False claims about vaccines, specifically COVID vaccines, continue to do the rounds online.
A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not been formally approved and that millions have therefore been vaccinated without clear guidelines.
Social posts refer to an article by a Swiss website called Uncut-News, which says that the EMA published a paper in January saying “there is no guideline which reflects the quality requirements for regulators and industry on mRNA containing vaccines”.
Uncut-News says that while the paper focuses specifically on veterinary vaccines, this is still a worry for humans when these vaccines are administered on a large scale.
The website also takes issue with this line in the paper: “mRNA vaccines and their manufacturing process are a novel technology, and the resulting products differ from other types of vaccines”.
Wilful misinterpretation and baseless criticism
It claims that this means that mRNA technology is experimental, giving credibility to anti-vaxxers, and goes on to suggest that millions were contaminated with unsafe, unregulated vaccines during the COVID-19 pandemic.
However, this is all misleading, as it misinterprets what the EMA document says and stirs up criticism of vaccines without any basis.
The cited paper is authentic and is explicit that it’s only dealing with mRNA vaccines for veterinary use.
It does reference COVID, but in a way that praises the regulation and testing of the vaccines used to combat the pandemic.
“In the area of human medicinal products, the number applications for clinical trials and marketing authorisations for mRNA containing products significantly increased over the last few years and a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic,” the EMA says in the paper.
It adds that this experience could be a great help in developing guidelines for the development of mRNA vaccines for veterinary use.
“Considering the scientific developments in recent years including the 29 experience gained during the COVID pandemic in the human medicinal products area and the first expected submissions for mRNA vaccines for veterinary use, such a guideline should be developed to ensure appropriate support in development and manufacturing of mRNA vaccines for veterinary use,” the paper says.
‘Novel’ does not mean ‘experimental’
Respected public health bodies around the world assure that the mRNA COVID vaccines are safe.
The World Health Organization says that before receiving validation from regulatory agencies such as the EMA, “COVID-19 vaccines were subject to rigorous testing in clinical trials to prove that they meet internationally agreed benchmarks for safety and efficacy”.
To give another example, John Hopkins Medicine in the US says that the vaccines “are very safe and very good at preventing serious or fatal cases of COVID-19”.
“The risk of serious side effects associated with these vaccines is very small,” it adds.
Another clue that the Uncut-News article is misleading is that it cites a post on X from an openly anti-vaxx account, with seemingly no expert credentials.
Just like Uncut-News, the post also makes the false claim that the EMA has “admitted” mRNA vaccines are experimental.
The term “novel” doesn’t mean that this particular vaccine technology is experimental, but rather that it is newer compared to traditional vaccine methods, such as delivering inactivated or live attenuated vaccines.
In fact, novel vaccine technologies tend to improve the safety, speed and effectiveness at which vaccines are produced and administered.
mRNA vaccines became a lot more apparent in public discourse during the COVID pandemic, largely thanks to the Pfizer and Moderna vaccines used to combat the virus.
They work by teaching cells to produce a protein that triggers an immune response, helping the body to recognise and fight off a given virus.
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