CDC pings Harvard Medical, $1MM Grant
https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf
CDC pinged Harvard Medical to see if they could find inefficiencies in VAERS and were wondering if they could create an automated system for monitoring adverse reactions. The research was conducted during 2007-2010.
"Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA)."
"Preliminary data were collected form June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified."
"Likewise, fewer than 1% of vaccine adverse events are reported."
They were doing this study b/c they were asked if there was a way to create an automated monitoring system. They were able to automate their Harvard Pilgrim system. So, as requested, Harvard Medical was ready to completely automate the VAERS system across the entire country (US) in order to collect more robust data.
https://www.cdc.gov/media/pressrel/2009/r090925.htm
"Harvard Pilgrim Health Care, Boston. Richard Platt, M.D., and Kenneth D. Mandl, M.D. 1) Personally Controlled Health Records and Social Networks, and 2) Electronic Support for Public Health: Diabetes Mellitus. These have the major goal of furthering the integration of electronic health records (EHRs) and personal health records with public health functions and outcomes. This builds upon the activities of an existing CDC public health informatics center of excellence to support public health practice to prevent chronic diseases and their effects."
So, if you read the conclusion, you'll see that it appears that the CDC fired or restructured the entities overseeing the Harvard Medical findings, and completely cut off communication with Harvard Medical.
Extrapolate on the CDC's response (or lack thereof). They didn't want to have an automated system because they didn't like the findings when the system was automated.
Now see this article:
https://www.nytimes.com/2021/02/12/health/covid-vaccine-how-safe.html
"...the much-touted system the government designed to monitor any dangerous reactions won't be capable of analyzing safety data for weeks or months, according to numerous federal health officials."
"For now, federal regulators are counting on pathwork of existing programs that they acknowledge are inadequate because of small sample size, missing critical data or other problems."
"In interview, F.D.A. officials acknowledged that a promised monitors system, known as BEST, is still in its developmental stages. They expect it to start analyzing vaccine safety data sometime soon--but likely not until after the Biden administration reaches its goal of vaccinating 100 million people"
A system was ready to go in 2010. Re-read the Harvard Medical grant findings. lmfao...
So, the question: is VAERS still capturing ~1% of adverse reactions to vaccinations?
Let's cross-reference some data.
Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021
https://jamanetwork.com/journals/jama/fullarticle/2776557
Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine
https://jamanetwork.com/journals/jama/fullarticle/2775646
can find this on CDC website here:
https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm
See "Table. Characteristic of Reported Cases of Anaphylaxis Follwoing Receipt of Pfizer-BioNTech (9 943 247 Doses) and Moderna (7 581 429 Doses) COVID-19 Vaccines--Vaccine Adverse Events Reporting System (VAERS), US, December 14, 2020-January 18, 2021."
https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf
CDC pinged Harvard Medical to see if they could find inefficiencies in VAERS and were wondering if they could create an automated system for monitoring adverse reactions. The research was conducted during 2007-2010.
"Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA)."
"Preliminary data were collected form June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified."
"Likewise, fewer than 1% of vaccine adverse events are reported."
They were doing this study b/c they were asked if there was a way to create an automated monitoring system. They were able to automate their Harvard Pilgrim system. So, as requested, Harvard Medical was ready to completely automate the VAERS system across the entire country (US) in order to collect more robust data.
https://www.cdc.gov/media/pressrel/2009/r090925.htm
"Harvard Pilgrim Health Care, Boston. Richard Platt, M.D., and Kenneth D. Mandl, M.D. 1) Personally Controlled Health Records and Social Networks, and 2) Electronic Support for Public Health: Diabetes Mellitus. These have the major goal of furthering the integration of electronic health records (EHRs) and personal health records with public health functions and outcomes. This builds upon the activities of an existing CDC public health informatics center of excellence to support public health practice to prevent chronic diseases and their effects."
So, if you read the conclusion, you'll see that it appears that the CDC fired or restructured the entities overseeing the Harvard Medical findings, and completely cut off communication with Harvard Medical.
Extrapolate on the CDC's response (or lack thereof). They didn't want to have an automated system because they didn't like the findings when the system was automated.
Now see this article:
https://www.nytimes.com/2021/02/12/health/covid-vaccine-how-safe.html
"...the much-touted system the government designed to monitor any dangerous reactions won't be capable of analyzing safety data for weeks or months, according to numerous federal health officials."
"For now, federal regulators are counting on pathwork of existing programs that they acknowledge are inadequate because of small sample size, missing critical data or other problems."
"In interview, F.D.A. officials acknowledged that a promised monitors system, known as BEST, is still in its developmental stages. They expect it to start analyzing vaccine safety data sometime soon--but likely not until after the Biden administration reaches its goal of vaccinating 100 million people"
A system was ready to go in 2010. Re-read the Harvard Medical grant findings. lmfao...
So, the question: is VAERS still capturing ~1% of adverse reactions to vaccinations?
Let's cross-reference some data.
Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021
https://jamanetwork.com/journals/jama/fullarticle/2776557
Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine
https://jamanetwork.com/journals/jama/fullarticle/2775646
can find this on CDC website here:
https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm
See "Table. Characteristic of Reported Cases of Anaphylaxis Follwoing Receipt of Pfizer-BioNTech (9 943 247 Doses) and Moderna (7 581 429 Doses) COVID-19 Vaccines--Vaccine Adverse Events Reporting System (VAERS), US, December 14, 2020-January 18, 2021."
per 1 MM cases, VAERS is saying that 4.7 people per 1MM doses are having an anaphylactic reaction; Moderna saying 2.5 cases per 1MM. This is what is stated by VAERS when looking at the data over this time period.
Sounds good, right? Seems rare.
So, let's look to JAMA...
Acute Allergic Reactions to mRNA COVID-19 Vaccines
https://jamanetwork.com/journals/jama/fullarticle/2777417
Sounds good, right? Seems rare.
So, let's look to JAMA...
Acute Allergic Reactions to mRNA COVID-19 Vaccines
https://jamanetwork.com/journals/jama/fullarticle/2777417
Jamanetwork
Acute Allergic Reactions to mRNA COVID-19 Vaccines
This study examines the incidence of acute allergic reactions to mRNA COVID-19 vaccine administrations in health care employees in Massachusetts.
"We prospectively studied Mass General Brigham (MGB) employees who received their first dose of an mRNA COVID-19 vaccine (12/16/2020-2/12/2021, with the follow-up through 2/18/2021) (eMethods in the Supplement)."
"Of 64,900 employees who received their fist dose of a COVID-19 vaccine, 25,929 (40%) received the Pfizer-BioNTech vaccine and 38,971 (60%) received the Moderna vaccine. At least 1 symptom survey was completed by 52,805 (81%)."
"Anaphylaxis to the mRNA COVID-19 vaccines is currently estimated to occur in 2.5 to 11.1 cases per 1 million doses, largely in individuals with a history of allergy. Allergic concerns contribute to vaccine hesitancy; we investigated acute allergic reaction incidence after more than 60 000 MRNA COVID-19 vaccine administrations."
"In this prospective cohort of health care employees, 98% did not have any symptoms of an allergic reactions after receiving an mRNA COVID-19 vaccine. The remaining 2% reported some allergic symptoms..."
"...however, severe reactions consistent with anaphylaxis occured at a rate of 2.47 per 10 000 vaccinations."
That's 10,000, sirs. Their study was 2.47 per 10,000 vaccinations. This was a controlled study. When we look at VAERS it was ~2.5 per 1,000,000. YUGE difference. This is exactly what Harvard Medical discovered back in 2010, that VAERS is capturing < 1%.
This is from a discussion that happened at the CDC:
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-01/06-COVID-Shimabukuro.pdf
They were talking about deaths in nursing homes. What you'll see is that they're trying to protect themselves from an argument. They were about to have a mass vaccination program throughout all of the nursing homes in the US. They wanted to make sure that all of the people that would die "naturally" wouldn't somehow corrupt the vaccine deaths.
So, this is their argument:
see "Estimated background mortality in LTCF residents (cont.)"
- Among 1.3 million LTCF (Long Term Care Facility) residents (2M x 65%) vaccinated over the 29-day risk period (December 21-January 18)
- Expect (to see a natural death rate) 11,440 deaths among LTCF residents (=286,000*4%) following vaccination
*THIS IS THE ARGUMENT* it's like a hedge, it's like saying, "We told you, that if there's 11,400 reports in VAERS we can discount those ahead of time because that would have been the natural death rate. Sure, it was merely days after they received their vaccines, but we've already planted the seed in our argument to show you that we expected that." This positions the CDC to not be concerned until deaths are > 11,400.
- By comparison, VAERS received 129 reports of death following COVID-19 vaccination in LTCF residents through January 18, 2021
*NOTE* There wasn't a drop in the death rate, it shows that virtually no one in these LTCF was reporting the deaths. The reports were underperforming, just as shown by Harvard Medical back in 2010 (129 deaths out of 11,440 is < 1%).
- Mortality in LTCF residents is high and substantial numbers of deaths in this population will occur following vaccination as temporally-associated coincidental events.
So, it seems nothing has changed with VAERS since 2010 based on the Harvard Medical findings.
"Of 64,900 employees who received their fist dose of a COVID-19 vaccine, 25,929 (40%) received the Pfizer-BioNTech vaccine and 38,971 (60%) received the Moderna vaccine. At least 1 symptom survey was completed by 52,805 (81%)."
"Anaphylaxis to the mRNA COVID-19 vaccines is currently estimated to occur in 2.5 to 11.1 cases per 1 million doses, largely in individuals with a history of allergy. Allergic concerns contribute to vaccine hesitancy; we investigated acute allergic reaction incidence after more than 60 000 MRNA COVID-19 vaccine administrations."
"In this prospective cohort of health care employees, 98% did not have any symptoms of an allergic reactions after receiving an mRNA COVID-19 vaccine. The remaining 2% reported some allergic symptoms..."
"...however, severe reactions consistent with anaphylaxis occured at a rate of 2.47 per 10 000 vaccinations."
That's 10,000, sirs. Their study was 2.47 per 10,000 vaccinations. This was a controlled study. When we look at VAERS it was ~2.5 per 1,000,000. YUGE difference. This is exactly what Harvard Medical discovered back in 2010, that VAERS is capturing < 1%.
This is from a discussion that happened at the CDC:
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-01/06-COVID-Shimabukuro.pdf
They were talking about deaths in nursing homes. What you'll see is that they're trying to protect themselves from an argument. They were about to have a mass vaccination program throughout all of the nursing homes in the US. They wanted to make sure that all of the people that would die "naturally" wouldn't somehow corrupt the vaccine deaths.
So, this is their argument:
see "Estimated background mortality in LTCF residents (cont.)"
- Among 1.3 million LTCF (Long Term Care Facility) residents (2M x 65%) vaccinated over the 29-day risk period (December 21-January 18)
- Expect (to see a natural death rate) 11,440 deaths among LTCF residents (=286,000*4%) following vaccination
*THIS IS THE ARGUMENT* it's like a hedge, it's like saying, "We told you, that if there's 11,400 reports in VAERS we can discount those ahead of time because that would have been the natural death rate. Sure, it was merely days after they received their vaccines, but we've already planted the seed in our argument to show you that we expected that." This positions the CDC to not be concerned until deaths are > 11,400.
- By comparison, VAERS received 129 reports of death following COVID-19 vaccination in LTCF residents through January 18, 2021
*NOTE* There wasn't a drop in the death rate, it shows that virtually no one in these LTCF was reporting the deaths. The reports were underperforming, just as shown by Harvard Medical back in 2010 (129 deaths out of 11,440 is < 1%).
- Mortality in LTCF residents is high and substantial numbers of deaths in this population will occur following vaccination as temporally-associated coincidental events.
So, it seems nothing has changed with VAERS since 2010 based on the Harvard Medical findings.