A poster which has been made to look like it comes from the Medical and Healthcare products Regulatory Agency (MHRA) has been shared on social media, and asks people to report any side effects from Covid-19 vaccines. Full Fact readers have asked us whether the poster is genuine, but it is not.
The poster talks about the importance of the Yellow Card scheme, which is the UK system for collecting reports of safety concerns such as potential side effects involving medical devices and medicines, including vaccines.
It claims that Yellow Card reports are essential to ensure the Covid-19 vaccines are safe and effective and will enable the vaccines to move out of phase 3 clinical trials and be granted “full approval”.
However, these claims are not entirely true.
The poster itself
The poster is a pretty good imitation of similar graphics published by the MHRA but there are still some clues which suggest that it might not be genuine.
Doing a Google image search for “MHRA Coronavirus (Covid-19) vaccine injury report scheme” returned very similar graphics to the fake one. These images led to a legitimate MHRA webpage which linked to various resources for its “Every report counts campaign”, including posters.
However, none of the posters or images there matched the image we’re checking.
And while the style was quite similar (using the same graphics of people and colour scheme), there were some key differences.
The real posters use a slightly different typeface and the MHRA’s logo looks different in the fabricated poster. There is also a grammatical error in the fake poster.
The MHRA confirmed to Full Fact that the image on social media did not come from them.
The claims
The claims made in the fake poster are also not entirely accurate.
It is true that the MHRA has launched a campaign promoting the Yellow Card scheme, and it is important people report suspected side effects from vaccines so they can be investigated.
But the fake poster then says: “This [data] will allow [the vaccines] to move out of the phase 3 clinical trials and be granted full approval by the European Medical Agency as it currently only has temporary approval by the MHRA.”
This doesn’t accurately represent how vaccine approval works nor the place of Yellow Card reports in the process.
Vaccines, like other drugs, go through a number of stages before being released.
Before human trials, vaccines must be shown to be safe and effective in animals.
Then, phase 1 trials among up to 100 adults are focused on making sure the vaccine has no major safety concerns, and to work out the most effective dose.
Phase 2 trials involve a few hundred participants and are more focused on checking the vaccine works consistently, and starting to look for any side effects.
Phase 3 trials are then conducted among, typically, thousands of participants and are used to gather statistically significant and robust data on a vaccine’s safety and efficacy.
Following phase 3, the vaccine manufacturer can submit all their data to the regulatory body (which in the UK is the MHRA) which will then decide whether to licence the vaccine.
The four Covid-19 vaccines approved for use in the UK (Oxford-AstraZeneca, Pfizer-BioNTech, Moderna and Janssen) have all published data from their phase 3 trials demonstrating they are safe and effective.
Participants in these trials are being monitored for the next few years, but it’s wrong to suggest that Yellow Card reports are needed for the vaccines to “move out of the phase 3 clinical trials.”
It is also wrong to suggest, as some on social media have done, that because these trials are ongoing, people who take the vaccines are themselves in clinical trials. Some drugs also go through trials after being fully rolled out, known as phase 4 trials, which don’t mean that people regularly prescribed them are in clinical trials themselves.
Analysis of the Yellow Card reports so far shows that, other than well-known, temporary, mild and moderate side effects, such as fatigue, the risk of serious illness is very low.
One possible link between the AstraZeneca vaccine and a rare blood clot has been identified. The latest data shows around one in 400,000 people who have been given a dose of the vaccine have died of one of these blood clots in the UK.
The poster claims the vaccines have received “temporary approval” which is essentially correct.
The Pfizer and AstraZeneca vaccines have received temporary authorisation via regulation 174 of the Human Medicines Regulation 2012, while the Moderna and Janssen vaccines have received “conditional marketing authorisation”, a type of licence.
We’ve written about the different types of authorisation for vaccines before.
Normally, vaccines go through a process to obtain marketing authorisation (also known as a licence). In certain scenarios, however, for example in response to “pathogenic agents”, the MHRA may use different types of authorisation.
Regulation 174 temporary authorisations are triggered by the government, rather than applied for by the drug company, and authorise the emergency supply of an unlicensed medicine in response to an unmet public health need.
The process doesn’t allow them to be turned into full permanent licenses, although that doesn’t stop Pfizer or AstraZeneca applying for a license for their vaccines in the future.
A conditional marketing authorisation, as held by Moderna and Janssen for their Covid vaccines, is applied for by the company in question. It is also a form of temporary authorisation, but can be converted into a full, permanent marketing authorisation, or licence.
The MHRA has previously told Full Fact that temporary authorisation and conditional marketing authorisations are “regulatory tools that enable medicines to be approved at the earliest time possible during an emergency situation, as soon as there are robust data to show that the benefits outweigh the risks” and added that no vaccine would be authorised in this way “unless the expected high standards are met”.
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