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Pfizer says it could apply for emergency use authorization of COVID-19 vaccine by late November

Pfizer Inc. said Friday it could apply for emergency use authorization in the United States of its COVID-19 vaccine by late November. In an open letter, Pfizer Chairman and CEO Albert Bourla made the announcement about the progress in developing a coronavirus vaccine with its partner BioNTech, a biotechnology company that manufactures immunotherapies.

“I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine,” Bourla said.

Bourla said Pfizer is “operating at the speed of science,” but there are three steps that must happen before the company can release its COVID-19 vaccine.

“First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients.” Then the “vaccine must be proven safe, with robust safety data generated from thousands of patients.” The last step is demonstrating that the “vaccine can be consistently manufactured at the highest quality standards.”

“We may know whether or not our vaccine is effective by the end of October,” Bourla said, based on its 40,000-person clinical trial. “To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo.”

“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,” Bourla wrote. “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.”

Bourla noted, “The timelines above reflect our best estimates of when these important milestones could be achieved.”

A BioNTech spokesperson confirmed the time frame for the potential EUA application to the FDA.

This is the first time any “leading Western vaccine developer provided such a specific timeline,” according to the Wall Street Journal.

“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,” as reported by Reuters.

This comes at a time when COVID-19 cases in the U.S. are climbing slightly, but the coronavirus deaths are relatively level this month.

“The spread of the coronavirus appeared to be accelerating this week in the U.S. with a key indicator in 44 of the 50 states and Washington, D.C. flashing an ‘ominous’ warning sign,” a health official told the Wall Street Journal on Tuesday.

On Monday, Johnson & Johnson announced it had paused a large, late-stage clinical trial of its coronavirus vaccine after one of its volunteers became ill with an unexplained sickness. The company pointed out that illnesses, even severe cases, “are an expected part of any clinical study, especially large studies.”

On Tuesday, pharmaceutical company Eli Lilly said it paused a government-sponsored antibody treatment trial because of a “potential safety concern.”

Last month, President Donald Trump said that a COVID-19 vaccine would be distributed within 24 hours of completion of phase 3 trials and FDA approval. The president touted that all Americans will have access to the coronavirus vaccine by April.

“As part of Operation Warp Speed, my administration has manufactured one of the most promising vaccines in advance, and it will be fairly long in advance, as soon as a vaccine is approved, the administration will deliver it to the American people immediately. Distribution will begin within 24 hours,” President Trump said.

The coronavirus vaccine will be free for all Americans, but initially the COVID-19 vaccine will likely be available to higher-risk groups, such as health care workers, essential workers, the elderly, and those with health conditions that make them more vulnerable to COVID-19.

Dr. Scott Atlas, a member of the White House coronavirus response task force, said the COVID-19 vaccine would not be a forced vaccination.

In July, the U.S. Department of Health and Human Services and the Department of Defense (DoD) announced an agreement with Pfizer for an initial order of 100 million doses of a coronavirus vaccine for the price of $1.95 billion, following EUA or licensure. The agreement provides the U.S. government an option to purchase an additional 500 million doses.

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Trump warns US could become Venezuela on steroids, tells Mark Levin: Biden ‘doesn’t know he’s alive’

With only a month and a half until the 2020 election, President Donald Trump gave an in-depth interview on Fox News’ “Life, Liberty, & Levin,” where he discussed the potential coronavirus vaccine, Joe Biden, mail-in voting, and the mainstream media.

“You know it and I know it, Joe doesn’t know he’s alive,” Trump said of the former vice president. “It’s a sad thing that’s going on. The whole thing is a sad thing.”

Trump called Biden’s running mate Kamala Harris the “most liberal person in the Senate.”

The president warned that if policies from far-left Democrats are instituted, the U.S. could become the next Venezuela.

“And I used to say we’ll be another Venezuela, but I never really…I don’t know that I believed it fully,” he revealed. “That wasn’t too long ago. But I do. If that kind of stuff gets put in, we will be another Venezuela, except on major steroids.”

Trump called former White House national security adviser John Bolton a “stupid person.” He added, “What he did, I think was highly illegal, I mean his book is loaded up with confidential and classified information.” Trump said he’s letting Attorney General William Barr handle the investigation into Bolton and he isn’t getting involved.

Of James Mattis, the president said he disagreed with him “very much,” and noted that the retired United States Marine Corps general was “fired by President Obama, he was fired…like a dog he was fired.”

Trump attacked the mainstream media, calling The New York Times “stone-cold dishonest.”

“The worst lie of all is that I’m standing over the grave of soldiers from many years ago, warriors of many years ago, who I cherish. I’m very strong on the military. I love the military and I respect the military,” Trump told host Mark Levin. “And they made up a lie that I called them suckers and losers,” Trump said of The Atlantic report that used anonymous sources. Trump said that he doesn’t read The Atlantic, adding “most other people don’t either.”

Trump stated he would like to strengthen the nation’s libel laws.

Trump said, “Every one of these cities that has problems is run by Democrats.”

He pointed out that people have gotten desensitized about the violence in Chicago. “Look at Chicago, where 58 people were shot. Now the reports are, ’58 people were shot this weekend in Chicago, ten died, okay, now let’s get on to the weather.’ They’ve gotten almost used to it.”

Trump also talked about mail-in voting and called them “unsolicited ballots.”

“They have no idea who they’re sending them to, you know they’re sending them to the wrong people,” Trump stated, adding that Democrats “want it to be a mess.”

Trump said that Democrats and the mainstream media are “denigrating” a potential COVID-19 vaccine that could save lives. Trump claimed that his political rivals and the media are creating a “terrible situation” instead of being hopeful about obtaining a coronavirus vaccine “in record time,” and not in “two or three years.”

“Instead of saying, ‘Wow, that’s great. It’s going to save a lot of lives and people are going to be protected, and this whole thing will end faster’ … They started denigrating it,” he told Levin.

Trump accused the media and Democrats of downplaying the potential coronavirus vaccine, “when actually it’s one of the greatest things that anyone’s done, and I’m not saying me – I’m saying anyone. It’s so incredible.”

“You would think they’d be happy and thrilled and jumping up and down,” Trump told Levin. “Instead … it’s just a terrible situation.”

“The reason they’re doing it is because they think I’ll get credit if we have a vaccine anywhere near the election, but certainly before the election,” Trump claimed. “But essentially we’re there now anyway, and we’re ready to distribute very rapidly.”

Earlier this month, Trump said that a COVID-19 vaccine could be ready “during the month of October,” right before the Nov. 3 presidential election.

“It’s a tremendous thing that they’ve done and we’ve all done together,” Trump continued. “Then we’re ready to distribute it very quickly, and we’ll do our senior citizens first – the most vulnerable, … especially if they have a problem with a heart or they have diabetes or something.”

“I have totally changed the FDA process,” Trump said. “Same safety, but the speed is from a different world, and we should have the vaccine approved very soon.”

The president praised the “great companies” attempting to develop a COVID-19 vaccine, including Johnson & Johnson, Pfizer, and Moderna. The pharmaceutical companies are in Phase 3 trials, “right at the end of the process.” Last week, Trump announced that the COVID-19 vaccine would be distributed within 24 hours of completion of Phase 3 trials and approval by the FDA.

Levin mentioned Democratic governors who ordered nursing homes and long-term care facilities to accept patients who were infected with COVID-19.

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2020 Election Coronavirus vaccine Covid vaccine Intelwars Life liberty & levin Mark Levin President Trump President trump interview

President Trump warns US could become Venezuela on steroids, tells Mark Levin: Biden ‘doesn’t know he’s alive’

With only a month and a half until the 2020 election, President Donald Trump gave an in-depth interview on Fox News’ “Life, Liberty, & Levin,” where he discussed the potential coronavirus vaccine, Joe Biden, mail-in voting, and the mainstream media.

“You know it and I know it, Joe doesn’t know he’s alive,” Trump said of the former vice president. “It’s a sad thing that’s going on. The whole thing is a sad thing.”

Trump called Biden’s running mate Kamala Harris the “most liberal person in the Senate.”

The president warned that if policies from far-left Democrats are instituted, the U.S. could become the next Venezuela.

“And I used to say we’ll be another Venezuela, but I never really…I don’t know that I believed it fully,” he revealed. “That wasn’t too long ago. But I do. If that kind of stuff gets put in, we will be another Venezuela, except on major steroids.”

Trump called former White House national security adviser John Bolton a “stupid person.” He added, “What he did, I think was highly illegal, I mean his book is loaded up with confidential and classified information.” Trump said he’s letting Attorney General William Barr handle the investigation into Bolton and he isn’t getting involved.

Of James Mattis, the president said he disagreed with him “very much,” and noted that the retired United States Marine Corps general was “fired by President Obama, he was fired…like a dog he was fired.”

Trump attacked the mainstream media, calling The New York Times “stone-cold dishonest.”

“The worst lie of all is that I’m standing over the grave of soldiers from many years ago, warriors of many years ago, who I cherish. I’m very strong on the military. I love the military and I respect the military,” Trump told host Mark Levin. “And they made up a lie that I called them suckers and losers,” Trump said of The Atlantic report that used anonymous sources. Trump said that he doesn’t read The Atlantic, adding “most other people don’t either.”

Trump stated he would like to strengthen the nation’s libel laws.

Trump said, “Every one of these cities that has problems is run by Democrats.”

He pointed out that people have gotten desensitized about the violence in Chicago. “Look at Chicago, where 58 people were shot. Now the reports are, ’58 people were shot this weekend in Chicago, ten died, okay, now let’s get on to the weather.’ They’ve gotten almost used to it.”

Trump also talked about mail-in voting and called them “unsolicited ballots.”

“They have no idea who they’re sending them to, you know they’re sending them to the wrong people,” Trump stated, adding that Democrats “want it to be a mess.”

Trump said that Democrats and the mainstream media are “denigrating” a potential COVID-19 vaccine that could save lives. Trump claimed that his political rivals and the media are creating a “terrible situation” instead of being hopeful about obtaining a coronavirus vaccine “in record time,” and not in “two or three years.”

“Instead of saying, ‘Wow, that’s great. It’s going to save a lot of lives and people are going to be protected, and this whole thing will end faster’ … They started denigrating it,” he told Levin.

Trump accused the media and Democrats of downplaying the potential coronavirus vaccine, “when actually it’s one of the greatest things that anyone’s done, and I’m not saying me – I’m saying anyone. It’s so incredible.”

“You would think they’d be happy and thrilled and jumping up and down,” Trump told Levin. “Instead … it’s just a terrible situation.”

“The reason they’re doing it is because they think I’ll get credit if we have a vaccine anywhere near the election, but certainly before the election,” Trump claimed. “But essentially we’re there now anyway, and we’re ready to distribute very rapidly.”

Earlier this month, Trump said that a COVID-19 vaccine could be ready “during the month of October,” right before the Nov. 3 presidential election.

“It’s a tremendous thing that they’ve done and we’ve all done together,” Trump continued. “Then we’re ready to distribute it very quickly, and we’ll do our senior citizens first – the most vulnerable, … especially if they have a problem with a heart or they have diabetes or something.”

“I have totally changed the FDA process,” Trump said. “Same safety, but the speed is from a different world, and we should have the vaccine approved very soon.”

The president praised the “great companies” attempting to develop a COVID-19 vaccine, including Johnson & Johnson, Pfizer, and Moderna. The pharmaceutical companies are in Phase 3 trials, “right at the end of the process.” Last week, Trump announced that the COVID-19 vaccine would be distributed within 24 hours of completion of Phase 3 trials and approval by the FDA.

Levin mentioned Democratic governors who ordered nursing homes and long-term care facilities to accept patients who were infected with COVID-19.

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Trump accuses Democrats and media of ‘denigrating’ potential coronavirus vaccine: ‘It’s just a terrible situation’

President Donald Trump accused Democrats and the mainstream media of “denigrating” a potential coronavirus vaccine that could save lives. The president said his political opponents and the media are creating a “terrible situation” instead of being excited about the possibility of getting a COVID-19 vaccine “in record time.”

Earlier this month, Trump said that a coronavirus vaccine could be ready “during the month of October,” right before the Nov. 3 presidential election.

“And what’s happening is, all of a sudden, you’ll have this incredible vaccine, and because of that fake rhetoric — it’s a politic rhetoric; that’s all it is. Just for politics,” Trump said during a Sept. 7 press conference. “Because now they see we’ve done an incredible job, and in speed like nobody has ever seen before. This could’ve taken two or three years, and instead it’s going to be — it’s going to be done in a very short of period of time. Could even have it during the month of October.”

During an interview that will air Sunday on Fox News’ “Life, Liberty, & Levin,” Trump told host Mark Levin, “Instead of saying, ‘Wow, that’s great. It’s going to save a lot of lives and people are going to be protected, and this whole thing will end faster’ … They started denigrating it.”

Trump said the media and Democrats are diminishing the potential coronavirus “when actually it’s one of the greatest things that anyone’s done, and I’m not saying me – I’m saying anyone. It’s so incredible.”

“You would think they’d be happy and thrilled and jumping up and down,” Trump said. “Instead … it’s just a terrible situation.”

“The reason they’re doing it is because they think I’ll get credit if we have a vaccine anywhere near the election, but certainly before the election,” Trump told Levin. “But essentially we’re there now anyway, and we’re ready to distribute very rapidly.”

“It’s a tremendous thing that they’ve done and we’ve all done together,” Trump explained. “Then we’re ready to distribute it very quickly, and we’ll do our senior citizens first – the most vulnerable, … especially if they have a problem with a heart or they have diabetes or something.”

“I have totally changed the FDA process,” Trump added. “Same safety, but the speed is from a different world, and we should have the vaccine approved very soon.”

Joe Biden hinted that the president was politicizing the potential coronavirus vaccine.

“A vaccine would offer a way back to normalcy and a path toward better days for all of us… But it’s not going to happen overnight,” Biden said on Wednesday in Delaware. “One thing is certain, we can’t allow politics to interfere with a vaccine in any way.”

“Americans have had to endure President Trump’s incompetence and dishonesty when it comes to testing and personal protective equipment,” Biden continued. “We can’t afford to repeat those fiascos when it comes to a vaccine, when it occurs. The stakes are too high.”

“So let me be clear, I trust vaccines. I trust scientists. But I don’t trust Donald Trump. And at this moment, the American people can’t either,” the Democratic presidential nominee said.

Biden’s running mate Sen. Kamala Harris was accused of promoting a “dangerous conspiracy theory” and “anti-vaxxer” talking points for her comments about a possible COVID-19 vaccine.

When asked if she would get an approved COVID-19 vaccine, Harris said, “Well, I think that’s gonna be an issue for all of us. I will say that I would not trust Donald Trump, and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he’s talking about. I will not take his word for it.”

Harris said scientists would “be muzzled, they’ll be suppressed, they will be sidelined, because [Trump is] looking at an election coming up in less than 60 days, and he’s grasping for whatever he can get to pretend that he’s been a leader on this issue when he’s not.”

Trump praised the companies working on the coronavirus vaccine, including Johnson & Johnson, Pfizer and Moderna. The pharmaceutical companies are in Phase 3 trials. On Friday, Trump announced that the COVID-19 vaccine would be distributed within 24 hours of completion of Phase 3 trials and approval by the FDA.

On BlazeTV, Steven Crowder exposed how the mainstream media launched attacks on Trump regarding the potential of a COVID-19 vaccine this year.

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US awards $1.6 billion to Novavax for COVID-19 vaccine research and development

The federal government awarded biotech firm Novavax, Inc., $1.6 billion for a COVID-19 vaccine, which would ideally be distributed to 100 million people by January 2021 if found to be safe and effective.

This is the most recent in a succession of biotech companies that have received awards from the federal government for researching a safe and effective vaccine to fight against the coronavirus pandemic.

What are the details?

On Tuesday, the Maryland-based company said that the U.S. is paying the vaccine maker the sum in order to speed up development of a coronavirus vaccine.

“What this Warp Speed award does is it pays for production of 100 million doses, which would be delivered starting in the fourth quarter of this year, and may be completed by January or February of next year,” Novavax chief executive Stanley Erck told Reuters.

According to the New York Times, “the deal is the largest that the Trump administration has made so far with a company as part of Operation Warp Speed, the sprawling federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible.”

The Times reports that the company “has never brought a product to market.”

In a Sunday interview, Erck said that he was not certain where the $1.6 billion in government funds would be drawn from, but a spokesperson for the company later said that the funds would be taken from a “collaboration” between the U.S. Health and Human Services Department and the Department of Defense.

Health and Human Services Secretary Alex Azar said that adding Novavax to Operation Warp Speed’s “diverse portfolio” — which includes AstraZeneca, Johnson & Johnson, Merck, and Moderna Therapeutics, among others — “increases the odds that we will have a safe, effective vaccine as soon as the end of this year.”

The U.S. awarded $1 billion to AstraZeneca in May, $450 million to Johnson & Johnson in March, $38 million to Merck in May, and $483 million to Moderna Therapeutics in April.

The Times reported that the company “would ensure that 100 million doses — enough for 50 million people to receive an additional shot and a booster — are delivered by the first quarter of 2021,” so long as its vaccine is proven to be safe and effective following expedited clinical trials.

According to CNBC, Novavax stock skyrocketed more than 35% in pre-market trading following the announcement.

You can read more about the award as well as the company’s background here.

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