Exclusive: UK auditing Indian vaccine site amid scramble for shots-sources

By Neha Arora, Krishna N. Das and Euan Rocha

NEW DELHI (Reuters) – Britain’s drug regulator is auditing manufacturing processes at Serum Institute of India (SII) which could pave the way for AstraZeneca’s COVID-19 vaccine to be shipped from there to the UK and other countries, according to two sources close to the matter.

SII, the world’s largest vaccine manufacturer, is currently mass producing the AstraZeneca vaccine, developed in conjunction with Oxford University, for dozens of poor and middle-income countries but not the UK, which has been getting its supply of the shot primarily from domestic facilities.

If the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) gives SII’s manufacturing process for the Oxford/AstraZeneca shot a greenlight it would allow the drug to be exported to the UK and to other countries which recognize MHRA’s clearances, one of the sources said.

Reuters could not determine what was the rationale for the audit. SII did not respond to a request for comment on it. The MHRA confirmed that an inspection was happening but declined further comment.

“Due to commercial confidentiality we do not comment on inspections that are still ongoing,” the regulator’s chief executive Dr. June Raine said in a statement to Reuters.

The two sources, who asked not to be named as the matter is private, said the audit should be relatively routine for SII, as its site already supplies other vaccines to the UK.

The inspection comes as countries around the world scramble to secure vaccine supplies amid supply disruptions and delivery cuts from leading drugmakers such as Pfizer Inc, Moderna and AstraZeneca.

It was not immediately clear whether an MHRA approval would allow the UK or AstraZeneca to route SII volumes of COVISHIELD – the brand name under which SII markets the AstraZeneca shot – to the EU, which has been pressuring the UK for supply from AstraZeneca’s facilities in the UK, amid shortages in Europe.

AstraZeneca executives told EU officials last week that to accelerate supplies to the bloc, it could provide it with some doses manufactured outside Europe, two EU sources told Reuters. One said the SII could be a supplier.

AstraZeneca, which has previously tapped SII to help fulfill some of its vaccine orders from Brazil, South Africa and Saudi Arabia, did not respond to a request for comment on whether it needs SII to help meet commitments in the UK, or in any other nations that would recognize an MHRA certification.

It was not immediately available to comment on the reported offer to supply the EU with shots from the SII.

INSPECTIONS

The EU’s drug regulator, the European Medicines Agency (EMA), audits sites from which it plans to source medicines but during the global pandemic, with multiple COVID-19 vaccines being developed, it is also partly leaning on inspections carried out by some other international regulators.

“Inspection outcomes for Covid-19 vaccines conducted by the MHRA will be considered by EMA,” said the regulator. Any such approved sites would also need an EMA sign off before they can export to the EU, the regulator told Reuters.

MHRA declined to comment on specifics, but Raine said it was collaborating “with international partners in response to the global pandemic and on matters of mutual interest.”

The UK has expressed an interest in purchasing vaccines from SII, according to the second source, along with a government official in New Delhi. The two sources said the volumes or timelines for any such purchases were unclear.

A UK government spokeswoman said: “Any discussions that have taken place between the UK Government and India on vaccines are not related to securing extra vaccine supply to the UK.”

The UK has so far ordered 100 million doses of AstraZeneca’s vaccine.

“Most countries have approached us and India’s government,” SII told Reuters, but it did not comment on any UK outreach. “We are trying our best to meet demand, and supply the vaccine to as many countries as possible, keeping India as the priority.”

SII’s chief executive, Adar Poonawalla, told Reuters in late January, his family-owned firm was keen to support AstraZeneca’s supply needs but its primary focus was on India and other poorer nations in Asia and Africa. He said at the time SII had no plans to divert supplies to Europe.

(Neha Arora and Krishna N.Das reported from New Delhi and Euan Rocha reported from Mumbai; Additional reporting by Paul Sandle, Kate Kelland and Alistair Smout in London, Francesco Guarascio in Brussels and Ludwig Burger in Frankfurt; Editing by Carmel Crimmins)

WHO says all hypotheses still open in probe into virus origins

By Reuters Staff

GENEVA (Reuters) – – All hypotheses are still open in the World Health Organization’s search for the origins of COVID-19, WHO Director-General Tedros Adhanom Ghebreyesus told a briefing on Friday.

A WHO-led mission in China said this week that it was not looking further into the question of whether the virus escaped from a lab, which it considered highly unlikely. The United States has said it will review the mission’s findings.

“Some questions have been raised as to whether some hypotheses have been discarded. Having spoken with some members of the team, I wish to confirm that all hypotheses remain open and require further analysis and study,” Tedros said.

“Some of that work may lie outside the remit and scope of this mission. We have always said that this mission would not find all the answers, but it has added important information that takes us closer to understanding the origins of the COVID-19 virus,” he said.

The mission has said its main hypotheses are that the virus originated in a bat, although there are several possible scenarios for how it passed to humans, possibly first by infecting another species of animal.

The former administration of U.S. President Donald Trump said it believed the virus may have escaped from a lab in the Chinese city of Wuhan. China has strongly denied this, and says the Wuhan Institute of Virology was not studying related viruses.

Overflowing Czech hospitals seek patient transfers as ‘UK variant’ rages

By Robert Muller

NACHOD, Czech Republic (Reuters) – Jan Mach had coped with his eastern Czech district hospital’s COVID-19 wards filling up – until 22 new arrivals on Monday alone were too much and he had to seek outside help.

On Wednesday, ambulances took 15 patients to hospitals as much as 230 km (140 miles) away, as closer ones were also packed.

“We have been close to our ceiling in the past 14 days, we have touched it several times,” director Mach said, adding the 339-bed hospital had 120 COVID-19 patients. “On Monday alone we took in 22 patients and that was beyond our means.”

Nachod and Trutnov, neighboring districts on the Polish border 150 km east of Prague, are among several regions that have seen incessant spread of the disease, despite a national lockdown.

A new, more infectious variant of the virus first detected in Britain is the likely reason – data from January showed between 45% and 60% of new patients were infected with the UK variant.

On Friday, the region of 550,000 reported just four free beds in COVID-19 wards and eight in high dependency and intensive care units (ICUs) treating coronavirus patients.

“We are taking in patients in a more serious condition and younger patients, I mean born 1970 and later, we had not seen that in the autumn,” Mach said.

Patients who would normally be treated in high-dependency units or ICU have had to be given therapies such as high-flow oxygen on normal wards due to the shortage of beds.

Mach spoke minutes after overseeing another ICU patient being transferred to another hospital. Staff dressed in full-body protective gear pushed the trolley past piles of equipment boxes, one of them with the hand-written label “body bags.”

The Czech Republic has ranked among the European countries worst-hit by the pandemic. Only Portugal has reported more new cases per capita in the past two weeks, according to the European Centre for Disease Prevention and Control (ECDC).

As of Friday morning, the country of 10.7 million had reported 17,902 COVID-19 related deaths.

Still, the parliament voted on Thursday not to extend a national state of emergency, which will lift some of current lockdown measures including the closure of shops, a loosely policed ban on gatherings and a night-time curfew.

Petr Stepanek, chief surgeon in the resuscitation unit at Nachod hospital, said the situation was “very tense”.

“It is about the ‘British’ variant,” Stepanek said. “If a majority of the population has already had it, thank God. If not, then the situation can become very dramatic.”

(Reporting by Robert Muller; Writing by Jan Lopatka; Editing by Alex Richardson)

COVID maths: All the virus in the world would fit in a coke can

LONDON (Reuters) – All the COVID-causing virus circulating in the world right now could easily fit inside a single cola can, according to a calculation by a British mathematician whose sum exposes just how much devastation is caused by minuscule viral particles.

Using global rates of new infections with the pandemic disease, coupled with estimations of viral load, Bath University maths expert Kit Yates worked out there are around two quintillion – or two billion billion – SARS-CoV-2 virus particles in the world at any one time.

Detailing the steps in his calculations, Yates said he used the diameter of SARS-CoV-2 – at an average of about 100 nanometers, or 100 billionths of a meter – and then figured out the volume of the spherical virus.

Even accounting for the coronavirus’ projecting spike proteins and the fact that the spherical particles will leave gaps when stacked together, the total is still less than in a single 330 milliliter (ml) cola can, he said.

“It’s astonishing to think that all the trouble, the disruption, the hardship and the loss of life that has resulted over the last year could constitute just a few mouthfuls,” Yates said in a statement.

More than 2.34 million people have died in the COVID-19 pandemic so far, and there have been almost 107 million confirmed cases worldwide.

(Reporting by Kate Kelland, editing by Alexandra Hudson)

White House says no specific decisions on domestic air travel under review

By David Shepardson

WASHINGTON (Reuters) – The White House on Thursday rejected media reports it is considering any new domestic air travel restrictions.

“To be clear, there have been no decisions made around additional public health measures for domestic travel safety. The administration is continuing to discuss recommendations across the travel space, but no specific decisions are under consideration,” a White House spokesman told Reuters.

Reports that the administration was considering imposing restrictions on travel to Florida brought denunciations from many Republican lawmakers.

The chief executives of major U.S. airlines are scheduled to meet virtually on Friday with the White House’s COVID-19 response coordinator to discuss travel-related issues, Reuters reported Wednesday.

The meeting with coronavirus response coordinator Jeff Zients and other administration officials involved in COVID-19 issues comes as airlines, aviation unions and other industry groups have strongly objected to the possibility of requiring COVID-19 testing before boarding domestic flights.

Southwest Airlines Co Chief Executive Gary Kelly and the leaders of the airline’s unions urged President Joe Biden in a letter not to mandate COVID-19 testing, saying it would put “jobs at risk.”

“Such a mandate would be counterproductive, costly, and have serious unintended consequences,” said the letter, which was dated Tuesday and released on Wednesday.

The Centers for Disease Control and Prevention (CDC) last month said the Biden administration was “actively looking” at expanding mandatory COVID-19 testing to U.S. domestic flights. The CDC on Jan. 26 began requiring negative COVID-19 tests or evidence of recovery from the disease from nearly all U.S.-bound international passengers age 2 and older.

One idea that has been under review within the Biden administration is for the CDC to issue recommendations advising against travel to areas of the United States with high COVID-19 caseloads, but no decisions have been made and recommendations would not be binding, officials said.

CDC officials have repeatedly urged Americans not to travel unless necessary.

(Reporting by David Shepardson; Editing by Lisa Shumaker)

Not perfect, but saves lives, AstraZeneca says as Africa backs COVID-19 shot

By Pushkala Aripaka and Ludwig Burger

(Reuters) – AstraZeneca’s COVID-19 vaccine is not perfect, but will have a big impact on the pandemic, its chief executive predicted on Thursday, as the drugmaker pledged to double output by April and the African Union gave its backing for the shot.

The two-dose inoculation, developed with Oxford University, has been hailed as a “vaccine for the world” because it is cheaper and easier to distribute than some rivals.

But its rapid approval in Europe and elsewhere has been clouded by doubts over its most effective dosage and interval between doses.

Data at the weekend also showed it was less effective against a fast-spreading variant of the virus in South Africa, prompting the country to pause rollout of the shot, and the company has also been embroiled in a row with the European Union over supply delays.

“Is it perfect? No, it’s not perfect, but it’s great. Who else is making 100 million doses in February?” CEO Pascal Soriot said on a conference call about the vaccine.

“We’re going to save thousands of lives and that’s why we come to work everyday.”

The company said it aimed to produce more than 200 million doses per month by April, double this month’s level as the world tries to tame a pandemic that has killed 2.35 million.

Head of operations Pam Cheng said on the call that the group was working to further expand global capacity and productivity.

AstraZeneca has set a target to produce 3 billion doses this year, with India’s Serum Institute making much of that aimed at poorer nations.

On Wednesday, the company enlisted Germany’s IDT Biologika as a contract manufacturer, but the bulk of IDT’s contribution will only come onstream late next year.

AstraZeneca said it expected much-anticipated data from the U.S. trial of the vaccine before the end of March, and that it was confident the shot offered relatively good protection against severe disease and death for the South African variant. Its disappointing results were against milder cases.

However, after rising to become Britain’s most valuable company last summer, the company has now slipped to sixth, in a move some analysts attribute to doubts over the vaccine.

“In a year or two we will look back and everybody will realize we made a big impact,” Soriot said.

POSTER CHILD

AstraZeneca’s shares were up 0.95% in afternoon trade, paring some earlier gains, after the company forecast a pick up in earnings growth this year on strong demand for its cancer and other new therapies.

It has pledged not to make any money from its COVID-19 vaccine during the pandemic.

It has been a tumultuous week for the drugmaker after South Africa put on hold giving the shot to its citizens, choosing one developed by its U.S. rival Johnson & Johnson instead.

That came after the trial data raised concerns about the AstraZeneca vaccine’s effectiveness on mild symptoms from the more infectious 501Y.V2 variant of the virus dominant in South Africa, which has spread to 41 nations around the world.

Despite that blow, the World Health Organization endorsed the British vaccine on Wednesday and the African Union said it would target its use in countries that have not reported cases of the variant.

Kenya and Morocco are also planning to administer it.

AstraZeneca said it expected 2021 revenues to rise by a low teens percentage and core earnings of $4.75 to $5.00 per share, as it beat expectations for fourth-quarter sales.

The earnings guidance equates to 18-24% growth, after 15% in 2020, but was a little lower than the $5.10 per share analysts were expecting, as the company flagged more spending this year.

The COVID-19 vaccine is not included in the guidance and the company said its sales would be reported separately from the first quarter of 2021.

While public interest is focused on the vaccine, AstraZeneca’s core business of diabetes, heart, kidney, and cancer medicines has been steadily growing, helping the company to turn around years of decline.

“The company is arguably the poster child for big pharma turnarounds,” said Third Bridge senior analyst Sebastian Skeet.

(Reporting by Pushkala Aripaka and Ludwige Burger. Editing by Josephine Mason and Mark Potter)

Cheap old homes draw millennials escaping pandemic cages

By Daniel Fastenberg

NORWICH, Conn. (Reuters) – American millennials with budget constraints are breaking out of their pandemic coops to find affordable dream homes in far-flung places.

For funeral home director Kate Reinhart, from Utah, that dream is an octagonal Victorian that recalls the macabre Addams Family mansion seen in cartoons, films and a TV series.

It helped that her scientist husband Cameron found his first job near Norwich, Connecticut, a town with one of the largest concentrations of 18th- and early 19th-century houses in New England.

For just $85,000 the couple bought the 1885 house replete with stained glass, artisanal light fixtures and winding banisters. They plan to put some $100,000 into a massive renovation.

“I do feel like we appreciate it more now during the pandemic to have more space to ourselves,” Kate said. “People are more self-conscious about being on top of each other in tiny apartment buildings. In New York City, people are fleeing to here.”

The trend is clear from visits to CheapOldHouses, a website founded by Elizabeth Finkelstein in 2016 to promote the purchase and preservation of historical houses.

Followers of the site’s Instagram account have steadily doubled every week since U.S. pandemic lockdowns began in March, to about 20,000, she said. About 42% are aged 25-34, and about 75% are women.

“The mantra of real estate has always been ‘location, location, location.’ For the first time that’s being flipped a little bit on its head,” Finkelstein said. “We are living in a time when people are willing to kind of take risks, maybe risks that they’ve been wanting to take their whole life.”

Homes on CheapOldHouses.com tend to be in the U.S. Midwest, South and Rust Belt, where many sell for less than $100,000. Houses that cost more in North America, Europe and elsewhere are also listed in Finkelstein’s monthly newsletter.

“We feature homes people can realistically buy, but also use their hands on as opposed to sitting in a cubicle all day long,” she said.

A net 70,000 people left the New York metropolitan region in 2020, resulting in roughly $34 billion in lost income, estimated Unacast, a location analytics provider.

More millennials may leave big cities even after the pandemic is over, Finkelstein said.

“With so many offices going remote, people have more opportunity to just say, ‘maybe I don’t need to be paying more than half my income in rent. And I can, I can take that leap.'”

(Reporting by Reuters Television; Writing by Richard Chang; Editing by Rosalba O’Brien)

Vaccinated people need not quarantine post COVID-19 exposure, CDC says

(Reuters) – People who have received the full course of COVID-19 vaccines can skip the standard 14-day quarantine after exposure to someone with the infection as long as they remain asymptomatic, U.S. public health officials advised.

The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday the vaccines have been shown to prevent symptomatic COVID-19, thought to play a greater role in the transmission of the virus than asymptomatic disease.

“Individual and societal benefits of avoiding unnecessary quarantine may outweigh the potential but unknown risk of transmission (among vaccinated individuals),” the CDC said.

The agency has laid down strict criteria for people who would no longer have to quarantine after the vaccinations, including having received both doses of a two-dose vaccine.

People who choose not to quarantine should do so only if they received their last dose within three months, and should only avoid 14 days quarantine after their last shot, the time it takes to develop immunity, CDC said.

Fully vaccinated persons who do not quarantine should still watch for symptoms for 14 days following an exposure.

Two-dose vaccines from Pfizer Inc and Moderna Inc have been authorized for emergency use in the United States. Johnson & Johnson applied for a U.S. authorization of its single-dose shot last week.

(Reporting by Manas Mishra and Rama Venkat in Bengaluru; Editing by Shounak Dasgupta and Sriraj Kalluvila)

Germany extends lockdown until March 7

By Sabine Siebold and Andreas Rinke

BERLIN (Reuters) – Germany will extend restrictions to curb the spread of the coronavirus until March 7, though schools and hair salons may open sooner, Chancellor Angela Merkel and leaders of the 16 federal states agreed on Wednesday.

The number of new daily infections in Germany has been falling, prompting some regional leaders to push for a timetable to ease the lockdown, but concerns are growing about the impact of more infectious variants of the virus on case numbers.

“We know that these mutants are a reality now, and with that it (the infection rate) will increase. The question is how quickly it will increase,” Merkel told journalists in a news conference.

Under the agreement, some exceptions will be made to a strict lockdown which has been in place since mid-December.

Hairdressers will be allowed to reopen from March 1 and individual states can decide on how to re-start school classes. Merkel, who has adopted a cautious approach throughout the pandemic, has said nurseries and primary schools take priority.

The rest of the economy can start to re-open gradually where the spread of the virus drops to no more than 35 new cases per 100,000 people over seven days.

On Wednesday, that number was 68, having fallen from a high near 200 in late December. It was last below 50 in October.

BUSINESS ANGST

Some business and industry associations have pushed for an easing of the restrictions as soon as possible, citing the damage inflicted on Europe’s biggest economy, which shrank by 5% last year.

“The situation is serious,” the BDI industry and BDA employers groups said. “We urgently call for an easing plan.”

However, the Ifo economic think-tank said a lockdown extension until mid-March was bearable and that a swifter easing that triggered a surge in cases could create greater damage.

Germany reported 8,072 new cases on Wednesday and a further 813 deaths, bringing the total death toll to 62,969.

(Writing by Madeline Chambers; Editing by Maria Sheahan, Gareth Jones and Cynthia Osterman)

Fed’s Powell calls for broad national drive to full employment

By Howard Schneider and Ann Saphir

WASHINGTON (Reuters) – Invoking post-World War II efforts to reach full employment and pledging continued loose monetary policy to help the process, Federal Reserve Chair Jerome Powell made a broad call Wednesday for a “society-wide commitment” to get Americans back to work, particularly minorities and those ousted from lower-paying jobs during the pandemic.

“Given the number of people who have lost their jobs and the likelihood that some will struggle to find work in the post-pandemic economy, achieving and sustaining maximum employment will require more than supportive monetary policy,” Powell said in remarks to the Economic Club of New York. “It will require a society-wide commitment, with contributions from across government and the private sector.”

While the Fed has already promised that borrowing costs for companies and households will be kept low as the economy recovers, Powell’s remarks spoke to the need for a more comprehensive approach to end the jobs crisis that followed the onset of the coronavirus last spring. In scope and approach, including a call for long-term investment, the remarks aligned closely with the sort of proposals being discussed by President Joe Biden and his Treasury Secretary and former Fed chair Janet Yellen.

The United States remains about 9 million jobs short of where it was a year ago.

“Fully realizing the benefits of a strong labor market will take continued support from both near-term policy and longer-run investments so that all those seeking jobs have the skills and opportunities that will enable them to contribute to, and share in, the benefits of prosperity,” Powell said.

His remarks come as the Biden administration pushes a $1.9 trillion emergency spending bill through Congress, while also laying plans for a longer-term infrastructure effort that some analysts expect will also be in the trillions of dollars.

Though the Fed has no direct say over how the federal government spends money or how much it raises, central bank policy does influence the interest rate the government pays and thus the cost particularly of longer-term investments.

During the pandemic, Fed policymakers have generally set concerns about the level of federal debt to the side and focused more on the economy’s immediate needs.

Powell on Wednesday cemented that stance, noting that after World War II, as the economy transitioned from wartime and needed to absorb millions of returning soldiers in the labor force, the Employment Act of 1946 committed the government “to use all practicable means” to see that anyone willing and able to work can find “useful employment.”

“At present, we are a long way from such a labor market,” he said.

(Reporting by Howard Schneider and Ann Saphir; Editing by Andrea Ricci)