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The US officially relocated its Embassy to Jerusalem on Monday, formally upending decades of American foreign policy in a move that was met with clashes and protests along the Israeli-Gaza border.At least 43 Palestinians were killed in Gaza as deadly protests took place ahead of and during the ceremony in Jerusalem — making it the deadliest day there since the 2014 Gaza war.President Donald Trump did not attend the ceremony in Jerusalem's Arnona neighborhood, but in a video message broadcast at the event he congratulated Israel, saying the opening had been "a long time coming.""Today, Jerusalem is the seam of Israel's government. It is the home of the Israeli legislature and the Israeli supreme court and Israel's prime minister and president. Israel is a sovereign nation with the right like every other sovereign nation to determine its own capital, yet for many years, we failed to acknowledge the obvious, the plain reality that Israel's capital is Jerusalem," Trump said in the pre-recorded remarks. 1021

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 White House announced Tuesday that official public tours of the complex will resume September 12, nearly six months after tours were suspended during the onset of the coronavirus pandemic.While the White House resumes tours, a number of social distancing guidelines will be implemented, including mandatory face coverings for all visitors over the age of 2. Tours will only operate two days a week, Friday and Saturday, from 8 to 11 a.m. Capacity for the tours will be at 18%.On a given year, the White House welcomes over 1 million visitors to the complex each year. And even with the large number of tours, the demand for tours far exceeds the supply.The White House tours are generally held away from working areas of the White House.While the White House is resuming tours, a number of other capital-area facilities have remained closed to the public since March, including the US Capitol. As of Tuesday, the National Zoo and the National Air and Space Museum in Virginia are the only Smithsonian institutions to be currently open. 1047

The Susan B. Anthony Museum has something to say about President Trump’s recent decision to pardon the suffragette.“Objection! Mr. President, Susan B. Anthony must decline your offer of a pardon today,” the museum’s President and CEO Deborah Hughes posted online.President Donald Trump announced Tuesday that he would sign a pardon for Susan B. Anthony on the 100th anniversary of the ratification of the 19th Amendment.Anthony voted in a presidential election in 1872. She was arrested about a week later and eventually convicted of "knowingly, wrongfully, and unlawfully" voting without the right to do so. She was fined 0. 636

The U.S. Food and Drug Administration updated its guidance on face coverings on Tuesday, adding information about wearing expired surgical masks.According to the FDA, face and surgical masks may still offer protection even if they've passed their designated shelf life or expiration date."If there is no date available on the face mask label or packaging, facilities should contact the manufacturer. The user should inspect all masks before use and, if there are concerns such as degraded materials (such as elastic) or visible tears," the agency recommends that you should discard the product.However, when it comes to re-using surgical disposal masks, the CDC recommends discarding them after one use.You can clean reusable masks, the CDC says, and recommends washing them after each use. For N95s, which the CDC considers a one-time-use product, but can be re-worn if cleaned with an approved decontamination method. 927

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