Tag Archives: COVAX

WHO agrees compensation fund for serious COVAX vaccine side effects

By Kate Kelland

LONDON (Reuters) – The World Health Organization has agreed a no-fault compensation plan for claims of serious side effects in people in 92 poorer countries due to get COVID-19 vaccines via the COVAX sharing scheme, resolving a big concern among recipient governments.

The program, which the WHO said was the first and only vaccine injury compensation mechanism operating on an international scale, will offer eligible people “a fast, fair, robust and transparent process,” the WHO said in a statement.

“By providing a no-fault lump-sum compensation in full and final settlement of any claims, the COVAX program aims to significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process,” the statement said.

Questions of how compensation claims would be handled in the event of any serious COVID-19 vaccine side effects, which are likely to be very rare, had been a worry for countries due to get COVID-19 shots via the COVAX plan.

Countries funding their own COVID-19 vaccine procurement also plan their own liability programs.

The WHO-agreed plan, which has been under discussion for several months, is designed to cover serious side effects linked to any COVAX-distributed vaccines until June 30, 2022, to COVAX’s Advance Market Commitment-eligible economies – a group of 92 poorer states which includes most African and Southeast Asian countries.

The program will be financed initially from donor funding to the AMC as an extra charge on all doses of COVID-19 vaccines distributed through COVAX. Applications can be made via a portal at http://www.covaxclaims.com from March 31, 2021, the WHO said.

Seth Berkley, chief executive of the GAVI vaccine alliance which co-leads COVAX, said the agreement on the compensation fund was “a massive boost” for COVAX, which aims to secure equitable global access to COVID-19 vaccines.

“It helps those in countries who might have such effects, manufacturers to roll out vaccines to countries faster, and is a key benefit for lower-income governments procuring vaccines through (COVAX),” Berkley said.

The WHO said it was also working with the insurance firm Chubb to secure insurance coverage for the program.

(Reporting by Kate Kelland; Editing by Alison Williams)

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)

Explainer-When and how will COVID-19 vaccines become available?

By Julie Steenhuysen and Carl O’Donnell

NEW YORK (Reuters) – Pfizer Inc with partner BioNTech SE and Moderna Inc have released trial data showing their COVID-19 vaccines to be about 95% effective at preventing the illness, while AstraZeneca Plc this week said its vaccine could be up to 90% effective.

If regulators approve any of the vaccines in coming weeks, the companies have said distribution could begin almost immediately with governments around the world to decide who gets them and in what order. The following is an outline of the process:

WHEN WILL COMPANIES ROLL OUT A VACCINE?

Pfizer, Moderna and AstraZeneca have already started manufacturing their vaccines. This year, Pfizer said it will have enough to inoculate 25 million people, Moderna will have enough for 10 million people and AstraZeneca will have enough for more than 100 million people.

The U.S. Department of Defense and the Centers for Disease Control and Prevention (CDC) will manage distribution in the United States, likely starting in mid-December with an initial release of 6.4 million doses nationwide.

UK health authorities plan to roll out an approved vaccine as quickly as possible, also expected in December.

In the European Union, it is up to each country in the 27-member bloc to start distributing vaccines to their populations.

WHO WOULD GET AN APPROVED VACCINE AND WHEN IN THE UNITED STATES?

Upon authorization from the U.S. Food and Drug Administration, the CDC has said first in line for vaccinations would be about 21 million healthcare workers and 3 million residents in long-term care facilities.

Essential workers, a group of 87 million people who do crucial work in jobs that cannot be done from home, are the likely next group. This includes firefighters, police, school employees, transportation workers, food and agriculture workers and food service employees.

Around 100 million adults with high-risk medical conditions and 53 million adults over the age of 65, also considered at higher risk of severe disease, are the next priority.

U.S. public health officials said vaccines will be generally available to most Americans in pharmacies, clinics and doctors offices starting in April so that anyone who wants a shot can have one by the end of June.

It is unclear when a vaccine will be available for children. Pfizer and BioNTech have started testing their vaccine in volunteers as young as 12.

WHEN WILL A VACCINE BE AVAILABLE IN OTHER COUNTRIES?

The European Union, the United Kingdom, Japan, Canada and Australia are all running rapid vaccine regulatory processes.

Many of AstraZeneca’s doses this year are expected to go to the United Kingdom, where health officials have said that if approved they could begin vaccinating people in December. At the top of their list is people living and working in care homes.

In Europe, the E.U. drugs regulator has said it could rule on the safety of a COVID-19 vaccine in December.

Most countries have said the first vaccines will go to the elderly and vulnerable and frontline workers like doctors.

Countries say they are buying vaccines via the European Commission’s joint procurement scheme, which has deals for six different vaccines and nearly 2 billion doses.

Delivery timelines vary and most countries are still drawing up plans for distributing and administering shots.

Italy expects to receive the first deliveries of the Pfizer-BioNTech shot and AstraZeneca’s shot early next year. Spain plans to give vaccines in January.

In Bulgaria, the country’s chief health inspector expects the first shipments in March-April. Hungary’s foreign minister said doses will land in the spring at the earliest.

Germany, home to BioNTech, expects to roll out shots in early 2021 with mass vaccination centers in exhibition halls, airport terminals and concert venues. It will also use mobile teams for care homes. Front-line healthcare workers and people at risk for serious COVID-19 are expected to get inoculated first.

WHEN WILL DEVELOPING COUNTRIES HAVE ACCESS TO VACCINES?

COVAX, a program led by the World Health Organization and the GAVI vaccine group to pool funds from wealthier countries and nonprofits to buy and distribute vaccines to dozens of poorer countries, has raised $2 billion.

Its first goal is to vaccinate 3% of the people in these countries with a final goal of reaching 20%. It has signed a provisional agreement to buy AstraZeneca’s vaccine, which does not require storage in specialized ultra cold equipment like the Pfizer vaccine.

It is expected but not certain that less wealthy countries in Africa and South East Asia, such as India, will receive vaccines at low or no cost under this program in 2021. Other countries such as those in Latin America may buy vaccines through COVAX. Several are also striking supply deals with drugmakers.

HOW MUCH WILL IT COST?

Vaccine makers and governments have negotiated varying prices, not all of which are public. Governments have paid from a few dollars per AstraZeneca shot to up to $50 for the two-dose Pfizer regimen. Many countries have said they will cover the cost of inoculating their residents.

(Reporting by Carl O’Donnell and Julie Steenhuysen; Additional reporting by Michael Erman in New York, Caroline Copley in Berlin, Francesco Gaurascio in Brussels, Josephine Mason in London, Krisztina Than in Budapest and Tsvetelia Tsolova in Sofia; Editing by Caroline Humer and Bill Berkrot)

COVID-19 vaccine may be ready by year-end: WHO’s Tedros

By Stephanie Nebehay

GENEVA (Reuters) – A vaccine against COVID-19 may be ready by year-end, the head of the World Health Organization (WHO) said on Tuesday, without elaborating.

WHO Director-General Tedros Adhanom Ghebreyesus called for solidarity and political commitment by all leaders to ensure equal distribution of vaccines when they become available.

“We will need vaccines and there is hope that by the end of this year we may have a vaccine. There is hope,” Tedros said in closing remarks to the WHO’s Executive Board meeting that examined the global response to the pandemic.

The EU health regulator has launched a real-time review of a COVID-19 vaccine developed by U.S. drugmaker Pfizer and Germany’s BioNTech, it said on Tuesday, following a similar announcement for rival AstraZeneca’s jab last week. The announcement by the European Medicines Agency (EMA) could speed up the process of approving a successful vaccine in the bloc.

Nine experimental vaccines are in the pipeline of the WHO-led COVAX global vaccine facility that aims to distribute 2 billion doses by the end of 2021.

So far some 168 countries have joined the COVAX facility, but neither China, the United States nor Russia are among them. The Trump administration has said it is relying instead on bilateral deals to secure supplies from vaccine makers.

“Especially for the vaccines and other products which are in the pipeline, the most important tool is political commitment from our leaders especially in the equitable distribution of the vaccines,” Tedros said.

“We need each other, we need solidarity and we need to use all the energy we have to fight the virus,” he said.

(Reporting by Stephanie Nebehay in Geneva; Editing by Michael Shields and Alexandra Hudson)

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)

Factbox: Latest on the worldwide spread of coronavirus

(Reuters) – Coronavirus infections slowed in Australia and New Zealand, while Britain said it was at a “tipping point” on COVID-19 as European countries mulled tightening restrictions to curb a sharp resurgence in cases.

EUROPE

* Britain is at a tipping point on COVID-19, health minister Matt Hancock said, warning that a second national lockdown could be imposed if people don’t follow government rules designed to stop the spread of the virus.

* The Czech government could declare a state of emergency if a recent spike in cases continues in the coming days, Health Minister Adam Vojtech said.

* Protesters in some poorer areas of Madrid that are facing a lockdown to stem a soaring infection rate took to the streets on Sunday to call for better health provisions, complaining of discrimination by the authorities.

* Russia reported 6,148 new cases on Sunday, the second straight day when the daily number of cases exceeded 6,000.

* French health authorities reported 10,569 new confirmed COVID-19 cases on Sunday, down from the previous day’s record increase of 13,498.

ASIA-PACIFIC

* Schools in Seoul and nearby areas resumed in-person classes for the first time in almost a month after daily cases dropped to the lowest levels since mid-August.

* Australia’s coronavirus hotspot of Victoria reported on Monday its lowest daily rise in infections in three months, although state Premier Daniel Andrews said there were no plans yet to ease restrictions sooner than expected.

* New Zealand Prime Minister Jacinda Ardern lifted all coronavirus restrictions across the country, except in second-wave hotspot Auckland, as the number of new infections slowed to a trickle.

AMERICAS

* The United States set a one-day record with over 1 million coronavirus diagnostic tests being performed, but the country needs 6 million to 10 million a day to bring outbreaks under control, according to various experts.

* Brazil and Argentina, Latin American nations seeking more time to commit to the global COVID-19 vaccine facility known as COVAX, said they intend to do so as soon as possible after missing Friday’s deadline.

MIDDLE EAST AND AFRICA

* Morocco signed a deal with Russia’s R-Pharm to buy a COVID-19 vaccine produced under a license from Britain’s AstraZeneca, the health ministry said, as its total number of cases approached 100,000.

* Israel entered a second nationwide lockdown at the onset of the Jewish high-holiday season, forcing residents to stay mostly at home amid a resurgence in new cases.

MEDICAL DEVELOPMENTS

* Moderna Inc said it was on track to produce 20 million doses of its experimental coronavirus vaccine by the end of the year, while maintaining its goal of readying 500 million to 1 billion doses in 2021.

ECONOMIC IMPACT

* British manufacturers see no evidence of a ‘V’-shaped recovery from the pandemic underway and many are planning to slash investment, a business survey showed.

(Compiled by Devika Syamnath and Alex Richardson; Edited by Shounak Dasgupta)

Latin American nations seek more time to join WHO vaccine plan

By Anthony Boadle

BRASILIA (Reuters) – Several Latin American countries have informed the World Health Organization (WHO) they intend to request more time to sign up for its global COVID-19 vaccine allocation plan known as COVAX, an official at the WHO’s regional branch said on Thursday.

Countries have until midnight on Friday to formalize legally binding commitments to COVAX, a mechanism for pooled procurement and equitable distribution of eventual vaccines.

A representative for the GAVI Alliance, the COVAX secretariat, said by email that details of which nations have joined COVAX will only be made public after the deadline.

Health officials in Mexico, which has the worst outbreak in Latin America after Brazil, said their country would sign the commitment on time. Brazil, which has the world’s most severe outbreak outside the United States and India, was still studying what to do, a ministry spokesperson said.

More than 170 countries have joined the global vaccine plan to help buy and distribute immunization shots for COVID-19 fairly around the world, WHO’s director general Tedros Adhanom Ghebreyesus said on Thursday.

Jarbas Barbosa, assistant director of the Pan-American Health Organization, said in a briefing on Wednesday that Latin American countries were having trouble meeting the deadline and some wanted to push back the date.

Barbosa said all countries in the Americas except the United States had expressed interest in the vaccine facility, even those that have separate agreements with vaccine makers, because it gives them an added guarantee of access to doses.

Ten Latin American countries are among 90 poor nations in the world that will not have to pay for the vaccine, while the others in the region will pay an “accessible” price through COVAX, Barbosa said.

Colombian President Ivan Duque confirmed on Wednesday that his government was joining COVAX and Paraguay’s health ministry said it has already signed, even as it plans to buy the vaccine being developed by AstraZeneca PLC and Oxford University.

(Reporting by Anthony Boadle in Brasilia, Diego Ore in Mexico City, Julia Cobb in Bogotá, Daniela Desantis in Asunción; Editing by Daniel Flynn and Chizu Nomiyama)

WHO’s Tedros says ‘vaccine nationalism’ would prolong pandemic

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – WHO Director-General Tedros Adhanom Ghebreyesus said on Friday that “vaccine nationalism” would only slow the effort to quash the pandemic and called for vaccines to be used fairly and effectively.

Tedros said 78 high-income countries had now joined the “COVAX” global vaccine allocation plan, bringing the total to 170 countries, and the “number is growing”. He urged others to join by the Sept. 18 deadline for binding commitments.

Joining the plan guaranteed those countries access to the world’s largest portfolio of vaccines, with nine candidates currently in the pipeline, he said, adding that a further four were “promising”.

The WHO and the GAVI vaccine alliance are leading the COVAX facility, aimed at helping buy and distribute vaccination shots fairly around the world.

But some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join COVAX.

“Vaccine nationalism will prolong the pandemic, not shorten it,” Tedros told a WHO briefing in Geneva, without mentioning any specific countries.

“If and when we have an effective vaccine, we must also use it effectively … In other words, the first priority must be to vaccinate some people in all countries, rather than all people in some countries,” he said, adding that priority should be given to healthcare workers, the elderly and those with underlying conditions.

Tedros thanked Germany, Japan, Norway and the European Commission for joining COVAX during the last week.

“Certainly by the middle of 2021 we should start to see some vaccines actually moving into countries and populations,” said WHO chief scientist Soumya Swaminathan, reiterating earlier comments.

Noting that there were 13 experimental vaccines currently in clinical trails, Swaminathan called it an “optimistic scenario” since the typical success rate of 10% could mean several vaccines are approved.

But Swaminathan said that no vaccine should be approved for a worldwide rollout until it had undergone sufficient scrutiny.

“No vaccine is going to be mass-deployed until regulators are confident, governments are confident, and the WHO is confident it has met the minimum standard of safety and efficacy,” she said.

Results were expected from some of the candidates already in phase 3 trials, each involving thousands of participants, by the end of the year or early 2021, Swaminathan said.

“We are not going to have enough for the whole world right at the beginning,” she said adding that scaling up of manufacturing would take time.

“Eventually there will be enough for everyone but it will mean prioritization,” she said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Alison Williams and Giles Elgood)

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)

Exclusive: Vaccine group says 76 rich countries now committed to ‘COVAX’ access plan

By Kate Kelland

LONDON (Reuters) – Seventy-six wealthy nations are now committed to joining a global COVID-19 vaccine allocation plan co-led by the World Health Organization (WHO) that aims to help buy and fairly distribute the shots, the project’s co-lead said on Wednesday.

Seth Berkley, chief executive of the GAVI vaccines alliance, said the plan, known as COVAX, now has Japan, Germany, Norway and more than 70 other nations signed up, agreeing in principle to procure COVID-19 vaccines through the facility for their populations.

“We have, as of right now, 76 upper middle income and high income countries that have submitted confirmations of intent to participate – and we expect that number to go up,” Berkley told Reuters in an interview.

“This is good news. It shows that the COVAX facility is open for business and is attracting the type of interest across the world we had hoped it would.”. COVAX coordinators are in talks with China about whether it might also join, Berkley said.

“We had a discussion yesterday with the (Chinese) government. We don’t have any signed agreement with them yet,” but Beijing had given “a positive signal”.

Chinese Foreign Ministry spokeswoman Hua Chunying told a briefing on Wednesday that China “supports COVAX and has been in communication with WHO and other parties” about it.

COVAX is co-led by GAVI, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI). It is designed to discourage national governments from hoarding COVID-19 vaccines and to focus on first vaccinating the most high-risk people in every country.

Its backers say this strategy should lead to lower vaccine costs for everyone and a swifter end to the pandemic that has claimed some 860,000 lives globally.

Wealthy countries that join COVAX will finance the vaccine purchases from their national budgets, and will partner with 92 poorer nations supported through voluntary donations to the plan to ensure vaccines are delivered equitably, Berkley said.

Participating wealthy countries are also free to procure vaccines through bilateral deals and other plans.

The United States said on Tuesday it would not join COVAX due to the Trump administration’s objection to WHO involvement, a move described by some critics as “disappointing.” Berkley said he was not surprised by the U.S. decision, but would seek to continue talks with Washington.

In what appeared to be a change of position on Wednesday, the European Union said its member states could buy potential COVID-19 vaccines through COVAX.

COVAX coordinators sought to add flexibility to joining agreements to encourage greater participation, Berkley said.

The WHO describes COVAX as an “invaluable insurance policy” for all countries to secure access to safe and effective COVID-19 vaccines when they are developed and approved. The plan’s coordinators have set a deadline of Sept. 18 for countries signing up to make binding commitments.

Asked to comment on the U.S. decision not to join COVAX, and on talks with China, a WHO spokesperson said: “Countries have until Sept. 18 to sign binding agreements…, so we’ll have more to say on countries that have joined then.”

COVAX’s objective is to procure and deliver 2 billion doses of approved vaccines by the end of 2021. It currently has nine COVID-19 vaccine candidates in its portfolio employing a range of different technologies and scientific approaches.

A handful are already in late-stage clinical trials and could have data available by year end.

(Reporting by Kate Kelland; Additional reporting by Stephanie Nebehay in Geneva and Yew Lun Tian in Beijing; Editing by Bill Berkrot and Mark Heinrich)