The Food and Drug Administration (FDA) is considering approving the administration of new covid vaccines without going through the human trial phase. FDA could approve the new versions against the Omicron variant and its subvariants as early as this week without them having passed the necessary process to demonstrate that they are safe and work in humans.
The Wall Street Journal (WSJ) noted that the drug agency wants to change this step in testing onto others such as mouse research or simple reliance on the original vaccines. "Real-world evidence from current Covid-19 mRNA vaccines, which have been administered to millions of individuals, shows us that the vaccines are safe," said FDA Commissioner Robert Califf.
Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe. As we know from prior experience, strain changes can be made without affecting safety.
- Dr. Robert M. Califf (@DrCaliff_FDA) August 25, 2022
In this way, the FDA wants to follow the process it already uses with other vaccines such as influenza, which are updated every year to combat mutations in the virus. However, several voices warned of the dangers of this procedure. WSJ collected testimony from Paul Offit, FDA consultant and director of the Vaccine Education Center at the Children's Hospital of Philadelphia:
It makes me uncomfortable that we are moving forward, that we are giving millions or tens of millions of doses to people based on mouse data.
The FDA plans to approve these reinforcements later this week. However, human trials for Moderna's subvariant-targeted vaccine have recently begun and for the Pfizer-BioNTech vaccine are expected to start this month. Therefore, the results will not be available before the reinforcement campaign planned by the government for the fall. The solution: skip a fundamental step in the approval of vaccines, that of testing them in humans.
According to the Centers for Disease Control and Prevention (CDC), the BA.5 variant of Omicron is responsible for almost 89% of covid cases, while BA.4 accounts for 3.6% and BA.4.6 for 7.%. As winter approaches in the northern hemisphere and a new wave of cases is predicted, experts are now torn between those who want to meet all safety requirements and complete clinical trials. The same applies to those who choose to skip the human testing, even in small groups, and those who choose to skip the human testing. It appears that the FDA will listen to the latter.