U.N. chief: time for national plans to help fund global COVID-19 vaccine effort

By Michelle Nichols and Stephanie Nebehay

NEW YORK/GENEVA (Reuters) – U.N. chief Antonio Guterres said on Wednesday it is time for countries to start using money from their national COVID-19 response to help fund a global vaccine plan as the World Bank warned that “broad, rapid and affordable access” to those doses will be at the core of a resilient global economic recovery.

The Access to COVID-19 Tools (ACT) Accelerator and its COVAX facility – led by the World Health Organization and GAVI vaccine alliance – has received $3 billion, but needs another $35 billion. It aims to deliver 2 billion vaccine doses by the end of 2021, 245 million treatments and 500 million tests.

At a high-level virtual U.N. event on the program, WHO chief Tedros Adhanom Ghebreyesus said the financing gap was less than 1% of what the world’s 20 largest economies (G20) had committed to domestic stimulus packages and “it’s roughly equivalent to what the world spends on cigarettes every two weeks.”

German Chancellor Angela Merkel pledged $100 million to GAVI to help poorer countries gain access to a vaccine and Johnson & Johnson Chief Executive Alex Gorsky committed 500 million vaccine doses for low-income countries with delivery starting in mid-2021.

“Having access to lifesaving COVID diagnostics, therapeutics or vaccines … shouldn’t depend on where you live, whether you’re rich or poor,” said Gorsky, adding that while Johnson & Johnson is “acting at an unprecedented scale and speed, but we are not for a minute cutting corners on safety.”

U.S. President Donald Trump has said that a vaccine against the virus might be ready before the Nov. 3 U.S. presidential election, raising questions about whether political pressure might result in the deployment of a vaccine before it is safe.

“We remain 100 percent committed to high ethical and scientific principles,” Gorsky said.

GAVI Chief Executive Seth Berkley said that so far 168 countries, including 76 self-financing states, have joined the COVAX global vaccines facility. Tedros said this represented 70% of the world’s population, adding: “The list is growing every day.”

China, Russia and the United States have not joined the facility, although WHO officials have said they are still holding talks with China about signing up. The United States has reached its own deals with vaccine developers.

‘LONG HAUL’

World Bank President David Malpass said the pandemic could push 150 million people into extreme poverty by 2021 and the “negative impact on human capital will be deep and may last decades.”

“Broad, rapid and affordable access to COVID vaccines will be at the core of a resilient global economic recovery that lifts everyone,” he said.

Guterres said that the ACT-Accelerator was the only safe and certain way to reopen the global economy quickly.

But he warned that the program needed an immediate injection of $15 billion to “avoid losing the window of opportunity” for advance purchase and production, to build stocks in parallel with licensing, boost research, and help countries prepare.

“We cannot allow a lag in access to further widen already vast inequalities,” Guterres said.

“But let’s be clear: We will not get there with donors simply allocating resources only from the Official Development Assistance budget,” he said. “It is time for countries to draw funding from their own response and recovery programs.”

U.N. Secretary-General Guterres called on all countries to step up significantly in the next three months.

Billionaire Bill Gates told the U.N. event that the Bill & Melinda Gates Foundation had signed an agreement with 16 pharmaceutical companies on Wednesday.

“In this agreement the companies commit to, among other things, scaling up manufacturing, at an unprecedented speed, and making sure that approved vaccines reach broad distribution as early as possible,” Gates said.

Britain’s Foreign Secretary Dominic Raab – a co-host of the meeting along with Guterres, the WHO and South Africa – urged other countries to join the global effort, saying the ACT-Accelerator is the best hope of bringing the pandemic under control.

Said Merkel: “We’re in for the long haul and we need more support.”

(Reporting by Michelle Nichols and Stephanie Nebehay; Editing by Chizu Nomiyama, Paul Simao and Jonathan Oatis)

COVID-19 death toll could double to two million before vaccine in wide use: WHO

GENEVA/ZURICH (Reuters) – The global death toll from COVID-19 could double to 2 million before a successful vaccine is widely used and could be even higher without concerted action to curb the pandemic, an official at the World Health Organization said on Friday.

“Unless we do it all, (2 million deaths) … is not only imaginable, but sadly very likely,” Mike Ryan, head of the U.N. agency’s emergencies program, told a briefing on Friday.

The number of deaths about nine months since the novel coronavirus was discovered in China is nearing 1 million

“We are not out of the woods anywhere, we are not out of the woods in Africa,” said Ryan.

He said young people should not be blamed for a recent increase in infections despite growing concerns that they are driving its spread after restrictions and lockdowns were eased around the world.

“I really hope we don’t get into finger wagging: it’s all because of the youth,” said Ryan. “The last thing a young person needs is an old person pontificating and wagging the finger.”

Rather, indoor gatherings of people of all ages were driving the epidemic, he said.

The WHO is continuing talks with China about its possible involvement in the COVAX financing scheme designed to guarantee fast and equitable access globally to COVID-19 vaccines, a week after the deadline for committing passed.

“We’re in discussions with China about the role they may play as we go forward,” said Bruce Aylward, WHO senior adviser and head of the ACT-Accelerator program to back vaccines, treatments and diagnostics against COVID-19.

He confirmed that Taiwan has signed up to the scheme, even though it is not a WHO member, bringing the total to 159 participants. Some 34 are still deciding.

Talks with China also include discussion of the world’s second-largest economy potentially supplying vaccines to the scheme, he said.

The UN agency published on Friday draft criteria for the assessment of emergency use of COVID-19 vaccines to help guide drugmakers as vaccine trials reach advanced stages, said WHO assistant director-general, Mariangela Simao.

The document will be available for public comment until Oct. 8, she said.

Earlier on Friday, a Chinese health official said the WHO had given its support for the country to start administering experimental coronavirus vaccines to people even while clinical trials were still underway.

(Reporting by Stephanie Nebenay and Emma Farge in Geneva and Michael Shields in Zurich; Writing by Josephine Mason in London; Editing by Hugh Lawson, Timothy Heritage, Kirsten Donovan)

Russia’s Putin wants stronger WHO, proposes conference on coronavirus vaccine

NEW YORK (Reuters) – Russian President Vladimir Putin told the U.N. General Assembly on Tuesday that the World Health Organization should be strengthened to coordinate the global response to the coronavirus pandemic and proposed a high-level conference on vaccine cooperation.

“We are proposing to hold an online high-level conference shortly for countries interested in cooperation in the development of anti-coronavirus vaccines,” Putin said.

“We are ready to share experience and continue cooperating with all states and international entities, including in supplying the Russian vaccine which has proved reliable, safe, and effective, to other countries,” he said.

Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, and did so before large-scale trials were complete, stirring concern among scientists and doctors about the safety and efficacy of the shot.

Several countries are now considering adopting emergency measures that would fast-track approval of a vaccine in a similar way, however.

Putin took a veiled swipe at the United States, saying that removing “illegitimate sanctions” would help the world recover from the coronavirus pandemic.

“In general, freeing the world trade from barriers, bans, restrictions and illegitimate sanctions would be of great help in revitalizing global growth and reducing unemployment,” he said.

Putin also proposed that leading space powers sign a binding agreement that would ban “the placement of weapons in outer space, threat or use of force against outer space objects.”

(Reporting by Michelle Nichols and Andrew Osborne; Editing by Chizu Nomiyama and Rosalba O’Brien)

At U.N., Trump demands action against China over virus, Xi urges cooperation

By Michelle Nichols and Steve Holland

(Reuters) – U.S. President Donald Trump used the United Nations General Assembly on Tuesday to attack China’s handling of the coronavirus pandemic, saying the world body “must hold China accountable” for its actions related to the outbreak.

By contrast, China’s President Xi Jinping struck a conciliatory tone in his pre-recorded virtual address to the General Assembly, calling for enhanced cooperation over the pandemic and stressing that China had no intention of fighting “either a Cold War or a hot one” with any other country.

The leaders of the world’s two largest economies laid out their competing visions as relations have plunged to their worst level in decades against the backdrop of the pandemic, with coronavirus tensions aggravating trade and technology disputes.

Trump, facing a November re-election battle with the United States dealing with the world’s highest official number of deaths and infections from the coronavirus, focused his speech on attacking China.

Trump accused Beijing of allowing people to leave China in the early stages of the outbreak to infect the world while shutting down domestic travel.

“We must hold accountable the nation which unleashed this plague onto the world, China,” he said in remarks taped on Monday at the White House and delivered remotely to the General Assembly due to the pandemic.

“The Chinese government, and the World Health Organization – which is virtually controlled by China – falsely declared that there was no evidence of human-to-human transmission,” he said.

“Later, they falsely said people without symptoms would not spread the disease … The United Nations must hold China accountable for their actions.”

The president promised to distribute a vaccine and said: “We will defeat the virus, and we will end the pandemic.”

In introducing Xi’s remarks, China’s U.N. ambassador Zhang Jun said China “resolutely rejects the baseless accusations against China.”

“The world is at a crossroads. At this moment, the world needs more solidarity and cooperation, but not confrontation,” he said.

‘GET THROUGH THIS TOGETHER’

In his address, in what appeared to be an implicit rebuke to Trump, Xi called for a global response to the coronavirus and giving a leading role to the World Health Organization, which the U.S. president has announced plans to leave.

“Facing the virus, we should enhance solidarity and get through this together,” he said. “We should follow the guidance of science, give full play to the leading role of the World Health Organization and launch a joint international response to beat this pandemic. Any attempt of politicizing the issue, or stigmatization, must be rejected.”

The death toll from the spread of the coronavirus in the United States surpassed 200,000 on Monday, by far the highest official number of any country.

Trump also attacked China’s record on the environment, but leveled no direct criticism at Beijing over human rights.

The president, a frequent critic of the United Nations, said that if it was to be effective, it must focus on “the real problems of the world” like “terrorism, the oppression of women, forced labor, drug trafficking, human and sex trafficking, religious persecution, and the ethnic cleansing of religious minorities.”

Earlier, U.N. Secretary-General Antonio Guterres warned that the world was “moving in a very dangerous direction” with U.S.-China tensions.

“We must do everything to avoid a new Cold War,” he told the assembly. “Our world cannot afford a future where the two largest economies split the globe in a Great Fracture — each with its own trade and financial rules and internet and artificial intelligence capacities.

“A technological and economic divide risks inevitably turning into a geo-strategic and military divide. We must avoid this at all costs.”

(Reporting by Michelle Nichols, Steve Holland, Arshad Mohammed and David Brunnstrom; Writing by David Brunnstrom; Editing by Mary Milliken and Howard Goller)

Trump to tell U.N. it ‘must hold China accountable for their actions’ on virus

WASHINGTON (Reuters) – U.S. President Donald Trump will tell the United Nations General Assembly on Tuesday it “must hold China accountable for their actions” related to the coronavirus pandemic.

“The Chinese government, and the World Health Organization – which is virtually controlled by China – falsely declared that there was no evidence of human-to-human transmission,” Trump will say, according to excerpts released ahead of delivery.

“Later, they falsely said people without symptoms would not spread the disease … The United Nations must hold China accountable for their actions,” he will say.

Trump taped his speech on Monday at the White House for delivery remotely to the General Assembly, which convened virtually this week.

The president promised to distribute a vaccine and said: “We will defeat the virus, we will defeat the virus, and we will end the pandemic” and enter a new era of prosperity, cooperation and peace.

Trump, a frequent critic of the United Nations, also said in the excerpts that if the UN is to be effective, it must focus on “the real problems of the world” like “terrorism, the oppression of women, forced labor, drug trafficking, human and sex trafficking, religious persecution, and the ethnic cleansing of religious minorities.”

(Reporting by Steve Holland; Editing by Chizu Nomiyama and Howard Goller)

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

Biden rejects Trump claim that vaccine is imminent

U.S. Democratic presidential candidate Joe Biden on Thursday bluntly contradicted President Donald Trump’s suggestion that a coronavirus vaccine may be only weeks away, warning Americans they cannot trust the president’s word.

“The idea that there’s going to be a vaccine and everything’s gonna be fine tomorrow – it’s just not rational,” Biden said during a CNN town hall in Moosic, Pennsylvania.

Trump again said on Wednesday that a vaccine for COVID-19 could be ready for distribution ahead of the Nov. 3 election.

Most health experts, including Robert Redfield, the director of the Centers for Disease Control and Prevention, have said a vaccine will likely not be widely available until mid-2021.

Israel imposes second lockdown

Israel will enter a second nationwide lockdown on Friday at the onset of the Jewish high-holiday season, forcing residents to stay mostly at home amid a resurgence in new coronavirus cases.

The country’s initial lockdown was imposed in late March and eased in May as new cases tapered off, reaching lows in the single digits.

But in the past week, new cases have reached daily highs of over 5,000, and Israeli leaders now acknowledge they lifted measures too soon.

The new lockdown will last three weeks and coincides with the start of the Jewish New Year, Rosh Hashana, traditionally a time for large family gatherings and group prayer.

UK COVID hospital admissions double every eight days

Britain’s health minister said that the novel coronavirus was accelerating across the country, with hospital admissions doubling every eight days, but he refused to say if another national lockdown would be imposed next month.

The United Kingdom has reported the fifth-highest number of deaths from COVID-19 in the world after the United States, Brazil, India and Mexico, according to data collected by Johns Hopkins University of Medicine.

COVID-19 cases started to rise again in Britain in September, with between 3,000 and 4,000 positive tests recorded daily in the last week. More than 10 million people are already in local lockdowns.

China reports highest new cases since Aug. 10

Mainland China reported 32 new COVID-19 cases on Thursday, marking the highest daily increase in more than a month and up sharply from nine cases reported a day earlier.

Although the latest increase still remains well below the peaks seen at the height of the outbreak in China early this year, it is the biggest since Aug. 10 and suggests continued COVID-19 risks stemming from overseas travelers coming into the country as the pandemic rages on in other parts of the world.

The National Health Commission said that all new cases were imported infections. Mainland China has not reported any local COVID-19 infections since mid-August.

Canada’s Ontario clamps down on parties

Canada’s most populous province will clamp down on social gatherings to prevent “reckless careless people” from spreading the coronavirus at illegal parties, Ontario Premier Doug Ford said on Thursday.

His warning came as the nation’s top medical officer said authorities could potentially lose the ability to manage the pandemic.

Indoor social events in Toronto, Canada’s biggest city – along with Ontario’s Peel and Ottawa regions – would be authorized to include no more than 10 people, down from a previous limit of 50, Ford said.

“This is a serious situation, folks. We will throw the book at you if you break the rules,” he told a news conference.

(Compiled by Linda Noakes; Editing by Hugh Lawson)

Moderna would seek limited emergency use of COVID-19 vaccine based on early data

By Julie Steenhuysen

CHICAGO (Reuters) – If Moderna Inc’s COVID-19 vaccine proves to be at least 70 percent effective, the company plans to seek emergency authorization for its use in high-risk groups, the company’s chief executive told Reuters.

Moderna’s vaccine candidate – mRNA-1273 – is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who didn’t.

Vaccines must demonstrate they are at least 50% more effective than a placebo to be considered for approval. To prove that, government officials have said, at least 150 COVID-19 infections must be recorded among trial participants with at least twice as many occurring among the placebo group.

If a vaccine is especially effective, companies could have their answer sooner.

An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.

If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek U.S. regulatory approval for Emergency Use Authorization (EUA).

“If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90% efficacy, we will indeed consider approval,” Stephane Bancel, Moderna’s chief executive officer, said in a telephone interview.

“At such a level of efficacy, if we get there, we can protect a lot of lives in the people at the highest risk, and so, we will consider filing for an EUA for a very limited population,” Bancel said.

He said the FDA will determine whether the benefit of the vaccine to a small group of high-risk individuals outweighs the risk of not having a full readout of safety data from all 30,000 study participants.

The two groups of high-risk individuals who might be covered in such an EUA would be healthcare workers and the elderly, Bancel said.

Bancel said the company wants to gather more data on the safety of the vaccine in the study population over a period of several months before seeking full FDA approval.

Moderna released its study protocol on Thursday, making public details on how its vaccine will be evaluated. If the vaccine does not reach the efficacy mark after 53 cases, the data safety and monitoring board will take another interim look at the data after 106 cases, and a final look after 151 people in the trial become infected with the virus.

Public health officials have said that approving a vaccine for widespread use based on a small number of cases would not offer enough safety information to show how the vaccine would perform.

Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government under its Operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.

In a presentation to investors on Tuesday, Pfizer Inc said the company has enrolled more than 29,000 people in its 44,000-volunteer trial to test an experimental COVID-19 vaccine the company is developing with German partner BioNTech.

Pfizer expects to have enough data to show whether the vaccine works by the end of October.

(Reporting by Julie Steenhuysen; editing by Peter Henderson and Cynthia Osterman)

U.S. plans to distribute COVID-19 vaccine immediately after regulators authorize it

NEW YORK (Reuters) – The U.S. government on Wednesday said it will start distributing a COVID-19 vaccine within one day of regulatory authorization as it plans for the possibility that a limited number of vaccine doses may be available at the end of the year.

Officials from the Department of Health and Human Services and the Department of Defense on Wednesday held a call with reporters and then released documents on the distribution plans that it is sending to the states and local public health officials.

The federal government will allocate vaccines for each state based on the critical populations recommended first for vaccination by the U.S. Centers for Disease Control and Prevention. That group is expected to include essential healthcare workers.

The document, called the COVID-19 Vaccination Program Interim Playbook, said that “limited COVID-19 vaccine doses may be available by early November 2020 if a COVID-19 vaccine is authorized or licensed by FDA by that time, but COVID-19 vaccine supply may increase substantially in 2021.”

Officials also said they were working to make sure there was no cost to patients for the vaccine.

(Reporting by Michael Erman and Caroline Humer in New York and Mrinalika Roy in Bengaluru; Editing by Chizu Nomiyama; Editing by Chizu Nomiyama)

Widespread COVID-19 vaccinations not expected until mid-2021, WHO says

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – The World Health Organization does not expect widespread vaccinations against COVID-19 until the middle of next year, a spokeswoman said on Friday, stressing the importance of rigorous checks on their effectiveness and safety.

None of the candidate vaccines in advanced clinical trials so far has demonstrated a “clear signal” of efficacy at the level of at least 50% sought by the WHO, spokeswoman Margaret Harris said.

Russia granted regulatory approval to a COVID-19 vaccine in August after less than two months of human testing, prompting some Western experts to question its safety and efficacy.

U.S. public health officials and Pfizer Inc said on Thursday a vaccine could be ready for distribution as soon as late October. That would be just ahead of the U.S. election on Nov. 3 in which the pandemic is likely to be a major factor among voters deciding whether President Donald Trump wins a second term.

“We are really not expecting to see widespread vaccination until the middle of next year,” Harris told a U.N. briefing in Geneva.

“This phase 3 must take longer because we need to see how truly protective the vaccine is and we also need to see how safe it is,” she added. This referred to the phase in vaccine research where large clinical trials among people are conducted. Harris did not refer to any specific vaccine candidate.

All data from trials must be shared and compared, Harris said. “A lot of people have been vaccinated and what we don’t know is whether the vaccine works…at this stage we do not have the clear signal of whether or not it has the level of worthwhile efficacy and safety…,” she added.

The WHO and GAVI vaccine alliance are leading a global vaccine allocation plan known as COVAX that aims to help buy and distribute shots fairly. The focus is on first vaccinating the most high-risk people in every country such as healthcare workers.

COVAX aims to procure and deliver 2 billion doses of approved vaccines by the end of 2021, but some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join.

“Essentially, the door is open. We are open. What the COVAX is about is making sure everybody on the planet will get access to the vaccines,” Harris said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Frances Kerry)

Unlikely that a COVID-19 vaccine will be ready in October, but not impossible, Fauci says

WASHINGTON (Reuters) – Top U.S. infectious diseases expert Anthony Fauci said on Thursday it is unlikely a COVID-19 vaccine will be ready by the end of October, but that it is not impossible.

“I think most of the people feel it’s going to be November, December,” Fauci said in a CNN interview when asked about the possibility of an earlier release, adding a clinical trial could prompt drug developers to decide a vaccine works sooner. “It is conceivable that you can have it by October, though I don’t think that that’s likely.”

(Reporting by Lisa Lambert; Editing by Chizu Nomiyama)