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The UK bought all the Midazolam France had. This is false. The Department of Health and Social Care has confirmed that all of the Midazolam stockpiled in the UK for the Covid-19 crisis was sourced within the UK and was produced for the UK market. It appears that this claim is based on reports of some French-label versions of the drug being stockpiled for use in the UK. Phase three trials for Covid-19 vaccines haven’t been done. This is untrue. Analyses of data from phase three trials for all three Covid-19 vaccines (Pfizer/BioNTech, Oxford/AstraZeneca, Moderna) authorised for use in the UK have been published in peer-reviewed studies in medical journals. Covid-19 vaccines don’t meet the legal definition of a vaccine. It is unclear what legal definition is being referred to, but Covid-19 vaccines meet the legal criteria for medicinal products. A lot of the vaccine ingredients haven’t been tested for their efficacy. This is false. Efficacy data has been published for all three Covid-19 vaccines approved for use in the UK. All of the animals used in vaccine trials died. There is no evidence for this. If animals had died after being vaccinated, human trials would have been stopped, which they weren’t. It is common practice in animal trials to euthanize the subjects so they can be examined. The MHRA put out a tender for Artificial Intelligence (AI) to handle reports of adverse Covid-19 vaccine reactions. This is true. In November 2020 it was reported that GenPact, a professional services firm, had been awarded a £1.5m contract to build an AI tool that could process the expected high volume of reports of adverse reactions occurring after, though not necessarily caused by, Covid-19 vaccination. Covid-19 vaccines have the capacity to change your DNA. It is untrue that Covid-19 vaccines, which include mRNA vaccines, have the capacity to affect your DNA. mRNA vaccines work by introducing a molecule into the body which instructs cells to build a disease-specific antigen. The antigen is then recognised by the immune system which produces antibodies to fight the real thing. A viral video made by influencer Kate Shemirani, posted on Facebook, makes a number of false claims. The six-minute clip contains many unsubstantiated statements—including several that Full Fact has checked in the past. This article does not address every claim made in the video, including those made about specific individuals. Here’s a look at seven key claims made throughout the video. Stay informed Be first in line for the facts – get our free weekly email Subscribe Towards the start of the video Ms Shemirani says we know we bought lots of Midazolam, and questions where the drug has gone. She also said sales of the drug had risen exponentially in the UK, and asked why did we buy all of what France had? Midazolam is a sedative and sleep-inducing drug, and is often used in intensive care or as a palliative care medicine during end-of-life care to ease agitation or restlessness in the patient. It is true that the UK has stockpiled a number of medicines, including Midazolam, throughout the pandemic, but the drug was not imported from France and the UK certainly didn’t buy all France’s stock of Midazolam. The claim appears to come from an article published in the Pharmaceutical Journal in May 2020, in which the Department of Health and Social Care (DHSC) confirmed that some French label stock of Midazolam was being sold in the UK market. It is unclear whether this stock had already reached France or had been produced and held in the UK. Midazolam has been on the UK government’s list of medicines that cannot be exported since March 2020. A spokesperson for the DHSC told us: As part of our coronavirus response, we are doing everything we can to ensure patients throughout the UK continue to access the medicines they need. To manage increases in demand, we have been building UK stockpiles of key medicines, including midazolam, which are used to support Covid-19 patients in intensive care and at the end of life. All of the Midazolam purchased for the UK Covid-19 medicines stockpile was sourced within the UK, has been licensed for use in the UK and was destined for the UK market. This claim, referring to the Covid-19 vaccines, is untrue. Analyses of the data from phase three trials for all three Covid-19 vaccines (Pfizer/BioNTech, Oxford/AstraZeneca and Moderna) authorised for use in the UK have been published in peer-reviewed studies in medical journals, as we recently reported. Phase three trials are trials in thousands of people to determine vaccine safety and efficacy, and are the last stage before a vaccine is put forward to healthcare agencies for authorisation and licensing. The fact that completion dates for phase three trials are set for 2023 has been previously used to question vaccine safety. As we have written before, these dates are set in the future to allow for follow-ups to take place. It is unclear what law is being referred to here, and no further details have been provided. Full Fact has been sent other versions of this claim, which have described the vaccine as a medical device, as opposed to a medicinal product such as a vaccine. If we look at the relevant law, in this case Section 2 of the Human Medicines Regulations 2012, medicinal products are defined as any substance or combination of substances presented as having properties of preventing or treating disease in human beings and any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action. University of York law lecturer Dr Isra Black, who specialises in healthcare law, told Full Fact that, while we can’t be sure Ms Shemirani is referring to this definition, as the Covid-19 vaccines contain substances that are administered to elicit an immune response, it appears that they meet the criteria for a medicinal product. On the other hand, claims that Covid-19 vaccines are medical devices—language that is also used in the video—don’t appear to be consistent with the legal definition of a medical device. The Medical Devices Directive defines a medical device as an instrument, apparatus, appliance, software, material or other article... intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease... [and which] does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means. Dr Black pointed out that, by definition, vaccines operate by immunological means, and so do not meet the definition of a medical device. As we have previously reported, the three coronavirus vaccines currently approved for use in the UK through temporary authorisations have been through all the normal stages of vaccine testing, including animal and human studies. All three are effective at significantly reducing the risk of contracting symptomatic Covid-19. The efficacy rate is calculated by comparing the number of vaccinated people who catch the disease to the number of unvaccinated people who catch the disease. We have looked at claims about animal deaths during Covid-19 vaccine trials before. In those trials the vaccines did not kill every animal they were tested on. Chris Magee, head of policy and media at UK non-profit Understanding Animal Research (UAR), told us that in the case of Covid-19 vaccines, data already existed to indicate the vaccines were safe, which enabled researchers to run animal trials alongside the early stages of human trials. Had the animals died during this process, he said, the human trials would have been immediately halted. The fact that they were not indicates the animals did not die unexpectedly. He also said animals used in drug trials are usually euthanized, so scientists can examine their internal organs for signs of pathology. This means if animals do die during medical trials, it isn’t necessarily due to the drug being trialed. This is true. In November 2020 it was reported that GenPact, a professional services firm, had been awarded a £1.5m contract to build an AI tool that could process the expected high volume of Covid-19 vaccine adverse drug reactions (ADRs). Reports of adverse reactions following Covid-19 vaccinations are collected through the MHRA’s Yellow Card reporting system. The MHRA says: The nature of Yellow Card reporting means that reported events are not always proven side effects.Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness. The MHRA told Full Fact in November that it was expecting around one Yellow Card report per 1,000 doses administered. At the time of writing, more than 48 million doses in total have been administered. The contract terms state that the MHRA’s existing systems would be unable to handle the volume of ADRs that will be generated during the UK’s largest ever vaccination programme. This is a common claim that has been repeated throughout the pandemic, and one that we have previously addressed. It usually refers to mRNA vaccines, such as the Pfizer/BioNTech and Moderna vaccines. The mRNA vaccines work by introducing RNA into the body which instructs cells to build proteins, also called antigens, found on the SARS-CoV-2 virus. The antigen is then recognised by the immune system which produces antibodies to fight the real thing. It doesn’t change the body’s DNA. This article is part of our work fact checking potentially false pictures, videos and stories on Facebook. You can read more about this—and find out how to report Facebook content—here. For the purposes of that scheme, we’ve rated this claim as partly false because claims about vaccine trials and efficacy are false while some claims, including the award of a contract to an AI company are broadly true.
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