FDA’s direction on vaccine development against COVID-19

Last Tuesday, the U.S Food and Drug Administration has released its standards on how it will proceed to analyze experimental vaccines against the SARS-CoV-2. It is very clear that the agency will be expecting real-world safety evidence and effectiveness in large trials in order to approve a vaccine that really works. So, the mere detection of an immune response in a candidate’s blood test, that it is identified relatively quickly, won’t be enough.

Actually, the FDA sees the approval based on the so-called surrogate endpoints too risky in this particular condition; in fact, the past teaches us that this process could provide non-effective drugs to the patients, found only after a series of further analysis. In the case of COVID-19 this has to be avoided, therefore it is fundamental to release a vaccine with a solid demonstration of effectiveness. In order to guarantee this, FDA has also indicated as a threshold that the product should act at least 50% better than a placebo in reducing the infection or illness risks.

For the next future, an absolute transparent standard and real data effectiveness will be requested from the drug makers, because knowledge of how immunity works against the novel coronavirus are at the very beginning and it is not imaginable to approve a vaccine that puts people at risk of infection and consequently open the possibility that the process could not be at all trusted by the population.