Global Statistics

All countries
Updated on September 26, 2022 6:11 pm
All countries
Updated on September 26, 2022 6:11 pm
All countries
Updated on September 26, 2022 6:11 pm

Global Statistics

All countries
Updated on September 26, 2022 6:11 pm
All countries
Updated on September 26, 2022 6:11 pm
All countries
Updated on September 26, 2022 6:11 pm
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Is The Covid Vaccine Considered An Experimental Drug

Will The Mrna Vaccines Change My Dna

Is the COVID-19 Vaccine an Experimental Drug?

No, thats not possible, experts said. The messenger RNA in the Pfizer and Moderna vaccines that helps create the immune response against the coronavirus doesnt enter the nucleus of the cells where DNA resides.

There literally is no physical connection between the RNA in these vaccines and the DNA in our cellular nuclei, Schwartz said. So theres no possibility for that connection, let alone for effects or adaptations.

What You Need To Know

  • COVID-19 vaccines are safe and effective.
  • Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.
  • CDC recommends you get a COVID-19 vaccine as soon as possible.
  • If you are fully vaccinated, you can resume activities that you did prior to the pandemic. Learn more about what you can do when you have been fully vaccinated.

Thrombosis With Thrombocytopenia Syndrome

Thrombosis occurs when blood clots block blood vessels. Thrombocytopenia is a condition in which a low blood platelet level interferes with the formation of blood clots.As of November 24, 2021, more than 16.4 million doses of the Johnson & Johnson/Janssen COVID-19 vaccine have been given in the United States. CDC and FDA identified 54 confirmed reports of people who got the Johnson & Johnson/Janssen COVID-19 vaccine and later developed TTS. TTS after Johnson & Johnson/Janssen COVID-19 vaccination is rare.

Women ages 50 and younger especially should be aware of the rare but increased risk of this adverse event associated with the Johnson & Johnson/Janssen vaccine. There are other COVID-19 vaccine options available. Learn more about Johnson & Johnson/Janssen COVID-19 vaccine and TTS.

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Serious Safety Problems Are Rare

In rare cases, people have experienced serious health events after COVID-19 vaccination. Any health problem that happens after vaccination is considered an adverse event. An adverse event can be a side effect that was caused by the vaccination or a coincidental event, such as an unrelated fever, that happened following vaccination.

To date, the systems in place to monitor the safety of these vaccines have found four serious types of adverse events following COVID-19 vaccination, with evidence that suggests an increased risk after certain types of COVID-19 vaccinations were administered. They are:

The Vaccine Makes Women Infertile

COVID Vaccine Stocks Long Call or Put? The mumps vaccine ...

This comes from former Pfizer employee Mike Yeadon. His prediction was that the vaccine might trigger an off-target attack against a placenta protein because there was a tiny bit of similarity between it and the target COVID spike protein. If that were true, you should see the same effect in women whove had COVID because they produce antibodies to the spike protein. But women whove had COVID have no trouble getting pregnant. Nor do women whove had the vaccine.

Yeadon was also wrong in claiming that asymptomatic people could not spread COVID.

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What Safety And Effectiveness Data Are Required To Be Submitted To Fda For An Eua Request For A Vaccine Intended To Prevent Covid

COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer.

For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the studys primary efficacy endpoint.

Part of FDAs evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices.

What Does This Mean For Me

Employers, retailers and venue operators could have required that their workers and customers be vaccinated under the emergency use authorization, but some held off, awaiting full approval. If your employer or school didnt already mandate that you get vaccinated, its more likely to happen now.

President Biden called on private businesses, nonprofits and local government leaders to require employees to get vaccinated. Do what I did last month, he said, referring to the vaccine mandate imposed on White House staff in July. On the heels of the FDA announcement, the Pentagon said it would be mandating the shots for members of Americas military.

The majority of Americans support vaccine mandates, according to a recent Morning Consult/Politico poll. The group most likely to oppose them are Republicans, who, polling data indicate, are also the largest group of unvaccinated people.

The Pentagon says it will require service members to receive the COVID-19 vaccine now that the Pfizer vaccine has received full FDA approval.

Think of getting vaccinated like wearing your seat belt in your car or your helmet on your bike: They arent guarantees, but youll feel and be, statistically a lot safer.

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Uk Records 91743 New Covid Cases And 44 More Deaths

Britain reported 91,743 new Covid cases on Monday, the second highest figure since the start of the pandemic, as the Omicron variant continues to spread rapidly.

The number of deaths within 28 days of a positive Covid test was 44.

The Omicron variant of the coronavirus is spreading faster than the Delta variant and is causing infections in people already vaccinated or who have recovered from the Covid disease, the head of the World Health Organization said on Monday.

There is now consistent evidence that Omicron is spreading significantly faster than the Delta variant, Tedros Adhanom Ghebreyesus told a news briefing at the WHOs new headquarters in Geneva.

And it is more likely people vaccinated or recovered from Covid-19 could be infected or re-infected, Tedros said.

Kuwait will require anyone who has been vaccinated against Covid for nine months to get a booster shot, the government tweeted on Monday.

Kuwait will also require travellers to quarantine at home for 10 days unless they receive a negative PCR test for coronavirus within 72 hours of their arrival.

Countries across Europe have moved to reimpose tougher measures to stem a new wave of Covid infections spurred by the highly transmissible Omicron variant, with the Netherlands leading the way by imposing a nationwide lockdown.

All non-essential stores, bars and restaurants in the Netherlands will be closed until 14 January.

His office said:

Reports Of Death Are Rare

Experimental Covid-19 pill shows promise in preliminary testing

More than 459 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through November 29, 2021. During this time period, VAERS received 10,128 reports of death among people who received a COVID-19 vaccine.

FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it is unclear that the vaccine was the cause. Reports to VAERS of health problems or deaths following vaccination do not necessarily mean that a vaccine caused a health problem. Reports to VAERS provide information on possible concerns, and allow scientists to look more closely at VAERS and other health data to figure out whether the problem was related to vaccination. CDC clinicians review reports of death to VAERSincluding death certificates, autopsy, and medical records.

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How Long Will The Trials Take To Complete

Each trial is designed to follow participants and collect safety and immunogenicity data for about two years. However, a trial can be temporarily paused or stopped due to safety issues, futility or strong evidence of efficacy. It is difficult to predict exactly how long it will take to generate enough data to determine the safety and efficacy of various vaccine candidates because that depends on the actual incidence of SARS-CoV-2, the virus that causes COVID-19. The trials are event-driven , meaning that statisticians have estimated that a certain number of cases of COVID-19 among trial participants must be observed for a high probability of detecting a percent reduction in disease incidence in the vaccinated group compared to the placebo group that is not due to chance. The primary analysis occurs once this threshold of cases has been observed. The trial protocols also stipulate if and when the Data and Safety Monitoring Board can perform interim analyses before reaching the point for primary analysis.

Eua Experience During Covid

During the COVID-19 pandemic, the FDA has issued an unprecedented number of EUAs. Arguably, not all of these EUAs were justified many were granted for products that had little data behind them. At least some of these products can and should be seen as experimental.” For example, hydroxychloroquine was granted an EUA for the purpose of treating patients with COVID-19 without strong data, so the drug could reasonably be seen as an experimental treatment for COVID-19 at the time the EUA was granted. That EUA was subsequently revoked. Because, despite great hype, the evidence did not show effectiveness against COVID-19, and it never moved into the category of an established treatment.

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Millions Of People Have Safely Received A Covid

More than 485 million doses of COVID-19 vaccine had been given in the United States from December 14, 2020, through December 13, 2021. To view the current total number of COVID-19 vaccinations that have been administered in the United States, please visit the CDC COVID Data Tracker.

COVID-19 vaccines are safe and effective. COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines met the Food and Drug Administrations rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization . Learn more about EUAs in this video.external icon

The Pfizer-BioNTech, Moderna, and Johnson & Johnson/Janssen COVID-19 vaccines will continue to undergo the most intensive safety monitoring in US history. This monitoring includes using both established and new safety monitoring systems to make sure that COVID-19 vaccines are safe.

Natural Immunity Is Always Stronger Than The Vaccines

China rapidly expands use of experimental COVID

This is partly false. Natural immunity does tend to last longer than immunity acquired from vaccination, but it depends on the pathogen. The tetanus vaccine, for example, provides stronger immunity than the disease itself. Research indicates the COVID-19 vaccines provide more consistent and safer protection than getting sick.

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How Is Niaid Working To Ensure Diversity Among Volunteers In The Vaccine Clinical Trials Why Is Enrolling Diverse Groups Important

Long-standing systemic health and social inequities have put many people from racial and ethnic minority groups at increased risk of getting sick and dying from COVID-19. Race and ethnicity are risk markers for other underlying conditions that impact health including socioeconomic status, access to health care, and increased exposure to the virus due to occupation . According to the CDC, people who are Black or African American, Hispanic or Latino, American Indian or Alaska Native and Asian are more likely to die from COVID-19. Black and African American people are 3.7 times more likely to be hospitalized for COVID-19 as compared to white people. Hispanic or Latino people are 4.1 times more likely to be hospitalized, American Indian or Alaska Native people are 4 times as likely to be hospitalized, and Asian people are 1.2 times as likely to be hospitalized.

It is important that U.S. clinical trials enroll a volunteer population that at least reflects the diversity of the U.S. population, or more ideallyreflects the population of those at increased risk of COVID-19.

The NIAID-funded COVID-19 Prevention Network is working with stakeholders to reach priority populations, including Native Americans, Black Americans , the Latinx community, people who are at higher risk of exposure to SARS-CoV-2 infection due to occupation, people with pre-existing health conditions, people living in assisted living facilities and communities experiencing health disparities.

Natural History Museum And Edinburgh Castle Closed By Covid

Belgiums health ministers have agreed to start vaccinating children aged between five and 11 against coronavirus.

Ministers said the vaccination is highly recommended for children with conditions that put them at high risk for complications from Covid. Those children will be invited to receive their jabs as a priority before the end of the month.

EU regulators last month approved a reduced-dose vaccine made by Pfizer-BioNTech for use in the five-to-11 age group.

To counter a new spike in case of the virus, which has already claimed 27,900 lives in Belgium, the government has tightened rules for schools and nurseries, bringing school holidays forward and asking children aged six and over to wear masks. In addition, classes must close when two children from the same class test positive.

Jamie Grierson

Bereaved families and friends who lost loved ones to Covid have criticised Boris Johnson over a photo that has emerged showing the prime minister at a gathering in the Downing Street garden with wine and cheese alongside his wife and up to 17 staff in an apparent breach of lockdown rules.

The photograph was shared with the Guardian following No 10s denial last week that there was a social event on Friday 15 May 2020, including wine, spirits and pizza, inside and outside the building. Johnsons spokesperson said Downing Street staff were working in the garden in the afternoon and evening.

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Mrna Vaccines Are A Medical Device Not A Vaccine Nope

I first came across the claim that mRNA-based COVID-19 vaccines are not really vaccines at all from a very familiar antivaccine propaganda blog that Ive followed as part of my effort to stay on top of all the latest antivaccine talking points since its very inception, Age of Autism. It comes courtesy of an antivaccine quack named Dr. Ken Stoller and was posted a couple of weeks ago to the AoA website under the title, Pfizer, Moderna et al Covid Products are Medical Devices Not Vaccines.

Basically, Dr. Stoller is into all manner of autism quackery and pseudoscience, be it vaccines as a cause of autism, hyperbaric oxygen to treat autism , chelation therapy, and many others. And conspiracy theories. Naturally, he believes that They are keeping you from learning about the evidence that vaccines cause autism and that his quackery works to reverse it.

Unfortunately , Dr. Stollers claims regarding COVID-19 mRNA vaccines are rather ridiculous even on the surface:

Lets dive into the core of Stollers claim, which, as many antivaxxers cant resist, he cant help but preface by comparing COVID-19 vaccination to the Tuskegee syphilis experiment, but only a billion-fold worse:

Heres how the CDC actually does define a vaccine, a definition that is easily found on the CDC website under Immunization: The Basics:

And heres the FDAs definition of a vaccine:

I also cant help but address Dr. Stollers conclusion:

The Vaccine Has Been Assessed And Approved By Medsafe

Experimental COVID-19 drug reduced hospitalizations and deaths by half, Merck says

Medsafe are our regulatory agency, and their job is to ensure the safety of all medicines and medical devices used in New Zealand. They are there to protect the population against harm from medicines.

While agencies in countries under COVID-19 siege gave emergency use approval for these vaccines, New Zealand had the luxury of putting the vaccines through the full approval process. As COVID-19 is currently a pandemic disease, and the situation is evolving rapidly, the vaccine has been given provisional approval. Medsafe have asked the manufacturer to provide ongoing information about the vaccine, this is normal. For example, if there are any changes to the manufacturing processes or site of manufacture, Medsafe want to know the details. This does not mean that the vaccine is unsafe. If the vaccine was not very safe then Medsafe would not authorise its use. It is as simple as that.

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What Is An Emergency Use Authorization

I think that understanding what constitutes an Emergency Use Authorization is critical to our understanding of whether COVID-19 vaccines are experimental or not.

The legal framework for an Emergency Use Authorization is laid out in 21 U.S.C. §360bbb-3 of the Federal Food, Drugs and Cosmetics Act. The specific provision is titled Unapproved product, and then required conditions, and the clause says that the Secretary shall establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed

of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown and

of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

On February 4, 2020, the Secretary of Health and Human Resources determined that COVID-19 is a public health emergency with the potential to affect the health and security of U.S. citizens. Thus, the Secretary determined that the EUA was appropriate and justified. Before issuing a EUA, the FDA concluded that the following requirements were met:

  • SARS-CoV-2 can cause a serious or life-threatening disease/condition
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