I'm not sure I would trust a tattoo parlor to ink me with a design so complicated. Here's why:
QR code. Very apt.
AstraZeneca vaccine clinical trial "pause"
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AZ is denying reports that there is a TM or any other firm diagnosis at this point. Diagnosis TBD,
A
anon_mlxxvlbug9dpa
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Yes but it was a pittance and is ultimately why the public pools weren’t saving much money.
AstraZeneca coronavirus vaccine clinical trials resume in U.K. after pause over safety concerns
Won’t be enough Covid-19 vaccines till 2024: Serum Institute’s Adar Poonawalla
Adar Poonawalla’s remarks came a day after Union health minister Harsh Vardhan said a vaccine against the coronavirus disease would be ready by early next year.
Adar Poonawalla, the chief executive of Serum Institute of India (SII), has warned there won’t be enough vaccines against the coronavirus disease (Covid-19) for everyone in the world till the end of 2024, according to a report on Monday.
The CEO of the world’s largest vaccine manufacturer has estimated that the world will need around 15 billion doses of the Covid-19 shot if it is a two-dose vaccine. “It’s going to take four to five years until everyone gets the vaccine on this planet,” Poonawalla told the Financial Times.
The Pune-based pharma firm has partnered with five international pharmaceutical firms, including AstraZeneca and Novavax, to develop a Covid-19 vaccine and committed to producing one billion doses, of which it has pledged half to India.
Poonawalla’s remarks came a day after Union health minister Harsh Vardhan said a vaccine against the coronavirus disease would be ready by early next year. “It may be ready by the first quarter of next year,” he had said.
On SII’s word to produce a billion doses, he said that the commitment far exceeded the capacity of other vaccine producers. “I know the world wants to be optimistic on it... [but] I have not heard of anyone coming even close to that [level] right now,” he told the business daily in a video call from London.
The Financial Times reported that as part of SII’s agreement with AstraZeneca, the firm will aim to produce vaccine doses that cost around $3 for 68 countries and under its agreement with Novavax, for 92 countries.
The company may also partner with Russia’s Gamaleya Research Institute to manufacture the Sputnik vaccine, according to the newspaper.
Last week, human trials of the Oxford vaccine candidate by AstraZeneca were halted after a volunteer fell sick in the UK following which the Serum Institute of India also paused the trials as it was issued a show-cause notice by the Drug Controller of India. The trials, however, have resumed in Britain.
After the human trials of the Oxford vaccine resumed in the UK late last week, Poonawala had tweeted, “As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end.”
Adar Poonawalla’s remarks came a day after Union health minister Harsh Vardhan said a vaccine against the coronavirus disease would be ready by early next year.
Adar Poonawalla, the chief executive of Serum Institute of India (SII), has warned there won’t be enough vaccines against the coronavirus disease (Covid-19) for everyone in the world till the end of 2024, according to a report on Monday.
The CEO of the world’s largest vaccine manufacturer has estimated that the world will need around 15 billion doses of the Covid-19 shot if it is a two-dose vaccine. “It’s going to take four to five years until everyone gets the vaccine on this planet,” Poonawalla told the Financial Times.
The Pune-based pharma firm has partnered with five international pharmaceutical firms, including AstraZeneca and Novavax, to develop a Covid-19 vaccine and committed to producing one billion doses, of which it has pledged half to India.
Poonawalla’s remarks came a day after Union health minister Harsh Vardhan said a vaccine against the coronavirus disease would be ready by early next year. “It may be ready by the first quarter of next year,” he had said.
On SII’s word to produce a billion doses, he said that the commitment far exceeded the capacity of other vaccine producers. “I know the world wants to be optimistic on it... [but] I have not heard of anyone coming even close to that [level] right now,” he told the business daily in a video call from London.
The Financial Times reported that as part of SII’s agreement with AstraZeneca, the firm will aim to produce vaccine doses that cost around $3 for 68 countries and under its agreement with Novavax, for 92 countries.
The company may also partner with Russia’s Gamaleya Research Institute to manufacture the Sputnik vaccine, according to the newspaper.
Last week, human trials of the Oxford vaccine candidate by AstraZeneca were halted after a volunteer fell sick in the UK following which the Serum Institute of India also paused the trials as it was issued a show-cause notice by the Drug Controller of India. The trials, however, have resumed in Britain.
After the human trials of the Oxford vaccine resumed in the UK late last week, Poonawala had tweeted, “As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end.”
His wife is hot...just sayin'.Won’t be enough Covid-19 vaccines till 2024: Serum Institute’s Adar Poonawalla
Adar Poonawalla’s remarks came a day after Union health minister Harsh Vardhan said a vaccine against the coronavirus disease would be ready by early next year.
Adar Poonawalla, the chief executive of Serum Institute of India (SII), has warned there won’t be enough vaccines against the coronavirus disease (Covid-19) for everyone in the world till the end of 2024, according to a report on Monday.
The CEO of the world’s largest vaccine manufacturer has estimated that the world will need around 15 billion doses of the Covid-19 shot if it is a two-dose vaccine. “It’s going to take four to five years until everyone gets the vaccine on this planet,” Poonawalla told the Financial Times.
The Pune-based pharma firm has partnered with five international pharmaceutical firms, including AstraZeneca and Novavax, to develop a Covid-19 vaccine and committed to producing one billion doses, of which it has pledged half to India.
Poonawalla’s remarks came a day after Union health minister Harsh Vardhan said a vaccine against the coronavirus disease would be ready by early next year. “It may be ready by the first quarter of next year,” he had said.
On SII’s word to produce a billion doses, he said that the commitment far exceeded the capacity of other vaccine producers. “I know the world wants to be optimistic on it... [but] I have not heard of anyone coming even close to that [level] right now,” he told the business daily in a video call from London.
The Financial Times reported that as part of SII’s agreement with AstraZeneca, the firm will aim to produce vaccine doses that cost around $3 for 68 countries and under its agreement with Novavax, for 92 countries.
The company may also partner with Russia’s Gamaleya Research Institute to manufacture the Sputnik vaccine, according to the newspaper.
Last week, human trials of the Oxford vaccine candidate by AstraZeneca were halted after a volunteer fell sick in the UK following which the Serum Institute of India also paused the trials as it was issued a show-cause notice by the Drug Controller of India. The trials, however, have resumed in Britain.
After the human trials of the Oxford vaccine resumed in the UK late last week, Poonawala had tweeted, “As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end.”
Didnt noticed. You know me, I just don't pay attention to that sort of thing.
How good is the Oxford/AstraZeneca Covid vaccine?
Interim results from phase 3 trials in Britain and Brazil found the vaccine to be 70.4% protective. More than 20,000 volunteers were involved in the trials and half of those were in the UK. Investigators recorded 30 cases of Covid-19 in people who had two doses of the vaccine and 101 in those who received a control jab. In those who received two full doses, the vaccine was 62% protective. But it appears to work better when given initially as a half-dose followed by a full dose, with protection then rising to 90%.
How does it differ from other vaccines?
The Oxford vaccine, named ChAdOx1 nCoV-19, is based on a different technology to the two recent “mRNA” vaccines from Pfizer/BioNTech and Moderna, both of which performed well against Covid. No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.
Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins. The vaccines use lipid nanoparticles to deliver the mRNA into muscle cells which manufacture the spike protein and prime the immune system, guarding against infection. In principle, mRNA vaccines may be faster to develop and easier to manufacture.
While BioNTech’s vaccine must be stored at -70C to -80C, making distribution a complex logistical challenge, Moderna’s vaccine can be stored in a fridge at 2C to 8C for a month. Oxford’s vaccine can also be stored in standard refrigerators, making distribution far easier. Other coronavirus vaccines are under development and use the virus itself in a weakened or inactive form. This is the same approach used in highly effective vaccines for polio and measles.
Interim results from phase 3 trials in Britain and Brazil found the vaccine to be 70.4% protective. More than 20,000 volunteers were involved in the trials and half of those were in the UK. Investigators recorded 30 cases of Covid-19 in people who had two doses of the vaccine and 101 in those who received a control jab. In those who received two full doses, the vaccine was 62% protective. But it appears to work better when given initially as a half-dose followed by a full dose, with protection then rising to 90%.
How does it differ from other vaccines?
The Oxford vaccine, named ChAdOx1 nCoV-19, is based on a different technology to the two recent “mRNA” vaccines from Pfizer/BioNTech and Moderna, both of which performed well against Covid. No mRNA vaccine has ever been approved by regulators, but the Oxford approach has been used in vaccines given safely to thousands of people of all ages for diseases ranging from TB and malaria to Mers (another coronavirus) and Ebola, for which it is now being used in Uganda and the Democratic Republic of the Congo. Oxford opted for the chimp virus because it has the potential to generate a strong immune response and, since it cannot grow in humans, it should be safe.
Two other frontrunner vaccines, from BioNTech (developed with Pfizer) and Moderna (developed with the US National Institute of Allergy and Infectious Diseases), perform well, according to interim results from phase 3 human trials, achieving more than 90% efficacy. These are based on technology that is new to the vaccine field. Both use genetic material called mRNA, or messenger RNA, which tells human cells how to make coronavirus spike proteins. The vaccines use lipid nanoparticles to deliver the mRNA into muscle cells which manufacture the spike protein and prime the immune system, guarding against infection. In principle, mRNA vaccines may be faster to develop and easier to manufacture.
While BioNTech’s vaccine must be stored at -70C to -80C, making distribution a complex logistical challenge, Moderna’s vaccine can be stored in a fridge at 2C to 8C for a month. Oxford’s vaccine can also be stored in standard refrigerators, making distribution far easier. Other coronavirus vaccines are under development and use the virus itself in a weakened or inactive form. This is the same approach used in highly effective vaccines for polio and measles.
I wouldn't be so sure. Stock is headed lower - notes out from Wall Street Biotech analysts are bearish and D Lowe also seems skeptical:
Science | AAAS
blogs.sciencemag.org
AZ has pledged to make no-profit off the vaccine, so I'm not sure why Wall Street matters on that front.
Also seeing some really dumb analyst takes on the subject.
Also seeing some really dumb analyst takes on the subject.
Earlier this year, I bought Moderna and AstraZenca stocks. After Moderna's announcement, AZN was dipping, causing me to put them on stop-loss orders. Just removed the stop. We will see how they perform.I wouldn't be so sure. Stock is headed lower - notes out from Wall Street Biotech analysts are bearish and D Lowe also seems skeptical:
Science | AAAS
What is odd is the big difference in efficacy for the two dosing schedules, in which a lower first dose was better than a higher first dose. In the Lowe blog post that JDB linked, speculation is that your body may develop some antibodies to the viral vector itself and thus destroy the ability of the second shot to deliver DNA to make spike protein.
The low-high combo was about 90% effective. Given cheapness and ease of distribution, this could be a winner. The vector-free mRNA approach, though, precludes this immune response to the viral vector.
J&J is also an adenovirus so we will see how it compares.
The low-high combo was about 90% effective. Given cheapness and ease of distribution, this could be a winner. The vector-free mRNA approach, though, precludes this immune response to the viral vector.
J&J is also an adenovirus so we will see how it compares.
The one guy griping about them releasing data "too early" and that the US won't approve the vaccine. Just total dumb analyst stuff that has no bearing on the real world.
That's precisely the problem... it's speculation and even AZ and Oxford don't have the exact explanation.
We cannot and should not try and convince a populace with an unfortunate growing skepticism among vaccines to take a product with mixed efficacy signals and lacking in safety data.
It may get there, but it isn't a preferred option right now IMO.
I know zero about biotech and pharma, but Leerink is a well known bank in that realm. Sell side analyst research is typically mediocre, at best, but that guy, in theory, knows more than the collective board about these products.
I mean, the guy was head of marketing for Merck's vaccine division back in the day:
Covid-19: Oxford University vaccine is highly effective
The coronavirus vaccine developed by the University of Oxford is highly effective at stopping people developing Covid-19 symptoms, a large trial shows.
Interim data suggests 70% protection, but the researchers say the figure may be as high as 90% by tweaking the dose.
The results will be seen as a triumph, but come after Pfizer and Moderna vaccines showed 95% protection.
However, the Oxford jab is far cheaper, and is easier to store and get to every corner of the world than the other two.
Prof Andrew Pollard, the trial's lead investigator, said he was "really pleased" with the results as "it means we have a vaccine for the world".
However, protection was 90% in an analysis of around 3,000 people on the trial who were given a half-sized first dose and a full-sized second dose.
Prof Pollard said the finding was "intriguing" and would mean "we would have a lot more doses to distribute."
The analysis also suggested there was a reduction in the number of people being infected without developing symptoms, who are still thought to be able to spread the virus.
Ultimately I expect a phased deployment of the various vaccines. Depending on which gets approved first, I would expect the Pfizer and Moderna vaccines first and to the most vulnerable -- the elderly and the frontline workers.
The two mentioned vaccines' challenges are the high cold chain distribution and storage requirements.
The Moderna and Pfizer vaccines require two dosages around 15 days apart, and stored at -80 degrees, distributing it in that condition globally is a challenge -- with the higher risk that the vaccine deteriorates at higher temperatures and a higher proportion of wastage potentially.
The resources to power those conditions (dry ice needs to be replenished every 5 days for a max of 15 days) and the raw materials for the vaccines themselves.
So technically vaccinating everyone in the world would require more than 15 billion vaccine doses, and that doesn’t allow for vaccine's that are spoiled, broken or end up lost in the back of a freezer.
I mentioned earlier, the AstraZeneca/Oxford vaccine (doesn't require the extreme storage conditions, but requires two doses) ---- will be the more widely distributed vaccine due to it's far cheaper cost and accessibility.
The two mentioned vaccines' challenges are the high cold chain distribution and storage requirements.
The Moderna and Pfizer vaccines require two dosages around 15 days apart, and stored at -80 degrees, distributing it in that condition globally is a challenge -- with the higher risk that the vaccine deteriorates at higher temperatures and a higher proportion of wastage potentially.
The resources to power those conditions (dry ice needs to be replenished every 5 days for a max of 15 days) and the raw materials for the vaccines themselves.
So technically vaccinating everyone in the world would require more than 15 billion vaccine doses, and that doesn’t allow for vaccine's that are spoiled, broken or end up lost in the back of a freezer.
I mentioned earlier, the AstraZeneca/Oxford vaccine (doesn't require the extreme storage conditions, but requires two doses) ---- will be the more widely distributed vaccine due to it's far cheaper cost and accessibility.
rubbish. The efficacy is far inferior and the safety data is noticeably absent.
hopefully J&J knocks it out of the park and we don’t even need to hear about AZ. Single dose would be a game changer, particularly given the dosing differential issues with AZ.
Let's be clear here, the Brits have failed. It's looking like the Fall of Singapore.
www.cnn.com
Here's a recap (TLDR version in BOLD)...
1) AZ did NOT provide the underlying data that validated the efficacy, whereas the prior two mRNA vaccine trials did.
In a press release Monday, the pharmaceutical giant announced that its vaccine is on average 70% effective. However, the company did not state the data that led them to that conclusion.
"Absent knowing this, it's hard to know the significance of their findings," said Dr. Paul Offit, a member of the FDA's Vaccines and Related Biological Products Advisory Committee, which will review Covid-19 vaccines before they are put on the market.
When two other pharmaceutical companies, Pfizer and Moderna, released their efficacy results earlier this month, they did include the data that led to their results.
.....
2) AZ did not provide a breakdown of those that contracted COVID between vaccinated and placebo - that seems like obvious info to disclose.
In its press release, AstraZeneca said a total of 131 study participants developed Covid-19 but did not say how many of those people had received the Covid-19 vaccine and how many did not.
....
3) It was previously put on hold twice because of safety issues and yet, no safety data was provided.
The AstraZeneca trial was put on hold twice because government regulators were concerned about two study participants who became seriously ill. Regulators later allowed the trial to resume.
"I'd like to know the data specifically about those serious adverse reactions that caused the trial to go on pause," said Dr. William Schaffner, a member of the CDC's Advisory Committee on Immunization Practices, which will also be reviewing the vaccines before they're allowed on the market.
...
4) Even the own team doesn't know why there was efficacy divergence, but it will take weeks and months to figure out
The group that received the half-dose initially was 90% protected against Covid-19, and the group that received two full doses was only 62% protected.
One of the lead Oxford researchers, Dr. Adrian Hill, said it would take "probably weeks and months" to understand why the lower dose yielded much better results.
....
5) the sample size for the 90% was far smaller than the other vaccines
Dr. Saad Omer, a vaccine specialist at the Yale School of Medicine, noted that the group with the 90% efficacy rate was relatively small -- just 2,741 study participants -- and those results might not hold up when more people are given this regimen.
He noted a lack of clarity about several aspects of AstraZeneca's data.
"I hate to criticize fellow academics, or anyone for that matter, but releasing information like this is like asking us to try and read the tea leaves," Omer said.
Experts have questions about AstraZeneca's vaccine data | CNN
Vaccine experts -- including those who serve on advisory committees for the US Food and Drug Administration and the US Centers for Disease Control and Prevention -- have questions about data released Monday by AstraZeneca about its Covid-19 vaccine.
Here's a recap (TLDR version in BOLD)...
1) AZ did NOT provide the underlying data that validated the efficacy, whereas the prior two mRNA vaccine trials did.
In a press release Monday, the pharmaceutical giant announced that its vaccine is on average 70% effective. However, the company did not state the data that led them to that conclusion.
"Absent knowing this, it's hard to know the significance of their findings," said Dr. Paul Offit, a member of the FDA's Vaccines and Related Biological Products Advisory Committee, which will review Covid-19 vaccines before they are put on the market.
When two other pharmaceutical companies, Pfizer and Moderna, released their efficacy results earlier this month, they did include the data that led to their results.
.....
2) AZ did not provide a breakdown of those that contracted COVID between vaccinated and placebo - that seems like obvious info to disclose.
In its press release, AstraZeneca said a total of 131 study participants developed Covid-19 but did not say how many of those people had received the Covid-19 vaccine and how many did not.
....
3) It was previously put on hold twice because of safety issues and yet, no safety data was provided.
The AstraZeneca trial was put on hold twice because government regulators were concerned about two study participants who became seriously ill. Regulators later allowed the trial to resume.
"I'd like to know the data specifically about those serious adverse reactions that caused the trial to go on pause," said Dr. William Schaffner, a member of the CDC's Advisory Committee on Immunization Practices, which will also be reviewing the vaccines before they're allowed on the market.
...
4) Even the own team doesn't know why there was efficacy divergence, but it will take weeks and months to figure out
The group that received the half-dose initially was 90% protected against Covid-19, and the group that received two full doses was only 62% protected.
One of the lead Oxford researchers, Dr. Adrian Hill, said it would take "probably weeks and months" to understand why the lower dose yielded much better results.
....
5) the sample size for the 90% was far smaller than the other vaccines
Dr. Saad Omer, a vaccine specialist at the Yale School of Medicine, noted that the group with the 90% efficacy rate was relatively small -- just 2,741 study participants -- and those results might not hold up when more people are given this regimen.
He noted a lack of clarity about several aspects of AstraZeneca's data.
"I hate to criticize fellow academics, or anyone for that matter, but releasing information like this is like asking us to try and read the tea leaves," Omer said.
Let's be clear here, the Brits have failed. It's looking like the Fall of Singapore.
Experts have questions about AstraZeneca's vaccine data | CNN
Vaccine experts -- including those who serve on advisory committees for the US Food and Drug Administration and the US Centers for Disease Control and Prevention -- have questions about data released Monday by AstraZeneca about its Covid-19 vaccine.
Here's a recap (TLDR version in BOLD)...
1) AZ did NOT provide the underlying data that validated the efficacy, whereas the prior two mRNA vaccine trials did.
In a press release Monday, the pharmaceutical giant announced that its vaccine is on average 70% effective. However, the company did not state the data that led them to that conclusion.
"Absent knowing this, it's hard to know the significance of their findings," said Dr. Paul Offit, a member of the FDA's Vaccines and Related Biological Products Advisory Committee, which will review Covid-19 vaccines before they are put on the market.
When two other pharmaceutical companies, Pfizer and Moderna, released their efficacy results earlier this month, they did include the data that led to their results.
.....
2) AZ did not provide a breakdown of those that contracted COVID between vaccinated and placebo - that seems like obvious info to disclose.
In its press release, AstraZeneca said a total of 131 study participants developed Covid-19 but did not say how many of those people had received the Covid-19 vaccine and how many did not.
....
3) It was previously put on hold twice because of safety issues and yet, no safety data was provided.
The AstraZeneca trial was put on hold twice because government regulators were concerned about two study participants who became seriously ill. Regulators later allowed the trial to resume.
"I'd like to know the data specifically about those serious adverse reactions that caused the trial to go on pause," said Dr. William Schaffner, a member of the CDC's Advisory Committee on Immunization Practices, which will also be reviewing the vaccines before they're allowed on the market.
...
4) Even the own team doesn't know why there was efficacy divergence, but it will take weeks and months to figure out
The group that received the half-dose initially was 90% protected against Covid-19, and the group that received two full doses was only 62% protected.
One of the lead Oxford researchers, Dr. Adrian Hill, said it would take "probably weeks and months" to understand why the lower dose yielded much better results.
....
5) the sample size for the 90% was far smaller than the other vaccines
Dr. Saad Omer, a vaccine specialist at the Yale School of Medicine, noted that the group with the 90% efficacy rate was relatively small -- just 2,741 study participants -- and those results might not hold up when more people are given this regimen.
He noted a lack of clarity about several aspects of AstraZeneca's data.
"I hate to criticize fellow academics, or anyone for that matter, but releasing information like this is like asking us to try and read the tea leaves," Omer said.
How you can equate the Fall of SG and the vaccine is beyond me. 🙄 🙄
Anyway, it was a press release -- like Pfizer a couple of weeks ago. Let's wait for the sub-studies and the results.
This vaccine on the surface would offer much more hope that the Pfizer option.
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I was just trying to rile you up.
You hit on precisely the difference - while those others were also press releases, they also released the underlying data that supported the efficacy, safety and experimental procedures. We have much less of that with AZ according to plenty of global experts.
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