mRNA COVID Shots Cause Myocarditis
Thank you all for coming. I’m going to be discussing the safety
label update for myocarditis associated with mRNA Covid vaccines,
which we just put forward. This came out on June 25th, 2025. The FDA approved a required
updated warning, which is a class warning for all mRNA Covid 19 vaccines
in conjunction with the manufacturers. I’m going to walk you through the the updated warning
and the basis for the warning. First of all, I’d like to thank David
Kaslow and the vaccine team and Richard Forshee
and the pharmacovigilance team for writing, coordinating
and deploying this safety label change. I also like to note this SLC was initiated
prior to my joining the agency, and note I’m not using the FDA branch
abbreviations in the hopes that this presentation will be more
accessible to the general public. The updated safety label. The updated safety label
for the mRNA Covid vaccines, harmonizes the age range across products
and adds additional data about the adverse event of myocarditis
and what we know. It’s based on two factors. It’s based first, on the unadjusted crude incident
rate from the 2023 to 2024 formulation, and it’s also based on persistent
and concerning cardiac MR findings. So this is slide that we put together. This is the FDA
analysis of the best system, which is an observational data system
that that captures myocarditis and pericarditis following immediately
afterwards the first seven days Covid 19 mRNA vaccination. And what you see here
is that even in 2023, 2024, the last year for which we have data,
you see a rate of myo and pericarditis of eight out of a million
in all persons in this age range and in the highest risk demographic group, young men between the ages of 12 and 24. It’s about 27 per million. Notably, the best data set does not allow us
to disambiguate the risk by product, and as such,
this is a class mRNA safety label. The second piece of evidence
that is captured in the new safety label update is some concerning findings we’ve noted with late
gadolinium enhancement. Now, late gadolinium
enhancement is a radiographic abnormality
seen on cardiac resonance imaging. And this is how it’s been described
prior to in the literature. In the context of myocarditis. Mild sorry patchy myocardial and focal subepicardial
enhancement as an expression of potentially irreversible
injury is how it’s been described. The FDA notably funded a study
led by Jane and colleagues in 2024, which showed a among hospitalized patients with Covid 19 induced myocarditis
a high proportion, the majority had initial late
gadolinium enhancement on cardiac MR, the most concerning at five months
of follow up, 60% of these patients
continued to have LGE, and our
results for late gadolinium enhancement are consistent with many,
many others, as I’ll show you here. This was a study from Australia
that followed post six months for post
Covid 19 vaccine induced myocarditis. Over half of the patients
were still reporting symptoms. 67% had abnormal follow up
cardiac MRs, and 35% showed
what was listed as evidence of fibrosis. I did a quick systematic review,
pulling all available publications documenting a late gadolinium enhancement,
and these are some takeaway summaries. 92% is occurring in men, 90%
had LGE at presentation, but most concerning 72% have persistent LGE
even months thereafter. Very consistent with the FDA
sponsored study, late gadolinium enhancement
is not a benign clinical finding. Multiple studies document
that LGE is a poor prognostic factor that’s in many cardiac settings,
including for patients with myocarditis. LGE has been associated
with increased future cardiovascular events
and even increased mortality. We do not know the precise implications
for LGE from vaccine induced myocarditis, in part because the follow
up is necessarily so limited. For this reason, the US FDA, and the sponsors have issued an SLC
with the following two main points. One the updated, unadjusted incidence
of myocarditis and or pericarditis was approximately 27
per million, or 1 in 37,000. In males, 12 to 24 years of age
for the 2023 to 2024 formulation. And two at a median follow up
of approximately five months, Post-vaccination. Persistence of abnormal cardiac
magnetic resonance imaging findings that are a marker for myocardial
injury was common. So that’s our class safety warning. And I think it’s an important warning that was issued
with the hard work of the team here. And I want to take a minute
to talk a little bit about the history of Covid 19 vaccine
induced myocarditis. The background and history. So the first reports of this phenomenon
were actually came to us by way of Israel. As many of you know, Israel
aggressively partnered with Pfizer to have a large, wide scale distribution
of the mRNA vaccines. And the first reports were reported
in the Jerusalem Post in February of 2021 that a young man had been admitted to the intensive care
unit with myocarditis after the vaccine. In February 2021, Myocarditis safety signals were triggered
in the VAERS data set, and this is a nice timeline
put together by a reporter of Covid 19 vaccines and myocarditis. By April 2021, there were at least two deaths
and 60 cases reported from Israel. And these and the reports said that these details
had been sent to the US FDA and the CDC. And yet, by April 27th, 2021, then centers for Disease
Control and Prevention director said
regarding this phenomenon, quote, we have not seen a signal
and we’ve actually looked intentionally for the signal in the over
200 million doses we’ve given. Yet at this time,
the CDC was aware of 14 cases of post-vaccine myocarditis reported
by the Department of Defense. The Department of Defense would be one
of the first to publish this phenomenon, Myocarditis, following immunization with many Covid
vaccines among military members. And these early reports documented rather
consistently an elevation in myocarditis
risk, particularly to men, particularly for dose two. The CDC, initially in the first half of 2021,
had planned a Health alert network action, which ultimately
was not released, and this occurred through the following series of events,
which was obtained through FOIA obtained emails in May 2020 for 2021. Vaccine safety meeting, which included
FDA and CDC officials, includes the following draft notes. Quote is VAERS signaling for mild
pericarditis now? And the answer for the age
group 16 to 17 and 18 to 24. Yes. On May 25th, 2021, one day
following the meeting where the FDA and CDC officials
acknowledge the safety concern, the Biden White House distributed talking points to top health officials
downplaying the risk of myocarditis. On May 26th, 2021, two days
after that meeting, then acting FDA commissioner
and CDC director notes, quote, the FDA does not concur with the issuance
of the Health Alert Network, and instead it was published as a less formal clinical
consideration on the website. The rates of post-vaccine myocarditis in men
between the ages of 13 and 24 from 2021 have been documented in a number
of publications and public documents. In August of 2021,
in an FDA regulatory action, we document that based on health insurance
claims, Optum data set the rate of post-vaccination myocarditis
from the Pfizer BioNTech vaccine was approaching 200 cases per million,
or approximately 1 in 5000. Prospective study in Hong Kong,
published in 2021 showed post-vaccination Myocarditis was approximately 1 in 3000 for the second Pfizer
dose in 13 to 18 year old men, and using the VSD Vaccine
Safety Datalink data, Schaff and colleagues showed approximately
1 in 2000 risk of post second mRNA dose
in 18 to 24 year old men. There’s an elegant analysis
put together by the team, led by Tracy Beth Hogue and others, of post-vaccine
myocarditis rates reported in 2021. And basically you see across different
demographic categories, with the far right being men
between the ages of 12 and 17, an elevated risk that in some publications
exceeded 300 per million. Active surveillance from Hong Kong
confirmed a broadly similar risk. Men between the ages of 13 and 18,
a 1 in 2700 had experienced myocarditis
and were hospitalized following dose two of the Pfizer product. And the vaccine safety data link, in a very interesting analysis by Scharf
and colleagues, was found to have initially missed 64% of Myo
and pericarditis cases. The authors note, Quote an incomplete list of ICD
ten codes and delays in hospital claims data were responsible for the difference
between the VSD reported estimate and a careful chart review estimate. Stratification by demographic factors
is key to unpacking the myocarditis risk from Covid 19, and an analysis
led by Benjamin Knutson and myself. Prior to joining the FDA, we analyzed publications
that examined the risk of vaccines and myocarditis that had zero stratifiers,
in other words, looking at all the doses given and the entire population,
all the way to for stratifiers, which included looking only at men in certain age ranges
and only certain products and certain doses. And as you can see,
there is an association between looking in the right
subpopulation, where this is a known safety concern, and the actual rate
with which you’ll find the safety signal. VSD chart review from myo and pericarditis
for the first Pfizer booster documented a rate slightly lower than I think
the initial estimates, but 1 in 6800. In another analysis, led by Scharf
and colleagues from Kaiser Permanente. Some analysts
based on these emerging safety signal have argued for years that there was some concern
about mandatory coercive boosting, particularly of young men, particularly those
who may have also recently had Covid 19. And you can see among the authors of one
such analysis, there are many names that may be familiar to you. The United States in general,
I think, exhibited some potentially missed opportunities
for engaging in mitigation on this important safety risk, notably
spacing the doses of the first two doses further apart was a strategy
deployed in Europe approximately one year before the CDC allowed providers
to consider it. Another strategy was specific
products were restricted for use in the under 30 year old age group
in multiple European countries. That action was never
taken in the United States. Severity and long term sequela. The CDC data published from a few years ago in 2022, documented
clinical outcomes 90 days after post-vaccination myocarditis in 12
to 29 year olds, notably at presentation. This is from various submissions,
so there is a reporting element to this. At presentation, 25% of these patients were initially
admitted to the intensive care unit. One patient required extracorporeal
membrane oxygenation or ECMO. At 90 days after diagnosis, Over 25% continued to be prescribed
cardiac medications. Over 30% remained on activity restrictions
to avoid strenuous exercise. Over half of these patients
had more than one persistent abnormality on cardiac MR. Only 66% of these patients were known to have fully recovered, and 17%
had not fully recovered by three months. There have also been reports of deaths due
to fulminant myocarditis. This is one report in New England
Journal of Medicine. There are several other reports. As is the case with all idiosyncratic adverse events,
these are likely to exist on a spectrum. There’s undoubtedly
some people who have mild or subclinical myocarditis and undoubtedly
also some deaths may be implicated. And we, in our own sponsored data,
find that 2% of hospitalized patients required inotropes. Myocarditis from vaccines is a distinct clinical entity,
likely immunologically mediated. Many analysts have compared this vaccine induced myocarditis against myocarditis
following Covid 19 infection. Yet many of these studies failed
to disambiguate myocarditis after Covid 19 infection versus troponin elevations
seen in the setting of severe illness. Furthermore, patients, many, can still get
Covid 19 at some distance after vaccination, accepting the risks of
both the vaccine product and the illness. Though very likely the illness, The former is mitigated, though
also plausibly, there may be a ceiling to that mitigation with additional doses. Hospitalizations from Covid often fail to disambiguate Covid 19 being the cause
of hospitalization versus Covid 19 being a bystander
diagnosed at hospitalization, the rates of Covid 19
severe outcomes are declining, with widespread vaccine and natural immunity
and the evolving nature of the virus. And as such, the FDA will perform
a new benefit risk assessment in this target group to continue
to reassess the benefit risk balance. Take home points. The FDA concludes that the 2023 to 2024
mRNA vaccines have an unadjusted crude risk of myocarditis of 27
per million in young men. This risk has persisted across all of the
doses of the product that we’ve examined. Vaccine induced myocarditis,
when leading to hospitalization, is associated with baseline
and persistent late gadolinium enhancement in the majority of patients
in our funded study. LGE is a known poor prognostic marker. Generally, though, the full implication of
it is unknown in this specific setting. Because of these
factors, an SLC was issued, FDA, SLC was initiated by career
FDA staff. It represents the latest action by FDA
to accurately convey the safety of these products. This may not be the final action,
which is contingent on further data. The US FDA will not negotiate on safety. Because of these factors, the commissioner and I outlined a Covid 19 vaccine framework
in the New England Journal of Medicine, which broadly will require randomized
controlled trials before addition, before extending additional delays and space
to healthy Americans under the age of 65. At the same time,
our framework will continue to provide additional doses to vulnerable populations
based on immunogenicity. Providers should consider recent Covid 19
infection, the absolute risk of severe Covid
19, and recent safety label changes when pursuing Covid
19 vaccination, particularly in young men. Public trust. Public trust is delicate. In order to regain it, FDA will pursue
safety signals with the best available scientific methods and ensure that our marketing authorizations are made
only to populations where we have substantial confidence
the benefits outweigh the risks. Our recent SLC action is a step
towards rebuilding public trust, so thank you all for your time
and attention. We’re going to stop the recording,
and then we’re going to turn it over to Doctor Butler
for some operational matters. Thank you.
Today, FDA provided important updates on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men.
