Editor’s note: This article is part of a series of articles by The Defender responding to the latest media coverage of vaccines, triggered by the nomination of Robert F. Kennedy Jr. to lead the U.S. Department of Health and Human Services.
An attorney associated with Robert F. Kennedy Jr. on Wednesday accused mainstream media of “deliberately stoking fear and outrage about vaccines in an attempt to derail Donald Trump’s nomination” of Kennedy for secretary of the U.S. Department of Health and Human Services.
In an op-ed published in The Wall Street Journal, Aaron Siri said a recent New York Times report mischaracterized three narrow petitions his firm filed with the U.S. Food and Drug Administration (FDA). The petitions raised concerns about specific versions of three different vaccines, including one polio vaccine.
Contrary to the Times headline, “Kennedy’s Lawyer Has Asked the F.D.A. to Revoke Approval of the Polio Vaccine,” the petitions did not ask the FDA to revoke the polio or any other vaccine.
The Times also wrongly implied that Siri filed the petitions on behalf of Kennedy.
“The attempts to stoke fear are based on legal work I did for a different client, which I never discussed with Mr. Kennedy,” Siri wrote.
Although Siri said he has worked for Kennedy, including representing Kennedy’s presidential campaign, he filed the FDA petitions on behalf of another client — Informed Consent Action Network (ICAN).
Siri explained that one of the petitions he filed on behalf of ICAN related to IPOL, one of six polio-containing vaccines currently licensed by the FDA. The drug protects people from severe symptoms but does not stop transmission.
Citing FDA documents, Siri wrote that IPOL was licensed for children based on a clinical trial with no control group and only three days of safety review after injection. That is “patently insufficient” to determine possible effects on growing children, he said. Most drugs go through multiyear placebo-controlled trials.
ICAN’s petition asked the FDA to require a proper trial for IPOL, especially given that under the National Childhood Vaccine Injury Act of 1986 IPOL’s manufacturer, Sanofi, is protected from liability for injuries caused by the vaccine.
“No one, least of all our client, wants anyone to have polio. The goal is simply to ensure that vaccines are subject to proper testing for safety and efficacy. The media’s outrage should be directed at the FDA, which licensed a novel vaccine after collecting so little data.”
ICAN filed a second petition with the FDA pertaining to the use of two hepatitis B vaccines for infants and toddlers. The FDA licensed the vaccines based on trials with no control group and monitored the trial participants for side effects for a period of only five or fewer days after vaccination.
“The media again ignored this serious safety gap while making it appear that our client sought to eliminate all hepatitis B vaccines, which isn’t anywhere close to being true,” Siri wrote.
ICAN filed the third petition in response to a peer-reviewed study that found the amount of aluminum adjuvant — a cytotoxic and neurotoxic vaccine ingredient added to generate a stronger immune response — in 13 vaccines did not match the amount listed on the FDA-approved label.
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The petition asked the FDA to confirm that the vaccines were accurately labeled or to pause their distribution until it could do so.
Siri wrote:
“This shouldn’t have been a controversial request. Everyone should agree that the label on a product that is injected into babies should reflect what is in the vial. It is hard to see how anyone can read these petitions and not share these concerns.”
Since Congress passed the 1986 act, the number of vaccines the CDC recommends for children during their first year of life has jumped from three to 29, Siri wrote.
During that time rates of chronic diseases among children have skyrocketed.
Siri concluded:
“We must be able to raise valid questions about vaccines without fear that anyone who deviates from the accepted orthodoxy will be smeared as a radical. There are many issues that divide Americans, but drug and vaccine safety should unite us.
“The media should take a second look at what vaccine-safety advocates are actually saying. Then we can have a scientifically informed national conversation about how to ensure that the medications we give our children are safe.”
