RFK, Vaccines, and the FDA
As President-elect Trump prepares to return to the White House this January, many continue to question his choices for key cabinet positions. Perhaps his most controversial appointment so far is Robert F. Kennedy Jr. (commonly referred to as RFK) as Secretary of the Department of Health and Human Services. And a recent vaccine-related controversy is not helping.
Before Christmas, The New York Times released a story detailing that Aaron Siri, a vaccine injury attorney and a member of RFK’s legal team, petitioned the Food and Drug Administration in 2022 to revoke its approval of the Polio Vaccine, which is still being reviewed. Since the story broke, RFK has distanced himself from Siri and insists he is “all for” the polio vaccine. His spokesperson also released a statement indicating, “Mr. Kennedy believes the Polio Vaccine should be available to the public and thoroughly and properly studied.”
Not everyone is convinced. Congressman and polio survivor Steve Cohen believes “his position on vaccines disqualifies him for consideration as a Secretary of Health and Human Services.” Senate Republican Leader Mitch McConnell (also a polio survivor) denounced efforts to “undermine public confidence in proven cures” and urged RFK to “steer clear of even the appearance of association with such efforts.”
His associations with Siri aside, RFK has been an outspoken skeptic about vaccines—questioning their benefits and emphasizing their alleged harms. As the incoming HHS Secretary, he will have considerable influence over the FDA. President-elect Trump previously stated he would let RFK “go wild” on health policy, and he’s reaffirmed his support since.
While RFK’s skepticism of vaccines and future influence over the FDA causes many to panic, he primarily emphasizes “transparency” in the vaccine development and approval process. Many politicians and the FDA’s vaccine chief agree. To that end, let us review the historical role the FDA played in regulating vaccines.
Although the modern FDA began in 1962, the agency did not regulate vaccines until 1972. By then, the US already had vaccines for smallpox, diphtheria, tetanus, pertussis, polio, measles, mumps, and rubella. All these vaccines were grandfathered in and are currently part of the standard vaccine schedule—meaning the FDA played a modest role in approving and regulating them.
Since 1972, the FDA has only approved seven vaccines that appear on the vaccine schedule: Hib, hepatitis A, hepatitis B, varicella, pneumococcal, influenza, and rotavirus. Some of these play a relatively minor role in public health. Only 27 states require children to get the Hepatitis A vaccine before starting school. Rarely serious or fatal, varicella, also called chickenpox, was considered mild enough that parents with infected children commonly hosted “chickenpox parties” to expose others purposefully. Influenza vaccines (flu shots) do not follow the standard FDA review process because they are annually updated. Despite being FDA approved, the rotavirus vaccine was taken off the market in 1999 due to rare but serious side effects. Another rotavirus vaccine was approved in 2006 and 2008.
During the COVID-19 pandemic, the FDA issued emergency use authorizations for three COVID-19 vaccines. However, under Operation Warp Speed, each vaccine underwent an accelerated approval process, significantly truncating the usual FDA review process for new vaccines. Eventually, these vaccines received full FDA approval without undergoing the entire process.
However, the US also produced a pandemic-related vaccine in record time before the modern FDA existed. As I previously wrote in The Beacon:
From 1957-1958, the 1958 influenza (often referred to as the Asian Flu) spread through the United States, infecting 20 million individuals and causing 116,000 deaths. At this time, the FDA held significantly less regulatory authority and did not regulate vaccines.
Similar to Moderna’s COVID-19 vaccine, medical scientists developed a vaccine for the 1958 influenza before the virus reached the United States. Without the FDA prolonging approval, cooperation between public health agencies and private vaccine developers distributed 60 million doses of the vaccine during the first two months of the pandemic.
Consequently, hospitals were not overwhelmed and there was “no serious disruption of community life” during the 1957-1958 pandemic. As an article written at the time in the Journal of the American Medical Association noted, quick development, approval, and distribution of the vaccine “made it possible for a nation to organize in advance of an oncoming epidemic for the first time in history.”
RFK has the potential to dramatically change vaccine policy. To do that, he will need to influence the FDA strongly and unprecedentedly. Unfortunately, I do not think many concerned citizens understand how involved (or uninvolved) the FDA has been in vaccination policy. This article is my attempt to promote transparency.
