“The coronavirus poses evolving risks to economic activity,” says Fed Chair Jay Powell in a statement posted on the central bank’s website. “We will use our tools and act as appropriate to support the economy.”
Stocks are bouncing off session lows, the S&P 500 now down 1.55% and Nasdaq 0.9%.
Amid fears of a looming pandemic, scientists in the US and across the
globe are scrambling to develop vaccines – including in Israel, where
one group of researchers says it could be ready in just three weeks and
available for use within 90 days.
The scientists at the Galilee Research Institute, known as MIGAL, are
adapting its vaccine against the avian coronavirus infectious
bronchitis virus, or IBV, to work for the novel coronavirus known as
COVID-19, the Jerusalem Post reported.
“Congratulations to MIGAL on this exciting breakthrough. I am
confident that there will be further rapid progress, enabling us to
provide a needed response to the grave global COVID-19 threat,” said
Ofir Akunis, Israel’s minister of science and technology.
The independent research institute, which specializes in the fields
of biotechnology, environmental sciences and agriculture, says on its
website that its team “includes 80 PhDs and a total of 260 researchers”
at 53 labs.
Its vaccine for IBV, a bronchial illness that affects poultry, has
already been proven in preclinical trials conducted at Israel’s
Veterinary Institute, according to the news outlet.
“Our basic concept was to develop the technology and not specifically
a vaccine for this kind or that kind of virus,” said Dr. Chen Katz,
MIGAL’s biotech group chief.
“The scientific framework for the vaccine is based on a new protein
expression vector, which forms and secretes a chimeric soluble protein
that delivers the viral antigen into mucosal tissues by self-activated
endocytosis, causing the body to form antibodies against the virus,” he
added.
Endocytosis is the process in which substances are brought into cells
by surrounding the material with membranes that form vesicles
containing the ingested material.
The researchers discovered that the poultry coronavirus is very
similar genetically to the human one — and that it uses the same
infection method, Katz said.
“All we need to do is adjust the system to the new sequence,” he
said. “We are in the middle of this process, and hopefully in a few
weeks we will have the vaccine in our hands. Yes, in a few weeks, if it
all works, we would have a vaccine to prevent coronavirus.”
The oral vaccine will have to go through a regulatory process, including clinical trials, he noted.
MIGAL CEO David Zigdon said the vaccine could “achieve safety approval in 90 days,” according to the Jerusalem Post.
“Given the urgent global need for a human coronavirus vaccine, we are
doing everything we can to accelerate development,” he added.
Akunis said he has instructed his ministry’s director-general to speed up all approval processes.
“We are currently in intensive discussions with potential partners
that can help accelerate the in-human trials phase and expedite
completion of final-product development and regulatory activities,” he
said.
In the US, Massachusetts-based drugmaker Moderna has sent its first
batch of an experimental vaccine – called mRNA-1273 — to the National
Institute of Allergy and Infectious Diseases for testing just six weeks
after it began working on it, according to CNN.
The biotech firm in Cambridge said the first vials of the
experimental product would be used in a planned Phase 1 study, which
involves testing on a small number of healthy people.
NIAID Director Anthony Fauci told CNN that a clinical trial could
start by the end of April, but the process of testing and regulatory
approvals would last at least a year.
He said this week that the approval process could be expedited after a
successful Phase 1 trial, but that even when proceeding at breakneck
speed, a vaccine would not be ready for use for at least a year or 18
months.
In Texas, meanwhile, scientists at the Baylor College of Medicine in
Houston who worked on a vaccine for SARS several years ago are working
on immunization against the novel coronavirus, or COVID-19.
“We know that virus is 80 percent similar to the current SARS-2 virus
that causes COVID-19, but at the same time, we’re also engineering a
potentially new vaccine that will be much more specific against the
COVID-19,” Dr. Maria Bottazzi of the Center for Vaccine Development at
Baylor told ABC 13.
Dr. Kathryn Stephenson, a Harvard Medical school professor and head
of of the clinical trials unit for the Center for Virology and Vaccine
Research at Beth Israel Deaconess Medical Center, told the Boston Globe
that vaccines must undergo extensive testing with progressively larger
groups of people.
“You can make a vaccine, but you’re not going to put that into humans
until you’re pretty confident in your product,” said Stephenson, whose
center also is working on a coronavirus vaccine.
Other companies rushing to develop a vaccine include Inovio, GlaxoSmithKline, Sanofi and Johnson & Johnson.
Meanwhile, Israeli company BATM said Thursday it has developed a
quick diagnostic kit to test for the coronavirus — and that production
was underway at a facility in Rome owned by Adaltis, which produces
medical testing devices, the Times of Israel reported.
Glaukos (NYSE:GKOS) tumbled as much as 35%,
to its lowest point since August 2018, after issuing soft guidance for
2020 sales and JPMorgan downgraded its shares to Neutral from
Overweight.
All Americans, regardless of political party, want access to timely,
high-quality health care. The question is how to get there. Do we
harness the power and innovation of the private sector, or do we hand it
to the government and hope for the best?
Canada has chosen the latter route, and at one of the most recent
debates among Democratic presidential candidates, Sen. Bernie Sanders
once again touted its government-run health care system as a model for
America.
Alas, Sanders’ sanitized version of Canadian health care doesn’t remotely fit the facts.
No more out-of-pocket expenses? In reality, Canadians’ out-of-pocket
health costs are nearly identical to what Americans pay — a difference
of roughly $15 per month. In return, Canadians pay up to 50% more in
taxes than Americans, with government health costs alone accounting for
$9,000 in additional taxes per year. This comes to roughly $50 in
additional taxes per dollar saved in out-of-pocket costs.
Keep in mind these are only the beginning of the financial hit from
“Medicare for all.” Canada’s public system does not cover many large
health costs, from pharmaceuticals to nursing homes to dental and
vision.
As a result, public health spending in Canada accounts for only 70%
of total health spending. In contrast, “Medicare for all” proposals
promise 100% coverage. This suggests the financial burdens on Americans,
and distortions to care, would be far greater than what Canadians
already suffer.
Canada’s limited coverage may surprise Americans, but the key is
understanding what “universal” means in “universal care.” Universal
systems mean everybody is forced to join the public system. It
emphatically does not mean everything is free. Indeed, out-of-pocket
costs are actually significantly higher in Sweden, Denmark and Norway
than they are in America.
More serious than the financial burdens is what happens to quality of
care in a government-run system. Canada’s total health costs are about
one-third cheaper than the United States as a percent of gross domestic
product, but this is achieved by undesirable cost-control practices. For
example, care is ruthlessly rationed, with waiting lists running into
months or years.
The system also cuts corners by using older and cheaper drugs and
skimping on modern equipment. Canada today has fewer MRI units per
capita than Turkey or Latvia. Moreover, underinvestment in facilities
and staff has reached the point where Canadians are being treated in
hospital hallways.
Predictably, Canada’s emergency rooms are packed. In the province of
Quebec, wait times average over four hours, leading many patients to
just give up, go home and hope for the best.
Seeing a specialist can take a shockingly long time. One doctor in
Ontario called in a referral for a neurologist and was told there was a
four-and-a-half year waiting list. A 16-year-old boy in British Columbia
waited three years for an urgent surgery, during which his condition
worsened and he was left a paraplegic. One Montreal man finally got the
call for his long-delayed urgent surgery, but it came two months after
he had died.
Canadians have found a way to escape the rationing, the long waits and substandard equipment. They go to the United States.
Every year, more than 50,000 Canadians fly to get their surgeries
here because they can get high-quality care and fast treatment at a
reasonable price. They willingly pay cash for care that, for the vast
majority of Americans, is covered by insurance, private or public.
Far from being a model of government-run health care, Canada serves
as a warning of the unintended consequences of socialized medicine: high
taxes, long waits, staff shortages and substandard drugs and equipment.
Those suffering the most are the poor, who cannot afford to fly abroad
for timely treatment. Far from the feel-good rhetoric, socialized
medicine in Canada has proved a bait-and-switch that has never lived up
to the promise.
In Washington today, there are very sound proposals on the table to
reduce health care costs. They include reforms to assure price
transparency, increase competition and repeal price-hiking mandates.
That is the best way forward.
Canada’s system of socialized medicine has created high taxes and suffering patients. That’s not what Americans want or deserve. Peter St. Onge is the senior economist at the Montreal Economic
Institute and author of the recent Heritage Foundation report “How
Socialized Medicine Hurts Canadians and Leaves Them Worse Off
Financially.” https://www.burlingtoncountytimes.com/opinion/20200227/opinion-canadian-health-care-warning-not-beacon
The new COVID-19 coronavirus case in California, announced by CDC
late Wednesday, appears to involve someone who was already in the
healthcare system, perhaps with active disease.
A statement released by UC Davis Medical Center in Sacramento,
California, noted the patient was transferred from another northern
California hospital with “suspected viral infection,” and care teams
took appropriate infection prevention precautions.
“Upon admission, our team asked public health officials if this case could be COVID-19.
We requested COVID-19 testing by the CDC, since neither Sacramento
County nor the California Department of Public Health is doing testing
for coronavirus at this time. Since the patient did not fit the existing
CDC criteria for COVID-19, a test was not immediately administered,” UC
Davis Medical Center said. CNN reported the patient was admitted to the hospital on Feb. 19,
but a test was not ordered by the CDC until Feb. 23. The patient was
then put on airborne precautions and strict contact precautions. The
test was confirmed positive on Wednesday.
UC Davis also confirmed they are asking “a small number of employees
to stay home and monitor their temperature,” out of an abundance of
caution.
The patient is reportedly a resident of Solano County, according to CNN, which is where Travis Air Force Base is located. A number of repatriated citizens from the Diamond Princess cruise ship are currently under quarantine there, and in the last week, four new cases of coronavirus have been confirmed from this group, according to ABC 10. These patients are receiving treatment at local area hospitals. https://www.medpagetoday.com/infectiousdisease/publichealth/85114
Third time’s the charm for Acacia Pharma.
The Cambridge, UK-based company on Thursday finally secured FDA
approval for its treatment for patients with postoperative nausea &
vomiting (PONV), who are symptomatic despite having received
prophylactic treatment.
The drug, an intravenous formulation of the selective dopamine D2 and
D3 antagonist amisulpride, was shown to help patients in four positive
pivotal clinical trials by 2017. But manufacturing troubles repeatedly
hobbled the company’s quest to get the therapy — branded Barhemsys — on
to the US market.
In late 2017, Acacia submitted an FDA application to market the drug —
designed to help the 30-40% of surgical patients who suffer from PONV
despite prior prophylaxis, as well as for combination prophylaxis in
high-risk patients — only to receive a rejection in October 2018.
The US agency made its decision based on a pre-approval inspection of
a facility run by the contract manufacturer of the drug’s main
ingredient — amisulpride — and not on clinical or non-clinical data in
the application, assured Acacia in a press release, adding that the FDA
had asked for no extra studies or data analyses related to the
treatment.
Julian Gilbert
With renewed enthusiasm later that month, Acacia’s contract
manufacturer had agreed to “institute a corrective and preventive action
plan that will rectify the deficiency identified as quickly as
possible. We continue to plan for a launch in the first half of 2019,”
Acacia chief Julian Gilbert said in a statement.
Acacia then resubmitted its marketing application in December,
indicating that the FDA’s concerns outlined in the complete response
letter had been resolved. But in May 2019, the company received another
rejection, with the FDA flagging the same concerns.
“We are on track to complete the qualification of an alternative
supplier of amisulpride and plan to engage with FDA as soon as possible
to determine the most rapid route to obtaining approval,” Gilbert said
in a statement at the time.
Now with the approval in tow, Acacia said it expects to launch the therapy in the second half of this year.
Acacia Pharma’s second product, remimazolam injection, is currently under review by the FDA for use in procedural sedation.
Around 10 PM ET last night, the FDA said that it is aware of a drug
shortage related to an active pharmaceutical ingredient (API)
manufacturer affected by the coronavirus, but the agency stopped short
of revealing what drug it is.
“The shortage is due to an issue with manufacturing of an active
pharmaceutical ingredient used in the drug. It is important to note that
there are other alternatives that can be used by patients. We are
working with the manufacturer as well as other manufacturers to mitigate
the shortage. We will do everything possible to mitigate the shortage,”
FDA Commissioner Stephen Hahn said in a statement.
An FDA spokesperson also confirmed to Focus that the agency cannot
disclose the drug in shortage “as it is confidential commercial
information.”
But she also explained why the FDA is in a difficult position with respect to such shortages and keeping the public informed.
“While manufacturers are legally required to report drug supply
disruptions to FDA, they are not required to provide the detailed
information on their supply chain that we have needed to monitor the
drug supply since the onset of the outbreak,” the spokesperson said. “We
need the cooperation of the drug companies in order to obtain accurate
information as we proactively take steps to mitigate drug shortages, and
companies will be less willing to provide this voluntary information if
they cannot trust FDA not to disclose commercial confidential
information such as drug names, company names or exact location of
facilities.”
Although it may be difficult to ascertain which drug is affected,
recently added drug shortages to FDA’s list include Allergan’s treatment
for complicated intra-abdominal infections, Avycaz (ceftazidime and
avibactam), Mylan’s blood pressure drug pindolol 10mg (and Sun
Pharmaceutical provides the same drug), and Pfizer’s chemotherapy
fludarabine phosphate for injection.
Allergan told Focus in a statement: “We are experiencing an out of
stock situation for AVYCAZ (ceftazidime and avibactam) for injection
(2.5g) as we await regulatory approval on a new third-party
manufacturer, which will ultimately allow us to continue our supply in
the U.S. This situation is not related to any product or safety issue.
All currently available AVYCAZ supply is unaffected and not at risk for
recall…To be clear our recent drug shortage of AVYCAZ is not related to
the coronavirus.”
The reasoning behind Mylan and Sun’s shortages is listed as “shortage
of active ingredient,” and Mylan did not respond to a request for
comment.
And for fludarabine, the FDA listing says discontinuation of the
manufacture of the drug is due to API supplier market exit. The current
supply is expected to be exhausted next August.
A Pfizer spokesperson told Focus the shortage “is completely
unrelated and pre-dates the outbreak…The majority of our finished
product and active pharmaceutical ingredient are sourced from countries
other than China. To date, we have not seen a disruption to our supply
as a result of the virus.”
