A LEAFLET RELEASED by Dolores Cahill ahead of the Dublin Bay South by-election made a number of misleading claims about Covid-19 vaccines.
Cahill was an independent candidate in the Dublin Bay South by-election held on Thursday. She was eliminated on the third count.
In her election leaflet, Cahill claimed that mRNA vaccines “have never been approved” and also made a misleading claim about deaths associated with vaccine clinical trials.
The controversial UCD professor has made similar claims in the past, some of which have already been debunked by The Journal.
The leaflet said mRNA vaccines “have never been approved/licensed in the world to date”.
It also said: “According to EU data, there are over 15,000 deaths and 1.6 million adverse reactions posted in the four SARS-CoV2/COVID-19 mRNA clinical trials in the EU alone.”
The source for this is listed as the European Medicines Agency EudraVigilance database, as of 19 June 2021.
The leaflet also said Cahill has been “outspoken on the dangers” of mRNA vaccines.
Cahill shared an image of the leaflet on her Facebook page at the end of June. The post was shared over 300 times and had almost 2,000 comments at the time of publication.
Let’s take a closer look at these claims.
Trials
‘According to EU data, there are over 15,000 deaths and 1.6 million adverse reactions posted in the four SARS-CoV2/COVID-19 mRNA clinical trials in the EU alone.’
In her election leaflet, Cahill says this claim comes from the EudraVigilance database run by the European Medicines Agency (EMA).
The Journal has previously debunked claims about deaths from Covid-19 vaccines which reference this source.
First of all, there are two mRNA vaccines currently approved in the EU and many other parts of the world – Pfizer and Moderna.
A third mRNA vaccine – CureVac – is under rolling review by the EMA, but it has not yet been approved for use.
The German company recently provided interim analysis of its late-stage clinical trials which showed a lower efficacy (47%) against Covid-19 than those provided by other vaccines.
For a vaccine to be approved, it must undergo three stages of clinical trials.
Each phase involves more people, with phase three trials involving thousands of volunteers.
After a vaccine is approved, companies continue to monitor the drug in what is called a phase four trial.
This is intended to survey the real-world effectiveness of a drug and it continues to evaluate the safety of a drug as it is administered.
The EudraVigilance system mentioned in the leaflet manages and analyses information on suspected adverse reactions to medicines approved by the EMA.
Its database lists suspected side-effects from vaccines as well as suspected fatalities.
However, like other systems, these are suspected adverse reactions which could relate to vaccination – but this is not necessarily the case.
Often, the reported outcome and its link to vaccination has not been verified.
The EudraVigilance system website said the suspected side effects are medical events that have been observed after a person received a Covid vaccine, but they are not necessarily related to or caused by the vaccine.
The site says these events “may have been caused by another illness or be associated with another medicine taken by the patient at the same time”.
The EMA assesses a number of factors to determine whether the event was caused by the vaccine.
Ireland operates a similar system on a national basis, through the Health Products Regulatory Authority.
As the HPRA explained for a previous FactCheck, there will inevitably be deaths among people who have received the Covid-19 vaccine.
This does not mean these people died as a result of the Covid-19 vaccine.
Figures about any deaths and reactions are based on suspected reports that have not been confirmed.
It is misleading to say the deaths and adverse reactions are linked to vaccine trials.
Approval
mRNA vaccines “have never been approved/licensed in the world to date”.
This is a false claim Cahill has also made previously. It featured in a previous FactCheck focused on false claims about insurance policies.
Four vaccines have been approved for use in the European Union (and thereby Ireland) under conditional marketing authorisation.
This method is used for medicines that address unmet medical needs of patients on the basis of “less comprehensive clinical data than normally required”.
Although this means the vaccines are approved relatively quickly, the process guarantees that the medicine meets rigorous standards for safety, efficacy and quality and that comprehensive data is still provided.
Two mRNA vaccines have been issued with this approval – Pfizer and Moderna – and two viral vector vaccines – AstraZeneca and Janssen (Johnson & Johnson).
Other vaccines have also been approved for use in a similar way in other countries/jurisdictions – including Sinovac and Sputnik V.
Essentially, the vaccines are approved once enough data is available to show the benefits outweigh the risks and that there are safeguards and controls in place after the authorisation is issued.
The EMA said this type of approval has been used during the Covid-19 pandemic to “expedite the approval of safe and effective Covid-19 treatments and vaccines”.
Although it’s a sped-up process, it means the vaccine is authorised for use in the European Union, and similar processes are used for approval across the world.
‘Dangers’
Cahill has been “outspoken on the dangers” of mRNA vaccines.
Around 3.32 billion vaccine doses have been administered across the world, according to Our World in Data. Almost one-quarter of the world’s population has received at least one dose. These include mRNA vaccines.
Messenger RNA is a new type of vaccine using technology that has been in development for decades.
Traditionally, vaccines have mostly involved giving people a weakened or killed germ, or parts of a germ. mRNA vaccines are different.
This type of Covid vaccines essentially trains the immune system to recognise and attack the SARS-Cov-2 coronavirus without ever having actually encountered it before.
mRNA Pfizer and Moderna vaccines were approved following rigorous rounds of clinical trials and testing.
No mRNA vaccine has been approved before now, because scientists have had to overcome a number of obstacles to produce a vaccine that is effective.
These obstacles included things like how to modify mRNA in a way that would not produce a violent immune response, how to encourage a person’s immune system to accept a vaccine’s mRNA, and getting cells to make protein to fight the new disease.
Research into mRNA vaccines ramped up after the arrival of Covid-19 last year, partly helped by a huge amount of scientific collaboration across the globe.
The technology will also likely be used in other areas in the future.
The CDC in the US said further mRNA vaccine technology could allow for one vaccine to provide protection for multiple diseases. This could decrease the number of vaccines needed for protection against common vaccine-preventable diseases, the CDC said.
So although it is a relatively new type of technology, the approved mRNA vaccines have been deemed safe by several authorities across the globe after extensive testing and examination.
The Journal’s FactCheck is a signatory to the International Fact-Checking Network’s Code of Principles. You can read it here. For information on how FactCheck works, what the verdicts mean, and how you can take part, check out our Reader’s Guide here. You can read about the team of editors and reporters who work on the factchecks here
Have you gotten a message on WhatsApp or Facebook or Twitter that you’re not sure about and want us to check it out? Message or mail us and we’ll look into debunking it. WhatsApp: 085 221 4696 or Email: answers@thejournal.ie
To embed this post, copy the code below on your site
have your say