A new study has shown that millions of migrants may be denied COVID-19 vaccines from the global programme due to big pharmaceutical companies’ scared of being sued due to harmful side effects.

This stunning revelation was based on words from officials of these big companies as well as internal documents from Gavi, the charity operating the program.

Considering the devastating effects of the pandemic on a global scale since 2019, over 5 million fatal cases have been reported not to talk of the devastating effects it had on the global economy.

As of now, only about 7% of of people residing in low-income countries have received COVID shots.

One of the main reason for this is due to the haording by richer countries, export restrictions, and red tape.

There have alsobeen hampering of numerous programs due to hesitancy among the general public all of which have contributed to these uneven numbers across the globe in regards to vaccine distribution.

Then comes the legal concerns that COVID vaccine manufacturers are fearing. Despite the fact that officials says that unvaccinated people give an ideal environment for coronavirus to mutate into another terrifying variant in the near future.

However, COVID vaccine manufacturers often require countries around the world to indemnify them for any adverse effect suffered by individuals due to the vaccines – says the United Nations.

But in the case of refugees where governments are often not in full control, the situation becomes even more complicated.

With a number of people displaced across the world in countries such as Myanmmar, Afghanistan, and Ethiopia, these issues are beyond the reach of national governments’ vaccination campaigns according to Reuters.

Currently, there is a global program in place called COVAX, meant to be a last resort reserve of shots to be administered by humanitarian groups. The aim is to help refugees, migrants, and asylum-seekers as well as those afflicted by natural disasters or any event that’s taken them out of the reach of their goverment’s help.

Gavi is one of such humanitarian group put in place since the year 2000 to promote vaccination across the globe.

There is however a humanitarian buffer as Gavi, which also operates COVAX with the World Health Organization (WHO) made it known that in applying for covid vaccines, organizations – mainly NGOs, can’t bear legal risks, as deliveries from stockpiled vacines can only be made of vaccine manufacturers are willing to accept liabilities.

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.

According to Gavi, over two-thirds of COVAX doses have come from big pharmas like Pfizer, AstraZeneca, and Moderna even though the latter has declined to make any comment on the matter.

AstraZeneca and Pfizer on the other hand said they were in talk with Gavi but failed to detail what they had spoken about.

However, the three big pharmas stated they were willing to provide their doses to poorer countries across the globe at a relatively cheaper prices.

Pfizer in particular stated that it was in a collaboration with the governments in countries like Jordan and Lebanon in order to donate doses for refugees.

However, up until now, less than 2 million does have been sent so far from the buffer according to Gavi despite the fact that there are about 167 million people at risk of being excluded from national programs according to a United Nations data that was 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.

Because of the fact that vaccine makers are refusing to take on the liability, this has become a major hurdle in attempts to provide vaccines for the buffer, says a spokesperson for Gavi.

The humanitarian organization didn’t comment on the details in the documents, but stated that 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.

On the other hand are three Chinese pharmaceuticals willing to shoulder the legal risk when their vaccines are delivered through the buffer.

Those companies includes SonoVac BioTech, SinoPharm Group, and Clover Biopharmaceuticals.

None of the three pharmas responded 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.

According to International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), “no company has refused to consider” taking on the legal risk.

But in the case of shots delivered from the buffer, it stated that some firms thought they could not do so without full knowledge of where and how vaccines would be used.

How difficult it would be to monitor vaccines for safety in refugee camps as well as delivery are parts of the challenges that aren’t suitable for all types of vaccines, according to the European Federation of Pharmaceutical Industries and Association (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 could potentially lead to an increase in vaccine hesitancy as well as slow down recovery rate 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.

According to public data, a program put in place in the United States has not paid out anything; even the one setv up by the WHO for lower income countries hasn’t yielded anything, says WHO.

In Europe, a handful of compensation awards have been granted for undisclosed amounts of money, official data from Denmark, Germany, Norway and Switzerland show.

One of the main reason for the low number of reported cases among refugees globally is due to the fact that testing isn’t always systematic and infections can reportedly generate only mild symptoms – especially in younger people.

In cramped conditions with a weak healthcare, there is certainly going to be a high infection risk due to exposure.

Now, combine that with low levels of vaccination in a mobile population, that could potentially cause an emergence of another variant and be a vector for infection, says Mireille Lembwaido, Global Vaccination Coordination at the Internation Organization of Migration (IOM), a UN-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

According to Francois Nosten, a French professor that helps with the coordination of healthcare for people from Myanmar, living on the border with Thailand, is one of those waiting waiting for vaccines.

Back in June, the put in a request from the Humanitarian Buffer for 70,000 doses – some for some of the 90,000 individuals sheltering in camps along the border, but most for unregistered migrants in the border town of Mae Sot and villages closeby.

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.

For how long will this go?

Due to the unprecedented speed in an effort to quickly develop a COVID vaccine, all of these are parts of the root-cause of the legal concerns shared among vaccine makers, says EFPIA.

Due to the fact that big pharmas often buy insurance that cover liability for vaccines’ potential adverse effect, the adverse effect of COVID has led these companies to develop the vaccines so fast 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.

On the other hand are some governments as well as international agencies donating to compensation schemes to reimburse victims as well as avoid lengthy litigation.

There was also an emergency law invoked by the US government to provide legal immunity for COVID vaccine makers in case of side effects from shots used in the country.

The only exception is for instances of “willful 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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