World Medical Association’s Declaration of Helsinki places principle of informed consent at center of experimental medical research
Los Angeles, CA – America’s Frontline Doctors (AFLDS) today urged the Biden administration to adhere to accepted international standards as it pursues an evolving goal of vaccinating 300 million Americans by summer with the announced purchase of 200 million additional Pfizer and Moderna inoculations. In particular, AFLDS is calling on President Biden and his COVID-19 response team to observe the principle of “informed consent” outlined in the World Medical Association’s Declaration of Helsinki, the internationally recognized set of ethical guidelines concerning medical research with human subjects.
“Before the Biden administration embarks on its mass vaccination program using a treatment not fully approved by the FDA, the president needs to level with the American public. First, internationally recognized rules governing informed consent should dictate distribution and administration at federal and state levels. Second, in keeping with those protocols and the AFLDS Vaccine Bill of Rights, no citizen can be mandated, coerced, forced or pressured to take a COVID-19 vaccine, the human health impacts of which are still being researched. Third, disastrous public protocols, such as general lockdowns and bans on in-person schooling, must end immediately,” said America’s Frontline Doctors.
Both the Pfizer-BioNTech and Moderna vaccines are labeled “investigational” or experimental by the Food and Drug Administration. The federal agency issued an emergency use authorization (EUA) for the Moderna experimental vaccine on December 18, a week after the FDA signed off on an EUA for Pfizer. An emergency use authorization is not the same as FDA approval. With the anticipated purchase of 200 million additional doses of the two-shot vaccines, President Biden’s COVID-19 response is expected to be the largest experimental medication program in US history. And, while mRNA vaccines have been studied in the past for the flu, Zika, and rabies, this is the first inoculation using genetic code authorized to treat a coronavirus.
“AFLDS is not opposed to at-risk populations having access to these vaccines. However, informed consent is the bedrock of medical research involving human subjects and remains the best set of ethical principles to guide our use of experimental vaccines. You cannot have effective informed consent and public or private mandates when dealing with an experimental drug,” said AFLDS.
“These principles are clear: All medical participation in experimental trials such as the COVID-19 experimental vaccine rollout must remain voluntary, be conducted transparently and with the full slate of benefits and side effects articulated, and guarantee potential immunization patients the option of withdrawing this consent at any time, without reprisal. If President Biden and his administration fail to adhere to these simple guidelines in a clear and consistent way, the American people are right to doubt his commitment to transparent medical ethics in the fight against the COVID-19 pandemic.”