One year after the declaration of the COVID-19 pandemic by the World Health Organization (WHO) and despite the implementation of mandatory physical barriers and social distancing, humanity remains challenged by a long-lasting and devastating public health crisis. Non-pharmacological interventions (NPI) are efficient mitigation strategies. The success of these intense NPI is dependent on the approval and commitment of the population. The launch of a mass vaccination program in many countries in late December 2020 with mRNA vaccines, adenovirus-based vaccines, and inactivated virus vaccines has generated hope for the end of the pandemic. Current issues: The continuous appearance of new pathogenic viral strains and the ability of vaccines to prevent infection and transmission raise important concerns as we try to achieve community immunity against SARS-CoV-2 and its variants. The need of a second and even third generation of vaccines and the possibility of potentially harmful side-effects of the vaccines (i.e. venous thromboembolism ) have already been acknowledged. Perspectives: There is a critical and urgent need for a balanced and integrated strategy for the management of the COVID-19 outbreaks organized on three axes: (1) Prevention of the SARS-CoV-2 infection, (2) Detection and early diagnosis of patients at risk of disease worsening, and (3) Anticipation of medical care (PDA). Conclusion: The “PDA strategy” integrated into state policy for the support and expansion of health systems and introduction of digital organization (i.e. telemedicine, artificial intelligence and machine learning technology) is of major importance for the preservation of citizens’ health and life world-wide.

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This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients.