COVID-19 Tools

It is crucial that the World Health Organisation, as a credible neutral body, should appoint a group of experts to compile an updated list of the current status of the clinical trials and to specify how to communicate the results. We believe that this should be within the WHO framework of The Access to COVID-19 Tools (ACT) Accelerator initiative. This overview should identify all aspects of the vaccine production and the trial methodology. For example, production methods should specify all the ingredients including antigens, adjuvants, stabilisers, antibiotics and preservatives.

Companies should be encouraged to publish a paper with their trial design, methods and results in a peer-reviewed journal. And given that we should strive to publish these papers as rapidly as possible, journals should prioritise them, and ensure rigour and timeliness in their peer-review process.

The scientific publication should at least include the following:

• detailed study design
• method of recruiting participants
• sample size in total and by study arm.
• main characteristics of the study population including age, gender, ethnicity, health status and other key variables.
• detailed features of the vaccine
• storage requirements
• dose
• route of administration and schedule
• trial duration
• total accrual time
• loss to follow-up, as specified in the standard protocols for clinical trials investigating vaccines.

Safety and efficacy evaluation should identify the primary and secondary endpoints. Results need to be presented systematically, with precise statistical analyses and specification of the overall efficacy and sub-group efficacy (with confidence intervals), and adverse effects analyses by age group and sex. The authors also need to discuss the strengths and limitations of the trial. There are other relevant questions that the company should discuss, such as the possible impact of carrying out the trial in a limited time. In addition, the authors must present the current understanding of the following:

• estimates of how long after immunisation it takes to be protected
• the estimated duration of protection
• whether vaccination will prevent transmission
• to what extent violations of the cold-chain affect the efficacy of the vaccine
• could there be atypical disease in vaccinated subjects. 

Governments, public health professionals and society as a whole must support fair and equitable access for every country. To help with the logistical and practical aspects of making this happen, all the information from the clinical trials must have incontrovertible credibility. In summary, with covid-19 vaccines there are reasons to be hopeful, but we need to address the concerns. We strongly advocate for the need to define a standard protocol on what data must be released before a company starts to market its vaccine. This should be complemented with guidelines on how to compare the benefits of each new vaccine as it becomes available. We believe the WHO is best suited to coordinate such a process.