Summary CDC Finally Releases VAERS Safety Monitoring Analyses For COVID Vaccines | ZeroHedge www.zerohedge.com
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The CDC conducted an analysis of the safety of mRNA COVID-19 vaccines in U.S. adults and found 770 different types of adverse events, with significant increases in reports of serious adverse events compared to other vaccines.
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- NASDAQ is trading in a tight range between 10800 and 11400, with 10800 being the "must hold" level.
- Josh Guetzkow conducted a safety signal analysis of the COVID-19 vaccine adverse events in 2021 and found over 700 safety signals.
- The CDC's Vaccine Safety Datalink Rapid Cycle Analysis used millions of medical records to analyze 18 Adverse Events of Special Interest.
- Analysis of safety signals in the fall of 2021 stratified by age groups showed that appendicitis, lymphadenopathy, and myocarditis had increased risk after vaccination but not after a positive SARS-CoV-2 test.
- The CDC has released VAERS safety signal analysis based on adverse events (AEs) among U.S. adults for mRNA COVID-19 vaccines, from Dec. 14, 2020 to July 29, 2022. There were 770 different types of AEs that showed clear safety signals.
Summaries
206 word summary
Zerohedge provides daily recaps of important news stories and follows US markets, property prices, and FX trades. They offer a premium upgrade and contact information. The CDC analyzed millions of medical records related to the COVID-19 vaccine and found no higher rate of adverse events than for non-COVID-19 vaccines. Josh Guetzkow conducted an analysis with the MedAlerts Wayback Machine and found over 700 safety signals that need further investigation. The CDC stratified their analysis by age and gender, and found increased risk for appendicitis, lymphadenopathy, and myocarditis after vaccination but not after a positive SARS-CoV-2 test. The US has administered over 600 million vaccine doses and the CDC used a disproportionality analysis called PRRs to compare the new drug/vaccine to existing ones considered safe. They found a higher proportion of reports with serious adverse events for Moderna (9.6%) and Pfizer (12.6%). The CDC analyzed the safety of mRNA COVID-19 vaccines in U.S. adults using VAERS, finding 770 different types of adverse events. For children aged 5-11, 66 safety signals were identified and 96 for those aged 12-17. Reports of serious adverse events were twice as many compared to other vaccines given to adults, and 5.5 times larger than all serious reports for adult vaccines since 2009.
568 word summary
The CDC has conducted a safety signal analysis of mRNA COVID-19 vaccines among U.S. adults using the Vaccine Adverse Events Reporting System (VAERS). They identified 770 different types of adverse events, including thrombo-embolic, cardiac, neurological, hemorrhagic, hematological, immune-system and menstrual issues. For 5-11 year-olds, 66 safety signals were detected, while 96 signals were detected in 12-17 year-olds. Twice as many reports for the vaccine were classified as serious compared to other vaccines given to adults, and the number of serious adverse events reported in less than two years was 5.5 times larger than all serious reports for vaccines given to adults in the US since 2009.
The CDC used a type of disproportionality analysis called proportional reporting ratios (PRRs) to compare the new drug/vaccine to existing ones considered safe, looking for a higher proportion of particular adverse events. Only adverse events with a PRR of at least 2 and a Chi-square value of at least 4 were included in the tables and marked in yellow to indicate a safety signal. The overall proportion of reports with serious adverse events was 9.6% for Moderna and 12.6% for Pfizer. The US has administered over 600 million COVID vaccine doses by the end of July. The CDC has conducted an analysis of VAERS reports to identify safety signals related to this large number of vaccines given out. The CDC has calculated confidence intervals for 543 safety signals and determined that for the 18+ age group, there are 57 AEs with a Chi-square larger than myocarditis and 68 with a Chi-square larger than pericarditis.
Analysis of safety signals in the fall of 2021 stratified by age groups showed that appendicitis, lymphadenopathy, and myocarditis had increased risk after vaccination but not after a positive SARS-CoV-2 test. A study published in the New England Journal of Medicine (NEJM) also found an increase in lymphadenopathy following Pfizer vaccination.
Objections to the reliability of VAERS reports have been raised, but the CDC's analysis takes into account all reported events and does not artificially inflate reports. The objection that the vaccines are mainly given to older people who tend to have health problems is dealt with since the analyses are stratified by age groups.
Guetzkow noted that the onus is on regulators to further investigate the safety signals he found as they need further investigation. The CDC used millions of medical records to analyze 18 Adverse Events of Special Interest related to the COVID-19 vaccine and found no higher rate than for non-COVID-19 vaccines. Josh Guetzkow conducted a safety signal analysis with the MedAlerts Wayback Machine and found over 700 signals. His analysis, as well as one in the New England Journal of Medicine, showed that more events reported, including for comparator vaccines, leads to a larger Chi-square. Myo-pericarditis appears to disproportionately affect younger men and should be stratified by age and gender.
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An analysis of adverse events has revealed that more events reported, including for comparator vaccines, leads to a larger Chi-square. Additionally, myo-pericarditis appears to disproportionately affect younger men and so a proper safety signal should be stratified by age and gender. Josh Guetzkow, a senior lecturer at The Hebrew University of Jerusalem, conducted a safety signal analysis of the COVID-19 vaccine adverse events in 2021. He used the MedAlerts Wayback Machine to filter serious reports and found over 700 safety signals. A similar analysis in the New England Journal of Medicine only studied 23 outcomes.
The CDC's Vaccine Safety Datalink Rapid Cycle Analysis used millions of medical records to analyze 18 Adverse Events of Special Interest. The CDC concluded that the rate of AE of the COVID-19 vaccines was not higher than that of the non-COVID-19 vaccines.
Guetzkow noted that the onus is on regulators to further investigate the safety signals he found as they need further investigation. The Centers for Disease Control and Prevention (CDC) uses Vaccine Adverse Event Reporting System (VAERS) data to publish papers in top medical journals. VAERS data is not verified and cannot be trusted, however, it may provide insight into safety signals.
Analysis of safety signals in the fall of 2021 stratified by age groups showed that appendicitis, lymphadenopathy, and myocarditis had increased risk after vaccination but not after a positive SARS-CoV-2 test. A study published in the New England Journal of Medicine (NEJM) found an increase in lymphadenopathy following Pfizer vaccination.
It is important to note that the PRR methodology does not depend on the number of doses administered, but rather the rate of reporting of a specific AE out of all AEs for that vaccine. Estimates suggest that there were over 538 million doses of flu given to people 18+ from July 2015-June 2020, and over 100 million flu doses administered annually to this age group alone.
The objection that the vaccines are mainly given to older people who tend to have health problems is dealt with since the analyses are stratified by age groups. This objection does not dismiss the safety signal analysis out of hand, but rather calls for better and more refined research. The US has administered approximately 600 million COVID vaccine doses by the end of July, an unprecedented number. The CDC has conducted an analysis of VAERS reports to identify safety signals related to the large number of vaccines given out. The CDC has calculated confidence intervals for 543 safety signals and determined that for the 18+ age group, there are 57 AEs with a Chi-square larger than myocarditis (Chi-square=303.8) and 68 with a Chi-square larger than pericarditis (Chi-square=229.5). The larger the Chi-square value, the less likely the signal is due to chance. PRR can be thought of as an indicator of how strong the signal is, while the Chi-square is a measure of how clear or unambiguous the signal is.
Objections to the reliability of VAERS reports have been raised, such as fraudulent reports, but the CDC's analysis takes into account all reported events. This method does not artificially inflate reports, but rather shows that certain events have a higher rate of reporting than others. Adverse events (AEs) reported with mRNA COVID vaccines can cause myocarditis and pericarditis. AEs with a safety signal of equal or greater size should be considered potentially causal and investigated more thoroughly.
The CDC provided an Excel table to look at the types of AEs that generated the most number of reports. After dropping the new COVID-era AEs, there were 503 AEs with a PRR larger than myocarditis (PRR=3.09) and 552 with PRRs larger than pericarditis (PRR=2.82). This means that 66.4% of the AEs had a bigger safety signal than myocarditis and 77.3% were larger than pericarditis.
For 12-17 year-olds, there were 96 AEs with PRRs larger than myocarditis and 67 for 5-11 year-olds. The list of AEs is much shorter for these age groups, but any AE with a signal of equal or greater size should be considered potentially causal and investigated more thoroughly. The CDC examined 772 adverse events reported to VAERS for mRNA COVID-19 vaccines from December 14, 2020 to July 29, 2022. They grouped these into different types of non-COVID related adverse events and calculated PRRs and Chi-square values to determine safety signals.
Adverse events were divided by age group and PRRs calculated separately for each group. The CDC also compared reports for the Pfizer and Moderna vaccines, finding that the overall proportion of reports with serious adverse events was 9.6% for Moderna and 12.6% for Pfizer.
The only adverse events included in the tables were those that satisfied at least one of two conditions: a PRR of at least 2 and a Chi-square value of at least 4. These were marked in yellow to indicate a safety signal. The CDC has been slow in responding to FOIA requests for the safety signal analysis of the Vaccine Adverse Events Reporting System (VAERS). After initially claiming they had never done the analysis, they eventually admitted to doing it from March 25, 2022 to the end of July.
The analysis uses a type of disproportionality analysis called proportional reporting ratios (PRRs). This compares the new drug/vaccine to existing ones considered safe, looking for a higher proportion of particular adverse events. The PRR is calculated by taking the number of reports for a given adverse event divided by the total number of reports and then dividing that by the same ratio for one or more existing comparator vaccines. A PRR of 2 or greater, and a Chi-square value of 4 or greater is required for a safety signal.
The CDC has subjected COVID-19 vaccines to the most rigorous safety monitoring the world has ever known. The CDC analysis of VAERS reports for mRNA COVID-19 vaccines revealed a large number of highly alarming safety signals. Twice as many reports for the vaccine were classified as serious compared to other vaccines given to adults, and the number of serious adverse events reported in less than two years was 5.5 times larger than all serious reports for vaccines given to adults in the US since 2009.
For 5-11 year-olds, there were 66 safety signals, including Kawasaki's disease, menstrual irregularities, vitiligo, and vaccine breakthrough infection. For 12-17 year-olds, there were 96 safety signals, including myocarditis/pericarditis, chest pain, appendicitis & appendectomies, ventricular dysfunction and cardiac valve incompetencies, pericardial and pleural effusion, chest pain, increased troponin levels, being in intensive care, and having anticoagulant therapy.
The CDC admitted to only having started its safety signal analysis in early 2021, despite VAERS being touted as our early warning vaccine safety system. The results of their safety signal analysis were generally consistent with EB data mining conducted by the FDA, revealing no additional unexpected safety signals. The CDC has released VAERS safety signal analysis based on adverse events (AEs) among U.S. adults for mRNA COVID-19 vaccines, from Dec. 14, 2020 to July 29, 2022. There were 770 different types of AEs that showed clear safety signals, including thrombo-embolic, cardiac, neurological, hemorrhagic, hematological, immune-system and menstrual issues. Analysis was authored by Professor Josh Guetzkow via Jackanapes Junction and Tyler Durden of Wolf Street.