Refugees Left Behind as Drugmakers Balk at COVID Vaccine Liability Under COVAX Buffer

In June, Francois Nosten, a French professor who coordinates healthcare for people from Myanmar living along the Thai border, put in a request for 70,000 COVID-19 vaccine doses. By December he was still waiting. Nosten, whose main work is malaria research, expects the shots this month and has been told they will be Sinopharm's. His request is one small test of a problem laid out in internal Gavi documents reviewed by Reuters: some of the world's biggest vaccine makers are reluctant to accept legal liability for side effects, and that reluctance is choking off a reserve meant for people no government is vaccinating.

The reserve is COVAX's Humanitarian Buffer, a last-resort stockpile of shots for refugees, migrants, asylum-seekers and people cut off from government help by disasters or conflict. Gavi, the public-private vaccine alliance created in 2000, set it up in March 2021 and planned to hold back up to 5% of the doses reaching COVAX, roughly 70 million so far. The buffer has no mechanism for compensating anyone harmed by a vaccine. Where the NGOs applying for doses cannot carry the legal risk themselves, Gavi says, deliveries can go ahead only if the manufacturer accepts liability.

Many manufacturers have asked countries to indemnify them against adverse events, the United Nations says, and that is impossible where governments are not in control. Gavi's documents, written for a board meeting starting at the end of November, say the firms willing to accept liability supply only a minority of COVAX doses. Pfizer and BioNTech, AstraZeneca and Moderna together account for more than two-thirds. Moderna declined to comment. Pfizer and AstraZeneca said they were in talks with Gavi but said no more. Pfizer added that it is working directly with the governments of Jordan and Lebanon to donate doses for refugees.

Three Chinese companies, SinoVac, Sinopharm and Clover Biopharmaceuticals, have agreed to shoulder the risk for buffer deliveries, as has Johnson & Johnson. Paul Stoffels, its chief scientific officer, said the company was proud to help protect the world's most vulnerable people. But these four firms have supplied less than a third of COVAX's doses, and Clover's shot is not yet approved, so it is not in use. The result: under 2 million doses have left the buffer. The only delivery so far, just over 1.6 million Sinopharm doses, reached Iran in November, where many displaced Afghans have arrived, according to UNICEF Iran. That is enough for about 800,000 people, and UNICEF says more will likely be needed. The UN data cited in the documents put the number at risk of exclusion from national programmes at about 167 million.

Industry groups describe the hesitation as caution, not refusal. The IFPMA said no company has refused to consider accepting the risk, but some felt they could not without knowing where and how their vaccines would be used. The EFPIA said continuous safety monitoring in refugee camps would be hard, and that people may blame a vaccine for unrelated problems, producing lawsuits that publicly question its safety and feed hesitancy. Evidence on actual litigation is thin. A US compensation programme has paid nothing, and neither has the WHO scheme for lower-income countries. A handful of awards, for undisclosed sums, have been made in Denmark, Germany, Norway and Switzerland. In the US, an emergency law shields drug makers except in cases of wilful misconduct. John T. Monahan of Georgetown University said manufacturers try to minimise legal risk almost everywhere, and that accepting carve-outs could make full immunity harder to win later.

The cost of delay is concrete on the Thai-Myanmar border. Nosten's Border Health Foundation is one of eight organisations worldwide to apply to distribute buffer shots and one of three Gavi has approved. His request covers some of the roughly 90,000 people in camps, but mostly unregistered migrants in Mae Sot and nearby villages. About 20,000 doses are earmarked for camp residents through the International Rescue Committee. Its Thailand director, Darren Hertz, said the group is grateful for any vaccine and judges the chance of a refugee suing over side effects to be extremely low. The IRC is handling significant outbreaks in five of nine border camps, with about 3,000 confirmed cases and at least 26 deaths. Applicants cannot choose their vaccine; Nosten said J&J's single dose would be easier than Sinopharm's two, but called Sinopharm better than nothing. Gavi says delivery arrangements are still being finalised.

The buffer matters because other routes are narrow. More than 100 governments have pledged to vaccinate displaced people where possible, the IOM says, but migrants are often excluded in practice by administrative or cultural barriers, and at least 40 countries have not included unauthorised migrants. UNHCR's Ann Burton said the liability issue is one reason agencies were slow to apply. Mireille Lembwadio of the IOM warned that leaving mobile, crowded populations unvaccinated could help spread the virus and its variants worldwide. Gavi's documents warn that unless all manufacturers accept liability, access will remain a challenge, and new crises will add demand. Gavi's chief, Seth Berkley, appealed publicly in September for drugmakers to drop their indemnity demands.