NIH tests therapies to help cut hospital stays for COVID-19 patients

(Reuters) – The U.S. National Institutes of Health (NIH) has started a late-stage trial to evaluate if immune-modulating therapies from three drugmakers can help reduce the need for ventilators for COVID-19 patients and shorten their hospital stay.

The NIH said on Friday it has selected three agents for the study – Johnson & Johnson unit Janssen Research’s Remicade, Bristol Myers Squibb’s Orencia and Abbvie Inc’s experimental drug cenicriviroc.

The study will enroll up to 2,100 hospitalized adults with moderate to severe COVID-19 symptoms in the United States and Latin America.

Immune-modulating therapies are medications that alter the way the immune system works. Severe infections are believed to be triggered by an over-reaction of the immune system, known as a “cytokine storm,” and drugs that suppress certain elements of the immune system can play a role in arresting a rapid escalation of symptoms.

This can lead to acute respiratory distress syndrome and multiple organ failure, among other life-threatening complications.

The NIH said its clinical trial – ACTIV-1 Immune Modulators (IM) – will last six months, and the agency will study if the therapeutics can restore balance by modulating that immune response.

All patients will be given Gilead Sciences Inc’s antiviral drug remdesivir – the current standard of care – and also be randomly assigned to receive a placebo or one of the immune modulators as an add-on treatment, the NIH said in a statement.

Remdesivir was one of the drugs used to treat U.S. President Donald Trump’s coronavirus infection, and has been shown in previous studies to have cut time to recovery, though the European Union is investigating it for possible kidney injury.

(Reporting by Vishwadha Chander in Bengaluru, Editing by Sherry Jacob-Phillips)

Pfizer says earliest COVID-19 vaccine application to U.S. regulators would be after election

By Manas Mishra and Michael Erman

(Reuters) – Pfizer Inc said on Friday it may file for U.S. authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the U.S. election as President Donald Trump has promised.

Pfizer said that it may say if the vaccine is effective as soon as this month based on its 40,000 person clinical trial but that it also needs safety data that will not be available until November at the earliest.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.

Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall.

The president’s rush to a vaccine has also raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine.

U.S. health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalized a requirement that the vaccine makers collect two months of safety data on one-half of trial participants.

Pfizer’s comments on its time line raise the possibility of U.S. authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. AstraZeneca’s U.S. trial has been on hold since September.

After the FDA announced the two-month requirement on Oct. 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on Nov. 3., Trump called the move a ‘political hit job.’

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical. (https://bit.ly/31bWdpP)

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

Pfizer’s shares rose 2.1% in premarket trading, while BioNTech’s U.S-listed shares were up 4% before the opening bell. Moderna was unchanged and U.S. futures were higher.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey, Patricia Weiss in Frankfurt; writing by Caroline Humer in New York; Editing by Patrick Graham, Saumyadeb Chakrabarty and Steve Orlofsky)

Twitter unblocks Trump campaign account

(Reuters) – U.S. President Donald Trump’s Twitter election campaign account was unblocked on Thursday after the social media campaign temporarily restricted it saying a video from the account about Democratic presidential candidate Joe Biden’s son violated its rules.

The video posted by the @TeamTrump account referred to a New York Post story from Wednesday that contained alleged details of Hunter Biden’s business dealings with a Ukrainian energy company and said the former vice president had met with an adviser of the company.

The Trump campaign, with 2.2 million followers, said in a new tweet it was “re-posting the video Twitter doesn’t want you to watch.” Twitter did not respond to a request for a comment about why the account had been unblocked.

“Joe Biden is a liar who has been ripping off our country for years,” the video was captioned.

Twitter said earlier the video violated its rules against posting private information, adding the account may need to delete the post in order to continue tweeting.

“It’s going to all end up in a big lawsuit and there are things that can happen that are very severe that I’d rather not see happen, but it’s probably going to have to,” Trump said, when asked about the move by Twitter.

Twitter said on Wednesday the Post story violated its “hacked materials” policy, which bars the distribution of content obtained through hacking that contains private information or trade secrets, or puts people at risk of physical harm.

Facebook Inc and Twitter took proactive steps on Wednesday to restrict dissemination of the Post story in the hours after it was published.

Twitter had placed similar restrictions on the account of White House Press Secretary Kayleigh McEnany on Wednesday, after she shared the Post story.

Other Twitter, users, including a journalist, said their accounts had been suspended because they had posted a link to the New York Post story. The accounts were unblocked after they deleted the offending tweets.

After Twitter imposed the restrictions, the U.S. Senate Judiciary Committee moved to subpoena Twitter’s Chief Executive Jack Dorsey.

Committee Chairman Lindsey Graham and Republican senators Ted Cruz and Josh Hawley said the committee will vote on sending the subpoena on Tuesday, Oct. 20 and plans to have Dorsey in front of the committee by Oct. 23.

Dorsey said on Twitter Wednesday “our communication around our actions on the @nypost article was not great. And blocking URL sharing via tweet or DM with zero context as to why we’re blocking: unacceptable.”

(Reporting by Munsif Vengattil in Bengaluru, Elizabeth Culliford in London, and Nandita Bose and David Shepardson in Washington; Editing by Shinjini Ganguli and Lisa Shumaker)

Split screen: Trump and Biden to headline dueling town halls

By Joseph Ax

(Reuters) – U.S. President Donald Trump and Democratic challenger Joe Biden will hold dueling prime-time town halls on Thursday instead of their second presidential debate, which was canceled after Trump declined to take part in a virtual matchup.

With less than three weeks to go until the Nov. 3 vote, the Republican president is searching for ways to change the dynamics of a race in which Biden has a double-digit advantage in some national polls.

Nearly 15 million Americans, a record for this date, have cast ballots, according to the U.S. Elections Project at the University of Florida, as voters seek to avoid in-person lines on Election Day because of concerns about the novel coronavirus.

North Carolina, a highly competitive state, began more than two weeks of in-person early voting on Thursday. Local news reports showed long lines of voters eager to cast ballots, and Trump was due to hold an afternoon rally in Greenville in the eastern part of the state.

Trump’s campaign is counting on a surge of last-minute votes. But Reuters/Ipsos polling conducted between Oct. 9 and Oct. 13 shows there are far fewer undecided likely voters this year – around 8% – and they are just as likely to pick Biden as they are Trump.

Four years ago at this stage of the campaign, more than twice as many people were similarly wavering between Trump and his Democratic opponent, Hillary Clinton.

The Reuters/Ipsos polling shows Biden holding a 10 percentage-point lead nationally, with a tighter margin in the battleground states that will help decide the election.

Both candidates have been visiting those states this week, with Trump holding rallies in Florida, Pennsylvania and Iowa and Biden traveling to Ohio and Florida.

Trump has pulled into a statistical tie with Biden in Florida, a key battleground, with 47% support versus Biden’s 49%, and a credibility interval of 4 points, a Reuters/Ipsos opinion poll showed.

Thursday’s town halls, in which each candidate will field questions from voters, will take place at 8 p.m. EDT (0000 GMT), with Trump on NBC from Miami and Biden on ABC from Philadelphia.

Trump pulled out of the scheduled debate when the commission in charge of organizing the event said it would be held virtually after the president contracted the coronavirus. A final debate is still scheduled for Oct. 22 in Nashville, Tennessee.

On Thursday, the Biden campaign said two people involved in the campaign had tested positive for COVID-19, including one on the staff of U.S. Senator Kamala Harris, Biden’s running mate.

Although neither Biden nor Harris was in close contact with the people, the campaign said it was cancelling Harris’ travel until after Sunday, “in line with our campaign’s commitment to the highest levels of precaution.”

Trump has returned to the campaign trail after spending several days being treated for the virus in a military hospital.

NBC said on Wednesday that Clifford Lane, clinical director at the National Institutes of Health, and the government’s top infectious disease specialist, Anthony Fauci, had concluded “with a high degree of confidence” that Trump was no longer “shedding infectious virus.”

The election could be the most closely contested in recent memory due to a deeply divided electorate and the possibility that Trump will challenge widely used mail-in ballots, claiming without evidence they are fraudulent.

(Reporting by Trevor Hunnicutt and Chris Kahn in New York and Doina Chiacu and James Oliphant in Washington; Writing by Joseph Ax and Sonya Hepinstall; Editing by Colleen Jenkins and Matthew Lewis)

Trump’s son Barron tested positive for COVID-19, says Melania Trump

WASHINGTON (Reuters) – President Donald Trump’s 14-year-old son, Barron, tested positive for COVID-19 but exhibited no symptoms after both of his parents contracted the virus, first lady Melania Trump said on Wednesday.

“Luckily he is a strong teenager and exhibited no symptoms,” Melania Trump said in a statement. She said she and Barron had since tested negative for the virus.

Donald Trump told a rally in Des Moines, Iowa, that Barron “is just fine now” and said it was an example of why schools should reopen.

“I don’t even think he knew he had it, because they’re young and their immune systems are strong and they fight it off,” Trump said. “Get the kids back to school,” he said.

Melania Trump said her symptoms were “minimal” and that she hoped to resume her duties as first lady “as soon as I can.”

“I experienced body aches, a cough and headaches, and felt extremely tired most of the time,” she said.

“I chose to go a more natural route in terms of medicine, opting more for vitamins and healthy food,” Melania Trump said.

Donald Trump spent three nights in a military hospital after announcing on Oct. 2 that he and Melania had tested positive.

To treat the virus, he received an experimental dual antibody therapy developed by Regeneron Pharmaceuticals Inc and Gilead Sciences Inc’s antiviral remdesivir, as well as the steroid dexamethasone.

“In one way I was glad the three of us went through this at the same time so we could take care of one another and spend time together,” Melania Trump said.

(Reporting by Eric Beech; Editing by Leslie Adler and Peter Cooney)

Trump’s Supreme Court pick lauded as ‘unashamedly pro-life’ in hearing’s third day

By Lawrence Hurley, Patricia Zengerle and Andrew Chung

WASHINGTON (Reuters) – President Donald Trump’s Supreme Court nominee Amy Coney Barrett faced fresh questioning at her Senate confirmation hearing on Wednesday, with the panel’s Republican chairman lauding her as “unashamedly pro-life” even as Democrats worry that she could vote to overturn the 1973 ruling legalizing abortion nationwide.

Barrett, a conservative federal appellate judge who is the Republican president’s third selection for a lifetime job on the top U.S. judicial body, was in the third day of her four-day Senate Judiciary Committee confirmation hearing.

“This is history being made folks,” Senator Lindsey Graham, the chairman of the panel, said. “This is the first time in American history that we’ve nominated a woman who is unashamedly pro-life and embraces her faith without apology, and she’s going to the court. A seat at the table is waiting for you.”

“It will be a great signal to all young women who share your view of the world,” Graham added.

Under questioning by Graham, Barrett reiterated her comments from Tuesday that the landmark 1973 Roe v. Wade ruling that recognized a woman’s constitutional right to abortion was not a “super-precedent” that could never potentially be overturned.

Barrett, a devout Catholic and a favorite of religious conservatives, told the committee on Tuesday she could set aside her religious beliefs in making judicial decisions.

Barrett would be the fifth woman to serve on the court and the second Republican appointee.

During 11 hours of questioning on Tuesday, she sidestepped questions on contentious social issues and told the committee she had no agenda on issues such as the Affordable Care Act, popularly known as Obamacare. Democrats say Barrett’s confirmation would threaten healthcare for millions of Americans and they have said the Senate should not consider filling the vacancy until after the presidential election.

Barrett, 48, would tilt the court even further to the right, giving conservative justices a 6-3 majority. Republicans have a 53-47 Senate majority, making Barrett’s confirmation a virtual certainty.

Barrett has declined to say whether she would recuse herself from the major Obamacare case to be argued on Nov. 10, in which Trump and Republican-led states are seeking to invalidate the law. She said the case centers on a different legal issue than two previous Supreme Court rulings that upheld Obamacare that she has criticized.

In response to Democratic suggestions that she would vote to strike the entire law down if one part is found to be unlawful, Barrett on Wednesday told Graham that when judges address the legal question raised in the case, the “presumption” is that Congress did not intend the whole statute to fall.

Barrett agreed with Graham that if a statute can be saved, it is a judge’s duty to do so. Barrett indicated she was in favor of a broad reading of the “severability doctrine” in which courts assume that when one provision of a law is unlawful, Congress would want the rest of the statute to remain in place.

“I think insofar as it tries to effectuate what Congress would have wanted, it’s the court and Congress working hand in hand,” Barrett said of the doctrine.

Barrett on Tuesday also refused to say whether the 2015 ruling legalizing gay marriage nationwide was wrongly decided. Barrett deflected Democrats’ questions about whether she would participate in any dispute resulting from the Nov. 3 presidential election, promising only to follow rules giving justices the final say on recusal.

Trump has urged the Senate, controlled by his fellow Republicans, to confirm Barrett before Election Day. Trump has said he expects the Supreme Court to decide the election’s outcome as he faces Democratic challenger Joe Biden.

The hearing is scheduled to end on Thursday with testimony from outside witnesses, with Republicans already preparing for committee vote next week.

Trump nominated Barrett to a lifetime post on the court on Sept. 26 to replace the late liberal Justice Ruth Bader Ginsburg. The four-day confirmation hearing is a key step before a full Senate vote due by the end of October on Barrett’s confirmation.

(Reporting by Andrew Chung in New York and Lawrence Hurley and Patricia Zengerle in Washington; Editing by Will Dunham)

U.S. Supreme Court ends Democratic lawmakers’ anti-graft lawsuit against Trump

By Jan Wolfe

WASHINGTON (Reuters) – The Supreme Court on Tuesday put an end to a lawsuit brought by congressional Democrats that accused President Donald Trump of violating anti-corruption provisions in the U.S. Constitution with his business dealings.

The justices refused to hear an appeal by 215 Senate and House of Representatives Democrats of a lower court ruling that found that the lawmakers lacked the necessary legal standing to bring the case that focused on the Republican president’s ownership of the Trump International Hotel in Washington.

The lawmakers accused Trump of violating the Constitution’s rarely tested “emoluments” clauses that bar presidents from taking gifts or payments from foreign and state governments without congressional approval. The lead plaintiff in the case is U.S. Senator Richard Blumenthal of Connecticut.

Trump faces two similar lawsuits – one brought by an advocacy group and the other by the Democratic attorneys general of Maryland and the District of Columbia. Those cases likely would be dismissed as moot if Trump loses his Nov. 3 re-election bid, according to University of Richmond law professor Carl Tobias.

Elizabeth Wydra, a lawyer for the Democratic lawmakers, said they were disappointed by the denial.

“With today’s cert denial, this critical anti-corruption provision of our Constitution has been weakened, and the American people are the worse off for it,” said Wydra, president of the Constitutional Accountability Center.

Trump International Hotel in Washington is located in a historic building just blocks from the White House. The hotel, opened by Trump shortly before he was elected in 2016, became a favored lodging and event space for some foreign and state officials visiting Washington.

Unlike past presidents, Trump has retained ownership of his business interests while serving in the White House. The emoluments lawsuits have accused him of making himself vulnerable to bribery by foreign governments.

In the case brought by congressional Democrats, the U.S. Court of Appeals for the District of Columbia Circuit in February ruled that individual members of Congress have limited ability to litigate questions affecting the legislative branch as a whole.

The appeals court said it was bound by a 1997 Supreme Court decision that held that six members of Congress lacked the legal standing to challenge the constitutionality of a law dealing with presidential vetoes. The lawmakers appealed, telling the Supreme Court that the D.C. Circuit misapplied the 1997 precedent.

Justice Department lawyers, arguing for the Trump administration, had urged the high court not to hear the Democratic appeal. They argued that the lower court correctly held that “federal legislators generally lack standing to sue to enforce the asserted institutional interests of Congress.”

(Reporting by Jan Wolfe; editing by Will Dunham and Grant McCool)

Pelosi rejects Trump COVID-19 aid offer, dimming hopes of quick deal

WASHINGTON (Reuters) – U.S. House Speaker Nancy Pelosi rejected President Donald Trump’s latest offer on COVID-19 stimulus on Tuesday, in the latest sign that a bipartisan deal on coronavirus relief remains unlikely ahead of the November election.

In a letter to colleagues, Pelosi laid out what Democrats view as the shortcomings of a $1.8 trillion White House stimulus proposal that has also met resistance from Republicans in the U.S. Senate who say it is too large.

“Tragically, the Trump proposal falls significantly short of what this pandemic and deep recession demand,” Pelosi said. She also described the offer made last week by Treasury Secretary Steven Mnuchin as “one step forward, two steps back.”

But Pelosi said she remained hopeful for a deal and appeared to leave the door open to further talks with Mnuchin: “Significant changes must be made to remedy the Trump proposal’s deficiencies. Updates will continue.”

The letter made it clear that Democrats view the White House offer as deficient on state and local government aid, COVID-19 testing and tracing, rental assistance, worker safety, child care, relief for small employers and other areas.

“The president only wants his name on a check to go out before Election Day and for the market to go up,” the top Democrat in Congress wrote. “The president’s attitude is shameful, when the need for immediate and meaningful action could not be more urgent.”

House Democrats formally received the latest White House offer over the weekend, Pelosi said, days after Trump withdrew from negotiations and then decided to resume talks.

With their latest proposal facing resistance from both Democrats and Republicans, Trump administration officials on Sunday called on Congress to pass a stripped-down stimulus bill.

(Reporting by Doina Chiacu and David Morgan; Editing by Lisa Lambert and Chizu Nomiyama)

Researchers find elevated radiation near U.S. fracking sites

(Reuters) – Radiation levels downwind of U.S. hydraulic fracturing drilling sites tend to be significantly higher than background levels, posing a potential health risk to nearby residents, according to a study by Harvard researchers released on Tuesday.

The study, published in the journal Nature, adds to controversy over the drilling method known as fracking, which has helped the United States become the world’s biggest oil and gas producer over the past decade but which environmentalists say threatens water and air.

President Donald Trump supports fracking because of its economic benefits, and his Democratic rival Joe Biden has promised to continue to allow it if elected even though he aims to impose an ambitious plan to fight climate change.

Areas within 20 kilometers (12 miles) downwind of 100 fracking wells tend to have radiation levels that are about 7% above normal background levels, according to the study, which examined thousands of the U.S. Environmental Protection Agency’s radiation monitor readings nationwide from 2011 to 2017.

The study showed readings can go much higher in areas closer to drill sites, or in areas with higher concentrations of drill sites.

“The increases are not extremely dangerous, but could raise certain health risks to people living nearby,” said the study’s lead author, Petros Koutrakis.

Radioactive particles can be inhaled and increase the risk of lung cancer.

Koutrakis said the source of the radiation is likely naturally-occurring radioactive material brought up to the surface in drilling waste fluids during fracking, a process that pumps water underground to break up shale formations.

The study found the biggest increases in radiation levels near drill sites in states like Pennsylvania and Ohio that have higher concentrations of naturally occurring radioactive material beneath the surface, and lower readings in places like Texas and New Mexico that have less.

It also found less pronounced increases in particle radiation levels near conventional drilling operations.

Koutrakis said further study was needed to determine whether the radiation was being released during the drilling process, or from wastewater storage nearby.

“Our hope is that once we understand the source more clearly, there will be engineering methods to control this,” he said.

(Reporting by Richard Valdmanis; Editing by Marguerita Choy)

U.S. Supreme Court rebuffs Planned Parenthood defunding case

By Andrew Chung

(Reuters) – The U.S. Supreme Court on Tuesday turned away South Carolina’s bid to cut off public funding to Planned Parenthood, the latest case involving a conservative state seeking to deprive the women’s healthcare and abortion provider of government money.

The justices declined to hear South Carolina’s appeal of a lower court ruling that prevented the state from blocking funding under the Medicaid program to Planned Parenthood South Atlantic, the organization’s regional affiliate.

Planned Parenthood South Atlantic operates clinics in Charleston and Columbia, South Carolina, where it provides physical exams, cancer and other health screenings, as well as abortions. Each year the clinics serve hundreds of patients who receive Medicaid, a government health insurance program for low-income Americans.

Numerous Republican-governed states have pursued direct and indirect restrictions involving abortion. Planned Parenthood often is targeted by anti-abortion activists. Planned Parenthood is the largest single provider of abortions in the United States and also receives millions of dollars in public funding for other healthcare services.

Planned Parenthood and Medicaid patient Julie Edwards sued the state’s Department of Health and Human Services in 2018 after officials ended the organization’s participation in the state Medicaid program.

The state took the action after Governor Henry McMaster, a Republican, issued executive orders declaring that any abortion provider would be unqualified to provide family planning services and cutting off state funding to them. The state’s action forced Planned Parenthood to turn away Medicaid patients seeking healthcare services, according to a court filing.

South Carolina already did not provide Medicaid reimbursements for abortion except in cases of rape, incest, or if the mother’s life was in danger, as required by federal law.

The Richmond, Virginia-based 4th U.S. Circuit Court of Appeals blocked the state’s decision in 2019, saying that by ending Planned Parenthood’s Medicaid agreement for reasons unrelated to professional competency, the state violated Edwards’ right under the federal Medicaid Act to receive medical assistance from any institution that is “qualified to perform the service.”

In appealing to the Supreme Court, the state’s health department said Medicaid recipients do not have a right to challenge a state’s determination that a specific provider is not qualified to provide certain medical services.

The Supreme Court in 2018 rejected similar appeals by Louisiana and Kansas seeking to terminate Planned Parenthood’s Medicaid funding. At that time, three conservative justices – Clarence Thomas, Samuel Alito and Neil Gorsuch – said the court should have heard the states’ appeals.

President Donald Trump has asked the Senate to confirm his Supreme Court nominee Amy Coney Barrett, a favorite among religious conservatives, before the Nov. 3 election. Barrett was picked to replace liberal Justice Ruth Bader Ginsburg, a supporter of abortion rights who died on Sept. 18.

(Reporting by Andrew Chung and Jan Wolfe; editing by Will Dunham and Grant McCool)