Proper Informed Consent May Be Missing for COVID Vaccines, States Physicians for Civil Defense
TUCSON, Ariz., March 29, 2021 /PRNewswire/ -- In the rush to administer more than a million doses of COVID vaccines daily, proper consent is not being always documented, according to patients' reports to Physicians for Civil Defense.
These products are not FDA approved, but are only available under an Emergency Use Authorization (EUA), notes Jane Orient, M.D., the organization's president. By law, persons must be free to accept or decline such products.
All vaccine recipients should sign a consent form and be given a copy of an EUA Fact Sheet.
The Fact Sheet for the Moderna COVID-19 product lists symptoms of a severe allergic reaction, and also states: "These may not be all the possible side effects of the Moderna COVID-19 Vaccine. Serious and unexpected side effects may occur. The Moderna COVID-19 Vaccine is still being studied in clinical trials."
Unlike the package insert for approved vaccines or drugs, or consent for a surgical procedure, the Fact Sheet does not elaborate on what these serious side effects might be, such as bleeding, blood clots, paralysis, miscarriage, or death, states Dr. Orient. Nor does it remind recipients that serious effects, such as infertility, cancers, or birth defects might not appear for years. People might want to consider the following:
The consent form states that the vaccinee has carefully considered risks and benefits.
Physicians for Civil Defense provides information to help save lives in the event of natural or man-made disasters.
Contact: Jane M. Orient, M.D., (520) 323-3110, [email protected]
SOURCE Physicians for Civil Defense
