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 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.
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. and
its partner BioNTech SE, AstraZeneca PLC and Moderna Inc., 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
https://twitter.com/GaviSeth/status/
1440780492324818945?s=20 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,
Sinopharm Group Co. Ltd, and Clover Biopharmaceuticals Co. Ltd,
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 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.
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.
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 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.
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."
(Edited by Jospehone Mason and Sara Ledwith)
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