4 June 2021
What is claimed
A poster from the MHRA makes various claims about vaccines and the importance of Yellow Card reports.
This poster is not from the MHRA.
What is claimed
Yellow Card data will allow vaccines to exit phase 3 clinical trials and be given full approval.
Yellow Card data are not required for vaccines to “move into” phase 3 trials. Phase 3 trials for vaccines reported their primary findings, and participants followed up for several years.
What is claimed
Vaccines have only temporary MHRA approval.
It’s just right. Vaccines Pfizer and AstraZeneca received temporary licenses, while vaccines Moderna and Janssen received temporary licenses that offer the possibility to become permanent licenses in the future.
A poster made to look like the origin of Medical and Healthcare Regulate Agency (MHRA) products in the past shares on social media, and asked people to report any side effects from Covid-19 vaccines. Real Question readers asked us if the poster was real, but it wasn’t.
The poster talks about the importance of Yellow Card Plan, which is the UK’s system for collecting reports on safety concerns such as potential side effects involving medical devices and medicines, including vaccines.
It said Yellow Card reports are important to ensure Covid-19 vaccines are safe and effective and can exclude vaccines from phase 3 clinical trials and be given “full approval”.
However, these claims are not entirely true.
The poster itself
The poster is a good imitation of the same graphics published by the MHRA but there are still indications that suggest it may not be true.
Doing a Google image search for “MHRA Coronavirus (Covid-19) vaccine damage report” is back same graphic to fake. These images carry a legitimate MHRA webpage involving various resources for “Each report counts campaign”, including posters.
However, none of the posters or images there matched the image we examined.
And while the style is pretty much the same (using the same people graphic and color scheme), there are some significant differences.
The MHRA confirmed in Full Fact that the social media image is not from them.
The claims made by the fake poster are also not entirely correct.
It is true that there is the MHRA launched a campaign promotes the Yellow Card scheme, and it is important that people report suspected side effects from vaccines so they can be investigated.
But the fake poster says: “It is [data] can [the vaccines] to pass phase 3 clinical trials and be given full approval by the European Medical Agency as currently there is only temporary MHRA approval. “
It does not accurately represent how the vaccine was approved nor the place on the Yellow Card reports in the process.
Vaccines, like other drugs, go through a count the episodes before release.
Prior to human trials, vaccines must be shown to be safe and effective in animals.
Subsequently, phase 1 trials among up to 100 adults focused on ensuring that the vaccine did not cause safety concerns, and to achieve the most effective dose.
Phase 2 trials involved several hundred participants and were particularly focused on regularly reviewing vaccines, and starting to look for any side effects.
Phase 3 trials were conducted immediately, among the average, thousands of participants and were used to gather important statistics and robust data about the safety and efficacy of a vaccine.
After stage 3, the vaccine manufacturer can submit all their data to the governing body (which in the UK is the MHRA) which will decide whether to license the vaccine.
Four Covid-19 vaccines have been approved for use in the UK (Oxford-AstraZeneca, Pfizer-BioNTech, Modern and Janssen) published all the data from their phase 3 testing showing that they were safe and effective.
Participants in these trials were observed for next year, but is wrong to suggest that Yellow Card reports are necessary for vaccines to “pass phase 3 clinical trials.”
The suggestion is also wrong, as it were some on social media have already done so, that because these trials are ongoing, people who are vaccinated are themselves in clinical trials. Some drugs also go through trials after complete curling, known to phase 4 test, which is not to say that people who regularly prescribe them are in clinical trials.
Analysis of Yellow Card reports so far it has been shown that, apart from the notable, temporary, mild and moderate side effects, such as fatigue, the risk of serious illness is very short.
A possible connection between the AstraZeneca vaccine and a rare blood clot has been identified. The latest data shows about one in 400,000 people given a dose of the vaccine have died of one of these blood clots in the UK.
The poster claims that the vaccines have received “temporary approval” which is quite correct.
the Pfizer and AstraZeneca Vaccines received temporary approval by regulation 174 of Managing Human Medicines 2012, while the Modern and Janssen Vaccines receive a “conditional commercial permit”, a class of license.
We wrote about different types of permitting for vaccines in the past.
Usually, vaccines passing a process to obtain marketing permission (also known as a license). In certain situations, however, for for example in response of “pathogenic agents”, the MHRA may use a variety of different permissions.
The regulation 174 temporary permits were issued by the government, rather than applied by the drug company, and allowed the emergency provision of an unlicensed drug in response to an unsatisfactory public health need. .
They are not allowed in the process to become fully permanent licenses, even if it does not prevent Pfizer or AstraZeneca from applying for a license for their vaccines in the future.
A conditional marketing permit, such as that held by Moderna and Janssen for their Covid vaccines, was applied by the company in question. This is also a form of temporary permission, but can be changed to a full, permanent marketing permit, or license.
The MHRA has ago The Truth is told that temporary permits and conditional permits to sell are “control devices that can approve medications as soon as possible during an emergency situation, in the event that there is strong data to show that the benefits outweigh the risks ”and added that the vaccine should not be allowed in this way“ unless the expected high standards are met ”.