The U.S. Centers for Disease Control and Prevention (CDC) said earlier today that coronavirus testing is now available in 78 state and local laboratories across all 50 states.
The agency has 75K test kits for public lab use
with more available soon according to Dr. Nancy Messonnier, director of
the CDC’s immunization and respiratory diseases unit.
Most of the testing will likely be done in the
private sector (all major reference labs are now online). The FDA will
allow the use of laboratory-developed tests (LDTs) as long as they are
verified by the CDC, while they wait for Emergency Use Authorization.
According to Johns Hopkins University, the number
of U.S. cases is now 560, although the number should spike since testing
is now widely available (in other words, the U.S. infection rate has
been underreported due to the paucity of COVID-19 tests).
People who contract the novel coronavirus
emit high amounts of virus very early on in their infection, according
to a new study from Germany that helps to explain the rapid and
efficient way in which the virus has spread around the world.
At the same time, the study
suggests that while people with mild infections can still test positive
by throat swabs for days and even weeks after their illness, those who
are only mildly sick are likely not still infectious by about 10 days
after they start to experience symptoms.
The study, by scientists in Berlin and Munich, is one of the first
outside China to look at clinical data from patients who have been
diagnosed with Covid-19, the disease caused by the coronavirus, and one
of the first to try to map when people infected with the virus can
infect others.
It was published Monday on a preprint server, meaning it has not yet
been peer-reviewed, but it could still provide key information that the
public health response has been lacking.
“This is a very important contribution to understanding both the
natural history of Covid-19 clinical disease as well as the public
health implications of viral shedding,” said Michael Osterholm, director
of the University of Minnesota’s Center for Infectious Diseases
Research and Policy.
The researchers monitored the viral shedding of nine people infected
with the virus. In addition to tests looking for fragments of the
virus’s RNA, they also tried to grow viruses from sputum, blood, urine,
and stool samples taken from the patients. The latter type of testing —
trying to grow viruses — is critical in the quest to determine how
people infect one another and how long an infected person poses a risk
to others.
Importantly, the scientists could not grow viruses from throat swabs
or sputum specimens after day 8 of illness from people who had mild
infections.
“Based on the present findings, early discharge with ensuing home
isolation could be chosen for patients who are beyond day 10 of symptoms
with less than 100,000 viral RNA copies per ml of sputum,” the authors
said, suggesting that at that point “there is little residual risk of
infectivity, based on cell culture.”
Public health officials and hospitals have been trying to make sense
of patients who seem to have recovered from Covid-19 but who still test
positive for the virus based in throat swabs and sputum samples. In some
cases, people test positive for weeks after recovery, the World Health Organization has noted.
Those tests are conducted using PCR — polymerase chain
reaction — which looks for tiny sections of the RNA of the virus. That
type of test can indicate whether a patient is still shedding viral
debris, but cannot indicate whether the person is still infectious.
The researchers found very high levels of virus emitted from the
throat of patients from the earliest point in their illness —when people
are generally still going about their daily routines. Viral shedding
dropped after day 5 in all but two of the patients, who had more serious
illness. The two, who developed early signs of pneumonia, continued to
shed high levels of virus from the throat until about day 10 or 11.
This pattern of virus shedding is a marked departure from what was
seen with the SARS coronavirus, which ignited an outbreak in 2002-2003.
With that disease, peak shedding of virus occurred later, when the virus
had moved into the deep lungs.
Shedding from the upper airways early in infection makes for a virus
that is much harder to contain. The scientists said at peak shedding,
people with Covid-19 are emitting more than a 1,000 more virus than was
emitted during peak shedding of SARS infection, a fact that likely
explains the rapid spread of the virus. The SARS outbreak was contained
after about 8,000 cases; the global count of confirmed Covid-19 cases
has already topped 110,000.
Osterholm said the data in the paper confirm what the spread of the
disease has been signaling — “early and potentially highly efficient
transmission of the virus occurs before clinical symptoms or in
conjunction with the very first mild symptoms.”
The study also looked at whether people who have been infected shed infectious virus in their stool. The report
of last month’s international mission to China — co-led by the WHO and
China — said that in several case studies in China, “viable virus” had
been recovered from stool but that isn’t likely driving transmission of
the virus.
The German researchers found high levels of viral fragments in 13
stool samples from four patients in their study, but they were unable to
grow virus from any of them. The paper noted, though, that all the
patients had mild illness, and the fact that they could not find virus
in their stool doesn’t rule out that it could happen in other cases.
“Further studies should therefore address whether SARS-CoV-2 shed in
stool is rendered non-infectious though contact with the gut
environment,” they wrote, adding that their findings suggest measures to
try to stop spread of the virus should focus on respiratory tract
transmission — protecting others from the coughs and sneezes of people
infected with the virus.
Virus could not be grown from blood or urine samples taken from the patients, the authors reported.
The study also noted that people who are infected begin to develop
antibodies to the virus quickly, typically within six to 12 days. The
rapid rise of antibodies may explain why about 80% of people infected
with the virus do not develop severe disease.
Even as companies rush to develop and test vaccines against the new
coronavirus, the Bill and Melinda Gates Foundation and the National
Institutes of Health are betting that scientists can do even better than
what’s now in the pipeline.
If, as seems quite possible, the Covid-19 virus becomes a permanent
part of the world’s microbial menagerie rather than being eradicated
like the earlier SARS coronavirus, next-gen approaches will be needed to
address shortcomings of even the most cutting-edge vaccines: They take
years to develop and manufacture, they become obsolete if the virus
evolves, and the immune response they produce is often weak.
With Gates and NIH funding, the emerging field of synthetic biology
is answering the SOS over Covid-19, aiming to engineer vaccines that
overcome these obstacles. “It’s all of us against the bug,” said Neil
King of the University of Washington, who has been part of the hunt for a
coronavirus vaccine since 2017.
Although the Gates Foundation is spreading its bets among several
cutting-edge vaccine platforms, including those using genetic material,
one based on synthetic biology has real promise. “We may need an
approach that can get you millions and even billions of doses,” said
immunologist and physician Lynda Stuart, who directs the foundation’s
vaccine research. Gates announced last month that it will funnel $60 million to Covid-19 research, including vaccines.
A vaccine created through the tinkering of synbio looks not only
scalable to a level of billions but also like it will work without the
need for refrigeration. All that, Stuart said, “will be super important
to protect people from coronavirus who are otherwise left behind, such
as those in sub-Saharan Africa.”
King and his synbio colleagues knew there would be another
coronavirus epidemic, like the SARS and MERS outbreaks before this one,
he said, “and there will be another one after this,” perhaps from yet
another member of this virus family. “We need a universal coronavirus
vaccine.”
Achieving that is so high on scientists’ to-do list that when
President Trump visited NIH last week, his tour included the lab that’s
collaborating with UW’s, and researchers showed him a mock-up of what
synthetic biology can do: Design and build nanoparticles out of proteins
and attach viral molecules in a repetitive array so that, when the
whole thing is packed into a vaccine, it can make people resistant to
the new coronavirus. (The human immune system has evolved to interpret
repetitive arrangements of molecules as a sign of danger: bacterial cell
walls have repetitive chemical groups on them.)
With a few tweaks, the nanoparticle can be studded with molecules
from additional coronaviruses to, scientists hope, protect against all
of them — the original SARS virus, MERS, and, crucially, a mutated form
of the Covid-19-causing virus, called SARS-CoV-2.
Even compared to the DNA and RNA vaccines against Covid-19 that
Moderna Therapeutics, CureVac, and Inovio Pharmaceuticals are speeding
toward human testing, the synbio approach has advantages. These companies’
experimental vaccines contain synthetic (that is, lab-made) strands of
RNA or DNA that code for protein molecules on the virus’s surface. Once
the vaccine delivers the genetic material into cells, the cells follow
the genetic instructions to churn out the viral protein. The idea is
that the body would see that as foreign, generate antibodies to it, and
if all goes well thereby acquire immunity to the virus. But safety tests
of mRNA vaccines have turned up adverse events, and it’s not clear how potent they’ll be. Moderna plans to begin safety testing in healthy volunteers next month.
With all due respect to nature, synthetic biologists believe they can
do better. Using computers, they are designing new, self-assembling
protein nanoparticles studded with viral proteins, called antigens:
these porcupine-like particles would be the guts of a vaccine. If tests
in lab animals of the first such nanoparticle vaccine are any
indication, it should be more potent than either old-fashioned viral
vaccines like those for influenza or the viral antigens on their own
(without the nanoparticle).
The first step toward the molecule that was presented to Trump is to “play Legos with proteins,” as King put it.
That starts with the nanoparticle — the body of the porcupine. Its
shape and composition must be such that the protein’s building blocks
not only spontaneously self-assemble and stick together but also turn
into something that can display the viral antigens in a way the immune
system will strongly respond to. Using a computational protein-design
algorithm, scientists might determine that, for instance, a nanoparticle
25 nanometers across and made of 60 identical pieces is ideal for
presenting the antigens sotheir most immunity-inducing side faces
outward, where the immune system can most easily “see” it.
“We might try 1 million variants on the computer” before finding the
optimal shape and protein composition, meaning which protein sequence
will spontaneously form the ideal nanoparticle, King said.
The next step is to take lab-made DNA that codes for the designed
protein, stick it into E. coli bacteria, and wait for the bugs to follow
the genetic instructions, manufacturing the desired protein like a
tiny, living assembly line. Extracted from the bacteria, purified, and
mixed together in a test tube, the proteins spontaneously self-assemble
into the bespoke nanoparticle.
“When it works, we get exactly the protein we designed by computer, with every atom where we want it,” King said.
The next step is to stick the quills onto the porcupine. For the
virus that causes Covid-19, the quills are the “spike protein,” a
molecule that fits into receptors on cells and ushers the virus inside.
Scientists led by UW’s David Baker predicted the structure of this antigen from the virus’s genome, and scientists at the University of Texas, Austin, and NIH confirmed it with a Nobel-winning form of electron microscopy.
King and his colleagues then scrutinize the spike protein to see
which part of it might work best in a vaccine and how to position
multiple copies of it. “It turns out that if you stick 20 of them onto
your nanoparticle in an ordered, repetitive array, you can get a
stronger immune response than with the [spike] protein alone,” Baker
said — another reason why the nanoparticle approach might prove more
effective than RNA and DNA vaccines. NIH and the UW groups have begun
testing the antigen-studded nanoparticles in mice to see what kind of
immune response they trigger.
Making nanoparticles the core of a vaccine “does a number of useful
things,” Stuart said. It reduces or eliminates the need for an adjuvant,
an ingredient that boosts the immune response; the nanoparticle is
enough on its own. Sticking antigens on it makes the whole complex so
tolerant of heat (“you could almost boil it,” Stuart said) that
refrigeration isn’t necessary, a crucial feature for vaccines to be
deployed in resource-poor countries. And because the nanoparticle can be
studded with antigens from several viruses, she said, “you could get a
pan-coronavirus vaccine.”
They’re cautiously optimistic because of a recent success. An
experimental vaccine against respiratory syncytial virus (RSV), the main
cause of pneumonia in children, is also made of a computer-designed
nanoparticle that self-assembles from protein building blocks and is
studded with an engineered version of RSV’s key antigen. When tested in
mice and monkeys, it produced 10 times more antibodies than an
experimental RSV vaccine based on traditional technology, King’s team reported last year in Cell. The Seattle biotech start-up Icosavax is moving the vaccine toward clinical trials. (King chairs its scientific advisory board.)
It was the first time the structure and other characteristics of an
antigen had been designed at the atomic level and incorporated into a
vaccine, scientists at vaccine giant GSK wrote, hailing the work as “a quantum leap” in vaccine design.
The Gates Foundation, in addition to supporting the research, is
working to pair the scientists with manufacturers, Stuart said: “We want
to identify the people who can manufacture these at scale.”
As Covid-19 spreads, “scale” is looking larger than anyone imagined.
New York’s jailbirds are helping to combat the coronavirus.
Gov. Cuomo on Monday unveiled what he called the state’s weapon
against despicable price-gougers taking advantage of coronavirus fears —
a new hand sanitizer produced by New York prison inmates.
Cuomo said the “superior product” is not only cheaper than brands
made by greedy commercial businesses but also will be ready available to
New York governments, the MTA, schools and even the prisons where it’s being made.
“It’s much cheaper for us to make it ourselves than to buy it on the
open market,” said Cuomo, adding that a gallon jug of the state-produced
product costs $6 to make.
It has a “floral bouquet” fragrance, the governor added.
Corcraft, the state Corrections Department’s manufacturing service
fueled by inmate workers, is manufacturing the sanitizer, Cuomo said.
He said that while the CDC recommends products with 60 percent
alcohol and private manufacturers such as Purell contain 70 percent, New
York’s version is 75 percent.
He said the state will be churning out 100,000 gallons a week and then ramp up production as needed. https://nypost.com/2020/03/09/coronavirus-in-ny-cuomo-unveils-states-hand-sanitizer-made-by-prisoners/
Swiss customs officers began examining Italian commuters’ Swiss work
permits on Monday and Austria readied spot health checks of people
crossing its southern border in an effort to contain the coronavirus.
Italy, which is the worst-hit European nation, has imposed a virtual
lockdown on the northern region of Lombardy and parts of neighboring
Veneto.
In a new measure, the Swiss government required Italians who work in
Switzerland to show papers proving they have a job before entering. The
customs agency said it was using spot checks and “risk-based” border
controls.
But Italians will not be prevented from working in Switzerland, a
decision that is important for the economy of the Italian-speaking
southern canton of Ticino, where more than 70,000 Italian cross-border
commuters hold work permits.
Nearly 4,000 work in the canton’s health care system, Swiss media
say. “This should ensure the continued functioning of the Ticino health
system,” the Swiss government said.
Bern has told Swiss residents not to go to affected regions in
northern Italy but the border remains open for goods and international
trains have been operating largely on schedule.
“If the situation degenerates we would accept with pain other
measures but, even though there are some difficulties at customs, the
situation is manageable,” the head of Ticino’s chamber of commerce, Luca
Albertoni, told broadcaster RTS.
Switzerland has reported 312 confirmed cases of the COVID-19 so far and two deaths. Austria has reported 131 confirmed cases.
BUYING TIME
Under Austria’s new measures, mobile health check teams will from
Tuesday check travelers in the Brenner pass region and other crossing
points.
“Our goal remains to contain the coronavirus as long as and as well
as possible to prevent more people falling ill and thus buy time until
there is an effective therapy against the virus,” said the governor of
Tyrol province, Guenther Platter.
Carinthia province said it would conduct “fever checks” at the
border, while the Red Cross had begun mobile throat swabs by specially
trained medics.
Slovenia will start health checks at the Ljubljana airport and is
preparing to do so at the Italian border, Health Minister Ales Sabeder
said. He did not say when they would start.
Croatia said people arriving from the areas mostly affected —
including northern Italy, South Korea, China, and Iran — would have to
go into quarantine for 14 days.
In the French ski resort of Montgenevre, close to the border with
Italy, the number of visitors were normal at the weekend. Local
officials did not plan any specific measures for the moment.
Austria’s state rail operator, OeBB, said staff now get off at the
border with Italy instead of going to the final destination. The same
applies to Italian trains heading north.
The head of the Port Authority — who has been visiting local airports — has the coronavirus, Gov. Andrew Cuomo said Monday.
Cuomo said he himself “could have been in contact” with infected PA
Executive Director Rick Cotton but hasn’t been tested because he’s an
“improbable positive,” meaning he isn’t likely to have the virus.
The governor didn’t say how Cotton may have contracted the
potentially deadly bug but noted that the executive director “has been
at the airports, obviously, when many people were coming back with the
virus.
Cuomo specifically mentioned JFK Airport in Queens.
Cotton “will be working from home, and now the senior team that works
with Rick will also be tested so several of them may be on quarantine
and they’ll be working from home,” Cuomo said.
The PA chief and his “senior leadership team” are under a 14-day quarantine, officials later added.
Cuomo also revealed that the state total of confirmed coronavirus cases is now at 142, or 37 more than Sunday.
They include at least six more in New York City and an additional 37
in Westchester County, which is currently the hardest-hit area in the
state.
“These numbers are going to continue to go in one direction — and that is up,” Cuomo warned. https://nypost.com/2020/03/09/coronavirus-in-ny-head-of-port-authority-rick-cotton-has-coronavirus/
As New York Gov. Andrew Cuomo declares a state of emergency amid a spike in coronavirus cases, the state’s attorney general, Letitia James, is going after a Chrisitan televangelist for “false advertising.”
A guest of The Jim Bakker Show on Feb. 12, Sherrill
Sellman, was asked if the “Silver Solution,” sold for $125 on his
website, would be effective against the coronavirus.
“Let’s say it hasn’t been tested on this strain of the coronavirus,”
Sellman, a naturopathic doctor, is quoted as saying, “but it’s been
tested on other trains of the coronavirus and has been able to eliminate
it within 12 hours.”
Lisa Landau sent a “cease and desist” letter to Bakker, who has
previously served jail time for federal fraud and conspiracy charges in
the 90s, on March 3 giving him 10 business days to comply or possibly
face a fine of $5,000 per violation.
“Your show’s segment may mislead consumers as to the effectiveness of
the Silver Solution product in protecting against the current
outbreak,” Landau wrote.
The World Health Organization said there is no known FDA approved
medicine or vaccine able to prevent or treat COVID-19 at this time.
“As we experience more cases of coronavirus, it is imperative that
New Yorkers remain calm, but stay vigilant,” the attorney general said
in a statement.
“In addition to being mindful about our health, we must also beware
of unscrupulous actors who attempt to take advantage of this fear and
anxiety to scam or deceive consumers. I encourage anyone who believes
they are the victim of a scam or predatory action to contact my office
and file a complaint,” she added.
Bakker served five years of a 45-year sentence for stealing millions
from his ministry, The Praise the Lord Club. He was also accused of
raping Jessica Hahn, a church’s secretary, in the 1980s. Bakker
testified that he had been set up, arguing that sex with Hahn was
consensual. https://www.foxnews.com/us/new-york-televangelist-jim-bakker-silver-solution-coronavirus