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OT: Who will be the first company with a successful corona vaccine? Pfizer news.

T2Kplus10

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Pfizer and their partner (German drugmaker BioNTech) making big news today, but many others companies working on vaccines as well:

https://www.cnbc.com/2020/07/01/pfi...in-early-stage-coronavirus-vaccine-trial.html

Pfizer shares jumped by nearly 7% in premarket trading Wednesday after it released positive results from its closely watched early-stage human trial on a coronavirus vaccine.

The trial evaluated 45 people. Each participant received 10, 30 or 100 microgram doses of the vaccine or a placebo.

The company coronavirus vaccine produced neutralizing antibodies, which researchers say is important for acquiring protection, in all participants who received two of the 10 or 30 microgram doses after 28 days, according to the preliminary data, which were posted in a paper released on MedRXiv. The company said the levels of neutralizing antibodies were 1.8 to 2.8 times higher than in recovered Covid-19 patients.

After 28 days, all participants in the two lower dose groups had significant levels of binding antibodies, the company said.

“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” Kathrin Jansen, head of Pfizer’s vaccine research and development, said in a press release. “We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency.”

The U.S.-based pharmaceutical giant has been working alongside German drugmaker BioNTech. The company’s experimental vaccine contains genetic material called messenger RNA, or mRNA. The mRNA is a genetic code that tells cells what to build — in this case, an antigen that may induce an immune response for the virus.

Pfizer said the vaccine was generally well-tolerated, though the experimental vaccine also caused fever in some patients, especially for those who were in the 100 microgram group. Most patients reported pain at the injection site, which was mild to moderate, the company said, except in one of 12 subjects who received a 100 microgram dose, which was severe.

The findings posted Wednesday have not been peer-reviewed yet.

The effort by Pfizer and BioNTech is one of several working on a potential vaccine to prevent Covid-19, which has infected more than 10 million people worldwide and killed at least 511,851, according to data compiled by Johns Hopkins University. There are more than 100 vaccines currently under development, according to the World Health Organization.

Another leading vaccine candidate from biotech firm Moderna is expected to enter a late-stage trial later this month, pending data from a mid-stage trial.

Hopes to get a vaccine to market are high, but scientists are setting expectations low for how quickly it can happen. Developing, testing and reviewing any potential vaccine is a long, complex and expensive endeavor that could take years, global health experts say.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, has said he is “cautiously optimistic” scientists can find a safe and effective vaccine by early 2021.

Scientists hope the antibodies provide some degree of protection against getting Covid-19, but they can’t say that definitively yet since it hasn’t been studied and some patients appear to have been reinfected after recovering from the virus. Scientists conducting larger vaccine studies later this year hope to answer that.

Pfizer said it expects to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021. The company intends to begin a mid-stage trial as early as this month.
 
More info on Pfizer's trial, they are working on 4 different vaccines with the winner going into a large trial required for FDA approval:

https://www.statnews.com/2020/07/01...m-pfizer-and-biontech-shows-positive-results/

An experimental Covid-19 vaccine being developed by the drug giant Pfizer and the biotech firm BioNTech spurred immune responses in healthy patients, but also caused fever and other side effects, especially at higher doses.

The first clinical data on the vaccine were disclosed Wednesday in a paper released on MedRXiv, a preprint server, meaning it has not yet been peer-reviewed or published in a journal.

“We still have a ways to go and we’re testing other candidates as well,” said Philip Dormitzer, the chief scientific officer for viral vaccines at Pfizer’s research laboratories. “However, what we can say at this point is there is a viable candidate based on immunogenicity and early tolerability safety data.”

The study randomly assigned 45 patients to get one of three doses of the vaccine or placebo. Twelve receive a 10 microgram dose, 12 a 30 μg dose, 12 a 100 μg dose, and nine a placebo. The 100 μg dose caused fevers in half of patients; a second dose was not given at that level.

Following a second injection three weeks later of the other doses, 8.3% of the participants in the 10 μg group and 75% of those in the 30 μg group developed fevers. More than 50% of the patients who received one of those doses reported some kind of adverse event, including fever and sleep disturbances. None of these side effects was deemed serious, meaning they did not result in hospitalization or disability and were not life-threatening.

The vaccine generated antibodies against SARS-CoV-2, the virus that causes Covid-19, and some of these antibodies were neutralizing, meaning that they appear to prevent the virus from functioning. Levels of neutralizing antibodies were 1.8- to 2.8-times the level of that in the recovered patients.

It’s not certain that higher antibody levels will lead to immunity to the virus. To prove that, Pfizer will need to conduct large studies that aim to prove that people who have received the vaccine are at least 50% less likely to become infected. Those studies are expected to begin this summer, mostly in the United States. Pfizer is testing four different versions of the vaccine, but only one will advance to larger studies.

The current study did not include pregnant women, and no other information on the ethnic diversity of participants was noted, although the paper does say that future studies will need to include a more diverse group.

The second dose, a booster shot, was required for immunity. The patients who received the single 100 μg dose had lower antibody levels than those who received two shots of the lower doses.

Fourteen Covid-19 vaccines are currently in human trials, according to the Milken Institute, including entrants from Inovio, CanSino, AstraZeneca, and Moderna. More are expected to start soon, including entrants from Merck, Johnson & Johnson, and Sanofi. In total, 178 vaccines are in various stages of development.

The Pfizer/BioNTech vaccine, like the Moderna vaccine, is based on a technology called messenger RNA, which uses a key genetic messenger found in cells to create protein that the immune system then learns to attack. Moderna has not yet published data on its vaccine but is expected to do so soon.
 
Without reading the article, do we know once approved how quickly it can roll out to basically everyone in world?

I know these are first steps and am grateful, but when me and my family can get it is the real finish line.
 
Without reading the article, do we know once approved how quickly it can roll out to basically everyone in world?

I know these are first steps and am grateful, but when me and my family can get it is the real finish line.
Full scale product will take some time, but less time than people assume. The major vaccine companies have already agreed to pool their production capacity for whatever vaccine makes it across the finish line first. As such, if the Pfizer vaccine "wins" the race, you will see J&J, GSK, Sanofi, AZ, and Merck all manufacture this due to the worldwide need.

I bet many people in the US will have access to the vaccine within 3-6 months of approval. People at risk would likely get it first.
 
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HA! HA! Sad but true.

There are currently 14 vaccine candidates in human trials, very proud of my industry for stepping up! Let's get it done.
Could save your industry from national health care. Would be a "win" for the private sector.. if they can deliver it cheaply too.
 
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I bet the first "successful" vaccine/large trial will be announced by the end of the year. Perhaps approval and availability in the spring? What are your sources saying?
He was 50/50 that we’d have one by winter, but that was a few months ago. He’s updated that to the Spring. Let’s just say he’s a guy who would know. We didn’t get into much else as we were discussing some investment/funding topics.
 
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Pfizer and their partner (German drugmaker BioNTech) making big news today, but many others companies working on vaccines as well:

https://www.cnbc.com/2020/07/01/pfi...in-early-stage-coronavirus-vaccine-trial.html

Pfizer shares jumped by nearly 7% in premarket trading Wednesday after it released positive results from its closely watched early-stage human trial on a coronavirus vaccine.

The trial evaluated 45 people. Each participant received 10, 30 or 100 microgram doses of the vaccine or a placebo.

The company coronavirus vaccine produced neutralizing antibodies, which researchers say is important for acquiring protection, in all participants who received two of the 10 or 30 microgram doses after 28 days, according to the preliminary data, which were posted in a paper released on MedRXiv. The company said the levels of neutralizing antibodies were 1.8 to 2.8 times higher than in recovered Covid-19 patients.

After 28 days, all participants in the two lower dose groups had significant levels of binding antibodies, the company said.

“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” Kathrin Jansen, head of Pfizer’s vaccine research and development, said in a press release. “We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency.”

The U.S.-based pharmaceutical giant has been working alongside German drugmaker BioNTech. The company’s experimental vaccine contains genetic material called messenger RNA, or mRNA. The mRNA is a genetic code that tells cells what to build — in this case, an antigen that may induce an immune response for the virus.

Pfizer said the vaccine was generally well-tolerated, though the experimental vaccine also caused fever in some patients, especially for those who were in the 100 microgram group. Most patients reported pain at the injection site, which was mild to moderate, the company said, except in one of 12 subjects who received a 100 microgram dose, which was severe.

The findings posted Wednesday have not been peer-reviewed yet.

The effort by Pfizer and BioNTech is one of several working on a potential vaccine to prevent Covid-19, which has infected more than 10 million people worldwide and killed at least 511,851, according to data compiled by Johns Hopkins University. There are more than 100 vaccines currently under development, according to the World Health Organization.

Another leading vaccine candidate from biotech firm Moderna is expected to enter a late-stage trial later this month, pending data from a mid-stage trial.

Hopes to get a vaccine to market are high, but scientists are setting expectations low for how quickly it can happen. Developing, testing and reviewing any potential vaccine is a long, complex and expensive endeavor that could take years, global health experts say.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, has said he is “cautiously optimistic” scientists can find a safe and effective vaccine by early 2021.

Scientists hope the antibodies provide some degree of protection against getting Covid-19, but they can’t say that definitively yet since it hasn’t been studied and some patients appear to have been reinfected after recovering from the virus. Scientists conducting larger vaccine studies later this year hope to answer that.

Pfizer said it expects to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021. The company intends to begin a mid-stage trial as early as this month.

Was a human pincushion from 1960 to 1991, keeping my shot record up to date for trips to the Far East at taxpayer expense. Some number of shots produced a reaction, largely expected, mostly light fever and/or soreness. The shot lady once told me the shots give you a very mild case of the disease. Every disease is different.
 
They will, the need is too great and profit on this would cause a huge backlash.
Played with a guy today at Bel Air Country Club who would know. Estimates are north of 20MM Chinese deaths due to Covid.
 
Moderna’s phase 3 trial is starting next week. 3 other phase 3 trials are starting in August, September and January.
 
Full scale product will take some time, but less time than people assume. The major vaccine companies have already agreed to pool their production capacity for whatever vaccine makes it across the finish line first. As such, if the Pfizer vaccine "wins" the race, you will see J&J, GSK, Sanofi, AZ, and Merck all manufacture this due to the worldwide need.

I bet many people in the US will have access to the vaccine within 3-6 months of approval. People at risk would likely get it first.
I know Merck just went on a hiring spree because they have too much work to do with Covid. My wife has been bitching for months they need more people. They finally gave the OK to hire who they need as people have been getting pulled off her standards department to strictly work on Covid stuff.

On another note Gilead is taking a public relations beating on how they're charging for Remdesivir. US gave them $70mil. for studies, now no generic available here in the states only over seas. A dose here is $700(you need 5) over seas $71.
 
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Without reading the article, do we know once approved how quickly it can roll out to basically everyone in world?

I know these are first steps and am grateful, but when me and my family can get it is the real finish line.
Depends very much on the nature of the vaccine. A genetically engineered one can be rolled out super quick. If you have to grow stuff, will take much longer.
 
All the Bernie Sanders socialist smears and rants against big pharma seem like abject idiocy today.
 
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EmphyCorp N115 Non-Steroidal Nasal Spray for COVID-19 with no adverse effects is now finishing it's Clinical Trial (it is also a Preventative).....see prior PR Newswire Press Releases for EmphyCorp, EmphyCorp N115 News...
 
How will vaccines be distributed in the beginning

Will certain groups like those in nursing homes be given it ASAP

will you get it immediately or wait to see
 
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I know Merck went on a hiring spree because they have too much work to do with Covid. My wife has been bitching for months they need more people. They finally gave the OK to hire who they need as people have been getting pulled off her standards department to strictly work on Covid stuff.

On another note Gilead is taking a public relations beating on how they're charging for Remdesivir. US gave them $70mil. for studies, now no generic available here in the states only over seas. A dose here is $700(you need 5) over seas $71.

we are also taking one of our packaging lines out of mothballs to get ready
 
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