BRUSSELS/BANGKOK (REUTERS) – Tens of millions of migrants may be denied Covid-19 vaccines from a global programme because some major manufacturers are worried about legal risks from harmful side effects, according to officials and internal documents from Gavi, the charity operating the programme, reviewed by Reuters.

Nearly two years into a pandemic that has already killed more than five million people, only about 7 per cent of people in low-income countries have received a dose.

Vaccine deliveries worldwide have been delayed by production problems, hoarding by rich countries, export restrictions and red tape.

Many programmes have also been hampered by hesitancy among the public.

The legal concerns are an additional hurdle for public health officials tackling the coronavirus – even as officials say unvaccinated people offer an ideal environment for it to mutate into new variants that threaten hard-won immunity around the world.

Many Covid-19 vaccine manufacturers have required that countries indemnify them for any adverse events suffered by individuals as a result of the vaccines, the United Nations says.

Where governments are not in control, that is not possible.

The concerns affect people, such as those displaced by the Myanmar, Afghanistan and Ethiopian crises, who are beyond the reach of national governments’ vaccination schemes.

For refugees, migrants and asylum-seekers, as well as people afflicted by natural disasters or other events that put them out of reach of government help, the global programme known as Covax created a Humanitarian Buffer – a last-resort reserve of shots to be administered by humanitarian groups.

Gavi, the vaccine alliance, is a public-private partnership set up in 2000 to promote vaccination around the world.

But that buffer does not have any mechanism to offer compensation. Gavi, which operates Covax with the World Health Organisation (WHO), says that where those applying for doses, mainly non-governmental organisations, cannot bear legal risks, deliveries from that stockpile can be made only if vaccine-makers accept liability.

The companies that are willing to do so under these circumstances provide only a minority of the programme’s vaccines, according to people familiar with the matter and the documents, written by Gavi staff for a board meeting starting at the end of November.

More than two-thirds of Covax doses have come from Pfizer and its partner BioNTech, AstraZeneca and Moderna, Gavi says.

Moderna declined to comment. AstraZeneca and Pfizer said they were in talks with Gavi but declined to comment further. All three said they are committed to making doses available to poorer nations at relatively low prices.

Pfizer said it was collaborating directly with governments in Jordan and Lebanon to donate doses to refugees.

Mainly because of the legal concerns, less than two million doses have so far been sent from the buffer, Gavi says.

About 167 million people risk being excluded from national programmes, according to UN data cited in the documents.

Unless all the firms accept legal liability, “access to vaccines for some populations will remain a challenge”, the Gavi documents say, adding that new crises will generate additional demand to cover displaced populations.

The vaccine makers’ reluctance to take on the legal risks is “a major hurdle” in attempts to provide vaccines for the buffer, a spokesperson for Gavi told Reuters.

Gavi did not comment on the details in the documents, but said applications for vaccines are confidential until the doses are delivered.

In September, Gavi’s chief executive Seth Berkley tweeted an appeal to drugmakers to waive their requirements for legal indemnity.

Three Chinese drugmakers have agreed to shoulder legal risks when their shots are delivered through the buffer: Sinovac Biotech, Sinopharm Group and Clover Biopharmaceuticals, according to the Gavi document.

The drugmakers did not respond to requests for comment.

Johnson & Johnson of the United States confirmed it would waive a requirement for indemnity for deliveries from the buffer. “We are proud to be part of this effort to protect the world’s most vulnerable people,” said Dr Paul Stoffels, vice chairman of the executive committee and chief scientific officer. He did not elaborate.

More than 100 national governments have promised to offer vaccines where possible to all the displaced people on their soil, according to the International Organisation for Migration (IOM), a UN-related body that advises governments and migrants.

However, IOM says migrants and refugees are often effectively excluded from such schemes because of administrative or cultural hurdles.

In cases where governments are not in charge or have not agreed to vaccinate migrants, Covax’s Humanitarian Buffer is the only option.

At least 40 countries have yet to include unauthorised migrants in their vaccination programmes, according to the IOM – it and the UNHCR declined to name the countries.

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