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Updated on August 7, 2022 5:29 pm
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Updated on August 7, 2022 5:29 pm
All countries
Updated on August 7, 2022 5:29 pm

Global Statistics

All countries
Updated on August 7, 2022 5:29 pm
All countries
Updated on August 7, 2022 5:29 pm
All countries
Updated on August 7, 2022 5:29 pm
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Is The Covid Vaccine Experimental

Distortion Behind Claim Of Danger

Experimental Coronavirus Vaccine Administered To Human Test Subject In Seattle

Hotze distorts the facts in attempting to claim that the mRNA vaccines are dangerous.

He claims that the vaccines will cause your immune system to be hyper-charged because its having to fight off all these viral proteins that your own body is making all the time, and it will overreact when exposed to any type of coronavirus in the future. He goes on to say that, in previous studies dealing with coronaviruses, the animals died from an immune system hyper reaction, when they were later exposed to the coronavirus against which they had been previously vaccinated.

There is no evidence that the COVID-19 mRNA vaccines result in such an immune response.

Hotzes website post of the video references a commentary article from October, before any COVID-19 vaccine was authorized by the FDA, in which two researchers warned about the possibility that COVID-19 vaccine candidates could cause antibody-dependent enhancement of disease, or ADE. ADE is a phenomenon that occurs when a previous infection or vaccination generates antibodies that dont neutralize the virus but instead enhance the virus ability to infect cells, which can lead to a worse illness instead of preventing it.

We have not seen any cases of enhanced SARS-CoV-2 disease, either in animal models or in vaccinated humans, she added.

Other experts also have explained that there is no evidence indicating ADE is an issue with the COVID-19 vaccines.

Myth: The Side Effects Of The Covid

FACT: In April 2021, the CDC temporarily paused and then resumed use of the Johnson & Johnson vaccine. Read full story.

The Pfizer and Moderna COVID-19 vaccines can have side effects, but the vast majority are very short term not serious or dangerous. The vaccine developers report that some people experience pain where they were injected body aches headaches or fever, lasting for a day or two. These are signs that the vaccine is working to stimulate your immune system. If symptoms persist beyond two days, you should call your doctor.

If you have allergies especially severe ones that require you to carry an EpiPen discuss the COVID-19 vaccine with your doctor, who can assess your risk and provide more information about if and how you can get vaccinated safely.

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Fda And The Vaccine Review Process

  • Clinical trials. The FDA requires rigorous testing of vaccines through a series of clinical trials to make sure they work and are safe before authorizing or approving them for the public. The laboratories that conduct the trials are independent from the vaccine companies and the government, so the information they convey to the FDA for its approval process is not biased.
  • Risks and benefits. FDA approval of a vaccine involves careful assessment of risks and benefits. Before approval can happen, the clinical trials and other data used by the agency must demonstrate that the benefits of a vaccine are greater than its risks for those who will be vaccinated.
  • Continual monitoring. After authorization or approval, monitoring continues: The FDA continues to examine data for adverse effects among the people receiving the vaccine. If any problems are linked to a vaccine, the FDA may pause the administration of that vaccine to do more studies and ensure that the problem does not outweigh the vaccines benefit.
  • Manufacturing guidelines. The FDA also sets strict guidelines for vaccine manufacturers and requires that they test the vaccine doses in batches to ensure the quality and effectiveness of the vaccines remain consistent and reliable.

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Myths And Facts About Covid

CDC has updated its recommendations for COVID-19 vaccines with a preference for people to receive an mRNA COVID-19 vaccine . Read CDCs media statement.

Accurate vaccine information is critical and can help stop common myths and rumors. It can be difficult to know which sources of information you can trust. Learn more about finding credible vaccine information.

Below are myths and facts about COVID-19 vaccination.

What Data Have To Be Provided For Special Populations And Age Groups

Why you should take coronavirus vaccine news with a grain of salt ...

Vaccine studies focus on adults, including older adults, as well as people with underlying diseases that put them at particular risk of severe COVID-19 disease. Some studies may also include adolescents from 16 years of age.

People above 65 years of age should represent at least a quarter of the total number of participants in studies. This group is at greatest risk of severe COVID-19 disease.

Results from earlier safety and immunogenicity testing determine whether these people should be included in large clinical studies.

Studies should also include people from ethnic minorities.

Investigations into the use of COVID-19 vaccines in children are planned for once there is sufficient information from studies in adults and adolescents.

For more information, see

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The Vaccines Were Developed Fast But Not Recklessly

The science behind these vaccines is not completely new. The plug-and-play platforms such as the viral-vectors and mRNA were already available and had already been tested in humans. All that needed to happen to prepare a vaccine candidate for human trials was to plug in the instructions to make the SARS-CoV-2 spike protein. The technology was ready and waiting. Human data was available for all of these vaccine platforms, including previous coronaviruses such as MERS and SARS.

Getting a vaccine through a series of human trials to assess efficacy and safety has traditionally taken some years. This is for the following reasons:

  • Money the process costs in the order of billions and if the product does not work or there is not a big enough market then it will be a financial disaster
  • Reliance on Big Pharma Relying on big pharma to fund financially risky adventures such as vaccine development left us vulnerable but no one else would do it.
  • Recruiting participants to studies It can take years to recruit sufficient participants into a vaccine trial.
  • Accruing enough events in a vaccine trial to demonstrate that the vaccine works
  • Regulatory agencies weighed down with bureaucracy that move at a snails pace.

Speed, not haste, is saving many lives.

Using Data To Approve Covid

As of August 2021, hundreds of millions of COVID-19 vaccine doses have been given to people in countries all over the world.

People who get the vaccines are encouraged to report any problems, including any severe side effects. A cooperative effort between the U.S. Centers for Disease Control and Prevention and the FDA, the Vaccine Adverse Event Reporting System collects and analyzes reports from people who received a vaccination and who experienced an adverse event, such as a severe side effect, after getting the shot.

As a result, we now have even more evidence that all three of the FDA-authorized COVID-19 vaccines are safe for most people who receive them, and that all three work well to prevent severe coronavirus disease.

Like other fully approved vaccines used to help prevent illnesses, the FDA-authorized COVID-19 vaccines can cause temporary aches, pains and fever in some people, but the risk of serious side effects is extremely low.

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Myth: Researchers Rushed The Development Of The Covid

FACT: Studies found that the two initial vaccines are both about 95% effective and reported no serious or life-threatening side effects. There are many reasons why the COVID-19 vaccines could be developed so quickly. Here are just a few:

  • The COVID-19 vaccines from Pfizer/BioNTech and Moderna were created with a method that has been in development for years, so the companies could start the vaccine development process early in the pandemic.
  • China isolated and shared genetic information about COVID-19 promptly, so scientists could start working on vaccines.
  • The vaccine developers didnt skip any testing steps, but conducted some of the steps on an overlapping schedule to gather data faster.
  • Vaccine projects had plenty of resources, as governments invested in research and/or paid for vaccines in advance.
  • Some types of COVID-19 vaccines were created using messenger RNA , which allows a faster approach than the traditional way that vaccines are made.
  • Social media helped companies find and engage study volunteers, and many were willing to help with COVID-19 vaccine research.
  • Because COVID-19 is so contagious and widespread, it did not take long to see if the vaccine worked for the study volunteers who were vaccinated.
  • Companies began making vaccines early in the process even before FDA authorization so some supplies were ready when authorization occurred.

The COVID-19 Vaccines: What you need to know | Las vacunas anticovid-19: información imprescindible

Experimental Covid Vaccines Another Anti

China approves experimental coronavirus vaccine trials

And here we go with another one of those silly anti-vaxxers tropes the COVID-19 vaccines are experimental, and the government/Big Pharma/Bill Gates are conspiring to test the vaccine on innocent people. Nothing could be further from the truth.

The claim that the COVID-19 vaccines are experimental probably arises from the fact that most of them received anEmergency Use Authorization in the USA and other countries. The anti-vaxxers what to use the EUA to make a strawman argument that EUA is equivalent to a risky, experimental drug that will cause great harm to you.

But if these anti-vaccine activists spent just a little bit of time to understand the high-quality science behind these vaccines and the Emergency Use Authorizations, they might move on to some other topic. But in case someone finds this article among all of the nonsense on the internet, looking to find out if COVID-19 vaccines are, in fact, experimental, lets debunk that with actual facts.

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Experts Say Her Symptom Combination Is Unusual

Two vaccine experts told Medscape Medical News that Choi’s symptoms were the extreme case and the vast majority of people will not experience her level of discomfort.

But they both agree Choi’s message is an important reminder that providers need to be prepared to answer questions when the rollouts begin.

Her story may also point out the need for creating a hotline with 24/7 access so that if patients do experience severe symptoms they can get answers right away, they said.

William J. Moss, MD, executive director of the International Vaccine Access Center at Johns Hopkins’ Bloomberg School of Public Health in Baltimore told Medscape Medical News that spotlights on individual cases of extreme side effects should be paired with spotlights on the experience of a patient with COVID-19 in an intensive care unit to give proper context.

“The type of side effects we’re seeing with the Pfizer and Moderna vaccines are typical of any vaccine, though there is a spectrum,” Moss said.

“The numbers I’ve seen range from maybe 2% to 10% ÂÂâ maybe up to 15% â of people having these kinds of really noticeable side effects. Again all transient. But some people have more severe than others.” Moss continued. He notes that any inflammatory response is normal.

“What we don’t want is for people to be surprised by that,” he said.

An important point, Moss says, is that “these are always transient, lasting 12-36 hours, maybe 48 hours.”

First Show That The Vaccines Are Safe

The Biologic Control Act and Public Health Service Act authorized the FDA to license vaccines if the vaccines are shown to be safe, pure, and potent. To determine that, vaccines have to first be tested in non-clinical studies and then, in addition, on humans.

Further, sponsors of a vaccine must submit data before a vaccine can be licensed, including but not limited to:

  • data derived from nonclinical and clinical studies showing the products safety, purity, and potency
  • a description of manufacturing methods for the vaccine
  • data establishing the products stability through the dating period and
  • a representative sample of the product and summaries of results of tests.
  • After this data is submitted, the FDA reviews and evaluates the sponsors data and information to determine whether the vaccine is in fact safe, pure, and potent. Only after that determination can a vaccine finally be licensed. Finally, vaccines continue to be safe even after licensure because the FDA continues to monitor vaccines to detect any rare, serious, or unexpected adverse events through the use of multiple surveillance methods.

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    Want To Inform Others About The Accuracy Of This Story

    Lead Stories is working with the CoronaVirusFacts/DatosCoronaVirus Alliance, a coalition of more than 100 fact-checkers who are fighting misinformation related to the COVID-19 pandemic. Learn more about the alliance here.

    Lead Stories Managing Editor Dean Miller has edited daily and weekly newspapers, worked as a reporter for more than a decade and is co-author of two non-fiction books. After a Harvard Nieman Fellowship, he served as Director of Stony Brook University’s Center for News Literacy for six years, then as Senior Vice President/Content at Connecticut Public Broadcasting. Most recently, he wrote the twice-weekly “Save the Free Press” column for The Seattle Times.

    Preliminary Study Indicates People With Combo Shot Experience Higher Boost In Omicron

    Volunteers get first round of experimental coronavirus vaccine

    Moderna’s experimental COVID-19 vaccine that combines its original shot with protection against the Omicron variant appears to work, the company announced Wednesday.

    COVID-19 vaccine makers are studying updated boosters that might be offered in the fall to better protect people against future coronavirus surges.

    Moderna’s preliminary study results show people given the combination shot experienced a higher boost in Omicron-fighting antibodies than if they just got a fourth dose of the original vaccine.

    “We believe strongly that this data supports an update of the vaccine,” Stephen Hoge, Moderna’s president, said Wednesday.

    Today’s COVID-19 vaccines all are based on the original version of the coronavirus. They’re still providing strong protection against severe disease, hospitalization and death even after the appearance of the super-contagious Omicron variant especially if people have had an initial booster dose.

    But the virus continues to mutate rapidly in ways that let it evade some of the vaccines’ protections and cause milder infections.

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    The Vaccines Aren’t Safe For Pregnant Women

    This is missing context. Clinical trials for the coronavirus vaccines did not include pregnant women, but their exclusion was not atypical. Preliminary research conducted since the trials has found no safety problems associated with pregnant women receiving the vaccines, though experts say more study is needed. Since the coronavirus vaccines do not contain live virus, they are not thought to pose a risk to a growing fetus. It has been recommended that pregnant women get vaccinated against COVID-19, as they are more at risk for severe illness.

    Full Fda Approval Of A Covid

      The three COVID-19 vaccines authorized for use in the U.S. are safe and effective in helping prevent serious disease or death due to the coronavirus. These vaccines were granted an emergency use authorization, or EUA, by the Food and Drug Administration . The Pfizer/BioNTech COVID-19 vaccine received full approval by the FDA on Aug. 23, 2021.

      Lisa Maragakis, M.D., M.P.H., senior director of infection prevention, and Gabor Kelen, M.D., director of the Johns Hopkins Office of Critical Event Preparedness and Response, explain what that means.

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      ‘i Would Do It Again In A Heartbeat’

      Choi wants to be clear that her message is not meant to warn about the vaccine itself: “I would do it again in a heartbeat even if I knew I was going to have the same reaction,” she said.

      Her message, rather, is that providers may be underestimating the effort it will take to be ready to contradict misinformation. They should reassure patients that the symptoms come because the body is training itself to fight the virus.

      Albert Rizzo, MD, chief medical officer for the American Lung Association, says the side effects Choi experienced are uncommon â especially all at once â with the Pfizer vaccine as well as with the other two frontrunners from Moderna and Oxford/AstraZeneca.

      “People should not expect to get that many side effects,” he said.

      However, milder side effects, such as soreness at the injection site, are common, he said.

      Part of the message to patients should include the riskâbenefit balance: an emphasis should be placed on weighing the deadly risk of COVID-19 as well as the benefit of helping protect society at large against potential vaccine side effects, he said.

      Providers should partner with other trusted influencers within cultures, particularly among people of color, where trust of vaccines is particularly low, Rizzo said. Leaders who understand both the hesitancy and the need for the vaccine can help reinforce the clinical message.

      “We can’t just from on high say this is an important thing to do,” he said.

      Show Sources

      Nurse Shares Covid Vaccine Side Effects From Trial

      Experimental coronavirus vaccine showing promising results

      Nurse researcher Kristen Choi, PhD, experienced first-hand a “worst-case scenario” of potential side effects after receiving an experimental COVID-19 vaccine in a phase III trial. She says providers should be prepared to reassure patients if reports of similar experiences spread when vaccine rollouts begin.

      “This was the highest fever I can ever remember having, and it scared me,” said Choi, with the School of Nursing at UCLA.

      Choi volunteered to participate in Pfizer’s COVID-19 vaccine trial in August. When she came back for the second dose in September she began to experience distressing symptoms.

      The symptoms, she writes in a piece published online today in JAMA Internal Medicine, started with immediate pain at the injection site. By nightfall, she felt “felt light-headed, chilled, nauseous, and had a splitting headache” and went to bed.

      She woke up at midnight and the symptoms had intensified and she could hardly move her arm from injection-site pain. Choi slept fitfully and when she woke up at 5:30 AM her thermometer read 104.9 °F.

      Because the trial was blinded, Choi wasn’t told whether she received the vaccine or placebo, but the symptoms left her with little doubt.

      After all, even Choi, who administers vaccines and whose career centers on research, began to fear something was wrong when symptoms flared even though she was thoroughly briefed on potential side effects. She says rational went out the window when her fever spiked.

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