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Managing Rare Thrombotic Events Following COVID-19 Vaccination
A single-center, retrospective study examined the management of thrombotic events in patients presenting with thrombocytopenia following vaccination against COVID-19.
The early identification of thrombocytopenia and thrombosis (VITT) and immune thrombocytopenia (ITP) after vaccination against COVID-19 were crucial for successfully caring for patients presenting with thrombocytopenia, according to a recent study published in Research and Practice in Thrombosis and Haemostasis.1
Blood Clot Modelimage credit: Matthieu - stock.Adobe.Com
The study authors reflected on emerging evidence of thrombocytopenic and thrombotic events in some patients after receiving a COVID-19 vaccination. While rare, VITT and ITP following vaccination require urgent evaluation and therapy initiation.2
Despite emerging data on the occurrence of VITT and ITP following vaccination, there is insufficient information available pertaining to the long-term management of these events, the authors explained.1
To better understand these adverse hemolytic events, treatment approaches, the diagnostic process, and to address the shortcomings in literature, the researchers reported on patients at a tertiary care center in Canada who presented with thrombocytopenia following their COVID-19 vaccine.
Nine adult patients with new-onset thrombocytopenia at The Ottawa Hospital between April 1, 2021, and May 31, 2021, were retrospectively reported on. These presentations of thrombocytopenia began between 4 and 42 days after receiving a COVID-19 vaccine, which included the Pfizer-BioNTech mRNA, Moderna mRNA, and Astra Zeneca adenovirus vector-based vaccines.
The treatment regimens for VITT and ITP included a corticosteroid approach with daily prednisone at a dose of 1 mg/kg over the initial few days before tapering over the next 2-3 months. For VITT, it was also recommended to administer non-heparin anticoagulation; some cases can necessitate intravenous immunoglobulin (IVIG).
Additionally, 4-42 days prior to patients' symptom onset, heparin-induced thrombocytopenia (HIT) testing was sent for individuals with a COVID-19 vaccination record and a platelet count under 150. This testing utilized the Immucor PF4 Enhanced enzyme-linked immunosorbent assay (ELISA) to assess for anti-PF4 autoantibodies. If a patient registered a positive PF4 binding assay, the serotonin release assay (SRA) was performed as a confirmation test for VITT.
The 9 included patients had an average age of 55 years, with a close-to-equal gender distribution. The majority of patients received the Astra Zeneca vaccine (n = 7) while the others received Pfizer (n = 2). No one had been exposed to heparin and all patients were negative for COVID-19 infection.
Positive results from the HIT ELISA tests came back for 3 patients and further testing with SRA diagnosed VITT in a 4th patient. There were 5 patients who went on to develop ITP—4 of whom did not have an associated thrombosis. The fifth patient had a history of ITP and was diagnosed with deep vein thrombosis.
All patients who developed VITT stayed oral anticoagulation treatment following 9 months of treatment. Three of the 4 patients with VITT were admitted to the hospital and subsequently treated with corticosteroids, non-heparin parenteral anticoagulation, and IVIG. The authors observed that patient 1 had a good response to treatment; however, this was not the case in patients 2 or 3. Patient 2 endured recurrent thrombocytopenia throughout their steroid taper and needed to be readmitted for steroids and IVIG. The third patient experienced 2 incidences of cerebral venous sinus thrombosis (CVST) progression and refractory thrombocytopenia. Their hospital stay lasted 15 days and their complications required 7 treatments of plasma exchange. While patient 4 was not admitted to the hospital, they did receive outpatient treatment with a DOAC for pulmonary emboli, to which they responded well.
Of the 5 patients who went on to develop ITP, 1 experienced success treating their condition with eltrombopag and apixaban as an outpatient, but the remaining 4 were admitted to the hospital.
Patients with VITT all continued to get their next round of the COVID-19 mRNA vaccine, whereas all patients except for 2 who had ITP continued with the next vaccine round. Of the 2 who did not have their next dose, 1 declined because of their experience with adverse hematologic events and the other was not recommended to continue because of their history of thrombocytopenia following their previous vaccine doses.
"Early identification was key to the successful management of VITT and ITP events following COVID-19 vaccination. The patient cases described in our study add to the currently limited literature on long-term management of VITT and ITP, particularly in refractory cases, and provides guidance around future COVID-19 vaccinations," the authors concluded.
Reference
1. Ge M, Ladha D, Lymer J, et al. Thrombocytopenia with and without thrombosis following covid-19 vaccination: long-term management. Res Pract Thromb Haemost. Published online February 29, 2024. Doi: 10.1016/j.Rpth.2024.102357
2. Vaccine-induced immune thrombotic thrombocytopenia. American Society of Hematology. Updated May 9, 2022. Accessed March 12, 2024. Https://www.Hematology.Org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia
COVID Vaccine Study Prompts Misleading Claims About Potential Side Effects
On December 14, 2020, Sandra Lindsay, a nurse at New York's Long Island Jewish Medical Center, became the first person to receive a non-trial dose of the COVID-19 vaccine in the United States—kicking off the largest public health campaign in history. By March 2023 more than 5.55 billion people, approximately 72.3 percent of the world's population, had received at least one dose of a COVID-19 vaccine.
Researchers continue to monitor and study the impact, effectiveness, and risks of the COVID-19 vaccines. On February 14, 2024, the largest global COVID-19 vaccine safety study to date was published by the Global COVID Vaccine Safety Project (GCoVS) to identify potential links between COVID-19 vaccines and events that could affect health. These links, also known as safety signals, give researchers insights into potential causal relationships that should be investigated further.
The landmark study, which has drawn significant media attention thanks to its scale, has also spawned widespread anti-vaccine rhetoric across the internet because it identified some new safety signals. These claims, however, overemphasize the risk of adverse events mentioned in the study and ignore the broader cost-benefit analysis used in vaccine development.
"Breaking : New study released shows troubling results. 99 million people included in study shows possible HEART damage and Brain disorders from COVID VACCINES," one post reads.
Interpretations of the study have gone particularly viral on X (formerly Twitter), where many posts warning the public of vaccine-induced heart, brain, and blood disorders have received tens of thousands of views.
The Dispatch Fact Check talked with one of the study's lead authors and two vaccine researchers to determine what is—and isn't—true about the results.
Organized by the GCoVS, researchers across dozens of institutions leveraged the Global Vaccine Data Network (GVDN), a "consortium of research sites ready to conduct globally coordinated epidemiologic studies of the safety of vaccines," to evaluate the risk of 13 different adverse events following COVID-19 vaccination with Moderna and Pfizer's mRNA vaccines, as well as Oxford/AstraZeneca's adenovirus-vector vaccine. Researchers analyzed datasets that encompassed 99 million vaccinated individuals and 242 million total vaccine doses, and they compared the frequency of adverse events against rates expected before getting a COVID-19 vaccination.
The study did confirm links between COVID-19 vaccination and rare occurrences of myocarditis, pericarditis, Guillain-Barré syndrome, and a particular form of stroke called cerebral venous sinus thrombosis. Other adverse events also identified as potential safety signals include immune thrombocytopenic purpura and acute disseminated encephalomyelitis. These events were extremely rare, however, and the study's authors note that additional research is needed to determine if they are linked to vaccination or have any clinical relevance.
One important conclusion of the study was that most of the newly identified safety signals were related almost entirely to the first dose of the Oxford/AstraZeneca vaccine—which was never approved for use in the U.S.—and, to a lesser extent, the first dose of the Moderna vaccine.
"We did not see these signals following further doses of these two COVID-19 vaccines, nor did we see them after any dose of the Pfizer/BioNTech vaccine, which has been more widely used," Dr. Anders Hviid, a professor of pharmacoepidemiology and co-author of the study, told The Dispatch Fact Check.
Additionally, most of these adverse events were extremely rare. "As an example, the association between the first dose of Moderna and acute inflammation of the brain and spine would, if causal, correspond to 1 case per 1.75 million vaccinated," Hviid explained. "It is only due to the sheer scale of our study that we have been able to identify this minute potential risk."
The adverse events identified in the study are also not unique to COVID-19 vaccination—similar risks are correlated with both longer-established vaccines and the diseases they protect against. "I would not expect them to be that unique to COVID-19 vaccines," Hviid said. "The scope of the global COVID-19 vaccination program has been extraordinary, which is probably why we detect these very rare adverse events at all. The number of COVID-19 vaccines administered in such a close time frame is unparalleled in history."
Guillain-Barré syndrome, for example—an immune disorder that has been shown to develop in rare occurrences after the administration of the Oxford/AstraZeneca vaccine—can also occur following COVID-19 infection itself or after the administration of vaccines against other diseases. "Any viral infection can be associated with Guillain-Barré syndrome," Dr. Matthew Laurens, a professor of pediatrics at the University of Maryland's Center for Vaccine Development and Global Health, told The Dispatch Fact Check. "You can even get the flu and get Guillain-Barré syndrome as a result."
Risk levels with vaccines must be viewed in comparison to both the risks and benefits associated with not being vaccinated. For example, even though individuals are at an increased risk of developing myocarditis after receiving a COVID-19 vaccination (excess occurrences of myocarditis have been estimated to occur in 1 to 10 people per million in the month following vaccination), this risk is substantially lower than the estimated 40 occurrences per million of myocarditis after an individual is infected with COVID-19 itself. Not being vaccinated potentially poses an even more serious risk of myocarditis. "Just because a vaccine has a very rare side effect associated with it doesn't mean it's not safe," Laurens explained. "We have to look at, for instance, how many lives were saved with the COVID-19 vaccine development. We see that nearly 20 million deaths were averted just in the first year after COVID-19 vaccines were deployed."
A careful consideration of risks and rewards is standard practice in the development and deployment of vaccines. "Any medical intervention has a risk and benefit balance," Dr. Chris Beyrer, an epidemiologist and director of the Duke Global Health Institute told The Dispatch Fact Check. "What the very large study of almost 100 million people vaccinated against COVID-19 shows us is that there are real but rare risks to vaccination, but the benefits far outweigh these risks. The benefits include reductions in serious illness with COVID-19, reductions in hospitalizations, and reductions in deaths."
Adverse events, even when rare, remain important to both scientists and public health officials, which is why cohort studies like that conducted by the GCoVS are a focus of continued research. However, the presence of rare side effects alone does not mean that the costs of a particular medical intervention outweigh its benefits. "It's very reassuring that the side effects are very few and the ones that are particularly devastating are extremely rare," Laurens remarked. "It takes very large studies looking at a lot of people to actually find them and uncover them."
If you have a claim you would like to see us fact check, please send us an email at factcheck@thedispatch.Com. If you would like to suggest a correction to this piece or any other Dispatch article, please email corrections@thedispatch.Com.
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Study Largely Confirms Known, Rare COVID-19 Vaccine Side Effects
SciCheck DigestAn international study of around 99 million people confirmed known serious side effects of COVID-19 vaccination. It also identified a possible relationship between the first dose of the Moderna vaccine and a small risk of a neurological condition. Social media posts about the study left out information on the vaccines' benefits and the rarity of the side effects.
Full StoryCOVID-19 vaccines — like all vaccines and other medical products — come with side effects, including serious side effects in rare cases. The vaccines were rolled out to protect people from a novel virus that has killed millions of people globally and would likely have killed millions more without the arrival of the vaccines. There is a broad consensus from experts and governmental health agencies that the benefits of COVID-19 vaccination outweigh the risks.
Researchers have scrutinized the COVID-19 vaccines' safety and continue to do so. A study published Feb. 12 in the journal Vaccine reported on an international group of more than 99 million people who received COVID-19 vaccines, primarily finding links to known rare side effects. The study largely focused on the Pfizer/BioNTech and Moderna vaccines, which have been widely given in the U.S., as well as the AstraZeneca vaccine, which was never authorized in the U.S.
"What we take away, is that the Covid-19 vaccination campaigns have been very effective in preventing severe disease," study co-author Anders Hviid, head of the department of epidemiology research at the Statens Serum Institut in Denmark, told us in an email. "The few serious side effects that we have observed in this and other studies have been rare."
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Many popular posts on social media have shared results from the study, some lacking the context that the identified health problems are rare, that most aren't new and that the vaccines have proven benefits. Various posts made unfounded claims, stating or implying that people should not have received the vaccines, that the risks outweigh the benefits or that the risk of the rare side effects is greater than was reported in the study.
"Hundreds of millions of people were used as lab rats and now the truth that WE ALL ALREADY KNEW can no longer be denied," said one popular post, referring to the vaccines as "experimental" and "UNTESTED." The post shared a screenshot of the headline of a New York Post article about the new study, which read, "COVID vaccines linked to slight increases in heart, brain, blood disorders: study."
"This thing was forced on people who faced almost no risk from Covid," said another widely read post. "It is completely unacceptable." The post shared statistics from the paper without making it clear that serious health problems after vaccination were rare and that risk varied by vaccine type and dose.
The Vaccine study confirmed that the Moderna and Pfizer/BioNTech vaccines are linked in rare cases to myocarditis and pericarditis, conditions involving inflammation of the heart muscle and lining. The rate of myocarditis was most elevated after the second dose of the Moderna vaccine. Myocarditis risk — which is greatest in men in their late teens and early twenties — was identified via vaccine safety monitoring and first reported in 2021. Based on the current evidence, the CDC says, the benefit of vaccination outweighs the risk of these conditions, which improve for most people after medical treatment and rest.
The study confirmed neurological and blood clotting conditions associated with the AstraZeneca vaccine. In the U.S., these problems were linked to the Johnson and Johnson vaccine, contributing to this vaccine no longer being recommended or available.
The study also identified a new possible safety signal indicating a potential link between the first dose of the Moderna and AstraZeneca vaccines and rare neurological conditions. This included an association between the first doses of the vaccines and acute disseminated encephalomyelitis, or ADEM, an autoimmune condition that causes inflammation of the brain and spinal cord.
Hviid emphasized that the researchers only saw these neurological events after first doses of the two vaccines. "We did not see these signals following further doses of these two Covid-19 vaccines, nor did we see them after any dose of the Pfizer/BioNTech vaccine which has been more widely used," he said.
"We are also talking about very rare events," Hviid continued. "As an example, the association between the first dose of Moderna and acute inflammation of the brain and spine would, if causal, correspond to 1 case per 1.75 million vaccinated. It is only due to the sheer scale of our study, that we have been able to identify this minute potential risk."
Study Bolsters the Evidence Serious COVID-19 Vaccine Side Effects Are RareThe Vaccine study drew on national or regional health records from eight countries with institutions participating in the Global Vaccine Data Network, an international group that studies vaccine safety. The researchers analyzed health outcomes after around 184 million doses of the Pfizer/BioNTech vaccine, 36 million doses of the Moderna vaccine and 23 million doses of the AstraZeneca vaccine.
The researchers focused on 13 health problems that either had a known association with vaccination or for which there was some rationale to investigate whether there was an association. To determine whether the health problems were associated with vaccination, they compared the expected rates of the health problems — or the number of health events that should occur based on background rates in the regions studied — with the number of events they observed in the 42 days after vaccination.
"This study confirms the primary already detected and validated side effects established by previous literature," Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvania's Perelman School of Medicine, told us via email, referring to the rare heart conditions associated with the Moderna and Pfizer/BioNTech vaccines, as well as the rare conditions associated with the AstraZeneca and Johnson and Johnson vaccines.
Morris said that findings on ADEM — the rare autoimmune neurological condition linked to first doses of the Moderna and AstraZeneca vaccines — "might be a new safety signal."
ADEM involves inflammation to the brain and spinal cord, arising most often in children following an infectious illness. It has a sudden onset and typically eventually improves, with a full recovery in many, although not all, cases.
After the first dose of the Moderna vaccine, researchers observed seven ADEM cases, when they expected two. As we've said, Hviid calculated the rate of this side effect — if ultimately shown to be related to vaccination — to be 1 in 1.75 million following the first dose of the Moderna vaccine.
The data show "this was indeed an EXTREMELY rare adverse event," Morris said, referring to ADEM. "It is understandable at this incidence rate why it may not have been detected before now, and why a study with 99 million participants like this is important to find even the most rare serious adverse events that are potential minority harm risks of these vaccines."
The authors of the study wrote that more research is needed into ADEM following COVID-19 vaccination, saying that "the number of cases of this rare event were small and the confidence interval wide, so results should be interpreted with caution and confirmed in future studies." The authors also wrote that neurological events have been found to occur at a much higher rate after COVID-19 than after COVID-19 vaccination.
The study means that "early warning systems are solid," said Marc Veldhoen, an immunologist at the Instituto de Medicina Molecular João Lobo Antunes in Portugal, in a post on X, formerly known as Twitter. "To avoid any adverse reaction is not possible, but, identifying those at higher risk may be possible."
Identifying those at greater risk of side effects can help guide decisions on which vaccines to recommend and what problems doctors should watch for in their patients.
Editor's note: SciCheck's articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.Org's editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.
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