No Increased Risk of Neurological Conditions After COVID-19 Vaccination March 17, 2022 A study of over 8 million participants found no correlation between COVID-19 vaccination and developing neurological conditions. However, a risk of some neurological conditions was increased after COVID-19 infection. The approved vaccines are highly effective against preventing severe COVID-19 disease, hospitalization, and death. However, the rapid rollout of the vaccines left some unanswered questions about the long-term effects of COVID-19 vaccination. One study, published today in The BMJ, examined the association between COVID-19 vaccines, COVID-19 infection, and risk of immune meditated neurological events. The investigators looked for evidence of 4 neurological conditions: Bell’s palsy (facial weakness), encephalomyelitis (inflammation of the brain and spinal cord), Guillain-Barré syndrome (a nerve condition), and transverse myelitis (inflammation of the spinal cord). The study included 8330497 people who received at least 1 dose of a COVID-19 vaccine by January 13, 2022, ascertained from primary care records in the UK and Spain. At the time, there were 5 COVID-19 vaccines authorized by the European Medicines Agency, including the Pfizer-BioNTech and Moderna mRNA vaccines, the Oxford-AstraZeneca and Janssen viral vector vaccines, and the recombinant spike protein nanoparticle vaccine Novavax. Overall, 4376535 people received AstraZeneca, 3588318 received Pfizer-BioNTech, 244913 received Moderna, and 120731 received Janssen. The study also included a total of 735870 unvaccinated people infected with COVID-19, and 14330080 people from the general population, studied retroactively to estimate historical background pre-pandemic. The patient primary care records came from The Clinical Practice Research Datalink (CPRD) AURUM in the UK, and the Information System for Research in Primary Care (SIDIAP) database in Spain. Post-vaccination rates of Bell’s palsy, encephalomyelitis and Guillain-Barré syndrome were consistent with rates established from the background study cohort. Transverse myelitis events were < 5 in all vaccinated groups and could not be analyzed. Notably, rates of Bell’s palsy, encephalomyelitis and Guillain-Barré syndrome were all higher than anticipated after COVID-19 infection. The study was not causational, so the investigators did not speculate on why this was. Broken down by individual risk the increased likelihood of developing a neurological condition after COVID-19 infection was small, but even a small risk can burden the healthcare system. The results from such large studies show that neurological conditions are no more common among vaccinated people than among unvaccinated people (without prior COVID-19 infection). “We may never be able to tell exactly what caused an individual to develop a neurological condition, but COVID-19 vaccination is a highly unlikely reason for most,” the investigators concluded. https://www.contagionlive.com/view/...logical-conditions-after-covid-19-vaccination Published Study of Neurological Problems after Vaccination Conclusion We found no safety signal for any of the studied immune mediated neurological events after vaccination against covid-19. Infection with SARS-CoV-2 was, however, associated with an increased risk of Bell’s palsy, encephalomyelitis, and Guillain-Barré syndrome. References ↵ WHO. COVID-19 Dashboard. Geneva: World Health Organization, 2020. https://covid19.who.int (accessed 14 January 2022). ↵ European Medicines Agency. 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https://en.wikipedia.org/wiki/Nuremberg_trials or https://en.wikipedia.org/wiki/Trial_of_Slobodan_Milošević or the trial against Putin later for war crimes.
UK Study Links COVID Vaccines to Neurological Disorders By Ralph Ellis Oct. 27, 2021 -- A study conducted in the United Kingdom found that people vaccinated against COVID-19 may have neurological conditions such as Guillain-Barre Syndrome, but that people who actually catch COVID have a much higher chance of having those conditions, the BBC reported. “The risks of adverse neurological events following SARS-CoV-2 infection are much greater than those associated with vaccinations, highlighting the benefits of ongoing vaccination programs,” concluded the study published in Nature Medicine. Researchers looked at National Health Service records of 32 million people to trace reactions to COVID vaccinations, the BBC said. The researchers looked at how people fared a month after their first dose of vaccine and a month after testing positive for COVID. One of the reactions traced was Guillain-Barre Syndrome, a neurological disorder mostly found in people over 50. GBS usually shows up a few days or weeks after a cold, stomach virus, or the flu. In rare cases, surgery or different vaccinations can trigger it. Symptoms include muscle weakness, reflex loss, and numbness or tingling in parts of your body. For vaccinated people, the study found 38 extra cases of GBS for every 10 million adults receiving the Oxford-AstraZeneca vaccine and 60 extra cases of hemorrhagic stroke (brain bleed) for every 10 million adults receiving the Pfizer/BioNTech vaccine, the BBC said. Among people who tested positive for COVID, researchers found 145 extra GBS cases per 10 million with a positive test, 123 extra brain inflammation disorder cases per 10 million people, and 163 extra cases of myasthenia-like disorders per 10 million people. Brain inflammation cases included encephalitis meningitis and myelitis, or inflammation of the spinal cord. Myasthenia-like disorders included immune conditions affecting the nerves and muscles. A study of a smaller population in Scotland found the same link between GBS and the AstraZeneca vaccine but they didn’t find increased risks for people who received the Pfizer vaccine, the BBC said. https://www.webmd.com/vaccines/covi...inks-covid-vaccines-to-neurological-disorders wrbtrader
Operation Warp Speed On May 15, 2020, President Donald Trump officially announced the public-private partnership.[4][1][9] The purpose of Operation Warp Speed was to coordinate Health and Human Services-wide efforts, including the NIH ACTIV partnership for vaccine and therapeutic development, the NIH RADx initiative for diagnostic development, and work by BARDA.[1] Operation Warp Speed was formed to encourage private and public partnerships to enable faster approval and production of vaccines during the COVID-19 pandemic.[2] The name was inspired by terminology for faster-than-light travel used in the Star Trek fictional universe, evoking a sense of rapid progress.[10][11] The Food and Drug Administration announced on June 30, 2020, that a vaccine would need to be at least 50% effective for diminishing the severity of COVID-19 symptoms to obtain regulatory and marketing approval.[12] In January 2021, White House press secretary Jen Psaki announced that the program was expected to undergo a restructure and renaming under the Biden administration.[13][14] Also in January 2021, Dr. Moncef Slaoui, former Operation Warp Speed lead, was told not to use the name Operation Warp Speed anymore.[15] At the end of February 2021, responsibilities of Operation Warp Speed were transferred into the White House COVID-19 Response Team.[7][16] https://en.wikipedia.org/wiki/Operation_Warp_Speed Operation Warp Speed: implications for global vaccine security Summary Several global efforts are underway to develop COVID-19 vaccines, and interim analyses from phase 3 clinical testing have been announced by nine organisations: Pfizer, the Gamaleya Research Institute of Epidemiology and Microbiology, Moderna, AstraZeneca, Sinopharm Group, Sinovac Biotech, Johnson & Johnson, Novavax, and CanSino Biologics. The US programme known as Operation Warp Speed provided US$18 billion in funding for development of vaccines that were intended for US populations. Depending on safety and efficacy, vaccines can become available through mechanisms for emergency use, expanded access with informed consent, or full licensure. An important question is: how will these Operation Warp Speed vaccines be used for COVID-19 prevention in global health settings? We address some key questions that arise in the transition from US to global vaccine prevention efforts and from ethical and logistical issues to those that are relevant to global vaccine security, justice, equity, and diplomacy... https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00140-6/fulltext wrbtrader
Study finds no increased risk of rare neurological events after covid vaccination An increased risk was, however, seen after covid-19 infection A study of more than eight million people published by The BMJ today finds no increased risk of rare neurological events after covid-19 vaccination. An increased risk of Bell’s palsy (facial weakness), encephalomyelitis (inflammation of the brain and spinal cord) and Guillain-Barré syndrome (a nerve condition) was, however, seen after covid-19 infection. Following reports that some people developed Guillain-Barré syndrome after receiving the Oxford-AstraZeneca or Pfizer-BioNTech covid vaccines, the European Medicines Agency listed Guillain-Barré syndrome as a rare side effect of these vaccines. However, so far the results from research into the risk of Guillain-Barré syndrome - and other immune mediated neurological disorders - after covid-19 vaccination have been mixed. To address this, researchers set out to study the association between covid-19 vaccines, infection with SARS-CoV-2 (the virus responsible for covid-19), and risk of immune mediated neurological events. Their findings are based on data from two large electronic primary care health record databases in the UK and Spain. They included 8.3 million individuals who received at least one dose of a covid-19 vaccine (Oxford-AstraZeneca, Pfizer-BioNTech, Moderna or Johnson & Johnson) and 735,870 unvaccinated individuals with a positive covid-19 test result. A further 14.3 million people from the general population were also studied retrospectively (before the pandemic) to estimate historical background rates. This group were unvaccinated and had no previous covid, because neither existed at the time. The events of interest to the research team were four immune mediated neurological disorders: Bell’s palsy (facial weakness), encephalomyelitis (inflammation of the brain and spinal cord), Guillain-Barré syndrome (a nerve condition), and transverse myelitis (inflammation of the spinal cord). Rates of these disorders were estimated in the 21 days after the first vaccine dose, 90 days after a positive test result, and between 2017 and 2019 for background rates in the general population group. Rates of Bell’s palsy, encephalomyelitis and Guillain-Barré syndrome were, however, higher than expected after covid-19 infection. This is an observational study so can’t establish cause, and the researchers cannot rule out the possibility that unknown differences between groups or misclassification of disorders may have affected their results. But they point out that several other studies have also reported increased risks of immune mediated neurological events after covid-19 infection, suggesting their results are robust. As such, they say: “We found no safety signal for any of the studied immune mediated neurological events after vaccination against covid-19. Infection with SARS-CoV-2 was, however, associated with an increased risk of Bell’s palsy, encephalomyelitis, and Guillain-Barré syndrome.” Further evidence is needed to understand the long term adverse events of vaccination and SARS-CoV-2 infection, while larger cohorts are also needed to study the effect of vaccination on different age groups, particularly among younger populations, they add. Importantly, all risks - even those observed after SARS-CoV-2 infection - are small in absolute terms for the single individual, write experts in a linked editorial. However, they note that even small absolute risks “can lead to a substantial burden on the healthcare system in the context of mass vaccination and widespread infection.” Researchers and clinicians have a responsibility to discuss these findings with affected patients and their families, they say, while at the same time acknowledging the inherent uncertainties in making patient level inferences from population level studies. One approach would be to explain that although neurological conditions do occasionally occur shortly after covid-19 vaccination, good evidence from very large studies shows that these conditions are no more common among vaccinated people than among unvaccinated people. “We may never be able to tell exactly what caused an individual to develop a neurological condition, but covid-19 vaccination is a highly unlikely reason for most,” they conclude. [Ends] Notes for editors Research: Association between covid-19 vaccination, SARS-CoV-2 infection, and risk of immune mediated neurological events: population based cohort and self-controlled case series analysis Editorial: The neurological safety of covid-19 vaccines https://www.bmj.com/company/newsroo...-neurological-events-after-covid-vaccination/ wrbtrader