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Portuguese Nurse Dies Suddenly After Receiving COVID Vaccine

This article was originally published by Tyler Durden at ZeroHedge.

The latest suspicious death to occur days (or, in some cases, even hours) after a patient received their first dose of a COVID-19 vaccine has surfaced in Portugal, where a pediatric surgery assistant in Porto (who was reportedly in “perfect health” when she received her first dose of the Pfizer vaccine) has died suddenly.

Health authorities are investigating the death. Meanwhile, scientists from around the world continue to criticize the European Union for its comparatively sluggish vaccine rollout, which only began on an emergency basis a little more than one week ago.

The patient was identified on Monday as Sonia Azevedo, 41, a mother of two who worked as a surgical assistant at the Instituto Portugues de Oncologia, a cancer hospital in Porto. She was among the 538 healthcare workers at IPO who received their first dose of the Pfizer-BioNTech vaccine last Wednesday. Azevedo had dinner with her family on New Year’s Eve but was found dead in her bed the following morning.

Now her family members are demanding answers about the circumstances of her death, RT reports.

“I want to know what caused my daughter’s death” her father Abilio told the Portuguese tabloid Orreio da Manha. He described her as a “well and happy” person who “never drank alcohol, didn’t eat anything special or out of the ordinary.”

Azevedo was so proud to be among the first to receive the vaccine, she changed her Facebook profile picture to reflect that. “Covid-19 vaccinated,” she wrote under a selfie with her face mask on. “We don’t know what happened.

It all happened quickly and with no explanation,” Azevedo’s daughter Vania Figueiredo told the paper. “I didn’t notice anything different in my mother. She was fine. She just said that the area where she had been vaccinated hurt, but that’s normal…”

Portugal, which has a population of around 10 million, has so far reported more than 427K cases and over 7.1K deaths due to COVID. While Germany is leading the EU in vaccinations, Portugal is lagging behind even Argentina, according to data provided by Bloomberg.

What they don’t tell you is that many among the first wave of individuals designated to receive the vaccine have been turning it down, including many health care workers like Azevedo.

The post Portuguese Nurse Dies Suddenly After Receiving COVID Vaccine first appeared on SHTF Plan – When It Hits The Fan, Don’t Say We Didn’t Warn You.

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They Want You Muzzled Permanently: Wear Your Mask Even If You Get The Vaccine

The authorities and rulers are telling the public that they must continue to wear their face masks even after they get the “effective” COVID-19 vaccine. Mainstream media and the authoritarian ruling class is trying to convince the public to muzzle themselves permanently.

The country’s first coronavirus vaccinations are now being distributed to the sheep willing to take this thing. The FDA granted the Pfizer vaccine emergency authorization for use, and it’s expected that soon, possibly by this week, it will do the same for the Moderna vaccine. In trials, the Pfizer vaccine was 95% effective in preventing COVID-19, and the Moderna vaccine stands at 94%, both significantly more effective than many scientists anticipated.

If the vaccines are actually as effective as they say they are, why do we need masks? If masks worked, why do we need this rushed, unproven, and unwanted vaccine? No one is asking these questions in the mainstream media, so it’s time we start thinking for ourselves and undoing the years of brainwashing from listening to psychopathic politicians and their lapdog public relations department, the mainstream media.

Both versions of the vaccine require two injections. If you get them both, your chances of getting infected with the coronavirus are likely low. But even if you get vaccinated in the near future, experts say it’ll be months until you can ditch the masks and hug everyone around you.

The main challenge? Studies of the COVID-19 vaccines only measured whether vaccinated people developed symptoms, not whether they got infected. We know that you can become infected with the coronavirus and be asymptomatic, meaning you never develop symptoms. Asymptomatic people can still spread COVID-19 to others. So we don’t know whether a vaccine prevents asymptomatic infections and if there’s still the possibility that a vaccinated person could transmit the virus without knowing it. –GM Today

So basically, you can still get the coronavirus if you get two shots of the “effective” COVID-19 vaccine. And then you’ll be “asymptomatic” and won’t know you’re sick, and could still infect others. So instead of the side effects of getting a cold, those who choose to take the vaccine face severe side effects, including death, that the Big Pharma companies won’t be liable for.

Does anyone still believe this vaccine is for our own good? It’s getting ridiculous that people are still so blind to what’s going on here.

“As long as you have enough people who are vaccinated, then if in the odd chance someone gets infected, there are very few susceptible people to spread it to,” explains Eric Sachinwalla, the medical director of Infection Prevention and Control at Einstein Medical Center Philadelphia.

Just In Time For The Vaccine: A New COVID Strain Has Been Found

 

The post They Want You Muzzled Permanently: Wear Your Mask Even If You Get The Vaccine first appeared on SHTF Plan – When It Hits The Fan, Don't Say We Didn't Warn You.

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FDA now investigating after multiple allergic reactions to Pfizer COVID vaccine reported across US

The Food and Drug Administration said on Friday they are investigating after multiple allergic reactions were reported in people who had just received Pfizer’s coronavirus vaccine.

The new development comes just days after the Pfizer vaccine began to be administered nationwide.

What did the FDA say?

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a press conference that five allergic reactions occurred this week in more than one state.

The reactions were reportedly similar to those seen in the United Kingdom last week.

“We are working hand in hand with the Centers for Disease Control and Prevention, and we’ve actually been working closely with our United Kingdom colleagues, who of course reported the allergic reaction. I think we’ll be looking at all the data we can from each of these reactions to sort out exactly what happened, and we’ll also be looking to try to understand which component of the vaccine might be helping to produce them,” Marks said, the Hill reported.

Marks explained that scientists were not certain what caused the allergic reactions, but pointed to polyethylene glycol as the possible “culprit.” The ingredient is present in both the Pfizer and the Moderna vaccine.

What’s the background?

At least two of the reactions happened at the same hospital in Juneau, Alaska.

As the New York Times reported, the reactions happened within minutes of vaccine administration:

[The first worker] experienced a rash over her face and torso, shortness of breath and an elevated heart rate. Dr. Lindy Jones, the hospital’s emergency department medical director, said the worker was first given a shot of epinephrine, a standard treatment for severe allergic reactions. Her symptoms subsided but then re-emerged, and she was treated with steroids and an epinephrine drip. When doctors tried to stop the drip, her symptoms re-emerged yet again, so the woman was moved to the intensive care unit, observed throughout the night, then weaned off the drip early Wednesday morning, Dr. Jones said.

The second worker received his shot on Wednesday and developed eye puffiness, lightheadedness and a scratchy throat 10 minutes after the injection, the hospital said in a statement. He was taken to the emergency room and treated with epinephrine, Pepcid and Benadryl, although the hospital said the reaction was not considered anaphylaxis. The worker was back to normal within an hour and released.

Still, the FDA said the vaccine is safe for most Americans who have allergies, Reuters reported.

The agency only warned those Americans who have a history of severe allergic reactions, or a history of allergic reactions to ingredients present in either vaccine, from immediately receiving the vaccine.

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Pfizer vaccine to get official nod from FDA, vaccinations could start Monday, says HHS secretary

The United States is set to distribute and administer its first vaccine against the novel coronavirus.

On Friday morning, Health and Human Services Secretary Alex Azar announced that the U.S. Food and Drug Administration would grant emergency use authorization for Pfizer and BioNTech’s COVID-19 vaccine in a matter of days and that millions of doses would soon be shipped to administration centers across the country.

The secretary indicated that the first vaccines could be administered as early as Monday.

“I’ve got some good news for you,” Azar told ABC News anchor George Stephanopoulos on “Good Morning America.”

“Just a little bit ago, the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine,” he continued. “So in the next couple of days, probably as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine.

“We could be seeing people getting vaccinated Monday, Tuesday of next week,” he said.

The vaccine was approved for emergency use by officials in the United Kingdom last week and was immediately administered to British citizens. In the U.S., however, the vaccine has still been undergoing review by an FDA advisory board.

On Thursday, the panel, made up of independent scientific experts and infectious disease doctors and statisticians, green-lighted the vaccine for use in a 17-4 vote, with one member abstaining. The move cleared the way for the agency to approve the vaccine shortly.

Millions of vaccinations are readied to be shipped in short order once the formal approval is granted.

Last month, Pfizer chief executive Albert Bourla said that his company was prepared “to ship to most of the places [in the U.S.] overnight” — an impressive operation considering the vaccine requires storage in vials which can maintain a temperature between -94 and -112 degrees Fahrenheit.

In a joint statement, the companies said they expect to produce up to 50 million vaccine doses globally in 2020 and more than 1 billion doses by the end of next year.

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Pfizer says it is seeking emergency use of COVID-19 vaccine Friday

Drug manufacturing giant Pfizer said earlier this week that it would be seeking emergency use of its COVID-19 vaccine in a matter of “days.”

Well, that day has come.

The company announced that it is asking the Food and Drug Administration’s regulators on Friday for approval of its vaccine, which, as the Associated Press reported, starts the clock on the process that could bring the drug to the public as early as December — and hopefully bring about an end to the pandemic.

Pfizer said Wednesday that clinical trials had shown its vaccine is 95% effective and appears to be safe.

The company said its most recent trial included 44,000 subjects, of which 170 developed COVID-19. But 162 of those were folks who had received the placebo, meaning only eight subjects who had received the actual vaccine contracted the virus.

The trial also found that there were no “serious safety issues” with the vaccine and that the “severe” side effects of the shot were fatigued (3.8% of subjects) and headaches (2% of subjects). The company also said the vaccine’s efficacy was consistent “across age, gender, race and ethnicity demographics.”

Considering the urgency of the situation, “the FDA is expected to move quickly,” the Wall Street Journal reported:

Given the urgency, the FDA is expected to move quickly. The timing of the filing is in line with industry and government officials’ projections for authorization and distribution to begin next month. Pfizer said the filing could allow for distribution to begin by the middle to end of December.

A green light would cap the fastest vaccine development program ever in the West, going from laboratory to authorization in less than a year. Pfizer, which partnered with Germany’s BioNTech in March, has so far spent about $2 billion on the effort. Pfizer has said it is ready for a quick approval.

CEO Albert Bourla told the New York Times Tuesday that his company is ready to ship the vaccine “overnight.”

According to the AP, about 25 million shots could be available in the U.S. in December.

The company also said it could have 50 million doses available globally by the end of the year, the AP said.

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Pfizer CEO says vaccine is ready to be shipped ‘overnight’ across US once FDA authorizes

The chief executive of Pfizer, the pharmaceutical company behind the development of a vaccine with 95% effectiveness against COVID-19, said this week that his company is ready to ship the vaccine “overnight” to most places in the United States once it receives emergency use authorization from the U.S. Food and Drug Administration.

Pfizer, who produced the vaccine in conjunction with German company BioNTech, is expected to submit a request for that authorization “within days,” according to a Wednesday press release about the conclusion of its Phase 3 human trials.

During an interview with the New York Times DealBook Online Summit the day before, Pfizer CEO Albert Bourla explained that his company is prepared “to ship to most of the places [in the U.S.] overnight” — which is quite a feat considering the vaccine requires storage in vials at a temperature between -94 and -112 degrees Fahrenheit.

In order to distribute the vaccine safely and effectively, Pfizer produced special packaging containers to move the product while maintaining the required low temperature.

“Those boxes are isothermic boxes that have a GPS and also a temperature meter so we know at any point where the box is and what is the temperature so if something goes wrong, which we don’t anticipate, we will not use the vaccine,” explained Bourla in the interview. “Every box is a small box like that and can take 1,000 to 5,000 doses. And when we ship it, we don’t need to use refrigeration. So we can ship it in cars, trucks, planes, boats, whatever. In the US, we will ship to most of the places overnight.”

“So once we receive an address from the government, the next day the product will be there,” he continued. “And once people receive it they can keep it for weeks in the box or they can keep it for months in their freezers or they can put it in refrigeration and keep it for a week, approximately. I think that the demand will be so big, it’s going to be injected in hours rather than days or weeks. So we feel very confident about it.”

On Wednesday, Pfizer and BioNTech announced that a final assessment of trial data on their vaccine showed it was 95% effective against the disease and that it had cleared the safety milestone required by the FDA for emergency use. The two companies added that the vaccine’s efficacy was consistent “across age, gender, race and ethnicity demographics.”

“Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021,” they said in the statement.

A second vaccine, developed by Moderna, has also reported stunningly high success against COVID-19 in its human trials this week and also plans to apply for emergency use authorization in short order.

Barring any hiccups in the process, this means an effective vaccine could be available to millions of Americans by the end of the year.

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Report: Pfizer plans to seek FDA approval for COVID vaccine in ‘days,’ trials find it 95% effective

According to a report from the Wall Street Journal, Pfizer and BioNTech SE plan to submit their vaccine to the FDA for approval in a matter of “days” after Pfizer determined through clinical trials that its coronavirus vaccine is over 95% effective and appears to be safe.

According to the report, Pfizer’s clinical trial involved 44,000 subjects. Of those subjects, 170 of them developed the coronavirus with at least one symptom; however, 162 of those subjects received the placebo. Only eight adults contracted the coronavirus who received the actual vaccine, which means that the vaccine is considered to be 95% effective — about the same as the vaccines for shingles and the measles.

Additionally, the “severe” side effects of the vaccine were found to be fatigue, which was reported by 3.8% of study participants, and headaches, which were reported by 2% of study participants. Researchers conducting the study noted that there were no “serious safety issues” with the vaccine and that the vaccine appears to be “well tolerated” thus far, but noted that they are still compiling final data.

Pfizer told the Wall Street Journal that they anticipate having this data compiled and ready to submit to regulators “within days,” which would place the vaccine on track for delivery in 2020, if the vaccine is approved by the FDA.

In a statement, Pfizer CEO Albert Bourla said, “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

Moderna, Inc. likewise appears to be close to final development of their coronavirus vaccine, which has been found to have a 94% effectiveness rate in early trials.

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Trump administration says 20 million Americans will get COVID vaccine by end of December

President Donald Trump held a press conference in the Rose Garden on Friday to give an update on Operation Warp Speed and the development and production of vaccines for COVID-19. The administration said that vaccine development has progressed to the point where they hope about 20 million Americans will be immunized from the virus by the end of December.

“The past nine months my administration has initiated the single greatest mobilization in U.S. history pioneering, developing, and manufacturing therapies and vaccines in record time, numbers like nobody’s seen before,” Trump said. “No medical breakthrough of this scope and this magnitude has ever been achieved this rapidly and this quickly, and we’re very proud of it.”

Trump spoke with leaders of Operation Warp Speed. Dr. Moncef Slaoui, the scientific head of the project, projected that up to 20 million coronavirus vaccines could be distributed by the end of the year.

“We plan to have enough vaccine doses available for use in the U.S. population to immunize about 20 million individuals in the month of December and another 25 to 30 million per month on an ongoing basis from there on,” Dr. Slaoui said.

He added that by February or March, if we more vaccines approved, even more Americans will be able to be immunized going forward.

Slaoui added that four of the six vaccines supported by Operation Warp Speed have reached phase 3 trials, and he encouraged Americans to volunteer for clinical testing.

On Monday, Pfizer and BioNTech announced that clinical trials for their COVID-19 vaccine were “more than 90% effective,” causing the stock market to rally. The pharmaceutical manufacturers will appeal to the Food and Drug Administration for emergency approval to begin using the vaccine as early as the end of November. They believe the can make at least 50 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

President Trump gave Operation Warp Speed credit for Pfizer’s vaccine advancements, though Pfizer denied that it accepted federal funds to develop a vaccine.

“As a result of Operation Warp Speed, Pfizer announced on Monday that its China virus vaccine is more than 90% effective. This far exceeds any and all expectations. Nobody thought they’d get to that level, and we have others coming which we think will be an equal level, maybe more if that’s possible,” Trump said.

The president noted that earlier this year, his administration reached an agreement with Pfizer to provide $1.95 billion to support vaccine distribution.

“Our investment will make it possible for the vaccine to be provided by Pfizer free of charge,” Trump claimed, adding that Pfizer’s denial of participating in Operation Warp Speed was an “unfortunate misrepresentation.”

“We will work to secure an emergency use authorization, which will be coming down extremely soon,” Trump continued. The administration “will coordinate the distribution of the vaccine.”

“Front-line workers, the elderly, and high-risk Americans” will receive priority for vaccine distribution, according to the president.

Trump also criticized New York Democratic Gov. Andrew Cuomo for casting doubt on the effectiveness of a vaccine approved by the Trump administration. He said that the federal government will not provide New York with vaccine doses until the governor gives them approval to do so.

“He wants to take his time with a vaccine. He doesn’t trust where the vaccine’s coming from. These are coming from the greatest companies anywhere in the world, the greatest labs in the world, but he doesn’t trust the fact that it’s this White House, this administration,” Trump said.

“So we won’t be delivering it to New York until we have authorization to do so. That pains me to say that. This is a very successful, amazing vaccine at 90 percent and more,” he added.

“I hope he doesn’t handle this as badly as he’s handling the nursing homes,” Trump remarked.

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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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