Author Topic: takes over a year (Jan.2020)  (Read 321 times)

gsgs

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takes over a year (Jan.2020)
« on: January 30, 2020, 02:12:13 am »
January 27th, 2020, 11:50 AM
Fauci,NIH : 1 year
Fauci said it would take a few months until the first phase of clinical trials begins and
more than a year until a vaccine is available

Tregoning, Imperial College at Bloomberg : 5-6 Months

University of Queensland : 16 weeks , 6 months
The team hopes to develop a vaccine over the next six months, which may be used to help
contain this outbreak,” he said. “The vaccine would be distributed to first responders,
helping to contain the virus from spreading around the world.” (Paul Young)

Dr. Tal Zaks, Moderna’s chief medical officer, committed to getting that done
on CEPI’s 16-week timeline. And the company will be able to manufacture the
eventual vaccine in a matter of a few months, Zaks said. That should cover
clinical trials, he said, but if the vaccine ends up working — and the 2019-nCoV
outbreak drags on — the company would have to rely on someone else to
churn out the massive number of doses required to halt the virus.

David Weiner , Inovio : "much faster".

Gregory Glenn from Novavax says that his firm is working on developing a
vaccine for the China coronavirus, and work on that could take two to three months.

CEPI : In 16 Wochen sollen die ersten Impfstoffe gegen das neuartige Coronavirus
getestet werden Eine Erfolgsgarantie gebe es allerdings nicht.
Laut Experten dürfte es aber mindestens ein Jahr dauern, bis ein fertiger Impfstoff
zur Verfügung steht.

-----------------------------------------
I speculate they could somehow reduce the testing phase, if time urges,
That makes it somehow risky, but hey, the pandemic is the bigger risk.
I can't find any statements on this, though. But maybe they mustn't talk
about this ... it's all commercial,legal.government - they can't just speak freely.

Jan.29
China coronavirus: Hong Kong researchers have already developed vaccine but need
time to test it, expert reveals

Johnson & Johnson JNJ, +0.70%  now plans to initiate development of a vaccine
candidate for 2019-nCoV and is also providing its antiviral HIV treatment Prezcobix in
China for investigational purposes.
Becton Dickinson and Co. BDX, -0.02%, the diagnostics company, is sending
instruments used in diagnostic testing to China

TAWA — Canada’s chief public health officer says it will likely take at least a year
before a vaccine is developed to protect people against the new coronavirus t
 Dr. Theresa Tam

Jan.29 , Novartis CEO
it will take over a year until there is a vaccine

[in Europe or worldwide ? also in China with maybe reduced trial-regulations ? ]

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Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines
 administered by tablet rather than by injection, announced on Jan.31 that it has initiated
a program to develop a coronavirus vaccine candidate based on its proprietary oral
vaccine platform, VAAST.
----------------------------------------------------------------------------
Feb-05   Sweden: Karolinska joins global hunt for coronavirus vaccine.
--------------------------------------------------------------------
Der britische Epidemiologe Jeremy Farrar geht davon aus, dass ein Impfstoff gegen das neuartige Coronavirus 2019-nCoV zu spät kommen wird, um die drohende globale Ausbreitung der Seuche zu verhindern. „Realistischerweise wird ein Impfstoff frühestens zum Jahresende fertig oder in einem Jahr – und das wäre schon in Rekordzeit“, sagte Farrar dem „Spiegel“. Wenn man Pech habe, werde es „niemals gelingen“.

Der Direktor des Wellcome Trust

„Es könnte sogar sein, dass das neuartige Coronavirus anders als Influenzaviren nicht nur hauptsächlich saisonal auftritt, sondern das ganze Jahr kursiert“, so der Mediziner weiter. Er bezweifelt, dass die Bewohner westlicher Metropolen wie München oder Paris im Falle einer Pandemie eine wochenlange Abriegelung ihrer Städte wie in China hinnehmen würden.

Wenn alles nach Plan läuft, könnte es bis zum Jahresende ein Serum geben. Ist ein Impfstoff gefunden, muss er noch einen langen Weg bis zur Zulassung gehen.

-------------------------------------------------------------
« Last Edit: February 15, 2020, 03:24:54 am by gsgs »

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gsgs

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Re: takes over a year (Jan.2020)
« Reply #1 on: February 13, 2020, 03:35:18 am »
----------------------------------------------------------------------
Researchers in China and the US are developing a vaccine for the new Coronavirus.
If all goes well, they may run the first tests in three months. A vaccine would be
available mid-year — at the very earliest.
https://www.dw.com/en/coronavirus-vaccine-a-race-against-time/a-52174737
------------------------------------------------------------------
Even if it all goes well, the earliest a vaccine against nCoV could be introduced would
be the summer of 2020.
-----------------------------------------------------------------
Another potential approach against the coronavirus nCoV is with monoclonal antibodies,
which can activate specific immunological reactions in the body.
Herbert Virgin at Vir Biotechnology in Illinois, USA, says his company has developed
antibodies which have shown themselves to be effective against SARS and MERS in
laboratory tests. Some were reportedly able to neutralize coronaviruses. "It's possible that
they could also treat the Wuhan virus," says Virgin.
-----------------------------------------------------------------
Prof. Mark Harris, a virologist at the School for Molecular and Cell Biology at the
University of Leeds in the UK, estimates the mortality rate of nCoV to be at 0.1 percent.
---------------------------------------------------------
A spokesman for the Institutes (NIH) said that it could be a few months before the first
 clinical trials of the vaccine get underway – and a year or more before it’s available.
----------------------------------------
Meanwhile, Baylor College of Medicine in Houston is also reported to be working on a vaccine.
----------------------------------------
so they are going to test it on animals who so far have not been found to catch the virus
 so whats that going to prove apart from if it does not kill an animal it MAY be ok for
 humans why not just test it on a confirmed subject and bypass animal crue..
--------------------------------------
Feb.12
The first vaccine targeting the new coronavirus could be 18 months away, and the outbreak
could end up creating a global threat potentially worse than terrorism, the WHO has warned.
--------------------------------------------------
At least a dozen research teams globally have already made headway in vaccine research
against the new coronavirus.
-----------------------------------------------------
Dr. Anthony Fauci, director of the NIAID, said they are on track to test their vaccine by April.
“Whenever you’re dealing with a vaccine, there’s always a potential for glitches,”
 “Right now, all those glitches, they’ve been overcome.”
Phase one of human testing will still take at least three months to complete, he said.
Then a decision has to be made about whether the vaccine will advance to a phase two trial.
“The risk is the companies now have to invest a lot of money,” Fauci said. “You would
have to do a trial of several hundred to several thousand people to see if it works —
that usually takes anywhere from several months to a couple of years.”
Even with expedited approval, phase two of the new coronavirus vaccine would require
a time investment of at least a year, he said.
------------------------------------------------
The 'holy grail' universal vaccine
Another competitive advantage the team enjoys is Hogue’s prior experience working
on a SARS vaccine, which should speed up their work on the new coronavirus vaccine,
since the new virus is about 80% similar to SARS at the genetic level.
In hindsight, Hogue wishes she had continued to work on her SARS vaccine.
"At the time we were pursuing this, we didn't have all that background and understanding
that there were a lot of these SARS-like viruses that could infect humans,” she said.
-------------------------------------------------------
An expert in infectious diseases on Monday said it was possible there could be a vaccine
against the new virus originating in China "at the very earliest" by September.
Chair of Infectious Disease Epidemiology at Imperial College London, Professor Azra Ghani,
added "it's more likely to be towards the end of the year".
----------------------------------------------------------
In Kooperation mit dem Forscherteam um Sutter arbeitet auch eine Gruppe
um den Virologen Stephan Becker, Direktor des Instituts für Virologie an der
Philipps Universität Marburg und Koordinator des Forschungsbereichs
Neu auftretende Infektionskrankheiten am Deutschen Zentrum für
Infektionsforschung (DZIF), an einem Impfstoffkandidaten.
Wenn der politische oder medizinische Druck hoch genug sei, dann würden
die Zulassungsverfahren beschleunigt, zeigten seine Erfahrungen.
-------------------------------------------------------


« Last Edit: February 13, 2020, 06:03:30 am by gsgs »

gsgs

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Re: takes over a year (Jan.2020)
« Reply #2 on: March 02, 2020, 10:58:13 am »
@HelenBranswell
This feels very optimistic for vaccine for the masses.
Some people *may* get vaccinated in 18 months. But it won't be most of us.
----------------------------------------------------
@florian_krammer
Vaccines against SARS-CoV-2 will be very important. But don't get fooled by press releases.
To get them will take time.
 Merck and J&J did their phase 1-2-3 more or less in parallel. Will the FDA / EMA allow such
an approach for covid-19 vaccine?. I would hope so.
@nataliexdean
If Phase 3 trials are successful, there is also a precedent for immediately providing the vaccine
under an emergency use authorization (pre-licensure) as long as recipients provide informed
consent. This has been done in the DRC for Ebola.
Woman shrugging
@fodaazul
6 to 18 months? There’s 4 to 16 months left only


« Last Edit: March 02, 2020, 11:09:10 am by gsgs »

gsgs

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Re: takes over a year (Jan.2020)
« Reply #3 on: March 03, 2020, 03:25:08 am »
https://www.republicworld.com/world-news/rest-of-the-world-news/expert-virus-vaccine-possible-by-sep-at-earliest.html

Azra Chani
Azra Ghani,

Weiner, Imp.Coll.London
“We were able to go from no vaccine to a vaccine tested in the clinic in about 18 months — 15 to 18 months,”
 “And we were able to design and develop and move into the clinic in 11 months [MERS].”
Keith Chappell at the University of Queensland in Brisbane, Australia, thinks he can do even better
https://cbdnewsupdate.com/timetable-for-a-vaccine-against-the-new-coronavirus-maybe-this-fall/
Even in the rosiest of scenarios, Hatchett says, once the vaccine is in hand, it still needs to get to the people who need it, and that takes time — at least weeks to months, depending on the urgency.
“We are making very aggressive efforts in the hopes of having a vaccine available — some form of vaccine available, potentially, as early as this fall,” Hatchett says.

gsgs

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Re: takes over a year (Jan.2020)
« Reply #4 on: March 03, 2020, 03:59:07 am »
Fauci repeating on Mar02 : Fauci :
“A year to a year and a half,” referring to the amount of time it will likely take to
deploy an effective vaccine to large populations.

[ with their approach ? with current US-vaccine-laws ? ]
==================================================

More than 20 new crown pneumonia vaccines are being developed worldwide, and these
have made new progress
-----------------------------------------------------------------------------------
American pharmaceutical company Inovio Pharmaceuticals said on March 3 that the company is
 accelerating the development of a vaccine schedule for the treatment of new coronary pneumonia.
 Inovio is currently expected to provide 1 million doses of vaccines using existing resources
by the end of the year.
-------------------------------------------------------------------------------------------------
It is reported that the laboratory team led by Professor Robin Shattock, head of mucosal
infections and immunology at Imperial College London, focuses on the development of a
coronavirus vaccine. They developed the vaccine within 14 days and last week Began
to enter the animal test stage, and it is possible to conduct human trials within 5 months.
 If progress is smooth, human clinical trials will be conducted this summer. (Finished by
Health Times reporter Qiao Jingfang)
----------------------------------------------------------------------------------------------
! Professor Ning Yi from the School of Public Health of Peking University said in an interview
with a Health Times reporter that the fastest time from vaccine development to market is 6 months,
and the probability of successful vaccine development before August is "zero".
--------------------------------------------------------------------------------------------
US pharmaceutical company Moderna has sent vaccine samples to U.S. government researchers
this Monday. It is expected to be tested on 45 healthy volunteers by the end of April. The first
phase will take at least three months. Then entering the second phase will require hundreds of
volunteers to test, and the rocket speed will also take 6-8 months. That is to say, the fastest time
is one to one and a half years.
-------------------------------------------------------------------------------------
« Last Edit: March 05, 2020, 06:18:33 am by gsgs »

gsgs

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Re: takes over a year (Jan.2020)
« Reply #5 on: June 17, 2020, 07:26:55 am »
2020/06/17

Das Tübinger Biotechunternehmen CureVac geht davon aus, dass es bis Mitte kommenden Jahres
einen Corona-Impfstoff geben könnte.

gsgs

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Re: takes over a year (Jan.2020)
« Reply #6 on: June 24, 2020, 07:12:59 am »
22.05.2020 · “This contract with AstraZeneca is a major milestone in Operation Warp
Speed’s work toward a safe, effective, widely available vaccine by 2021,” U.S. Health
Secretary Alex Azar said.

Operation Warp Speed Aims to Deliver 300M Vaccine Doses by January.

A potential coronavirus vaccine developed by French drugmaker Sanofi and Britain's
GlaxoSmithKline is expected to be approved by the first half of 2021.

Sanofi said it had capacity to produce up to 1 billion doses a year

Shionogi and the NIID aim to put the vaccine on the market in fall 2021.

Pfizer/BioNTech 2M per dec31, 200M in 2021

AS, May, total capacity sourced for one billion doses through 2020 and into 2021;

AstraZeneca (ticker: AZN) has arranged for enough capacity to supply one billion doses of the vaccine in 2020 and 2021

May 21 (Reuters) - AstraZeneca expects to be able to deliver a billion doses of a possible
COVID-19 vaccine this year and next

AstraZeneca says it has secured capacity to produce 2 billion doses

84-90% of vaccine candidates fail (have "attrition") in Phase III clinical trials[4][54]

Walter Ricciardi,WHO : there is quite a strong probability that the vaccine will work

Sanofi would be able to supply up to 360 million doses of its mRNA vaccine annually

In April, Sanofi said it had manufacturing capacity for 600 million doses for its recombinant
vaccine, with the ambition to double production by mid-2021.

Sanofi said it had capacity to produce up to 1 billion doses a year

23.06.2020 · Sanofi said it had capacity to produce up to 1 billion doses a year of its recombinant
vaccine, and that it would be able to supply up to 360 million doses of its mRNA vaccine annually.

"We believe the probability of success is high enough that we are willing to support the
manufacturing at-risk," Dr. Hatchett said.

 AstraZeneca said it reached a second agreement with the Serum Institute of India to provide
one billion doses for low and middle-income countries, including 400 million by the end of this year.

Last month, AstraZeneca agreed to provide 100 million doses to the U.K., with an initial
supply of 30 million doses per September.

Initial supplies of any successful vaccine are expected to be limited. Some drugmakers have
sought to set up manufacturing capacity in multiple countries, in case individual countries
impose export bans on any successful vaccines produced within their borders.

June 04, 2020

 Jun 16 ,  HHS says vaccine likely by January

 when a safe and effective vaccine will be developed and distributed, and on Tuesday, the
Department of Health and Human Services said that January 2021 is a likely timeframe for
when that might happen.
The projection is based on the current efforts of HHS' Operation Warp Speed, an initiative that
aims to deliver 300 million doses

 stay-at-home and other social-distancing orders have cost the country an estimated $25 billion per day,

 We cannot promise a 100% chance of success, but we've maximized the probability of success," said Mango.

Bourla made the decision to spend $1 billion on the project, so if the vaccine works, it can be
made available this autumn.

At current rates, the US economy is losing about $40 billion a week.


--------------------
STAT : 2 doses may be needed


gsgs

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Re: takes over a year (Jan.2020)
« Reply #7 on: August 02, 2020, 12:46:25 am »
Aug02 , > Russia preparing mass vaccination against #coronavirus for October -
teachers and doctors first, Fauci concerned they are not testing enough
---------------------------------------------------------------------------
Jul28 , Nach den Plänen von Biontech sollen im Erfolgsfall bis Ende des Jahres zunächst 100 Millionen
Impfstoffdosen weltweit geliefert werden. Bis Ende 2021 streben Biontech und der
US-Pharmakonzern Pfizer an, mehr als 1,3 Milliarden weitere Dosen bereitzustellen.
---------------------------------------------------------------------------
Aug03
https://www.forbes.com/sites/stevensalzberg/2020/08/02/start-vaccinating-now/
We Should Consider Starting Covid-19 Vaccinations Now
Steven Salzberg
 > why not start administering millions of doses right now? We should. [without phase 3]
{the risk from side effects being lower than the risk from COVID due to vaccine-delays}

# I was wondering, why this hadn't been widely discussed already since February.
# Also, the number of people/animals in the phases and the number of phases,
# that should all have been optimized for this situation
# and not just been taken from previous regulations
---------------------------------------------------------------------------------
Aug.09
EU-Gesundheitsministerin Kyriakides hofft, dass in sechs Monaten ein #Corona-Impfstoff zur Verfügung steht.
-------------------------------------------------------------------------------
Aug.11
Russland hat einen Impfstoff gegen das #Coronavirus für die breite Verwendung zugelassen.
Die Testphase wurde allerdings verkürzt.
 Russia registers a COVID-vaccine for brought usage.
The testphase has been shortened.
Putin's daughter is already vaccinated with 2 shots
Russia hoped to launch mass production within weeks and turn out “several million”
doses per month by 2021.
# So, presumably they have not millions of doses this year and they are
# basically doing what others call "phase 3" although probably
# with more people
HCWs can volunteer to get it first
--------------------------------------------
Russia claimed today it had approved a COVID-19 vaccine
- tested in just 76 people
- may be given to “a small number of citizens from vulnerable groups,”
- cannot be used widely until 2021
https://www.sciencemag.org/news/2020...-press-release
-------------------------------------------
Brazil and Israel are interested in the vax (to buy it ?!)
----------------------------------------------------------------------------------
Aug13
Das RKI rechnet nicht damit, dass ein Impfstoff bereits im Herbst 2020 zur Verfügung stehen wird“:
-------------------------------------------------------------------------------
Curevac schließt die beschleunigte Zulassung des möglichen Corona-Impfstoffes nicht aus.
Politische Entscheidung.
Die Ergebnisse der kürzlich gestarteten klinischen Erprobung des Impfstoffkandidaten
sollen demnach im Herbst veröffentlicht werden. Die Zulassung sei nach bisheriger
Planung für die erste Hälfte kommenden Jahres geplant.
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« Last Edit: August 16, 2020, 07:06:28 am by gsgs »