The new era of vaccines: scientific challenges and their regulatory needs

The COVID-19 pandemic has confirmed that vaccines for infectious diseases have made the greatest contribution to global health of any intervention. On the other hand, it was not long ago that vaccines for cancer were just a dream for the future, whereas now they represent a viable option for active immunotherapy. Vaccines for the prevention of infectious diseases are referred to as traditional vaccines or prophylactic or preventive vaccines because they intend to directly prevent pathologies, whereas cancer vaccines are mainly therapeutic vaccines because they are used to treat cancer after it has already appeared. From the scientific point of view, both infectious and cancer vaccines aim to harness the immune system as part of the mechanism of action to achieve the therapeutic effect. Although for a long time the development of efficacious vaccines has relied on the better-known models of the immune response to infections, the recent breakthrough in cancer immunotherapy has disclosed the great advantage of sharing knowledge of host immunity to design novel vaccines. In addition, the recent remarkable technological advancements are now fostering a rapid evolution of the therapeutic potential of vaccinations. This new and vivid scientific landscape inevitably calls for a more suitable regulatory environment to promote the advancement in vaccines for infectious, degenerative and cancer diseases. Therefore, it has become urgent to clarify ambiguities in vaccinology, to absorb most meaningful scientific achievements in the processes for navigating the regulatory maze to bridge scientific challenges and regulatory needs.

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