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)

U.S. secures 300 million doses of potential AstraZeneca COVID-19 vaccine

By Aakash B, Guy Faulconbridge and Kate Holton

BENGALURU/LONDON (Reuters) – The United States has secured almost a third of the first 1 billion doses planned for AstraZeneca’s experimental COVID-19 vaccine by pledging up to $1.2 billion, as world powers scramble for medicines to get their economies back to work.

While not yet proven to be effective against the coronavirus, vaccines are seen by world leaders as the only real way to restart their stalled economies, and even to get an edge over global competitors.

After President Donald Trump demanded a vaccine, the U.S. Department of Health and Human Services (HHS) agreed to provide up to $1.2 billion to accelerate British drugmaker AstraZeneca’s vaccine development and secure 300 million doses for the United States.

“This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021,” U.S. Health Secretary Alex Azar said. The first doses could be available in the United States as early as October, according to a statement from HHS.

The vaccine, previously known as ChAdOx1 nCoV-19 and now as AZD1222, was developed by the University of Oxford and licensed to AstraZeneca. Immunity to the new coronavirus is uncertain and so the use of vaccines is unclear.

The U.S. deal allows a late-stage, or Phase III, clinical trial of the vaccine with 30,000 people in the United States.

Cambridge, England-based AstraZeneca said it had concluded agreements for at least 400 million doses of the vaccine and secured manufacturing capacity for 1 billion doses, with first deliveries due to begin in September.

Now the most valuable company on Britain’s blue-chip FTSE 100 Index, AstraZeneca has already agreed to deliver 100 million doses to people in Britain, with 30 million as soon as September. Ministers have promised Britain will get first access to the vaccine.

VACCINE SCRAMBLE

With leaders across the world surveying some of the worst economic destruction since at least World War Two and the deaths of more than 327,000 people, many are scrambling for a vaccine.

The U.S. government has struck deals to support vaccine development with Johnson & Johnson (J&J), Moderna and Sanofi, sparking fears the richest countries will be able to protect their citizens first.

Sanofi’s chief angered the French government earlier this month when he said vaccine doses produced in the United States could go to U.S. patients first, given the country had supported the research financially.

“We have a lot of things happening on the vaccine front or the therapeutic front,” Trump told reporters at the White House when asked about the AstraZeneca announcement. “You’re going to have a lot of big announcements over the next week or two” on therapeutics.

Trump, during a Thursday visit to a Ford Motor Co plant in Michigan, said the U.S. military is “in gear so we can give out 150 to 250 million shots quickly.”

AstraZeneca said it was in talks with governments and partners around the world – such as the Serum Institute of India – to increase access and production and is speaking to various organizations on fair allocation and distribution.

“We would like to thank the U.S. and UK governments for their substantial support to accelerate the development and production of the vaccine,” AstraZeneca Chief Executive Pascal Soriot said.

The Serum Institute of India, the world’s largest maker of vaccines by volume, has dedicated one of its facilities with a capacity to produce up to 400 million doses annually to producing the Oxford vaccine.

“We are scaling up on a conservative basis of about 4 to 5 million doses a month to begin with,” Chief Executive Adar Poonawalla told Reuters, adding the company was in discussions with AstraZeneca.

COVID-19 PROTECTION?

A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 across several trial centers in southern England. Data from the trial is expected shortly.

There are currently no approved treatments or vaccines for COVID-19.

Governments, drugmakers and researchers are working on around 100 programs. Experts are predicting a safe, effective means of preventing the disease could take 12 to 18 months to develop.

Only a handful of the vaccines in development have advanced to human trials, an indicator of safety and efficacy, and the stage at which most fail.

“AstraZeneca recognizes that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk,” it said.

Other drugmakers including Pfizer Inc, J&J and Sanofi are in various stages of vaccine development.

U.S.-based Inovio Pharmaceuticals said Wednesday its experimental vaccine produced protective antibodies and immune system responses in mice and guinea pigs.

And Moderna this week released positive data for its potential vaccine, which it said produced protective antibodies in a small group of healthy volunteers.

(Reporting by Aakash Jagadeesh Babu in Bengaluru, Ludwig Burger in Frankfurt and Zeba Siddiqui in New Delhi; writing by Guy Faulconbridge; editing by Alexander Smith, Jan Harvey, Mark Potter, Jonathan Oatis and Leslie Adler)

U.S. government gives states nearly $2 billion to combat opioid crisis

FILE PHOTO: An exterior view of the United States Health and Human Services Building on C Street Soutwest in Washington, U.S., July 29, 2019. REUTERS/Tom Brenner

(Reuters) – The U.S. Department of Health and Human Services (HHS) said on Wednesday it will offer states more than $1.8 billion in new funding to fight the opioid epidemic.

The funds will be used for expanding access to treatments for opioid overdosing and to gather case data from across states, the HHS said.

The Centers for Disease Control and Prevention will spend $900 million over three years – about $301 million in the first year – to help states and territories track overdose data as closely as possible, the HHS said https://www.hhs.gov/about/news/2019/09/04/trump-administration-announces-1-8-billion-funding-states-combating-opioid.html in a statement.

Meanwhile, HHS unit Substance Abuse and Mental Health Services Administration is awarding about $932 million to support prevention, treatment and recovery services.

Prescription opioid pain treatments and drugs like heroin and the more potent fentanyl were responsible for 47,600 U.S. deaths in 2017, according to the government, with only a small decline last year.

Drugmakers such as Johnson & Johnson and Endo International Plc are facing several lawsuits brought by states, counties and municipalities that seek to hold the companies responsible for opioid abuse nationwide.

A U.S. judge on Tuesday rejected efforts by major drugmakers, pharmacies and distributors to dismiss claims that they caused the nation’s opioid crisis, clearing the way for a landmark trial even as the judge pushes for a nationwide settlement.

(Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli)

Trump administration bans abortion referrals at U.S.-funded clinics

FILE PHOTO: A sign is pictured at the entrance to a Planned Parenthood building in New York August 31, 2015. REUTERS/Lucas Jackson/File Photo

WASHINGTON (Reuters) – The Trump administration said on Friday that taxpayer-funded family planning clinics which primarily serve low-income Americans will no longer be able to refer patients for abortions, a move that critics vowed to challenge in court.

The new regulation was announced by the U.S. Department of Health and Human Services as part of Title X, a government family planning program that serves about 4 million people.

The program currently subsidizes health centers such as those run by the non-profit Planned Parenthood, which provides contraception, health screenings and abortions. Planned Parenthood serves about 41 percent of Title X patients and receives up to $60 million a year in federal funds for family planning services.

To continue receiving taxpayer subsidies under the program, health clinics will have to comply with the new rule. Its key elements include “prohibiting referral for abortion as a method of family planning,” the health department said in a statement, adding that the rule “eliminates the requirement that Title X providers offer abortion counseling and referral.”

The rule would also require “clear financial and physical separation between Title X funded projects and programs or facilities where abortion is a method of family planning,” the statement said. The law already bans recipients of Title X funds from using those funds to perform abortions.

Conservative groups praised the administration’s move. “We thank President Trump for taking decisive action to disentangle taxpayers from the big abortion industry led by Planned Parenthood,” said Marjorie Dannenfelser, president of the anti-abortion group Susan B. Anthony List.

But officials from the states of New York and California immediately began talking about going to court. “We will take legal action,” New York’s Attorney General Letitia James said in a statement. “These new rules are dangerous and unnecessary, and will prevent millions of Americans from obtaining the care they need and deserve.”

Planned Parenthood’s president, Leana Wen, called the new rule “unconscionable and unethical.”

“This rule compromises the oath that I took to serve patients and help them with making the best decision for their own health,” Wen said in a statement. “Patients expect their doctors to speak honestly with them, to answer their questions, to help them in their time of need.”

(Reporting by Susan Cornwell; Aditional reporting by Julian Mincer; Editing by Tom Brown)

Most children, parents separated at U.S.-Mexican border reunited: court filing

After being reunited with her daughter, Sandra Elizabeth Sanchez, of Honduras, speaks with media at Catholic Charities in San Antonio, Texas, U.S., July 26, 2018. REUTERS/Callaghan O'Hare

By Tom Hals

(Reuters) – About 1,400 children of some 2,500 separated from their parents at the U.S.-Mexican border have been reunited with their families, the U.S. government said in a court filing on Thursday.

Government lawyers said 711 other children were not eligible for reunification with their parents by Thursday’s deadline, which was set by a federal judge in San Diego. In 431 of these cases, the families could not be reunited because the parents were no longer in the United States.

The parents and children were separated as part of President Donald Trump’s “zero tolerance” policy toward illegal immigration. Many of them had crossed the border illegally, while others had sought asylum at a border crossing.

The American Civil Liberties Union, which brought the case against the government, said in Thursday’s court filing that data showed “dozens of separated children still have not been matched to a parent.”

ACLU attorney Lee Gelernt accused the government in a statement of “picking and choosing who is eligible for reunification” and said it would “hold the government accountable and get these families back together.”

In a call with journalists after the court filing, U.S. Department of Health and Human Services official Chris Meekins said it was awaiting guidance from the court about how to proceed with the children of 431 parents no longer in the United States. The Office of Refugee Resettlement is an agency of department.

The government did not say in the call or in its court filing how many of those parents were deported.

One immigrant, Douglas Almendarez, told Reuters he believed that returning to Honduras was the only way to be reunited with his 11-year-old son.

“They told me: ‘He’s ahead of you’,” said Almendarez, 37, in the overgrown backyard of his modest soda shop several hours drive from the Honduran capital of Tegucigalpa. “It was a lie.”

The ACLU said the government has not yet provided it with information about the reunifications of children aged 5-17 with their parents, including the location and timing of them.

“This information is critical both to ensure that these reunifications have in fact taken place, and to enable class counsel to arrange for legal and other services for the reunited families,’ it said.

LOST IN ‘BLACK HOLE’

Immigration advocates said the government’s push to meet the court’s deadline to reunite families was marred by confusion, and one said children had disappeared into a “black hole.”

Maria Odom, vice president of legal services for Kids in Need of Defense, said two children the group represented were sent from New York to Texas to be reunited with their mother. When they arrived, they learned their mother had already been deported, Odom told reporters during a conference call.

Odom said her group does not know where the children, aged 9 and 14, have been taken.

It was an example, she said, “of how impossible it is to track these children once they are placed in the black hole of reunification.”

The U.S. Department of Homeland Security did not immediately respond to a request for comment.

An outcry at home and abroad forced U.S. President Donald Trump to order a halt to the separations in June. U.S. Judge Dana Sabraw in San Diego ordered the government to reunite the families and set Thursday as the deadline.

Sabraw has criticized some aspects of the process, but in recent days, he has praised government efforts.

The ACLU and government lawyers will return to court on Friday to discuss how to proceed.

(Reporting by Tom Hals in Wilmington, Del.; additional reporting by Loren Elliott in McAllen, Texas, Nate Raymond in Boston and Callaghan O’Hare in San Antonio; writing by Bill Tarrant; editing by Grant McCool)

U.S. charges hundreds in major healthcare fraud, opioid crackdown

U.S. Attorney General Jeff Sessions addresses a news conference to announce a nation-wide health care fraud and opioid enforcement action, at the Justice Department in Washington, U.S. June 28, 2018. REUTERS/Jonathan Ernst

By Nate Raymond

(Reuters) – The U.S. Justice Department on Thursday announced charges against 601 people including doctors for taking part in healthcare frauds that resulted in over $2 billion in losses and contributed to the nation’s opioid epidemic in some cases.

The arrests came as part of what the department said was the largest healthcare fraud takedown in U.S. history and included 162 doctors and other suspects charged for their roles in prescribing and distributing addictive opioid painkillers.

“Some of our most trusted medical professionals look at their patients – vulnerable people suffering from addiction – and they see dollar signs,” U.S. Attorney General Jeff Sessions said.

The arrests came as part of an annual fraud takedown overseen by the Justice Department. The crackdown resulted in authorities bringing dozens of unrelated cases involving alleged frauds that cost government healthcare programs and insurers more than $2 billion.

Officials sought in the latest crackdown to emphasize their efforts to combat the nation’s opioid epidemic. According to the U.S. Centers for Disease Control and Prevention, the epidemic caused more than 42,000 deaths from opioid overdoses in the United States in 2016.

In a report released on Thursday, the U.S. Department of Health and Human Services’ Office of Inspector General said about 460,000 patients covered by Medicare received high amounts of opioids in 2017 and 71,000 were at risk of misuse or overdose.

Those figures were slightly down from 2016, but the report said the high level of opioid use remained a concern. The report said almost 300 prescribers had “questionable prescribing” that warranted further scrutiny.

Many of the criminal cases announced on Thursday involved charges against medical professionals who authorities said had contributed to the country’s opioid epidemic by participating in the unlawful distribution of prescription painkillers.

The cases included charges in Texas against a pharmacy chain owner and two other people accused of using fraudulent prescriptions to fill bulk orders for over 1 million hydrocodone and oxycodone pills that were sold to drug couriers.

“The perpetrators really are despicable and greedy people,” U.S. Health and Human Services Secretary Alex Azar said at a press conference.

The Justice Department also announced other cases unrelated to opioids, including schemes to bill the government healthcare programs Medicare, Medicaid and Tricare as well as private insurers for medically unnecessary prescription drugs and compounded medications.

(Reporting by Nate Raymond in Boston; Editing by Chizu Nomiyama and Tom Brown)