MESSAGE
| DATE | 2020-09-06 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout - NYLXS] Vaccine testing being dragged out
|
https://www.wsj.com/articles/covid-19-vaccine-developers-prepare-joint-pledge-on-safety-standards-11599257729?mod=hp_lead_pos2
someone believes in the COVID-19 Vaccine. I honestly believe this is an
anti-Trump political manuvuer which is willing to kill millions of us to
assert political will.
the main focus of these companies need to be to get a vaccine out while
millions suffer lock downs, closed schools, and increasing suicide
rates. There is just no excuse.
"A draft of the joint statement, still being finalized by companies
including Pfizer Inc., PFE -0.11% Johnson & Johnson JNJ -0.64% and
Moderna Inc. MRNA -3.45% and reviewed by The Wall Street Journal,
commits to making the safety and well-being of vaccinated people the
companies’ priority. The vaccine makers would also pledge to adhere to
high scientific and ethical standards in the conduct of clinical studies
and in the manufacturing processes."
Translation: They are dragging there ass and we are never getting a
vaccine no matter the damage.
See this for a reference:
https://www.washingtonpost.com/history/2020/03/07/vaccines-self-testing-polio-salk-coronavirus/
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wsj.com
Covid-19 Vaccine Developers Prepare Joint Pledge on Safety, Standards
Peter Loftus and Jared S. Hopkins
8-10 minutes
Several drug makers developing Covid-19 vaccines plan to issue a public
pledge not to seek government approval until the shots have proven to be
safe and effective, an unusual joint move among rivals that comes as
they work to address concerns over a rush to mass vaccination.
A draft of the joint statement, still being finalized by companies
including Pfizer Inc., PFE -0.11% Johnson & Johnson JNJ -0.64% and
Moderna Inc. MRNA -3.45% and reviewed by The Wall Street Journal,
commits to making the safety and well-being of vaccinated people the
companies’ priority. The vaccine makers would also pledge to adhere to
high scientific and ethical standards in the conduct of clinical studies
and in the manufacturing processes.
The companies might issue the pledge as soon as early next week,
according to two people familiar with the matter. The statement would
join a growing number of public assurances by industry executives that
they aren’t cutting corners in their rapid testing and manufacturing of
the vaccines.
“We believe this pledge will help ensure public confidence in the
Covid-19 vaccines that may ultimately be approved and adherence to the
rigorous scientific and regulatory process by which they are evaluated,”
the draft statement says.
It’s far from business as usual at the Indianapolis headquarters of Eli
Lilly, with only a sixth of the pharma company’s employees working
on-site to develop potential Covid-19 treatments. WSJ’s Peter Loftus
takes us inside. Photo: Eli Lilly
Many Americans are skeptical or hesitant about taking a Covid-19
vaccine, in large part as a result of concerns that vaccine development,
or potential authorizations, are being rushed. Vaccine development
usually takes years, yet Covid-19 shots are progressing at a rapid pace
as companies and countries rush to stop the spread of the coronavirus.
Now, spurred on by concerns over whether any such regulatory decision
could come before a vaccine is fully vetted by regulators, scientists
and industry executives are making unusually public assurances about
commitment to their products working safely.
covid-19 vaccine development
The companies’ draft statement says the drugmakers will submit
applications for government emergency-use authorization or licensure of
vaccines based on “substantial evidence of safety and efficacy” from
Phase 3 clinical trials conducted under Food and Drug Administration
guidance. Phase 3 studies, which are the final stages of testing, are
designed to prove whether the shots can reduce rates of symptomatic
Covid-19 disease compared with people without vaccination.
Several vaccines are in—or will soon start—large clinical trials of at
least 30,000 people, with potential for interim results in the coming
months, and possible emergency-use authorization or outright approval.
Last week, the Centers for Disease Control and Prevention, which is
expected to be involved in distributing vaccines, notified U.S. states
that they should be ready to launch Covid-19 vaccination campaigns by
November. An FDA meeting of outside experts to discuss Covid-19 vaccines
was also scheduled for late October.
That timeline, just before the Nov. 3 presidential election, raised
concerns among some scientists and other experts that the Trump
administration would rush a vaccine to bolster President Trump’s
re-election prospects. The U.S. government has pledged to deliver 300
million doses by January 2021 and is readying distribution.
The FDA has said it won’t green light a Covid-19 vaccine unless it is
proven to be 50% effective compared with a placebo.
A vaccine FDA decision in the coming weeks would come on the heels of
controversy of two high-profile emergency-use authorizations.
Its recent authorization of convalescent plasma to treat Covid-19
patients faced accusations of politicization, and criticism for not
being based on a placebo-controlled study. The emergency-use
authorization of hydroxychloroquine, an antimalarial touted by Mr.
Trump, which was rescinded over concerns of safety and efficacy, also
drew criticism.
As the coronavirus continues to spread around the globe, companies and
academic labs are racing to develop a vaccine that would help society
get back to normal. But there could also be costs to moving too quickly.
WSJ’s Daniela Hernandez explains. Photo illustration: Laura Kammermann
Pfizer Chief Executive Albert Bourla said the company expects to have
enough data in October to file for an emergency-use authorization if the
study results are positive. For Pfizer and Moderna’s vaccines, subjects
must return several weeks later to get a second dose, leaving just a few
weeks of evaluation for even the first subjects enrolled for a coming
regulatory filing.
Paul Offit, director of the Vaccine Education Center at Children’s
Hospital of Philadelphia, who is on the FDA vaccine-advisory committee,
said in an interview Thursday that it seemed unlikely there would be
enough data to demonstrate efficacy of the Covid-19 vaccines in
late-stage testing by the end of October. He expected that wouldn’t
happen before early next year.
Government officials have in recent days tempered expectations about the
timing of a vaccine.
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Moncef Slaoui, lead adviser of the White House’s Covid-19
vaccine-development program, told Science Magazine this week that he
would resign if Trump officials pushed for an emergency-use
authorization he didn’t back. Mr. Slaoui, a former GlaxoSmithKline PLC
executive, said on National Public Radio on Thursday that it was
unlikely the trials’ data would be done by October.
Drug companies and executives have issued statements and spoken at
forums intended to bolster trust in the vaccine-development process in
recent days.
“We all understand the need to move with urgency given the pandemic, but
we will not sacrifice safety under any set of circumstances,” Merck &
Co.’s CEO Ken Frazier said Thursday at an event hosted by the
International Federation of Pharmaceutical Manufacturers and
Associations, a trade group. Merck said in July it planned to start the
first human study for one of its experimental vaccines by the end of
September, and a second one to enter testing by the end of this year.
At the same forum, Mr. Bourla, Pfizer’s CEO, said the company would
never submit any vaccine for authorization or approval before “we feel
it is safe and effective.” He also said Pfizer hasn’t felt any political
pressure to rush a vaccine out. “We will not cut corners,” Mr. Bourla said.
The Biotechnology Innovation Organization, another trade group, also
Thursday published an open letter to the industry stating principles for
developing Covid-19 vaccines and treatments, and for assessing the
release of data from the continuing clinical trials.
The letter also says, “Political considerations should be put aside by
Republicans and Democrats.”
Write to Peter Loftus at peter.loftus-at-wsj.com and Jared S. Hopkins at
jared.hopkins-at-wsj.com
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
washingtonpost.com
The gutsy — possibly crazy — scientists who risked death testing
vaccines on themselves
Michael S. Rosenwald
4-5 minutes
In 1875, high up in the Andes mountains, hundreds of Peruvian railroad
workers began coming down with a strange fever, which was followed by
severe joint pain and then death.
As the body count soared, alarm set in across the country. Desperate to
explain the origins of this strange new malady, a Peruvian medical
society announced a contest.
A 26-year-old medical student named Daniel Carrión entered.
Scientists in Peru had a hunch the fever was connected to verruga
peruana, also known as Peruvian warts. But they struggled to prove a
link. To Carrión, whose father was a well-known physician, there was a
simple solution.
If someone injected him with tissue from a wart on one of the sick
patients and then he got sick, then voilà! Problem solved — there’s the
connection. But there was another problem: Those who got the fever
generally died.
Carrión was undeterred.
“Once he made the decision that experimentation on a human was
necessary, he must have asked himself: On whom?” wrote Lawrence K.
Altman, a physician and New York Times reporter in his history of
self-experimentation in medicine. “Carrión answered that question in the
only way his conscience would allow: Myself.”
He got the fever. And he died.
In the race to discover how disease spreads and what treatments might
stop it, someone has to be tested first.
That someone is often the doctor in the white coat. Jonas Salk tested
the polio vaccine — which contained a nonliving form of the virus — on
himself and his children before giving it to strangers. In 1986, Daniel
Zagury, a French immunologist, appointed himself to be the first person
dosed with an experimental AIDS vaccine.
A 2012 study identified 465 episodes of doctors’ self-experiments, with
140 of them related to dangerous infectious diseases. Eight
self-experiments resulted in death, including physicians and scientists
trying to curtail outbreaks of plague, typhus, cholera and yellow fever.
What would posses someone to, say, drink a hearty soup infused with
cholera bacteria, as Max Joseph Pettenkofer did in 1892?
“Historically, self experimentation was an important part of the
scientific process, allowing medical advances that would have been hard
to achieve otherwise,” wrote two researchers in a rollicking 2018 paper
titled “Adventures in self experimentation.”
And why?
“Because no sane human would agree to be a research participant and no
ethical review board in its right mind would approve the experiment,”
the researchers wrote.
Fair enough.
In more modern times, vaccines such as the one being pursued for the
novel coronavirus are tested on animals for months and often years
before reaching humans. It’s a deliberative process that has frustrated
President Trump, who recently asked vaccine manufacturers, “How fast can
you get it done?”
Throughout history, though, impatient and desperate scientists have
decided to throw their own necks in the ring.
Twelve self-experimenters have won Nobel Prizes for their efforts,
including Charles Jules Henri Nicolle, a French scientist who in the
early 1900s took lice from typhus-infected chimps, crushed them up and
made a vaccine that he tested on himself.
Werner Forssmann, a German, won a Nobel in 1956 for cardiac
catheterization, which he first performed on himself, inserting a tube
into a vein that he then directed into his heart. (Yes, his heart. Yes,
he lived.)
Carrión, of course, didn’t live to see fame. But his bravery is
immortal. In Peru, hospitals and soccer stadiums are named after him.
And yet he never authored a single scientific paper.
--
So many immigrant groups have swept through our town
that Brooklyn, like Atlantis, reaches mythological
proportions in the mind of the world - RI Safir 1998
http://www.mrbrklyn.com
DRM is THEFT - We are the STAKEHOLDERS - RI Safir 2002
http://www.nylxs.com - Leadership Development in Free Software
http://www.brooklyn-living.com
Being so tracked is for FARM ANIMALS and extermination camps,
but incompatible with living as a free human being. -RI Safir 2013
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