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The revolution is coming. The much-anticipated video premiere of “Hamilton” will be available on Disney+ Friday, July 3.Here are the details: The video is 2 hours and 41 minutes long, and includes a minute countdown for intermission. It was recorded using several cameras during two of the last performances of the initial 2016 Broadway run of the hit musical, and includes most of the original cast.It will only be available on the Disney+ streaming service starting at 12 a.m. PT/3 a.m. ET on Friday. Disney is holding a Twitter watch party later in the day at 7 p.m. ET/4 p.m. PT. 591
The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6274

The racial justice movement is inspiring hope and change.Two of the oldest hate fighting and civil rights nonprofits are joining forces to build ties between Black and Jewish people.“You can’t really fight one kind of hate unless you're going to fight all of them, right, so we can’t be saying anti-Semitism is bad and not be engaged right now in this great movement to challenge systemic racism,” said Shira Goodman with Anti-Defamation League Philadelphia.The Anti-Defamation League and National Urban League are kicking off the partnership in Philadelphia.They're starting a voting rights project trying to energize young voters.They're using young leaders from both groups to recruit younger poll workers and produce mailers and social media videos encouraging people to exercise one of the greatest tools to change.“We want to be able to give people accurate information and also hold each other accountable by having a voting plan, maybe having a buddy they are going to text back and forth, ‘did you go to the polls did you request your ballot?’”Philadelphia is just the start of this partnership for equality. They're looking at future projects to promote economic empowerment, equal access to justice, update hate crime laws and address discrimination in housing and employment.“It’s building on our shared histories as Blacks and Jews of having worked together, having both struggled in America and also saying we want to not sit on that history, we want to build a new future together,” said Goodman.The partnership and focus come at critical time for minorities which tend to face more voter suppression. 1624
The White House announced Friday that President Donald Trump intends to appoint Mehmet Oz, better known as Dr. Oz, to his council on sport, fitness and nutrition.Oz is well-known as a host of an eponymous television show on health and medical issues and, before that, for appearances on "The Oprah Winfey Show." But he has become a lightning rod for controversy for featuring what critics say is unscientific advice on his show.In 2015, a group of doctors criticized him harshly, saying he manifested "an egregious lack of integrity" in his TV and promotional work and called his faculty position at Columbia University unacceptable.Oz defended himself in a written statement at the time, saying, "I bring the public information that will help them on their path to be their best selves. We provide multiple points of view, including mine which is offered without conflict of interest."The-CNN-Wire 906
The University of Washington’s Institute for Health Metrics and Evaluation now projects that 68,000 American lives would be saved between now and March 1 by near universal wearing of masks.The IHME released the updated model on Thursday.The IHME’s coronavirus projections have been frequently cited in the past by the White House’s coronavirus task force. The group uses state data along with other metrics to create projections on the number of coronavirus-related deaths throughout the US.Among the projections released by the IHME, the number of active hospitalizations in the United States tied to the coronavirus is expected to double by mid-January.The COVID Tracking Project, a project led by The Atlantic, shows that current coronavirus-related hospitalizations hurdled the 60,000 mark in the US on Tuesday for the first time since the start of the pandemic. The number of people hospitalized with COVID-19 has more than doubled in the last six weeks throughout the US.By Friday, the number of people hospitalized with COVID-19 neared 70,000.A number of hospital systems in the US are nearing capacity already.And the IHME’s director Chris Murray warns that his estimates are on the conservative side.“The fall winter surge, you know, driven by people going indoors, having more indoor contact and, you know, it's what we've seen play out in Europe and now we're catching up,” Murray told CNN. “So we're seeing the huge exponential rise in cases, deaths starting to follow suit. We're already at over a thousand deaths a day, quite a bit more than that. So our numbers that see us getting to, you know, 2,200 deaths a day in mid-January, are perhaps conservative, and that does require 33 states to put in mandates. So, absolutely it can go much worse than that."Murray’s projection forecasts roughly an additional 200,000 coronavirus between now and March 1. The estimate drops to 132,000 if masks are nearly all situations outside of the household.By March 1, it’s possible that a number of high-risk Americans and health care workers will be vaccinated. The White House said on Friday that it intends on distributing 20 million vaccine doses by the end of December, and 25 to 30 million doses for each subsequent month. The vaccines would come in two doses. 2276
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