• Refugees lack COVID shots because drugmakers fear lawsuits, documents s

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    BRUSSELS/BANGKOK, Dec 16 (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 5
    million people, only about 7% 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 read more .

    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 Organization (WHO),
    says that where those applying for doses, mainly NGOs, can't bear legal
    risks, deliveries from that stockpile can only be made 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 Inc. (PFE.N)
    and its partner BioNTech SE (22UAy.DE), AstraZeneca PLC (AZN.L) and
    Moderna Inc. (MRNA.O), 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 for refugees.

    Mainly because of the legal concerns, less than 2 million doses have so
    far been sent from the buffer, Gavi says. About 167 million people risk
    being excluded from national programmes, according to United Nations
    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 CEO, 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 Ltd (SVA.O),
    Sinopharm Group Co. Ltd (1099.HK), and Clover Biopharmaceuticals Co.
    Ltd, according to the Gavi document. The drugmakers did not respond to
    requests for comment.

    Johnson & Johnson (JNJ.N) 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 Paul Stoffels, Vice Chairman of the Executive Committee
    and Chief Scientific Officer. He did not elaborate.

    However, less than one-third of COVAX supplies have come from these
    four firms, COVAX data shows: Clover's shot has not yet been approved
    so is not in use.

    The global industry association, the International Federation of
    Pharmaceutical Manufacturers and Associations (IFPMA), said "no company
    has refused to consider" taking on the legal risk. However, in the case
    of shots delivered from the buffer, it said some firms felt they could
    not do so without full knowledge of where and how vaccines would be
    used.

    It would be hard to continuously monitor vaccines for safety in refugee
    camps, and delivery is logistically very challenging and not suitable
    for all types, said the European Federation of Pharmaceutical
    Industries and Associations (EFPIA), which represents large
    pharmaceutical companies in Europe.

    People may blame vaccines for problems that emerge afterwards even if
    they are unrelated, it said.

    "This could then lead to an increased number of litigation cases ...
    during which the safety and efficacy of the vaccine would be publicly questioned," it said in a statement to Reuters. That might lead to
    increased vaccine hesitancy and a slower recovery from the pandemic, it
    said.

    So far there is scant information on COVID vaccine litigation, but
    claims made to out-of-court compensation programmes are one measure of
    the risk. A programme in the United States has so far not paid out
    anything, public data show; neither has one set up by the WHO for lower
    income countries, the WHO said. In Europe, a handful of compensation
    awards have been granted for undisclosed amounts of money, official
    data from Denmark, Germany, Norway and Switzerland show read more .

    Globally there have been few reported COVID infections among refugees,
    migrants and asylum-seekers testing is not always systematic and
    infections can generate only mild symptoms especially in younger
    people.

    But cramped conditions and weak healthcare expose them to high
    infection risk. This, combined with low levels of vaccination in a
    mobile population could favour the emergence of new variants and be a
    vector for infection, said Mireille Lembwadio, Global Vaccination
    Coordinator at the International Organization of Migration (IOM), a U.N.-related body that advises governments and migrants.

    "Leaving them unvaccinated could help spread the virus and its variants
    across the world," she said.

    WAITING FOR DOSES

    Francois Nosten, a French professor who helps coordinate healthcare for
    people from Myanmar living on the border with Thailand, is one of those
    waiting for vaccines. In June, he put in a request from the
    Humanitarian Buffer for 70,000 doses some for some of the 90,000 or
    so who are sheltering in camps along the border, but most for
    unregistered migrants in the border town of Mae Sot and nearby
    villages.

    Nosten, whose main work is researching malaria, is expecting the doses
    - a fraction of the more than 8 billion administered worldwide - this
    month. He has been told they will come from Sinopharm, and he hopes
    they can help inoculate key at-risk groups in Thailand's Tak province.
    Gavi said delivery arrangements are still being finalised.

    About 20,000 doses will be given to people in the camps by the
    International Rescue Committee (IRC), a humanitarian group working with
    Nosten.

    "At this point whatever vaccine we can secure we are grateful for,"
    said its Thailand Director, Darren Hertz. He added that the IRC
    believed the likelihood that a member of the refugee population would
    attempt to take legal action in case of side-effects was "extremely
    low."

    Hertz said the IRC has received a handful of ad hoc vaccine donations
    from the Thai government and is currently tackling significant
    outbreaks in five of nine camps on the border, where about 3,000 cases
    have been confirmed, including at least 26 deaths. A Thai foreign
    ministry spokesperson confirmed the government was working with the IRC
    on providing vaccinations in shelters along the border.

    Nosten's charity, Border Health Foundation (BHF), is one of eight
    organisations worldwide that have applied to distribute the shots from
    the Humanitarian Buffer and one of three to be approved, Gavi said.

    Ann Burton, Chief of Public Health at the U.N. refugee agency UNHCR,
    said the liability issue was one reason agencies have been slow to
    apply. The programme has also been delayed by the general shortage of
    vaccines and administrative hurdles read more .

    Organisations applying for supplies from the buffer may not choose
    which vaccines they receive. Working with displaced people, Nosten said
    it would be more convenient to give them Johnson & Johnson's vaccine,
    which offers protection after a single dose instead of the two doses
    needed for Sinopharm's.

    But the Sinopharm version will be "better than nothing," he said.

    More than 100 national governments have promised to offer vaccines
    where possible to all the displaced people on their soil, according to
    the IOM. However, the U.N. group says migrants and refugees are often effectively excluded from such schemes because of administrative or
    cultural hurdles.

    In cases where governments aren't 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.

    Gavi set up the buffer in March 2021, planning to reserve up to 5% of
    vaccine doses as they become available to COVAX, which would amount to
    roughly 70 million doses so far.

    The only shots delivered from the buffer so far - just over 1.6 million Sinopharm doses landed in Iran in November, where high numbers of
    displaced Afghans have arrived, UNICEF Iran said. That's enough to
    inoculate about 800,000 people; more will likely be needed, UNICEF
    said.

    NEED FOR SPEED

    The vaccine makers' legal concern is rooted in the unprecedented speed
    of the effort to develop the COVID shots, the EFPIA said.

    In normal circumstances, drugmakers buy insurance to cover liability
    for vaccines' potential adverse effects. But COVID forced them to
    develop drugs so quickly that some side effects - for instance, a rare blood-clotting condition in some of those who took the AstraZeneca
    vaccine - are emerging as shots go into people's arms.

    Many governments and international agencies have set up compensation
    schemes to reimburse victims and avoid lengthy litigation. An emergency
    law invoked by the U.S. government provides legal immunity for drug
    companies for side effects from their COVID-19 vaccines used in the
    country. The only exception is for instances of "wilful misconduct."

    For drug companies, accepting potential liability runs counter to
    standard practice.

    "Vaccine manufacturers try to minimize legal risks in almost every
    setting," said John T. Monahan, Professor at Georgetown University.
    "The gold standard is full immunity from lawsuits. If they accept
    carve-outs, it may become more difficult to reach that goal."

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