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Highly anticipated COVID-19 vaccine data from Pfizer unlikely to come before Election Day: CEO

ABC News Corona Virus Health and Science

“This will not be a Democratic vaccine or Republican vaccine.”

Pfizer executives said in a third-quarter investor presentation on Tuesday they have not seen the first interim efficacy data yet. The Data Monitoring Committee, an independent group of experts monitoring the clinical studies and the data collection, “has not conducted any interim efficacy analyses to date,” according to Pfizer.

The slight delay from an earlier prediction of data by the end of October means results will likely not be known by Election Day, despite claims by President Donald Trump for months that a vaccine is “weeks away.”

The Data Monitoring Committee has thresholds for review that are triggered when a certain number of trial volunteers become sick with COVID-19. The first interim analysis is scheduled to happen when 32 people develop COVID-19, according to Pfizer’s extensive clinical trial protocol.

Bourla said, however, the company is still on track for a November application for authorization, if the vaccine shows to be effective and, just as importantly, safe.

Pfizer CEO Albert Bourla had previously said the company “may know whether or not our vaccine is effective by the end of October.”

Once there are 32 volunteers infected with COVID-19, Pfizer will analyze how many of them received the vaccine and how many received a placebo. If more than 76.9% of the grouping is in the placebo group, Pfizer will consider the vaccine efficacious.

Once an independent review board releases information on the trials, the company will need a week to review it internally, Bourla said.

Pfizer plans to release the interim data if it is negative (worse than 11.8%) or positive (better than 76.9%) for efficacy. If the data is somewhere in between, Pfizer will wait for more conclusive results, Bourla said.

“In case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know,” he explained to investors, adding that the company “reached the last mile here and we expect these things will start coming soon, so let’s all have patience.”

He said he is “cautiously optimistic” the vaccine will work based on earlier studies.

PHOTO: Medical syringes stand in front of the Pfizer company logo, Oct. 12, 2020.

Medical syringes stand in front of the Pfizer company logo, Oct. 12, 2020.

Pfizer said it expects efficacy and safety data will be available in November, and if it is, it will apply for emergency use authorization.

Pfizer’s vaccine candidate was also developed with the German biotech firm BioNTech. There are 150 clinical trial sites around the world.

More than 42,000 participants have been enrolled and nearly 36,000 have received a second dose of the vaccine. Expanding the number of participants has allowed trials to include additional populations, among them children between 12 and 18 and people with preexisting conditions.

When

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Pfizer says it could still deliver a Covid-19 vaccine in 2020

Pfizer executives expressed measured optimism Tuesday over the prospect of providing a coronavirus vaccine in 2020 as the pharma giant reported lower third-quarter profits due to disruption in healthcare that dented drug demand.

Pfizer Chief Executive Albert Bourla said the drug giant could supply some 40 million doses in the United States in 2020 if clinical testing proceeds as expected and regulators approve a vaccine.

“If all goes well, we will be ready to distribute an initial number of doses,” said Bourla, who pointed to a US government contract for Pfizer to supply 40 million doses by the end of this year and 100 million doses by March 2021.

But Bourla said the company still had not reached key benchmarks in assessing vaccine efficacy. Pfizer has said previously that it could have the data in October.

Bourla said the company expects to file for emergency use authorization for its Covid-19 vaccine in the third week of November, roughly in line with earlier timetables. 

Asked if he was “bullish” the vaccine would work, Bourla said: “I’m not bullish a vaccine will work. I’m cautiously optimistic that the vaccine will work.” 

Regarding earnings, Pfizer reported a 71 percent drop in profit to $2.2 billion. The year-ago period included a large gain connected to a transaction.

Revenues dipped four percent to $12.1 billion, missing analyst estimates.

Pfizer estimated a revenue hit of $500 million connected to Covid-19 due to lower pharma demand in China and fewer wellness visits from patients in the US.

The company saw an 11 percent drop in its hospital business in emerging markets, primarily due to fewer elective surgeries in China and shorter in-patient hospital stays in the country.

This effect was partially offset by increased demand for the Prevnar-13 vaccine for pneumonia “resulting from greater vaccine awareness for respiratory illnesses,” the company said. 

Pfizer also cited strong performance in its biopharma business due to good sales for cancer drug Ibrance, anticoagulant Eliquis and other medications.

Shares edged up 0.1 percent to $37.97 in afternoon trading.

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Pfizer Reports Lower Earnings As Covid-19 Hits Revenues

Pfizer reported lower third-quarter profits Tuesday as Covid-19 dented demand for some medicines from patients whose regular health care patterns were disrupted.

The drugmaker, which is working on clinical trials for a coronavirus vaccine, reported a 71 percent drop in profit to $2.2 billion. The year-ago period included a large gain connected to a transaction.

Revenues dipped four percent to $12.1 billion, missing analyst estimates.

Pfizer estimated a revenue hit of $500 million connected to Covid-19 due to lower pharma demand in China and fewer wellness visits from patients in the US.

Pfizer reported lower third-quarter profits, in part due to lower pharma demand as patients' normal patterns of healthcare were disrupted due to Covid-19 Pfizer reported lower third-quarter profits, in part due to lower pharma demand as patients’ normal patterns of healthcare were disrupted due to Covid-19 Photo: AFP / DOMINICK REUTER

The company saw an 11 percent drop in its hospital business in emerging markets, primarily due to fewer elective surgeries in China and shorter in-patient hospital stays in the country.

This effect was partially offset by increased demand for the Prevnar-13 vaccine for pneumonia “resulting from greater vaccine awareness for respiratory illnesses,” the company said.

Pfizer also cited strong performance in its biopharma business due to good sales for cancer drug Ibrance, anticoagulant Eliquis and other medications.

Pfizer said its Phase 3 Covid-19 trial had enrolled more than 40,000 participants, with nearly 36,000 having received their second vaccination as of Monday.

Shares rose 0.7 percent to $38,20 in pre-market trading.

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Pfizer Sets Up Its ‘Biggest Ever’ Vaccination Distribution Campaign

In Kalamazoo, Mich., a stretch of land the size of a football field has been turned into a staging ground outfitted with 350 large freezers, ready to take delivery of millions of doses of Covid-19 vaccine before they can be shipped around the world.

The facility is a hub in the sprawling supply chain

Pfizer Inc.

has built to handle the delivery of a vaccine widely awaited as a possible relief from the coronavirus pandemic. The U.S. pharmaceutical giant says it wants to deliver up to 100 million doses this year and another 1.3 billion in 2021.

Like other drugmakers testing potential vaccines, Pfizer is urgently laying the groundwork with its logistics partners so it can move quickly if its vaccine gets the go-ahead from the Food and Drug Administration and other regulators around the world.

“It’s the biggest-ever vaccination campaign,” said Tanya Alcorn, Pfizer’s supply-chain vice president. “If we get the FDA approval, we will be able to ship the vaccines very shortly after.”

The New York-based drugmaker is working with Germany’s

BioNTech SE

on one of several experimental Covid-19 vaccines in late-stage testing. Pfizer says it may know whether its vaccine works by the end of October and that it could be ready to apply for emergency-use authorization of its Covid-19 vaccine by late November.

The company’s effort to deliver relief to pandemic-weary populations will revolve around refrigerated storage sites at two of the company’s final assembly centers—the Kalamazoo facility and another in Puurs, Belgium—and rely on dozens of cargo-jet flights and hundreds of truck trips every day. Distribution centers in Pleasant Prairie, Wis., and in Karlsruhe, Germany, have been outfitted for extra storage capacity.

Pfizer so far has spent about $2 billion on developing the vaccine and setting up the distribution network.

The U.S. government placed an initial order for 100 million doses, with the option to purchase 500 million additional doses. The EU ordered 200 million doses with an option for another 100 million. Japan ordered 120 million doses and the U.K. 30 million. Countries in South America and in the Asia-Pacific region also have placed significant orders.

In a typical vaccination campaign, pharmaceutical companies would wait until their product is approved before buying raw materials, establishing manufacturing lines and setting up supply chains to ship a vaccine.

Pfizer Chief Executive Albert Bourla said that the company began setting the groundwork for its supply chain in March, when it kicked off its vaccine development.

“Ensuring over a billion people globally have access to our potential vaccine is as critical as developing the vaccine itself,” he said.

Pfizer says it is preparing for distribution in case the vaccine wins authorization, with hundreds of thousands of doses already in the company’s warehouses in the U.S. and Europe.

Cool Box

To make sure its Covid-19 vaccine doses arrive at hospitals and clinics frozen and potent, Pfizer created

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Pfizer Says Earliest U.S. Filing for COVID-19 Vaccine Would Be Late November | Top News

By Manas Mishra and Michael Erman

(Reuters) – Pfizer Inc said on Friday it could file in late November for U.S. authorization of the COVID-19 vaccine it is developing, suggesting that a vaccine could potentially be available in the United States by the end of the year.

That timeline makes it unlikely, however, that a vaccine will be available before the U.S. election, as President Donald Trump has promised. Pfizer, which is developing the vaccine with German partner BioNTech <22UAy.F>, said that it may confirm if the vaccine is effective as soon as this month but that it also needs safety data from a 44,000-person clinical trial that will not be available until next month.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares fell slightly of rival vaccine maker Moderna Inc

, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said, noting that he published the letter to provide greater clarity on the timeline for the vaccine.

People around the world are counting on a vaccine to control the spread of the coronavirus, which has killed more than a million people and ravaged the global economy.

Fears of delays were raised after trials for two rival vaccines were put on hold in the United States in recent weeks.

Trump has said repeatedly that there would be a vaccine available before the Nov. 3 election.

When asked about the Pfizer news, White House spokesman Judd Deere said, “The president continues to be optimistic that we will have one or more vaccines very soon, before the end of the year.”

The U.S. government’s Operation Warp Speed program has spent billions of dollars on development of vaccines and treatments. It has signed a deal to buy Pfizer vaccine shots if they work.

But the rush to develop a vaccine has raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review.

U.S. health officials have sought to assuage those concerns. Earlier this month, the FDA formalized a requirement that the vaccine-makers collect two months of safety data on one-half of trial participants.

Pfizer has been trying to demonstrate that its decision-making is being driven by science rather than politics, Mizuho analyst Vamil Divan said.

“Just getting it to the market is only a small part of it,” Divan said. “People should actually be willing to take it.”

Rival vaccine-maker Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC

. AstraZeneca’s U.S. trial has been on hold

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Pfizer delivers final blow to Trump’s hope for preelection vaccine

There won’t be a coronavirus vaccine ready before Election Day, despite President Donald Trump’s repeated promises and vaccine makers’ breakneck speed.

The president’s last best hope for meeting that deadline fizzled Friday as Pfizer announced that it would not seek emergency authorization from the Food and Drug Administration before the third week of November. The company is the only frontrunner in the vaccine race that has said it could have proof its vaccine works by Nov. 3.

For Trump, the failure to meet that deadline is a self-inflicted defeat. The Election Day target was always an artificial one, created by a president who for months has touted it on the campaign trail and press briefing stage. When his administration’s top scientists disputed the timeline, Trump accused them of slowing down progress for political reasons.

In the meantime, dozens of companies, universities and government agencies are working at record speed — cutting years off the normal development process to deliver a vaccine for the virus that has killed nearly 220,000 people in the U.S. and 1 million worldwide. That historic push is still on track to deliver a vaccine by early 2021, roughly a year after the virus first emerged.

“It was never going to happen. It was utterly unrealistic,” said Lawrence Gostin, director of the WHO Collaborating Center on National and Global Health Law at Georgetown University. “Vaccines follow a timeline of good science, they don’t follow a timeline of electoral politics.”

Since the beginning of the pandemic, federal health officials including infectious disease expert Anthony Fauci, CDC Director Robert Redfield and Health and Human Services Secretary Alex Azar have said that a vaccine is most likely by the end of the year or early 2021.

But those projections have always been riddled with caveats. Enrollment in clinical trials to test the shots’ safety and efficacy does not always proceed as quickly as companies would like. Too few people in those trials may be exposed to the virus, delaying the collection of crucial data. And the studies may find that a vaccine is dangerous — or simply doesn’t work.

“Nature is hard. You can’t use your political rhetoric to bamboozle nature,” said Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania and an adviser to Democratic presidential candidate Joe Biden. Emanuel penned a letter to Pfizer this month with dozens of scientists raising concerns about speeding the vaccine before safety data was clear.

Two manufacturers, AstraZeneca and Johnson & Johnson, recently paused clinical trials after each reported a serious illness in their studies. While J&J only halted the trials this week, AstraZeneca still has not resumed U.S. studies that stopped in September.

Executives at Moderna, another frontrunner whose vaccine relies on a still-unproven technology, has said it will not be ready to submit an emergency authorization application to FDA until late November. Pfizer, meanwhile, continues to expand its trial — first to enroll thousands more adults, and most recently to

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Pfizer delivers final blow to Trump’s hope for pre-election vaccine

Executives at Moderna, another frontrunner whose vaccine relies on a still-unproven technology, has said it will not be ready to submit an emergency authorization application to FDA until late November. Pfizer, meanwhile, continues to expand its trial — first to enroll thousands more adults, and most recently to include teens. Those moves could further push back its timeline, because the FDA expects companies applying for emergency authorization to submit two months of data on at least half of trial participants.

“Just because we are waiting until the end of the year instead of October — just to keep things in perspective, this is still a land speed record for vaccines,” said Peter Hotez, a virologist and dean of the National School of Tropical Medicine at the Baylor College of Medicine. Hotez has worked on several shots including a potential SARS vaccine, each of which has taken years if not decades of work to develop and test.

But the rapid pace of coronavirus shot development thus far hasn’t satisfied Trump, whose administration has put the quest for a vaccine at the center of its pandemic response efforts.

“We’ll have the vaccine soon, maybe before a special date. You know what date I’m talking about,” he said in an early September news conference. When FDA pushed to beef up its standards for authorizing emergency use of coronavirus vaccines, he called it “a political move more than anything else.”

The agency revised its guidance to make sure drug makers submitted enough data to reveal any side effects from their shots, Hotez said. It “wasn’t done to punish the president, it was done to protect the public to ensure that we have vaccines that work and are safe,” he said.

As vaccine timelines turned hazy, Trump turned his attentions to drugs known as monoclonal anitbodies. He declared an experimental antibody by drug a “cure” earlier this month, after receiving the treatment during his hospitalization for Covid-19. The president has repeatedly promised the cocktails will soon be available to every American who needs them.

Yet within a week of his initial promise, Eli Lilly — the other company with an antibody drug in late-stage clinical trials — paused its studies over safety concerns.

The bumps on the road to a vaccine or an antibody drug leave health officials with tools that Trump and other White House officials have long questioned: mask-wearing, social distancing and widespread testing.

Trump’s antibody rhetoric “was a pivot when it was clear that the vaccines weren’t going to fill his timeline. And its quite clear that the antibodies aren’t going to fill his timeline either,” said Emanuel.

But the longer timeline for vaccines could help public confidence in an eventual shot. Most registered voters want manufacturers to fully test vaccines even if it delays delivering the shots to Americans, according to a recent POLITICO/Morning Consult poll.

Nearly half of those voters, across party affiliations, said they believe Trump is pressuring FDA to deliver shots sooner and 35 percent believe it will

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Coronavirus Vaccine: Pfizer Says It Won’t Seek Authorization Before Mid-November

The chief executive of Pfizer said on Friday that the company would not apply for emergency authorization of its coronavirus vaccine before the third week of November, ruling out President Trump’s assertion that a vaccine would be ready before Election Day on Nov. 3.

In a statement posted to the company website, the chief executive, Dr. Albert Bourla, said that although Pfizer could have preliminary numbers by the end of October about whether the vaccine works, it would still need to collect safety and manufacturing data that will stretch the timeline to at least the third week of November.

Close watchers of the vaccine race had already known that Pfizer wouldn’t be able to meet the requirements of the Food and Drug Administration by the end of this month. But Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.

In doing so, the company had aligned its messaging with that of the president, who has made no secret of his desire for an approved vaccine before the election. He has even singled out the company by name and said he had talked to Dr. Bourla, whom he called a “great guy.”

Some scientists applauded Pfizer’s announcement.

“This is good, really good,” said Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego who was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.

He said company officials had assured him that a vaccine would most likely not be authorized before the election, but the letter Friday is “even more solid about their not being part of any political machinations.”

Dr. Bourla has pushed back against any suggestion that Pfizer’s vaccine timeline was politically motivated. In September, Pfizer was the driving force behind a pledge by nine vaccine companies to “stand with science” and not put forward anything that had not been properly vetted. Earlier this month, he published an open letter to employees that said he “would never succumb to political pressure” and expressing disappointment that “we find ourselves in the crucible of the U.S. presidential election.”

Pfizer is one of four companies testing a coronavirus vaccine in late-stage clinical trials in the United States, and it has been the most aggressive in its timeline estimates. Moderna, AstraZeneca and Johnson & Johnson have said that later in the year is more likely, matching the predictions of federal health officials. (AstraZeneca and Johnson & Johnson’s trials have been paused for potential safety concerns, which could further delay their outcomes.)

In interviews, Mr. Bourla has said that he expects a “conclusive readout” by late October, with an application for emergency authorization that could be filed “immediately.”

Pfizer’s trial of 44,000 volunteers tests the vaccine by giving one group the vaccine, another group the placebo, and waiting until a certain number of people become infected with the

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