FDA requires randomized control studies for early treatment medications — but not for boosters
The CDC reports that as of April 8, 98.3 million Americans had received a COVID booster.
On March 29, the U.S. Food and Drug Administration (FDA) authorized a second booster for the immunocompromised and adults over age 50.
These authorizations were made not because of solid evidence the boosters are effective but rather to remedy the fact that the primary vaccine series has been widely shown to have waning efficacy within a few months.
As reported by The Defender, Dr. Peter Marks, director of the FDA’s vaccine division, Center for Biologics Evaluation and Research, admitted the fourth booster dose approved last week was a “stopgap measure” — in other words, a temporary measure to be implemented until a proper solution may be found in the future.
Despite the lack of solid evidence, the FDA continues to recommend and authorize boosters.
Yet when it comes to early treatment options, the agency holds medicines — including those the agency has already licensed and approved for other uses — to a different standard.
In this CNN interview from August 2021, Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, warns people not to take ivermectin for COVID because “there is no clinical evidence that this works.”
With regard to hydroxychloroquine, Fauci said, “We know that every single good study — and by good study, I mean randomized control study in which the data are firm and believable — has s shown that hydroxychloroquine is not effective in the treatment of Covid-19”, as reported by the BBC on July 29, 2020.
Where, then, are the randomized control studies in which the data are firm and believable that show boosters are effective at preventing COVID?
There aren’t any. None have been done.
As of today, the FDA still refuses to authorize the use of ivermectin and hydroxychloroquine to treat COVID despite hundreds of studies that demonstrate significant benefits (ivermectin, hydroxychloroquine) in prevention as well as early and late treatment.
The double standard here is blatant. There are no randomized control studies that show boosters are effective in preventing COVID.