Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

Gatti, Milo; Raschi, Emanuel; Moretti, Ugo; Ardizzoni, Andrea; Poluzzi, Elisabetta; Diemberger, Igor

doi:10.3390/vaccines9010019

Cited by 12 publications

(16 citation statements)

References 43 publications

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“…In the COVID-19 era, pharmacovigilance plays a crucial role for real-time safety monitoring of pharmaceuticals: the global vaccination campaign exemplifies the importance of post-marketing studies for timely detection of rare but serious AEs such as myocarditis, thrombocytopenia, and cerebral venous sinus thrombosis, which may not be fully appreciated in the pre-marketing setting, especially for medications receiving accelerated conditional approval through the so-called rolling review [ 44 ]. In particular, spontaneous reporting databases, such as the FDA Adverse Event Reporting System (FAERS) and WHO-Vigibase, have been successfully exploited to characterize the safety profile of drugs, thus informing clinical practice for proactive monitoring [ 45 , 46 ].…”

Section: Safety Issuesmentioning

confidence: 99%

Janus Kinase Inhibitors and Coronavirus Disease (COVID)-19: Rationale, Clinical Evidence and Safety Issues

et al. 2021

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We are witnessing a paradigm shift in drug development and clinical practice to fight the novel coronavirus disease (COVID-19), and a number of clinical trials have been or are being testing various pharmacological approaches to counteract viral load and its complications such as cytokine storm. However, data on the effectiveness of antiviral and immune therapies are still inconclusive and inconsistent. As compared to other candidate drugs to treat COVID-19, Janus Kinase (JAK) inhibitors, including baricitinib and ruxolitinib, possess key pharmacological features for a potentially successful repurposing: convenient oral administration, favorable pharmacokinetic profile, multifunctional pharmacodynamics by exerting dual anti-inflammatory and anti-viral effects. Baricitinib, originally approved for rheumatoid arthritis, received Emergency Use Authorization in November 2020 by the Food and Drug Administration in combination with remdesivir for the treatment of COVID-19 in hospitalized patients ≥ 2 years old who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. By July 2021, the European Medicines Agency is also expected to issue the opinion on whether or not to extend its use in hospitalised patients from 10 years of age who require supplemental oxygen. Ruxolitinib, approved for myelofibrosis, was prescribed in patients with COVID-19 within an open-label Emergency Expanded Access Plan. This review will address key milestones in the discovery and use of JAK inhibitors in COVID-19, from artificial intelligence to current clinical evidence, including real world experience, and critically appraise emerging safety issues, namely infections, thrombosis, and liver injury. An outlook to ongoing studies (clinicaltrials.gov) and unpublished pharmacovigilance data is also offered.

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Section: Safety Issuesmentioning

confidence: 99%

Janus Kinase Inhibitors and Coronavirus Disease (COVID)-19: Rationale, Clinical Evidence and Safety Issues

et al. 2021

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“…Overall, the median time to onset was [2][3][4][5][6][7][8][9][10][11][12][13][14] days after vaccine injection. Pericarditis onset was delayed compared to myocarditis with a median time to onset of 8 [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] axillary, sweats and chills, fever, headache) appeared at day 1 (70, 45%), followed at day 3 to 4 by chest pain (107, 68%) and shortness of breath (26, 17%). Electrocardiogram (ECG) was abnormal for 68 (43%) patients with myocarditis and troponin was elevated for 41 (26%).…”

Section: Demographics and Characteristics Of Cases From The Worldwide Vigibasementioning

confidence: 99%

“…[5][6][7] A descriptive analysis of drug associated myopericarditis spontaneous reports in the United States (1990States ( -2018 identified that about 0.1% of the cases were related to vaccines. 8 To date, inflammatory cardiac reactions following vaccination have been mostly reported with live-virus vaccines, such as the smallpox vaccine, 6,9,10 and inactivated influenza vaccines, 11 Cases reports of myocarditis/pericarditis secondary to next-generation vaccine platforms, used to prevent COVID-19, have been reported. [12][13][14][15][16][17] Vaccination is critical to contain the SARS-CoV-2 pandemic.…”

Section: Introductionmentioning

confidence: 99%

Cardiac Inflammation after COVID-19 mRNA Vaccines: A Global Pharmacovigilance Analysis

Chouchana

Blet

Al-Khalaf

et al. 2021

Preprint

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Background To counter the COVID-19 pandemic, mRNA vaccines, namely tozinameran and elasomeran, have been authorized in several countries. These next generation vaccines have shown high efficacy against COVID-19 and demonstrated a favorable safety profile. As widespread vaccinations efforts are taking place, incidents of myocarditis and pericarditis cases following vaccination have been reported. This safety signal has been recently confirmed by the European Medicine Agency and the U.S. Food and Drug Administration. This study aimed to investigate and analyze this safety signal using a dual pharmacovigilance database analysis. Methods This is as an observational study of reports of inflammatory heart reactions associated with mRNA COVID-19 vaccines reported in the World Health Organization's global individual case safety report database (up to June 30th 2021), and in the U.S. Vaccine Adverse Event Reporting System (VAERS, up to May 21st 2021). Cases were described, and disproportionality analyses using reporting odds-ratios (ROR) and their 95% confidence interval (95%CI) were performed to assess relative risk of reporting according to patient sex and age. Results At a global scale, the inflammatory heart reactions most frequently reported were myocarditis (1241, 55%) and pericarditis (851, 37%), the majority requiring hospitalization (n=796 (64%)). Overall, patients were young (median age 33 [21-54] years). The main age group was 18-29 years old (704, 31%), and mostly males (1555, 68%). Pericarditis onset was delayed compared to myocarditis with a median time to onset of 8 [3-21] vs. 3 [2-6] days, respectively (p=0.001). Regarding myocarditis, an important disproportionate reporting in males (ROR, 9.4 [8.3-10.6]) as well as in adolescents (ROR, 22.3 [19.2-25.9]) and 18-29 years old (ROR, 6.6 [5.9-7.5]) compared to older patients were observed. Conclusions The inflammatory heart reactions, namely myocarditis and pericarditis, have been reported world-wide shortly following COVID-19 mRNA vaccination. An important disproportionate reporting among adolescents and young adults, particularly in males, was observed especially for myocarditis. Guidelines must take this specific risk into account and to optimize vaccination protocols according to sex and age. While the substantial benefits of COVID-19 vaccination still prevail over risks, clinicians and the public should be aware of these reactions and seek appropriate medical attention.

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“…Regulatory authorities throughout the world then fast-tracked approvals for these vaccines under the emergency use of authorization in December 2020 [1]. Furthermore, companies have been racing to find a vaccine for the coronavirus, which has killed over 1.5 million people and infected more than 65 million since it emerged in China in December of last year [3].…”

Section: Introductionmentioning

confidence: 99%

First Report of Acute Myocarditis Post-Pfizer-BioNTech COVID-19 Vaccination in the Kingdom of Bahrain

Chachar¹,

Yousuf²,

Sulaibikh³

et al. 2021

Cureus

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We present a case of a 24-year-old male patient who presented to our institution five days after receiving his first dose of Pfizer-BioNTech vaccine to rule out acute coronary syndrome due to chest pain along with troponin increase and ECG changes. Acute coronavirus disease 2019 (COVID-19) infection was excluded based on a negative real-time reverse transcription-polymerase chain reaction (RT-PCR) test of specimens acquired using nasopharyngeal swabs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and all other viral serologies were found to be negative. Coronary angiogram showed normal coronaries, and the presence of late gadolinium enhancement, which is indicative of myocarditis, was identified using cardiac magnetic resonance imaging (MRI). Our case report raises concern that the COVID-19 vaccine may cause myocarditis as a rare side effect.

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Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase

Cited by 12 publications

References 43 publications

Janus Kinase Inhibitors and Coronavirus Disease (COVID)-19: Rationale, Clinical Evidence and Safety Issues

Janus Kinase Inhibitors and Coronavirus Disease (COVID)-19: Rationale, Clinical Evidence and Safety Issues

Cardiac Inflammation after COVID-19 mRNA Vaccines: A Global Pharmacovigilance Analysis

First Report of Acute Myocarditis Post-Pfizer-BioNTech COVID-19 Vaccination in the Kingdom of Bahrain

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