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By Francesco Guarascio and Panu Wongcha-um
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% https://ourworldindata.org/covid-vaccinations
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.
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 Josephine Mason and Sara Ledwith)
