26 Dec, 2020. Procurement contracts for vaccines have forced governments to consider whether they should give legal indemnity to vaccine makers

“The potential compensations to be paid are likely to be too much for any entity – either vaccine producers or poorer countries – to assume by themselves,” said Keiji Fukuda, a clinical professor at the University of Hong Kong who previously worked for the World Health Organization (WHO).
Countries’ regulators have repeatedly emphasised that serious adverse effects caused by vaccinations generally are rare – about one or two per million doses.
But the full picture on possible side-effects is not yet known, with Covid-19 vaccines having been developed at an unprecedented speed – developing a vaccine typically takes up to a decade. Some side-effects may be found only after large-scale vaccination.
At least eight people have reported serious allergic reactions after receiving the Pfizer and BioNTech mRNA vaccine in the past two weeks, according to Science magazine.
“On the one hand, the Covid-19 vaccines are urgently needed and could be used by billions of people,” Fukuda said. “On the other hand, there is little experience with them and the full risks for serious adverse events is not clear.”
Covax, a global initiative aimed at securing equitable access to Covid-19 vaccines for 92 low and middle-income countries, also seeks to indemnify suppliers with the aim of removing barriers to acquiring doses.
Co-led by the Coalition for Epidemic Preparedness Innovations, the vaccine alliance Gavi – backed by the Bill & Melinda Gates Foundation – and the WHO, the Covax programme published a briefing note in November addressing the issue.
The note said that “countries and territories will be required to indemnify the manufacturer” and that Covax was “exploring backstopping guarantees for these indemnification obligations”.
Under normal circumstances, vaccine manufacturers and distributors would get insurance to cover the risks, but such coverage may not be available for the current pandemic because of its unprecedented scale, the note added.

Covax said it would establish a no-fault compensation mechanism for people suffering serious side-effects after receiving a vaccine from its programme. The level of compensation would depend on the severity of the effect and the GDP per capita of the country, it said, with payment funded by a levy on vaccines, involving contributions from manufacturers and participating countries.
No-fault compensation programmes for vaccine side-effects, first initiated in the 1960s, are designed to reduce the need to resort to legal action to access compensation, by not requiring the injured party to prove negligence or fault by a vaccine provider or manufacturer.
Of the WHO’s 194 member states, at least 25 – mostly high-income ones – have previously implemented such a mechanism, according to an analysis of no-fault compensation programmes published in the journal PLOS One in May.

Although the programmes in all of those countries require proof of the causal relationship between vaccination and side-effect, they vary when it comes to aspects such as the source of funding and who oversees it.
In the United States, vaccine manufacturers are protected from legal liability when providing products to combat public health emergencies such as a pandemic, under the 2005 Public Readiness and Emergency Preparedness Act. In 2010, the legislation established a compensation fund for people suffering adverse side-effects, which has since paid out on 29 of the 499 claims filed, with 10 cases still under medical review, according to the Health Resources & Services Administration.
Given the low approval rate for claims, legal experts have questioned the worth of the scheme, Reuters has reported.


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