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WASHINGTON — The U.S. government on Tuesday will start distributing 30,000 doses of an experimental monoclonal antibody drug to fight COVID-19, the one President Donald Trump received last month.Over the weekend, the Food and Drug Administration agreed to allow emergency use of the therapeutic, casirivimab and imdevimab, made by Regeneron Pharmaceuticals Inc., for people with mild-to-moderate symptoms who are at high risk of developing serious illness because of their age or other medical conditions.The treatment was not authorized for use in sicker, hospitalized patients or those who need extra oxygen.President Donald Trump was given the therapeutic treatment when he contracted coronavirus in October. The Department of Health and Human Services said the federal government announced funding over the summer to support large-scale manufacturing of casirivimab and imdevimab.The agency will allocate “these government-owned doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug,” reads a statement from HHS.“Beginning immediately, weekly allocations to state and territorial health departments will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data hospitals and state health departments enter into the HHS Protect data collection platform,” reads the HHS statement.Antibodies bind to the virus and help the immune system eliminate it. The Regeneron drug is a combo of two antibodies that seemed to do this well in lab tests.The emergency use authorization allows limited use of a drug while studies continue to test its safety and effectiveness. Early results suggest it may reduce COVID-19-related hospitalization or emergency room visits.The drugs are given as a one-time treatment through an IV and takes about an hour.Under federal contracts, the drugs for now will be supplied for free, although patients may have to pay part of the cost of the IV treatment. 2036
WASHINGTON (AP) — A more conservative Supreme Court appears unwilling to do what Republicans have long desired — kill off the Affordable Care Act. That includes its key protections for pre-existing health conditions and subsidized insurance premiums that affect tens of millions of Americans. The justices met a week after the election and remotely in the midst of a pandemic that has closed their majestic courtroom to hear the highest-profile case of the term so far. They took on the latest Republican challenge to the law known as “Obamacare,” with three appointees of President Donald Trump, an avowed foe of the health care law, among them.But at least one of those Trump appointees, Justice Brett Kavanaugh, seemed likely to vote to leave the bulk of the law intact, even if he were to find the law’s now-toothless mandate that everyone obtain health insurance to be unconstitutional.“It does seem fairly clear that the proper remedy would be to sever the mandate provision and leave the rest of the act in place,” Kavanaugh said.Chief Justice John Roberts, who wrote two earlier opinions preserving the law, stated similar views, and the court’s three liberal justices are almost certain to vote to uphold the law in its entirety. That presumably would form a majority by joining a decision to cut away only the mandate, which now has no financial penalty attached to it. Congress zeroed out the penalty in 2017, but left the rest of the law untouched.“I think it’s hard for you to argue that Congress intended the entire act to fall if the mandate were struck down when the same Congress that lowered the penalty to zero did not even try to repeal the rest of the act. I think, frankly, that they wanted the court to do that, but that’s not our job,” Roberts said.Tuesday’s arguments, conducted by telephone and lasting two hours, reached back to the earlier cases and also included reminders of the coronavirus pandemic. The justices asked about other mandates, only hypothetical, that might have no penalties attached: To fly a flag, to mow the lawn or even, in a nod to current times, to wear a mask.“I assume that in most places there is no penalty for wearing a face mask or a mask during COVID, but there is some degree of opprobrium if one does not wear it in certain settings,” Justice Clarence Thomas said.The court also spent a fair amount of time debating whether the GOP-led states and several individuals who initially filed lawsuits had the right to go into court. 2495
WASHINGTON — President Donald Trump aims to take credit for the speedy development of forthcoming coronavirus vaccines, even as his administration is coming under scrutiny for failing to lock in a chance to buy millions of additional doses of one of the leading coronavirus vaccine contenders this summer.That decision could delay the delivery of a second batch of doses until manufacturer Pfizer fulfills other international contracts.The revelation was first reported by the New York Times and later confirmed to the Associated Press by people familiar with the matter.Earlier this year, Pfizer agreed to make 100 million doses of its COVID-19 vaccine — enough to inoculate 50 million Americans — and gave the federal government the option to purchase up to five times as many doses. Then, this summer, Trump administration officials reportedly declined an offer to purchase 100 million more doses of the Pfizer vaccine.According to the Times, Pfizer must now also fulfill hefty orders from other countries — notably, an order for 200 million doses from the European Union — before making more doses for the U.S.In a statement, the Department of Health and Human Services said it was confident that Pfizer would be able to fulfill it's current 100 million dose order, and pointed to the fact that several other vaccine candidates are near approval — including one from Moderna, which could be approved by the end of th month.“We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna,” an HHS spokesperson said in a statement to the Times.The reports came on the eve of Trump’s plans to host a White House summit on Tuesday, aimed at celebrating the expected approval of the first vaccine later this week.At that event, Trump plans to sign an executive order aimed at prioritizing the supply of U.S. vaccines for Americans — though the order does not appear to have legal sway, according to the New York Times.Officials from President-elect Joe Biden’s transition team were not invited to Tuesday's event at the White House, despite the fact that the Biden administration will handle the bulk of the distribution work. 2281
WASHINGTON — As COVID-19 cases skyrocketed before the Thanksgiving holiday weekend, the coordinator of the White House coronavirus response warned Americans to “be vigilant” and to limit celebrations to “your immediate household.” For many Americans that guidance has been difficult to abide, including for Dr. Deborah Birx herself. The day after Thanksgiving, Birx traveled to one of her vacation properties on Fenwick Island in Delaware. She was accompanied by three generations of her family from two households. Kathleen Flynn, whose brother is married to Birx's daughter, told the Associated Press she came forward about the travel out of concern for her own parents, and acknowledged there was family friction over the incident. Birx confirmed to the Associated Press she traveled to the Delaware property, but declined to be interviewed for the report. The Centers for Disease Control and Prevention has asked Americans not to travel over the holidays and discourages indoor activity involving members of different households.Birx joins a growing list of high-profile leaders on the federal and state level who have been criticized for appearing to disregard their own rules and warnings for slowing the spread of the coronavirus. Most notably, California Governor Gavin Newsom, who is facing a recall effort in his state after he was seen inside a posh restaurant after telling people to avoid socializing. 1423
WASHINGTON — Congress is defying President Donald Trump on removing Confederate symbolism from the military.The Senate on Thursday joined the House in approving legislation that would rename bases like Fort Bragg and Fort Benning that are named for Confederate officers.The Senate vote was an overwhelming 86-14 vote. Earlier this week, the House passed the measure with a 295-125 vote.The Senate passage opens the door for the Senate and House Armed Services Committees to open negotiations for a final version of the bill. Once that bill is passed, it would head to Trump's desk.Even if Trump were to veto the bill, Thursday's vote indicates that Congress could override it and make the bill a law.Trump has said he favors that military bases keep the names of Confederate military leaders, despite efforts from Pentagon officials to change the name. Trump says renaming the bases would be re-writing history; critics say it's inappropriate for U.S. military bases to bear the names of those who fought on the side of slavery and against the Union.There are currently 10 Army bases throughout the U.S. named after Confederate generals, as well as a number of smaller military institutions with such names.The legislation would approve 1 billion in spending for the military and also includes a 3% pay raise for the troops. 1335