Francesco Guarascio, Panu Wongcha –

BRUSSELS/BANGKOK, (Reuters) – Some major vaccine manufacturers may refuse to supply COVID-19 vaccinations for millions of migrants, as they are concerned about the legal consequences of side effects. This is according to internal documents and officials from Gavi, which oversees the program.

Nearly two decades after a pandemic which has killed over 5 million people worldwide, only 7% have been vaccinated in low-income nations. Production problems and hoarding in rich countries have all impeded vaccine deliveries around the world. Hesitancy by the general public has also hampered many programs.

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. The United Nations states that many COVID-19 vaccine makers have asked for countries to indemnify them in the event of adverse effects suffered by patients as a direct result of their vaccines.

It is impossible to control governments when they aren’t in charge.

These concerns concern people such as the displaced persons from the Myanmar, Afghanistan, and Ethiopian crises who are not eligible for national government vaccination programs.

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 that was established in 2000 to encourage vaccination all over the globe.

However, this buffer doesn’t have any compensation mechanism. Gavi is a COVAX operator with the World Health Organization.

These companies offer only a fraction of the vaccines in these conditions, according to sources familiar with it and documents written by Gavi staff to be presented to the board at the beginning of November.

COVAX has been used in more than half of all COVAX doses. Pfizer Inc. (NYSE) with its partner BioNTechSE (NASDAQ:), AstraZeneca, (NASDAQ:), PLC and Moderna Gavi states that (NASDAQ:) Inc. Moderna refused to comment. Pfizer, AstraZeneca, and Pfizer both said they had been in contact with Gavi. However, they declined to provide further details. They all stated that they were committed to making low-cost doses of medication available for poorer countries. Pfizer indicated that it had partnered directly with Lebanon and Jordan to help refugees receive doses.

Gavi states that less than 2,000,000 doses have been sent to the buffer so far, mainly due to legal issues. The documents cite data from the United Nations that shows about 167 millions people could be excluded from programs.

If all of the companies do not accept legal liability, there is no way to access vaccines for some people.

A spokesperson for Gavi said that the reluctance of vaccine manufacturers to accept legal risk is “a major obstacle” to attempts to supply vaccines to the buffer. Gavi declined to comment on details of the documents but stated that applications for vaccines remain confidential until they are received. 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.

China’s three drugmakers, SinoVac Biotech Ltd and Sinopharm Group Co (OTC): Three Chinese drugmakers agreed to take legal risk when shots pass through buffer. According to the Gavi, Clover Biopharmaceuticals Co. Ltd. Requests for comment were not answered by the drugmakers.

Johnson & Johnson (NYSE:) 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 didn’t elaborate.

COVAX data indicates that less than one third of COVAX supply has come from these four companies. Clover’s shot is still not approved and therefore, it is currently not being used.

International Federation of Pharmaceutical Manufacturers and Associations, a global industry association (IFPMA), stated that no company had refused to accept the risk. It said that some companies felt they couldn’t do it without knowing the exact location and methods of vaccines.

The European Federation of Pharmaceutical Industries and Associations, which represents major European pharmaceutical companies, stated that it would be difficult to monitor the safety of vaccines in refugee camps.

It stated that vaccines may be blamed by people for problems that arise afterward, even if these issues are not connected.

It stated in a statement that it could lead to more litigation cases… where the safety and effectiveness of the vaccine will be publically questioned.” It warned that this could lead to greater vaccine hesitancy, and slower recovery from pandemic.

There is not much information available on COVID vaccine litigation. However, claims to out-of court compensation programs are one indicator of the danger. According to public data, no US program has paid out any money. A WHO programme for low-income countries has not been established, according to the WHO. A handful of European compensation awards were granted for unspecified amounts of money. Official data from Denmark and Germany, Norway, Switzerland, and Switzerland shows this.

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.

However, they are more at risk from infection if their healthcare is poor and the conditions in which they live are difficult. Combining this with low vaccination levels in mobile populations can lead to new infections and could be an indicator of infection. Mireille Lembwadio is the Global Vaccination Coordinator for the International Organization of Migration. This U.N.-related organization advises countries and migrants.

“Leaving them unvaccinated can spread the virus and variants throughout the world,” she stated.

WAITING FOR DOOSES

Francois Nosten is a French professor and helps to coordinate health care for Myanmar residents living near the Thai border. 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 is a malaria researcher and is anticipating the dosages. This is a small fraction of the 8 billion worldwide. They will be delivered by Sinopharm and Nosten hopes that they can inoculate the Tak province’s key populations at risk. Gavi stated that delivery arrangements remain to be finalized.

International Rescue Committee, a humanitarian organisation working alongside Nosten will distribute approximately 22,000 doses of medication to those in camps.

Darren Hertz (IRC Thailand Director) stated that at this stage, any vaccine they can obtain we are thankful for. The IRC stated that it was unlikely that any refugee would try to sue for side effects.

Hertz claimed that IRC had received only a few ad hoc vaccination donations from Thailand and was currently working to control significant outbreaks in five out of nine camps along the border. There have been approximately 3,000 cases, with at least 26 deaths. The spokesperson for the Thai foreign ministry confirmed that the government is working closely with IRC to provide vaccinations at border shelters.

Gavi explained that Nosten’s charity Border Health Foundation, (BHF), was one of only eight worldwide organizations to apply to the Humanitarian Buffer to distribute the shots.

Ann Burton is the Chief of Public Health for UNHCR. She said that one reason why agencies were slow to apply was the liability issue. A general lack of vaccines as well as administrative obstacles have also delayed the programme.

Organizations that apply for vaccine supplies may be unable to choose the vaccines they will 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.

However, the Sinopharm version is “better than anything,” he stated.

According to IOM, more than 100 countries have pledged to provide vaccines to any displaced persons living on their territory. According to the U.N., refugees and migrants are frequently excluded from vaccine programs because of cultural or administrative hurdles.

COVAX’s Humanitarian Buffer will be the sole option in situations where government aren’t responsible or don’t agree to vaccinate migrants. 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 created the buffer in February 2021. It was designed to hold as much as 5% of all vaccine doses that become available to COVAX. That would make it a total of roughly 70,000,000 doses.

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. UNICEF stated that this is enough to inoculate approximately 800,000. More will be required.

NEED SPEED

According to the EFPIA, vaccine manufacturers’ concerns are rooted in an unprecedented pace of development of COVID shots.

Drugmakers usually purchase insurance to insure against the potential negative effects of vaccines. COVID made it necessary to quickly develop vaccines. Some side effects, such as a rare condition that causes blood clots in people who have taken the AstraZeneca vaccination, are now being discovered.

International agencies and governments have created compensation plans to help victims get their money back and avoid long litigation. A U.S. emergency law provides legal immunity to drug firms for side effects of COVID-19 vaccines they used in the United States. Only “wilful misconduct” is exempt.

Drug companies must accept potential liability. This is against the norm.

John T. Monahan (Professor at Georgetown University) stated that “vaccine manufacturers attempt to minimize legal risks almost everywhere,” The gold standard for immunity is complete immunity to lawsuits. It may be more challenging to achieve that goal if they agree to carve outs.

Edited by Sara Ledwith and Jospehone Mason