Vaccine manufacturers such as Modern (+6.06%), BIONTECH (+4.01%) or Pfizer (+2.26%) have celebrated on Wall Street the New regulatory guide of the US Food and Medicines Administration (FDA) for Annual reinforcements against COVID-19 destined for healthy Americans under 65 years. And, the FDA Commissioner Marty Makary, and the main Vinay Prasad vaccine regulator, have published an article in 'The New England Journal of Medicine' in which they point out that, «although the rapid development of multiple vaccines against COVID-19 in 2020 represents an important scientific, doctor and regulatory achievement, The benefit of the repeated doseespecially among low-risk people who have previously received multiple doses of vaccines against COVID-19 have had multiple infections by COVID, or both, It is uncertain«Therefore, with the aim of providing guidance and promoting evidence generation, the FDA has adopted a New Vaccination Regulatory Framework. «The new COVID-19 philosophy of the FDA represents a balance between regulatory flexibility and commitment to reference science,» they explain. «The FDA will approve vaccines for high -risk people and, at the same time, it will require solid and reference data on low -risk people. «In this sense, they indicate that, based on the Immunogenicity (Proof that a vaccine can generate antibody titles in people), «may make favorable benefit-risgo findings for adults over 65 years old and for all people over 6 months with one or more risk factors that put them at high risk of serious COVID-19 «. For all healthy people (those without severe risk factors of COVID-19) between the ages of 6 months and 64 years, the FDA anticipates the need for random controlled tests that evaluate clinical results before biological license requests may be granted. «As far as possible, By approving a vaccine against COVID-19 for high-risk groupsthe FDA will encourage manufacturers to perform random controlled trials in the population of healthy adults as part of their commitment after marketing. «Thus, these clinical trials will guide the future guidelines of the FDAbut, «what is more important, they will provide information that health professionals and the American population urgently need.»