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1.
MMWR Morb Mortal Wkly Rep ; 71(30): 971-976, 2022 Jul 29.
Article in English | MEDLINE | ID: covidwho-1964793

ABSTRACT

The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥5 years receive 1 booster dose of a COVID-19 vaccine after completion of their primary series.* On March 29, 2022, the Food and Drug Administration (FDA) authorized a second mRNA booster dose ≥4 months after receipt of a first booster dose for adults aged ≥50 years and persons aged ≥12 years with moderate to severe immunocompromise (1,2). To characterize the safety of a second mRNA booster dose among persons aged ≥50 years, CDC reviewed adverse events and health impact assessments reported to v-safe and the Vaccine Adverse Event Reporting System (VAERS) after receipt of a second mRNA booster dose during March 29-July 10, 2022. V-safe is a voluntary smartphone-based U.S. active surveillance system that monitors adverse events occurring after COVID-19 vaccination. VAERS is a U.S. passive surveillance system for monitoring adverse events after vaccination, managed by CDC and FDA (3). During March 29-July 10, 2022, approximately 16.8 million persons in the United States aged ≥50 years received a fourth dose.† Among 286,380 v-safe registrants aged ≥50 years who reported receiving a second booster of an mRNA vaccine, 86.9% received vaccines from the same manufacturer for all 4 doses (i.e., homologous vaccination). Among registrants who reported homologous vaccination, injection site and systemic reactions were less frequent after the second booster dose than after the first booster dose. VAERS received 8,515 reports of adverse events after second mRNA booster doses among adults aged ≥50 years, including 8,073 (94.8%) nonserious and 442 (5.1%) serious events. CDC recommends that health care providers and patients be advised that local and systemic reactions are expected after a second booster dose, and that serious adverse events are uncommon.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Middle Aged , mRNA Vaccines/adverse effects
2.
Ann Fam Med ; 20(20 Suppl 1)2022 04 01.
Article in English | MEDLINE | ID: covidwho-1962965

ABSTRACT

Context: Tertiary care hospital provided onsite COVID-19 vaccine roll out as a work benefit for all care team members with medically supervised waiting period at the time of the distribution of the first round of the novel mRNA COVID-19 vaccines. Little was known about the immediate hypersensivity reactions or what might predispose to cross reactivity. Objective: We developed a working protocol to continuously track the vaccines administered, the patient history of allergy and hypersensistivity, the reactions observed and the care plan developed (determination of allergy to mRNA vaccines or normal vaccine response). Continuous process improvement allowed us to change protocols as the CDC developed guidance. Every patient was observed for at least 15 minutes and every reaction was reviewed by a physician supervising the waiting area. We aimed to determine if there were predictors of adverse, immediate reaction to the vaccine and to assess prevalence of risk factors (history of allergy to polyethylene Glycol or polysorbate; allergy to other injectable medication or vaccines; hypersensitivity to multiple substances). Study Design: Cohort study of all employees who received a first mRNA COVID-19 vaccine between December 16 and January 7th. Descriptive statistics were developed with demographic and medical history recorded, reactions noted and treatment given. Setting or Dataset: Tertiary care hospital in urban area. Population Studied: Employees who received an mRNA COVID-19 vaccine. Intervention/Instrument: Clinical records from employee vaccine clinic. Outcome Measures: Record of immediate response, determination of allergy. Results: We served over 7000 individuals with approximately 10% having a history of anaphylactic reaction. We had fewer with history of anaphylaxis to medications or vaccines. We delivered these vaccines safely, and observed three cases of immediate anaphylaxis on first dose of mRNA and over 50 cases of immediate allergic hypersensitivity. We did not see any patterns that predicted these reactions (gender, age or medical history). Expected Outcomes: We used this data to inform our employee health vaccination campaign and to inform the health system as strategies and safety protocols for vaccination of the population were developed.


Subject(s)
Anaphylaxis , COVID-19 Vaccines , mRNA Vaccines , Anaphylaxis/epidemiology , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Humans , mRNA Vaccines/adverse effects
3.
Front Public Health ; 10: 876966, 2022.
Article in English | MEDLINE | ID: covidwho-1952821

ABSTRACT

Introduction: The year 2020 saw the emergence of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which became a great threat to public health worldwide. The exponential spread of the disease with millions of lives lost worldwide saw the emergence of an accelerated vaccine development with emergency approval from well-known regulatory bodies such as the US Food and Drug Administration, followed by widespread vaccine deployment despite a paucity in safety profile data. This issue becomes even more pronounced when it involves expectant mothers considering the possible undesirable effect toward the unborn child. Method: This was a retrospective cohort study which was conducted at six general hospitals in the state of Penang, Malaysia. All the pregnant employees who have consented to take the mRNA COVID-19 vaccine and participate in this study were monitored from the time of their first vaccination and up to 28 days after they delivered their babies. Results: All the participants had adequate maximum vertical pocket (MVP) and no obvious anomalies or detection of intrauterine growth restriction (IUGR) were detected during the second trimester. However, one subject was reported to have miscarried during the second trimester. The reported mean neonate birth weight was 3.0 kg with the mean Apgar score of 8.8 and 9.8 at 1 and 5 min, respectively. Approximately seven (5.8%) neonates were reported to be small for their gestational age. Another three (2.5%) neonates were reported to have anomalies. Conclusion: As a whole, the inference that can be made from this study is that mRNA COVID-19 vaccine appears to be safe in pregnant women regardless of the trimester as the findings did not show obvious safety warning signs.


Subject(s)
COVID-19 Vaccines , COVID-19 , Health Personnel , Pregnancy Complications, Infectious , Pregnant Women , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Delivery of Health Care , Female , Hospitals, General , Humans , Malaysia , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Retrospective Studies , SARS-CoV-2 , Vaccination/adverse effects , mRNA Vaccines/adverse effects
4.
J Immunother Cancer ; 10(7)2022 07.
Article in English | MEDLINE | ID: covidwho-1950234

ABSTRACT

Anti-SARS-CoV-2 antibodies are crucial for protection from future COVID-19 infections, limiting disease severity, and control of viral transmission. While patients with the most common type of hematologic malignancy, B cell lymphoma, often develop insufficient antibody responses to messenger RNA (mRNA) vaccines, vaccine-induced T cells would have the potential to 'rescue' protective immunity in patients with B cell lymphoma. Here we report the case of a patient with B cell lymphoma with profound B cell depletion after initial chemoimmunotherapy who received a total of six doses of a COVID-19 mRNA vaccine. The patient developed vaccine-induced anti-SARS-CoV-2 antibodies only after the fifth and sixth doses of the vaccine once his B cells had started to recover. Remarkably, even in the context of severe treatment-induced suppression of the humoral immune system, the patient was able to mount virus-specific CD4+ and CD8+ responses that were much stronger than what would be expected in healthy subjects after two to three doses of a COVID-19 mRNA vaccine and which were even able to target the Omicron 'immune escape' variant of the SARS-CoV-2 virus. These findings not only have important implications for anti-COVID-19 vaccination strategies but also for future antitumor vaccines in patients with cancer with profound treatment-induced immunosuppression.


Subject(s)
COVID-19 Vaccines , COVID-19 , Lymphoma, B-Cell , Antibodies, Viral , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , RNA, Messenger/genetics , SARS-CoV-2 , T-Lymphocytes , Vaccines, Synthetic , Viral Vaccines , mRNA Vaccines/adverse effects
7.
BMJ ; 378: e070483, 2022 07 13.
Article in English | MEDLINE | ID: covidwho-1932664

ABSTRACT

OBJECTIVE: To assess the risk of adverse events associated with heterologous primary (two dose) and booster (three dose) vaccine schedules for covid-19 with Oxford-AstraZeneca's ChAdOx1-S priming followed by mRNA vaccines (Pfizer-BioNTech's BNT162b2 or Moderna's mRNA-1273) as compared with homologous mRNA vaccine schedules for covid-19. DESIGN: Nationwide cohort study. SETTING: Denmark, 1 January 2021 to 26 March 2022. PARTICIPANTS: Adults aged 18-65 years who received a heterologous vaccine schedule of priming with ChAdOx1-S and one or two mRNA booster doses (with either the BNT162b2 or mRNA-1273 vaccine) were compared with adults who received a homologous BNT162b2 or mRNA-1273 vaccine schedule (ie, two dose v two dose, and three dose v three dose schedule). MAIN OUTCOME MEASURES: The incidence of hospital contacts for a range of adverse cardiovascular and haemostatic events within 28 days after the second or third vaccine dose, comparing heterologous versus homologous vaccine schedules. Secondary outcomes included additional prioritised adverse events of special interest. Poisson regression was used to estimate incidence rate ratios with adjustment for selected covariates. RESULTS: Individuals who had had a heterologous primary vaccine (n=137 495) or a homologous vaccine (n=2 688 142) were identified, in addition to those who had had a heterologous booster (n=129 770) or a homologous booster (n=2 197 213). Adjusted incidence rate ratios of adverse cardiovascular and haemostatic events within 28 days for the heterologous primary and booster vaccine schedules in comparison with the homologous mRNA vaccine schedules were 1.22 (95% confidence interval 0.79 to 1.91) and 1.00 (0.58 to 1.72) for ischaemic cardiac events, 0.74 (0.40 to 1.34) and 0.72 (0.37 to 1.42) for cerebrovascular events, 1.12 (0.13 to 9.58) and 4.74 (0.94 to 24.01) for arterial thromboembolisms, 0.79 (0.45 to 1.38) and 1.09 (0.60 to 1.98) for venous thromboembolisms, 0.84 (0.18 to 3.96) and 1.04 (0.60 to 4.55) for myocarditis or pericarditis, 0.97 (0.45 to 2.10) and 0.89 (0.21 to 3.77) for thrombocytopenia and coagulative disorders, and 1.39 (1.01 to 1.91) and 1.02 (0.70 to 1.47) for other bleeding events, respectively. No associations with any of the outcomes were found when restricting to serious adverse events defined as stay in hospital for more than 24 h. CONCLUSION: Heterologous primary and booster covid-19 vaccine schedules of ChAdOx1-S priming and mRNA booster doses as both second and third doses were not associated with increased risk of serious adverse events compared with homologous mRNA vaccine schedules. These results are reassuring but given the rarity of some of the adverse events, associations cannot be excluded.


Subject(s)
COVID-19 , Hemostatics , Thromboembolism , mRNA Vaccines , 2019-nCoV Vaccine mRNA-1273/adverse effects , Adult , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Humans , Immunization, Secondary , RNA, Messenger , Thromboembolism/etiology , Vaccination/adverse effects , Vaccines, Synthetic , mRNA Vaccines/adverse effects
9.
N Engl J Med ; 387(2): 109-119, 2022 07 14.
Article in English | MEDLINE | ID: covidwho-1900734

ABSTRACT

BACKGROUND: Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (Covid-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal Covid-19 vaccination may confer protection against Covid-19 in infants. METHODS: We used a case-control test-negative design to assess the effectiveness of maternal vaccination during pregnancy against hospitalization for Covid-19 among infants younger than 6 months of age. Between July 1, 2021, and March 8, 2022, we enrolled infants hospitalized for Covid-19 (case infants) and infants hospitalized without Covid-19 (control infants) at 30 hospitals in 22 states. We estimated vaccine effectiveness by comparing the odds of full maternal vaccination (two doses of mRNA vaccine) among case infants and control infants during circulation of the B.1.617.2 (delta) variant (July 1, 2021, to December 18, 2021) and the B.1.1.259 (omicron) variant (December 19, 2021, to March 8, 2022). RESULTS: A total of 537 case infants (181 of whom had been admitted to a hospital during the delta period and 356 during the omicron period; median age, 2 months) and 512 control infants were enrolled and included in the analyses; 16% of the case infants and 29% of the control infants had been born to mothers who had been fully vaccinated against Covid-19 during pregnancy. Among the case infants, 113 (21%) received intensive care (64 [12%] received mechanical ventilation or vasoactive infusions). Two case infants died from Covid-19; neither infant's mother had been vaccinated during pregnancy. The effectiveness of maternal vaccination against hospitalization for Covid-19 among infants was 52% (95% confidence interval [CI], 33 to 65) overall, 80% (95% CI, 60 to 90) during the delta period, and 38% (95% CI, 8 to 58) during the omicron period. Effectiveness was 69% (95% CI, 50 to 80) when maternal vaccination occurred after 20 weeks of pregnancy and 38% (95% CI, 3 to 60) during the first 20 weeks of pregnancy. CONCLUSIONS: Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age. (Funded by the Centers for Disease Control and Prevention.).


Subject(s)
COVID-19 Vaccines , COVID-19 , Hospitalization , Pregnancy Complications, Infectious , mRNA Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/therapeutic use , Female , Hospitalization/statistics & numerical data , Humans , Infant , Mothers , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/prevention & control , SARS-CoV-2 , Vaccination/statistics & numerical data , Vaccines, Synthetic , mRNA Vaccines/adverse effects , mRNA Vaccines/therapeutic use
11.
Eur J Med Res ; 27(1): 80, 2022 Jun 02.
Article in English | MEDLINE | ID: covidwho-1875029

ABSTRACT

BACKGROUND: Vaccination against SARS-CoV-2 has been the main tool to contain the pandemic. The rush development of the 3 vaccines and their expedited approval have led to inoculation of millions of patients around the world, leading to a containment of the disease. Despite continuous viral mutations and the identification of weaker variants, the severity of the infections has been mild, with many patients being either asymptomatic or recovering at home. Currently the focus has shifted from the host of organ damage related to the infection to potential side effects of the vaccine. Myocarditis has been reported as one of the potential side effects from the mRNA vaccine, affecting young healthy individuals. Up to September 30, 2021, 1.243 cases of myocarditis after vaccination with BNT162b2 Comirnaty© were registered in young adults by the Paul-Ehrlich-Institute in Germany alone. The exact pathophysiology and the risk factors for myocarditis following vaccination remain unclear. We present a case series of eight patients with cardiac symptom shortly after SARS-CoV-2 mRNA vaccination (BNT162b6, Biontech, Comirnaty© or mRNA-1237 Moderna, Spikevax©). PATIENTS AND METHODS: Eight patients between 13 and 56 years of age, vaccinated with either BNT162b2 or mRNA-1273 mRNA vaccine between January and August 2021 developed cardiac side effects shortly after either their first or second dose of the vaccine. Clinical data were retrieved from the clinical information system and analyzed. To support diagnosis of myocarditis or pericarditis, cardiac magnetic resonance imaging (MRI) was performed shortly after the onset of symptoms, with further investigations in severe cases. Symptoms were defined as dyspnea, chest pain and cardiac arrhythmia as determined by electrocardiography. RESULTS: Eight patients (5 males and 3 females) developed cardiac symptoms compatible with myocarditis, according to the CDC criteria, shortly after SARS-CoV-2 mRNA vaccination. Three patients (2 males, 1 female) required hospitalization due to severe chest pain and elevated troponin levels. All patients recovered fully within 7 days from the symptom onset. CONCLUSIONS: Our data suggest that cardiac adverse events such as myocarditis or pericarditis shortly after SARS-CoV-2 mRNA vaccination are rare but possible and occur particularly in male patients.


Subject(s)
BNT162 Vaccine , COVID-19 , Myocarditis , Vaccination , mRNA Vaccines , Adolescent , Adult , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , Chest Pain , Female , Humans , Male , Middle Aged , Myocarditis/chemically induced , Pericarditis/chemically induced , SARS-CoV-2/genetics , Vaccination/adverse effects , Vaccines, Synthetic/adverse effects , Young Adult , mRNA Vaccines/adverse effects
12.
BMJ Open ; 12(5): e059223, 2022 05 25.
Article in English | MEDLINE | ID: covidwho-1865178

ABSTRACT

OBJECTIVES: To combine spontaneously reported data from multiple countries to estimate reporting rate, and better understand risk factors for myocarditis and pericarditis following COVID-19 messenger RNA (mRNA) vaccines. DESIGN: Systematic review of spontaneously reported data from UK, USA and European Union/European Economic Area (EU/EEA) and of the scientific literature. DATA SOURCES: UK Yellow Card scheme, Vaccine Adverse Event Reporting System (VAERS), EudraVigilance were searched from date of vaccine launch to 14 March 2022-16 March 2022. PubMed/MEDLINE and Embase were searched to 15 March 2022. ELIGIBILITY CRITERIA: We included publicly available spontaneous reporting data for 'Myocarditis' and 'Pericarditis' from UK, USA and EU/EEA following COVID-19 mRNA vaccines. Pharmacoepidemiological observational studies investigating myocarditis/pericarditis following mRNA COVID-19 vaccines were included (no restrictions on language or date). Critical Appraisal Skills Programme tools assessed study quality. DATA EXTRACTION AND SYNTHESIS: Two researchers extracted data. Events of myocarditis and pericarditis were presented for each data source, stratified by vaccine, age, sex and dose (where available). Reporting rates were calculated for myocarditis and pericarditis for each population. For published pharmacoepidemiological studies, design, participant characteristics, and study results were tabulated. RESULTS: Overall, 18 204 myocarditis and pericarditis events were submitted to the UK, USA and EU/EEA regulators during the study period. Males represented 62.24% (n=11 331) of myocarditis and pericarditis reports. In the UK and USA, most reports concerned vaccinees aged <40 years (59.7% and 47.3% of reported events, respectively); trends in age were less clear for EU/EEA. Reports were more frequent following a second dose (47.1% of reports, where data available). Reporting rates were consistent between the data sources. Thirty-two pharmacoepidemiological studies were included; results were consistent with our spontaneous report analyses. CONCLUSIONS: Younger vaccinees more frequently report myocarditis and pericarditis following mRNA COVID-19 vaccines than older vaccinees. Results from published literature supported the results of our analyses.


Subject(s)
COVID-19 Vaccines , COVID-19 , Myocarditis , Pericarditis , mRNA Vaccines , Adult , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Europe/epidemiology , Female , Humans , Male , Myocarditis/chemically induced , Pericarditis/chemically induced , SARS-CoV-2 , United Kingdom/epidemiology , United States/epidemiology , Vaccination/adverse effects , mRNA Vaccines/adverse effects
15.
Cell Rep Med ; 3(5): 100631, 2022 05 17.
Article in English | MEDLINE | ID: covidwho-1799660

ABSTRACT

Two doses of Pfizer/BioNTech BNT162b2 mRNA vaccine elicit robust severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-neutralizing antibodies with frequent adverse events. Here, by applying a high-dimensional immune profiling on 92 vaccinees, we identify six vaccine-induced immune dynamics that correlate with the amounts of neutralizing antibodies, the severity of adverse events, or both. The early dynamics of natural killer (NK)/monocyte subsets (CD16+ NK cells, CD56high NK cells, and non-classical monocytes), dendritic cell (DC) subsets (DC3s and CD11c- Axl+ Siglec-6+ [AS]-DCs), and NKT-like cells are revealed as the distinct cell correlates for neutralizing-antibody titers, severity of adverse events, and both, respectively. The cell correlates for neutralizing antibodies or adverse events are consistently associated with elevation of interferon gamma (IFN-γ)-inducible chemokines, but the chemokine receptors CCR2 and CXCR3 are expressed in distinct manners between the two correlates: vaccine-induced expression on the neutralizing-antibody correlate and constitutive expression on the adverse-event correlate. The finding may guide vaccine strategies that balance immunogenicity and reactogenicity.


Subject(s)
BNT162 Vaccine , COVID-19 , Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , BNT162 Vaccine/adverse effects , BNT162 Vaccine/immunology , BNT162 Vaccine/therapeutic use , COVID-19/immunology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19 Vaccines/therapeutic use , Humans , SARS-CoV-2/genetics , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/immunology , Vaccines, Synthetic/therapeutic use , mRNA Vaccines/adverse effects , mRNA Vaccines/immunology , mRNA Vaccines/therapeutic use
16.
Food Chem Toxicol ; 164: 113008, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1796846

ABSTRACT

The mRNA SARS-CoV-2 vaccines were brought to market in response to the public health crises of Covid-19. The utilization of mRNA vaccines in the context of infectious disease has no precedent. The many alterations in the vaccine mRNA hide the mRNA from cellular defenses and promote a longer biological half-life and high production of spike protein. However, the immune response to the vaccine is very different from that to a SARS-CoV-2 infection. In this paper, we present evidence that vaccination induces a profound impairment in type I interferon signaling, which has diverse adverse consequences to human health. Immune cells that have taken up the vaccine nanoparticles release into circulation large numbers of exosomes containing spike protein along with critical microRNAs that induce a signaling response in recipient cells at distant sites. We also identify potential profound disturbances in regulatory control of protein synthesis and cancer surveillance. These disturbances potentially have a causal link to neurodegenerative disease, myocarditis, immune thrombocytopenia, Bell's palsy, liver disease, impaired adaptive immunity, impaired DNA damage response and tumorigenesis. We show evidence from the VAERS database supporting our hypothesis. We believe a comprehensive risk/benefit assessment of the mRNA vaccines questions them as positive contributors to public health.


Subject(s)
COVID-19 , Exosomes , G-Quadruplexes , Immunity, Innate , MicroRNAs , Neurodegenerative Diseases , Vaccines, Synthetic , mRNA Vaccines , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Exosomes/metabolism , Humans , MicroRNAs/genetics , MicroRNAs/metabolism , Neurodegenerative Diseases/metabolism , RNA, Messenger/genetics , RNA, Messenger/metabolism , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Vaccination/adverse effects , Vaccines, Synthetic/adverse effects , mRNA Vaccines/adverse effects
17.
J Cosmet Dermatol ; 21(6): 2315-2317, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1774854

ABSTRACT

BACKGROUND: Treatments based on hyaluronic acid represent one of the most largely used practice of esthetic medicine. In the literature, it has already been described delayed reaction after vaccine like flu vaccine mediated by T-lymphocytes. AIM: We report three cases of dermal filler reactions following mRNA vaccination against SARS-CoV-2; all the patients had received the filler months or even years before the vaccine. PATIENTS: Patient one: A 60-year-old female patient that was treated one year ago in the lip developed swelling days after getting mRNA Pfizer Biotech vaccine. She received her booster of Pfizer vaccination one week before. Patient two: A 45-year-old female patient treated in the lip two years before developed angioedema days after getting her booster of Pfizer Biotech vaccine. In this case, it was necessary to prescribe cortisone per os. Patient three: A 40-year-old female patient treated for the nasolabial fold five months before developed erythema and edema after receiving the booster of Moderna Vaccine. RESULTS: As demonstrated in our three case reports, even the booster of vaccine can cause delayed inflammatory reactions in patients that have previously received fillers. CONCLUSION: Delayed inflammatory reactions in patients that have received filler in the past are uncommon and usually self-limited. Those are the first example reported in the literature of reaction after the booster dose without any previous symptoms.


Subject(s)
COVID-19 Vaccines , COVID-19 , Dermal Fillers , Hyaluronic Acid , Inflammation , Adult , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Dermal Fillers/adverse effects , Female , Humans , Hyaluronic Acid/adverse effects , Inflammation/chemically induced , Middle Aged , SARS-CoV-2 , mRNA Vaccines/adverse effects
19.
Nat Immunol ; 23(4): 532-542, 2022 04.
Article in English | MEDLINE | ID: covidwho-1764192

ABSTRACT

The use of lipid-formulated RNA vaccines for cancer or COVID-19 is associated with dose-limiting systemic inflammatory responses in humans that were not predicted from preclinical studies. Here, we show that the 'interleukin 1 (IL-1)-interleukin 1 receptor antagonist (IL-1ra)' axis regulates vaccine-mediated systemic inflammation in a host-specific manner. In human immune cells, RNA vaccines induce production of IL-1 cytokines, predominantly IL-1ß, which is dependent on both the RNA and lipid formulation. IL-1 in turn triggers the induction of the broad spectrum of pro-inflammatory cytokines (including IL-6). Unlike humans, murine leukocytes respond to RNA vaccines by upregulating anti-inflammatory IL-1ra relative to IL-1 (predominantly IL-1α), protecting mice from cytokine-mediated toxicities at >1,000-fold higher vaccine doses. Thus, the IL-1 pathway plays a key role in triggering RNA vaccine-associated innate signaling, an effect that was unexpectedly amplified by certain lipids used in vaccine formulations incorporating N1-methyl-pseudouridine-modified RNA to reduce activation of Toll-like receptor signaling.


Subject(s)
Inflammation , Interleukin 1 Receptor Antagonist Protein , Interleukin-1 , Animals , COVID-19 , Inflammation/immunology , Inflammation/metabolism , Interleukin 1 Receptor Antagonist Protein/genetics , Interleukin 1 Receptor Antagonist Protein/immunology , Interleukin-1/genetics , Interleukin-1/immunology , Lipids , Mice , RNA , Vaccines, Synthetic , mRNA Vaccines/adverse effects , mRNA Vaccines/metabolism
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