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 two billion vaccine doses by the end of 2021 to cover 20 per cent 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.
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“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.”
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.
Oxfam: 9/10 people living in the developing world will miss out on the COVID-19 vaccine
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.
To meet its target of vaccinating at least 20 per cent 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.
Coronavirus: The challenges in distributing vaccines
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.
© 2020 Reuters
Canada's coming month of Pfizer COVID-19 vaccine shipments will be reduced by half – CTV News
Over the next month Canada will be experiencing a “temporary” delay in Pfizer-BioNTech vaccine shipments due to the pharmaceutical giant’s expansion plans at its European manufacturing facility, with the shortage resulting in an average of 50 per cent of coming doses delayed each week.
While shipments will continue in the coming weeks, the amount of doses in them will be lessened, sometimes by hundreds of thousands of doses.
“Pfizer has confirmed that Canada’s deliveries will be impacted for the next four weeks. We will see an average reduction over this timeframe of 50 per cent of expected deliveries. There will minimal impact next week… The most profound impact will be in the week of January 25,” said Maj.-Gen. Dany Fortin, who is leading Canada’s logistical rollout.
This setback to Canada’s short-term COVID-19 vaccine delivery schedule means the number of doses going to each province and territory will have to be readjusted. Fortin said that the allocations will begin to scale back up in the first two weeks of February, before returning to the size of doses originally anticipated.
Canada was planning on receiving between 124,800 and 366,600 Pfizer doses every week between now and the end of February, as part of the plan to have six million doses total from Pfizer and Moderna by the end of March when Phase 1 ends.
The delivery for the week of Jan. 25, which Fortin said is likely to see the largest reduction, was set to be 208,650 doses. If that’s reduced by half, Canada will receive 104,325 Pfizer doses that week, which is fewer than the forecasted allocation received this week.
“In my conversation this morning with Pfizer, it was very clear that we’re are still correct in our planning assumption to receive approximately four million doses of Pfizer by March 31,” Fortin said,
Fortin said that knew the company would at some point need to scale-up their manufacturing to ramp-up its mass production, but the news of the looming construction project was brought to the federal government’s attention in the last 24 hours, according to Treasury Board President Jean-Yves Duclos.
Procurement Minister Anita Anand announced the delay on Friday, saying all nations who are receiving vaccines from this Pfizer facility will be receiving fewer doses.
“It is a temporary reduction, it’s not a stoppage… We will make up those doses,” Anand said.
Addressing the setback during his Rideau Cottage address on Friday, Prime Minister Justin Trudeau said that shipments have largely been ahead of schedule so far, but that “with an undertaking this historic, it’s only to be expected that there will be a few bumps along the way.”
Norway, which is also receiving Pfizer doses from its Europe facilities has announced that “for some time ahead” their deliveries will be reduced. In the coming week their shipment will be reduced by approximately 18 per cent.
“The reduction is due to a reorganisation at Pfizer in connection with an upgrade of production capacity… It is not yet clear how long it will take before Pfizer is up to maximum production capacity again,” said the statement published by the Norwegian Institute of Public Health.
The government sought to ensure that all countries who will be impacted, will be “equitably treated” in terms of delivery reductions, according to Anand. Fortin confirmed later Friday that this will be the case, with all seeing deliveries reduced by 50 per cent on average.
Anand said that while Canada is expecting to be able to catch up, the delay is “unfortunate.”
“However such delays and issues are to be expected when global supply chains are stretched well beyond their limits,” Anand said.
By end of the day Friday, the federal government will have distributed a total of 929,000 doses of the two approved COVID-19 vaccines, around 84 per cent of which have been administered.
WON’T IMPACT PHASE 2
The plan is to receive “more than” one million doses of approved vaccines every week, on average, starting in April with Phase 2.
Trudeau said that while this issue is out of Canada’s hands, the country “must still get ready for the ramp-up,” in Phase 2.
Fortin said the delays “will not change our second quarter goals,” though he could not guarantee future delays. He said he understands and feels the “disappointment,” but “we need to move forward.”
He committed to keep all key stakeholders, and Canadians appraised of any future delivery schedule changes.
The ongoing initial vaccination stage has seen Canada pushing to properly allocate and prioritize key groups like residents and staff in long-term care homes as well as front-line health-care workers.
In this first stage of the vaccine campaign, Canada has seen both doses sitting in freezers as well as provinces saying they are running short, while those on the front line have sought to sort out who should and shouldn’t be receiving shots at this time.
“It was with precisely these types of issues in mind that Canada pursued the aggressive procurement strategy that we did,” Anand said. “This approach of ensuring diversity and volume months ago is what now gives us flexibility and margins to remain on track in difficult times.”
Asked whether Canada will be looking to revisit their decision to not procure additional Moderna doses to make up the shortage over the next few weeks, Fortin said the amount scheduled to arrive from that company will stay the same.
As previously reported, the additional 16 million Moderna doses that the federal government left on the table in talks with that company would not be arriving until late 2021.
As for whether Canada looked into being able to receive Pfizer shipments from the United States facility, Fortin said that the federal government looked into it, but for now Canada’s line of doses will continue to come exclusively from the European facility.
Health Minister Patty Hajdu added that because as part of the regulatory approval granted to Pfizer, Health Canada approves the manufacturing sites as well as the vaccine itself.
“So, should we procure from even the same company a different site, then there would need to be review of the manufacturing data,” she said.
Several federal officials sought to reassure Canadians Friday that the country remains on track to vaccinate everyone who wants to be, by the end of September.
Pfizer-BioNTech delaying vaccine deliveries to Canada due to production issues – CP24 Toronto's Breaking News
The Canadian Press
Published Friday, January 15, 2021 10:13AM EST
Last Updated Friday, January 15, 2021 2:47PM EST
OTTAWA – Canada faces an “unfortunate” delay in vaccine deliveries due to Pfizer production issues in Europe, federal officials revealed Friday, chalking it up to the challenges of an unprecedented mass immunization effort while insisting most Canadians will still be vaccinated by fall.
Prime Minister Justin Trudeau said Ottawa was “working day in and day out to get vaccines delivered as quickly as possible” but acknowledged that Pfizer-BioNTech doses have been derailed in the short-term.
Trudeau said this is why Canada has one of the most diverse vaccine portfolios in the world, pointing to seven bilateral agreements he says ensure “flexibility when it comes to supply chains.”
“I want to be very clear: this does not impact our goal to have enough vaccines available by September for every Canadian who wants one,” Trudeau said from outside Rideau Cottage.
Procurement Minister Anita Anand said earlier Friday that production issues will temporarily reduce promised doses to Canada, as well as all countries that receive vaccines from Pfizer’s European facility.
While the company assured Canada it will still be able to deliver four million doses by the end of March, Anand acknowledged that is no longer guaranteed.
“This is unfortunate. However such delays and issues are to be expected when global supply chains are stretched well beyond their limits,” Anand said at a news conference.
“It’s not a stoppage.”
The immediate impact on Canada’s Pfizer-BioNTech supply was unclear.
According to the government’s website, more than 200,000 doses of the Pfizer-BioNTech COVID-19 vaccine were expected in each of the next two weeks and 1.4 million doses were expected in February.
Canada has received about 380,000 doses of the vaccine so far.
Pfizer Canada spokeswoman Christina Antoniou said the production facility in Puurs, Belgium is undergoing some modifications in the coming weeks to increase the number of doses it can pump out.
Pfizer hopes to double its 2021 production to two billion doses.
“Pfizer Canada will continue to pursue its efforts in anticipation that by the end of March, we will be able to catch up to be on track for the total committed doses for Q1,” Antoniou said.
The news comes as Ottawa released federal projections that suggest the pandemic may soon exceed levels seen in the first wave, rising to 19,630 cumulative deaths and 10,000 daily infections in a little over a week.
The modelling shows total cases could grow to nearly 796,630 from about 694,000, and that another 2,000 people could die by Jan. 24.
Chief Public Health Officer Dr. Theresa Tam urged sustained vigilance as a long-range forecast suggested rapid growth would continue without “quick, strong and sustained” measures.
Tam said that’s especially so in national hot spots of Quebec and Ontario, where a steady increase in hospitalizations has strained the health system’s ability to keep up with critical care demands. The projections do not take into account Quebec’s recently implemented four-week curfew or Ontario’s new stay-at-home orders.
Tam emphasized the need to reduce community spread to help relieve some of the pressure on hospitals and long-term care homes.
“The vaccine alone is not going to make a dent in some of that,” she said.
“As the older population in long-term care receive the vaccines we’re going to look very carefully to see if the serious illnesses and the deaths go down, but that’s also a factor of what’s happening in the community.”
It was an especially deadly day in Ontario, which reported 100 deaths linked to COVID-19, although that took into account a difference in database reporting between one of its health units and the province.
The province’s newly resolved tally added 46 deaths from Middlesex-London that occurred earlier in the pandemic.
Ontario also reported 2,998 new cases of COVID-19 with 800 of those new cases in Toronto, 618 in Peel Region and 250 in York Region.
Quebec reported 1,918 new COVID-19 cases and 62 more deaths, including nine that occurred in the past 24 hours.
Concern also remained in Atlantic Canada’s hot spot of New Brunswick, which reported 25 new cases and remains at the province’s second-highest pandemic alert level.
This report by The Canadian Press was first published Jan. 15, 2021.
Pfizer-BioNTech cutting back vaccine deliveries to Canada due to production issues – 680 News
OTTAWA — Procurement Minister Anita Anand says production issues in Europe will temporarily reduce Pfizer-BioNTech’s ability to deliver vaccines to Canada.
Anand says the U.S. drug-maker is temporarily reducing deliveries because of issues with its European production lines.
She adds that while the company says it will still be able to deliver four million doses by the end of March, that is no longer guaranteed.
“This is unfortunate. However such delays and issues are to be expected when global supply chains are stretched well beyond their limits,” Anand said at a news conference Friday. “It’s not a stoppage.”
Canada has received about 380,000 doses of the vaccine so far, and was supposed to get another 400,000 this month and almost two million doses in February.
The news comes as Ottawa released federal projections that suggest the pandemic may soon exceed levels seen in the first wave, rising to 19,630 cumulative deaths by Jan. 24.
Chief Public Health Officer Dr. Theresa Tam urged sustained vigilance as a long-range forecast suggested rapid growth in infections will continue without “quick, strong and sustained” measures.
Tam says that’s especially so in national hot spots of Quebec and Ontario, where a steady increase in hospitalizations has strained the health system’s ability to keep up with critical care demands.
This report by The Canadian Press was first published Jan. 15, 2021.
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