Vaccine Nationalism, Tight Supplies And Dodgy Data: How The Global Vaccine Roll Out Is Hitting Hurdles

UK Supplies Becoming “Tight”

As the first country in the world to approve a vaccination for widespread use to combat coronavirus, the UK has had a significant head start on the vaccination programme. One in nine adults have already received their first dose.

By the end of December, the UK's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), had approved vaccines from both Pfizer/BioNTech and Oxford/AstraZeneca. A third jab, produced by US-based Moderna, was also given the greenlight earlier this month, with the UK expected to receive around 75 million doses in Spring.

As a result, vaccination numbers have been strong, with over 6.5m people already receiving their first doses, including almost 80% of over-80s in England.

Meanwhile, the Novavax vaccine has proven to be 89% effective in UK trials and 60 million doses have been secured for the UK. A groundbreaking single dose version of the Covid-19 vaccine from Johnson & Johnson was also confirmed today to be 66% effective.

But after a relatively smooth start, there have been increasing signs that the UK's programme could be about to face significant pressures.

Having repeatedly stated that supplies were the "limiting" factor in extending the rollout, Health Secretary Matt Hancock went further on Monday, adding that doses of the vaccines were becoming "tight".

That was repeated by vaccines minister Nadhim Zahawi, who said the "new manufacturing processes" had resulted in "lumpy and bumpy" supplies, but insisted it would "get better and stabilises and improves going forward".

Their comments come amid fresh pressures on the major vaccine firms, with both AstraZeneca and Pfizer warning they were likely to fall behind on their supply targets and some countries likely to experience significant shortfalls as a result.

Earlier this month, Pzifer/BioNTech indicated that efforts to upscale their major production hub in Puurs, Belgium, would result in some delays for most European countries, including the UK.

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Fragile supply chain

Requiring storage and transportation at -70°c, the Pfizer jab has already proven a major logistical challenge with doses having to be transported in specialised containers and kept in ultra-low freezers.

As more countries approve the Pfizer jab, it is likely that further pressures will be placed on the already fragile supply chain, with industry groups warning the equipment and chemicals necessary to store the vaccine could also experience shortages.

Delayed dosing regime 

Meanwhile, in a bid to maximise coverage, the UK has adopted a controversial dosing regime which allows for the second dose of the jab to be delayed by as much as three months.

While the approach has been approved by the UK's drugs regulator and the Chief Medical Officers of all four nations, there has been criticism from other senior medics and even the vaccine manufacturers themselves.

In a joint statement published in the British Medical Journal, Pfizer and BioNTech said: "The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design... There is no data to demonstrate that protection after the first dose is sustained after 21 days."

That lack of data has already prompted the US Food and Drug Administration (FDA) to state they will not be altering their dosing schedule, while other senior medics have called for further evidence to demonstrate the plan's efficacy.

Dr Rosie Shire from the UK's Doctors' Association said she was "really concerned" about the lack of information underpinning the decision.

"The fact is that people are being vaccinated now and being put into what is effectively an unregulated unlicensed trial, whereby they're receiving this vaccination on the understanding that they don't know what's going on."

With Prime Minister Boris Johnson suggesting the lifting of lockdown restrictions is partially reliant on the progress of the vaccine rollout, the news of increasing supply issues will be of significant concern and given the UK's unique dosing strategy, the impact of vaccine shortages could be severe.

But with ministers repeatedly praising their efforts in vaccinating faster than other countries, there are growing fears of so-called "vaccine nationalism" taking hold in the decision making process.

Having already boasted about the UK's vaccine programme achieving better results than many EU countries combined, and social media posts from the Conservative Party echoing the statements, experts have raised concerns that the ongoing supply issues could force countries to put pressure on domestic vaccine producers to ensure their host countries receive supplies before others.

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An export row is raging

In a sign of the growing tensions, EU leaders announced this week that they were considering strict new rules on vaccine exports, potentially limiting the delivery of Pfizer vaccines to the UK.

With politics playing an increasing role in the response to the crisis, Health Secretary Matt Hancock even suggested in December that the UK's decision to approve the Pfizer jab had been sped up by Brexit – a claim he was forced to partially retract.

Speaking to Times Radio, Robert Yates, the director of the Global Health Programme at Chatham House, said recent comments from UK officials were "extremely concerning".

"I think the Conservative Party put out a tweet just a couple of weeks ago crowing that the UK has vaccinated more people than Italy, France, Germany and Spain combined," he said.

"Now, I think we get the politics of this but this really is not fostering this idea of collaboration..."

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EU Anger Over Vaccine Shortages

While the UK has raced ahead with its rollout, the EU has lagged behind in approving and distributing doses.

While each of the 27 member states have taken responsibility for creating their own priority lists, the EU Commission have led on evaluation and purchasing of the vaccines. While the bloc have already approved the Pfizer jab, the Oxford/AstraZeneca product  – which has already been administered to millions in the UK – was only approved on 29 January.

The EU has arrangements in place to purchase 300 million doses initially, with options to buy a further 100 million.

But the recent supply issues of both the Pzifer and AstraZeneca jabs threaten a major disruption to the EU's plans.

According to the Reuters news agency, one EU official said AstraZeneca's manufacturing woes could mean as much as 60% of the initial supply could be delayed.

Changes to Pfizer's manufacturing process have also caused delays, with the company saying the supply problems would only have a "temporary impact" on shipments in late January and February before significantly in March.

But the news has prompted intense anger among EU leaders, with Health Commissioner Stella Kyriakides accusing AstraZeneca of a "lack of clarity and insufficient explanations".

In a statement on Twitter, Kyriakides added: "Discussions with AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold."

"The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they had been delivered."

In a statement ahead of the EMA approval, AstraZeneca said problems at a manufacturing site were to blame for the reduction.

"While there is no scheduled delay to the start of shipments of our vaccine should we receive approval in Europe, initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain.

"We will be supplying tens of millions of doses in February and March to the European Union, as we continue to ramp up production volumes."

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Vaccine Wars

In a sign of the growing tensions, EU leaders are considering strict new rules on vaccine exports, potentially limiting the delivery of Pfizer vaccines to the UK.

Speaking earlier this week Kyriakides warned the EU was prepared to “take any action required to protect its citizens and rights", adding a "export transparency mechanism" could be put in place imminently.

The proposed strategy could mean EU manufacturers would have to secure permissions from the bloc before exporting doses to other countries, unless they were deemed a “humanitarian” delivery.

But German health minister denied the move amounted to “vaccine nationalism”, saying it was only fair that countries weathered the supply issues equally.

"I can understand if there are production problems, but then it has to affect everyone fairly and equally,” he said.

“This is not about 'EU first', this is about Europe's fair share, and that is why it makes sense that we have an export restriction."

And following ongoing talks between EU leaders and the drugmakers, European Council President Charles Michel said the bloc would consider "all legal options" to ensure supplies were maintained.

In a letter to four EU leaders, he wrote: "If no satisfactory solution can be found, I believe we should explore all options and make use of all legal means and enforcement measures at our disposal under the Treaties."

However, the comments have prompted fears that UK exports of the Pfizer jabs could be impacted, leading health secretary Matt Hancock to warn the proposed export measures were “not the right approach”.

"I'm sure that we can work with the EU to ensure that, whilst transparency is welcome, no blockers are put in place," he said.

"I would urge all international partners in fact to be collaborative and working closely together. And I think protectionism is not the right approach in the middle of a pandemic."

Meanwhile, responding to the plans, vaccine minister Nadhim Zahawi warned the plans amounted to the "dead end of vaccine nationalism".

And the UK minister added he was confident the dose supply would be maintained, adding: "No-one is safe until the whole world is safe."

But with multiple EU member states facing shortages, there is likely to be further tensions between EU leaders and manufacturers in the coming weeks and months.

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Numberwang

While the EU battles to boost its vaccine access, a strange row has developed between Oxford/AstraZeneca and the German media following reports that their vaccine was significantly less effective in older people.

It came after two major German newspapers, Handelsblatt and Bild, reported German government officials were expecting the European Medicines Agency (EMA) to conclude the jab was only 8% effective in the over-65s.

But the reports prompted an immediate response from the manufacturer who said the claims were "completely incorrect", highlighting UK officials had approved the jab without an upper age limit in December.

In an extraordinary statement pushing back at the reports, the German health ministry said the figures had been "muddled".

"At first sight it appears that two things have been muddled in the report," they wrote.

"Around 8% of participants in the AstraZeneca efficacy trials were aged between 56 and 69 years old, only three to four per cent were over 70.

"But one cannot deduce an efficacy of only 8 per cent with older people from that."

But the German government also hit out at AstraZeneca's data, saying it had been "know since the autumn that fewer seniors were included in the trials of other manufacturers.

On Friday the EMA approved the AstraZeneca vaccine for use in all adults over the age of 18, further discrediting German claims of ineffectiveness. 

The spat comes after German Chancellor Angela Merkel threw her weight behind the proposed EU export restrictions, saying: "The US has a war act in force on the export of vaccines, and in some cases on important supplies for vaccines."

She added: "That will trigger our basic instincts in Europe to say: 'If you're missing anything you need in your supply chain for drugs or vaccines, you will take a look at home and make sure you get that sorted."

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100 Million In 100 Days

With more than 25 million recorded cases and its death toll already rising above 400,000, the United States is under intense pressure to accelerate its vaccine programme.

Having previously promised to vaccinate 100 million people in the first 100 days of his administration, newly-elected President Joe Biden has increased his pledge to 1.5 million daily vaccinations following media suggestions that the target had nearly been reached under his predecessor, Donald Trump.

Taking questions from reporters on Tuesday, Mr Biden said he hoped the target could be increased.

"I think with the grace of God... we'll be able to get that to 1.5 million a day," he said.

"I hope we'll be able to increase as we go along so we'll get to 1.5 million, that is my hope."

But with the US health system already facing increasing pressure from the new, more infectious variants, the new President faces making some difficult choices.

One of those reportedly being considered is reversing the FDA decision to dismiss the UK's delayed dosing strategy in the hope a wider deployment could drive down infection rates among the most vulnerable.

Inheriting the vaccination programme put in place by President Trump, codenamed 'Operation Warp Speed', Mr Biden is faced with a slow and confusing system which has been criticised by some states who have reported having just a week's notice of major vaccine dose deliveries.

Faced with a major logistical challenge, President Biden has already pushed through a slew of executive orders aimed at getting the deployment under control, including boosting communication between federal and state officials.

But speaking earlier this week, CDC director Rochelle Walensky said the same supply issues facing other nations was likely to be a major hurdle.

"I think that the supply is probably going to be the most limiting constraint early on," Walensky said.

"We're really hoping that after that first hundred days we will have much more production."

With significant domestic issues in the vaccine supply process, there are growing concerns that President Biden could place further pressure on US-based firms, including Pfizer and Moderna, to ensure the country is not hampered by supply issues by exporting the vaccines abroad.

But recent analysis has given a stark warning to leaders over the short-term political advantage to be gained by engaging in vaccine nationalism.

In a new study by the International Chamber of Commerce, the group warned that blocking access to vaccines in an effort to increase domestic supplies could result in a $9.2 trillion hit to the global economy.

Instead, the group said investments by advanced economies in ensuring an equitable deployment of the vaccine could result in major economic returns by curtailing the worst economic impacts of the pandemic.

Welcoming the research, Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organisation, said: "I believe the world faces a catastrophic moral failure in equal access to the tools to combat the pandemic. This research shows a potentially catastrophic economic failure."

He added: "The longer we wait to produce vaccines, tests and treatments to all countries, the faster the virus will take hold, the potential for more variants will emerge, the greater the chance today's vaccines could become ineffective and the harder it will be for all countries to recover."

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From Russia With Love

While the West continues to battle over supplies of the Pfizer, Moderna and AstraZeneca jabs, other countries have pressed ahead with their own offerings.

Developed in a state-based lab, Russia has claimed its Sputnik-V jab is 91.4% effective in preventing infections and can be transported and stored easily as it does not require ultra-low temperatures.

Despite Russia's President Vladimir Putin declaring the vaccine a success in August before its limited trials were completed, the leader has yet to receive the jab, with a Kremlin spokesperson saying :"The President cannot use an uncertified vaccine."

Earlier this month, Mr Putin ordered a mass vaccination programme to begin, with doctors and older people placed at the top of the list.

But with growing skepticism about the vaccine's efficacy and a lack of senior Russian officials opting to take the jab, take-up has been low.

And even those who wish to receive the jab have faced delays and setbacks, with distribution hampered to areas of the country outside of major cities.

Despite the issues, Russia claimed earlier this month that they had vaccinated 1.5 million people - a fraction of their 146 million population. But even those relatively low figures have prompted doubt from some outside observers who claim the national totals do not tally with more conservative tallys produced by regional officials.

However, while Russia's domestic programme may be facing hurdles, the development of a homegrown vaccine has offered them fresh opportunities to increase their geopolitical reach by offering manufacturing contracts and vaccine deals to other nations.

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Rich Jab Poor Jab

The ability for Russia and other non-Western countries to press ahead with their style of 'vaccine diplomacy' has been made significantly easier by the insular focus in Western countries on deploying their vaccines to their own populations.

According to new analysis from the WHO, just one of the 29 poorest countries has begun any form of vaccination programme, with the West African nation of Guinea beginning their roll out earlier this month.

Offered doses of the Sputnik-V vaccine on a "experimental basis", Guinea has began their limited programme - offering just 55 people of their over 12 million population their first dose.

While wealthy countries push ahead with their deployment programmes, new analysis from the WHO has revealed just one of the 29 poorest countries has begun vaccinating their population.

But with Western nations buying up enough supplies of successful vaccines and promising potential products to vaccinate their populations many times over, it has opened the door for nations, such as Russia and China, to use the vaccine programme as a means of building influence with countries otherwise outside their sphere of influence.

Speaking earlier this month, Sakoba Keita, director general of Guinea's National Health Security Agency, said the country planned a wider deployment by the end of the first quarter, but said the programme was reliant on being offered supplies.

He said: "At the moment I cannot provide an exact date because we have not had any announcement of the supply of the first batch of vaccines, which could come to Guinea from any of our suppliers. Negotiations are ongoing."

Meanwhile, a growing disinformation campaign has already begun against the jabs used by Western countries, with China engaging in a major effort to stoke fears about their safety.

Coming in response to a WHO investigation into the handling of the pandemic by the ruling Communist Party, China has launched a media blitz to spread conspiracy theories about the US-made Pfizer jab, and the origins of the disease.

With further WHO investigations into the source of the outbreak, Chinese officials have attempted to deflect blame by reigniting debunked theories that a US military lab could have been the source of the infections.

Posting on Twitter, Chinese Foreign Ministry spokesperson Hua Chunying, said: "If the United State truly respects facts, it should open the biological lab at Fort Detrick, and give more transparency to issues like its 200-plus overseas bio-labs."

The disinformation effort comes after China pledged to give doses of their own vaccines to several less-developed nations in an effort to improve relations between them.

But the Chinese jabs - which are less sophisticated than those produced in the West - have faced criticism over their effectiveness, with a study by Brazilian medics concluding they provide efficacy of just 50%.

In response, Chinese state media have made unfounded claims about dozens of deaths related to the Pfizer jab, including in Germany and Norway - claims which have been strongly denied by Western health officials.

Speaking to the Associated Press, Dr Yuan Zeng, an expert of Chinese media at the University of Leeds said the disinformation campaign was "super, super dangerous".

But the British academic warned the claims and had already picked-up pace among China's educated middle-classes, leading to growing fears that propaganda efforts to discredit vaccines from other nations could continue.

It is why the WHO are urging leaders to take further steps to ensure less-developed countries are not excluded from accessing supplies of the vaccine, saying without a coherent strategy it could lead "another brick in the wall of inequality between the worlds of the world's haves and have-nots".

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