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Altavia
11-09-2020, 08:06 AM
Pfizer’s Covid-19 Vaccine Proves 90% Effective in Latest Trials - WSJ (https://www.wsj.com/articles/covid-19-vaccine-from-pfizer-and-biontech-works-better-than-expected-11604922300)

Pfizer’s Covid-19 Vaccine Proves 90% Effective in Latest Trials

U.S. drugmaker and partner BioNTech could ask FDA to permit wide use of vaccine for the new coronavirus by end of November

A vaccine developed by Pfizer Inc. PFE 0.03% and partner BioNTech SE proved better than expected at protecting people from Covid-19 in a pivotal study, a milestone in the hunt for shots that can stop the global pandemic.

The vaccine proved to be more than 90% effective in the first 94 subjects who were infected by the new coronavirus and developed at least one symptom, the companies said Monday.

The positive, though incomplete, results bring the vaccine a big step closer to getting cleared for widespread use.

Pfizer said it is on track to ask health regulators for permission to sell the shot before the end of this month, if pending data indicate the vaccine is safe.

The timetable suggests the vaccine could go into distribution this month or next, though U.S. health regulators have indicated they will take some time to conduct their review.

“Hopefully now we can move on and get this vaccine out there and make sure it’s doing what it’s supposed to do and stop” the virus, said Kathrin Jansen, Pfizer’s head of vaccine research and development, in an interview.

The findings came too early for researchers to assess the safety of the vaccine, which the U.S. Food and Drug Administration says must include two months of monitoring at least half the study’s subjects for side effects.

Pfizer said it remains on track to collect at least two months of safety data during the third week of November and could file for an emergency authorization shortly thereafter.

So far, no serious safety issues have arisen in the study, the companies said. The study has enrolled nearly 44,000 subjects in the U.S. and other countries.

It is unclear how long the protection the vaccine appears to provide lasts, since researchers haven’t been studying volunteers for very long.

The interim review of the vaccine’s effectiveness and safety was performed by an outside panel of independent experts known as a data-safety monitoring committee, which then shared its findings with Pfizer and BioNTech.

You never know what the outcome is, but we had a feeling that we did everything we could possibly do,” Dr. Jansen said.

The vaccine is among the most-advanced in development in the West, with others in late-stage testing from Moderna Inc., Johnson & Johnson and AstraZeneca PLC.

Covid-19 vaccines developed by researchers in China and Russia have already been given to people in those and certain other countries.

Pfizer and BioNTech’s vaccine uses a new and unproven technology, known as mRNA, short for the molecular couriers called messenger RNA that carry genetic instructions to cells.

The shots deliver mRNA that prompts cells to make a synthetic version of the spike protein that juts from the surface of the new coronavirus. That protein triggers the immune system to defend against the virus.

After the vaccine appeared to work safely in a smaller and earlier-stage study, Pfizer and Germany’s BioNTech began in July seeking thousands of healthy volunteers for the large final-phase trial to determine whether it could be given to the public.

Like most vaccine trials, just a fraction of the subjects must become sick to evaluate whether the two-dose shot from Pfizer and BioNTech works.

For the final analysis, 164 study subjects need to become infected and develop at least one symptom. Researchers, however, designed the trial to take peeks at how the shot is performing after smaller numbers get sick.

Researchers originally planned for a first interim analysis after 32 subjects became sick. After talking with the FDA, Pfizer agreed to conduct the early peek after at least 62 subjects became sick, Dr. Jansen said.

By the time the two sides came to an agreement, the number of subjects who developed Covid-19 symptoms reached 94, Dr. Jansen said.

Pfizer officials learned about the early, or interim, analysis Sunday after speaking with the data-safety monitoring committee, Dr. Jansen said. She said Pfizer has shared the outcome of the analysis with the FDA.

The FDA has said it won’t authorize a vaccine unless it is at least 50% effective. The agency and companies wanted to see an even higher rate during an early look at an initial set of subjects to be sure it really works.

In its first look, however, the Pfizer and BioNTech vaccine worked even better than the FDA and two companies had been seeking.

The two-dose vaccine was found to be more than 90% effective at seven days after the second dose, Pfizer said, meaning that subjects were protected four weeks after their first shot.

Pfizer didn’t disclose the breakdown of how many of the 94 subjects in the analysis received the vaccine or a placebo. In the study, half receive the vaccine, while the other half receive a placebo.

Although specific safety information wasn’t available, Dr. Jansen said the data-safety monitoring committee told Pfizer officials that any side effects were similar to those in earlier testing of the vaccine.

Previously, Pfizer said some subjects in its early-stage study of the vaccine reported side effects such as fatigue, headaches and chills, and they eventually recovered. There weren’t serious side effects.

The latest timetable for the vaccine to become widely available is consistent with what Pfizer Chief Executive Albert Bourla and BioNTech co-founder and Chief Executive Ugur Sahin have suggested.

Pfizer plans to monitor patients for two years after their second dose for safety and vaccine duration.

Write to Jared S. Hopkins at jared.hopkins@wsj.com

billethkid
11-09-2020, 08:18 AM
Interesting timing of announcement!

Bucco
11-09-2020, 09:28 AM
Interesting timing of announcement!

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? (https://www.bloomberg.com/news/articles/2020-11-09/pfizer-s-covid-vaccine-prevents-90-of-infections-in-large-study)

Stu from NYC
11-09-2020, 09:43 AM
Great news!

Boomer
11-09-2020, 11:45 AM
This is happy news. Go Pfizer!

Altavia
11-09-2020, 12:59 PM
More details on these very early results:

Covid-19 vaccine from Pfizer and BioNTech is strongly effective, data show (https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/)

Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate

Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.

The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.

The Phase 3 study is ongoing and additional data could affect results.

In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.

“I’ve been in vaccine development for 35 years,” William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told STAT. “I’ve seen some really good things. This is extraordinary.” He later added: “This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”

Although it is a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, a German company, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.

Nor is there any information yet on whether it prevents people from carrying the virus that causes Covid-19, SARS-CoV-2, without symptoms.

Because the vaccine has been studied for only a matter of months, it is impossible to say how long it will protect against infection with the virus. The vaccine does cause side effects, including aches and fevers, according to previously published data. Gruber said that he believed the side effect profile was comparable to standard adult vaccines, but probably worse than Pfizer’s pneumonia vaccine, Prevnar, or a flu shot.

The results have not been peer-reviewed by outside scientists or published in a medical journal, and even Pfizer and BioNTech have been given no other details about how the vaccine performed by the independent monitors overseeing the study.

Initial supplies of the vaccine, if authorized, will be limited. Pfizer says up to 50 million doses could be available globally. by the end of the year, with 1.3 billion available in 2021. There are also expected to be distribution challenges. The vaccine must be stored at super-cold temperatures, which could make it extremely difficult to deliver to many places. Pfizer has said it is confident those issues can be managed.

Although the estimate of the efficacy of the vaccine could change as the study is completed, it is close to a best-case scenario. That also bodes well for other vaccines in the late stages of testing, including those developed by Moderna, AstraZeneca, and Johnson & Johnson.

“If that headline really number really holds up, that is huge. That is much better than I was expecting and it will make a huge difference,” said Ashish Jha, the dean of the School of Public Health at Brown University. He cautioned, however, that it is always difficult to evaluate science via press release and that researchers will need to see the full results. He noted that side effects are something to watch, because even if there are no serious long-term complications, people feeling sick for a day or two could lead some to be hesitant to take a vaccine.

Both Pfizer’s vaccine and Moderna’s use messenger-RNA, or mRNA, technology, which uses genetic material to cause the body to create a protein from the virus; the immune system then recognizes the virus and learns to attack. Other vaccines in the late stages of development use genetically engineered viruses for a similar purpose, or pieces of protein that are directly injected. No mRNA product has ever been approved by regulators.

The story of how the data have been analyzed seems to include no small amount of drama. Pfizer, seeing an opportunity to both help battle a pandemic and demonstrate its research prowess, made decisions that were always likely to make its study the first of a Covid-19 vaccine to produce data — including its decision to have an independent group of researchers, known as a data safety and monitoring board, take an early look at the data in the 44,000-volunteer study before its completion.

The first analysis was to occur after 32 volunteers — both those who received the vaccine and those on placebo — had contracted Covid-19. If fewer than six volunteers in the group who received the vaccine had developed Covid-19, the companies would make an announcement that the vaccine appeared to be effective. The study would continue until at least 164 cases of Covid-19 — individuals with at least one symptom and a positive test result — had been reported.

That study design, as well as those of other drug makers, came under fire from experts who worried that, even if it was statistically valid, these interim analyses would not provide enough data when a vaccine could be given to billions of people.

In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.

Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.

This means that the statistical strength of the result is likely far stronger than was initially expected. It also means that if Pfizer had held to the original plan, the data would likely have been available in October, as its CEO, Albert Bourla, had initially predicted.
Gruber said that there will not be another interim analysis conducted in the study. He also said that Pfizer’s estimate that it could file for authorization of the vaccine by the third week of November was based on the assumption that the FDA would be willing to accept two-month safety data on half the volunteers in the study as initially planned, when it was to include 30,000 volunteers, not more than 44,000, as is now the case. Those discussions are ongoing.

But Gruber said he now expects that by the time of the planned meeting of the FDA’s vaccine advisory committee in December, the study’s efficacy portion could be completed, having reached 164 cases of Covid-19.

He also emphasized that although there will only be a few months of data from this study, results from earlier studies make him optimistic that immunity from the vaccine will not wane rapidly.


The study has enrolled 43,538 volunteers the companies said, and 38,955 have received their second dose. About 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.


Bourla, Pfizer’s CEO, said the results mark “a great day for science and humanity,” in a statement, saying they provide “initial evidence of our vaccine’s ability to prevent Covid-19.” He added: “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

Velvet
11-09-2020, 01:19 PM
Vaccine report is on 94 subjects (out of 20,000?)... not quite earth shattering yet. But I’m hopeful.

Stu from NYC
11-09-2020, 01:38 PM
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.

44Apple
11-09-2020, 02:25 PM
Don't want the vaccine? Don't take it, or any others that are coming.

rustyp
11-09-2020, 03:25 PM
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.

Pfizer took no development money from any political source. They were not part of "warp speed" initiative. The CEO announced today they made the announcement as soon as the independent analysis board published the results. Pfizer has every right to do as they please with their own product as long as there was no development contract. If announced prior to the day in question can you imagine how many people would take credit for their hard work and investment.

Bogie Shooter
11-09-2020, 03:50 PM
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 beginning of another conspiracy theory?
The sun will/may come up tomorrow more/or/less.......

stanley
11-09-2020, 04:27 PM
Pfizer took no development money from any political source. They were not part of "warp speed" initiative.

No development money but they still were/are going to make a lot of money, agreed to by the government and the present administration.

"THE U.S. GOVERNMENT HAS agreed to pay Pfizer and BioNTech nearly $2 billion for 100 million doses of the companies' potential coronavirus vaccine."

Being a newbie, it seems I am not allowed to post links.That is from USNews, July 22nd



Stan

blueash
11-09-2020, 04:55 PM
Vaccine report is on 94 subjects (out of 20,000?)... not quite earth shattering yet. But I’m hopeful.

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.amazonaws.com/2020-11/C4591001_Clinical_Protocol_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.

Velvet
11-09-2020, 05:46 PM
This is how I understood the results: 4300 people in study so 2150 (half) got vaccine. 94 people got infected so .0218 or if you look at only the vaccinated .0437 i.e. less than 5%. If I had tried to present conclusions based on 5% results in my economics studies they would have laughed me out of the room.

JGVillages
11-09-2020, 06:18 PM
This is how I understood the results: 4300 people in study so 2150 (half) got vaccine. 94 people got infected so .0218 or if you look at only the vaccinated .0437 i.e. less than 5%. If I had tried to present conclusions based on 5% results in my economics studies they would have laughed me out of the room.

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

Velvet
11-09-2020, 06:21 PM
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
11-09-2020, 06:35 PM
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.amazonaws.com/2020-11/C4591001_Clinical_Protocol_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
11-09-2020, 06:48 PM
Don't want the vaccine? Don't take it, or any others that are coming.

Only after I study the side effects.

rustyp
11-09-2020, 07:14 PM
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
11-09-2020, 07:17 PM
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
11-09-2020, 10:32 PM
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
11-10-2020, 07:06 AM
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
11-10-2020, 12:02 PM
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
11-10-2020, 12:50 PM
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
11-10-2020, 02:26 PM
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
11-10-2020, 03:36 PM
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
11-10-2020, 04:10 PM
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.amazonaws.com/2020-11/C4591001_Clinical_Protocol_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
11-18-2020, 07:50 AM
Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints | Pfizer (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine)

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 (https://www.businesswire.com/news/home/20201118005595/en/)

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
11-18-2020, 09:07 AM
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? (https://www.bloomberg.com/news/articles/2020-11-09/pfizer-s-covid-vaccine-prevents-90-of-infections-in-large-study)

WarpSpeed is funding Pfizer to distribute it.

Give the devil his due. Sheesh.

Bucco
11-18-2020, 12:05 PM
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 (https://apnews.com/article/ap-fact-check-joe-biden-donald-trump-politics-coronavirus-pandemic-76d1580f82b1586b207990396c1e3b5f)

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 (https://www.fiercepharma.com/pharma/pfizer-sidelines-us-government-covid-19-vaccine-distribution-plan-favor-its-own-reports)

The devil will lead you astray.

Bucco
11-18-2020, 12:14 PM
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.

Thy began studies BEFORE Warp speed existed

Becca9800
11-18-2020, 07:35 PM
Don't want the vaccine? Don't take it, or any others that are coming.

You go ahead and take it. I'll wait a bit to see how it works out for you.

Becca9800
11-18-2020, 07:41 PM
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? (https://www.bloomberg.com/news/articles/2020-11-09/pfizer-s-covid-vaccine-prevents-90-of-infections-in-large-study)

Nah. Pfizer only made a $1.95 BILLION deal to sell its vaccine to the federal gov't. No story here. Move on now.

Altavia
11-18-2020, 08:28 PM
Pfizer'''s COVID-19 vaccine was funded by Germany—not US Operation Warp Speed | Fortune (https://fortune.com/2020/11/09/pfizer-vaccine-funding-warp-speed-germany/)

Pfizer didn’t receive any funding from Operation Warp Speed for the development, clinical trial and manufacturing of the vaccine. Rather, its partner, BioNTech SE, has received money -- from the German government.

What the U.S. did, meanwhile, was commit to buying hundreds of millions of vaccines in advance to ensure Americans were among the first in line if it clinches an emergency-use authorization or approval from the FDA. The Trump administration agreed in July to pay almost $2 billion for 100 million doses, with an option to acquire as many as 500 million more, once that clearance comes.


Fact Sheet: Explaining Operation Warp Speed | HHS.gov (https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html)

July 22: HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product successfully receives FDA EUA or licensure, as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial, which began July 27th.

Velvet
11-18-2020, 09:27 PM
So, am I understanding this correctly? Once Pfizer has researched, developed and tested the vaccine, then if it is good enough, the US. will pay through Warp Speed to produce 100 million doses. How is this different from buying any other foreign product? Except some of the research is conducted in the US.

Altavia
11-18-2020, 10:47 PM
So, am I understanding this correctly? Once Pfizer has researched, developed and tested the vaccine, then if it is good enough, the US. will pay through Warp Speed to produce 100 million doses. How is this different from buying any other foreign product? Except some of the research is conducted in the US.

Not sure I follow your question but my understanding is the US vaccine will be manufactured at Pfizer sites in Kalamazoo, Andover, Massachusetts, and St. Louis for its U.S. COVID-19 production.

EU vaccine will be manufactured in Belgium and Germany where 300M doses have been ordered.

Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch | FiercePharma (https://www.fiercepharma.com/manufacturing/pfizer-to-incorporate-3-u-s-sites-for-possible-covid-19-vaccine-launch)

Velvet
11-18-2020, 10:58 PM
Wonderful, happy to hear that some of the vaccine will be produced in the US. Maybe the facilities were funded by Warp Speed?

Altavia
11-18-2020, 11:14 PM
Wonderful, happy to hear that some of the vaccine will be produced in the US. Maybe the facilities were funded by Warp Speed?

Pfizer didn’t receive any funding from Operation Warp Speed for the development, clinical trial and manufacturing of the vaccine.

Warp Speed will be paying $19.50 per shot for the vaccine and make it available for free in the US.

graciegirl
11-19-2020, 10:46 AM
Pfizer didn’t receive any funding from Operation Warp Speed for the development, clinical trial and manufacturing of the vaccine.

Warp Speed will be paying $19.50 per shot for the vaccine and make it available for free in the US.

I just read an article from The Wall Street Journal this morning with the quote below;

"The Food and Drug Administration is days away from beginning its evaluation of Covid-19 vaccines for emergency use—a process that could lead to vaccine distributions by year’s end to limited groups such as health-care workers and the elderly."

Altavia
11-19-2020, 12:17 PM
For anyone who wants a "shot" at getting a vaccine early, they are still searching for vaccine trial volunteers.

AdventHealth begins recruiting participants for Phase 3 COVID-19 Investigational vaccine clinical trial | AdventHealth Central Florida Media Resources | AdventHealth (https://www.adventhealth.com/business/adventhealth-central-florida-media-resources/news/adventhealth-begins-recruiting-participants-phase-3-covid-19-investigational-vaccine-clinical)

https://www.ensemblestudy.com/?utm_source=sponsor&utm_medium=Advent&utm_campaign=%7B%7B1st_optional_vendor_identifier% 7D%7D&utm_term=%7B%7B2nd_optional_vendor_identifier%7D%7 D&utm_content=%7B%7Bvendor_transactionID%7D%7D&atid=JANUSENXX0000790&ahchannel=vanity#!/