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Medicine Regulators need to explain how they concluded the benefits outweigh the risks in giving the Covid-19 Vaccines to children

<p><strong>The Pfizer Covid-19 injection has been given emergency use authorisation to be used in children over the age of 12 in the UK by the MHRA, whilst the Joint Committee on Vaccination and Immunisation (JCVI) have decided that vulnerable children over the age of 12 and all 16 and 17 year olds should be offered the Pfizer jab. Both authorities claim that their decision is based on the benefits outweighing any potential risks.</strong></p>
<p><strong>If this is the case, then the MHRA and JCVI need to explain how they came to this conclusion when just 1 in every 1.7 million children have died with Covid-19 in 18 months, whilst 1 in every 9 children suffered a serious adverse reaction to the Pfizer vaccine in the small and short clinical trial which left them unable to perform daily activities.</strong></p>
<p>According to <a href="https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-daily-deaths/weekly-total-archive/">official NHS data</a> published weekly, between March 2020 and the 11th August 2021 a total of 3,743 people have died with Covid-19 in UK hospitals who had no underlying conditions, whilst 85,410 have allegedly died with Covid-19 who had other serious underlying conditions.</p>
<p>These conditions include ailments such as chronic kidney disease, chronic neurological disease, chronic pulmonary disease, heart disease, and dementia.</p>
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<p>However, the vast majority of these deaths have occured in people over the age of 80, and people between the age of 60 and 79; the vast majority of which are closer to the age of 79. The number given by the NHS of people who have died with Covid-19 since March 2020, between the ages of 0 and 19, who had underlying conditions is just 38. Whilst the people who have died with Covid-19 snce March 2020, between the ages of 0 and 19, who had no other known underlying conditions stands at just 9.</p>
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<p>There are <a href="https://www.statista.com/statistics/281174/uk-population-by-age/">approximately 15.6 million people aged 19 and under</a> in the United Kingdom which means just 1 in every 410,526 children and teenagers have allegedly died with Covid-19 in 18 months, who had other serious pre-existing conditions. Whilst just 1 in every 1.7 million children have allegedly with Covid-19 in 18 months, who had no know pre-existing conditions.</p>
<p>Every death is of course a tragedy, especially when it is somebody so young, but we need to put these numbers into context now that an experimental injection is going to be given to children in the United Kingdom in the name of protecting them from Covid-19.</p>
<p>During the clinical trial to test the efficacy and safety of the Pfizer Covid-19 vaccine in children aged 12 and over, 1,127 children were given one dose of the mRNA jab, but only 1,097 children received the second dose. This fact in itself raises questions as to why 30 children did not receive a second dose of the Pfizer jab.</p>
<p>Of the 1,127 children who received a first dose of the jab a shocking 86% experienced an adverse reaction. Of the 1,097 children who received a second dose of the jab a shocking 78.9% experienced an adverse reaction.</p>
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<p>Of course these adverse reactions include things such as a sore arm, so therefore it is vital to know the rate of serious adverse reactions that occurred during the limited clinical trial.</p>
<p>For children 12 to 15 years of age, the Pfizer COVID-19 vaccine clinical trial found the overall incidence of severe adverse events which left them unable to perform daily activities, during the two-month observation period to be 10.7%, or 1 in 9, in the vaccinated group and 1.9% in the unvaccinated group, resulting in a vaccine risk of 8.8% or 1 in 11 vaccinated children.</p>
<p>Consequently, children who received the vaccine had nearly six times the risk of a severe adverse event occurring in the two-month observation period compared to children who did not receive the vaccine. In addition, the incidence of Covid-19 in the unvaccinated group was 1.6%, therefore, there were almost seven times more severe adverse events observed in the vaccinated group than there were Covid-19 cases in the unvaccinated group.</p>
<p>This information is all freely available to see in official Food an<a href="https://www.fda.gov/media/144413/download">d Drug Administration (FDA) documents</a> and official <a href="https://www.fda.gov/media/144413/download">Centre for Disease Control (CDC) document</a>s.</p>
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<p>As you can clearly see based on the number of children to have allegedly died with Covid-19 in 18 months, and the number of children to have suffered a serious adverse reaction in the clinical trial, the benefits of giving children the Covid-19 injection do not outweight the risks.</p>
<p>But there may be some who naively believe children should be given the injection because it will help to prevent transmission of the Covid-19 virus, but that is not what these experimental injections do.</p>
<p>The Pfizer clinical trial was not designed to observe asymptomatic infection with SARS-CoV-2 or the effect of the vaccine on the spread (transmission) of COVID-19. Consequently, <a href="https://www.fda.gov/media/144245/download">the FDA states</a> that “it is possible that asymptomatic infections<br />
may not be prevented as effectively as symptomatic infections” and “data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination.”</p>
<p>This is also proven by the fact thousands of fully vaccinated individuals are allegedly testing positive for Covid-19, being hospitalised and dying. The <a href="https://dailyexpose.co.uk/2021/08/06/new-latest-phe-report-shows-the-covid-19-vaccines-are-increasing-the-risk-of-hospitalisation-and-death-due-to-covid-19-significantly/">latest Public Health England report</a> shows that fully vaccinated individuals account for 65% of all alleged Covid-19 deaths since February 2021.</p>
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<p>Therefore due to the fact the Covid-19 vaccines do not prevent infection or transmission, 1 in every 9 children suffered a serious adverse reaction leaving them unable to perform daily activities during the clinical trial, and just 1 in every 1.7 million children having allegedly died with Covid-19 in 18 months, how on earth can the MHRA and JCVI justify giving the Covid-19 vaccine to children and claim that their decision is based on the potential benefits outweighing any risks?</p>
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<p>Video messages from Australian truck drivers have surfaced in some of the …</p>
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<p>The experimental Covid-19 injections are causing serious adverse reactions including death. In …</p>
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<h3 class="jp-relatedposts-headline"><em>Related</em></h3>
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source <a href="https://dailyexpose.co.uk/2021/08/23/medicine-regulators-need-to-explain-how-they-concluded-the-benefits-outweigh-the-risks-in-giving-the-covid-19-vaccines-to-children/">https://dailyexpose.co.uk/2021/08/23/medicine-regulators-need-to-explain-how-they-concluded-the-benefits-outweigh-the-risks-in-giving-the-covid-19-vaccines-to-children/</a>

revolution Medicine Regulators need to explain how they concluded the benefits outweigh the risks in giving the Covid-19 Vaccines to children

The Pfizer Covid-19 injection has been given emergency use authorisation to be used in children over the age of 12 in the UK by the MHRA, wh...

FDA Grants Full Approval to the Pfizer-BioNTech Covid-19 Vaccine

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<figure class="aligncenter is-resized"><img alt="Coronavirus: Canada approves Pfizer, BioNTech COVID-19 ..." height="392" loading="lazy" src="https://external-content.duckduckgo.com/iu/?u=https%3A%2F%2Fwww.boston25news.com%2Fresizer%2F6OI7spClv3b8RWE0HWrodC3-oo0%3D%2F1200x628%2Fd1hfln2sfez66z.cloudfront.net%2F12-02-2020%2Ft_814aa08bdc5d4fc885fe086716931436_name_UK_approves_Pfizer_coronavirus_vaccine_f_5fc77c65b639e84c3033f9fd_1_Dec_02_2020_12_02_45_poster.jpg&f=1&nofb=1" width="750" />
<figcaption>The FDA has announced that it has given the Pfizer Covid-19 full approval despite being linked to blood clots and other life-threatening adverse reactions.</figcaption>
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<p><strong>Today, the Food and Drug Administration (FDA) has given full approval to the Pfizer Covid-19 vaccine, despite the countless adverse reactions that the injection has caused.</strong></p>
<p>The Covid-19 vaccines have been granted Emergency Use Authorisation (EUA) meaning that the jabs are able to be distributed and used without having <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained" target="_blank" rel="noreferrer noopener">full approval</a>.</p>
<p>Pfizer’s Covid jab was granted EUA in December 2020, becoming the first Covid shot to get the federal nod.</p>
<p>The <a href="https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine">FDA website states that</a>: “On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.</p>
<p>“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”</p>
<p>It is believed that the approval of Pfizer’s two-dose shot will lead to more businesses and institutions enacting vaccine requirements. Many health experts have criticised the FDA for not green-lighting the vaccine sooner, whilst other censored doctors – such as Dr Mike Yeadon – have warned that the <a href="https://dailyexpose.co.uk/2021/08/05/dr-mike-yeadon-the-covid-vaccine-spike-proteins-damage-placenta-protein-in-vaccinated-women/" target="_blank" rel="noreferrer noopener">shots are a risk to public health and have been rushed.</a></p>
<p>The US Surgeon General, Dr Vivek Murthy, predicted Sunday that the authorisation of the vaccine would cause more educational institutions and businesses to enact vaccine mandates.</p>
<p>Dr Murthy told Fox News: “There are universities and businesses that have been considering putting in vaccine requirements in order to create a safer, a workplace, a learning environment.</p>
<p>“I think this announcement from the FDA would likely encourage them and make them feel more comfortable in putting some requirements in place.”</p>
<p>Some universities have announced that following the authorisation they will be mandating the Covid-19 vaccines for all students.</p>
<p>M. David Rudd, president of the University of Memphis, said that a vaccine mandate will be implemented once the Pfizer jab is granted FDA approval, according to the <a rel="noreferrer noopener" href="https://eu.commercialappeal.com/story/news/education/2021/08/20/university-memphis-pursue-vaccine-mandate-after-fda-approval/8214031002/" target="_blank">Memphis Commerical Appeal.</a></p>
<p>“Once the CDC provides full authorization, as is the case for the other vaccines, we will absolutely pursue [mandating COVID vaccines],” he said in the article published Friday. “My guess is once [full approval] occurs, it will be more difficult at the legislative level to disallow mandatory vaccinations simply because we have mandatory vaccinations in a number of areas.</p>
<p>“If in fact the vaccine is authorized within the coming week, we will be pursuing the issue, in coordination with the state immediately.”</p>
<p>Similarly, the president of Louisiana State University said that they will be requiring all students to get vaccinated following the FDA’s approval.</p>
<p>Of course, the FDA appears to have completely ignored the <a href="https://dailyexpose.co.uk/2021/08/19/shocking-uk-government-release-29th-report-on-adverse-reactions-to-the-covid-19-vaccines/" target="_blank" rel="noreferrer noopener">countless adverse reactions</a> that the <a href="https://dailyexpose.co.uk/2021/05/30/shocking-86-of-children-suffered-an-adverse-reaction-to-the-pfizer-covid-vaccine-in-clinical-trial/" target="_blank" rel="noreferrer noopener">Pfizer vaccine has caused</a>, including <a href="https://dailyexpose.co.uk/2021/04/18/heartbreaking-two-year-old-dies-after-having-the-pfizer-covid-vaccine/" target="_blank" rel="noreferrer noopener">causing harm to children</a>. Despite this, the federal agency has gone full steam ahead and has approved the jab, deeming it to be <a href="https://dailyexpose.co.uk/2021/06/09/pfizer-skipped-critical-testing-and-cut-corners-on-quality-standards-for-covid-vaccine/">“safe and</a> <a href="https://dailyexpose.co.uk/2021/06/09/pfizer-skipped-critical-testing-and-cut-corners-on-quality-standards-for-covid-vaccine/" target="_blank" rel="noreferrer noopener">e</a><a href="https://dailyexpose.co.uk/2021/06/09/pfizer-skipped-critical-testing-and-cut-corners-on-quality-standards-for-covid-vaccine/">ffective”</a> against Covid-19.</p>
<p><strong>It is believed that FDA approval of Moderna’s vaccine could be weeks away despite the jab recently being investigated for its <a href="https://bestlifeonline.com/moderna-myocarditis-news/" target="_blank" rel="noreferrer noopener">links to myocarditis</a>, which is inflammation of the heart.</strong></p>
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<div class="wp-block-coblocks-post-carousel__content" readability="13.674008810573"><time datetime="2021-08-23T20:30:00+01:00" class="wp-block-coblocks-post-carousel__date">August 23, 2021</time><a href="https://dailyexpose.co.uk/2021/08/23/medicine-regulators-need-to-explain-how-they-concluded-the-benefits-outweigh-the-risks-in-giving-the-covid-19-vaccines-to-children/" alt="Medicine Regulators need to explain how they concluded the benefits outweigh the risks in giving the Covid-19 Vaccines to children">Medicine Regulators need to explain how they concluded the benefits outweigh the risks in giving the Covid-19 Vaccines to children</a>
<p>The Pfizer Covid-19 injection has been given emergency use authorisation to be …</p>
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<p>An organisation set up to provide a confidential platform for healthcare workers …</p>
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<p>So, what’s going to happen next? I can tell you that. A …</p>
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<p>Video messages from Australian truck drivers have surfaced in some of the …</p>
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<div class="wp-block-coblocks-post-carousel__content" readability="18.11320754717"><time datetime="2021-08-23T07:56:31+01:00" class="wp-block-coblocks-post-carousel__date">August 23, 2021</time><a href="https://dailyexpose.co.uk/2021/08/23/scottish-government-wants-to-make-emergency-covid-19-powers-permanent/" alt="Scottish Government Wants to Make Emergency Covid-19 Powers Permanent">Scottish Government Wants to Make Emergency Covid-19 Powers Permanent</a>
<p>First Minister Nicola Sturgeon and the SNP have managed to push through …</p>
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<div class="wp-block-coblocks-post-carousel__content" readability="19.398773006135"><time datetime="2021-08-23T07:10:29+01:00" class="wp-block-coblocks-post-carousel__date">August 23, 2021</time><a href="https://dailyexpose.co.uk/2021/08/23/pfizer-covid-19-vaccine-destroys-t-cells-and-weakens-the-immune-system/" alt="Pfizer Covid-19 Vaccine Destroys T Cells and Weakens the Immune System">Pfizer Covid-19 Vaccine Destroys T Cells and Weakens the Immune System</a>
<p>The study, conducted by the Francis Crick Institute, found that the Pfizer …</p>
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<p>The experimental Covid-19 injections are causing serious adverse reactions including death. In …</p>
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<p>New evidence, including sworn affidavits from leading experts such as Professor Luc …</p>
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<p>Dr. Mike Yeadon posted on Telegram: "This very interesting paper discusses the …</p>
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<h3 class="jp-relatedposts-headline"><em>Related</em></h3>
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source <a href="https://dailyexpose.co.uk/2021/08/23/fda-grants-full-approval-to-the-pfizer-biontech-covid-19-vaccine/">https://dailyexpose.co.uk/2021/08/23/fda-grants-full-approval-to-the-pfizer-biontech-covid-19-vaccine/</a>

revolution FDA Grants Full Approval to the Pfizer-BioNTech Covid-19 Vaccine

The FDA has announced that it has given the Pfizer Covid-19 full approval despite being linked to blood clots and other life-threatening a...

Congress’s Democrat-on-Democrat hostage standoff, explained

<div><img class="ff-og-image-inserted" src="https://cdn.vox-cdn.com/thumbor/KcrKP0C2DcRgy1Hcf56vj-acQyc=/0x0:5472x2865/fit-in/1200x630/cdn.vox-cdn.com/uploads/chorus_asset/file/22227819/GettyImages_1230533059.jpg" /></div>
<p>On the surface, the latest dispute between moderate Democrats and party leaders in Congress seems trivial. It’s about which of Biden’s two big bills will move forward first in the US House. Will it be the bipartisan infrastructure deal, which <a href="https://www.cnbc.com/2021/08/10/senate-to-pass-bipartisan-infrastructure-bill.html">passed the Senate earlier this month</a>? Or will it be the coming <a href="https://www.vox.com/22577374/reconciliation-bill-biden-medicare-climate">Democrat-only “mega-bill”</a>, containing trillions in spending on health care, anti-poverty programs, climate, and more?</p>
<p>But the standoff — and a potential showdown this week — could have massive implications for President Joe Biden’s agenda.</p>
<p>Speaker Nancy Pelosi <a href="https://www.vox.com/2021/6/29/22554042/pelosi-manchin-infrastructure-deal-reconciliation">has said since June</a> that the mega-bill, in which progressives are placing their hopes for major change, must move forward before she’ll act on the far less sweeping bipartisan infrastructure deal.</p>
<p>But nine moderate House Democrats, led by Rep. Josh Gottheimer (D-NJ), are now demanding that <a href="https://www.washingtonpost.com/opinions/2021/08/22/reconciliation-can-wait-lets-do-infrastructure-first/">the order be flipped</a>. And they say they won’t support a budget vote this week unless their demands are met.</p>
<p>This is about much more than just timing, though. The fight is really about who will have the most leverage in shaping the still-unwritten mega-bill, which aims to enact much of Biden’s agenda in one fell swoop — and about whether it will pass at all.</p>
<p>Progressives have feared all year that, if the bipartisan infrastructure bill is signed into law, moderate Democrats might just decide to call it a day. That is, after all, the bill that Sens. Kyrsten Sinema and Joe Manchin helped shape and deeply care about. The fear was that those moderates might end up killing progressives’ beloved mega-bill altogether, or very severely scaling it back.</p>
<p>That’s why Pelosi, spurred by House progressives, <a href="https://www.speaker.gov/newsroom/62421">announced in June</a> that until the Senate passed the mega-bill, the House would take no action on the bipartisan infrastructure bill. She was basically taking Senate moderates’ precious deal hostage, to make sure they’d play ball with progressive priorities. President Biden has given <a href="https://twitter.com/sahilkapur/status/1429856067681406984?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Etweet">tacit</a> (and, initially, <a href="https://apnews.com/article/joe-biden-business-government-and-politics-7f9226bb825fcf72f2fe5056d1e20ac4">explicit</a>) approval to this strategy.</p>
<p>The coming mega-bill will advance through a special process called budget reconciliation (which allows it to bypass the Senate filibuster, and pass with a simple majority). But to unlock that process, Congress first needs to pass what’s called a budget resolution. The Senate did that earlier this month, and Pelosi <a href="https://www.nytimes.com/2021/08/11/us/politics/senate-budget-plan.html">called back the House</a> to do their part this week.</p>
<p>But then things hit a snag when some of Pelosi’s own moderate Democrats in the US House decided to take a hostage of their own. Rep. Gottheimer and eight other Democrats <a href="https://www.rollcall.com/2021/08/13/nine-centrist-house-democrats-threaten-to-oppose-budget-without-infrastructure/">released a letter</a> saying they would not vote for the budget resolution until the House passes the bipartisan infrastructure deal. That is: they’ve taken their own hostage, and are demanding Pelosi let the previous hostage go.</p>
<p>Democrats’ House majority is currently so narrow that, if four of their members defect and vote with Republicans, they can vote down a bill. So if Gottheimer’s group sticks to its guns, they could get their way. It is, however, possible that a deal of some sort will still be reached.</p>
<p>Of course, this isn’t just a petty squabble over who’s first in line. This battle is really about two groups — progressives and moderates — trying to maximize their leverage in shaping the coming, still-unwritten mega-bill.</p>
<p>Democrats <a href="https://www.vox.com/22577374/reconciliation-bill-biden-medicare-climate">have allotted $3.5 trillion for this bill</a> and have a rough plan for where it will go, but nothing is really set in stone yet, and many questions remain. Will the overall amount have to be cut substantially, <a href="https://www.politico.com/news/2021/08/23/sinema-35t-spending-bill-506583">as Sinema is demanding</a>? Will plans to spend on various areas have to be jettisoned? If so, what will get the heave — subsidized child care? Universal pre-K? The expanded child tax credit? Expanded Medicare benefits? How will the climate portions of the bill end up when they have to go through Manchin’s Energy and Natural Resources Committee?</p>
<p>Both progressives and moderates want to try and maximize their leverage to ensure those and many more questions are resolved to their liking. And there are two ways to try and shape a piece of legislation. You can ask nicely, or you can play hardball — threatening that you’ll vote no if you don’t get what you want.</p>
<p>Anyone can make threats. The question is whose threats actually come off as credible. Generally, threats to kill a bill seem most credible from those who would have political reasons for doing so (<a href="https://www.vox.com/22339531/manchin-filibuster-bipartisanship-senate-west-virginia">like Manchin</a>, who represents a state Trump won by nearly 39 points), or those with a history of defying leadership (like the late John McCain on the Republican side, whom Sinema seems to be <a href="https://apnews.com/article/joe-biden-az-state-wire-government-and-politics-6632b84d43dcd5f897dbaea36d780bbb">trying to channel</a>).</p>
<p>Typically it’s moderate Democrats who tend to be the toughest gets, holding out until the last minute. It’s often believed that progressives will just go along, because from their perspective, passing something — anything — is better than passing nothing.</p>
<p>But in this era of a polarized partisan Congress, politics is a team sport, with strong incentives even for moderates to support their president’s top legislative priorities. So sometimes, the moderates basically end up getting rolled. Leaders can cater to the base and gamble that moderates will cave in the end, perhaps with some minor face-saving changes, for fear of infuriating the base and making their party’s president look like a failure. (Whether this succeeds depends on the particular issue and the particular politicians it involves.)</p>
<p>Pelosi supercharged that latter dynamic by taking the bipartisan infrastructure bill hostage. For one, that’s a bill the moderates are most eager to pass, and that progressives don’t particularly care about. But even more importantly, Pelosi’s move means that Biden’s whole agenda depends on whether moderates and progressives can reach agreement on the mega-bill. So the moderates’ threat to kill it comes off as less credible, since they’d be making President Biden a failure.</p>
<p>That’s the theory anyway — though Sinema is trying to debunk it. Her spokesperson <a href="https://www.politico.com/news/2021/08/23/sinema-35t-spending-bill-506583">told Politico Monday</a> that “proceedings in the U.S. House will have no impact” on her views about the mega-bill, and reiterated that its current spending level is too high.</p>
<p>In other words: keep the hostage as long as you want. She’ll wait.</p>
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source <a href="https://www.vox.com/22637828/pelosi-gottheimer-budget-resolution-reconciliation-infrastructure">https://www.vox.com/22637828/pelosi-gottheimer-budget-resolution-reconciliation-infrastructure</a>

vox Congress’s Democrat-on-Democrat hostage standoff, explained

On the surface, the latest dispute between moderate Democrats and party leaders in Congress seems trivial. It’s about which of Biden’s two ...

Adam Serwer on the all-American politics of cruelty

<div><img class="ff-og-image-inserted" src="https://cdn.vox-cdn.com/thumbor/Wh93sq6eCfQUEMZ8JvEam4-X_nA=/0x393:5342x3190/fit-in/1200x630/cdn.vox-cdn.com/uploads/chorus_asset/file/22800279/1335521223.jpg" /></div>
<p>The phrase “The cruelty is the point” achieved mantra status during the Trump presidency. It was coined by Adam Serwer, a writer at the Atlantic and a sharp observer of race and American politics.</p>
<p>Serwer <a href="https://go.redirectingat.com/?id=66960X1516588&xs=1&url=https%3A%2F%2Fwww.penguinrandomhouse.com%2Fbooks%2F665171%2Fthe-cruelty-is-the-point-by-adam-serwer%2F&referrer=vox.com&sref=https%3A%2F%2Fwww.vox.com%2Fvox-conversations-podcast%2F22637762%2Fvox-conversations-adam-serwer-the-cruelty-is-the-point" rel="sponsored nofollow noopener" target="_blank" has-subtag="true" data-cdata='{"rewritten_url":"https://go.redirectingat.com?id=66960X1516588\u0026xs=1\u0026url=https://www.penguinrandomhouse.com/books/665171/the-cruelty-is-the-point-by-adam-serwer/\u0026referrer=vox.com\u0026sref=https://www.vox.com/vox-conversations-podcast/22637762/vox-conversations-adam-serwer-the-cruelty-is-the-point\u0026xcust=___vx__p_22401803__m_m-placeholder__s_s-placeholder__t_w__c_c-placeholder__r_r-placeholder__d_d-placeholder","subtag_max_length":50,"subtag_delim_length":3,"subtag_key":"xcust","subtag_data":{"id":"66960X1516588","xs":"1","url":"https://www.penguinrandomhouse.com/books/665171/the-cruelty-is-the-point-by-adam-serwer/","referrer":"vox.com","sref":"https://www.vox.com/vox-conversations-podcast/22637762/vox-conversations-adam-serwer-the-cruelty-is-the-point","xcust":"___vx__p_22401803__m_m-placeholder__s_s-placeholder__t_w__c_c-placeholder__r_r-placeholder__d_d-placeholder"},"encode_subtag":false}'>recently released an anthology</a> of his writings during the Trump era, including his now-<a href="https://www.theatlantic.com/ideas/archive/2018/10/the-cruelty-is-the-point/572104/">famous essay</a> on cruelty and Trumpism. The pieces in the collection span almost the entirety of American history and they touch on too many topics to summarize. But if there’s a unifying question, it’s this: What role does cruelty play in America?</p>
<p>Serwer’s answer is complicated but worth pondering. For him, individual cruelty isn’t really the problem. Sure, people can be cruel, but people can be lots of things, and a healthy society is more than capable of channeling our vices. Serwer’s argument is that the structure of American politics itself is cruel.</p>
<p>While Serwer recognizes that cruelty, over time, has been a bipartisan feature of American politics, he believes it’s now central to the Republican Party. This is not the same as saying individual Republicans are cruel; the point is that the GOP, as a matter of strategy, is incentivizing cruelty.</p>
<p>I spoke to Serwer for an episode of <a href="https://www.vox.com/vox-conversations-podcast"><em>Vox Conversations</em></a>. We discussed the role of cruelty in American life as well as some of the challenges of making these sorts of distinctions. We also talk about why cruelty is so effective as a mobilizing device for the GOP at this moment, and why, no matter how hard we try, we’ll never get rid of it.</p>
<p>Listen to our conversation below or on <a href="https://apps.apple.com/us/app/vox-conversations/id1215557536">Apple Podcasts</a>, <a href="https://podcasts.google.com/search/vox%20conversations">Google Podcasts</a>, <a href="https://open.spotify.com/show/6NOJ6IkTb2GWMj1RpmtnxP">Spotify</a>, or wherever you listen to podcasts.</p>
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source <a href="https://www.vox.com/vox-conversations-podcast/22637762/vox-conversations-adam-serwer-the-cruelty-is-the-point">https://www.vox.com/vox-conversations-podcast/22637762/vox-conversations-adam-serwer-the-cruelty-is-the-point</a>

vox Adam Serwer on the all-American politics of cruelty

The phrase “The cruelty is the point” achieved mantra status during the Trump presidency. It was coined by Adam Serwer, a writer at the Atl...

The Jeopardy hosting saga has become a cautionary morality tale

<div><img class="ff-og-image-inserted" src="https://cdn.vox-cdn.com/thumbor/MfVe7Z1gR2Bh6MneLbPMbFqfavM=/0x0:3000x1571/fit-in/1200x630/cdn.vox-cdn.com/uploads/chorus_asset/file/3510062/133292598.0.jpg" /></div>
<p>In the end, <em>Jeopardy</em> executive producer Mike Richards was the face of the legendary quiz show for approximately one day.</p>
<p>After a year of guest hosts, some of whom were backdoor-auditioning for the job of permanent host after the death of Alex Trebek last November, Richards drew confusion and backlash when news broke on August 11 that he would be stepping up <a href="https://www.thedailybeast.com/jeopardy-set-to-announce-mayim-bialik-and-mike-richards-splitting-host-duties">to take the gig</a>.</p>
<p>In comparison with more prominent candidates like legendary <em>Jeopardy</em> contestant Ken Jennings and superfan <a href="https://www.vox.com/culture/22557875/levar-burton-jeopardy-hosting-history">LeVar Burton</a>, Richards had zero name recognition outside <em>Jeopardy</em> viewers who’d watched him helm a few episodes as part of the show’s parade of guest hosts earlier this year. The casting news immediately spawned the <em>Jeopardy</em> in-joke “<a href="https://twitter.com/NickBossRoss/status/1423045827380092931">Who Is Mike Richards?</a>”</p>
<p>Though Richards has only been a <em>Jeopardy</em> producer for one tumultuous year, he’s a game show industry veteran who seems to have long-held aspirations of hosting a game show, any game show, himself. That ambition may have led him to pursue the chance to host <em>Jeopardy</em> once the opportunity presented itself.</p>
<p>But to a mostly unfamiliar public, Richards’s seemingly out-of-nowhere ascension predictably fueled a <a href="https://www.thedailybeast.com/jeopardy-host-frontrunner-mike-richards-alleged-history-of-harassment-discrimination">rising tide</a> of dissatisfaction and scrutiny, which then spurred discussion of trouble in his past. <a href="https://www.theringer.com/tv/2021/8/18/22631299/mike-richards-jeopardy-host-search-process-past-comments">The Ringer published an exposé</a> painting Richards as an opportunist with a history of making sexist, classist, and xenophobic remarks and detailing discrimination lawsuits made during his tenure at <em>The Price Is Right</em>. Very quickly, Richards looked unfit to continue the legacy of <em>Jeopardy</em>.</p>
<p>On Friday, August 20, he confronted that reality: Richards announced that he would be stepping down as host after a single day of taping the show — meaning the drawn-out search for a new permanent host to replace the late, <a href="https://www.vox.com/first-person/2019/3/20/18272876/jeopardy-alex-trebek">beloved</a> Trebek will continue a little while longer. Actress <a href="https://www.cnn.com/2021/08/23/media/mayim-bialik-jeopardy/index.html">Mayim Bialik</a>, who was a well-received guest host and had been slated to step in as a recurring host for occasional primetime episodes, will serve as the full-time host for now.</p>
<p>So: Who <em>is</em> Mike Richards, and how did he land, then lose, such a coveted job? His rise and fall feels almost scripted: A powerful man seems to override a fair selection process, then succumbs to scandal due to the skeletons in his closet. But this familiar story can tell us plenty about <em>Jeopardy</em> and its cultural role — and what might be next for the show itself.</p>
<p>Mike Richards became executive producer of <em>Jeopardy</em> a year ago, after the departure of longtime executive Harry Friedman at the end of the show’s 2019–2020 season. A jubilant <a href="https://variety.com/2019/tv/news/jeopardy-wheel-of-fortune-harry-friedman-mike-richards-1203318155/">announcement</a> about the switchover in August 2019 noted that Richards had programmed 4,000 hours of game shows during his career — a career that has seen Richards earn four Daytime Emmy awards and 19 nominations.</p>
<p>According to <a href="https://www.pepperdine.edu/magazine/2021/07/ahead-game/">an alumni profile</a> from Pepperdine University, the 46-year-old Richards began hosting a college TV show in the mid-’90s — <em>The Randumb Show</em>, described as “a weekly late-night sketch comedy talk show which won multiple college broadcasting awards.” Years later, Richards would revive a version of <em>The Randumb Show</em> in podcast form. But first, in 1997, as a new college grad, he leveraged it to gain an internship at <em>The Tonight Show</em> — and his career took off from there.</p>
<p>By the mid-aughts, Richards had moved from production assistant roles to hosting duties for reality shows like <a href="https://www.imdb.com/title/tt0460625/"><em>Beauty and the Geek</em></a>. In 2007, he auditioned to host <em>The Price Is Right</em> before assuming the role of <a href="https://variety.com/2008/scene/news/price-names-executive-producer-1117990000/">executive producer</a> instead. He has also reportedly auditioned to host <em>American Idol</em>.</p>
<p>These industry experiences, especially his intermittent hosting roles, might have made him a veteran primed for the <em>Jeopardy</em> job, but once he was named host, they also made him look insincere to many <em>Jeopardy</em> fans. As past <em>Jeopardy</em> champion Kristin Sausville <a href="https://www.theringer.com/tv/2021/8/18/22631299/mike-richards-jeopardy-host-search-process-past-comments">told</a> the Ringer, “[I]t looks like Richards just wanted to host a game show, any game show.”</p>
<p>Outside of his short tenure as a producer, Richards lacked an intimate tie to <em>Jeopardy</em> or a long-professed love for the show. This made him an outlier among the many guest hosts who helmed <em>Jeopardy</em> since Trebek’s illness and death. Popular guest host Ken Jennings is a <em>Jeopardy</em> legend, the most-winning contestant in the show’s history. NFL quarterback Aaron Rodgers, a lifelong fan, <a href="https://www.theringer.com/tv/2021/4/5/22368705/aaron-rodgers-jeopardy-guest-host-q-and-a">prepared for his stint</a> as host as intensely as if he were drilling for the Super Bowl. Fan-favorite Burton is a former <em>Celebrity Jeopardy</em> winner who’s been talking about his dream of hosting <em>Jeopardy</em> for nearly a decade.</p>
<p>Richards also came across to some viewers as a stand-in in other ways. As <a href="https://www.theringer.com/tv/2021/8/5/22611962/jeopardy-new-host-mike-richards-sony">reported</a> by the Ringer’s Claire McNear (a <em>Jeopardy</em> expert who <a href="https://www.twelvebooks.com/titles/claire-mcnear/answers-in-the-form-of-questions/9781538702321/">published a book</a> about the show in 2020), Richards may have pushed his way into guest-hosting the show earlier this year by seizing on a planned host’s scheduling conflict that the Ringer described as “minor.” In other words, Richards may have come up with a more-or-less artificial reason for him to take a spin as an emergency guest host, as if he were doing the show a favor by rescuing it from a crisis.</p>
<p>Regardless of how it came about, Richards’s perceived use of that temporary guest-hosting gig as a stepping stone to the permanent position looked like a power move. Richards seemed to be, in effect, crowning himself king.</p>
<p><em>Jeopardy</em> was at pains to stress, in <a href="https://www.jeopardy.com/jbuzz/news-events/jeopardy-welcomes-mayim-bialik-and-mike-richards-new-hosts">a press release</a> issued <a href="https://webcache.googleusercontent.com/search?q=cache:ftLvZtE2NmQJ:https://www.jeopardy.com/jbuzz/tagged/mayim-bialik+&cd=1&hl=en&ct=clnk&gl=us">August 11</a> that was later deleted, that the decision to elevate Richards was made not solely by him but rather “a senior group of executives at Sony Pictures Television,” based on “research from multiple panels and focus groups as well as input from the show’s partners and viewers.” Still, it’s difficult to align that insistence with audiences’ <a href="https://www.reddit.com/r/Jeopardy/comments/lpv887/jeopardy_recap_for_mon_feb_22_debut_of_mike/goeijuh/">general</a> <a href="https://www.seattletimes.com/entertainment/tv/news-that-mike-richards-might-be-new-jeopardy-host-met-with-resounding-meh-in-seattle/">ambivalence</a> about his hosting performance, as a brutal Morning Consult <a href="https://www.krqe.com/entertainment-news/poll-finds-jeopardy-fans-overwhelmingly-wanted-levar-burton-not-mike-richards-to-host/">poll after the announcement</a> suggests.</p>
<p>The whole situation smacked of opportunism — traits hardly befitting a program like <em>Jeopardy.</em> After all, the game show originally launched in the ’60s as <a href="https://www.history.com/news/quiz-show-scandal-fraud-jeopardy">a more honest alternative</a> to the scandal-laden trivia contests of the ’50s. In addition to the show’s “answer first, followed by the question” format serving as an antidote to more manipulative game show styles, <em>Jeopardy</em> has long generated a sense of unmatched community pride among its fans and contestants.</p>
<p>The show is a test of its audience’s intelligence and cleverness, and its egalitarian format makes it a microcosm of the American dream. The contest rewards anyone with a lot of knowledge and a little skill at making good bets, which is practically a template for how success in the US is theoretically supposed to work: On <em>Jeopardy,</em> we can see that fabled merit system reward nightly dividends.</p>
<p>The hosts are part of <em>Jeopardy</em>’s myth-making. In its decades-long run, the show has had only two main hosts — original host Art Fleming and longtime host Trebek, each with reputations that matched the show’s largely scandal-free record.</p>
<p>Given <a href="https://www.washingtonpost.com/lifestyle/media/jeopardy-mike-richards-journalism-media-claire-mcnear/2021/08/23/c91d090c-040d-11ec-a266-7c7fe02fa374_story.html">how leery many were</a> of Richards’s selection, it was all but a given that his reputation and past history would be highly scrutinized to make sure they could live up to the reputation of <em>Jeopardy</em> itself.</p>
<p>After <a href="https://variety.com/2021/tv/news/mike-richards-jeopardy-host-alex-trebek-1235034673/">the news broke</a> in early August that Richards was in talks to assume the role of host, media outlets began <a href="https://www.thedailybeast.com/jeopardy-host-frontrunner-mike-richards-alleged-history-of-harassment-discrimination">reporting</a> on several decade-old lawsuits involving Richards and allegations of sexism.</p>
<p><a href="https://www.hollywoodreporter.com/business/business-news/price-is-right-model-wins-393521/">One suit</a>, filed by former <em>The Price Is Right</em> model Brandy Cochran against the show’s production team in 2010, saw Cochran win $7.7 million in damages after the court found the production team had discriminated against her and then fired her for getting pregnant. Amid other allegations, Cochran said that Richards, then one of the show’s producers, refused to interact with her on set after implying he should have fired her before her pregnancy announcement. She also claimed Richards had pushed for the models to wear skimpier clothing onstage and had made derogatory comments about women in swimsuits.</p>
<p>In <a href="https://www.hollywoodreporter.com/business/business-news/price-is-right-lawsuit-pregnancy-discrimination-293805/">another lawsuit</a> filed alongside Cochran’s but later dismissed, <em>The Price Is Right</em> model Shane Stirling alleged that Richards joked that he’d fired five other models, only to be left with the one who had gotten pregnant.</p>
<p>Richards denied the allegations in court in 2012, and then <a href="https://www.thedailybeast.com/jeopardy-host-frontrunner-mike-richards-brushes-off-price-is-right-lawsuits-in-staff-memo?ref=author">denied them again</a> this month, sending an internal memo to staff in which he insisted, “The way in which my comments and actions have been characterized in these complaints does not reflect the reality of who I am or how we worked together on The Price is Right.”</p>
<p>Richards’s reputation took another hit, however, as the resurfaced lawsuits joined with other unsavory comments that McNear uncovered for the Ringer. These originated in a 2013 podcast titled <em>The Randumb Show</em>, recycling the name but not the format of Richards’s original college sketch show. The podcast and all of its 41 episodes were deleted from its hosting platform on August 17, but as reported by McNear, many of them featured Richards voicing a litany of controversial opinions.</p>
<p>In one episode, he referred to “booth babes” — women who cosplay and promote products at industry conventions — as “booth whores,” among other epithets. In other episodes, he made jokes drawing on harmful anti-Semitic stereotypes, prompting the <a href="https://twitter.com/ADL/status/1428446674574188546">Anti-Defamation League to call last week for an investigation</a> into his history.</p>
<p>In still more episodes, he mocked people on food stamps, welfare, and anyone who takes money from the government. He also dropped disparaging remarks about Haiti while discussing his guest’s apartment complex: “Does Beth live, like, in Haiti? Doesn’t it sound like that? Like, the urine smell, the woman in the muumuu, the stray cats.”</p>
<p>The Ringer noted that several times on the podcast, Richards praised figures like <em>American Idol</em> host Ryan Seacrest and <em>Survivor</em> host Jeff Probst — who, he claimed, have “actually made the world a safer place for what I like to call the ‘skinny white host,’ like [frequent game show host] George [Gray] and I. Which is, you’ll take a chance on someone that you don’t know.” Richards seemed to be implying that such hosts would make it easier for an unknown white man to be considered for future hosting gigs.</p>
<p>When it came to naming a new host for <em>Jeopardy,</em> Sony’s decision committee didn’t appear to want to take a chance on anyone but Richards. The only exception was offering a recurring slot to Bialik as the host of occasional primetime specials. (In the wake of Richards’ departure, Bialik will now serve as <a href="https://www.nytimes.com/2021/08/23/business/mayim-bialik-jeopardy-host.html"><em>Jeopardy</em>’s interim full-time host for at least 15 episodes</a>.)</p>
<p>As late as the day before he stepped down, with backlash still growing, Richards <a href="https://www.hollywoodreporter.com/tv/tv-news/mike-richards-adl-1235000199/">went to work</a> filming the new season, which was set to begin airing on September 13, 2021. He even <a href="https://www.theringer.com/tv/2021/8/18/22631299/mike-richards-jeopardy-host-search-process-past-comments">responded</a> to the Ringer’s investigation with a lengthy apology.</p>
<p>“It is humbling to confront a terribly embarrassing moment of misjudgment, thoughtlessness, and insensitivity from nearly a decade ago,” Richards said in a statement. “Looking back now, there is no excuse, of course, for the comments I made on this podcast and I am deeply sorry.”</p>
<p>Perhaps if Richards hadn’t already been widely perceived as a disingenuous crown-snatcher, his apology might have gone over better. Instead, within days, he was out.</p>
<p>On Friday, August 20, Richards announced through an official statement given to the Ringer’s McNear from Sony that he would be stepping down and that the studio would relaunch its search for a new host.</p>
<p>While many fans reacted to the news with jubilance, others were wearied at the thought of another protracted search for a new host. It’s unclear whether Sony will draw from the existing pool of now-seasoned hosts it has courted all year or whether it will look further afield.</p>
<p>In either case, the rounds of guest-hosting will resume for now. And because Richards was only declared host for a week — and only spent one day actually taping new episodes — the schedule shouldn’t experience much, if any, delay.</p>
<p>Many fans seem firmly behind LeVar Burton becoming <em>Jeopardy</em>’s next host, with celebrities including <a href="https://twitter.com/VancityReynolds/status/1428796230545645568">Ryan Reynolds</a> stepping in to comment on his fitness for the role. Other guest hosts have been the targets of scorn from fans because of their own less-than-stellar histories. As Daniel Feinberg <a href="https://www.hollywoodreporter.com/tv/tv-news/mike-richards-jeopardy-hosting-debacle-critics-notebook-1235000610/">wrote for the Hollywood Reporter</a>, “Selecting somebody with Richards’ background of ambitious ickiness was an affront to Alex Trebek’s legacy of fundamental decency, but I’m still more offended by what Dr. Oz’s guest run did to the show’s legacy of intellectual honesty.”</p>
<p>Meanwhile, while Bialik was a popular guest host, <a href="https://www.newsweek.com/mayim-bialik-faces-calls-step-down-jeopardy-host-after-mike-richards-departure-1621598">backlash did arise</a> against her selection alongside Richards, due to her <a href="https://www.thedailybeast.com/jeopardy-host-mayim-bialiks-ugly-history-of-shaming-weinsteins-victims-and-being-an-anti-vaxxer">history</a> of making anti-vaccine statements, along with <a href="https://www.nytimes.com/2017/10/13/opinion/mayim-bialik-feminist-harvey-weinstein.html">a 2017 New York Times op-ed</a> on Hollywood sexual misconduct in which she warned women in the industry against behaving “flirtatiously” and “having others celebrate your physical beauty.” She later <a href="https://www.vulture.com/2017/10/mayim-bialik-apologizes-for-controversial-weinstein-op-ed.html">apologized</a> for the op-ed, but that hasn’t stopped <em>Jeopardy</em> fans from escalating the push for her removal; since the August 23 announcement that Bialik will now be the show’s interim full-time host, social media attention has turned to further excavating her past.</p>
<p>Although it seems <a href="https://www.nytimes.com/2021/08/20/business/mike-richards-quits-jeopardy.html">Richards will continue</a> in his role as <em>Jeopardy</em>’s executive producer, some fans have <a href="https://www.newsweek.com/calls-grow-mike-richards-step-down-jeopardy-executive-producer-1621991">called on him</a> to resign from that job as well.</p>
<p>The result of this sequence of events is perhaps a reminder that <a href="https://idioms.thefreedictionary.com/Pride+goes+before+a+fall">pride goes before a fall</a>, or at least before scorned game show fans rummage through your past to prove you are unworthy of wearing <em>Jeopardy</em>’s crown. It’s also a reminder that <em>Jeopardy</em>’s importance extends beyond that of the average game show. Because the program combines intellectual curiosity with meritocracy in a way that makes geekery seem fashionable, <em>Jeopardy</em> stands as America’s most popular and culturally significant game show.</p>
<p>Its mostly scandal-free legacy, then, is a big deal — not only because the show is so popular, but because <em>Jeopardy</em> might just be one of the few cultural cornerstones that still unites Americans, one whose moral integrity and significance we can all agree on despite our many other differences. Throughout its decades-long run, <em>Jeopardy</em>’s biggest controversies have not been so large — such as complaints about <a href="https://www.today.com/popculture/jeopardy-contestant-addresses-critics-who-felt-he-was-too-arrogant-t218741">arrogant winners</a> or <a href="https://www.vox.com/culture/2019/5/2/18516852/jeopardy-james-holzhauer-record-winning-streak-hero-villain">card-shark contestant James Holzhauer</a>, whose mathematical gameplay was condemned by many fans as ruinous to the game’s spontaneity and fun.</p>
<p>The Mike Richards saga has threatened that legacy, and in its aftermath, with so much on the line, any future host will need to have a reputation that lives up to that of <em>Jeopardy</em> itself.</p>
<p>They’ll not only have Alex Trebek’s giant shoes to fill — they’ll have to convince the public that they deserve to wear them.</p>
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source <a href="https://www.vox.com/22634196/jeopardy-who-is-the-new-host-mayim-bialik-mike-richards-scandal-levar-burton">https://www.vox.com/22634196/jeopardy-who-is-the-new-host-mayim-bialik-mike-richards-scandal-levar-burton</a>

vox The Jeopardy hosting saga has become a cautionary morality tale

In the end, Jeopardy executive producer Mike Richards was the face of the legendary quiz show for approximately one day. After a year of ...

What full FDA approval for Covid-19 vaccines really means

<div><img class="ff-og-image-inserted" src="https://cdn.vox-cdn.com/thumbor/nS4_bY8ksW61B5Wd8jHQvVnZy18=/0x0:3000x1571/fit-in/1200x630/cdn.vox-cdn.com/uploads/chorus_asset/file/22793132/GettyImages_1331502512.jpg" /></div>
<p>Nearly nine months after the first Americans received their shots, the Covid-19 vaccine from Pfizer/BioNTech received <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine">full approval from the Food and Drug Administration</a> for people 16 and older on Monday. This could help increase the number of people willing to get vaccines and make it easier to compel those who are less willing — if health officials can cut through the mounting confusion around their efficacy, booster shots, and the threat of the <a href="https://www.vox.com/22547537/delta-coronavirus-variant-covid-19-vaccines-masks-lockdown">delta variant</a>.</p>
<p>Covid-19 vaccines from Johnson & Johnson, Pfizer/BioNTech, and Moderna have thus far been distributed across the US under <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">emergency use authorizations</a>. This form of limited approval allows the FDA to fast-track the distribution of drugs, vaccines, and medical devices during a public health emergency, like a pandemic.</p>
<p>Getting an emergency use authorization requires data from clinical trials showing that an intervention is safe and effective, but the bar for full approval is higher. Now, with 200 million people at least partially vaccinated, the FDA has effectively removed the asterisks from Pfizer/BioNTech’s mRNA vaccine.</p>
<p>“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Janet Woodcock, acting commissioner of the FDA, in a statement on Monday.</p>
<p>Full approval grants the vaccine manufacturers permission to advertise their products and allow them to continue selling them after the public health emergency around Covid-19 ends. For doctors, full approval also allows them to use vaccines off-label, potentially as booster shots.</p>
<p>But perhaps the most significant change would be a potential boost in public confidence in the vaccines, amid a rising tide of confounding information. Full approval could serve as a valuable messaging tool and help close some of the lingering gaps in immunization across the country.</p>
<p>A significant share of unvaccinated people — millions of people, according to polling — say that full approval will increase the likelihood that they’ll get a Covid-19 vaccine. These individuals may be hesitating “because they know there will be much more data available at the time of an approval ... three times as much data on safety and three times as much data on effectiveness,” said <a href="https://www.citizen.org/about/person/sidney-wolfe-md/">Sidney Wolfe</a>, founder and senior adviser at the health research group at Public Citizen.</p>
<p>More employers may also be willing to require vaccines among their workers (some have <a href="https://www.vox.com/22599791/covid-vaccine-mandate-legal-joe-biden-supreme-court-jacobson-massachusetts-boss-employer">already begun to do so</a>). And full approval from the FDA could bolster support for these vaccines in other countries that look to the US agency for its rigor. However, to get the maximum public health value out of a full approval, messengers from the president on down to local doctors have to be ready to explain what it all means.</p>
<p>For vaccines, the FDA grants emergency use authorizations after it reviews at least two months of follow-up results for clinical trial participants who received the actual injection. For full approval, known in FDA-speak as a “<a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber">biologics license application</a>,” the agency wants to see six months of data to ensure there are no widespread problems or to detect adverse reactions. Both reviews examine safety and efficacy while also studying what the optimal distribution strategy might be.</p>
<p>In May, <a href="https://investors.pfizer.com/investor-news/press-release-details/2021/Pfizer-and-BioNTech-Initiate-Rolling-Submission-of-Biologics-License-Application-for-U.S.-FDA-Approval-of-Their-COVID-19-Vaccine/default.aspx">Pfizer and BioNTech</a> submitted their license application. <a href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics">Moderna</a> began its application in June, and Johnson & Johnson said it will begin the process later this year.</p>
<p>With vaccines in general, almost all complications that occur tend to happen shortly after the vaccine is administered, often within a day or two. Most <a href="https://www.vox.com/22158238/covid-19-vaccine-side-effects-explained">side effects</a> of the Covid-19 vaccines in the US tend to be mild or moderate, ranging from pain at the injection site to fatigue to fever. A <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm">very small number</a> of recipients reported severe allergic reactions shortly after their shots, which is why most vaccine clinics have a waiting period where they can monitor patients for 15 to 30 minutes.</p>
<p>But in clinical trials, some extremely rare complications can be hard to detect even among tens of thousands of people after following them for two months. In April, the CDC and FDA paused the distribution of the <a href="https://www.vox.com/22158238/covid-19-vaccine-side-effects-explained">Johnson & Johnson Covid-19 vaccine</a> after 15 people reported a rare blood-clotting disorder out of the 8 million people who had received a dose at that point. After investigating, regulators concluded the benefits of the vaccine far outweigh the risks and allowed distribution to resume.</p>
<p>Monitoring clinical trial participants over six months also yields more information about how long protection from the vaccine lasts and whether any subsets of the population are more vulnerable. And it presents an opportunity to see how well the vaccines hold up against variants that were not widely circulating earlier in the pandemic.</p>
<p>This additional information — not just from clinical trials but from wide-scale distribution — helps the FDA identify any risks and better tailor its recommendations for use of the vaccine. Full approval also requires inspections of vaccine production facilities, looking at how the shots are made and how they’re packaged to ensure that production is consistent.</p>
<p>“That’s a much larger package of data, and that in itself means it takes much longer” to review, Wolfe said.</p>
<p>The licensing process for vaccines usually takes about a year. By granting full approval to the Pfizer/BioNTech vaccine just four months after the companies applied, Covid-19 vaccines have broken yet another speed record.</p>
<p>One caveat is that the full vaccine license only applies to the specific age groups included in a given clinical trial. The original trials mainly included adults, and Covid-19 vaccine testing in younger children has only recently begun, so the FDA has fully approved the Pfizer/BioNTech vaccine for use in adults 16 and older. Children 12 to 15 can continue to receive the shot under the emergency use authorization that was already in place.</p>
<p>At this point, the majority of adults in the US have received at least one dose of a Covid-19 vaccine under an emergency use authorization. The spread of the delta variant has increased the rate of new vaccinations, which reached more than a <a href="https://www.npr.org/sections/health-shots/2021/01/28/960901166/how-is-the-covid-19-vaccination-campaign-going-in-your-state">million doses in a day</a> on August 19, but the rate is still far below the April peak of more than 4.4 million doses per day. There remain pockets of the country where fewer than half of all eligible people have been vaccinated, and these regions are driving the rise in new Covid-19 cases, hospitalizations, and deaths.</p>
<p>There are several factors that <a href="https://www.vox.com/22587443/covid-19-vaccine-refusal-hesitancy-variant-delta-cases-rate">divide the vaccinated from the unvaccinated</a>, including political affiliation, race, income, and age. The reasons these people cite vary, such as a lack of access, a belief that Covid-19 isn’t that serious, and concerns that the vaccines have not been fully vetted.</p>
<p>According to polling from the <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/">Kaiser Family Foundation</a>, almost one-third of unvaccinated people said they would be more inclined to get a shot if it graduates from an emergency use authorization to a full license. Full FDA approval could mean a lot for this last group of people.</p>
<p>But convincing people to get shots is not the job of the FDA; that falls to other public health messengers, and they have to be prepared to seize the opportunity. “It can have a modest effect or be a game changer, depending on how it’s handled,” said <a href="https://www.kff.org/person/drew-altman/">Drew Altman</a>, president and CEO of the Kaiser Family Foundation. “It’s a question then of what the president does, what state and local public health leaders do, what the experts on television do.”</p>
<p>It’s not clear that people who cite the lack of FDA approval as a reason for not getting vaccinated are genuinely concerned with regulatory procedure or whether that’s just a proxy for general hesitancy. There’s also widespread confusion about the approval process: Kaiser’s polling also showed that at least two-thirds of US adults believed that Covid-19 vaccines already had full approval or weren’t sure about their regulatory status.</p>
<p>As for vaccine mandates, it’s already legal for private and public institutions to <a href="https://www.vox.com/22599791/covid-vaccine-mandate-legal-joe-biden-supreme-court-jacobson-massachusetts-boss-employer">require their employees and customers to get shots</a>. Companies like <a href="https://www.nytimes.com/2021/07/28/business/google-return-to-office-masks.html">Google</a>, <a href="https://www.nytimes.com/2021/07/30/business/covid-vaccine-mandates-rto.html">Disney, and Walmart</a> have begun to require many workers to get Covid-19 vaccines. But full approval could tip more employers, airlines, event venues, and other institutions that are on the fence to impose vaccinate mandates.</p>
<p>“I would look for significant movement on the part of more employers after full approval comes down from the FDA,” Altman said.</p>
<p>Now that the Pfizer/BioNTech vaccine is fully approved for people 16 and older, that doesn’t mean Moderna and Johnson & Johnson will stop distributing their vaccines under emergency use authorizations. While one of the conditions for granting an emergency use authorization is that there is no FDA-approved alternative available, emergencies like Covid-19 affect the calculus, the agency told Vox.</p>
<p>“For example, if the approved vaccine is only available in limited quantities, that vaccine may not be considered adequate to address the public health emergency,” said an FDA spokesperson in an email. “Another example would be if the vaccine is approved for use only in a limited population, then that vaccine may not be considered adequate to address the public health emergency for other populations.”</p>
<p>All the while, the dynamics of the pandemic are still changing, particularly with the surging <a href="https://www.vox.com/22547537/delta-coronavirus-variant-covid-19-vaccines-masks-lockdown">delta variant</a> of the coronavirus. While vaccines remain highly protective against severe Covid-19, delta seems to have increased the likelihood of <a href="https://www.vox.com/22575227/covid-19-post-vaccine-breakthrough-infection-cases">breakthrough infections</a>. <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e3.htm?s_cid=mm7034e3_w">Recent CDC data</a> suggests that the shots aren’t as protective for vulnerable people like older adults who were vaccinated many months ago.</p>
<p>To counter this, the FDA is now on the verge of <a href="https://www.npr.org/sections/health-shots/2021/08/19/1028594715/covid-booster-shots-are-coming-heres-what-you-need-to-know">approving booster doses</a> for many Covid-19 vaccine recipients. Meanwhile, the Centers for Disease Control and Prevention has gone back to recommending face masks in some circumstances for vaccinated people.</p>
<p>For health officials, it’s a fine line to walk: reassuring people vaccines are safe and effective while also noting that precautions are still needed. Regulators like the FDA also have to balance the needs of an urgent public health crisis with taking the time to go through the proper procedures.</p>
<p>And there are tough challenges that will remain even after a vaccine gets the bright green light from the FDA. There are still parts of the US where <a href="https://www.cnn.com/2021/08/18/health/us-coronavirus-wednesday/index.html">vaccination rates remain stubbornly low</a>, and many unvaccinated people are not just hesitant but outright refusing to get immunized. Convincing these holdouts is difficult, but necessary, because as long as they remain unprotected, the virus will have ample opportunity to wreak havoc.</p>
<p><strong>Update, August 23, 10 am ET:</strong> This article has been updated with the FDA’s full approval of the Pfizer/BioNTech vaccine.</p>
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source <a href="https://www.vox.com/22628681/covid-19-vaccine-delta-variant-fda-approved-pfizer-moderna">https://www.vox.com/22628681/covid-19-vaccine-delta-variant-fda-approved-pfizer-moderna</a>

vox What full FDA approval for Covid-19 vaccines really means

Nearly nine months after the first Americans received their shots, the Covid-19 vaccine from Pfizer/BioNTech received full approval from th...