Covid vaccines aren’t comparable to thalidomide scandal

23 September 2021
What was claimed

The length of time it took to discover thalidomide’s dangers proves more time should be spent researching medicines, particularly Covid-19 vaccines.

Our verdict

Thalidomide underwent a very different research and regulation process to Covid-19 vaccines. There is no evidence so far that any of the Covid-19 vaccines in use in the UK are unsafe for pregnant people.

An Instagram post which includes photos of children born with birth defects, appears to compare the thalidomide scandal with the roll-out of the Covid-19 vaccination programme.

While it doesn’t mention Covid-19 vaccines explicitly, text at the top of the post says: “This is why we wait years for approval”. This appears to refer to the speed at which Covid-19 vaccines were approved for emergency use across the world. Comments next to the post appear to make this connection. 

Other text on the image states that it took five years for the connection between thalidomide, birth defects and miscarriages to be established. 

It adds: “Don’t rush science”.

However, the roll-out of thalidomide was significantly different to that of the Covid-19 vaccination programme. From the studies conducted so far, there is no evidence the Covid-19 vaccines cause harm to unborn babies or pregnant women. 

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What was the thalidomide scandal?

Thalidomide is a drug that was used by thousands of people around the world to, among other conditions, relieve morning sickness during pregnancy in the late 1950s and early 1960s.

The drug was first licensed in Germany in 1956 and produced in the UK in 1958. It was withdrawn from sale in 1961 after evidence emerged it caused birth defects and stillbirths.

According to the Thalidomide Trust: “It is difficult to find accurate figures on the number of babies born with thalidomide damage as many were not carried full term.” It puts the number of infants affected at around 100,000, with the number being born at around 10,000.

Although withdrawn from sale in 1961, the National Institute for Health and Care Excellence (NICE)—who produce guidance on drugs for the NHS—has recommended thalidomide to treat myeloma (a type of bone cancer) for over 65s, with a number of restrictions.

Can you compare thalidomide with the Covid-19 vaccines?

There are many differences between the roll out of thalidomide and the current Covid-19 vaccination programme. 

Firstly, the Covid-19 vaccination programme has been strictly regulated unlike thalidomide, the dangers of which were not publicly acknowledged until 1961.  

In fact, both the UK medicines regulator the Medicines and Healthcare products Regulatory Agency (MHRA) and its adverse drug effects reporting programme (the Yellow Card scheme) exist now because of the thalidomide scandal. 

The Royal Pharmaceutical Society states: “Due to the thalidomide tragedy, it was recognised that changes to the way in which new medicines were tested and approved required a stricter, more focussed system of medicines regulation. 

“It also highlighted the important need for routine monitoring of the safety of medicines by a central body that was independent of the pharmaceutical industry - and so the Y[ellow] C[ard] S[cheme] was introduced.”

The thalidomide scandal resulted in both the Yellow Card scheme (which catalogues reported adverse effects to drugs, including Covid-19 vaccines) and the Medicines Act 1968 which, among other regulations, required all medicines to go through peer review and subsequent approval or be withdrawn. These were carried out in practice by the Medicines Division of the Department of Health and Social Security (as the Department of Health and Social Care was then known), then the Medicines Control Agency, which was then absorbed into what became the MHRA. 

As we have written before there are good reasons why the Covid-19 vaccines were developed as quickly as they were. The amount of time it would take to usually licence a drug is limited by funding, manpower and government support, challenges the Covid vaccines have not faced. 

Professor Peter Openshaw, professor of Experimental Medicine at Imperial College London, told Full Fact: “There is absolutely no reason to draw parallels with thalidomide: vaccines are not drugs, and the whole system of licencing has been completely reformed since that era. 

“There has never been as much research on which to base vaccine licensure - it was done very fast because we face a global emergency and almost unlimited resources were put into the studies.”

Research into thalidomide was not as thorough either. For example, the drug was not tested on pregnant animals before it was used in humans. All of the Covid-19 vaccines used in the UK underwent developmental and reproductive toxicity (DART) studies in pregnant animals and found no harmful effects.  While pregnant women were excluded from initial trials of the Covid-19 vaccines, there is now a growing body of recent evidence which has revealed no significant safety concerns in terms of maternal or neonatal outcomes, as one of our previous fact checks explains. 

While there isn’t long term-data on Covid-19 vaccines, simply because they have only recently come into use, there have been no reported safety concerns similar to those caused by thalidomide.

The comparison between the vaccines and thalidomide isn’t apt either. Thalidomide’s damage was caused by defects linked to a key protein in foetal development, and research into thalidomide led to the discovery that the placental barrier does not protect the foetus from birth defects.

​​The Royal College of Obstetricians and Gynaecologists website says: “The vaccine is considered to be safe and effective at any stage of pregnancy.” In addition, it previously told Full Fact that the evidence so far suggests that mRNA in the two vaccines recommended in pregnancy is unlikely to cross the placenta and the vaccines’ other contents are not known to be harmful. 

So, the safety, authorisation and rigorous testing the Covid-19 vaccines have passed through (including trials involving tens of thousands of participants and published in peer-reviewed journals) is in stark contrast to the development and regulation of thalidomide, making such a comparison between the vaccines and the drug misleading.

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