Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. — FDA statement on EAUs
In other words, if there is a viable option, an EAU should not be granted.
Safety and efficacy testing is still ongoing for this product. Details are in the Review Memorandum found in the FDA’s main page for this product. Therefore, no advertising for this product may legally use the terms “safe and effective”.
Sources:
- US Food & Drug Administration. “Janssen COVID-19 Vaccine.”
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine.
Food & Drug Administration.
This is the FDA’s main page for the Janssen COVID-19 Vaccine. Links to FDA letters, memos, reports, and other documents relating the Janssen COVID-19 Vaccine can be found here. - US Food & Drug Administration. “Emergency Use Authorization.”
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
Food & Drug Administration.
This is an information page describing the Emergency Use Authorization policies.
See also, on this site:
- August 22, 2005: Virology Journal: “Chloroquine is a potent inhibitor of SARS coronavirus infection and spread”
- July 2, 2020: Dr. Vladimir Zelenko publishes his COVID-19 treatment protocol.
- November 19, 2020: The United States Senate holds a hearing on Senate Hearing on COVID-19 Outpatient Treatment.