Some skeptics of vaccines are sharing false information on social networks, claiming that the drug thalidomide - which caused serious malformations in thousands of children during the 1950s - was approved at that time by the United States Food and Drug Administration ( FDA).
The misinformation is likely to undermine the FDA's credibility
after it granted full approval to pharmaceutical company Pfizer's coronavirus vaccine on Aug. 23.
[CDC urges pregnant women to get vaccinated against COVID-19 as severe cases of the delta variant rise]
"Thalidomide was also approved by the FDA," says a post accompanied by a photo of children with malformations, shared hundreds of times, and flagged as false information by Facebook.
Thalidomide was developed in the mid-1950s by the German laboratory Chemie Grünenthal.
It was initially used to treat nausea and vomiting in pregnant women, and was marketed in countries such as Spain, Norway, Japan, Canada, and the United Kingdom.
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But the drug was not sold in the United States or approved by federal health authorities
, largely thanks to Dr. Frances Oldham Kelsey, then a young pharmacologist who came to the Food and Drug Administration (FDA) in 1960.
She worked reviewing applications for new drugs to make sure they were safe before they went on the market.
One of the first requests that he had to evaluate was that of thalidomide, which was already being sold around the world.
[The United States wasted at least 15 million doses of COVID-19 vaccines]
Kelsey refused to approve the drug, alarmed by the lack of scientific research to show its safety.
"Dr. Kelsey, despite constant pressure from the company, refused to approve the application due to inadequate testing," the FDA says on its website.
At the end of 1961, thalidomide was withdrawn from Germany and the United Kingdom, after the first evidence emerged that it was causing malformations in children born to mothers who took it during pregnancy.
Thousands of children were born without limbs or with hands that protruded directly from their shoulders and with severe physical disabilities from thalidomide.
The tragedy, which was avoided in the United States, led then-President John F. Kennedy to sign a new law in 1962 to toughen the approval requirements for new drugs.
Dr. Frances Oldham Kelsey received the Presidential Distinguished Federal Civil Service Award from President John F. Kennedy in August 1962. Kelsey refused to approve the drug thalidomide due to a lack of evidence about its safety.
John Rous / AP
Dr. Kelsey, who was born in Canada and died in 2015, is considered a national hero for having avoided a health mishap in the United States and received multiple accolades throughout her career, including the Presidential Distinguished Federal Civil Service Award awarded to her. awarded by President Kennedy in 1962.
In 1997, thalidomide was endorsed by the FDA with strong restrictions, only for the treatment of lesions in patients with leprosy and multiple myeloma, a type of cancer in plasma cells.
It is not approved for use by pregnant women.
[Are vaccinated people protected against the delta variant of COVID-19?]
It is false to suggest that the drug that affected thousands of children more than 60 years ago was approved in the United States for pregnant women at that time.
Furthermore,
the development of thalidomide also cannot be compared to the scientific research supporting COVID-19 vaccines.
"Vaccines are safe and effective"
Dr. Susan Ellenberg, professor of biostatistics, medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania, told AFP that "the research around COVID-19 vaccines is' very different. of what was done with thalidomide. '"
"Thalidomide was studied at a time when there were very few regulatory requirements for drug approval," Ellenberg explained. "Whatever tests were done, they weren't even necessary, they were very small," he said.
In an image from 2013, a victim of thalidomide in Spain leaves a court in Madrid where it was judged whether the German pharmacy Gruenenthal should compensate a score of Spaniards who were born with congenital malformations due to the drug.
Andres Kudacki / AP
The thalidomide case is seen as a milestone in the drug and medical device evaluation process by the US federal authorities.
FDA standards are today considered among the strictest in the world, Dr. Henry Miller, a principal investigator at the Pacific Research Institute and who was a founding director of the FDA's Office of Biotechnology, told Politifact.
Experts have repeatedly said that US-approved COVID-19 vaccines, including Pfizer's, are safe even for pregnant women.
[Vaccines are extremely effective but they do not protect 100% from the coronavirus]
“The most recent evidence indicates that the COVID-19 vaccine during pregnancy is safe;
[...] in the Pfizer clinical trial, several participants became pregnant after vaccination and no safety problems were reported, "epidemiologist Sandra Albrecht, professor at Columbia University in New York, explained to Noticias Telemundo in May. .
In mid-August, the Centers for Disease Control and Prevention (CDC)
urged pregnant women to get vaccinated against COVID-19
, due to the high case of unvaccinated people seriously ill with the delta variant of the coronavirus.
"Vaccines are safe and effective, and it has never been more urgent to increase vaccination as we are faced with the highly communicable delta variant and we see severe results of COVID-19 among unvaccinated pregnant people," he said in a statement. Dr. Rochelle Walensky, Director of the CDC.
