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  • 2021-04-21 (xsd:date)
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  • Results of Covid-19 vaccine trials have been published and peer-reviewed (en)
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  • The Covid-19 vaccine trials have not yet been completed and therefore the results cannot be peer-reviewed. The Covid-19 vaccine trials have been published in peer reviewed journals. The data collection and analysis are ongoing, in order to allow up to two years of follow up on participants. Covid-19 is a flu and nothing more. Incorrect. Covid-19 has killed more people than flu in a given season and is caused by a different organism. Covid-19 is not classed as a ‘high consequence infectious disease’. This is true, because it no longer meets the criteria for an HCID. This doesn’t mean that it is no longer considered dangerous or significant. A Facebook post states that the Covid-19 vaccines will not have finished testing until 2023. The post says that therefore the vaccinations are unsafe and suggests that as a result, fact checkers have been spreading disinformation regarding the safety of the vaccines. In particular, the post states that studies on the three vaccines currently approved for use in the UK can’t have been peer-reviewed because they have not yet been completed. The post includes links to the clinical trial registration pages of some of these vaccines. The post also lists their study completion dates, as all being in 2023. Two of the three links offered in the Facebook post do link to the trial registration sites for Covid-19 vaccines (Pfizer and AstraZeneca). However, one of the links cited in the post connects to the registration page of a Moderna study using an mRNA vaccine to prevent the recurrence of melanoma rather than to a study of the Moderna vaccine for Covid-19. As such the quoted 2023 date for the completion of the Moderna vaccine in the facebook post is incorrect. The trial completion dates are set in the future (to allow for long term follow up), however analyses of the data from phase three trials have been published in peer-reviewed studies in medical journals. The post also shows a picture of a government website which says that as of March 2020 Covid-19 should no longer be classed a high consequence infectious disease. The Facebook post also says that Covid-19 is ‘nothing more than a flu’. As we have written about before, Covid-19 is no longer classed as a high consequence infectious disease but that does not mean that it is no longer considered dangerous or significant. We’ve also written many times about the fact Covid is more than just ‘a flu’. As for the claim that fact checkers are spreading misinformation, at Full Fact we aim to do exactly the opposite. We write articles to prevent the spread of bad information, and the harm that it can cause. We use reputable sources, and link to the evidence that we use so that readers can check it for themselves. Stay informed Be first in line for the facts – get our free weekly email Subscribe The National Institute of Health clinical trials website (which is a database from the US National Library of Medicine of global private and publicly funded medical research studies) lists studies with a start date, estimated primary completion date and estimated secondary completion date. For the Pfizer Covid-19 vaccine, for example the primary completion date is October 2021, and the estimated study completion date is April 2023. The primary completion date is the date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure and the estimated study completion date is the estimated date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures and adverse events. For the Pfizer vaccine, the primary outcomes include reactions like pain at the injection site, systemic side effects like a fever or vomiting, and adverse events. Many of the secondary outcome measures involve examining or measuring samples from participants up to two years after their final vaccine. The completion date therefore has to be a few years in the future. Data on key outcomes such as efficacy and safety have therefore been published in peer-reviewed journals, however data on long term protection and safety will continue to be collected over the coming years.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. The Medicines and Healthcare products Regulation Authority (MHRA) has said that Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. It added: The expected benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. In December 2020, the Pfizer and the Oxford-AstraZeneca research teams released their analyses of phase three safety and efficacy data. Moderna released theirs in February 2021. For Pfizer this was a peer-reviewed article in the New England Journal of Medicine including efficacy data from 43,500 participants (including placebo group), with two month safety data from 37,700 participants. For Oxford-AstraZeneca, this was a peer reviewed article in The Lancet, including interim analysis data from around 11,600 participants (although 23,800 participants were included in the wider trial) from April-November 2020. Moderna’s data was also peer-reviewed and released in the New England Journal of Medicine and included data from approximately 30,400 participants (15,200 of whom received the vaccine rather than a placebo). The second image included in the Facebook post, is a picture of a genuine page on the UK government website. The website says that as of 19 March 2020, COVID-19 is no longer considered to be a high consequence infectious disease in the UK. This is correct, but needs more context. We wrote about this in 2020. A high consequence infectious disease (HCID) is an acute infectious disease which meets certain criteria, for example it has a particularly high case fatality rate, a lack of treatment or way to prevent infection, it is difficult to diagnose, easy to transmit or spread, or it requires an ‘enhanced’ response. In January 2020, the HCID group recommended that Covid-19 be classified as a HCID. However, by March there was awareness that the mortality rates were lower than initially feared, there was improved clinical awareness, and an accurate test for SARS-CoV-2 (the virus that causes Covid-19) was available. As a result Covid-19 was removed from the list of HCIDs. Just because Covid-19 is not considered a HCID, does not mean it is not of importance. To put it into context, there are currently only 18 infectious diseases or strains of infectious diseases on the HCID list. One of them, Ebola Virus Disease, has a case fatality rate of 25-90%. There are many significant infectious diseases that are of concern, but may not meet HCID criteria. For example, three of the leading causes of infectious disease related deaths globally: tuberculosis, HIV/AIDS and malaria. We’ve previously written many times about why Covid-19 is more than ‘just a flu’. We’ve fact checked incorrect claims that Covid-19 is no worse than a bad flu season or that deaths from flu have been higher than Covid-19 (when in fact Covid deaths have been higher), or that flu deaths are being widely miscategorised as Covid-19 (which is also incorrect). We’ve also written before about the fact that while there has been a reduction of flu over the last year there is no evidence to suggest that Covid-19 is simply influenza in a new guise. Not least because they are caused by different viruses. Correction 22 July 2021 We corrected an earlier description of the MHRA in this article because while it has approved some Covid-19 vaccines across the UK others are approved for use in Northern Ireland via the EMA. 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 vaccine data has been peer-reviewed and published, and Covid-19 is no longer classified as an HCID, and is more than ‘just flu’. (en)
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