Covid vaccine makers blamed for 'onerous' contracts as dose donations dry up

Western governments have promised to donate billions of doses of coronavirus vaccines to poorer countries in a bid to end the pandemic.

But so far, those promises have been largely empty: all talk, no jabs.

In fact, of the 1.8 billion doses pledged by rich nations, only 261 million doses - 14 per cent - have been delivered so far, according to a report on Thursday from the People’s Vaccine Alliance, a pressure group pushing for equal access to jabs.

But it has transpired that at least part of the problem stems from onerous legal restrictions imposed on countries by vaccine manufacturers.

One insider to the donation process told The Telegraph that manufacturers were “dragging their feet” about getting doses to lower-income countries.

On Monday, a letter from the German government to Brussels also blamed “ongoing bureaucratic, logistical and legal problems” imposed by vaccine makers on countries wishing to donate.

German health official Thomas Steffen said the problems meant Germany may miss its target of donating 100 million doses this year. It has given around 17 per cent of this number so far.

A report released this week by the consumer rights group Public Citizen, which included details of the contracts of a number of governments with Pfizer - maker of one of the most widely-used vaccines - also outlined some of the key clauses that are contributing to the problems.

Clause 1: donations

Many governments require the approval of the vaccine manufacturer before they can donate any doses.

That is the case, for example, in the contract between Pfizer and the Brazilian government. Not only is Brazil unable to donate any doses without Pfizer’s permission, it also cannot accept any donations, as per their contract.

“It’s still a seller’s market,” said one official. “As a result a lot of manufacturers have been able to dictate their conditions to a large extent.”

Clause 2: liability

The nitty gritty of why this matters is also detailed in contracts, and lies chiefly around liability: who is responsible if something goes wrong with the vaccine.

While billions have now received Covid jabs worldwide - and serious side effects have been very rare - manufacturers and governments had to prepare in case widespread vaccine campaigns exposed more common problems.

Normally, manufacturers bear this risk, and have insurance in place to compensate people affected by serious side effects, or - in the worst-case-scenario - the families of people who die.

However, for a campaign of this scale and speed, the manufacturers did not want to take on this risk. Governments stepped in instead, under the “emergency use” terms of the approvals of the vaccines.

But when governments donate doses they also effectively pass on this liability to the country receiving the vaccine. That remains the case regardless of whether they donate the vaccines bilaterally or through Covax, the vaccine distribution scheme set up by the World Health Organization and others.

“There does seem to be some reticence [from manufacturers], even with donated doses, to have those doses go to lower income countries,” one official with knowledge of the workings of Covax said.

“It may be a feeling that some of the countries might not be able to fully bear the liability. So there is a feeling of a bit of stalling there.”

Covax does have a scheme to help lower-income countries meet this liability but legally, the countries still have to be written into the contract as bearing the full responsibility.

Clause 3: secrecy

All of the contracts include what are effectively gagging orders, preventing governments or other buyers from discussing pricing or other elements of their deals. This includes the European Union and the United States.

This is not unusual in drug contracts, but the lack of transparency has carried over into how the donations system works, too, insiders said, and there are issues with supply as well.

In the documents from Public Citizen, contracts with countries like Colombia make it clear that Pfizer makes the decisions on when to supply vaccines or on any delays, and the country “shall be deemed to agree to any decision.”

Clause 4: the rest

Not all of the delays are purposeful, sources said: donation is a very complex process.

It involves essentially transferring ownership of the vaccines - including the contracts originally agreed with the manufacturers - and everything that goes with that.

“Even things like the labelling language and stuff like that - there are a lot of hoops that have to be jumped through,” the official said.

National regulators are also an issue, and supply chains.

Pharmaceutical companies hit back at the blame game, suggesting that many of the issues were out of their hands.

A spokesperson for Pfizer said the company, alongside its partner BioNTech, was "happy to continue working with governments and global partners to faciliate onward donation".

She added: "We cannot speak directly to contracts, as these remain confidential in the interests of all parties concerned."

Moderna pointed to its global commitment to vaccine access, pointing out that it was “providing the regulatory, supply chain and pharmacovigilance support necessary” to allow donations to happen, particularly by working “closely with the US government and others that have purchased more vaccine than they need.”

It is worth pointing out that if rich governments had not done that, donations would not be necessary.

AstraZeneca said it had “put equitable access at the heart of its response to the pandemic”, facilitating the donation of 100 million vaccines worldwide. Of 1.7 bn doses released globally, two-thirds had been delivered to low and middle-income countries, a spokesperson said.

“The donation of vaccines is a complex administrative process with long lead times that are outside vaccine manufacturers’ control,” she added.

“Everyone engaged in this effort including donating and receiving countries, regulators, Covax and other multilateral organisations are working constructively to help accelerate delivery to those countries most in need as quickly as possible.”

Johnson & Johnson had not responded at the time of publication.

‘Is it enough? No. But it’s the best we have’

There are ways to make the process simpler, though, various officials on both sides of the debate told The Telegraph.

For example, donations through Covax are seen as being smoother than those done direct between countries; it has drawn up sample contracts with the manufacturers for EU countries to use, for example, based on existing deals allowing donations between Sweden and AstraZeneca, Belgium and Johnson & Johnson, and France and Pfizer.

However, the delays are frustrating many.

Maaza Seyoum, of the African Alliance and People’s Vaccine Alliance Africa - a member of the People’s Vaccine Alliance - said on Thursday: “Across the world health workers are dying and children are losing parents and grandparents.

“Governments must stop allowing pharmaceutical companies to play god while raking in astronomical profits and start delivering actual action that will save lives.”

In fact, avoiding this kind of mess was one of the aims of Covax in the first place, which was set up to provide a mechanism allowing lower income countries to access vaccines in their own right, rather than relying on donations from richer countries.

“Charity isn’t ideal,” said the official. “But we’ve had 146 million doses donated by sovereign governments from their national surpluses - it’s not much but it still means millions vaccinated who otherwise wouldn’t be.

“Is it enough? No. So we’re calling on governments to do more, manufacturers to do a lot more. But it’s the best we have now.”

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