Tag Archives: United States

U.S. govt to invest $42 million in Becton Dickinson to ramp up vaccination efforts

(Reuters) – Becton Dickinson and Co said on Wednesday the U.S. government will invest $42 million to expand the medical technology company’s manufacturing capacity for syringes and needles to support vaccination efforts against COVID-19.

The company has also finalized an initial order from the government for 50 million needles and syringes to be delivered by the end of December 2020.

As the pandemic continues to rage, drug makers’ push to mass produce their potential COVID-19 vaccines even before they are shown to work in trials is creating concerns over supplies, including potential shortage of vials.

Brokerage Evercore ISI said the Becton deal indicates the demand for syringes could be higher than expected, and the expansion of manufacturing capacity could add over $150 mln of revenue to the company.

The investment is under a public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Health and Human Services Office, Becton Dickinson said.

BARDA has invested more than $3 billion in vaccines and funded more than 30 projects as part of “Operation Warp Speed,” the White House program aimed at accelerating access to vaccines and treatments for the new coronavirus.

BARDA will get priority access to the injection devices from the new manufacturing lines, the company said.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Shinjini Ganguli)

U.S. says ‘deeply concerned’ by Beijing’s detention of Chinese law professor

Flags of U.S. and China are displayed at American International Chamber of Commerce (AICC)'s booth during China International Fair for Trade in Services in Beijing, China, May 28, 2019. REUTERS/Jason Lee

By Humeyra Pamuk

WASHINGTON (Reuters) – The United States on Tuesday said it was deeply concerned about China’s detention of Xu Zhangrun, a law professor who has been an outspoken critic of the ruling Communist Party, and urged Beijing to release him.

Xu, 57, a professor at the prestigious Tsinghua University, came to prominence in July 2018 for denouncing the removal of the two-term limit for China’s leader, which allows Xi to remain in office beyond his current second term.

According to a text message circulated among Xu’s friends and seen by Reuters, he was taken from his house in suburban Beijing on Monday morning by more than 20 policemen, who also searched his house and confiscated his computer.

“We are deeply concerned by the PRC’s detention of Professor Xu Zhangrun for criticizing Chinese leaders amid tightening ideological controls on university campuses in China. The PRC must release Xu and uphold its international commitments to respect freedom of expression,” U.S. State Department spokeswoman Morgan Ortagus wrote in a tweet.

The detention comes as a new national security law came into effect in Hong Kong last week. The sweeping legislation that Beijing imposed on the former British colony punishes what China defines as secession, subversion, terrorism and collusion with foreign forces, with up to life in prison.

Critics say the aim of the law is to stamp out a pro-democracy movement that brought months of protests, at times violent, to the city last year.

The imposition of the new law further deteriorated ties between Washington and Beijing, which had been at loggerheads for months over the handling of the coronavirus pandemic and a nearly two-year trade war.

On Monday, U.S. Secretary of State Mike Pompeo said the United States is “certainly looking at” banning Chinese social media apps, including TikTok, suggesting it shared information with the Chinese government, a charge it denied.

(Reporting by Humeyra Pamuk; Editing by Sandra Maler and Alistair Bell)

Trump administration to encourage schools to safely reopen amid coronavirus surge

By Alexandra Alper and Susan Heavey

WASHINGTON (Reuters) – President Donald Trump is pushing for schools to reopen in the fall and is hosting White House events on the topic on Tuesday, despite a steady increase in coronavirus infections across the country led by younger Americans and rising hospitalizations in many states.

Trump on Monday tweeted “SCHOOLS MUST OPEN IN THE FALL!!!”, as local officials across the country began pausing or scaling back their re-openings due to the surge in infections.

On Tuesday, he will hold a discussion at the White House on re-opening schools, while Vice President Mike Pence speaks with governors on the topic, according to a senior administration official who briefed reporters.

“It is really … critically important to get our schools open,” the official said, highlighting the role schools play in communities. “There are a variety of different strategies that schools can adopt that really minimize the risk and can open these schools quite safely.”

The call comes as state and local governments, which largely control schools for kindergarten through 12th grade, grapple with how to handle the upcoming school year, seeking to balance the need for education with the risk of spreading the highly contagious disease.

Educators say socialization and other benefits such as school food programs are critically important. Experts have also shown online learning exacerbates the divide between poorer and more wealthy Americans, who have greater access to technology.

Most working parents of school-age children also depend on in-person instruction to allow them to work.

But an alarming surge in cases in the United States, especially among younger people, has raised concerns about the increased risk of spread by children to vulnerable adults at home as well as to older teachers and school staff.

The U.S. Centers for Disease Control and Prevention “encourages school districts to make reopening plans that anticipate COVID-19 cases, minimize risk of spread and then limit the need for the potential of school closures,” the official said.

Florida, a Republican-led state, on Monday issued a sweeping executive order for children to return to school this fall, despite sharply rising new COVID-19 cases and hospitalizations there.

Asked about Florida, the senior administration official stressed that “these are state and local decisions at the end of the day and we are confident that state and local leaders across the country are taking these decisions very seriously.”

Michigan Governor Gretchen Whitmer, a Democrat, said it was too soon to decide on schools given the nature of the resurgent outbreak.

If Trump wants schools to re-open, he should call for masks to be worn nationwide, she told CNN, calling mask wearing “a simple, cost effective” solution to mitigate virus spread.

Colleges and universities are also weighing plans to resume this autumn, including calendar changes on online classes.

The Trump administration on Monday said foreign students must leave the country if their schools move to fully online classes, which could choke off revenue for those schools.

(Reporting by Alexandra Alper and Susan Heavey; Editing by Bill Berkrot)

U.S. signs $450 million contract with Regeneron for COVID-19 therapy

By Manojna Maddipatla

(Reuters) – The U.S. government signed a $450 million contract with Regeneron Pharmaceuticals Inc for its potential COVID-19 antibody cocktail, the drug maker said on Tuesday.

The agreement, the first by the Trump administration to support a therapy, comes under the government’s “Operation Warp Speed” program that is aimed at faster distribution of vaccines and treatments to fight the new coronavirus when trials are successful.

The United States is also funding manufacturing and several trials for potential vaccines and has rushed to secure billions of doses of the vaccines being tested by companies around the world.

Earlier in the day, Novavax Inc received a $1.6 billion grant, the biggest award yet from Operation Warp Speed, to cover testing, manufacturing and sale of a potential coronavirus vaccine.

Under the contract with Regeneron, signed with the HHS’ Biomedical Advanced Research and Development Authority and the Department of Defense, the doses manufactured under the project will be owned by the federal government.

Regeneron’s cocktail, REGN-COV2, contains an antibody made by the company and another isolated from recovered COVID-19 patients. Rivals Eli Lilly and AbbVie are also pursuing antibody therapies for the respiratory illness.

REGN-COV2 is being tested separately for both preventing and treating COVID-19, with a late-stage prevention trial being run jointly with the National Institutes of Health.

The agreement covers a fixed number of bulk lots intended to be completed in the fall of 2020, Regeneron said.

A range of 70,000 to 300,000 potential treatment doses or 420,000 to 1,300,000 prevention doses are expected to be available from these lots, with initial doses to be ready as early as end of summer.

The U.S. government would make the doses available to Americans at no cost, if EUA or product approval is granted, Regeneron said.

Shares of Regeneron were up 1.4% at $636.11. They have risen 67% so far this year.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

Brazil President Bolsonaro tests positive for coronavirus

SAO PAULO (Reuters) – Brazilian President Jair Bolsonaro said on Tuesday he tested positive for the novel coronavirus, adding in a television interview that he was in good health despite running a fever.

The right-wing populist, who has played down the severity of the virus which he has called a “little flu,” took the test on Monday after developing symptoms.

In the interview broadcast on state-run TV Brasil, Bolsonaro said he began feeling ill on Sunday and has been taking hydroxychloroquine, an anti-malarial drug with unproven effectiveness against COVID-19.

Brazil has the world’s second-largest outbreak behind the United States. Latin America’s largest country has more than 1.6 million confirmed cases and 65,000 COVID-19 deaths.

Bolsonaro has repeatedly defied local guidelines to wear a mask in public, even after a judge ordered him to do so in late June. Bolsonaro has also railed against social distancing rules supported by the World Health Organization.

Over the weekend, Bolsonaro attended several events and was in close contact with U.S. Ambassador Todd Chapman during July 4 celebrations. Pictures showed neither wearing a mask.

The U.S. embassy in Brasilia said via Twitter on Monday that the ambassador had lunch on July 4 with Bolsonaro, five ministers and the president’s son, Congressman Eduardo Bolsonaro. The ambassador had no symptoms, but would undergo testing and is “taking precautions,” the embassy said.

(Reporting by Ana Mano; Writing by Stephen Eisenhammer; Editing by Brad Haynes and Daniel Flynn)

Fed’s Bostic: Business ‘getting nervous again’ as virus surges

(Reuters) – The surge in U.S. coronavirus cases has made business owners “nervous again,” Atlanta Federal Reserve Bank President Raphael Bostic said on Tuesday, and prompted him to focus on company decisions over the next three to six weeks.

“We are hearing it more and more as we get more data. People are getting nervous again. Business leaders are getting worried. Consumers are getting worried. And there is a real sense this might go on longer than we have planned for,” Bostic said in webcast remarks to the Tennessee Business Roundtable.

A Fed survey released on Tuesday morning showed Americans may be hunkering down for a longer than expected fight against the virus and the economic fallout from it.

The poll of 1,869 people took place between June 3 and June 12, as the first signs emerged of a newly growing coronavirus caseload, showed 46% of respondents now think it will take more than a year for conditions to return to normal. That is up from 35% in an April survey.

In conversations with managers in his Southern district, where several states are facing a renewed health crisis, Bostic said he is asking “what are their plans for the next three weeks, six weeks, how are they thinking about staffing decisions.”

That period could prove critical in the pace of an economic recovery Bostic suggested may plateau sooner and at a lower pace than expected.

At the end of July, some of the programs approved to support businesses and families during the pandemic will expire, most notably the $600-a-week addition to unemployment benefits.

With the caseload growing again, Bostic said it may become apparent that a longer bridge to the post-pandemic world is needed.

“It is pretty clear this is going to go on beyond the expiration of relief efforts,” Bostic said, adding that as the fact becomes clear, elected officials might “strongly consider doing more.”

(Reporting by Howard Schneider; Editing by Chizu Nomiyama and Jonathan Oatis)

U.S. says Alaska, Delta, JetBlue, United, Southwest seek COVID aid

WASHINGTON (Reuters) – Five additional U.S. air carriers – Alaska Airlines, Delta Air Lines, JetBlue Airways, United Airlines and Southwest Airlines – plan to seek federal loans amid the novel coronavirus outbreak, the U.S. Department of Treasury said on Tuesday.

The airlines had signed letters of intent regarding the terms under which they could receive U.S. funds under coronavirus relief law known as the CARES Act, Treasury Secretary Steven Mnuchin said in a statement.

“We look forward to working with the airlines to finalize agreements and provide the airlines the ability to access these loans if they so choose,” he said.

Four other airlines – American, Frontier, Hawaiian and Sky West – had already sought out federal aid under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the department said last week.

National lockdowns amid the global coronavirus pandemic has crippled the industry, although travel has picked up in some areas as economies open up.

Airlines have until Sept. 30 to decide whether to take the loan and can furlough or eliminate jobs starting Oct. 1.

(Reporting by Susan Heavey; Editing by Doina Chiacu and Nick Zieminski)

U.S. government awards Novavax $1.6 billion for coronavirus vaccine

By Julie Steenhuysen

CHICAGO (Reuters) – The U.S. government has awarded Novavax Inc $1.6 billion to cover testing and manufacturing of a potential vaccine for the novel coronavirus in the United States, with the aim of delivering 100 million doses by January.

The award announced by the U.S. Department of Health and Human Services is the biggest yet from “Operation Warp Speed,” the White House initiative aimed at accelerating access to vaccines and treatments to fight COVID-19, the respiratory disease caused by the coronavirus.

Shares in Gaithersburg, Maryland-based Novavax rose 29% to $102 in morning trading.

“What this Warp Speed award does is it pays for production of 100 million doses, which would be delivered starting in the fourth quarter of this year, and may be completed by January or February of next year,” Novavax Chief Executive Stanley Erck told Reuters.

It will also cover the cost of running a large Phase III trial, the final stage of human testing.

Erck said Novavax expects results of its Phase I trial testing the vaccine’s safety within the next week or so. The company aims to start mid-stage trials in August or September, with Phase III testing starting in October, Erck added.

The HHS announcement follows a $456 million investment in Johnson & Johnson’s vaccine candidate in March, a $486 million award to Moderna Inc in April, and up to $1.2 billion in support in May for AstraZeneca PLC’s vaccine being developed with Oxford University. The U.S. government also awarded Emergent Biosolutions Inc $628 million to expand domestic manufacturing capacity for a potential coronavirus vaccine and drugs to treat COVID-19.

The addition of Novavax’s candidate to Operation Warp Speed’s portfolio “increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said in a statement.

Besides the massive cash infusion for Novavax, the U.S. government inked a $450 million contract with Regeneron Pharmaceuticals Inc to make and supply its antibody cocktail for COVID-19.

Novavax is somewhat of a dark horse in the race for a coronavirus vaccine. The company was not on the list of vaccine finalists for Warp Speed previously reported by the New York Times that included Moderna, AstraZeneca, Pfizer Inc, J&J and Merck & Co.

In May, Novavax received an additional $388 million in funding for COVID-19 vaccine development from the Coalition for Epidemic Preparedness Innovations (CEPI), a private foundation, after a $4 million investment in March. In June, the U.S. Defense Department awarded the company $60 million to support manufacturing of 10 million doses of its vaccine in 2020.

‘A BIG SCALE UP’

The company is in the process of transferring its vaccine technology to an unnamed contract manufacturer that has two large manufacturing facilities, its CEO said. That is in addition to the work being done by Emergent Biosolutions, which is making doses to supply the company’s smaller early and mid-stage clinical trials.

By early next year, Novavax expects to be able to make 50 million doses a month in the United States.

“It’s a big scale up in a few different manufacturing sites in the United States,” Erck said. “What it leaves us with is the capacity of making many more doses in the U.S. in 2021.”

Novavax did not start human safety trials until late May. One reason for the delay is that the vaccine is grown in insect cells, a process that can take 30 days before company scientists can start purifying it and making it in bulk.

“You lose a month or so there, but I don’t think we’re behind because of our data,” Erck said, referring to animal data showing a strong immune response and high levels of virus-killing antibodies.

Besides Moderna, the company trails two other candidates – one from AstraZeneca and Oxford University and one from Pfizer and BioNTech.

Jefferies analyst Jared Holz said the cash infusion “places Novavax in a very enviable position should its data look compelling later in the year.”

Although Novavax has not yet produced a licensed vaccine, Sanofi SA uses the same basic technology to make flu vaccine, “so the risk of us not succeeding is pretty low,” Dr. Gregory Glenn, president of research and development for Novavax, said in a telephone interview.

The Novavax vaccine works in conjunction with an adjuvant – a substance that boosts the immune response to help the body build a robust defense against the virus.

Currently, Novavax makes its adjuvant in Sweden. The company is building up U.S. manufacturing capacity for its adjuvant “so that we can make upwards of a billion doses of adjuvant in the United States,” Erck said.

Novavax also has a manufacturing plant in the Czech Republic and hopes to have two other plants in Europe and one in Asia, Erck said. The company is also working with a manufacturer in India. The aim there is to make more than 100 million doses a month, Erck said.

(Reporting by Julie Steenhuysen; Editing by Bill Berkrot and Will Dunham)

Televangelists, Dallas megachurch that hosted Pence approved for millions in pandemic aid

By Chris Prentice

WASHINGTON (Reuters) – A Dallas megachurch whose pastor has been a vocal supporter of President Donald Trump was approved for a forgivable loan worth $2 million to $5 million, according to long-awaited government data released on Monday.

Vice President Mike Pence spoke at a rally last month at the First Baptist Church of Dallas, whose pastor, Robert Jeffress, has been on Trump’s evangelical advisory board.

It was among the tens of thousands of religious organizations that received a total of $7.3 billion in pandemic aid from the Small Business Administration.

The list of religious organizations approved for about 88,400 small business loans also included Joyce Meyer Ministries Inc, a Missouri church which in 2007-2011 was investigated by the Senate over its finances. That church was approved for $5 million to $10 million – the largest sum an individual entity could apply for.

Neither organization immediately responded to requests for comment on the loans. Joyce Meyer fully cooperated with the Senate investigation and agreed to join the Evangelical Council for Financial Accountability.

Monday’s data released by the U.S. Treasury Department and Small Business Administration (SBA) named borrowers that were approved for loans of $150,000 or more under the $660 billion Paycheck Protection Program.

The data showed religious organizations accounting for more than 1 million of the 51.1 million jobs protected by the high profile program. The list of named religious organizations was heavily skewed toward Christian denominations, according to a Reuters analysis.

Launched on April 3, the Paycheck Protection Program allows small businesses, non-profits and individuals hurt by the pandemic to apply for a forgivable government-backed loan.

Critics of the program’s rules, though, say it is unconstitutional for religious groups to receive taxpayer funds because America’s founders, in a bid to preserve religious freedom for all, envisaged a strict separation between church and state.

“Going back to the founding of our country, one of the major principles is that no one should be forced to be taxed to propagate the religious ideas of another person,” said Alison Gill, vice president of legal and policy at religious equality watchdog American Atheists.

Among the other 19 religious organizations to be approved for between $5 million and $10 million was Oklahoma-based Life.Church Operations LLC. Its pastor Bobby Gruenewald said in response to Reuters questions that he was grateful that churches were able to qualify for the loans, but did not say how much his church got or whether it will seek loan forgiveness.

Also in the $5 million-$10 million bracket were the Roman Catholic Diocese of San Bernardino, California, which has publicly acknowledged its role in a decades-old sexual abuse scandal, and Willow Creek Community Church Inc. in Illinois. In 2018, the Chicago Tribune, citing court records, reported that Willow Creek paid $3.25 million to settle lawsuits alleging a church volunteer sexually abused children. Willow Creek did not respond immediately to request for comment.

A spokesman for San Bernardino diocese said its entities received about $8.5 million which were used to pay staff wages and utility costs, and that the diocese expects to seek loan forgiveness.

(Reporting by Chris Prentice; Additional reporting by Koh Gui Qing and Brad Heath; Editing by Michelle Price, Tom Lasseter and Gerry Doyle)

WHO to travelers: keep an eye on ‘anywhere and everywhere’ COVID-19

GENEVA (Reuters) – The World Health Organization on Tuesday urged travelers to wear masks on planes and keep themselves informed as COVID-19 cases surge again in some countries, prompting new restrictions in places like Australia.

Spokeswoman Margaret Harris urged people not to be caught off-guard by resurgent local epidemics and quarantine measures, saying: “If it’s anywhere, it’s everywhere and people travelling have to understand that.”

“This virus is widespread and people have to take that very, very seriously.”

The WHO said last month that it would update its travel guidelines ahead of the northern hemisphere summer holidays but they have not yet been released.

In the meantime, travelers should “remember things will change, or may well change”, Harris said at a Geneva briefing.

“We’re seeing a lot of upticks, a lot of changes in different countries, countries that had successfully shut down their first transmission are seeing second upticks,” she added, mentioning Australia and Hong Kong.

Lockdown measures were reimposed in Australia’s second biggest city on Tuesday, confining Melbourne residents to their homes unless undertaking essential business, as officials scramble to contain a coronavirus outbreak.

The WHO’s previous guidance for travelers has included common-sense advice applicable to other settings such as social distancing, washing your hands and avoiding touching your eyes, nose or mouth.

Harris also proposed on Tuesday wearing a mask on planes, a measure which is already a requirement of many airlines.

“If you are flying, there is no way you can social distance in a plane, so you will need to take other precautions including using a face covering,” she said.

(Reporting by Emma Farge, Stephanie Nebehay and Michael Shields; Editing by Catherine Evans)