Recently, a TrialSite correspondent in the United Kingdom (UK) pointed out a petition to the UK Government and Parliament with a growing number of signatures—presently over 55,000 and growing. According to the website, “The [UK] Government has commissioned a public inquiry into the COVID-19 pandemic and has no plans for a separate inquiry on vaccine safety.” Apparently, this previous clause was important for them to qualify that the vaccines, including safety, is the job of the UK Medicines Healthcare and Regulatory products Agency (MHRA). The UK Government has a duty to ensure that the populations of England, Wales, Scotland, and Northern Ireland are safe from prescribed drugs, or even more importantly, nationally mandated vaccines are safe.
This recent petition was just posted, and the petition count grows as this article was prepared. According to a person associated with the petition that wished to remain anonymous, if the number hit 100,000 it would require parliamentary debate. But they have already responded, and the TrialSite contact reports there is a concern the petition would be taken offline.
Members of the public are concerned about a spike in heart attacks since the rollout of the national COVID-19 vaccine program. The petitioners seek the government to implement an immediate and full scientific investigation to establish any potential link to the vaccines.
While the UK Government continues that MHRA only authorizes vaccines, including COVID-19 vaccines, based on “rigorous review of their safety, quality, and efficacy”…they go on to emphasize that based on the COVID-19 clinical trials programs, that the vaccines “have shown them to be effective and acceptably safe.” Importantly, the UK government notes “however, as part of its statutory functions, the MHRA continually monitors the use of the vaccines to ensure their benefits continue to outweigh any risks.”
They go on to emphasize, of course, this is the regulatory responsibility, but the UK Government and Parliament are intertwined with the mass UK vaccination program in a myriad of ways.
Ongoing Monitoring in UK
For drug or vaccine safety issues the MHRA manages a monitoring strategy, that is “continuous, proactive, and based on a wide range of information sources.” The government website proclaims this includes a “dedicated team of scientists reviewing information daily to look for safety issues or unexpected events.”
The Yellow Card System
In the UK, the drug regulators manage a system called the Yellow Card scheme, used to collect information on suspected adverse drug reactions (ADRs) to medicines and vaccines. This was intentionally set up to monitor these medicines and drugs because from time to time such products can produce ADRs. See the Yellow Card website.
Summary of Issues
According to the UK Government from the start of the pandemic to December 15, 2021, the MHRA has analyzed the following:
Vaccine Product# ADRs# Doses Administered% IncidencePfizer/BioNTech145,44646,400,0000.313%AstraZeneca240,06550,000,0000.480%Moderna24,7212,800,0000.883
What are the primary complaints?
As seen above, the incidences while never good, are still relatively rare. The vast majority of such ADRs are mild in nature and go away within days (e.g., soreness of arm, generalized flu-like symptoms, and the like), and the UK Government declares that the overwhelming numbers in the population last only a short while at most.
However, there are known concerns of risk such as myocarditis and pericarditis. For these cardiovascular-related health issues, the UK Government reports the following numbers:
Vaccine ProductIncidence of Myocarditis and PericarditisPfizer/BioNTech12 per million doses; 8 per million dosesAstraZeneca4 per million doses; 4 per million dosesModerna42 per million doses; 24 per million doses
With 1,889 deaths reported in the Yellow Card Fact Check, organizations are quick to point out that systems such as the Yellow Card are self-reported and cannot necessarily equate to a causal event based on the jab. However, the whole point of the Yellow Card system is to protect people, and consumers—not companies. So, if there is a spike in health-related issues and deaths then they must be thoroughly investigated to ensure the integrity of mission-critical regulatory systems such as MHRA.
TrialSite lists below updated deaths in the Yellow Card system.
Vaccine ProductDeathsPfizer-BioNTech666AstraZeneca1,164Moderna23Unspecified36