U.S., European COVID vaccine developers pledge to uphold testing rigor

By Ludwig Burger, Patricia Weiss and Caroline Copley

FRANKFURT (Reuters) – Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations will be held against in the global race to contain the coronavirus pandemic.

The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a “historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.

The companies said in a statement they would “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”.

The other signatories were Johnson & Johnson, Merck & Co., Moderna, Novavax, Sanofi and BioNTech.

The promise to play by established rules underlines a highly politicized debate over what action is needed to rein in COVID-19 quickly and to jump start global business and trade.

The head of the U.S. Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials – large-scale testing intended to demonstrate safety and efficacy – as long as officials are convinced the benefits outweigh the risks.

This prompted a call for caution from the World Health Organization (WHO).

Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticize a lack of testing.

The head of China’s Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country’s emergency-use program.

Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.

PROMISE ON SAFETY AND EFFICACY

“We want it to be known that also in the current situation we are not willing to compromise safety and efficacy,” said co-signatory Ugur Sahin, chief executive of Pfizer’s German partner BioNTech.

“Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here.”

BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the center of bitter U.S. politics before the Nov. 3 presidential election.

President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.

The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.

BioNTech’s Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.

The development race has intensified safety concerns about an inoculation, polls have shown.

Western regulators have said they would not cut corners but rather prioritize the review workload and allow for development steps in parallel that would normally be handled consecutively.

Sahin declined to comment on regulators specifically or on what events prompted the joint statement.

The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.

“What Russia did – and maybe also there are tendencies in the U.S. to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk,” said CEO Michael Scholl.

“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general.”

Leukocare is working with Italy’s ReiThera and Belgium’s Univercells to produce a COVID-19 vaccine currently in phase I testing.

(Reporting by Ludwig Burger, Patricia Weiss in Frankfurt and Caroline Copley in Berlin; Editing by Susan Fenton and Timothy Heritage)

Pakistan court sentences Christian to death on blasphemy charges

Paramilitary soldiers stand guard outside the Supreme Court building in Islamabad, Pakistan January 29, 2019. REUTERS/Saiyna Bashir

By Mubasher Bukhari

LAHORE, Pakistan (Reuters) – A Pakistani court on Tuesday sentenced a Christian man to death on blasphemy charges.

Asif Pervaiz, a garment factory worker, had been accused by his supervisor of sending derogatory remarks about the Muslim Prophet Muhammad to him in a text message.

Insulting the prophet carries a mandatory death penalty in Pakistan, a predominantly Muslim country.

Pervais was convicted after a trial in Lahore that ran since 2013. His lawyer Saif-ul-Malook told Reuters he would appeal the sentence.

The court order, seen by Reuters, said Pervaiz would first serve a three-year prison term for “misusing” his phone to send the derogatory text message. Then “he shall be hanged by his neck till his death.”

He was also fined 50,000 Pakistani rupees ($300), the order said.

Pervaiz told the court his supervisor made the accusation only after he had refused to convert to Islam, Saif-ul-Malook said. The complainant’s lawyer, Murtaza Chaudhry, denied this was the case.

Human rights groups say blasphemy laws are often misused to persecute minorities or even against Muslims to settle personal rivalries. Islamist extremism has been on the rise in Pakistan and such accusations can end up in lynchings or street vigilantism.

A U.S. citizen of Pakistani origin on a blasphemy trial in the northwestern city of Peshawar in July was shot dead in the courtroom by a teenager who told bystanders he killed him for insulting the Prophet Muhammad.

Since his arrest, the alleged shooter has been glorified as a “holy warrior” by supporters in Pakistan and thousands of Islamists have rallied to demand his release.

(Writing by Asif Shahzad; Editing by Angus MacSwan)

Senate to vote on COVID-19 aid as soon as this week: McConnell

WASHINGTON (Reuters) – The Republican-led U.S. Senate will introduce a new proposal on coronavirus relief legislation on Tuesday and could schedule a vote as soon as this week, Senate Majority Leader Mitch McConnell said.

He said the new proposal would target “some of the very most urgent healthcare, education, and economic issues.”

“It does not contain every idea our party likes. I am confident Democrats will feel the same. Yet Republicans believe the many serious differences between our two parties should not stand in the way of agreeing where we can agree and making law that helps our nation,” McConnell’s statement said.

Earlier, White House chief of staff Mark Meadows said he was hopeful there would be another round of federal COVID-19 stimulus funding before the Nov. 3 presidential election, but signaled no breakthrough in talks with congressional Democrats.

Interviewed on Fox Business Network, Meadows said he hoped legislation put forward by Senate Republicans would provide a basis for a future agreement with Democratic lawmakers and that negotiations were ongoing.

(Reporting by Susan Heavey and Doina Chiacu; Editing by Howard Goller)

House Democrats call for U.S. postal chief’s suspension, launch probe

(Reuters) – The head of the House Oversight panel on Tuesday urged the immediate suspension of U.S. Postmaster General Louis DeJoy following reports that he illegally reimbursed former employees for political contributions, and announced an investigation.

House Oversight and Reform Committee Chairwoman Carolyn Maloney, in a statement, said if the allegations are true, DeJoy faced “criminal exposure” not only for violating the law with the transactions but also for lying to Congress when he denied making them at a recent hearing.

“We will be investigating this issue, but I believe the Board of Governors must take emergency action to immediately suspend Mr. DeJoy, who they never should have selected in the first place,” she said.

The move follows accusations by former workers at DeJoy’s company that he reimbursed employees for campaign contributions to his preferred Republican politicians, an arrangement that would violate federal campaign finance law. The Washington Post and the New York Times both reported the allegations over the weekend, citing multiple unnamed former employees.

President Donald Trump on Monday said he would support an investigation into campaign contributions involving DeJoy, a Trump donor who is already facing a political fire storm after changes he implemented ahead of the November election that critics said could delay mail-in balloting.

On Tuesday, White House chief of staff Mark Meadows defended DeJoy and accused Democrats of launching a political probe in an election year.

“Louis DeJoy is an honorable man,” Meadows told reporters at the White House. “I’m sure he’ll cooperate completely, and we serve in a great country where you’re innocent until proven guilty.”

The House Oversight committee is already investigating USPS operational changes, including curbed overtime, and sent DeJoy a subpoena last week seeking related documents. New York’s attorney general has also separately filed a lawsuit over the issue.

Democrats have accused him of deliberately disrupting the Postal Service as millions of Americans consider whether to cast their vote by mail in the Nov. 3 presidential election, saying the changes could slow down mail delivery and delay ballots.

(Reporting by Kanishka Singh in Bengaluru; Additional reporting by Doina Chiacu; writing by Susan Heavey; Editing by Gerry Doyle and Steve Orlofsky)

Wildfires rage in California, stoked by extreme heat in U.S. West

(Reuters) – Three large wildfires burned in California and a fourth was growing quickly on Monday as a weekend heat wave lingered across large swaths of the western United States.

The Creek Fire, which has engulfed the Fresno area in central California and caused the emergency evacuation over the weekend of more than 200 people vacationing at a popular reservoir, was still not contained as of Monday afternoon, fire officials said.

The blaze, growing under “extreme weather conditions,” had devoured nearly 79,000 acres (32,000 hectares) of land, while a cause remained under investigation, the California Department of Forestry and Fire Protection (CalFire) said in a statement.

Officials in Madera County issued evacuation orders and urged the county’s 157,000 residents to leave if they felt unsafe.

A hiker who had just embarked on a multi-day trip when the Creek Fire broke out and had to find a way out of the blaze shared the harrowing experience on social media.

“We’re safe and we’re out, but wow, we hiked our way out of the #CreekFire yesterday,” Asha Karim posted on Twitter.

The Oak Fire in Mendocino County started burning around 1:26 pm on Monday afternoon, according to CalFire, and three hours later it had already torched 1,000 acres (400 hectares) and destroyed one structure.

Videos on social media showed the fire consuming pick-up trucks as it spread along Highway 101 near Willits, California.

“If you’re trying to get out of an evacuation area please call 911 for help. Don’t delay!” the Mendocino Sheriff’s Office wrote on Twitter.

San Francisco-based power provider PG&E said late on Monday that it began turning off power in “high fire-threat” areas. The outages will impact 172,000 customers in 22 counties, mostly in the Sierra Foothills, PG&E said, adding the shut off was a safety measure due to the extreme high and dry winds.

The California Independent Systems Operator, which runs most of the state’s power grid, again urged consumers to cut back on energy consumption and said it was monitoring wildfires throughout the state threatening power lines.

In Southern California, east of San Diego, more than 400 firefighters battled the Valley Fire, which burned more than 17,000 acres (6,900 hectares)in Cleveland National Forest. Video shared on social media showed firefighters dousing the flames, the air thick with ash and fire embers.

The blaze was 3% contained on Monday evening. Officials announced the deployment of military aircraft on Monday afternoon to help fight the flames.

A fire in San Bernardino County, southeast of Los Angeles, that officials said was caused by a pyrotechnic device used during a gender reveal party, kept burning through the night and was 7% contained as of Monday morning.

On Sunday, California Governor Gavin Newsom declared a state of emergency in Fresno, Madera, Mariposa, San Bernardino and San Diego counties due to the wildfires, which also prompted the U.S. Forest Service to temporarily close some national forests including the Sierra National Forest, the Angeles National Forest and the San Bernardino National Forest.

(Reporting by Maria Caspani and Gabriella Borter in New York; additional reporting by Kanishka Singh; Editing by Leslie Adler, Peter Cooney and Michael Perry)

White nationalism upsurge in U.S. echoes historical pattern, say scholars

By Katanga Johnson and Jim Urquhart

WASHINGTON (Reuters) – The first Black woman is on a major party presidential ticket, Americans of all races are showing their support for the Black Lives Matter movement and at the same time white nationalists are ramping up recruiting efforts and public activism.

That nationwide backing for America’s stated goal of equal rights for all has been met by a rise in hate-related activities is part of a decades-long pattern in the United States, six scholars and historians say – any expansion of civil rights for a minority group leads to a rise in intolerance.

“Each wave of civil rights progress brings us a little closer to real equity, but there will always be backlash from those who feel threatened by that progress,” said Cynthia Miller-Idriss, director of research with the Polarization and Extremism Research and Innovation Lab at American University in Washington. People who feel vulnerable to change become “eager to recruit and radicalize support to slow things down, even if by use of violence or radicalized propaganda,” she said.

After the first Black president, Barack Obama, was elected in 2008, the number of hate groups “ballooned,” Miller-Idriss said, just as Ku Klux Klan activity grew again after the 1954 Brown v. Board of Ed. decision desegregating schools, and during the 1960’s civil rights movement. Backlashes happened after women got the right to vote, and as LGBTQ rights expanded, too.

One of the things that makes this moment so heated is there’s been a bigger embrace by politicians, businesses and white people in general supporting racial justice movements than in the past, historians and civil rights experts said.

America rests on the “great social challenge of creating a successful harmonious, multiracial democracy,” said Simon Clark, a senior fellow at the Center for American Progress (CAP). The backlash against that accelerated during the Black Lives Matter protests and “is both a political one and a violent, social one,” he said.

Protests against excessive use of force by police and racism swept the United States, and the world, this summer after a Black man, George Floyd, died on May 25 while a white Minneapolis, Minnesota police officer kneeled on his neck.

The latest police shooting of a Black man, Jacob Blake, in Kenosha, Wisconsin on Aug. 23 has sparked more protests that have sometimes become violent.

Two white nationalist groups, who want an independent state for whites, told Reuters their numbers are also increasing, which Reuters could not independently confirm. The National Socialist Movement Corporation and the ShieldWall Network said many of the new prospects reject the Black Lives Matter protesters mainly out of fear the demonstrations will impose on their freedoms, such as the right to bear arms.

“I’ve got guns. I’ve got a lot of bullets and an armor, too. And if people come down my street looking for trouble, I am going to fight it,” Burt Colucci, self-described commander of the Corporation, said a prospective recruit told him in a recent phone call.

The New York-based Anti-Defamation League (ADL) has documented 3,566 “extremist propaganda incidents” and events in 2020, compared to 2,704 in the same period of 2019. Almost 80% of this year’s cases involve white nationalist ideology, the civil rights advocacy organization found. Anti-Semitic incidents and plots and attacks of terrorism among others made up the rest, the ADL said.

MARCH IN WASHINGTON

Patriot Front, a white nationalist group, marched in Washington in February, and flyers and leaflets advertising the group have been found on college campuses from Arizona to Vermont in recent months. White nationalist groups posted messages on Facebook this summer advocating bringing guns to Black Lives Matter protests, and staged demonstrations in Florida and Pennsylvania in July.

While the ethnic and racial diversity of the United States is growing, whites remain a majority, about 60% of all Americans, according to Pew Research Center analysis published a year ago.

One-third of eligible voters in the Nov. 3 elections, in which Senator Kamala Harris of Jamaican and Indian parentage is running on Democratic presidential candidate Joe Biden’s ticket, will be non-white, according to Pew, up from one-quarter in 2000.

Most Americans say they embrace diversity, according to a Reuters/Ipsos opinion poll last year about race, society, and their political engagement. Sixty-three percent said the statement “I prefer to live in a community with people who come from diverse cultures” reflects their point of view.

Among registered Democrats, that affirmative answer jumped to 78%, while among Republicans it dropped to 45%.

In the election campaign, Biden has accused President Donald Trump of stoking divisions. The Trump campaign has said that the president “works hard to empower all Americans.”

‘HEAR THE RAGE’

“I’ve never seen the country so divided – not only divided, but charged, on all sides,” said Billy Roper of the Arkansas-based white nationalist organization, ShieldWall Network.

America has been at similar crossroads before, though, the scholars and historians interviewed by Reuters say.

The Ku Klux Klan, founded at the end of the U.S. Civil War, is the oldest and most violent of white extremist organizations, according to the Southern Poverty Law Center (SPLC) civil rights advocacy group. The KKK, bent on reversing the federal government’s progressive policies during the period known as Reconstruction, used violence against Black people in Southern states, particularly to deny them the newly-won right to vote.

Women’s voting rights, granted in 1920, coincided with a rise of the word “bitch” in newspapers around the country, Representative Pramila Jayapal said recently on the floor of the House of Representatives because, she contends, voting “was just a little too much power for too many men across the country.”

During the early years of the civil rights movement, a number of monuments honoring the war heroes of the Confederacy, the slavery-supporting states that lost the Civil War, were erected in the South, according to a SPLC report.

At least 780 monuments remained in public places in the South and elsewhere in the United States as of February 2019, the report said, among other Confederate symbols that are deeply divisive. Of those monuments, 604 were dedicated before 1950, but 28 others were unveiled from 1950 to 1970 and 34 after 2000.

National legalization of gay marriage in 2015 contributed to a powerful resurgence in conservative politics and legal challenges to LGBTQ rights, advocates said.

Colucci says his group has seen an uptick in calls and emails after racial justice protests and growing corporate and public support for Black Lives Matter and other groups.

“Some of those e-mails, I mean, you could just hear the rage,” he told Reuters.

(Reporting by Katanga Johnson in Washington and Jim Urquhart; Additional reporting by Chris Kahn; Editing by Heather Timmons and Grant McCool)

‘Rare, dangerous’ heat wave to hit California, U.S. West

By Andrew Hay

(Reuters) – A record heat wave with temperatures of up to 125 Fahrenheit (49 Celsius) was set to punish California starting on Friday as another extreme weather event raised risks of more forest fires and rolling blackouts.

The “deadly heat wave” of “rare, dangerous and very possibly fatal” temperatures was forecast across Southern California for the U.S. Labor Day holiday weekend, the National Weather Service (NWS) in Los Angeles said.

Record or excessive heat was also expected in Nevada and western Arizona with “brutal” temperatures set to peak on Sunday and continue into Monday, the service said.

“There is a high risk for heat illness along with heightened fire weather concerns,” the NWS Los Angeles office reported, forecasting record high temperatures on Saturday and Sunday.

Climate scientists blame human activities for a two to three degree Fahrenheit rise in average temperatures in California since the early 20th century and say extreme wet-dry cycles are creating abundant parched vegetation to supercharge wildfires.

The long weekend’s heat event is expected to be hotter than the one in mid-August that helped trigger the second and third largest forest fires in California history that are still burning.

Death Valley in California’s Mojave desert recorded one of the hottest air temperatures ever on the planet of 130F on Aug. 17, and highs of around 124F were expected there on Sunday, the NWS said.

The California power grid asked power generators to delay any maintenance until after the weekend to prevent blackouts like the two nights of rolling outages seen in mid-August as residents cranked up their air conditioning.

(Reporting by Andrew Hay; Editing by Tom Brown)

WHO’s Tedros says ‘vaccine nationalism’ would prolong pandemic

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – WHO Director-General Tedros Adhanom Ghebreyesus said on Friday that “vaccine nationalism” would only slow the effort to quash the pandemic and called for vaccines to be used fairly and effectively.

Tedros said 78 high-income countries had now joined the “COVAX” global vaccine allocation plan, bringing the total to 170 countries, and the “number is growing”. He urged others to join by the Sept. 18 deadline for binding commitments.

Joining the plan guaranteed those countries access to the world’s largest portfolio of vaccines, with nine candidates currently in the pipeline, he said, adding that a further four were “promising”.

The WHO and the GAVI vaccine alliance are leading the COVAX facility, aimed at helping buy and distribute vaccination shots fairly around the world.

But some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join COVAX.

“Vaccine nationalism will prolong the pandemic, not shorten it,” Tedros told a WHO briefing in Geneva, without mentioning any specific countries.

“If and when we have an effective vaccine, we must also use it effectively … In other words, the first priority must be to vaccinate some people in all countries, rather than all people in some countries,” he said, adding that priority should be given to healthcare workers, the elderly and those with underlying conditions.

Tedros thanked Germany, Japan, Norway and the European Commission for joining COVAX during the last week.

“Certainly by the middle of 2021 we should start to see some vaccines actually moving into countries and populations,” said WHO chief scientist Soumya Swaminathan, reiterating earlier comments.

Noting that there were 13 experimental vaccines currently in clinical trails, Swaminathan called it an “optimistic scenario” since the typical success rate of 10% could mean several vaccines are approved.

But Swaminathan said that no vaccine should be approved for a worldwide rollout until it had undergone sufficient scrutiny.

“No vaccine is going to be mass-deployed until regulators are confident, governments are confident, and the WHO is confident it has met the minimum standard of safety and efficacy,” she said.

Results were expected from some of the candidates already in phase 3 trials, each involving thousands of participants, by the end of the year or early 2021, Swaminathan said.

“We are not going to have enough for the whole world right at the beginning,” she said adding that scaling up of manufacturing would take time.

“Eventually there will be enough for everyone but it will mean prioritization,” she said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Alison Williams and Giles Elgood)

U.S. CDC reports 186,173 deaths from coronavirus

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Friday said the number of deaths due to the new coronavirus had risen by 1,081 to 186,173 and reported 6,132,074 cases, an increase of 44,671 cases from its previous count.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, as of 4 p.m. ET on Sept. 3 compared with its previous report a day earlier.

The CDC figures do not necessarily reflect cases reported by individual states.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Vinay Dwivedi)

Serbia, Kosovo agreed to normalize economic ties, Trump says

By Jeff Mason

WASHINGTON (Reuters) – Serbia and Kosovo have agreed to normalize economic ties, U.S. President Donald Trump said on Friday, hailing what he called a “major breakthrough” more than a decade after Kosovo declared independence from Serbia in 2008.

Trump, speaking in the Oval Office with the leaders of both countries, said Serbia had also committed to moving its embassy to Jerusalem, and Kosovo and Israel had agreed to normalize ties and establish diplomatic relations.

Serbian President Aleksander Vucic told reporters there were still many differences between Serbia and the breakaway province, but said Friday’s agreement marked a huge step forward.

Kosovo Prime Minister Avdullah Hoti said the agreement should lead to mutual recognition between the two countries.

“Serbia and Kosovo have each committed to economic normalization,” Trump said. “By focusing on job creation and economic growth, the two countries were able to reach a major breakthrough.”

The announcement came after two days of high-level talks among the leaders and senior Trump aides, and follows close on the heels of last month’s historic agreement between Israel and the United Arab Emirates to normalize ties.

Ethnic Albanian-majority Kosovo declared independence from Serbia in 2008 after a NATO-led bombing campaign to curtail ethnic warfare. Serbia, backed by its large Slavic and Orthodox Christian ally Russia, does not recognize Kosovo’s independence, a precondition for Belgrade’s future membership in the European Union.

National Security Adviser Robert O’Brien, who participated in the meetings, said the agreement on expanding economic ties could pave the way for political solutions in the future.

A top EU official on Monday said EU-led negotiations, which broke down in 2018 but resumed in July, could lead to a deal within months.

The U.S. talks were previously set for June but delayed after Kosovo President Hashim Thaci was indicted for alleged war crimes during the 1998-99 guerrilla uprising against Serbian rule and its aftermath. He has denied the charges.

(Reporting by Jeff Mason; writing by Andrea Shalal; editing by Jonathan Oatis)