A century ago, one of the biggest safety concerns about vaccines was related to bacterial contamination. In 1916, four young children died in South Carolina after receiving the typhoid vaccine contaminated with Staphylococcus aureus. Twelve years later, 12 children from Queensland, Australia, died from contaminated vaccinations against diphtheria.
In the 1930s, vaccine makers began using preservatives called timerosals to halt the microbial growth in their products. For the next 60 years, it wasn’t very informed. The adverse effects appeared to be limited to local injection site reactions, according to the US Food and Drug Administration.
That changed in 1999 when US health officials asked pharmaceutical companies to remove thimeromonkeys from the vaccine. Although there was no evidence that it caused harm to the amount used, thimeromonkeys contain a form of mercury, which raised questions about whether thimeromonkeys could cause neurotoxicity when administered in childhood vaccinations.
The vaccine maker has removed it from all but a few shots, including multi-dose vials of the flu vaccine. In the meantime, subsequent studies confirmed that the relationship between vaccine thimerosal and neurodevelopmental issues, including autism, and the incidence of autism, continues to rise.
So public health experts were confused when preservatives appeared on the agenda for this week’s meeting with the Centers for Disease Control and Prevention with external vaccine advisors.
“They’re pediatrician at Colorado Children’s Hospital and pediatrician on the pediatric advisory board of the Society of Pediatrics at the CDC Advisory Committee on Vaccination Practices (ACIP), said:
The group is holding their first meetings on Wednesdays and Thursdays. This was when US Health and Human Services Director Robert F. Kennedy Jr. rejected the 17 members of the committee, claiming there was a conflict of interest, and set up eight new advisors a few days later. Public health experts and lawmakers have questioned the qualifications and background of several new panelists, and just before the meeting began, one member withdrew during the financial holdings screening, a HHS spokesperson said they had pulled the panel down to 7.
According to an agenda posted Monday, a presentation on “on thimeromonkeys in vaccines” is scheduled for Thursday morning, with “suggested recommendations” particularly regarding the flu vaccine thimeromonkeys. The meeting will close with a vote for the latter. This is a move that could lead to official CDC policies if adopted by agency leadership or without a confirmed director by Kennedy.
The last-minute addition of thimeromonal to the agenda is a red flag for vaccine experts who think science has resolved, and fears Kennedy, who led an anti-vaccine group called Children’s Health Defense, is questioning the safety of the vaccine. Lyn Redwood, another former child health defense leader, will be presenting on the topic at the meeting.
Here’s how Thimerosal ended up having such a hot button problem:
In 1997, New Jersey Democrat Frank Paron is concerned about mercury contamination in lakes and rivers in his community, but he required amendments to the US Food and Drug Administration’s reauthorization bill to intentionally catalog mercury compounds in drugs and foods.
That probably led to it Amazing findings: “If people were watching the vaccine, by six months, infants could receive more thimero monkeys than listed in some sources of what was considered safe levels of mercury.”
However, these limitations are set on the type of methyl Mercury found in some fish, which is known to be toxic. Thimerosal contains ethyl Mercury, another compound that is “inherently stable and more easily metabolized.”
That means it is cleared from the body faster than methylmercury, according to the CDC. The FDA notes that there were no existing guidelines for Ethylmercury.
Still, the discovery led to numerous emergency meetings between federal health officials and external groups and deciding what to do, Orenstein recalled.
“There was no evidence of harm from thimeromonkeys, but the general sentiment was, ‘Let’s get rid of it, because we don’t need it,'” he said. Moving to a single-dose container was more expensive for the manufacturer, but reduced the need for preservatives.
In 1999, the FDA sent a letter to US vaccine manufacturers asking for plans to remove Thimerosal, and by 2001, the CDC said the compounds had been removed or reduced from all vaccines routinely recommended for children under the age of six in the United States.
A message from the public health agency said, “We intend to make safe vaccines even safer.”
However, the die was cast. In 1998 the vaccine was already linked to autism. UK’s Andrew Wakefield has released a first-ever reorganization since claiming that the measles-Mumps-Lubera vaccine is linked to autism, but not because of thimeromonkeys.
Still, parents of children with autism were looking for answers.
One of those parents was Redwood, and in 1999 she recorded her son’s mercury exposure, saying, “At two months’ age, he received 125 times the acceptable exposure to mercury based on EPA guidelines for weight.”
“That was the real answer for me,” Redwood said in a video posted this month by Children’s Health Defense, “at this point my son is almost five years old and he has developed a regression after the first year of his life and was diagnosed with autism.”
A nurse practitioner, Redwood, spoke at the event and decided to become a supporter for publishing papers on thimeromonkeys and autism.
The uproar over the potential link between thimeromonkeys and autism was a surprise to Orenstein and his colleagues.
“Mercury itself was never involved as a major cause of autism,” Orenstein said. “But this was a big concern.”
It led to many studies on this issue, including a 2004 assessment by the Institute of Medicine (now known as the National Academy of Medicine), which concluded that “the body of epidemiological evidence refuses to refuse to refuse to reject a causal-containing vaccine and autism.” The same conclusion was reached on MMR vaccines and autism.
A 2010 survey by the CDC also found no links. And “even after thimeromonal was removed from almost all pediatric vaccines, autism rates continued to rise,” the agency noted.
Still, those who kept pushing back on the rebuttal autism connection included Kennedy, who published a book called “Thimerosal: Let the Science Sale” in 2014. Its subtitle calls for “As soon as known neurotoxins from vaccines – immediate removal of known neurotoxins.” It rejected the 2004 medical laboratory discovery, warning that millions of children in the United States and around the world “appear to be at risk of injuries caused by the vaccine thimeromonkey.”
Thimerosal is still present in “a small portion of influenza vaccines limited to large vials,” according to a post from the Vaccine Integrity Project, a group focused on combating vaccine misinformation launched at the University of Minnesota Infectious Disease Research and CIDRAP center.
The group suspects Thimerosal is included in the ACIP agenda this week. Presentation by Redwood and Voting by the Committee – “To generate more public discussions on vaccine risks.”
HHS did not reply to requests for comment regarding Redwood’s involvement at this week’s meeting, and Redwood declined to comment. However, her presentation slide was posted before the meeting and continued to insist that thimerosal presents a safety risk. The slides included in the presentation were first cited studies of animals that were likely to be absent. The obvious lead author told CNN that he published his research with similar titles, different journals, different animals, and dramatically different findings. The slide presentation was then updated and the slide was deleted.
CDC staff also posted their own reviews of the data, citing around 20 studies that showed “do not support the association between thimerosal-containing vaccines with autism spectrum disorder or other neurodevelopmental disorders.”
During a confirmation hearing of her Senate Health, Education, Labor and Pensions Committee, Dr. Susan Monares, whom President Donald Trump will lead the CDC on Wednesday, said “we haven’t seen the causal relationship between vaccines and autism.”
Despite the lack of evidence of harm, the decision to remove thimeromonkeys from most vaccines has had other consequences. At the same time, the FDA called for vaccine makers, and US health officials advised that babies born to mothers known to be negative for hepatitis B will not receive shots of the virus at birth, but two to six months later, thimeromonkeys were phased out.
However, Dr. Paul Offit, a vaccine scientist at Children’s Hospital of Philadelphia and a member of the 2007 English Journal of Medicine’s External Advisory Committee on Vaccines, wrote that about 10% of hospitals “suspended the use of hepatitis B vaccines for all newborns, regardless of the level of risk.” “One of our three-month-old children born to a Michigan mother who was infected with the hepatitis B virus, died of an overwhelming infection.”
Orenstein reflects on his decision to remove thimeromonkeys as hard.
“Fear kept it up, did research for a couple of years and then showed harm. And, LO and behold, we used this vaccine and this ingredient was harmful,” he said. “I didn’t know what the results of the research at the time would turn out, so I thought it would be better to pull that out of it.
“Autism issues,” he added.
CNN’s Brenda Goodman contributed to this report.
