A national study from Korea published in the European Heart Journal sheds important new light on complications related to COVID vaccine related myocarditis.
Good doctors still exist! They are the ones who's opinions change with more emerging evidence. There was a phrase for that...hmmmm......follow the science! But seriously, thank you Dr Koka for your writings. It's kept me sane from the constant propaganda of "safe and effective" when there was no long term data on either.
In order for the statement of 'safe and effective' to have any value whatsoever, it really needs to be backed up by some objective level of safety such as a rate of serious adverse events per 100,000. This can and should have been done before the vaccines were even trialed as part of an open debate on vaccine safety.
Thank you! Well written, very helpful information. I too have transitioned from the 2021 view that vaccines were on balance a positive to the 2023 view ‘well, maybe we needed more data.’ As a physician I was asked for my opinion by many friends, and my answer has necessarily morphed as more and more - and now even more - data appears. I also agree with those now saying, “shame on you, our public health leaders of 2021.”
Thank you for this enlightening report, which continues to add fuel to the covid vaccine harm fire. The U.S. government and health care industry have failed its citizenry.
Dr. Koka, journalist Rav Arora mentioned your work tonight in a positive light on VSRF. My family and friends will be pleased to have local access to a “team reality” cardiology. Your clinic is being recommended to many potential patients right now.
Do you have any information regarding the healh issues for those with VRM? How many of them would have been considered as having 'pre-existing conditions'?
Regarding the ~1100 cases that were labeled as not-vaccine related, do you know if there was an increase in myocarditis cases cases in 2021?
Since the vaccine roll out began, after reading the under powered clinical trials with symptomatic disease as its end point and touting 95% efficacy I was skeptical. As a physician working in public health at the time vaccines rolled out I found the hype was too much and willingness to follow much less acknowledge adverse events was not there. I quit because of it. I lost faith in the CDC FDA and the medical profession in general. When vaccine mandates rolled out and repeated boosters were pushed on flimsy data I knew our “experts” were not following evidence based data but following a narrative. I am glad my physician peers are seeing the light and hope we force the “vaccine safety surveillance system” to actually do its job, but also change the glossing over of what vaccines actually do. Because mRNA vaccines did not stop the virus and they did cause harm.
I would have put in place a far more rigorous vaccine AE surveillance program including mandatory reporting by HCWs to VAERs. We had nearly one year where the development of vaccines was on going to prepare and where we were told life would only return to normal if everyone was vaccinated. With a mass vaccination campaign with a novel vaccine platform for a novel virus planned one must ask why the CDC and FDA did nothing to improve vaccine AEs surveillance other than adding V-safe ? A mandatory reporting program would have improved quality of data collection. One way to make mandatory reporting easier is to facilitate reporting by using an EHR that employs a shareware add on. ESP-VAERS developed in 2010 by The Department of Population Medicine at Harvard Medical School along with Harvard Pilgrim Healthcare Institute in response to the Swine Flu Pandemic of 2009 does that. ESP-VAERS, or any other shareware EHR program, works by monitoring vaccinated individuals for new diagnoses, ER visits or hospitalizations, changes in laboratory values, allergies, or new medication prescriptions that might indicate a possible adverse reaction to the vaccine over a 30-day period post vaccination. If a change in any of the variables or an adverse event is detected the provider or physician is sent an electronic notice. If the data points toward a severe adverse event such as death or hospitalization a report is sent directly to VAERS in addition to the provider. Less severe events are sent to the provider and are screened as to whether they should be submitted to VAERS. It improves the quality and accuracy of surveillance.
All VAERS reports (V-safe reports are dumped into VAERS) should be fully vetted within a month of reporting, that means CDC staff talking to filers, obtaining medical records and any other pertinent data to review. There are over 15,000 people working at the CDC, 20-30 full time people can do this. If the CDC can't handle the task then the process should be subcontracted out to a firm that can. Otherwise VAERS is seen as useless pandering.
Since this was a worldwide pandemic I would also follow and communicate with surveillance agencies in other countries like the EUs EudraVigilance. They were way out in front of us in identifying AEs like VITTS and myocarditis. We led from behind on this playing catch up with a fragmented system that yielded conflicting results between the system's own entities.
The messaging on what vaccines could do needed to be far more transparent. The media was allowed to run wild with statements like "the virus stops when it comes to a vaccinated individual." From the initial roll out we never had any data to support those claims and yet our "experts" never countered those claims publicly. The RCTs did not include asymptomatic "cases" so they failed to answer the question of transmission. I would have demanded that be included. The messaging should have been clearer and repeated consistently: "we have no solid data to support the vaccine blocking transmission." Once we starting seeing studies that showed transmission was not blocked the messaging should have reflected that. We should have been honest in reporting breakthrough infections that started within 2-3 months of initial vaccinations. Over time with enough studies showing vaccinated individuals can shed and spread the virus the messaging shifted toward reducing severe illness and death. But ongoing transmission was never made clear to the public. The first time we saw an honest CDC MMWR report that acknowledged breakthrough infections and vaccinated transmitting the virus was in July 2021 when the Barnstable outbreak among predominantly vaccinated individuals was reported. Despite increasing evidence based data that the vaccines were not stopping infections or vaccinated individuals from shedding virus vaccine mandates were implemented at state and federal levels. I would have never supported mandating vaccines for work or school based upon the data. Studies that suggested vaccinated individuals were less likely to get infected did not take into account other mitigating behaviors like masking and social distancing. Those variables were much tougher to measure with observational studies. So I would have encouraged better studies.
Overall the response of the CDC, which filtered down to state and local departments of public health, and the FDA should have followed evidence based data, not the "science" mantra. The entire way the vaccine roll out, EUAs and mandates were handled did more to hurt vaccine acceptance and attitudes toward public health. There is a lot of lost ground that needs to be made up. The only way to do that is with truth and reconciliation in addition to redesigning the system.
Good doctors still exist! They are the ones who's opinions change with more emerging evidence. There was a phrase for that...hmmmm......follow the science! But seriously, thank you Dr Koka for your writings. It's kept me sane from the constant propaganda of "safe and effective" when there was no long term data on either.
In order for the statement of 'safe and effective' to have any value whatsoever, it really needs to be backed up by some objective level of safety such as a rate of serious adverse events per 100,000. This can and should have been done before the vaccines were even trialed as part of an open debate on vaccine safety.
Thank you! Well written, very helpful information. I too have transitioned from the 2021 view that vaccines were on balance a positive to the 2023 view ‘well, maybe we needed more data.’ As a physician I was asked for my opinion by many friends, and my answer has necessarily morphed as more and more - and now even more - data appears. I also agree with those now saying, “shame on you, our public health leaders of 2021.”
What would you have changed with the public health response of 2021?
Thank you for this enlightening report, which continues to add fuel to the covid vaccine harm fire. The U.S. government and health care industry have failed its citizenry.
Fantastic. Well-written, and rational.
Dr. Koka, journalist Rav Arora mentioned your work tonight in a positive light on VSRF. My family and friends will be pleased to have local access to a “team reality” cardiology. Your clinic is being recommended to many potential patients right now.
Do you have any information regarding the healh issues for those with VRM? How many of them would have been considered as having 'pre-existing conditions'?
Regarding the ~1100 cases that were labeled as not-vaccine related, do you know if there was an increase in myocarditis cases cases in 2021?
Since the vaccine roll out began, after reading the under powered clinical trials with symptomatic disease as its end point and touting 95% efficacy I was skeptical. As a physician working in public health at the time vaccines rolled out I found the hype was too much and willingness to follow much less acknowledge adverse events was not there. I quit because of it. I lost faith in the CDC FDA and the medical profession in general. When vaccine mandates rolled out and repeated boosters were pushed on flimsy data I knew our “experts” were not following evidence based data but following a narrative. I am glad my physician peers are seeing the light and hope we force the “vaccine safety surveillance system” to actually do its job, but also change the glossing over of what vaccines actually do. Because mRNA vaccines did not stop the virus and they did cause harm.
What would you have changed?
I would have put in place a far more rigorous vaccine AE surveillance program including mandatory reporting by HCWs to VAERs. We had nearly one year where the development of vaccines was on going to prepare and where we were told life would only return to normal if everyone was vaccinated. With a mass vaccination campaign with a novel vaccine platform for a novel virus planned one must ask why the CDC and FDA did nothing to improve vaccine AEs surveillance other than adding V-safe ? A mandatory reporting program would have improved quality of data collection. One way to make mandatory reporting easier is to facilitate reporting by using an EHR that employs a shareware add on. ESP-VAERS developed in 2010 by The Department of Population Medicine at Harvard Medical School along with Harvard Pilgrim Healthcare Institute in response to the Swine Flu Pandemic of 2009 does that. ESP-VAERS, or any other shareware EHR program, works by monitoring vaccinated individuals for new diagnoses, ER visits or hospitalizations, changes in laboratory values, allergies, or new medication prescriptions that might indicate a possible adverse reaction to the vaccine over a 30-day period post vaccination. If a change in any of the variables or an adverse event is detected the provider or physician is sent an electronic notice. If the data points toward a severe adverse event such as death or hospitalization a report is sent directly to VAERS in addition to the provider. Less severe events are sent to the provider and are screened as to whether they should be submitted to VAERS. It improves the quality and accuracy of surveillance.
All VAERS reports (V-safe reports are dumped into VAERS) should be fully vetted within a month of reporting, that means CDC staff talking to filers, obtaining medical records and any other pertinent data to review. There are over 15,000 people working at the CDC, 20-30 full time people can do this. If the CDC can't handle the task then the process should be subcontracted out to a firm that can. Otherwise VAERS is seen as useless pandering.
Since this was a worldwide pandemic I would also follow and communicate with surveillance agencies in other countries like the EUs EudraVigilance. They were way out in front of us in identifying AEs like VITTS and myocarditis. We led from behind on this playing catch up with a fragmented system that yielded conflicting results between the system's own entities.
The messaging on what vaccines could do needed to be far more transparent. The media was allowed to run wild with statements like "the virus stops when it comes to a vaccinated individual." From the initial roll out we never had any data to support those claims and yet our "experts" never countered those claims publicly. The RCTs did not include asymptomatic "cases" so they failed to answer the question of transmission. I would have demanded that be included. The messaging should have been clearer and repeated consistently: "we have no solid data to support the vaccine blocking transmission." Once we starting seeing studies that showed transmission was not blocked the messaging should have reflected that. We should have been honest in reporting breakthrough infections that started within 2-3 months of initial vaccinations. Over time with enough studies showing vaccinated individuals can shed and spread the virus the messaging shifted toward reducing severe illness and death. But ongoing transmission was never made clear to the public. The first time we saw an honest CDC MMWR report that acknowledged breakthrough infections and vaccinated transmitting the virus was in July 2021 when the Barnstable outbreak among predominantly vaccinated individuals was reported. Despite increasing evidence based data that the vaccines were not stopping infections or vaccinated individuals from shedding virus vaccine mandates were implemented at state and federal levels. I would have never supported mandating vaccines for work or school based upon the data. Studies that suggested vaccinated individuals were less likely to get infected did not take into account other mitigating behaviors like masking and social distancing. Those variables were much tougher to measure with observational studies. So I would have encouraged better studies.
Overall the response of the CDC, which filtered down to state and local departments of public health, and the FDA should have followed evidence based data, not the "science" mantra. The entire way the vaccine roll out, EUAs and mandates were handled did more to hurt vaccine acceptance and attitudes toward public health. There is a lot of lost ground that needs to be made up. The only way to do that is with truth and reconciliation in addition to redesigning the system.
Full disclosure: I am vaccinated
Well done! Especially liked the addition of the post-script. Yes, you are pro-vax!