PHREB Guidance on the Use of Placebo for COVID-19 Vaccine Trials
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When several vaccines are already available and being administered in the community, the use of placebo for COVID-19 vaccine trials would be unethical. Consistent with the National Guidelines and the Helsinki Declaration, standard care (available vaccines) should be provided to trial participants in the control groups.
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The trials should use other vaccines as comparators.
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Additionally, we should ensure that vaccine clinical trials are conducted only when the PHREB requirements in the attached Checklist (previously provided to the Vaccine Expert Panel) are implemented. Among these requirements, we highlight numbers 5 and 6, which are particularly important for all participants (placebo or otherwise) especially because of heightened risks and other developments related to the spread of the highly transmissible virus variant:
a. A certification from the LGU that the necessary support system for a vaccine trial is in place – hospitals, social services,
monitoring system for adverse events, database, etc.
b. A Health Insurance Policy (c/o Sponsor) that covers possible harm/injuries that may ensue from participation
in the vaccine trial.
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It is unethical to consider exceptions at this time (even if proponents may be convinced of an overwhelming scientific and social value of possible trials that can best be undertaken with placebo controls) because the healthcare system is stressed and is not in a position to address the needs of the participants who may encounter/experience moderate or severe infection or adverse events. This is consistent with the provisions of the National Guidelines and with the specific provision of the Helsinki Declaration that “while the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.”
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Regarding Ongoing Vaccine Trials that may still be using placebo:
a. We expect the research teams to stop the placebo arms and shift to vaccine controls in accordance
with the adaptive trial designs described previously by the VEP.
b. In view of heightened risks and other developments relating to the highly transmissible virus variant,
we require the research teams to report to the SJREB and PHREB ASAP regarding the management
of placebo controls.
c. All participants in ongoing trials should be reconsented and offered the option to be vaccinated for the following reasons:
i. The information provided to the participants when their consent was sought has significantly changed,
thereby rendering the original consent invalid.
ii. The risk-benefit ratio for participants has significantly changed and the appreciation of the ratio – and
the decision to act on the basis of such appreciation – should be made by the participants themselves.
iii. Although vaccines are still locally available only under EUA, it has been established that these are
capable of preventing risks of serious or irreversible harm that those on placebo will be exposed to.
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