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EXCLUSIVE: Emergency COVID vaccination scheme in legal jeopardy

‘Humanitarian organisations cannot take on liability for COVID-19 vaccines in the same way as national governments.’

A nurse displays the AstraZeneca/Oxford vaccine.
A nurse displays the AstraZeneca/Oxford COVID-19 vaccine supplied under the COVAX scheme at a hospital in Ethiopia, on 13 March, 2021. (Tiksa Negeri/REUTERS)

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Plans to allocate up to 100 million COVID-19 vaccine doses to humanitarian troublespots by the end of this year could be derailed because neither the drug companies nor the UN agencies and NGOs want to shoulder the risk of potential lawsuits.

COVAX, the worldwide vaccine-sharing initiative, agreed in March to set aside five percent of its vaccine doses for hard-to-reach communities left out of national rollout plans. Those groups include people in rebel-held warzones, migrants on the move, and camps of displaced people. Estimates include 167 million people likely to be missed out of national plans.

In those circumstances, instead of national health services that can’t or won’t do the job, NGOs, the Red Cross, and the UN could deliver and administer the jabs.

Although it’s behind schedule overall – and low on immediate supplies – COVAX recently opened up applications to aid groups wanting vaccine stocks from what it calls its “Humanitarian Buffer”. But the invitation to apply comes with a hitch.

Humanitarian agencies – including the World Health Organization, UNICEF, the Red Cross movement, and Médecins Sans Frontières – say they worry they won’t be able to apply for or administer the vaccines if they're expected to take on legal liability if things go wrong. Their concerns were summed up in a 2 June position paper written by a working group of health agencies, and obtained by The New Humanitarian.

In the paper, the Inter-Agency Standing Committee COVID-19 group – a policy forum chaired by the UN’s humanitarian coordination arm, OCHA – called for action from drug companies and Gavi, the leading organiser of COVAX.

“Gavi is undertaking discussions with manufacturers with the objective to ensure that the COVAX Humanitarian Buffer is operationalised as swiftly as possible,” said a spokesperson for Gavi, which says groups need to have indemnity agreements in place with the manufacturers if they want to receive vaccines.

OCHA, meanwhile, said talks were underway to address the problem.

“It is a critical tool to deliver COVID-19 vaccines to the most vulnerable people in the world who have not been covered by national vaccination campaigns,” an OCHA spokesperson said of the buffer. “Humanitarian organisations cannot take on liability for COVID-19 vaccines in the same way as national governments,” the spokesperson added.

Organisations say humanitarian stocks of the vaccine may be needed in countries such as Afghanistan, Burundi, Libya, Somalia, South Sudan, parts of Syria, and Yemen.

In Bangladesh – home to more than 900,000 Rohingya refugees who fled neighbouring Myanmar – no vaccines have been administered to its refugee population, although a rollout has begun for Bangladeshi citizens. Haiti, meanwhile, has yet to vaccinate anyone, after initially rejecting doses of AstraZeneca, and is now seeing cases rise.

“The global system has committed to ensuring vaccines reach all vulnerable populations and has found solutions to liability and indemnification in other contexts. This same spirit of problem-solving must be applied to humanitarian populations.”

AstraZeneca – a major supplier of vaccines to COVAX – declined to answer specific questions but said it provides 95 percent of its vaccine supply at “no profit”.

“We are aware of the issue related to the COVAX Humanitarian Buffer and are working collaboratively with COVAX partners to find a solution,” said an AstraZeneca spokesperson, who declined to be named for security reasons.

Requests to several other pharmaceutical companies producing COVID-19 vaccines, such as Moderna and Pfizer, went unanswered.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), an industry group representing drug companies, said it is “aware of the issue and we are working collaboratively with COVAX partners to find a solution”.

Fear of litigation

Unlike the NGOs, most countries have had little choice but to agree to take on the legal liability in case of any bad side-effects from COVID-19 vaccines.

Indemnity agreements between suppliers and individual countries generally mean that any individual can pursue a case within the limits of national law, but the costs of defending the drug company and any damages awarded would be picked up by the state.

COVAX has blunted, but not removed entirely, that prospect in low-income countries by setting up a no-fault compensation fund, which would allow patients to get compensation without an expensive court battle. Some countries set up national compensation schemes to limit litigation.

One senior aid agency official familiar with the COVAX buffer problems said NGOs could go bankrupt if sued for problems with the vaccine. The official spoke to The New Humanitarian on condition of anonymity due to sensitive negotiations.

“It is bizarre to expect local and global humanitarian and civil society organisations to not only shoulder the burden of delivering vaccines in excluded communities that can’t or won't be reached by governments, but also to take on liability for the vaccines themselves,” said the official. “The global system has committed to ensuring vaccines reach all vulnerable populations and has found solutions to liability and indemnification in other contexts. This same spirit of problem-solving must be applied to humanitarian populations.”

Another senior NGO official familiar with the process said the drug companies’ need to limit their liability at the early stages of rollout was understandable, but that as the situation progresses – and more evidence and regulatory approvals are forthcoming – they should start accepting a larger share of the risks, which could potentially run into the millions of dollars.

Eventually, the COVID-19 vaccines will get full regulatory approval through the normal channels, including from the WHO. It is unclear how far away that is, although COVAX expects not before June 2022.

Some companies have applied for full approval in the United States, to upgrade from “Emergency Use Authorisation” status. If granted, they typically would secure insurance for liability against any “Serious Adverse Event”. At that point, buyers would not be asked to indemnify suppliers.

The senior NGO official, who also spoke to The New Humanitarian on condition of anonymity because of the sensitivity of the issue, said some drug companies were making “astronomical” profits while asking for “liability-shedding”. The official added: “I don’t think the dramas around blood clots have helped at all”, referring to reactions to a possible side-effect of the AstraZeneca vaccine. Rare blood clotting issues have also been reported with the Johnson & Johnson vaccine.

Drug companies have reason to be concerned, according to Mark Chataway, of the communications firm Baird’s CMC, whose clients include pharmaceutical companies.

Chataway said that when new vaccines are approved rapidly for emergency use, the drug companies haven't had time to observe whether adverse events occur over the long term, and they may not have been able to run trials that are as large or as diverse as normal trials.

He pointed to the case of swine flu. Development was accelerated for the H1N1 flu vaccine at the request of governments, and a controversy ensued about whether it caused narcolepsy in rare cases. One boy in the UK was awarded £120,000 in damages, paid for by the state compensation scheme.

Considering complaints by aid agencies about risk-sharing and the humanitarian buffer, Chataway said drug companies face a particular threat: “As soon as a COVID vaccine is deployed among vulnerable people, the anti-vaxxers will swoop in to try to initiate frivolous – but costly and damaging – litigation.”

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