ABSTRACT
Background: Vaccines represent an efficient means to control the pandemic of Coronavirus Disease 2019 (COVID-19). Two mRNA-based emergency vaccines have recently been licensed for mass administration: BNT162b2 and mRNA-1273 COVID-19 vaccine. Delayed hypersensitivity reactions these new vaccines can range widely from localized skin symptoms to disseminated exanthemas. Locally confined reactions can be caused by the active component or the excipients in the vaccine. Both mRNA vaccines contain polyethylene glycol (PEG) 2000 lipid conjugate as excipient. PEG and its derivatives with clinical cross-reactivity (polysorbates, laureth-9) are ubiquitous in many drugs. The mRNA-1273 COVID-19 vaccine also contains trometamol, an organic amine used extensively. Method: We reported a series of 14 patients referred to our Allergy Department with suspected delayed large local reactions (DLLR): erythematous and edematous plaques ≥10 cm in diameter accompanied by pain or pruritus, after the administration of BNT162b2 or mRNA-1273 COVID-19 vaccine between January to February 2021. We describe cutaneous manifestations,latency time, treatment and duration of the lesions. We performed patch test in the upper back with PEG 400 1% in petrolatum (pet), PEG 3350 10% pet, PEG 3350 in aqueous solution (aq), PEG 4000 10% pet, polysorbate 80 1% pet, polysorbate 80 10% pet, laureth-9/ sodium lauril sulphate 1%, trometamol 0.50% aq (only in mRNA-1273 vaccinated patients), with readings at day 2 and day 4. Results: We collected 14 patients: 13 received mRNA-1273 and only one BNT162b2 COVID-19 vaccine. Most patients (13/14) reacted to the first dose. 42.9% had detectable serum specific IgG antibodies against SARS-CoV-2 in the last 3 months. The mean size of DLLR was 11.9 ± 1.6 cm and the latency time was 4.4 ± 1.8 days. Ten patients (71.4%) not receive any treatment, and four (28.6%) received topical corticosteroids. The mean duration of the reactions was 4.75 ± 2.7 days when treated and 4.5 ± 0.60 days without treatment, with no significant differences (p = 0.79). All patients completed vaccination with the second dose and 69.2% developed DLLR again. PT were negative in the 100% cases Conclusion: We didn't found any sensitization to excipients in our 14 cases series. We thought that DLLR may occur due to a non-specific inflammatory response or represent the normal immune response to the vaccination, and in our experience, this should not be a contraindication to receive further doses of mRNA vaccines.
ABSTRACT
Background: Vaccination has become increasingly relevant to prevent the global pandemic from coronavirus disease 2019 (COVID-19). Two mRNA-based emergency vaccines have recently been licensed for mass administration: BNT162b2 and mRNA-1273 COVID-19 vaccine. Delayed vaccines hypersensitivity reactions can be caused by residual proteins, or most frequently by excipients. Both mRNA vaccines contain polyethylene glycol (PEG) 2000 lipid conjugate as excipient. PEG and its derivatives with clinical cross-reactivity (polysorbates, laureth-9) are ubiquitous in many drugs. mRNA-1273 COVID-19 vaccine also contains trometamol, an organic amine used extensively. Method: We collected the patients referred to our Allergy Department with systemic skin delayed reaction after the administration of BNT162b2 or mRNA-1273 COVID-19 vaccine between January to February 2021. We recorded age, sex, personal history of allergies and previous SARS-CoV-2 infection. We describe cutaneous manifestations, latency time, treatment, and duration. We performed patch test (PT) in the upper back with PEG 400 1% in petrolatum (pet), PEG 3350 10% pet, PEG 3350 in aqueous solution (aq), PEG 4000 10% pet, polysorbate 80 1% pet, polysorbate 80 10% pet, laureth-9/ sodium lauril sulphate 1%, trometamol 0.50% aq (only in mRNA-1273 vaccinated patients), with readings at day 2 and day 4. Results: The study population comprised 11 patients: 6 (54.5%) received BNT162b2 and the rest received mRNA-1273 COVID-19 vaccine. Most patients (10/11, 90.9%) reacted to the first dose. Almost half of them (5/11, 45.4%) had detectable serum specific IgG antibodies against SARS-CoV-2 in the last 3 months. The most frequent manifestation was generalized maculopapular exanthema (6/11, 54.5%), 2 flaking palms, 1 acute generalized exanthematous pustulosis (AGEP), 1 micropapular exanthema accompanied by a 7-centimeter blister, and 1 multiple fixed drug eruption (MFDE). PT were negative in the 100% cases. We contraindicate the second dose of the vaccine in patients with severe skin reactions (MFDE, AGEP) after the first dose (2/10, 20%). The remaining patients received the second dose, reappearing systemic skin lesions in 1/8 (12.5%), having a maculopapular exanthema again. Conclusion: In our experience, mild exanthemas should not be a contraindication to receive further doses of mRNA vaccines. However, we recommended an exhaustive allergy workout in all patients with systemic skin delayed reaction.
ABSTRACT
Background: Rapid development of vaccines to prevent coronavirus disease 2019 (COVID-19) has become a global imperative. Two mRNA vaccines have been recently approved by European Medicines Agency: BNT162b2 and mRNA-1273 COVID-19 vaccine. They have demonstrated safety in 1-3 phase clinical trials but data in asthmatics vaccinated in real-life is scarce. We sought to assess the change in asthma control before and 4 weeks after the administration of mRNA vaccine against COVID-19 in adults diagnosed with mild to severe asthma. Method: We performed an observational descriptive study of asthmatic healthcare workers who were vaccinated in our Allergy Department. Asthma severity were measured following Spanish Guideline on the Management of Asthma (GEMA) criteria. Asthma control was evaluated prior to vaccination and 4 weeks after vaccination using Asthma Control Test (ACT) questionnaire. The mRNA vaccines were administered under medical supervision and 30 minutes observation. Results: We recorded a total of 52 asthmatic healthcare workers who receive COVID-19 vaccination in our Allergy Department. The mean age was 52.3 years (range 21-66) and 46 (88.5%) were female. Ten (19.2%) and 42 (80.8%) subjects received BNT162b2 and mRNA-1273 COVID-19 vaccine, respectively. Twenty patients (38.5%) had intermittent asthma, 8 (15.4%) mild, 18 (34.6%) moderate, and 6 (11.5%) severe asthma. One patient was receiving oral corticosteroids and one biologic treatment. Coexisting allergic diseases were common: 26 (50%) had allergic rhinitis, 5 (9.6%) atopic dermatitis, 18 (34.6%) food allergy, 19 (36.5%) drug allergy. Other comorbidities were cardiovascular disease (23.1%), obesity (21.2%), autoimmunity (19.2%) and nasal polyposis (5.8%). The ACT before vaccination was 24.2 (range 21-25, SD 1.4). We detected 2 (3.8%) patients with ACT<20 who were vaccinated once ACT was ≥20. Four weeks after the first and second dose of mRNA vaccine, ACT was 23.4 (range 10-25, SD 2.6) and 23.8 (range 12-25, SD 2.5), respectively. We found no statistical significant differences in ACT changes among intermittent, mild, moderate, and severe asthma. Conclusion: In our experience, asthma exacerbation after mRNA vaccination is infrequent and not related to asthma severity. Asthmatic population can safely receive mRNA vaccines against COVID-19.
ABSTRACT
OBJECTIVE: Spain is one of the European countries most affected by the COVID-19 pandemic. Epidemiologic studies are warranted to improve the disease understanding, evaluate the care procedure and prepare for futures waves. The aim of the study was to describe epidemiologic characteristics associated with hospitalized patients with COVID-19. METHODS: This real-world, observational, multicenter and retrospective study screened all consecutive patients admitted to 8 Spanish private hospitals. Inclusion criteria: hospitalized adults (age≥18 years old) with clinically and radiologically findings compatible with COVID-19 disease from March 1st to April 5th, 2020. Exclusion criteria: patients presenting negative PCR for SARS-CoV-2 during the first 7 days from hospital admission, transfer to a hospital not belonging to the HM consortium, lack of data and discharge against medical advice in emergency departments. RESULTS: One thousand and three hundred thirty-one COVID-19 patients (medium age 66.9 years old; males n= 841, medium length of hospital stayed 8 days, non-survivors n=233) were analyzed. One hundred and fifteen were admitted to intensive care unit (medium length of stay 16 days, invasive mechanical ventilation n= 95, septic shock n= 37 and renal replacement therapy n= 17). Age, male gender, leukocytes, platelets, oxygen saturation, chronic therapy with steroids and treatment with hydroxychloroquine/azithromycin were independent factors associated with mortality. The proportion of patients that survive and received tocilizumab and steroids were lesser and higher respectively than those that die, but their association was not significant. CONCLUSIONS: Overall crude mortality rate was 17.5%, rising up to 36.5% in the subgroup of patients that were admitted to the intensive care unit. Seven factors impact in hospital mortality. No immunomodulatory intervention were associated with in-hospital mortality.