3 Reasons Pfizer And BioNTech’s Coronavirus Vaccine Might Fail Even If It Works

Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) are on the cusp of producing phase 3 data that could show their coronavirus vaccine, BNT162, protects participants from developing COVID-19 better than placebo. But investors should be aware that there are some caveats that could result in a negative clinical trial even if the vaccine actually helps patients.

1. Early infection

The clinical trial starts classifying patients as positive for COVID-19 if the test occurs seven days after the second and final dose of the vaccine. Pfizer and BioNTech set the measurement based on the formation of antibodies in participants enrolled in earlier-stage studies, but if it takes longer to fully protect participants, some of the participants who received the vaccine could become infected between Day 7 and when the participant is truly protected, which would reduce the perceived effectiveness of the vaccine.

2. Virus in the nose

The vaccine is designed to create antibodies that can bind and inhibit the coronavirus once it enters the bloodstream. But the tests for COVID-19 look for the virus in patients’ noses.

Participants in the study could be protected from the coronavirus, but still test positive for COVID-19 because the immune system doesn’t wipe out the virus in the nose and upper respiratory tract where the test sample is taken.

It’s possible that a participant might end up being exposed to the virus, not end up developing COVID-19, but still, be counted as a positive case based on the detection of the virus in the patient’s nose.

3. False-positive testing

COVID-19 tests aren’t 100% accurate. A study of 90 patients who were tested with a COVID-19 test developed by Danaher’s (NYSE:DHR) Cepheid unit, which is being used in Pfizer and BioNTech’s study, produced two false-positive results.

Pfizer and BioNTech’s study also requires patients to have at least one symptom within four days before or after the positive test to be counted as a positive COVID-19 case, but many of the symptoms, including fever, cough, sore throat, diarrhea, and others, are associated with other more benign diseases.

With 21,000 volunteers in the study having received the vaccine, it’s easy to imagine that there might be a few participants who get a false positive test and also have one of those rather benign symptoms.

Hard to handicap

While all three issues are theoretically possible, it’s hard to determine how much they’ll end up affecting the patients who received the vaccine in the clinical trial. Unfortunately, even a small effect could sway the results, considering that the early study results hinge on very small numbers.

The first interim analysis, for example, comes after just 32 people in the study who have developed COVID-19. If six or fewer cases come from the group who received the vaccine, the study will be deemed a success, but a single false positive positive person in the group could push the analysis beyond the success criteria.

Of course, it’s equally likely that the three issues will result in a false positive in the placebo group,

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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.

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

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 says no COVID-19 vaccine data yet, could be week or more before it reports

By Michael Erman and Manas Mishra

(Reuters) – Drugmaker Pfizer Inc <PFE.N> said on Tuesday it does not yet have data from the late-stage trial of the COVID-19 vaccine it is developing with Germany’s BioNTech SE <22UAy.F>, and provided a timeline that makes its release unlikely ahead of the Nov. 3 U.S. presidential election.Pfizer said there had not yet been enough infections in the 44,000-volunteer trial to trigger an analysis of whether or not the vaccine works. An independent panel will conduct the first analysis when it reaches 32 infections.

Chief Executive Albert Bourla said after it has enough data for the analysis, it typically takes 5 to 7 days before the company can publicly release the data, meaning it is likely to happen after the election.

U.S. President Donald Trump had said a vaccine could be available before the Nov. 3 election, but in recent weeks his administration has emphasized that one will be ready this year.

Bourla has previously said the company could release data on whether or not the vaccine works as early as this month.

“For us, the election is an artificial milestone,” Bourla said on a conference call for the company’s earnings. “This is going to be not a Republican vaccine or a Democrat vaccine. It will be a vaccine for the citizens of the world.”

Pfizer shares were flat at $37.92.

Pfizer hopes to be the first U.S. drugmaker to unveil successful data from a late-stage COVID-19 vaccine trial, ahead of rival Moderna Inc <MRNA.O>. Pfizer and BioNTech launched their phase 3 study in late July.

The data monitoring board is scheduled to make its first assessment of the vaccine’s performance after 32 participants in the trial become infected with the novel coronavirus.

Healthcare investor Brad Loncar said it was difficult to draw a positive or negative conclusion from the fact that the trial has not yet had its first interim analysis.

“I think this means that the overall infection rate is a lot lower than Pfizer initially estimated,” Loncar said.

Dr. David Boulware, professor of medicine at University of Minnesota, said the study’s participants may be more adherent to social distancing guidelines than the general population.

“Who the vaccine trials really need are the people who don’t wear masks, who are going out to bars, who go to crowded events, who are singing in church choirs – those are the high risk people,” he said.

Boulware said that a data monitoring board could still review the data relatively quickly – perhaps in less than a day – once the trial hits its first interim point.

As the pandemic crimps demand for certain Pfizer therapies and damages global economies, investors are keenly focused on seeing the late-stage study data of the vaccine candidate being developed with BioNTech.

The company also said that if the trial is successful, it still expects to file for emergency authorization of the vaccine candidate from U.S. regulators shortly after it has enough safety data in late November.

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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.

Copyright AFP. All rights reserved.

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Chicago curfew; Louisiana football; Pfizer, kids vaccine

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COVID ravaged McKinley County, where roughly 74% of the population is non-Hispanic Native American — mostly Navajo and Zuni — and access to resources is scarce.

USA TODAY

As new cases of COVID-19 continue to rise across the U.S. and Europe, a patient from the Netherlands was airlifted to a German intensive care unit Friday, the first such international airlift since the global pandemic began.

In the U.S., new coronavirus restrictions in Chicago go into effect Friday for two weeks as the nation’s third largest city fights a surge of COVID-19 infections. Mayor Lori Lightfoot on Thursday announced a 10 p.m. curfew for all nonessential businesses and ordered bars and breweries without food licenses to shut down indoor service.

Meanwhile, in Louisiana, more high school football fans will be allowed to attend games in open-air stadiums in some parishes starting Friday. Stadiums will be allowed to have crowds at 50% capacity in parishes where less than 5% of coronavirus tests have been positive in the last two weeks, Gov. John Bel Edwards said Thursday.

Here’s what to know today:

  • France surpassed 1 million confirmed cases of COVID-19 Friday, according to Johns Hopkins University data. India, Brazil, Russia, Argentina and Spain previously passed that grim milestone.
  • The U.S. reported more than 71,000 new cases of COVID-19 on Thursday, according to Johns Hopkins data. The last time daily cases exceeded 71,000 was during the summer surge in July.
  • Wyoming on Thursday became one of the last states to reach 10,000 cases, with half of its infections reported in the last month, according to USA TODAY analysis. Only New Hampshire (9,994), Maine (6,063) and Vermont (1,987) had less than 10,000 cases as of Thursday night.
  • President Donald Trump and former Vice President Joe Biden sparred bitterly over the pandemic Thursday during the second and final debate. Trump claimed the virus would “go away” while Biden warned of a “dark winter.”
  • Pfizer is the only leading drug company that’s producing a coronavirus vaccine to allow minors into trails. The company recently lowered the age of participation to 16, aiming to include at least 3,000 older teens.  
  • The Food and Drug Administration on Thursday approved the antiviral drug remdesivir as a treatment for patients with COVID-19 who require hospitalization.

📈 Today’s numbers: The U.S. has reported more than 8.4 million cases and 223,000 deaths, according to Johns Hopkins University data. The global totals: 41.7 million cases and 1.1 million deaths.

🗺️ Mapping coronavirus: Track the U.S. outbreak in your state.

When will there be a COVID-19 vaccine? In general, scientists and public health experts say a COVID-19 vaccine could be approved at the earliest by December, but that doesn’t mean it will be widely available to most Americans. The federal government is developing a distribution plan that would get vaccines to various populations first, such as essential workers, those most vulnerable to COVID-19 and the elderly. See what USA TODAY’s expert panel has to say.

Why people of color are dying from COVID-19: Communities 

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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 CEO letter makes Thanksgiving earliest date for COVID vaccine

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Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.

USA TODAY

An open letter from the frontrunner COVID-19 vaccine producer published Friday ends any expectations a vaccine might be available before Election Day.

Pfizer Inc. CEO Albert Bourla’s letter says the earliest the company could apply for authorization for its COVID-19 vaccine is the third week of November.

The CEO of the other frontrunner, Moderna’s Stéphane Bancel , said at a biotechnology conference on Sept. 30 that it would not have enough safety data to apply for Food and Drug Administration authorization of its vaccine until Nov. 25.

The other two COVID-19 vaccine candidates in final stage clinical trials in the United States, Johnson & Johnson and AstraZeneca, are both on hold as possible adverse events are investigated.

That means there is now no chance any COVID-19 vaccine could be approved before the Presidential election on Nov. 3.

The news lays to rest a concern brewing in the public health community for months that a vaccine might be rushed through to provide a political win for President Donald Trump. He has said multiple times over the past six months he anticipated a COVID-19 vaccine would be available prior to the election.

That stance shifted on Oct. 6 when the White House embraced guidelines published by the Food and Drug Administration that likely would slow approval of a coronavirus vaccine by requiring drug makers to conduct trials for two months before requesting approval.

After that shift, the only way a vaccine could have come about prior to Nov. 3 would have been if absolutely everything went right in the Pfizer vaccine trials, which are the furthest along.

The timing would have been tight. The Pfizer vaccine requires two doses given 28 days apart and it launched its U.S. Phase 3 trials on July 27. The second shots would have begun on Aug. 24. Two months of follow-up after that second shot would be Oct. 23.

Bourla’s letter makes clear it will take longer than that. Based on the company’s current trial enrollment and dosing pace, “we estimate we will reach this milestone in the third week of November,” he wrote.

The company is “operating at the speed of science,” with safety as its No. 1 priority, he said.

Even then, there will be several important safety and oversight steps after the company applies for an Emergency Use Authorization for its vaccine.

“All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency,” he said.

The news is an important step in earning back the public’s trust and confidence in the vaccine evaluation and approval process, said Dr. Kelly Moore, associate director of Immunization Education, Immunization Action Coalition.

According to a poll from Informa Pharma Intelligence, a business intelligence provider, and research

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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 include teens.

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Pfizer says earliest U.S. filing for COVID-19 vaccine would be late November

(Reuters) – Pfizer Inc PFE.N 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 MRNA.O, 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.”

FILE PHOTO: The logo of U.S. pharmaceutical corporation Pfizer Inc. is seen at a branch in Zurich, Switzerland October 2, 2018. REUTERS/Arnd Wiegmann

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

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