed 2019-nCoV PCR assays. WHO will begin supporting its regional and country offices to make these tests available the first week of February 2020.

WHO is still not giving out kits. However, it will work with its network partners to help make tests available the first week of February. https://www.who.int/docs/default-source ... d0b2e480_2

Meanwhile, CDC is still testing using its own kits and making kits to send to the state laboratories and other countries.

On February 3, WHO announced that it was beginning to procure, assemble, and make available COVID "kits:"

Working with technical experts in health operations, WHO operational support and logistics has developed a “2019-nCoV kit”, similar to prepared treatment kits used for outbreaks of other high threat pathogens. In the coming days, the costing, procurement and assembly of these kits will be a priority.

https://www.who.int/docs/default-source ... f7347413_4

On February 5, WHO announced it's Strategic Preparedness and Response Plan. https://www.who.int/docs/default-source ... f7347413_4 The plan is available here: https://www.who.int/docs/default-source ... 022020.pdf

With respect to WHO's role in testing, the plan says:

WHO and partners will work to ensure the availability of tests, including through the screening validation of current academic and commercially available assays. WHO will work with commercial and non‐commercial agencies with the capacity to manufacture and distribute newly‐developed 2019‐nCoV molecular assays. WHO will begin supporting its regional and country offices to make these tests available from the first week of February 2020.

The plan also discusses the goal of developing the ability to process tests in country so that countries no longer have to ship test samples overseas. (Oversease shipment of samples was facilitated very early on for countries without adequate lab facilities.) To help meet that goal, the report said:

The Shipping Fund Programme established by the Global Influenza Surveillance and Response System will be used by countries as a mechanism to test clinical samples at international referral laboratories from patients who meet the suspect‐case definition. National capacity for detection of the novel coronavirus also needs to be strengthened so that diagnostic testing can be performed rapidly without the need for overseas shipping. One way this can be achieved
is by working with existing global networks for detection of respiratory pathogens, such as National Influenza Centres. Working with regional and national WHO laboratory focal points, WHO has compiled a global list of laboratories that have the technical capability to test for 2019‐nCoV but that lack the necessary reagents. WHO will procure and distribute testing kits to laboratories on this list that request reagents. The first shipment of kits will supply enough tests to screen 250 000 suspect cases.

So, still no WHO testing kits. But WHO explicitly explained which countries it would assemble kits for: labs that had the capability of processing tests, but did not have access to the reagents. At the time, the CDC was actually testing, and so doesn't appear to fall into that category. These appear to be the free WHO test kits that everyone is talking about.

On February 6, WHO listed 15 laboratories that were available to validate tests performed in other countries. Included in the list was the CDC. It also announced:

WHO is working to ensure 2019n-CoV test availability, including :a) screening of 2019n-CoV PCR protocols from academic laboratories for validation data, b) evaluation of the potential to use existing commercial coronavirus assays (e.g. SARS-CoV) to detect 2019-nCoV with high sensitivity, and c) working with commercial and non- commercial agencies with capacity to manufacture and distribute newly-developed 2019-nCoV PCR assays. To increase regional testing capacity, efforts to increase national capacity and provide regional reference laboratory support is ongoing. WHO has made 250,000 tests available to WHO Regional Offices and national laboratories. These tests are being shipped to 159 laboratories across all WHO regions.

So, WHO is shipping tests to laboratories that need the reagents in order to process tests. As far as I can tell, these are the "free WHO test kits" that the U.S. stupidly turned down.

What was the status of testing in the U.S. at that time? The day before the February 6 WHO statement that it was in the process of shipping kits, the CDC had announced that its testing kit was available for order by laboratories across the U.S. and the world:

A CDC-developed laboratory test kit to detect 2019 novel coronavirus (2019-nCoV) began shipping yesterday to select qualified U.S. and international laboratories. Distribution of the tests will help improve the global capacity to detect and respond to the 2019 novel coronavirus.

The test kit, called the Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCov) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel (CDC 2019-nCoV Real Time RT-PCR), is designed for use with an existing RT-PCR testing instrument that is commonly used to test for seasonal influenza.

The CDC 2019 novel coronavirus test is intended for use with upper and lower respiratory specimens collected from people who meet CDC criteria for 2019-nCoV testing. The test uses a technology that can provide results in four hours from initial sample processing to result.

“Our goal is early detection of new cases and to prevent further spread of the coronavirus,” said CDC Director Robert R. Redfield, M.D. “Distribution of these diagnostic tests to state laboratories, U.S. government partners and more broadly to the global public health community will accelerate efforts to confront this evolving global public health challenge.”

The test kit has not been FDA cleared or approved, however distribution and use of the test kits follows the U.S. Food and Drug Administration (FDA) February 4, 2020, issuance of an Emergency Use Authorizationexternal icon (EUA). The tests are being shipped through the International Reagent Resource (IRR)external icon, a CDC-established mechanism that distributes laboratory reagents domestically and globally.

Initially, about 200 test kits will be distributed to U.S. domestic laboratories and a similar amount will be distributed to select international laboratories. Each test kit can test approximately 700 to 800 patient specimens. Additional test kits will be produced and made available for ordering in the future from the IRR. At this time, each laboratory that places an order will receive one 2019-nCoV test kit.

The IRR is accepting orders for 2019-nCoV tests from qualified laboratories. This includes 115 qualified U.S. laboratories, such as state and local public health laboratories and Department of Defense (DoD) laboratories, as well as 191 qualified international laboratories, such as the World Health Organization (WHO) Global Influenza Surveillance Response System (GISRS) laboratories.

https://www.cdc.gov/media/releases/2020 ... -kits.html

So, the CDC decided to make its own test, just like labs did in six other countries, weeks before the WHO shipped test kits. It designed and produced a testing kit that worked, and was testing samples from the U.S. The WHO was telling countries that didn't have lab capacity to ship samples to the CDC for testing. And the CDC was making its kits available to qualified labs at the same time WHO was sending kits to labs around the world that needed the reagents to perform any testing at all.

So, Chap, can you or anyone else explain to me why it would have made any sense for the CDC -- at that point in time -- to say: Nevermind about our own test, which we've been using successfully to test samples and just announced was available to labs throughout the US and around the world. We're totally ditching all that and grabbing us some of those sweet, free WHO tests. (Sorry Bolivia and Angola -- I'm sure you can get some later.)

So, what went wrong? A week after the CDC made its test available, the CDC announced:

Now I’d also like to update you on our diagnostic test kits. As you know, this is a dynamic, rapidly evolving situation, and our response continues to be based on the latest science. We continue to be flexible to meet the public health challenges that the virus presents, and clearly a success is the CDC rapid development of a diagnostic and rapid deployments to the states, which was clearly important to try to bring the testing closer to patients to avoid delays that have been inherent in sending samples to CDC. When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories. Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct. During a response like this, we know things may not always go as smoothly as we would like. We have multiple levels of quality control to detect issues just like this one. We’re looking into all of these issues to understand what went wrong, and to prevent these same things from happening in the future

[/quote]

The CDC had a working test. But when the kits were shipped, some of them didn't pass the normal verification tests. Now, I suppose the CDC could have thrown up its hands at that point, screamed "we're doomed" and called up WHO. "Hello, WHO, this is the CDC. Yeah, that CDC. Say, we ran into a little problem with some of the test kits we shipped. Do you have any of those sweet, free kits that you shipped to other labs last week? Fix the kits or manufacture new ones? Oh, that would just be crazy. Can't you just give us the ones you were going to ship to Egypt? Or Sudan?"

I haven't been able to find when the WHO finished shipping the kits they obtained out. But, in my opinion, it was perfectly reasonable for the CDC to try and just fix the damn kits when it knew it had a test that worked just fine. If it had acquired a different test kit from another source, that kit would have had to be run through the FDA for approval, and the FDA wasn't moving with emergency speed.

Have any of these media stories quoted anyone from WHO saying "yeah, when we saw the CDC was having trouble with its test kits, we got on the horn to the President and offered to overnight ship a couple hundred test kits?" It's entirely possible I missed it. But i sure haven't seen anything approaching that.

Res Ipsa, thanks for that detailed explanation.

How was South Korea and other countries able to test tens of thousands of people per day? From what I understand SK is testing more than 20,000 per day now.

When 58 Utah Jazz players and personnel were tested by Oklahoma officials* that was half of their supply. That’s a stunningly low amount of kits for governmental health agencies.

* NBA teams are considered to be superspreaders for infectious diseases

- Doc

Icarus wrote:Res Ipsa, thanks for that detailed explanation.

How was South Korea and other countries able to test tens of thousands of people per day? From what I understand SK is testing more than 20,000 per day now.

You’re welcome.

Based on what I’ve read, there are a bunch of reasons. First, the SARS outbreak scared the crap out of them. They reacted by stockpiling metric buttloads of PPE and investing in infrastructure and equipment that would let them react quickly to future outbreaks. Like the US, they developed their own test. Unlike the US, there was no snag in early production.

They also knew fairly early on that the disease was spreading rapidly, starting with their infamous patient 31. They knew the specific religious group was actively spreading the virus, so they had a targeted population to trace and test.

Also, the supplies of PPE helped them right off the bat. Setting up a safe environment for testing is a significant problem. To keep the testing process itself from spreading the disease, you have to segregate people with symptoms from the other parents. You need to put them alone in a room with negative pressure and ventilation that goes straight outside. And, because the sampling process tends to make the patient cough or sneeze, the person taking the sample needs to wear PPE: gown, gloves, N95 respiratory mask, and goggles or face shield. And, to protect the next patient, you have to throw all that away and put on a clean set between every test.

When SK saw how fast they were burning through their large stockpile of gear, they went to the drive through testing. That lets them test without having to change the gear between every patient. China dealt with the testing problem by setting up “fever clinics,” where patients with symptoms would go to be tested. Both countries have more centralized government, so they were able to set up these systems fairly quickly.

SK is testing more widely than other nations. WHO, who are the pros at how to fight epidemics, doesn’t recommend mass testing of every one with symptoms. It recommends testing people with symptoms who had Close contact with another confirmed case or who recently traveled from a country with an outbreak. Otherwise, it recommends testing only patients in hospitals with severe respiratory symptoms and who have been treated and found negative for other causes.

That’s patient testing. WHO also recommends surveillance testing by incorporating COVID—19 testing into existing flu surveillance networks. Surveillance testing is how we find the prevalence of the disease in the general population. The US has a sophisticated flu surveillance system in place.

So, as I understand it, SK is going beyond WHO’s testing recommendations. We will have to see if it leads to a lower mortality rate when the dust is settled. It may change established procedures. But also keep in mind that SK has only tested about .5% of its population.

The US got off to a slower start because of the test kit snafu. That problem was compounded by the systems we have in place to try and make sure all medical tests are safe and effective. That’s the responsibility of the FDA. The FDA gave an emergency approval to one kit: the CDC’s.

The CDC originally controlled testing because it was the only lab with its kit. When the verification problem arose, the CDC worked on fixing the kits. Meanwhile, other US labs were sending their internally developed kits to the FDA for approval. For reasons that aren’t clear to me, the FDA treated these requests as standard requests for approval of medical tests. It did not use its authority to approve these other tests on the same emergency basis as it had with the CDC’s test.

I don’t know what everyone was thinking. I like to imagine meetings with people yelling at each other. Maybe the FDA thought the CDC could fix the test in a couple of days. Maybe they were lulled into a false sense of security by the travel ban or the fact they had contact traced the few cases they had found and had not found any cases of community transmission. I don’t know.

But it looks like to me that no one recognized a huge blind spot: no one seemed to ask “if the virus were circulating in our communities, what would the evidence look like and are we looking for that evidence? The obvious evidence would be people who are really sick with severe respiratory symptoms for which no cause can be identified. And they weren’t testing those cases unless they had close contact with a confirmed case or had recently traveled to China.

So, to me, it looks like both agencies thought they had more time than they actually did. So, the CDC went about trying to fix the kits and the FDA failed to use its emergency powers. So, our testing capacity stayed at what the CDC could process.

Only after evidence of community transmission surfaced did the two agencies act. The CDC offered a fix that it could have offered the first day. And the FDA began to use its emergency powers. At that point, the limiting factor changed from the availability of kits to testing capacity. Our state lab began testing instantly. But it has limited equipment, and could only test about 50 people a day. But then UW Virology received FDA approval and our capacity increased 10x.

But there was another problem. The President promised that every American would get tested with our beautiful tests. So, the CDC abandoned the WHO guidelines and punted to the discretion of individual doctors. That left the states and local health departments with no guidance at all on who should be tested as testing capacity began to increase. More importantly, the CDC provided no guidance to doctors and clinics for how to set up a safe testing environment.

Imagine being a doctor at this point. Every patient with cold or flu symptoms is now potentially infected with COVID-19. And it’s flu season. What do you do when Five patients call you the next morning with flu/COVID symptoms who want to be tested because the President said on TV that they could be tested with those beautiful tests? How do you set up part of your office for safe testing? How do you get ahold of the proper PPE? Who in your office has been given a fit test with an N95 mask? And no there were no instructions to do all this. In my area, there was total confusion. The local health department was scrambling around letting folks know what was required. And almost no one could do it. So the testing continues to e done where it has been done from the beginning — in hospitals. And because hospitals were not equipped to test large numbers of people with mild systems, they continued to test only those sick enough to be admitted for care.

So, the limiting factor in my area, I think, is lack of safe locations for testing. The UW has been soliciting samples from other states because they aren’t getting sufficient sufficient samples from Washington residents to keep them at capacity. As of a few days ago, the US had lab capacity to process tests for about 7500 people a day. But I’d bet we’re not using that capacity because of the safe location and other supply chain problems that have cropped up.

Which brings us to the ultimate limiting factor: PPE. The PPE used for testing is the same PPE used to protect the doctors and nurses who are caring for hospitalized COVID-19 patients. We don’t have enough PPE to test every American. We may not even have enough PPE to adequately protect doctors and nurses who will be providing care for the expected number of patients. One hospital here reported it was down to a four day supply of gloves. Another hospital employee reported they had run out of N95 respirators and were using less effective masks. We have one ER Doc in critical condition with COVID-19, and he won’t be the last. So, how much PPE should we use up testing people with mild symptoms?

TL/DR We have a decentralized public health system, which makes coordinated action difficult. Not enough of a sense of urgency early on. Politics getting in the way, resulting in a leadership vacuum that should have been filled by the CDC, plain old bad luck with the test kits, lack of infrastructure for safe testing, and not enough PPE. Result, slower rate of testing.

One more thing: the CDC had a plan for surveillance testing. It would have started Feb 14. But then, the kit snafu. Then every American gets tested. And the plan faded away.

Here’s an update of testing capacity in the US. Right now, US labs can process samples for 37,000 people per day. The limiting factor is likely kits, other needed supplies, reagents or safe testing sites.

ETA: Excellent article in the New Yorker on the testing roll out in the US https://www.newyorker.com/news/news-des ... -in-the-us

ETAA: Here's a fact-check of the claim that WHO offered the U.S. test kits and Trump declined them. https://www.politifact.com/factchecks/2 ... ejected-w/ According to the WHO spokesperson, no test kits were offered to the U.S.