COVID Vaccine Talk/Tracker - Pfizer's Finals Results: 95% Effective & No Safety Issues

@ wrote:

The Covid-19 vaccine being developed by Pfizer Inc. and BioNTech SE prevented more than 90% of infections in a study of tens of thousands of volunteers, the most encouraging scientific advance so far in the battle against the coronavirus. . .

The findings are based on an interim analysis conducted after 94 participants contracted Covid-19. The trial will continue until 164 cases have occurred. If the data hold up and a key safety readout Pfizer expects in about a week also looks good, it could mean that the world has a vital new tool to control a pandemic that has killed more than 1.2 million people worldwide.

“This is about the best the news could possibly be for the world and for the United States and for public health,” said William Gruber, Pfizer senior vice president for vaccine clinical research and development. It was better than even the best result he had hoped for, he said. . .

The data do have limits. For now, few details on the vaccine’s efficacy are available. It isn’t known how well the shot works in key subgroups, such as the elderly. Those analyses haven’t been conducted. And it isn’t known whether the vaccine prevents severe disease, as none of the participants who got Covid-19 in this round of analysis had severe cases, Gruber said.
[www.bloomberg.com]

Thought the topic deserved a thread of its own. It's not limited to just talk of Pfizer's vaccine. Feel free to post vaccine news of any company.

Edited 5 time(s). Last edit at 11/18/2020 02:30PM by shoptastic.

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I just read The Washington Post's full story on this and another similar vaccine that will probably be ready to report significant result within weeks. Producing TWO injections per person is going to be a HUGE challenge for the system in 2021, so we need to expect that top priority folks (Medical and other first responders) will account for most or all of 2021 production. That said, this is really quite amazing progress.

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This has been circulating online:

@ wrote:

“Dr. Jansen said the outside board did not say how many of those cases came from participants who had been vaccinated. But with a rate of more than 90% effectiveness, most had to have been in the placebo group.”
People possibly getting too excited too soon?
Actually the statistics support early confidence. Remember, no one expects 100% protection from any vaccine.

Based in MD, near DC
Shopping from the Carolinas to New York
Have video cam; will travel

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Even if it was 100% in trials, this is a vaccine that has issues as it apparently needs to be kept at -80. Dry ice is only -78 if I recall correctly. Distribution with it staying viable will be quite an issue.
@walesmaven wrote:

Actually the statistics support early confidence. Remember, no one expects 100% protection from any vaccine.
Yeah, 90% is about as close to a gold standard as possible. Early projections were hoping for even 50% efficacy. That was something I was aware of.

[www.nytimes.com] (quote was originally from here)
I think the part I highlighted that was debated on fintwit this morning was a possible misunderstanding of what was being said in the quotes (from the article linked here). We know from the study that 50% of participants got two doses of the vaccine and 50% were the placebo group (getting nothing). Pfizer has not release who got what and the question was what this 90% number meant (e.g., from which group were the infections coming from and at what rate).

I think the fear was that maybe people got the virus equally in both groups (or worse), meaning the vaccine had no effect or less effect that advertised. I saw other weird debates this morning too on what various parts of the study meant (as Pfizer, again, had not released details).

But, that wouldn't make sense for the unanimous euphoric medical community reaction if the vaccine didn't have such high efficacy. Until otherwise informed, I take the news in its best interpretation: that the vaccine is producing 90% prevention efficacy in those taking it. They note that this rate is subject to change over time, but the initial news is no doubt quite stunning.

Edited 2 time(s). Last edit at 11/10/2020 04:23AM by shoptastic.
@Flash wrote:

Even if it was 100% in trials, this is a vaccine that has issues as it apparently needs to be kept at -80. Dry ice is only -78 if I recall correctly. Distribution with it staying viable will be quite an issue.

Problem is that Americans never were able to switch to the metric system in the 1970's.

-70C = -94F, Required temp of the vaccine.

Dry ice sublimates at -78C = -109F
Liquid Nitrogen is -196C

I'm sure that is the least of their worries. Scientists don't use English measurements.
@Flash wrote:

Even if it was 100% in trials, this is a vaccine that has issues as it apparently needs to be kept at -80. Dry ice is only -78 if I recall correctly. Distribution with it staying viable will be quite an issue.
As noted above (to walesmaven), it wasn't so much being in trials that was at issue in my "worry post," but rather that Pfizer had not broken down what the 90% meant in regards to vaccinated vs. placebo group prevention efficacy and infection rates.

Although, I do currently take it to mean what the best interpretation would be and will do so until officially told otherwise (by Pfizer). Sorry to all if that produced unnecessary confusion.

I did see that temperature issue too later in the day. It's pretty temperamental - pun intended. smiling smiley Lots of logistics challenges, but I have faith we'll figure out a way to make it work.

One thing I've seen people say that could be good news is that perhaps this vaccine news will encourage Americans to stay safe during these upcoming three to six months, who otherwise may have been less virus-conscious. There is light at the end of the tunnel. Pending safety data in the next few weeks, we may have a gold standard vaccine for COVID-19.

--Don't die unnecessarily from COVID in the meantime.
--Wear masks & socially distance.
--Don't gather in crowded places.
--Protect others (if not yourself), until we can disseminate this vaccine.

This is projected (if nothing is done) to be a pretty brutal COVID winter. We're at 100,000+ U.S. cases several days in a row in the U.S. Europe is at their peaks too.

If there were ever a worthy time to lockdown (I don't expect this, but just saying) and/or aggressive go into virus-prevention mode, this would be it! You have sky-high infections, BUT also a gold standard vaccine ready to be stamped with approval. DON'T MESS THIS UP! Keep safe. Stay alive. Keep others safe!

I think the way I saw it worded was that the value of safety in the next few months is much higher now with this vaccine news. It's not all just hopeless and everyone doesn't just have to get it. I do hope it makes otherwise non-COVID safety compliant people think twice and do their part. It could mean the difference between one of their own loved ones surviving or not.

Edited 1 time(s). Last edit at 11/10/2020 04:54AM by shoptastic.
@SoCalMama wrote:

@Flash wrote:

Even if it was 100% in trials, this is a vaccine that has issues as it apparently needs to be kept at -80. Dry ice is only -78 if I recall correctly. Distribution with it staying viable will be quite an issue.
Problem is that Americans never were able to switch to the metric system in the 1970's.

-70C = -94F, Required temp of the vaccine.

Dry ice sublimates at -78C = -109F
Liquid Nitrogen is -196C

I'm sure that is the least of their worries. Scientists don't use English measurements.
I wonder how this affects Third World vaccination. Laurie Garrett (Pulitzer Prize winning journalist in medicine), B.S. Biology (UC Santa Cruz), Ph.D. studies*** in Immunology (Berkeley) has raised concerns about the need for refrigeration.

This could lead to a slower and globally disjointed vaccination campaign with pockets of the world (those without modern refrigeration, especially) having trouble getting it (at least for some time). As a result, that leaves us still vulnerable to COVID (albeit, better than before) until you have mass, global vaccination. Travel to and from places without vaccination should still be risky until total population vaccination. The U.S. (due to Pfizer co-funding/discovering it) will be among the first to get it. But that wouldn't make things totally safe just yet. Just some things to keep in mind.

***She left he Ph.D program to do medical journalism, which she found more rewarding - hence, the "studies" part.
The 'change over time' is critical. We will need to know who is experiencing change, and when. (And why and how!)

I feel for people who are frustrated and feel helpless against this disease. Many people want something right now! Meanwhile, research necessarily takes its time.




@shoptastic wrote:

@walesmaven wrote:

Actually the statistics support early confidence. Remember, no one expects 100% protection from any vaccine.
Yeah, 90% is about as close to a gold standard as possible. Early projections were hoping for even 50% efficacy. That was something I was aware of.

[www.nytimes.com] (quote was originally from here)
I think the part I highlighted that was debated on fintwit this morning was a possible misunderstanding of what was being said in the quotes (from the article linked here). We know from the study that 50% of participants got two doses of the vaccine and 50% were the placebo group (getting nothing). Pfizer has not release who got what and the question was what this 90% number meant (e.g., from which group were the infections coming from and at what rate).

I think the fear was that maybe people got the virus equally in both groups (or worse), meaning the vaccine had no effect or less effect that advertised. I saw other weird debates this morning too on what various parts of the study meant (as Pfizer, again, had not released details).

But, that wouldn't make sense for the unanimous euphoric medical community reaction if the vaccine didn't have such high efficacy. Until otherwise informed, I take the news in its best interpretation: that the vaccine is producing 90% prevention efficacy in those taking it. They note that this rate is subject to change over time, but the initial news is no doubt quite stunning.

Things are not to be judged good or bad merely because the public think so. - Tacitus
@SoCalMama wrote:

@Flash wrote:

Even if it was 100% in trials, this is a vaccine that has issues as it apparently needs to be kept at -80. Dry ice is only -78 if I recall correctly. Distribution with it staying viable will be quite an issue.

Problem is that Americans never were able to switch to the metric system in the 1970's.

-70C = -94F, Required temp of the vaccine.

Dry ice sublimates at -78C = -109F
Liquid Nitrogen is -196C

I'm sure that is the least of their worries. Scientists don't use English measurements.

[www.wsj.com] and other information is that the vaccine needs to be stored at -80 and that is indeed Celsius and is indeed where the issue lies. Dry ice will have issues maintaining that temperature as it only is -78, so not cold enough. One supermarket I am aware of here can sell you dry ice, but they are not making it. They rather have it for keeping freezers frozen when there is a power failure or equipment failure until the situation is resolved. The popularity of restaurant frozen treats and cold brew beverages has liquid nitrogen available, but it may even be too cold and damage the vaccine.

It is true that most of the world works on metric measures while the US does not, but in reality science tends to work in Kelvin for temperatures.
@Flash wrote:

It is true that most of the world works on metric measures while the US does not, but in reality science tends to work in Kelvin for temperatures.

Oh yeah. All of the labs that I have worked in use Kelvin scale. hahaha
After what I've read about the unprecedented temperature shipping, handling and administering requirements, I'm disheartened. I remain hopeful that other vaccine options will follow soon.
By the time the vaccine is available to me, we will have more information in terms of distribution, effectiveness, and safety. Application can reveal some differences from controlled testing.
It appears that both India and China are developing vaccines that do not have such stringent temperature requirements.

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If my understanding is correct, all the vaccines being worked on are using "live parts" so all are likely to need careful low temperature control. In one form or other the vaccines are presenting a living section of RNA for the body to 'learn' to make antibodies that will capture and deactivate the Covid-19 cells.

It is probably easiest to think of preservation of these "live parts" experientially. if you fill a bag with fresh strawberries and pop it in your home freezer, when you subsequently thaw it out you will have red mush because the moisture in the cells of the berry built large crystals which punctured the cell walls and when you thaw the mass you have the berry fluid from inside those cells and the mushy mass of berry remains. A commercial producer will rather have the cleaned berries on a belt going single layer through a dry ice or liquid nitrogen freezing unit such that the berries freeze almost instantly and thus have only have small ice crystals that don't destroy the cell walls. When you thaw these berries, they are individually frozen and there is not significant juice in the bag.

In the world outside the research laboratory, human eggs and sperm are sometimes frozen in liquid nitrogen such that there will still be the opportunity to have children after some medical procedure that could damage or destroy the ability to produce viable sperm or eggs in the future. Certainly not a process as simple as running strawberries through a freezer of liquid nitrogen, but it does result in living tissue that is still capable of its original function.
I saw an article where UPS built freezer farms. I'm sure Fedex has something similar. The NYTimes had an article where someone from Pfizer said they were currently designing a box/container that would keep the vaccine cold in transit.

[www.bloomberg.com]

@Flash wrote:

Even if it was 100% in trials, this is a vaccine that has issues as it apparently needs to be kept at -80. Dry ice is only -78 if I recall correctly. Distribution with it staying viable will be quite an issue.

Kim
While I am sure they will find ways to transport the vaccine, the likelihood of local pharmacies able to preserve the vaccine is likely to be the issue for distribution. I am in a county of about 3/4 of a million folks. Only the main pharmacy of the main part of the hospital is being set up to receive and administer the vaccine. My guess would be that the vaccine transport container is likely to hold 1000 doses so I can readily see lots of paperwork to establish priority for vaccine and appointments set up with some planning for the 3 week wait for the second dose. The mere logistics of this are likely to make it many many months before those wanting the vaccine will be able to get it.

I am thinking of the difficulty of getting Shingrix, the vaccine for Shingles. Only those over 65 or seriously at risk were eligible when it was first available. We were on the waiting list with nine different pharmacies for the vaccine after my significant other got a case of Shingles for I think it was 10 months before a pharmacy could give us our first shot with reasonable expectation they would be able to give us the second shot that could be taken anywhere from one to three months after the first shot.
Wow! We have Walgreen's and CVS that will give out the vaccine when it's ready. We also have 2 regional grocery chains that announced today they will have it as well at their pharmacies. All obviously with very limited doses but at least with more locations means more or easier access for some. I personally would rather go to a neighborhood pharmacy or grocery store than one of our hospitals which are located downtown with limited parking.

Kim


Edited 1 time(s). Last edit at 11/15/2020 12:30AM by kimmiemae.
Moderna announced a similar vaccine trial result Sunday/Monday. Of particular interest is the news about temperature requirements for the Moderna version.

From the Washington Post article of today:

"Moderna announced Monday that its vaccine can be stable at refrigerator temperatures for a month and frozen for up to six months. It will not require dilution at the point of care, unlike the Pfizer vaccine."

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Yes, this vaccine will certainly be easier to handle and distribute through small and large pharmacies alike.
We still have to see when one that can be used in Third World conditions may emerge. Mobile refrigeration units can only cover so much of that territory. But, a start can be made there as well.

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If standard refrigeration is all that is needed, that should be attainable in the Third World. There are many medications that require refrigeration and that can be powered by solar panels, a small generator or even a small refrigerator plugged into power outlets of a vehicle. So even a primitive clinic or occasional clinic should be able to deal with it.
It just occurred to me that the need for a second shot three weeks later may be an issue in places where transportation is difficult. Maybe some remote areas will need a sort of "circuit rise approach to delivering doses of vaccine at appropriate intervals. I suspect that various governments and NGOs already have their thinking-caps on and whirling.

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I suspect the NGOs are indeed watching all this closely. Thus far both vaccines coming out of efficacy trials are double dose but there are 8 more currently entering efficacy trials and 30 more close to trials. The two looking for FDA approval are very similar in their approach. There are some philosophically different vaccines being developed. And right now the massive push is for "ONE" vaccine that is safe and effective for all ages, all races and all pre-existing conditions. It is likely that some of the vaccines will be found to have better efficacy in different types of patients, just as currently some cancer treatments are found to be better with different types of patients.
This is one reason the research process is lengthy.

Things are not to be judged good or bad merely because the public think so. - Tacitus
@Shop-et-al wrote:

This is one reason the research process is lengthy.

And frankly one of the reasons why government funded basic research is so necessary. We would not have a number of the medicines and treatments available today without government efforts such as the Human Genome Project of the turn of the century and subsequently the CRISPR work. We likely would be much further along in the curative powers of CRISPR had stem cell research not been impeded for years by religious objections. Luckily it was found that donated cells from consenting adults could be treated to become stem cells and the work goes on for potential benefit to us all.
[www.bbc.com]

BBC put out a general time line and flow chart for research of this type. The links lead to interesting, related articles regarding covid news. I was saddened to learn that the Oxford trial was stopped after a participant fell ill. I was heartened by the suggestion that global cooperation might improve the typical odds, in which only 10% of efforts are successful. I was encouraged by the fact that every effort, regardless of result, contributes somehow to what is needed.

Things are not to be judged good or bad merely because the public think so. - Tacitus
FDA approves first at-home, rapid self-administered COVID test:
[www.cnn.com]
@ wrote:

"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home," FDA Commissioner Dr. Stephen Hahn said in a statement. . .

But some health experts urged caution.

"The data is just still emerging, Tom Bollyky, the director of the global health program and senior fellow for global health, economics, and development at the Council on Foreign Relations, told CNN. "Obviously with some past emergency use authorizations it pays to be cautious with what the FDA has put out here, but it's certainly a promising sign."
Anyone planning to do one of these?

Edited 1 time(s). Last edit at 11/18/2020 11:03AM by shoptastic.
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