Tag Archives: U.S. Government

U.S. to buy 10 million courses of Pfizer’s COVID-19 pill for $5.3 billion

By Manas Mishra

(Reuters) – Pfizer Inc said on Thursday the U.S. government would pay $5.29 billion for 10 million courses of its experimental COVID-19 antiviral drug, as the country rushes to secure promising oral treatments for the disease.

The deal is for around twice as many treatment courses as Merck & Co Inc has agreed to supply the United States under its contract. The price for the Pfizer pill is nearly 25%lower at roughly $530 per course, compared with about $700 for Merck’s.

Pfizer applied for emergency authorization of the drug, branded as Paxlovid, this week after reporting data showing that it was 89% effective at preventing hospitalization or death in at-risk people. The trial’s results suggest that Paxlovid surpasses Merck’s molnupiravir which was shown last month to halve the risk of dying or being hospitalized for COVID-19 patients at high risk of serious illness.

“While this pill still requires a full review by the Food and Drug Administration, I have taken immediate steps to secure enough supply for the American people,” President Joe Biden said in a statement. He added that his administration was making preparations to ensure the treatment is easily accessible and free.

Pfizer said it would begin deliveries of the treatment as soon as this year if it is authorized by the U.S. FDA.

Shares of Pfizer were up 0.65% at $51.20 on Thursday afternoon, while shares of Merck were nearly flat at $82.63.

Getting vaccinated should still be the priority for Americans but having pills that can keep people out of the hospital “could be a lifesaver,” said U.S. Secretary of Health and Human Services Xavier Becerra.

Pfizer has said it expects to manufacture 180,000 treatment courses by the end of next month and at least 50 million courses by the end of 2022.

Countries have scrambled to secure doses of the Pfizer and Merck oral drugs, based on promising data reported by both companies.

The U.S. government has so far secured 3.1 million courses of Merck’s COVID-19 pill for $2.2 billion, with the right to buy 2 million more courses in the future.

Drugs in the same class as Merck’s pill have been linked to birth defects in animal studies. Merck has said similar studies of its drug – for longer and at higher doses than used in humans – show that it does not cause birth defects or cancer.

(Reporting by Manas Mishra in Bengaluru, Additional reporting by Michael Erman in New Jersey; Editing by Ramakrishnan M. and Matthew Lewis)

U.S. government to buy $1 billion more worth of Merck’s COVID-19 pill

By Manas Mishra

(Reuters) – The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc and partner Ridgeback Biotherapeutics, the companies said on Tuesday.

The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more.

That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract.

The drug has been closely watched since data last month showed that when given early in the illness it could halve the chances of dying or being hospitalized for those most at risk of developing severe COVID-19.

“Molnupiravir, if authorized, will be among the vaccines and medicines available to fight COVID-19 as part of our collective efforts to bring this pandemic to an end,” said Frank Clyburn, president of Merck’s human health business.

President Joe Biden said on Friday that the United States had also secured millions of doses of Pfizer Inc’s rival antiviral drug, which was shown to cut by 89% the chance of hospitalization or death for adults at risk of severe disease.

The Pfizer negotiations were for a deal similar to the one with Merck – 1.7 million courses of the treatment upfront with an additional option for 3.3 million, a senior U.S. health official said on Tuesday, confirming a New York Times report.

Pfizer Chief Executive Officer Alfred Bourla said on Friday that the company plans to sell its treatment for around the same price for high-income countries as Merck, at roughly $700 for a course of therapy.

Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.

(Reporting by Manas Mishra and Leroy Leo in Bengaluru; Additional reporting by Jeff Mason in Washington; Editing by Anil D’Silva, Arun Koyyur and Sriraj Kalluvila)

Nigeria receives 4 million doses of covid-19 vaccines from U.S. government

By Felix Onuah

ABUJA (Reuters) – Nigeria has received 4 million doses of Moderna’s COVID-19 vaccines donated by the United States government, its health minister said on Monday, as the West African country battles a third wave of infections.

Osagie Ehanire said the vaccines, which arrived on Sunday, are undergoing validation by the country’s drug regulator. He said the doses will be distributed to the local states once they are certified fit for use.

The U.S. government last week shipped nearly 10 million doses to two of the most populous African countries – Nigeria and South Africa.

“Vaccination in Nigeria should soon begin with the arrival … of Moderna vaccines, thanks to the United States government,” Ehanire told a coronavirus briefing in Abuja.

He said Nigeria would receive over 40 million doses by the end of the year, without providing details.

The primary healthcare agency said last month that Nigeria had exhausted an initial supply of nearly 4 million shots and expects to receive nearly 8 million doses of COVID-19 vaccines by the end of August, including the U.S. government donation.

Nigeria, Africa’s most populous nation, has seen a rise in coronavirus cases since mid July. Some 174,315 cases and 2,149 deaths have been recorded since the pandemic began in early 2020, official data shows.

It recently detected the highly contagious Delta variant, with the health minister warning that the country was going through a third wave of the infection.

Resident doctors in Nigerian public hospitals began an indefinite strike on Monday over grievances that include the delayed payment of salaries and allowances, the doctors’ union said, as coronavirus infections rise.

(Writing by Chijioke Ohuocha; Editing by Sandra Maler)

United States buys 200 million more doses of Pfizer/BioNTech COVID-19 vaccine

(Reuters) -Pfizer Inc and German partner BioNTech said on Friday the U.S. government has purchased 200 million additional doses of their COVID-19 vaccine to help with pediatric vaccination as well as possible booster shots – if they are needed.

A Biden administration official with knowledge of the contract said that as part of the agreement, Pfizer will provide the United States with 65 million doses intended for children under 12, including doses available immediately after the vaccine is authorized for that age group.

The U.S. government also has the option to buy an updated version of the vaccine targeting new variants of the virus.

The deal comes as the Delta variant of the coronavirus sweeps across the country and drives up infections, contributing to the debate over whether or not Americans will need a booster dose this fall.

It also follows the government’s move in June to buy 200 million more doses of Moderna Inc’s COVID-19 vaccine.

The purchase brings the total number of doses of the Pfizer/BioNTech vaccine to be supplied to the United States to 500 million, of which roughly 208 million doses have already been delivered, as of Thursday’s data from the government.

“These additional doses will help the U.S. government ensure broad vaccine access into next year,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Pfizer last year signed a deal with the U.S. government for 100 million doses of the vaccine for nearly $2 billion, with an option to buy 500 million more doses.

A majority of the new doses will be supplied by the end of the year, and the remaining 90 million will be delivered by April 30, the companies said.

Pfizer and BioNTech have designed a new version of their vaccine targeting the Delta variant, which they plan to test in the coming weeks, but have said the current vaccine could also provide protection against the variant.

Pfizer earlier this month said the companies plan to seek authorization from U.S. and European regulators for a booster dose of their COVID-19 vaccine.

The U.S. government has said Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.

Advisers to the U.S. Centers for Disease Control and Prevention on Thursday considered evidence suggesting that a booster dose of COVID-19 vaccines could increase protection among people with compromised immune systems.

CDC scientists told advisers that boosters for the immunocompromised would need to wait for regulatory action from the U.S. Food and Drug Administration – either full approval of vaccines or amendments to their current emergency use authorizations – before the CDC could make a recommendation.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Sriraj Kalluvila, Maju Samuel and Dan Grebler)

Judge finds U.S. government 60% responsible in 2017 Texas church mass shooting

(Reuters) – A federal judge found the U.S. government 60% responsible for harm caused to victims of a 2017 mass shooting at a Texas church where 26 people died.

U.S. District Judge Xavier Rodriguez ruled on Tuesday that the government failed to exercise reasonable care in allowing the shooter, Devin Patrick Kelley, to obtain firearms he used in the Nov. 5, 2017, massacre at the First Baptist Church in Sutherland Springs, Texas.

Rodriguez said Kelley had pleaded guilty in 2012 to domestic violence charges dating from his time in the Air Force, but the Air Force did not record his criminal history in a federal database used to flag unauthorized firearms purchases.

“The government failed to exercise reasonable care in its undertaking to submit criminal history to the FBI,” the judge wrote. He ordered lawyers for the government and victims to file a proposed plan to bring individual damages cases to trial.

(Reporting by Jonathan Stempel in New York; Editing by Matthew Lewis)

U.S. Feb. budget deficit hits record $311 billion as COVID-19 costs, revenues rise

By David Lawder

WASHINGTON (Reuters) – The U.S. government posted a budget deficit of $311 billion in February, a record high for the month and up $76 billion from the same month last year, as outlays to fight the coronavirus pandemic remained high, the Treasury said on Wednesday.

Receipts for February rose 32% from the year-earlier period to $248 billion, a phenomenon due largely to a $45 billion reduction in tax refunds issued during the month because the 2021 tax filing season started about two weeks later than in 2020.

Individual and withheld income tax receipts also rose by $9 billion, which a Treasury official said was due to tax withholding on increased unemployment benefits, along with increased hours worked at higher wage rates as lower-wage earnings languished.

February outlays also grew 32% to $559 billion, with the biggest increases for unemployment benefit-related costs and health expenditures. Both receipts and outlays were record highs for February.

For the first five months of the 2021 fiscal year, the deficit rose 68% to a record $1.047 trillion for the period, beating the previous record deficit of $652 billion in October-February of fiscal 2010.

(Reporting by David Lawder; Editing by Andrea Ricci)

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)

Americans are spending coronavirus checks on rent and groceries

By Jonnelle Marte

(Reuters) – When Jessica Rosner saw the $1,200 coronavirus relief payment from the U.S. government was deposited into her bank account Wednesday morning, the furloughed behavioral therapist knew immediately how she would spend the cash.

The unemployment benefits she applied for two weeks ago have yet to come through. And Rosner, 23, who lives near Fort Lauderdale, Florida, still owed nearly $1,500 for April’s rent and about $200 for car insurance.

The “Economic Impact Payments” being issued under the $2.3 trillion CARES Act passed by Congress last month started landing in consumers’ bank accounts this week. The relief payments of up to $1,200 per adult and $500 per child are meant to soften some of the economic damage caused by the pandemic.

Americans’ lives have been upended by the crisis, with most schools and businesses closed, vacations canceled, and families mourning the more than 31,000 people killed by the virus.

The relief money is arriving in bank accounts as states across the country struggle to process unemployment claims filed by more than 22 million Americans over the past month, and helping some people cover the essentials.

“It’s going to get used quickly because there are so many people who need money right now,” said Claudia Sahm, a former Federal Reserve economist and now the director of macroeconomic policy at the Washington Center for Equitable Growth.

Preliminary results from a survey Sahm is conducting with Google and the University of Michigan suggest U.S. families plan to spend the money on essentials or pay off debt, Sahm said. That is the way stimulus checks were used during the financial crisis of 2008 and to counter an economic slowdown during the summer of 2001, she said.

Some people said they were planning to save the cash temporarily, an indication the payments may not lead to the immediate economic stimulation hoped for by the government.

Hyniah Herrin, 26, wanted to enroll in college this fall but put those plans on hold after she lost her two part-time jobs as a school bus driver and restaurant host in Philadelphia. The stimulus money landed in her bank account on Monday, and she’s holding on to it. “We don’t know when we’re going to be able to resume life,” Herrin said.

Steve Davison, 61, says the workload in his part-time job handling social media advertising for a forklift distributor hasn’t decreased because of the coronavirus outbreak. But Davison, who has not received a payment yet, said he is still living paycheck to paycheck and is worried about the future.

After he pays an old tax bill, he plans to hold on to the rest of the cash. “I’m just going to stash it because you never know what’s going to come up,” said Davison, who lives in Jersey City, New Jersey.

Treasury Department Secretary Steven Mnuchin said earlier this week that more than 80 million Americans would have the money deposited directly into their bank accounts by Wednesday morning.

Those who haven’t received the money can check their status and provide bank account information through a new “Get My Payment” app. Paper checks bearing President Donald Trump’s name on them will be sent out starting early next week to people who don’t use direct deposit.

(Reporting by Jonnelle Marte; Editing by Heather Timmons and Paul Simao)

U.S. direct payments likely to begin April 13: House panel

By David Morgan

WASHINGTON (Reuters) – Americans should start receiving direct deposit payments from the U.S. government around April 13 to help them cope with the coronavirus pandemic, but others may have to wait until mid-September to receive paper checks, according to a key congressional committee.

The government is expected to distribute 60 million payments of up to $1,200 per individual using bank deposit information gleaned from 2018 and 2019 income tax filings during the week of April 13, according to a memo from Democrats on the House of Representatives Ways and Means Committee.

But it will not begin to send out paper checks to those who do not have bank deposit information on file until about 21 days later on May 4, according to the memo, which was reviewed by Reuters.

The IRS expects to issue checks at a rate of about 5 million a week, meaning that some Americans may have to wait 20 weeks. Under the schedule, the last checks would not arrive until around Sept. 21.

“This timeline is subject to change,” the memo noted.

The money is intended to help individuals and families offset the economic impact of the pandemic. Government officials hope to see the coronavirus die out during the warmer summer months, though health experts have warned of a possible resurgence in the fall.

(Reporting by David Morgan; editing by Andy Sullivan, Chizu Nomiyama and Leslie Adler)

Cruise ship passengers await Florida deal allowing them to disembark

By Zach Fagenson

MIAMI (Reuters) – The U.S. government and Florida were working on a plan on Wednesday to allow thousands of cruise ship passengers exposed to an onboard coronavirus outbreak to disembark, a day after President Donald Trump urged the governor to drop his opposition to their docking.

Fort Lauderdale Mayor Dean Trantalis said he was not opposed to them docking in his city. But he said a clear protocol was needed to protect residents of his South Florida city from infection.

“There can be no missteps in this process,” he told CNN.

“We have to be comfortable knowing that they are being quarantined in such a way that they do not infect the rest of the community,” Trantalis said.

One of the two Dutch cruise ships involved is Holland America Line’s MS Zaandam. Nearly two-thirds of its passengers, those who passed a medical screening, were moved to the line’s sister ship, the Rotterdam.

Both vessels were on the way to Port Everglades in Fort Lauderdale, the Zaandam carrying nearly 1,050 passengers and crew, and the Rotterdam almost 1,450.

Florida has reported 6,490 cases of coronavirus, including 251 non-residents, and 85 deaths, according to the state website. It ranks eighth in the number of new cases reported in the past 24 hours, analyst Michael Newshel of investment bank Evercore ISI said in a research note.

For the country as a whole, the tally stands at more than 190,000 reported cases and nearly 4,000 deaths, a toll that shot up by more than 850 on Tuesday, by far the most for a single day. Nearly half of the new fatalities were in New York state, the epicenter of the pandemic despite closed businesses and deserted streets.

Florida Governor Ron DeSantis issued a stay-at-home order on Monday for four counties in southern Florida that will last until April 15 and then be reviewed. On Tuesday, he said the White House task force had not recommended a statewide order.

“If they do, that’s something that would carry a lot of weight with me,” DeSantis told reporters.

Florida’s Democrats in the U.S. Congress published an open-letter to DeSantis renewing a call for him to issue a statewide stay-at-home order, saying the decision cannot be left to county and municipal governments.

“This pandemic has not respected global borders so it certainly will not respect county borders,” said the letter, which was signed by U.S. Representative Lois Frankel and 12 other members of Congress.

SICK AND STUCK

Jennifer Allan, whose 75-year-old father and 70-year-old mother are sick and stuck aboard the cruise ship Zaandam, was asked on NBC’s “Today” what she would say if she could speak with DeSantis:

“I would beg him and everybody who has the power to make this happen that we need to look at the humanity of what’s going on right now. There needs to be compassion for these people.

Another Florida official, Broward County Mayor Dale Holness, said the port was being operated by a “unified command” of federal and state agencies discussing the situation.

“As it stands today, they’re going back and forth, working on a plan to ensure that we’re safeguarding the people of Broward County from further spread of this virus, but also seeing how we can find a way to deal with these folks” in a humanitarian manner, Holness said on MSNBC.

GRAPHIC: Tracking the spread of the global coronavirus – https://graphics.reuters.com/CHINA-HEALTH-MAP/0100B59S39E/index.html

NEW MONTH, NEW CONCERNS

With rent and mortgage payments due on Wednesday, the first day of the month, job losses soaring, medical equipment in short supply and a projected coronavirus death toll in the United States of up to 240,000 people, Americans steeled themselves for months of uncertainty.

Medical experts on the U.S. government’s coronavirus task force on Tuesday said they were predicting that even with strict observance of stay-at-home orders and other precautions, between 100,000 to 240,000 people could ultimately die from the respiratory disease.

Public health officials are debating whether to recommend that people wear protective face masks even as an emergency stockpile of medical equipment maintained by the U.S. government has nearly run out of protective gear.

U.S. Surgeon General Jerome Adams, interviewed on the NBC News “Today” program on Wednesday, said officials were weighing potential new guidelines given the role of asymptomatic people carrying the virus but that people wearing masks should try not to touch their face and should still save N95 masks for healthcare workers.

“Wearing a face covering does not mean that you don’t have to practice social distancing. The most important thing you can do is stay at home right now,” Adams said.

The start of April brings a moment of reckoning for millions who have lost jobs and are forced to stay at home – their rent and mortgage checks are due.

Many Americans have already lost their jobs – last week’s national unemployment claims exceeded 3 million, shattering previous records.

Coronavirus news: https://emea1.apps.cp.extranet.thomsonreuters.biz/cms/?navid=919104201

(Reporting by Susan Heavey, Doina Chiacu, Tim Ahmann, Daniel Trotta and Peter Szekely; Writing by Grant McCool; Editing by Howard Goller)