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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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Operation Warp Speed: Big Pharma To Test COVID-19 Vaccine On Children As Young As 12

The rollout of Operation Warp Speed, president Donald Trump’s plan to fast track a COVID-19 vaccine, is leading Big Pharma to test its product on children as young as 12. The goal of the current administration is to have a vaccine distributed by the military by the election.

If the government succeeds, people will be getting vaccinated during the beginning of November by the United States military. In fact, the Department of Defense has recently said there is great progress being made on this vaccine.

David Icke To LEOs & Military: “Look Your Children In The Eye” & Tell Them YOU Enforced Tyranny

According to a report by CNN, drugmaker Pfizer has plans to start testing its experimental coronavirus vaccine in children as young as 12, and parents have already expressed interest in enrolling their kids, the researcher leading the trial said on Tuesday. It will be the first coronavirus vaccine trial to include children in the United States. A team at Cincinnati Children’s Hospital will begin vaccinating teenagers aged 16 and 17 this week, and will move to enroll 12-to 15-year-olds later, said Dr. Robert Frenck, director of the Vaccine Research Center at the hospital.

The company confirmed on its website it has approval from the US Food and Drug Administration to enroll children as young as 12 in its trial.

“We really think a vaccine for adolescents and children is going to be critical for getting Covid under control,” Frenck told CNN in a telephone interview. –CNN

“I think one of the things that is important to remember is that although the death rate for children with Covid is lower than in older adults, it’s not zero,” he said, noting that more than half a million children have been diagnosed with coronavirus in the United States. “It is not a nonexistent infection in children.”

Bill Gates: The U.S. Should “Brainstorm” Ways To Reduce “Vaccine Hesitancy”

This vaccine will not be a choice for most.  There will be an effort to make sure you are “voluntarily” coerced into taking it.  Please don’t delude yourself into assuming otherwise. Brace for it, watch the progress and know what the punishments will be for refusing it.  They will be harsh, we’ve already been told that. Stay prepared, this is coming soon!

Medical Journal: Get The COVID-19 Vaccine, Or Be Punished HARSHLY

The post Operation Warp Speed: Big Pharma To Test COVID-19 Vaccine On Children As Young As 12 first appeared on SHTF Plan – When It Hits The Fan, Don't Say We Didn't Warn You.

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Vaccine developer says people must wear masks and socially distance even after vaccine is available

A vaccine developer at the Baylor College of Medicine told Business Insider that people should not expect an immediate return to normal life once a vaccine is available.

Several companies are working as quickly as possible to develop a safe and effective vaccine, which has been viewed by some as necessary for lockdowns to end and schools to reopen. While a vaccine may significantly reduce the risk of serious disease from the novel coronavirus, social distancing and face masks may still be a part of life, said vaccine developer Maria Elena Bottazzi.

“They automatically are going to say, ‘oh great, I’m just going to get my little vaccine, and I can go back and do exactly the things I was doing last year,'” Bottazzi told Business Insider. “That is absolutely not true.”

Ideally, Bottazzi said, a vaccine would give sterilizing immunity, meaning it would totally prevent people from becoming infected. Many vaccines don’t reach that level of effectiveness, however, and only reduce the chance of developing severe symptoms of a particular disease.

Vaccines improve over time, which means the first version of the COVID-19 vaccine that is made available to the public might not be 100% effective. In fact, Moderna’s vaccine, which is entering phase 3 of trials, is aiming to demonstrate 60% effectiveness.

Moderna CEO Stephanie Bancel said that if the vaccine reaches 90% effectiveness, then people can safely stop wearing masks — unless they have high-risk health conditions, in which case they may need to continue wearing them. Bancel said the company hopes to know more about their vaccine’s efficacy as early as October or as late as December.

For comparison, the 2019-2020 flu vaccine is only about 45% effective against the seasonal flu and typically ranges between 40% and 60% effectiveness every year. A vaccine was never successfully developed for the SARS coronavirus in 2002, and eventually demand for such a vaccine went away, as the virus ran its course and mostly disappeared without spreading nearly as widely as COVID-19 has.

In summary, the masks could be here to stay through the end of 2020, and potentially even longer depending on how successful the COVID-19 vaccines are.

“The moment you get a vaccine doesn’t mean you’re going to put your mask in the trash,” Bottazzi told Business Insider. “That is not going to happen. I hope people don’t think that is going to be the magic solution for all.”

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Big Pharma Stocks Up As COVID-19 Vaccine Trial Data To Be Published

Big Pharma stocks are going up as Operation Warp Speed continues and the mandatory COVID-19 vaccine trial data is expected to be released. Shares of AstraZeneca were active in premarket trading on Monday as investors prepare for the release of Phase 1 clinical trial data for the COVID-19 vaccine candidate being developed by the drugmaker and the U.K.’s University of Oxford.

The first set of trial data is expected to be published Monday in The Lancet, a British medical journal, according to Reuters. AstraZeneca’s stock was up 0.1% before the market opened. This vaccine candidate is considered one of the frontrunners, alongside experimental vaccines being developed by Moderna Inc. and Pfizer and BioNTech, in the race to develop a vaccine that can protect against coronavirus infections. AstraZeneca’s stock has gained 18.8% year-to-date, in comparison to the S&P 500, which is down 0.2%. –Market Watch

Isn’t it fantastic that Big Pharma is doing so well while many Americans are struggling with epic job losses and the threats of homelessness? But this was all done for your good…

More Proof Trump Is Working On Bill Gates’ Vaccine Under “Operation Warp Speed”

Tens of thousands of people have already volunteered to help bring a new COVID-19 vaccine into existence. As of last week, more than 107,000 people had signed up to take part in testing, according to a report by USA Today.

“That’s why we’re optimistic that we’re going to be able to get the trials enrolled in an expeditious way. I think we can do what we need to do,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. The milestone was reached just a week after the National Institutes of Health launched a clinical trial network for vaccines and other prevention tools to fight the pandemic.

Fauci Talks “Winter” Again: “We Will Have An Answer On A COVID Vaccine”

Fauci is Back And Already Helping To Drum Up Fear: “It Isn’t Over Yet!”

There will be a vaccine, and whether it’s mandatory or not, at this point, makes no difference. If you want to buy food, get on an airplane, or even cross state lines, then you’ll be forced to get the vaccine and show proof. Corporations will make sure they do their part to get you vaccinated.  Don’t believe for one second that this will be a choice in any sense of the word.

This is information that is designed to forewarn you of what’s coming. Do not submit to the fear, instead, prepare, open your eyes, and understand what’s going on. Things are going to get crazy in the coming months as this vaccine starts to roll to the public, and even those with their eyes still half-closed know this. Prepare, and make sure you know where you stand with this vaccine.  They will not make it easy to refuse it.

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Robert Kennedy Jr.: “Pharmaceutical Drugs Are Now The 3rd Leading Cause of DEATH” In US

In an interview with Lior Gantz of the Wealth Research Group, Robert F. Kennedy Jr. discussed the major problems facing the United States today when it comes to health. This is a MUST WATCH interview before you line up for the COVID-19 vaccine or any other vaccine for that matter!

This is an interview you’ll want to watch, as Kennedy talks about vaccine safety and efficacy, as well as how Big Pharma has taken over the government to dictate health policy. Their only concern was that YouTube would censor it or ban them altogether, so an exclusive portion of it, deemed too controversial for YouTube, since it involves the elite cabal, can only be accessed HERE!

Now that Big Pharma is in control, “pharmaceutical drugs are now the third leading cause of death in the United States after heart disease and cancer”, says Kennedy.  That’s huge, but it’s all by design.  Those in power, simply don’t care about us, and nothing is about health, it’s about profit.

“Anderson Cooper is sponsored by Pfizer,” says Kennedy. “And Merck sponsors Lester Holt.” Some of the biggest propagandists have a vested interest in making sure the public gets vaccinated, whether it’s safe and effective or not. They also get paid to push pharmaceutical drugs on the population using propaganda.

Because of the rampant pushing of these drugs, “pharmaceutical drugs are now the third leading cause of death in our country after cancer and heart disease,” Kennedy says.  Those numbers dwarf the coronavirus deaths (which are heavily manipulated.) Medical journals have become propaganda for big pharma.

All of this has cost Americans dearly.  We are paying for the propaganda with our health. Parents are being pressured to vaccinate their children even though it’s common knowledge those vaccines are not safe nor are they effective enough to warrant the potential outcomes.  Once a kid gets sick from a vaccine, big pharma has a customer for life. It’s a truly disturbing cycle.

For one example of the hypocrisy, Kennedy says he asked some health officials “how can you be recommending women don’t eat fish during pregnancy, and yet you’re giveng them vaccines during pregnancy that contain hundreds of times the aluminum that fish contains.”

Kennedy also talks about how Dr. Anthony Fauci got so much power and has squashed scientific research while pushing other studies in order to move his agenda forward.  Fauci has billions of dollars of funding at this disposal and can force scientists to comply with his commands and even manipulate the outcome of studies.

WealthResearchGroup.com has a long history of confronting crucial topics head-on, most recent of which is their call for gold $2,184/ounce, as a response of the irresponsible money printing (counterfeiting operation), led by The Federal Reserve System.

Later in the interview, Kennedy discusses how vaccines are created with in-depth detail as to why they cannot be made safe for everyone and efficacy is always low. He also details how the CDC knows that vaccines have caused the autism epidemic, but we are being lied to in order to prop up big pharma.

If you have the time, this interview is eye-opening and could help give you some information you may not have been privy to before. Consider watching the whole thing. It’s truly mind-blowing how low some people will go to make sure we sacrifice our health and pay for it with our money they’ve already taxed.

Make sure you check out WealthResearchGroup.com’s MOST-RECENT bombshell report on Bill Gates’ involvement in the vaccine monopoly HERE!

ACCESS both the interview and the EXCLUSIVE CENSORED transcript HERE:
https://www.wealthresearchgroup.com/ban/ 
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S**EW THE VACCINE: UNLEASHING THE DEVIL!

This article was contributed by Tom Beck with Portfolio Wealth Global. 

READ THIS LINE THREE TIMES OVER: THERE IS NO SCIENTIFIC WAY TO CREATE A SAFE VACCINE!

In America, vaccinations are monopolized by four companies: Pfizer, Merck, GlaxoSmithKline, and Sanofi. These companies are the biggest LOBBYISTS in Washington.

It’s not only the billions they POUR INTO lobbying that’s disgusting – it’s the media too!

Anderson Cooper is sponsored by Pfizer and NBC nightly news is backed by Merck, for example. The United States is one of only TWO COUNTRIES that allow TV ads about drugs!

There are 72 mandatory vaccinations, so these companies have ZERO COSTS when it comes to advertising vaccines since it’s forced upon parents. You cannot sue them, so there are no LEGAL COSTS, and since that’s the case, they don’t do SAFETY TESTING.

It’s the perfect business for them, so it’s no wonder Bill and Melinda Gates UNDERSTAND THE POTENTIAL!

This is madness and it has led to a massive rise in autism cases, as well as asthma, food allergies, and chronic diseases.

Vaccines are the most controversial topic in the world right now since these companies are attempting to BRAINWASH THE SHEEP to form a herd and get their shots, even though it has been proven TIME AND AGAIN that vaccines are BULLSHIT!

The World Health Organization, the CDC, the NIH, and other institutions are FOR-PROFIT when it comes to patenting. They have a vested interest in these vaccines, including that sneaky devil Dr. Anthony Fauci.

It is a mistake to believe anything that doctors tell you about vaccines; they’re the MESSENGERS of doom and have done no personal research on what they administer!

After doing my own research, these are facts that I uncovered. You may draw different conclusions, but know that there are hundreds of thousands of victims from these vaccines both alive and dead.

I tell you all this because the second any medical company announces that the vaccine is ready, you will be PRESSURED INTO it.

The media will present it as the only solution to this virus, which only impacts specific parts of the population.

Ultimately, you OWN YOUR BODY – it’s your property!

Don’t let them get you twisted on this matter.

RESEARCH THIS TOPIC!

EXCLUSIVE REPORTS, Featured In This Article and in Others, Which Are Considered ESSENTIAL READING:
1. Gold Investing – DOWNLOAD HERE!
2. Trump’s War with Mainstream Media – DOWNLOAD HERE!
3. Covid-19 Round2 Sell-Off Playbook – DOWNLOAD HERE!
4. Why The Dollar Is Dead – DOWNLOAD HERE!
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