Drugmakers rush to test whether vaccines stop coronavirus variant

By John Miller and Patricia Weiss

ZURICH/FRANKFURT (Reuters) – Drug makers including BioNTech and Moderna are scrambling to test their COVID-19 vaccines against the new fast-spreading variant of the virus that is raging in Britain, the latest challenge in the breakneck race to curb the pandemic.

Ugur Sahin, chief executive of Germany’s BioNTech which with partner Pfizer took less than a year to get a vaccine approved, said on Tuesday he needs another two weeks to know if his shot can stop the mutant variant of the virus.

Moderna expects immunity from its vaccine to protect against the variant and is performing more tests in coming weeks to confirm, the company said in a statement to CNN. Moderna did not immediately respond to Reuters’ requests for comment.

The mutation known as the B.1.1.7 lineage may be up to 70% more infectious and more of a concern for children. It has sown chaos in Britain, prompting a wave of travel bans that are disrupting trade with Europe and threatening to further isolate the island country.

Sahin said there are nine mutations on the virus.

While he does not believe any are significant enough to skirt the protection afforded by BioNTech’s mRNA vaccine, which was approved by the European Union on Monday, he said another 14 days or so of study and data collection are needed before offering a definitive answer.

“Scientifically it is highly likely that the immune response by this vaccine can also deal with this virus variant,” he said on a call with reporters.

“The vaccine contains more than 1,270 amino acids, and only 9 of them are changed (in the mutant virus). That means that 99% of the protein is still the same.”

Germany’s CureVac said it does not expect the variant to affect the efficacy of its experimental shot, which is based on the same messenger RNA (mRNA) technology used by Pfizer-BioNTech.

It started late stage clinical trials on its vaccine candidate last week and is constantly reviewing variants, which the company said are common as viruses spread.

Even though there are multiple mutations, BioNTech’s Sahin said, most of the sites on the virus that are recognized by the body’s T-cell response are unchanged, and multiple antibody binding sites are also conserved.

MRNA ADVANTAGE

In the event that the variant presents vaccine developers with an unexpected challenge, an advantage of mRNA is that scientists can quickly re-engineer genetic material in the shot to match that of the mutated protein, whereas modifying traditional vaccines would require extra steps.

“In principle, the beauty of the mRNA technology is we can directly start to engineer a vaccine which completely mimics this new mutation,” Sahin said.

“We could be able to provide a new vaccine technically within six weeks. Of course, this is not only a technical question. We have to deal with how regulators… would see that.”

Britain’s chief scientific adviser Patrick Vallance said on Saturday vaccines appeared to be adequate in generating an immune response to the variant of the coronavirus.

The World Health Organization (WHO) said on Tuesday it will convene a meeting of members to discuss strategies to counter the mutation.

WHO says no need for major alarm over new coronavirus strain

By Emma Farge and Michael Shields

GENEVA/ZURICH (Reuters) – The World Health Organization cautioned against major alarm over a new, highly infectious variant of the coronavirus that has emerged in Britain, saying this was a normal part of a pandemic’s evolution.

WHO officials even put a positive light on the discovery of the new strains that prompted a slew of alarmed countries to impose travel restrictions on Britain and South Africa, saying new tools to track the virus were working.

“We have to find a balance. It’s very important to have transparency, it’s very important to tell the public the way it is, but it’s also important to get across that this is a normal part of virus evolution,” WHO emergencies chief Mike Ryan told an online briefing.

“Being able to track a virus this closely, this carefully, this scientifically in real time is a real positive development for global public health, and the countries doing this type of surveillance should be commended.”

Citing data from Britain, WHO officials said they had no evidence that the variant made people sicker or was more deadly than existing strains of COVID-19, although it did seem to spread more easily.

Countries imposing travel curbs were acting out of an abundance of caution while they assess risks, Ryan said, adding: “That is prudent. But it is also important that everyone recognizes that this happens, these variants occur.”

WHO officials said coronavirus mutations had so far been much slower than with influenza and that even the new UK variant remained much less transmissible than other diseases like mumps.

They said vaccines developed to combat COVID-19 should handle the new variants as well, although checks were under way to ensure this was the case.

“So far, even though we have seen a number of changes, a number of mutations, none has made a significant impact on either the susceptibility of the virus to any of the currently used therapeutics, drugs or the vaccines under development and one hopes that will continue to be the case,” WHO Chief Scientist Soumya Swaminathan told the briefing.

The WHO said it expects to get more detail within days or weeks on the potential impact of the highly transmissible new coronavirus strain.

(Reporting by Emma Farge in Geneva and Michael Shields in Zurich; Writing by Josephine Mason; editing by Mark Heinrich)

WHO-led team expected in China in January to probe COVID-19 origins

By Stephanie Nebehay and Nikolaj Skydsgaard

GENEVA/COPENHAGEN (Reuters) – An international mission led by the World Health Organization (WHO) is expected to go to China in the first week of January to investigate the origins of the virus that sparked the COVID-19 pandemic, a member and diplomats told Reuters on Wednesday.

The United States, which has accused China of having hidden the outbreak’s extent, has called for a “transparent” WHO-led investigation and criticized its terms, which allowed Chinese scientists to do the first phase of preliminary research.

China reported the first cases of a pneumonia of unknown cause in Wuhan, central China, to the WHO on Dec. 31 and closed a market where the novel coronavirus is believed to have emerged.

Health ministers called on the WHO in May to identify the source of the virus and how it crossed the species barrier.

Now a team of 12-15 international experts is finally preparing to go to Wuhan to examine evidence, including human and animal samples collected by Chinese researchers, and to build on their initial studies.

Thea Fischer, a Danish member, said that the team would leave “just after New Year’s” for a six-week mission, including two weeks of quarantine on arrival.

“Phase 1 was supposed to be completed by now, according to the terms of reference, and we should have some results. If that’s what we get when we come to China…that would be fantastic. Then we are already in phase 2,” she told Reuters.

Keith Hamilton, an expert at the World Organization for Animal Health (OIE) who will take part, told reporters on Tuesday: “I anticipate the mission will take place quite soon.”

WHO spokesman Tarik Jasarevic said in an emailed reply to Reuters inquiry that the international team was working on logistical arrangements to travel to China as soon as possible. “We hope the team will be able to travel in January,” he said.

A Western diplomat said that the team was expected to leave in early January, ahead of WHO’s executive board opening on Jan. 18, adding: “There is strong pressure on China and on WHO.”

‘NEEDLE IN A HAYSTACK’

Hamilton said a similar but not identical virus was identified in a horseshoe bat, indicating that it was transmitted first to an animal, or intermediate host, before infecting humans.

“When we are doing animal surveillance, it’s difficult, it’s rather like looking for a needle in a haystack,” he said.

Peter Ben Embarek, the WHO’s top expert in animal diseases, said last month the mission would like to interview market workers about how they were infected with the virus.

“There is nothing to indicate that it would be man-made,” he added.

Chinese state media have suggested the virus existed abroad before it was discovered in Wuhan, citing its presence on imported frozen food packaging and scientific papers claiming it had been circulating in Europe last year.

Some Western countries have voiced concern at the delay in sending international experts.

One senior Western diplomat complained of a lack of transparency while experts were not on the ground talking to clinicians and researchers or inspecting lab samples.

But another Western diplomat said that the mission was on a “good footing” and that the WHO had to accept China’s terms to secure access.

(Reporting by Stephanie Nebehay in Geneva and Nikolaj Skydsgaard in Copenhagen; writing by Stephanie Nebehay; Editing by Alex Richardson)

WHO vaccine scheme risks failure, leaving poor countries no COVID shots until 2024

By Francesco Guarascio

BRUSSELS (Reuters) – The global scheme to deliver COVID-19 vaccines to poorer countries faces a “very high” risk of failure, potentially leaving nations home to billions of people with no access to vaccines until as late as 2024, internal documents say.

The World Health Organization’s COVAX program is the main global scheme to vaccinate people in poor and middle income countries around the world against the coronavirus. It aims to deliver at least 2 billion vaccine doses by the end of 2021 to cover 20% of the most vulnerable people in 91 poor and middle-income countries, mostly in Africa, Asia and Latin America.

But in internal documents reviewed by Reuters, the scheme’s promoters say the program is struggling from a lack of funds, supply risks and complex contractual arrangements which could make it impossible to achieve its goals.

“The risk of a failure to establish a successful COVAX Facility is very high,” says an internal report to the board of Gavi, an alliance of governments, drug companies, charities and international organizations that arranges global vaccination campaigns. Gavi co-leads COVAX alongside the WHO.

The report and other documents prepared by Gavi are being discussed at Gavi’s board meetings on Dec. 15-17.

The failure of the facility could leave people in poor nations without any access to COVID-19 vaccines until 2024, one of the documents says.

The risk of failure is higher because the scheme was set up so quickly, operating in “uncharted territory”, the report says.

“Current risk exposure is deemed outside of risk appetite until there is full clarity on the size of risks and possibilities to mitigate them,” it says. “It therefore requires intensive mitigation efforts to bring the risk within risk appetite.”

Gavi hired Citigroup last month to provide advice on how to mitigate financial risks.

In one Nov. 25 memo included in the documents submitted to the Gavi board, Citi advisors said the biggest risk to the program was from clauses in supply contracts that allow countries not to buy vaccines booked through COVAX.

A potential mismatch between vaccine supply and demand “is not a commercial risk efficiently mitigated by the market or the MDBs,” the Citi advisors wrote, referring to multilateral development banks such as the World Bank.

“Therefore it must either be mitigated through contract negotiation or through a Gavi risk absorption layer that is carefully managed by a management and governance structure.”

Asked about the documents, a Gavi spokesman said the body remains confident it can achieve its goals.

“It would be irresponsible not to assess the risks inherent to such a massive and complex undertaking, and to build policies and instruments to mitigate those risks,” he added.

The WHO did not respond to a request for comment. In the past it has let Gavi take the lead in public comments about the COVAX program.

Citibank said in a statement: “As a financial advisor, we are responsible for helping Gavi plan for a range of scenarios related to the COVAX facility and supporting their efforts to mitigate potential risks.”

SUPPLY DEALS

COVAX’s plans rely on cheaper vaccines that have so far yet to receive approval, rather than vaccines from frontrunners Pfizer/BioNTech and Moderna that use more expensive new mRNA technology. The Pfizer vaccine has already been approved for emergency use in several countries and deployed in Britain and the United States, and the Moderna vaccine is expected to be similarly approved soon.

COVAX has so far reached non-binding supply agreements with AstraZeneca, Novavax and Sanofi for a total of 400 million doses, with options to order several hundred million additional shots, one of the Gavi documents says.

But the three companies have all faced delays in their trials that could push back some possible regulatory approvals to the second half of 2021 or later.

This could also increase COVAX’s financial needs. Its financial assumptions are based on an average cost of $5.20 per dose, one of the documents says.

Pfizer’s vaccines costs about $18.40-$19.50 per dose, while Moderna’s costs $25-$37. COVAX has no supply deals with either of those firms. Nor is it prioritizing investment in ultra-cold distribution chains in poor countries, necessary for the Pfizer vaccine, as it still expects to use mostly shots which require more conventional cold storage, one of the Gavi documents says.

On Tuesday a WHO senior official said the agency was in talks with Pfizer and Moderna to include their COVID-19 vaccines as part of an early global rollout at a cost for poor countries possibly lower than current market prices.

Other shots are being developed worldwide and COVAX wants to expand its portfolio to include vaccines from other companies.

Rich countries, which have booked most of the currently available stocks of COVID-19 vaccines, are also planning to donate some excess doses to poor countries, although is not clear whether that would be through COVAX.

FINANCIAL PRESSURE

To meet its target of vaccinating at least 20% of people in poor countries next year, COVAX says it needs $4.9 billion in addition to $2.1 billion it has already raised.

If vaccine prices are higher than forecast, supply is delayed or the additional funds are not fully collected, the facility faces the prospect of failure, the documents say.

So far Britain and European Union countries are the main donors to COVAX, while the United States and China have made no financial commitments. The World Bank and other multilateral financial institutions are offering cheap loans to poor countries to help them buy and deploy vaccines through COVAX.

The facility is issuing vaccine bonds which could raise as much as $1.5 billion next year if donors agreed to cover the costs, one of the Gavi documents says. COVAX is also receiving funds from private donors, mainly the Bill and Melinda Gates Foundation.

But even under the best financial conditions, COVAX could still face failure, because of disproportionate financial risks caused by its complex deal-making process.

COVAX signs advance purchase contracts with companies on vaccine supplies that need to be paid for by donors or receiving countries that have the means to afford them.

But under clauses included in COVAX contracts, countries could still refuse to buy pre-ordered volumes if they prefer other vaccines, or if they manage to acquire them through other schemes, either faster or at better prices.

The facility could also face losses if countries were not able to pay for their orders, or even if herd immunity were developed too quickly, making vaccines no longer necessary, the Citigroup report said. It proposed a strategy to mitigate these risks including through changes in supply contracts.

(Reporting by Francesco Guarascio @fraguarascio; Editing by Peter Graff)

WHO warns against pandemic complacency amid vaccine rollout

GENEVA (Reuters) – Recent progress on COVID-19 vaccines is positive but the World Health Organization is concerned this has led to a growing perception that the pandemic has come to an end, WHO Director-General Tedros Adhanom Ghebreyesus said on Friday.

Britain approved Pfizer Inc’s COVID-19 vaccine on Wednesday, raising hopes that the tide could soon turn against a virus that has killed nearly 1.5 million people globally, hammered the world economy and upended normal life for billions.

“Progress on vaccines gives us all a lift and we can now start to see the light at the end of the tunnel. However, WHO is concerned that there is a growing perception that the COVID-19 pandemic is over,” he said.

Tedros said the pandemic still had a long way to run and that decisions made by citizens and governments would determine its course in the short run and when the pandemic would ultimately end.

“We know it’s been a hard year and people are tired, but in hospitals that are running at or over capacity it’s the hardest it can possibly be,” he said.

“The truth is that at present, many places are witnessing very high transmission of the COVID-19 virus, which is putting enormous pressure on hospitals, intensive care units and health workers.”

The virus emerged in Wuhan, China, a year ago since when more than 65 million people have been reported to be infected by the novel coronavirus globally and 1.5 million have died.

Two promising vaccines could soon receive emergency use authorization from the U.S. Food and Drug Administration, and some 20 million Americans could be vaccinated this year, helping stem the tide of the virus in the world’s worst hit country.

However, the WHO’s top emergency expert Mike Ryan also cautioned on Friday against complacency in the wake of vaccine roll-out, saying that although they were a major part of the battle against COVID-19, vaccines would not on their own end the pandemic.

“Vaccines do not equal zero COVID,” he said.

Ryan said some countries would have to sustain very strong control measures for some time into the future or they would risk a “blow up” in cases, and a yo-yoing of the pandemic.

“We are in a pivotal moment in some countries. There are health systems in some countries at the point of collapse,” he said, without referring to specific countries.

(Reporting by Stephanie Nebehay in Geneva and Michael Shields in Zurich; Writing by Toby Chopra; Editing by Jon Boyle, Catherine Evans and Raissa Kasolowsky)

U.N. warns 2021 shaping up to be a humanitarian catastrophe

By Michelle Nichols

NEW YORK (Reuters) – Next year is shaping up to be a humanitarian catastrophe and rich countries must not trample poor countries in a “stampede for vaccines” to combat the coronavirus pandemic, top U.N. officials told the 193-member U.N. General Assembly on Friday.

World Food Program (WFP) chief David Beasley and World Health Organization (WHO) head Tedros Adhanom Ghebreyesus spoke during a special meeting on COVID-19, which emerged in China late last year and has so far infected 65 million globally.

The pandemic, measures taken by countries to try to stop its spread and the economic impact have fueled a 40% increase in the number of people needing humanitarian help, the United Nations said earlier this week. It has appealed for $35 billion in aid funding.

“2021 is literally going to be catastrophic based on what we’re seeing at this stage of the game,” said Beasley, adding that for a dozen countries, famine is “knocking on the door.”

He said 2021 was likely to be “the worst humanitarian crisis year since the beginning of the United Nations” 75 years ago and “we’re not going to be able to fund everything … so we have to prioritize, as I say, the icebergs in front of the Titanic.”

U.N. Secretary-General Antonio Guterres and his top officials have also called for COVID-19 vaccines to be made available to all and for rich countries to help developing countries combat and recover from the pandemic.

Tedros appealed for an immediate injection of $4.3 billion into a world vaccine-sharing program.

“We simply cannot accept a world in which the poor and marginalized are trampled by the rich and powerful in the stampede for vaccines,” Tedros told the General Assembly. “This is a global crisis and the solutions must be shared equitably as global public goods.”

(Reporting by Michelle Nichols; Editing by Dan Grebler)

Coronavirus claims 1.5 million lives globally with 10,000 dying each day

By Shaina Ahluwalia and Sangameswaran S

(Reuters) – Over 1.5 million people have lost their lives due to COVID-19 with one death reported every nine seconds on a weekly average, as vaccinations are set to begin in December in a handful of developed nations.

Half a million deaths occurred in just the last two months, indicating that the severity of the pandemic is far from over. Nearly 65 million people globally have been infected by the disease and the worst affected country, United States, is currently battling a third wave of coronavirus infections.

In the last week alone, more than 10,000 people in the world died on average every single day, which has been steadily rising each passing week. Many countries across the world are now fighting second and third waves even greater than the first, forcing new restrictions on everyday life.

The novel coronavirus caused more deaths in the past year than tuberculosis in 2019 and nearly four times the number of deaths due to malaria, according to the World Health Organization.

Robert Redfield, the head of the U.S. Centers for Disease Control and Prevention, warned on Wednesday that the pandemic will pose the country’s grimmest health crisis yet over the next few months, before vaccines become widely available.

“I actually believe they’re going to be the most difficult time in the public health history of this nation,” Redfield told a livestream presentation hosted by the U.S. Chamber of Commerce Foundation.

The United States continues to lead in terms of fatalities, with over 273,000 deaths alone. North America and Latin American regions combined have more than 50% of all coronavirus deaths that have been reported.

The Latin American region, the worst-affected globally in terms of fatalities, recently surpassed over 450,000 deaths.

VACCINE HOPES

On Wednesday, Britain became the first country to approve the vaccine candidate developed by Germany’s BioNTech and Pfizer Inc, jumping ahead of the rest of the world in the race to begin a crucial mass inoculation program.

However, supplies are expected to be very limited in the early stages which means that every country beginning the drive will have to prioritize based on risk factors.

U.S. health regulators are expected to approve distribution and administration of the vaccine in mid-December.

Africa aims to have 60% of its population vaccinated against COVID-19 within the next two to three years, the African Union’s disease control group said on Thursday. The continent of 1.3 billion people has recorded more than 2.2 million confirmed coronavirus infections, according to a Reuters tally.

(Reporting by Shaina Ahluwalia and Sangameswaran S in Bengaluru; Editing by Lisa Shumaker)

U.S. reports over 10,000 coronavirus deaths last week

(Reuters) – The United States recorded 10,000 coronavirus deaths and over 1.1 million new cases last week, although state and health officials have said the Thanksgiving holiday likely caused numbers to be under-reported.

New cases fell 3.8% in the week ended Nov. 29, while deaths fell 3.9%, according to a Reuters analysis of state and county reports. Many testing centers were closed on Thursday for Thanksgiving and some private labs had reduced staffing or were closed on Friday, according to state and health officials.

They said that figures for cases and deaths this week may be abnormally high due to a backlog of data from last week.

Hospitals, which were not closed due to holidays, may provide the most accurate data for last week. Hospitalized COVID-19 patients reached a record high of nearly 93,000 on Sunday, up 11% from last week and double the number reported a month ago, according to the Reuters analysis.

Cases rose by 91% in Washington state last week, the biggest percentage increase in the country, followed by California at 31% and New York with a 25% increase.

Illinois reported 831 COVID-19 deaths last week, the highest for any state, followed by Texas with 806 deaths.

Across the United States, 9.8% of tests came back positive for the virus for a third week in a row, according to data from The COVID Tracking Project, a volunteer-run effort to track the outbreak. Out of 50 states, 29 had positive test rates above 10%. The highest rates were Iowa at 50%, Idaho at 44% and South Dakota at 41%.

The World Health Organization considers positive test rates above 5% concerning because it suggests there are more cases in the community that have not yet been uncovered.

(Graphic by Chris Canipe, writing by Lisa Shumaker, editing by Tiffany Wu)

U.S. infectious disease group backs Gilead’s remdesivir for COVID-19 treatment

By Rebecca Spalding

(Reuters) – The top U.S. infectious disease medical association said on Monday that Gilead Sciences Inc’s antiviral drug remdesivir should be used for hospitalized COVID-19 patients despite a World Health Organization (WHO) recommendation last week against its use.

The Infectious Diseases Society of America (IDSA) in updated guidelines said its experts back the drug for use in severe COVID-19 patients based on a clinical trial showing it reduced hospital stays. The WHO study that led to its recommendation against the drug suggested it had no benefit in saving lives or reducing the need for mechanical breathing assistance.

“As hospitals around the United States fill up, the IDSA panel views the effect of remdesivir speeding up time to recovery to be an important benefit,” Dr. Rajesh Gandhi, co-chair of the society’s COVID-19 treatment and management guidelines expert panel, said on a call with reporters. “Better medicines that improve survival are clearly needed.”

Unlike the trial that led to its U.S. regulatory approval, the WHO’s study was not placebo-controlled. Studies with a placebo comparison are generally considered more scientifically rigorous than those without a control group.

The IDSA also has advised against the routine use of Eli Lilly and Co’s COVID-19 antibody treatment bamlanivimab, which received U.S. emergency use authorization. The IDSA panel said it recommended against its routine use for ambulatory patients, but that it may still be appropriate for patients with increased risks after a discussion with their doctor.

“Antibodies may end up having a role. I think we just need more definitive data,” Dr. Gandhi said. “I want to keep our eye on what benefit they may end up having as well as which patients are most likely to benefit.”

It said Roche Holdings Ag’s rheumatoid arthritis drug Actemra, known chemically as tocilizumab, is not recommended for routine use in hospitalized COVID-19 patients, saying there was still not enough evidence supporting its benefits.

(Reporting by Rebecca Spalding; Editing by Bill Berkrot)

Travel restrictions challenge vaccine rollout, airlines warn

PARIS (Reuters) – Air cargo operators may struggle to distribute new COVID-19 vaccines effectively unless pandemic travel restrictions are eased, global airlines cautioned on Monday.

The warning came in vaccine transport guidelines issued by the International Air Transport Association (IATA), which is pushing governments to replace travel curbs and quarantines with testing.

“If borders remain closed, travel curtailed, fleets grounded and employees furloughed, the capacity to deliver life-saving vaccines will be very much compromised,” the IATA document said.

Moderna Inc. said on Monday its experimental COVID-19 vaccine had proved 94.5% effective in a clinical trial, a week after rival drugmaker Pfizer reported 90% efficacy findings for its vaccine. Once approved, both vaccines are likely to require transport and storage well below freezing, posing logistical hurdles.

Widespread grounding of passenger flights that normally carry 45% of global cargo in their holds has taken out capacity, thinning the air freight network and driving up prices.

Existing immunization campaigns have struggled with the partial shutdown. The World Health Organization and UNICEF “have already reported severe difficulties in maintaining their planned vaccine programs during the COVID-19 crisis due, in part, to limited air connectivity,” IATA said.

Vaccines will need to be shipped to developing countries reliant on passenger services for cargo, IATA’s head of cargo Glyn Hughes told Reuters. Even in industrialized states, vaccine dispersal may be a tighter bottleneck than production, requiring shipments to secondary airports on passenger jets.

In preparation for the challenge of mass vaccine distribution, governments should move to reopen key passenger routes backed by robust testing, the airline body argues.

“There are several more months for governments to go through the planning cycle,” Hughes said, leaving enough time to “get passenger networks safely resumed, looking at safe travel corridors (and) mutual acceptance of testing procedures.”

(Reporting by Laurence Frost; editing by David Evans)