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)

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)

‘At war time speed’, China leads COVID-19 vaccine race

By Sangmi Cha and Miyoung Kim

SEOUL/SINGAPORE (Reuters) – China is forging ahead in the race to develop a vaccine to help control the COVID-19 pandemic, with Sinovac Biotech’s experimental vaccine set to become the country’s second and the world’s third to enter final stage testing later this month.

While a laggard in the global vaccine industry, China, where the new coronavirus is thought to have originated, has brought state, military and private sectors together in a quest to combat a disease that has killed over 500,000 people worldwide.

Many other countries, including the United States, are coordinating closely with the private sector to try to win the vaccine development race, and China faces many challenges.

Its success in driving down COVID-19 infections makes it harder to conduct large-scale vaccine trials, and so far only a few other countries have agreed to work with it. After past vaccine scandals, Beijing will also have to convince the world it has met all safety and quality requirements.

But China’s use of command economy-type tools is so far yielding results.

A state-controlled entity, for example, completed two vaccine plants at what it called the “war time speed” of a couple of months, while state-owned enterprises and the military have allowed experimental shots to be used on staff.

The People’s Liberation Army’s medical research unit, which has been a driving force in China’s efforts to fight infectious diseases, is also working with private firms including CanSino to develop COVID-19 vaccines.

Challenging the West’s traditional dominance of the industry, China is behind eight of the 19 vaccine candidates in human trials, with Sinovac’s experimental shot and one jointly developed by the military and CanSino among the front runners.

It is also focused mainly on inactivated vaccine technology – a technology that is well known and has been used to make vaccines against diseases such as influenza and measles – something which could raise the chances of success.

By contrast, several Western rivals such as U.S.-based Moderna and Germany’s CureVac and BioNTech are using a new technology called messenger RNA that has never before yielded a product approved by regulators.

‘TRIED AND TRUE’

“It’s a tried and true strategy,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, about inactivated vaccine technology.

“If I had to pick a vaccine that I think would be the most likely to be safe and effective, it would be that one,” he said. Offit is also co-inventor of the rotavirus vaccine, RotaTeq, manufactured by Merck & Co Inc.

Four of the Chinese candidates in human trials are inactivated vaccines, including Sinovac’s and two vaccines from China National Biotec Group, a unit of state-owned China National Pharmaceutical Group (Sinopharm).

There are currently only two experimental COVID-19 vaccines in final Phase III trials – one from Sinopharm and another from AstraZeneca  and the University of Oxford. Sinovac’s is set to become the third later this month.

To speed up the process, China allowed Sinopharm and Sinovac to combine Phase I and Phase II trials for their vaccine candidates.

For CanSino’s experimental vaccine, the PLA research institute played a key role, with the two working on a method using an adenovirus – a similar approach to AstraZeneca’s.

The PLA has its own approval process for “military specifically-needed drugs”, and approved the military use of the candidate developed by its research unit and CanSino last month.

PLA lead scientist Chen Wei, who has been the face of its vaccine development effort, was among the first to take the experimental COVID-19 shot developed by her team, as well as its potential SARS treatment years before, according to state media.

CHALLENGES

China has challenges, though, as the epidemic has petered out in the country, hampering efforts to conduct large trials.

It has since shifted its focus overseas, but only a handful of countries have shown willingness to collaborate – UAE, Canada, Brazil, Indonesia and Mexico. Neither major European countries nor the United States have shown interest in China’s COVID-19 vaccines as they focus on their own projects.

China must also address concerns over its vaccine quality and safety issues following several scandals over substandard vaccines in recent years.

“The Chinese national regulatory authority has been improving its oversight,” said Jerome Kim, head of the International Vaccine Institute, a non-profit agency established as an initiative of the U.N. Development Program.

China introduced a law last year to regulate the vaccine industry, with heavier penalties for selling and making fake or low-quality vaccines than other drug products.

(Reporting by Roxanne Liu and Sangmi Cha; Additional reporting by Julie Steenhuysen in Chicago; Writing by Miyoung Kim; Editing by Mark Potter and Kate Kelland)

WHO reviewing report urging new guidance over airborne spread of coronavirus

By Stephanie Nebehay and Julie Steenhuysen

GENEVA/CHICAGO (Reuters) – The World Health Organization (WHO) is reviewing a report urging it to update guidance on the novel coronavirus after more than 200 scientists, in a letter to the health agency, outlined evidence the virus can spread in tiny airborne particles.

The WHO says SARS-CoV-2, the virus that causes COVID-19, spreads primarily through small droplets expelled from the nose and mouth of an infected person that quickly sink to the ground.

But in an open letter to the Geneva-based agency, published on Monday in the Clinical Infectious Diseases journal, 239 scientists in 32 countries outlined evidence that they say shows floating virus particles can infect people who breathe them in.

Because those smaller particles can linger in the air, the scientists are urging WHO to update its guidance.

“We are aware of the article and are reviewing its contents with our technical experts,” WHO spokesman Tarik Jasarevic said on Monday in an email.

How frequently the coronavirus can spread by the airborne or aerosol route – as opposed to by larger droplets in coughs and sneezes – is not clear.

Any change in the WHO’s assessment of risk of transmission could affect its current advice on keeping 1-metre (3.3 feet) of physical distancing. Governments, which rely on the agency for guidance policy, may also have to adjust public health measures aimed at curbing the spread of the virus.

Although the WHO has said it is considering aerosols as a possible route of transmission, it has yet to be convinced that the evidence warrants a change in guidance.

Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota, said the WHO has long been reluctant to acknowledge aerosol transmission of influenza, “in spite of compelling data,” and sees the current controversy as part of that simmering debate.

“I think the frustration level has finally boiled over with regard to the role that airborne transmission plays in diseases like influenza and SARS-CoV-2,” Osterholm said.

Professor Babak Javid, an infectious disease consultant at Cambridge University Hospitals, said airborne transmission of the virus is possible and even likely, but said evidence over how long the virus stays airborne is lacking.

If it can hang in the air for long periods of time, even after an infected person leaves that space, that could affect the measures healthcare workers and others take to protect themselves.

WHO guidance to health workers, dated June 29, says SARS-CoV-2 is primarily transmitted through respiratory droplets and on surfaces.

But airborne transmission is possible in some circumstances, such as when performing intubation and aerosol-generating procedures, the WHO says. They advise medical workers performing such procedures to wear heavy duty N95 respiratory masks and other protective equipment in an adequately ventilated room.

Dr. William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health, said the report under review at the WHO “makes many reasonable points about the evidence that this mode of transmission can happen, and they should be taken seriously.”

But how often airborne transmission happens, which is unknown, also matters.

“If airborne transmission is possible but rare, then eliminating it wouldn’t have a huge impact,” he said in emailed comments.

Officials at South Korea’s Centers for Disease Control said on Monday they were continuing to discuss various issues about COVID-19, including the possibility of airborne transmission. They said more investigations and evidence were needed.

(Reporting by Stephanie Nebehay and Julie Steenhuysen; Additional reporting by Sangmi Cha in Seoul; Editing by Alex Richardson and Tom Brown)

Cuomo blasts Trump’s COVID-19 response as U.S. death toll tops 130,000

By Lisa Shumaker and Maria Caspani

(Reuters) – As U.S. coronavirus cases surge and deaths topped 130,000, New York Governor Andrew Cuomo harshly criticized the White House’s COVID-19 response on Monday, accusing President Donald Trump of “enabling” the virus and downplaying its threat.

Infections are on the rise in 39 states, according to a Reuters tally, and 16 states have posted record daily case counts in July. The surge has prompted many local leaders to slow or roll back economic re-openings despite Trump’s insistence that the epidemic is being handled.

At a news conference on Monday, Cuomo, a Democrat who has clashed with the president over his efforts to tackle the health crisis, said Trump was “enabling” the virus if he failed to address the severity of the situation.

“Acknowledge to the American people that COVID exists, it is a major problem, it’s going to continue until we admit it and each of us stands up to do our part,” Cuomo said, directing his comments at the president.

During a speech at the White House on Saturday, Trump asserted without providing evidence that 99% of U.S. coronavirus cases were “totally harmless.”

Steve Adler, the Democratic mayor of Austin, Texas, on Monday also criticized Republican Trump’s message.

“It’s incredibly disruptive and the messaging coming from the president of the United States is dangerous,” Adler told CNN.

White House Chief of Staff Mark Meadows on Monday defended Trump, saying the president was not trying to play down the deaths.

“But it’s really to look statistically to know that whatever risks that you may have or I may have, or my, my children or my grandchildren may have, let’s look at that appropriately and I think that’s what he’s trying to do,” Meadows told reporters outside the White House.

RE-OPENINGS HALTED

Local leaders across the country are considering slowing down or rolling back business re-openings to curb spiking infection rates that are already overwhelming hospitals in some areas.

Mayor Carlos Gimenez of Florida’s Miami-Dade County, which currently has some 48,000 COVID-19 cases, issued an emergency order on Monday shutting down on-site dining at restaurants and closing ballrooms, banquet facilities, party venues, gyms and fitness centers, and short-term rentals.

“We can tamp down the spread if everyone follows the rules, wears masks and stays at least six feet (2 meters) apart from others. I am counting on you, our 2.8 million residents, to stop the spread so that we can get back to opening our economy,” Gimenez said in a statement.

After the announcement, some Miami chefs and restaurant owners said they felt they were facing the impossible predicament of balancing their businesses’ survival against the safety of their employees and guests.

“We’re burned out emotionally, we’re burned out financially, and we’re burned out from the trauma of seeing everything that’s happening,” said Karina Iglesias, a partner at two popular downtown Miami Spanish restaurants.

Nationally, cases are approaching 3 million, by far the highest tally in the world and double the infections reported in Brazil, the world’s second most-affected country.

Florida confirmed a record high 11,000 new cases in a single day, more than any European country reported in a day at the height of the crisis there.

Gimenez imposed an indefinite nightly curfew in Miami-Dade County on Friday and halted the re-openings of entertainment venues such as casinos and strip clubs.

In New York City, where the percentage of people testing positive for the virus has dropped to 1%, residents were allowed to enter nail and tanning salons on Monday as part of the city’s Phase III of reopening, but Mayor Bill de Blasio delayed the resumption of indoor dining indefinitely.

Soaring case numbers and packed hospitals in Texas have prompted some mayors and other local leaders to consider launching a new round of stay-at-home orders. Cities are getting together and lobbying the state’s governor to restore the authority to impose local anti-coronavirus measures, Austin Mayor Adler said.

“It’s something that we’re considering. It’s only to be used as a last resort,” Adler told CNN.

(Reporting by Lisa Shumaker, Doina Chiacu, Peter Szekely, Gabriella Borter and Zachary Fagenson; Writing by Gabriella Borter; Editing by Howard Goller and Bill Berkrot)

India tallies third-highest coronavirus cases but death rate low

By Alasdair Pal and Abhirup Roy

NEW DELHI/MUMBAI (Reuters) – India on Monday overtook Russia to record the world’s third-highest number of coronavirus infections at nearly 700,000, even as its hardest-hit state said it will allow hotels to reopen this week.

Health ministry data from the world’s second-most populous country showed more than 23,000 new cases on Monday, down slightly from Sunday’s record increase of almost 25,000. There have been almost 20,000 deaths in India since the first case was detected there in January.

India now trails only the United States and Brazil in the number of COVID-19 cases and it has recorded eight times as many cases as China, where the virus was first identified in late 2019.

But its death rate per 10,000 people is still a low 0.15, compared with 3.97 in the United States and 6.65 in the United Kingdom, according to a Reuters tally. Mainland China stands at 0.03.

Officials said they had reversed a decision to reopen the Taj Mahal, India’s most famous tourist attraction, in the city of Agra, on Monday, following a rise in new cases in the area.

Some other monuments in and around the capital New Delhi opened on Monday, albeit with very few visitors. India is pushing ahead with relaxations to its more than two-month lockdown amid grim economic forecasts.

New Delhi, along with Maharashtra, home to India’s financial capital Mumbai, and the southern state of Tamil Nadu account for about 60% of the total coronavirus cases in the country.

Maharashtra – the worst-hit state with nearly 210,000 cases – said it would let hotels outside containment zones reopen at 33% capacity from Wednesday and issued guidelines for staff and guests.

India is also seeing an uptake in cases in states such as Kerala, Karnataka and Assam, which until recently had been relatively unscathed.

“This is showing up as an urban health challenge,” said Dr Rajib Dasgupta, a professor of community health at the Jawaharlal Nehru University in New Delhi, noting it is exposing weaknesses in the public health system.

(Reporting by Alasdair Pal and Abhirup Roy; Additional reporting by Rajendra Jadhav and Sunil Kataria; Editing by Nick Macfie)

U.S. tops 130,000 deaths from COVID-19 after record surge in cases

By Lisa Shumaker and Doina Chiacu

(Reuters) – The number of U.S. coronavirus deaths exceeded 130,000 on Monday, following a surge of new cases that has put President Donald Trump’s handling of the crisis under the microscope and derailed efforts to restart the economy.

The overall rate of increase in U.S. deaths has been on a downward trend despite case numbers surging to record levels in recent days, but health experts warn fatalities are a lagging indicator, showing up weeks or even months after cases rise.

Nationally, cases are approaching 3 million, the highest tally in the world and double the infections reported in the second most-affected country Brazil. Case numbers are rising in 39 U.S. states, according to a Reuters analysis.

Sixteen states have posted new record daily case counts this month. Florida confirmed a record high 11,000 in a single day, more than any European country reported in a single day at the height of the crisis there.

As health experts cautioned the public not to gather in crowds to celebrate Independence Day over the weekend, U.S. President Donald Trump asserted without providing evidence that 99% of U.S. coronavirus cases were “totally harmless.”

At least five states have already bucked the downward trend in the national death rate, a Reuters analysis showed. Arizona had 449 deaths in the last two weeks of June, up from 259 deaths in the first two weeks of the month. The state posted a 300% rise in cases over the full month, the most in the country.

Steve Adler, the Democratic mayor of Austin, Texas, on Monday criticized the Republican Trump’s comment over the weekend that the virus was mostly harmless.

“It’s incredibly disruptive and the messaging coming from the president of the United States is dangerous,” Adler told CNN. “One of the biggest challenges we have is the messaging coming out of Washington that would suggest that masks don’t work or it’s not necessary, or that the virus is going away on its own.”

Soaring case numbers and packed hospitals in Texas have prompted some mayors and other local leaders to consider launching a new round of stay-at-home orders. Cities are getting together and lobbying the state’s governor to restore the authority to impose local anti-coronavirus measures, Adler said.

White House Chief of Staff Mark Meadows on Monday defended Trump’s comment over the weekend, saying the president was not trying to play down the deaths.

“But it’s really to look statistically to know that whatever risks that you may have or I may have, or my children or my grandchildren may have, let’s look at that appropriately and I think that’s what he’s trying to do,” he told reporters outside the White House.

The U.S. Centers for Disease Control and Prevention has forecast between 140,000 to 160,000 coronavirus deaths by July 25 in projections that are based on 24 independent forecasts.

(Reporting by Lisa Shumaker, Doina Chiacu and Gabriella Borter; Editing by Howard Goller)

U.S. Vice President Pence supports governors pausing re-openings

WASHINGTON (Reuters) – U.S. Vice President Mike Pence said on Thursday he supported governors who are pausing their states’ re-openings during the coronavirus pandemic, but sees no need for a national mandate for people to wear masks.

Pence also said he believed schools could reopen on time in the fall and that the United States would keep opening up after the coronavirus pandemic that shut down the economy for several months.

The vice president made the remarks before a visit to hard-hit Florida, which shattered records on Thursday when it reported over 10,000 new coronavirus cases, the biggest one-day increase in the state since the pandemic started, according to a Reuters tally.

“I don’t think there’s a need for a national mandate,” Pence said in an interview with CNBC.

“The truth is that we’re monitoring right now 12 states that have rising cases and rising positivity and we’re fully supporting efforts that governors are taking and local health officials are taking to encourage people to practice good hygiene, social distancing, wear a mask when social distancing is not possible.”

Pence said that the rise in coronavirus cases across Sunbelt states in recent weeks – California, Arizona, Texas and Florida – reflects younger Americans beginning to congregate in settings where the virus can spread.

He said he and President Donald Trump support efforts by governors of those states “to modify or pause aspects of their reopening.”

To contain the outbreak, Florida closed bars and some beaches, but the governor has resisted requiring masks statewide in public or reimposing a lock-down.

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

Florida shatters records with over 10,000 new COVID-19 cases in single day

By Lisa Shumaker

(Reuters) – Florida shattered records on Thursday when it reported over 10,000 new coronavirus cases, the biggest one-day increase in the state since the pandemic started, according to a Reuters tally.

Outbreaks in Texas, California, Florida and Arizona have helped the United States break records and send cases rising at rates not seen since April.

In June, Florida infections rose by 168% or over 95,000 new cases. The percent of tests coming back positive has skyrocketed to 15% from 4% at the end of May.

Florida, with 21 million residents, has reported more new daily coronavirus cases than any European country had at the height of their outbreaks.

To contain the outbreak, Florida has closed bars and some beaches but the governor has resisted requiring masks statewide in public or reimposing a lock-down.

Only one other state has reported more than 10,000 new cases in a single day. New York recorded 12,847 new infections on April 10, three weeks after the state implemented a strict lock-down that closed most businesses. While the state has relaxed many measures, it requires masks in public and mandates anyone arriving from 16 other U.S. states with high infections self-quarantine for two weeks.

Once the epicenter of the U.S. epidemic, New York saw cases rise by about 6% in June – the lowest rate in the entire country.

(Writing by Lisa Shumaker)