Was Pfizer’s Vaccine News Slow-Walked Until After the Election?

[jimnyc]

I can't say that they held back on this news, nor can I dispute it. In today's environment and division, nothing would surprise me. Plus, it is still 2020 for another 2 months.

--

Was Pfizer’s Vaccine News Slow-Walked Until After the Election?

As the coronavirus pandemic swept across the globe in the spring, President Trump announced his plan to fast-track an effective vaccine that would be available by the new year.

The goal of Operation Warp Speed, launched by the White House in May, was “to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” Congress appropriated $10 billion to fund the ambitious program.

The president and his team spent months touting the success of the public-private partnership. Pfizer, one of five companies selected in June as a candidate with the best chance of meeting the president’s deadline, entered into a $1.95 billion contract with the federal government in July to purchase 100 million doses. The agreement was part of Operation Warp Speed, according to a company press release.

Operation Warp Speed not only involved the use of federal tax dollars but the elimination of government roadblocks that would ordinarily delay a new vaccine’s approval. Hundreds of federal rules and regulations were relaxed to help fight COVID-19 and hasten the private sector’s progress on treatments for the virus. The government’s lengthy, burdensome immunization approval process—which lasts an average of 73 months—was slashed to 14 months. Health and Human Services Secretary Alex Azar promised his agency would “squeeze every last inefficiency” to achieve the president’s goal.

But just like every other aspect of coronavirus, the vaccine has been a political cudgel. Democrats, including Democratic presidential nominee Joe Biden and his running mate, Kamala Harris, have fueled public distrust about the vaccine.

“If Donald Trump tells us we should take it, I’m not taking it,” Harris said during the October 8 vice presidential debate. New York Governor Andrew Cuomo, responsible for the most COVID-19 fatalities in the country, also sowed fear about a vaccine. The scare tactics worked; public trust in a coronavirus vaccine has dropped since the summer.

A Nonpartisan Vaccine?

The president repeatedly expressed confidence that a vaccine might be ready before Election Day. Pfizer’s chief executive officer Albert Bourla said in a September 8 interview that his company’s phase three trials were “progressing very well” and that he expected a preliminary finding by the end of October.

But on October 27, as Americans already were voting for president amid panicked warnings of a second surge of coronavirus, Pfizer said data from its late-stage trial would not be available before November 3. “For us, the election is an artificial milestone,” Bourla told reporters. “This is going to be not a Republican vaccine or a Democrat vaccine. It will be a vaccine for the citizens of the world.”

Oddly, however, Joe Biden was the first to learn that the nonpartisan totally unbiased vaccine now is getting close to the greenlight stage. “Last night, my public health advisors were informed of this excellent news,” Biden said in a statement issued early Monday.

(According to some reports, the White House found out about Pfizer’s announcement from the media. The president didn’t tweet about it until Monday morning.)

News organizations cheered Pfizer’s announcement that its vaccine is 90 percent effective at preventing COVID-19; the stock market soared. One Pfizer official initially told the New York Times that the company was “never part of Operation Warp Speed.”

This prompted a victory lap from the Trump-hating media. MSNBCs Joy Reid tweeted that she “felt better” Pfizer wasn’t involved in Operation Warp Speed and she wouldn’t “go near anything that Trump or his politicized FDA had anything to do with.” Vanity Fair concluded that Vice President Mike Pence could “f**k off” after he commended Operation Warp Speed for facilitating Pfizer’s quick work. “The Trump administration is trying to take credit for the Pfizer vaccine, which of course it had nothing to do with,” the magazine snarked.

Rest - https://amgreatness.com/2020/11/09/was-pfizers-vaccine-news-slow-walked-until-after-the-election/

[pete311]

Really doesn't matter. It wasn't even part of the operation warp speed. Trump can't claim victory.

[Kathianne]

Really doesn't matter. It wasn't even part of the operation warp speed. Trump can't claim victory.

Once again, Mr. Facts Don't Matter

https://www.businesswire.com/news/home/20200722005438/en/Pfizer-BioNTech-Announce-Agreement-U.S.-Government-600


Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2


U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses
Americans to receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines
Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021




July 22, 2020 07:10 AM Eastern Daylight Time
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA).


“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year”


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The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.


Americans will receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines.


“We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”


“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”


The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product. Both collaborators are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.


“We are pleased to have signed this important agreement with the U.S. government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat. This agreement is one of many steps towards providing global access to a safe and efficacious vaccines for COVID-19. We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon. Our goal remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.


The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. On July 1st, Pfizer and BioNTech announced preliminary data from BNT162b1, the most advanced of the four mRNA formulations. The early data demonstrates that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19, and this was shown at relatively low dose levels. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported. On July 20th, the companies announced early positive update from German Phase 1/2 COVID-19 vaccine study, including first T Cell response data.


Recently, two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies. Further data from the ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable the selection of a lead candidate and dose level for an anticipated large, global Phase 2b/3 safety and efficacy study that may begin as early as later this month, pending regulatory approval.


If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020. The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial.


In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that aims to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.


About Pfizer: Breakthroughs That Change Patients’ Lives


At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.


Pfizer Disclosure Notice


The information contained in this release is as of July 22, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.


This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the BNT162 mRNA vaccine program, a collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, an agreement with the United States to manufacture and deliver BNT162 and other potential agreements, including their potential benefits, manufacturing and distribution and the expected timing of clinical trials and regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; risks associated with preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and future preclinical and clinical studies; whether and when any biologics license applications may be filed in any jurisdictions for any potential vaccine candidates under the collaboration; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such vaccine candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods indicated; whether and when a future production agreement with the United States will be reached; whether and when other supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities regarding any such vaccine candidates and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.


A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.


About BioNTech


Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.


BioNTech Forward-looking statements


This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the timing to initiate clinical trials of BNT162 and anticipated publication of data from these clinical trials; the timing for any potential emergency use authorizations or approvals; the potential to enter into additional supply agreements with other jurisdictions or the COVAX Facility; the potential safety and efficacy of BNT162; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.






Contacts
Pfizer:
Media Relations
Amy Rose
+1 (212) 733-7410
Amy.Rose@pfizer.com


Investor Relations
Chuck Triano
+1 (212) 733-3901
Charles.E.Triano@Pfizer.com


BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513 or +49 (0)151 1978 1385
Media@biontech.de


Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de

[jimnyc]

Really doesn't matter. It wasn't even part of the operation warp speed. Trump can't claim victory.

No thoughts or opinions of your own, just parroting the media. Pete, at one point I used to think you were a fairly intelligent guy. This is why I often pushed and nudged for you to participate and discuss more than a sentence. To offer more than a sentence or trolling. Not really sure why I thought this, I just did and hoped repeatedly that one day I would read a couple of paragraphs from you.

But it's not that you're a troll. You truly cannot participate like others. You only offer one liners and parroting because it's the best you can do. There were times that you could have blasted this one or that one with facts over the years, but still resorted to one liners. I'm just realizing that you simply don't have it.

And no, not like some psychological trick to get you to post or to prove me wrong, or right. It just is what it is. I tried looking on "our" old site, but saw one liners. Was happily surprised with some physics stuff way in the past & web related activities and assumed it would convert into intelligence discussing politics. I was wrong.

https://i.imgur.com/CMZOfnt.jpg https://i.imgur.com/BOBnOWB.gif

[pete311]

Once again, Mr. Facts Don't Matter

https://www.businesswire.com/news/home/20200722005438/en/Pfizer-BioNTech-Announce-Agreement-U.S.-Government-600


Once again, you're arrogance results in mistakes.

Agreeing to buy a vaccine doesn't mean it has anything to do with development. If I order 20 PCs for my company, does that mean I had a hand in developing the PCs?

[Kathianne]

Once again, you're arrogance results in mistakes.

Agreeing to buy a vaccine doesn't mean it has anything to do with development. If I order 20 PCs for my company, does that mean I had a hand in developing the PCs?

Then why were they doing the trials? Why did they get $2B dollars? To think I used to think you might think differently than most at either board, but were honest. Well we all find people we misjudge. Most of mine are finding folks better than I think, thanks for giving me a reminder that isn't always true.

https://nypost.com/2020/07/22/feds-order-100-million-doses-of-pfizers-covid-19-vaccine-for-2b/

[Tyr-Ziu Saxnot]

Really doesn't matter. It wasn't even part of the operation warp speed. Trump can't claim victory.

Really Pete?

Can you not read?

From the article--




""The president and his team spent months touting the success of the public-private partnership. Pfizer, one of five companies selected in June as a candidate with the best chance of meeting the president’s deadline, entered into a $1.95 billion contract with the federal government in July to purchase 100 million doses. The agreement was part of Operation Warp Speed, according to a company press release.""



""entered into a $1.95 billion contract with the federal government in July to purchase 100 million doses. The agreement was part of Operation Warp Speed, according to a company press release.""


1.95 billion dollar contract with the Federal government....

That was under Trump's authority and TRUMP led in getting that done.-Tyr