The Food and Drug Administration stated that the experimental COVID-19 vaccines need to provide at least two months of follow-up data after trial members have received their final injection. This is what the makers of the vaccines need to do in order to approve them.
This new requirement actually creates an impossible timeline for drugmakers – they cannot receive approval by the 3rd of November.
The FDA has updated its requirements. The vaccine makers should follow its participants for at least 2 months after they receive their final dosage. They need to do it in order to rule out any major side effects before submitting it for the approval.
According to the guidelines, the data will “provide adequate information to assess a vaccine’s benefit-risk profile including adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect.”
These requirements are mainly for those who are looking for rapid approval through the FDA’s emergency authorization pathway. This accelerated process is made for health emergencies, and it allows the medical products to get onto the market. They usually use a lower bar than the traditional FDA approval.
The FDA has stated that only vaccines that prove that are safe will be authorized for coronavirus. Dr. Peter Marks stated that this guidance was made to build public confidence and to ensure the use of COVID-19 vaccines when they are available. They will outline the entire process and the recommended scientific data.
However, the White House has blocked the FDA’s plans to publish the safety guidelines with the two-month data requirement, on the grounds that there is no medical reason for it.