BY ANISH KOKA
I not too long ago noticed a younger man who got here to see me as a result of his place of future employment, a big well being system was requiring him to finish the 1º collection of his COVID-19 vaccination. He was involved as a result of he had chest ache after his first mRNA vaccine and was uncomfortable with the dangers of a second mRNA dose. He tried to get a Johnson and Johnson vaccine and was advised by pharmacists he was not allowed to combine and match this specific vaccine as he had already obtained an mRNA dose. With no different possibility, he got here to ask me whether or not I believed a vaccine exemption was cheap in his case. He already had a household drugs doctor signal an exemption that had been denied by his future employer’s vaccine exemption committee. The younger man works on the “again finish” of the well being system remotely from dwelling and he has no affected person contact. The whole course of has precipitated him to lose his medical insurance from his former employer, and he was now paying out of pocket for an costly COBRA medical insurance plan. What follows is my letter to the vaccine exemption assessment committee concerning his case. (Printed with permission, solely the related names have been modified/redacted)
Pricey Vaccine Exemption Overview Committee,
I’m scripting this letter on behalf of John Smith DOB: xx/xx/xx in regard to a mandate from xxxx Well being that Mr. Smith obtain a second dose of an mRNA vaccine to finish his major COVID-19 vaccine collection.
Mr. Smith has requested me to render an opinion particularly associated to his cardiac danger of receiving a second dose of an mRNA vaccine. I’m a board-certified heart specialist in Philadelphia, Pennsylvania, and have been in energetic scientific follow for 13 years.
After reviewing the main points of his case, I’ve grave considerations about compelling him to obtain a second dose of an mRNA vaccine and wish to define the explanations for my conclusion on this letter. I’m going to particularly focus on his danger of an vital, now well-recognized, antagonistic occasion: vaccine myocarditis.
What follows is a few vital background details about vaccine myocarditis that has been gleaned during the last 2 years earlier than I focus on the particulars of Mr. Smith’s case.
It’s related to notice right here that as a doctor energetic clinically in each the inpatient and outpatient arenas, I’m an eyewitness to the extreme toll COVID-19 took on my sufferers within the Spring or 2020. I used to be impressed sufficient with the preliminary mRNA vaccine knowledge to accumulate the vaccine accessible from the Philadelphia Division of Well being (Moderna) and ran a number of vaccine clinics with a purpose to vaccinate my largely high-risk sufferers.
What follows is knowledge produced because the vaccine rollout that’s related to Mr. Smith’s case.
The mRNA vaccines trigger myocarditis
The dangers of the novel mRNA vaccine had been first clarified in April 2021 by Israeli researchers who first recognized a causal hyperlink between the mRNA vaccines and myocarditis and in addition famous the upper incidence of myocarditis after the “second dose in younger males.”
The best incidence of vaccine myocarditis is in younger males after the second dose
Quite a few subsequent research which have tried to quantify the chance of myocarditis are of variable high quality largely as a result of plenty of research used pooled danger estimates throughout your entire inhabitants, ignoring the statement that vaccine myocarditis has its highest incidence in younger males. Research that look at the incidence of myocarditis by age, intercourse, dose and producer present essentially the most granularity with regard to danger estimation. A scientific assessment of vaccine myocarditis papers clearly demonstrates the very best incidence of vaccine myocarditis in younger males after dose 2, and in addition highlights the uselessness of papers that don’t stratify incidence of myocarditis by age, intercourse and dose of vaccine.
Vaccine myocarditis is larger danger than COVID myocarditis in younger males
A complete research from England clearly demonstrated vaccine myocarditis to be extra frequent than COVID19 myocarditis in age < 40 regardless of the very fact this research enormously overestimates COVID19 myocarditis charges as a result of it underestimates the whole variety of COVID19 infections.
Current research convey into query the prognosis of COVID19 myocarditis
A latest cardiac imaging research recommend myocarditis will not be the most important mechanism of cardiac harm after a COVID-19 an infection.
An accompanying editorial notes “Information from COVID-Coronary heart present reassuring proof that myocarditis, as soon as predicted to be an rising public well being disaster attributable to COVID-19, is comparatively unusual even amongst hospitalized sufferers and is much less virulent than predicted in the course of the early days of the pandemic. It’s possible that elevated cardiac troponin concentrations throughout COVID-19 in lots of sufferers don’t mirror important new myocardial harm and fibrosis, however somewhat cardiac troponin launch from weak hearts with pre-existing scar within the setting of extreme sickness”
Information obtained by a document request from Sweden clearly exhibit elevated charges of myocarditis within the time interval after initiation of the COVID mass vaccination marketing campaign, with no considerable enhance within the price of myocarditis throughout widespread COVID within the yr prior.
This spike in myocarditis diagnoses seen solely after initiation of the vaccination marketing campaign is corroborated by rigorous research
6. requiring corroboration of a myocarditis prognosis with the suitable scientific context and cardiac imaging.
Restoration from a COVID an infection confers sturdy, sturdy safety in opposition to future COVID infections
A systematic assessment and meta-analysis of prior an infection with COVID suggests safety in opposition to re-infection “was very excessive and remained excessive even after 40 weeks.” The authors of this paper go on to recommend that “the immunity conferred by previous an infection needs to be weighed alongside safety from vaccination when assessing future illness burden from COVID-19”.
Vaccine myocarditis might be severe and life threatening.
The overwhelming majority of instances of vaccine myocarditis requires hospitalization for monitoring for deterioration. Whereas nearly all of sufferers are discharged dwelling to get better, the present advice is for recovering sufferers to keep away from strenuous exercise for six months. A majority of sufferers that observe up for cardiac MRI imaging are seen to have scar in long run observe up. There are additionally case stories of extreme morbidity and mortality from vaccine myocarditis leading to crucial sickness or dying.
Prior episodes of vaccine myocarditis have been linked to an elevated danger of myocarditis with future vaccinations
Two case stories from Australia describe myocarditis after administration of the Novavax vaccine to 2 younger people who had recovered from mRNA vaccine myocarditis.
The 2 case stories from Australia aren’t even the primary stories of Novovax myocarditis after mRNA vaccine myocarditis. In August, the CDC reported 29 instances of pericarditis, together with 5 in individuals with a historical past of pericarditis after mRNA COVID-19 vaccine;
Importantly, the Novovax vaccine is a protein-based vaccine that was hoped to not be related to myocarditis as was famous with the mRNA vaccines. Sadly, these report of myocarditis occurring after Novovax supply in sufferers who had a previous case of mRNA vaccine myocarditis suggests a historical past of vaccine myocarditis ought to function a contraindication to any future COVID-19 vaccines.
Abstract / Suggestions:
Mr. Smith is a 31 yr previous man with no medical historical past. He emphatically denies any historical past of cardiopulmonary illness. He obtained his first dose of a Pfizer mRNA COVID-19 vaccine in June 2021. He subsequently describes having sharp chest ache over the subsequent few weeks. He didn’t search any medical analysis on the time as he didn’t hyperlink the chest ache with the primary dose of the vaccine he obtained. The ache resolved a couple of weeks later. He has had COVID twice, first in September of 2020, and his second time in January of 2023.
His cardiac testing accomplished thus far encompass an electrocardiogram and an echocardiogram carried out Feb sixteenth, 2023 that had been each regular.
I feel it’s definitely potential Mr. Smith might have had myocarditis after the primary dose of his mRNA vaccine. As I mentioned with Mr. Smith, a cardiac MRI wouldn’t change my opinion on the matter as a traditional end result this many months from his authentic presentation wouldn’t rule out acute myocarditis. If he did have a case of vaccine myocarditis after his first dose of an mRNA vaccine, I feel he can be in danger for growing myocarditis with one other COVID-19 vaccination. I’ll word right here that Mr. Smith did attempt to fulfill the mandate to finish a major collection of a COVID-19 vaccination by making an attempt to get a Johnson and Johnson vaccine. He was turned away by the pharmacists who famous the Johnson and Johnson vaccine was not accredited to be given after a primary dose of an mRNA vaccine.
As I’ve detailed, whereas most instances of vaccine myocarditis haven’t been proven to end in extreme morbidity or mortality, there are clearly case stories of extreme vaccine myocarditis. Particularly given Mr. Smith has had two separate COVID infections, along with his most up-to-date an infection in January of 2023, it is rather unlikely that the unclear advantages of a second dose of a COVID-19 vaccine are outweighed by the chance of vaccine myocarditis.
I perceive the committee has considerations past particular person safety as regards to vaccination because it was hoped that vaccinations in opposition to COVID19 would cut back the chance of transmission of the virus and thus present safety to the group along with the person. As you realize, the preliminary randomized management trials weren’t designed to check for discount in transmission, and the diploma of discount in transmission is a matter of debate now. Past the unknown efficacy of the vaccines associated to transmission danger, there does seem like rising consensus concerning the equivalence of a previous an infection from COVID and vaccination. The meta-analysis on prior an infection referenced above prompted the Chairman of Drugs from UCSF, Dr. Bob Wachter to write :
Since almost all unvaxxed have been contaminated by now (many>as soon as), research lowers the case for vax mandates, since these w/ prior an infection possible have safety not materially worse than in the event that they had been vaxxed.
It must also be related that Mr. Smith is a non-clinical, distant employee who has no direct contact with sufferers or different healthcare workers.
For the entire above causes, I might respectfully ask members of the vaccine exemption committee to rethink and grant Mr. Smith an exemption from the corporate’s vaccine mandate.
Yours Sincerely,
Anish Koka MD
Heart specialist
Philadelphia, Pennsylvania
