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FDA hopes indemnification issues on COVID-19 vaccines will be 'settled soon'
FDA hopes indemnification issues on COVID-19 vaccines will be 'settled soon'
Food and Drug Administration (FDA) Director General Eric Domingo on Friday, Feb. 12, expressed hope that the indemnification issues surrounding the coronavirus disease 2019 (COVID-19) vaccines will soon be ironed out to ensure the smooth and timely roll out of the country’s vaccination program.
Domingo, in an online interview, said that in other countries such as the United States, United Kingdom, and Japan, there are laws for indemnification or compensation in case of any vaccine injury.
“I hope they settle it soon because I think that’s the last remaining point - the indemnification clause of the contract,” Domingo said. If not, he noted that that the timeline of the vaccination program might be affected.
Initially, Domingo said that World Heath Organization (WHO) was ready to ship the vaccines on Feb. 15. “We also prepared for it but I guess they will not ship the vaccines to the Philippines until the details of the contract have been settled,” he added.
Domingo said that there is no existing indemnification framework in the country. “In other countries, there is a legal framework for indemnification injury but here, we have no laws that will help, assist or compensate vaccine injuries,” he explained.
The need for indemnification, Domingo said, has never happened before because all products that the country procured prior the COVID-19 pandemic “are fully registered.”
However, Domingo said for the COVID-19 vaccines, these are under Emergency Use Authorization (EUA). “We are asking the companies to give it to us even if they are not ready to commercialize it or sell it yet,” he explained. “Since we decided to use them under EUA, what the companies want is the government will be responsible for any injury,” he explained.
This is the case for all vaccines under EUA, Domingo said. “Even the COVAX require an indemnification clause in their contract,” he added.
Domingo also expressed support to the proposal to set an Indemnification Fund so in case the the government needs it. “This is a common practice in other countries, for example there are adverse effects or death, the government can compensate the vaccine recipient or the family from the indemnification fund,” he added.
When he was still in Department of Health (DOH), Domingo said that they have been pushing for indemnification. “We should have something like that because it also helps decrease hesitancy in vaccination,” he ended.