[Velvet]

Originally Posted by JGVillages

43,000 not 4300. Numbers matter but not so much in economic studies.

Right you are, what is one zero? LOL in my defense hubby was talking continually at me about Formula 1 racing while I was trying to read and write.... So we are talking of Less than 1/2 a percent?

[Boomer]

Originally Posted by blueash

You're not understanding at all what they are reporting. Pfizer is following a group of people, about 43,000, half of whom got two doses of vaccine and half got two doses of a placebo. Then they watch to see what happens. The only way to know if a vaccine works is to either deliberately expose the participants to the disease or to allow for community exposure. If there is not any disease in a community then you will never know if the vaccine works as there will be zero cases in both groups.

So Pfizer had to just follow their participants and wait until a pre-determined number of cases had been diagnosed. Then look to see if the vaccinated group got fewer cases than the un-protected group. This report today is that they have reached their first pre-determined report level and those who got the shots were 90% less likely to get Covid than those who got two placebo doses. That is very good but does not answer a lot of questions. Pfizer will continue to follow their groups and will be reporting more data on both protection and side effects.

The efficacy study will terminate when they have about 160 people actually get Covid and then they will look at the rates in each group. They will follow longer to evaluate long term protection and long term side effects. The protocol is HERE https://pfe-pfizercom-d8-prod.s3.ama...ol_Nov2020.pdf

An independent panel is doing the analysis and all will be subject to FDA review which hopefully will be rigorous and not subject to outside influence. There is a problem with this vaccine in that it has rather severe requirements for storage, shipping and handling which is not an issue for some of the other vaccines in testing.

Thank you, Dr. blueash.

Pfizer’s CEO was quick to clarify that they were not a part of warp speed. This is not a rush job but it’s a start. Sounds like a really good start.

I read that Lipitor made them 100 billion between the time they patented it in 1997 and when the patent expired and it went generic. I thought they were the biggest pharmaceutical company in the world, but I just looked it up and it looks like the top spots move around a little — for now.

[Topspinmo]

Originally Posted by 44Apple

Don't want the vaccine? Don't take it, or any others that are coming.

Only after I study the side effects.

[rustyp]

Originally Posted by Boomer

Thank you, Dr. blueash.

Pfizer’s CEO was quick to clarify that they were not a part of warp speed. This is not a rush job but it’s a start. Sounds like a really good start.

I read that Lipitor made them 100 billion between the time they patented it in 1997 and when the patent expired and it went generic. I thought they were the biggest pharmaceutical company in the world, but I just looked it up and it looks like the top spots move around a little — for now.

I knew an employee at Pfizer and Lipitor was the goose that laid the golden egg. They have been searching for a repeat since. This will be interesting since the latest news is Pfizer has developed the vaccine but (shhh) in partnership with a German firm. The news is sure to dribble out within the next few days.

[blueash]

Originally Posted by Velvet

Right you are, what is one zero? LOL in my defense hubby was talking continually at me about Formula 1 racing while I was trying to read and write.... So we are talking of Less than 1/2 a percent?

I am mystified a bit that someone who studied economics doesn't understand the math involved. I'll give you a different example to see if it helps. Take 20,000 who wear seat belts and 20,000 who don't and after 12 months ask "Is there a lower death rate from automobile accidents in the seat belt wearing group?" As very few people in either group are going to have a bad accident in those 12 months your analysis will be of differences in those very few who had a bad accident. Say 10 people die in the no seat belt group but only one in the seat belt wearers. Yes, there are only 11 deaths in the 40,000 people but the power to detect a difference is clearly demonstrated. In this example seat belts are 90% effective in preventing deaths as where 10 died in the non-protected group, only one died in the belt wearers.

[Velvet]

I follow you, but, it seems you are not following me and I will try not to insult medical studies at the same time. The 90% is not what I am talking about. I am talking about the very small number of people that they are reporting on so far: 94 out of 43,000. Doesn’t matter what you compare it to, seatbelts or otherwise, it is still 94 people who got infected out of 43,000 people in the study. We don’t know about the 42,906 others.

[blueash]

Originally Posted by Velvet

I follow you, but, it seems you are not following me and I will try not to insult medical studies at the same time. The 90% is not what I am talking about. I am talking about the very small number of people that they are reporting on so far: 94 out of 43,000. Doesn’t matter what you compare it to, seatbelts or otherwise, it is still 94 people who got infected out of 43,000 people in the study. We don’t know about the 42,906 others.

Of course we do. Read the protocol. I provided the link. The other 43K did not get clinical Covid. They are just like the people in the seat belt study who did not get in a car accident. Next you might come back and say, why didn't they do blood tests to see if people got sub-clinical Covid not depend on symptomatic cases for analysis. Because blood tests look for antibodies and all or nearly all who got the vaccine should have antibodies from the shot.

This is why the study has to have huge numbers, to detect differences in an event with a low frequency in a general population. The other reason for large numbers is to find rare side effects. Obviously the bigger the test group the better chance of finding a rare event. In this study where about 22K got the pair of shots no significant side effects have been reported to the public. This is a public relations report from Pfizer not a sworn statement with complete data as they will be submitting to the FDA. But I think Pfizer would play it straight and be as honest as a corporation can be as if it turns out they were hiding or minimizing adverse outcomes it would be a serious blow to their image.

[Altavia]

Originally Posted by Stu from NYC

Interesting as to when this info was released and how they changed the study somewhat to make sure it would not be released in October.

The more effective the vaccine, the longer it takes to get enough data to compare the vacinated group.

E.g.: If the vaccine were only 50% effective, the announcement would be earlier.

[Velvet]

Originally Posted by blueash

Of course we do. Read the protocol. I provided the link. The other 43K did not get clinical Covid. They are just like the people in the seat belt study who did not get in a car accident. Next you might come back and say, why didn't they do blood tests to see if people got sub-clinical Covid not depend on symptomatic cases for analysis. Because blood tests look for antibodies and all or nearly all who got the vaccine should have antibodies from the shot.

This is why the study has to have huge numbers, to detect differences in an event with a low frequency in a general population. The other reason for large numbers is to find rare side effects. Obviously the bigger the test group the better chance of finding a rare event. In this study where about 22K got the pair of shots no significant side effects have been reported to the public. This is a public relations report from Pfizer not a sworn statement with complete data as they will be submitting to the FDA. But I think Pfizer would play it straight and be as honest as a corporation can be as if it turns out they were hiding or minimizing adverse outcomes it would be a serious blow to their image.

Thank you, I appreciate the explanation. I understand the testing was done one week after the second dose and they are not sure about the protection time as the antibodies have an unknown half life so there will be another test 2 weeks after the second dose to see how effective it still is etc. Therefore, I am cautiously optimistic.

[Byte1]

Not part of Warp Speed? Hmmm, so you don't think that Warp Speed competition could have been a motivating factor to get a vaccine out before the others? They may not have taken any money but they sure entered the race.

[rustyp]

Originally Posted by Byte1

Not part of Warp Speed? Hmmm, so you don't think that Warp Speed competition could have been a motivating factor to get a vaccine out before the others? They may not have taken any money but they sure entered the race.

Is to say you think the other drug makers wouldn't be scrambling to be first to market without Op Warp Spd ? That's a hard "pill" to swallow.

[blueash]

Originally Posted by Velvet

Thank you, I appreciate the explanation. I understand the testing was done one week after the second dose and they are not sure about the protection time as the antibodies have an unknown half life so there will be another test 2 weeks after the second dose to see how effective it still is etc. Therefore, I am cautiously optimistic.

Again I suggest you read the protocol,
https://pfe-pfizercom-d8-prod.s3.ama...ol_Nov2020.pdf
They begin the evaluation for efficacy 7 days after the second vaccine which is the beginning time at which they hope the vaccine will be protective. But they are following for Covid disease continuously from that day forward. In addition to looking at disease prevention they are also drawing blood at the many follow up visits the participants attend. They are continuing to see them until 24 months which obviously is in 2022. One of the blood tests being done is immunogenicity testing.

Again it should be emphasized that this report lacks any detail. For example, what is the patient age distribution in the study group. The protocol says they intend to have 40% of participants be age 55 or older. As the disease is most serious in those over 70 I'd like to know how many were in that age group and whether any efficacy was found. The numbers may be too small to know. The only reported data is on the whole group, not any subgroup.

Optimism is welcome but tempered with reality. I look forward to more data on this as well as the other products in testing by other manufacturers both here and abroad.

[Altavia]

Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints | Pfizer

PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS

* Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;

* 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group

* Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%

* Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved

* Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%

* Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe

* The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.

This press release features multimedia. View the full release here: Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints | Business Wire

There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.

To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.

In addition, the companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. These data also will be submitted to other regulatory agencies around the world.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue to collect efficacy and safety data in participants for an additional two years.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer’s facilities are part of the manufacturing and supply chain; St. Louis, MO; Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium. BioNTech’s German sites will also be leveraged for global supply.

Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.

[graciegirl]

Originally Posted by Bucco

As a side note to your implication...

"Among the frontrunners, theirs is the only vaccine project that did not take funding from the White House-led Operation Warp Speed program to bolster research, development or manufacturing. BioNTech received up to 375 million euros ($445 million) in development funding from the German government, however."

Bloomberg - Are you a robot?

WarpSpeed is funding Pfizer to distribute it.

Give the devil his due. Sheesh.

[Bucco]

Originally Posted by graciegirl

WarpSpeed is funding Pfizer to distribute it.

Give the devil his due. Sheesh.

I simply pointed out the truth since we were once again lied to by our government...



"AP FACT CHECK: Trump distorts on vaccine, state distribution

WASHINGTON (AP) — President Donald Trump on Friday wrongly claimed full credit for Pfizer Inc.’s announcement that its COVID-19 vaccine was robustly successful and suggested without evidence that a separate state review will cause a protracted delay for New York residents waiting for a vaccine.

A look at the statements, made during his first public remarks since his defeat by President-elect Joe Biden:

TRUMP: “As a result of Operation Warp Speed, Pfizer announced on Monday that its China virus vaccine was more than 90% effective. ...Pfizer said it wasn’t part of Warp Speed, but that turned out to be an unfortunate misrepresentation.”

THE FACTS: Not so much. Pfizer notably did not accept government money to develop, test or expand manufacturing capacity under Trump’s Operation Warp Speed initiative to quickly find a vaccine and treatments for the disease sweeping the country.

In fact, Pfizer partnered with the vaccine’s original developer, Germany’s BioNTech, in March and the following month announced the first human study in Germany. The White House announced Operation Warp Speed in May.[/B]

AP FACT CHECK: Trump distorts on vaccine, state distribution

Not the study was announced a month before warp speed.

Distribution is different

"Pfizer had already made it quite clear that it doesn’t need the U.S. government to help distribute its COVID-19 vaccine, should it be authorized by the FDA. Now it’s putting an exclamation point on that declaration.

The company will not use the government’s chosen distribution partner, McKesson, but rather its own system to deliver the COVID vaccine directly to healthcare providers, said Tanya Alcorn, Pfizer's vice president for biopharma global supply chain, during a recent webinar from the U.S. Chamber of Commerce. A Pfizer spokesperson confirmed that plan in an email to FiercePharma."

Pfizer goes solo on U.S. shot distribution, opting out of government channels | FiercePharma

The devil will lead you astray.