The FDA (Food and Drug Administration) is implementing strict rules on coronavirus vaccine release, just like they promised last month.
The new rule from the US FDA is that no vaccine should be released before the agency gets two months of data after the second dose of vaccines.
If the vaccine trial participants show no side effects two months after receiving the second dose, then the FDA will approve the vaccine for general use.
Emergency authorizations become impossible under the new rules, and there won’t be an available vaccine before Election Day, as President Trump promised on many occasions.
Any authorized vaccine needs to be safe before delivered to millions of people throughout the country and around the world.
The FDA officials say, “That would include “data from Phase 3 studies that include a median follow-up duration of at least two months after completion of the full vaccination regimen to help 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.”