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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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Let's go Brandon!

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