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84 protocols using comirnaty

1

Immediate Allergic Reactions to mRNA COVID-19 Vaccines

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We conducted a multicenter, retrospective study at Massachusetts General Hospital, Brigham and Women’s Hospital, Vanderbilt University Medical Center, Yale School of Medicine, and University of Texas Southwestern Medical Center from January 1, 2021, through June 30, 2021. At the time of study conduct, no COVID-19 vaccines had yet received full U.S. Food and Drug Administration (FDA) approval, although full approval has subsequently been given to both the Pfizer BioNTech vaccine (Comirnaty) and the Moderna vaccine (Spikevax).19 We included consecutive patients who experienced an immediate and potential allergic reaction to dose 1 of an mRNA COVID-19 Vaccine (Pfizer-BioNTech or Moderna) specified as (1) onset of symptoms within 4 hours, (2) at least 1 potentially allergic symptom, and (3) in-clinic or telehealth assessment by an allergy and immunology specialist performed after dose 1 of an mRNA COVID-19 vaccine. Potential allergic symptoms and signs included hives; swelling in the lips, eyes, tongue, or throat; throat tightness; metallic taste; numbness; tingling; flushing; erythema; tachycardia; hypertension; wheezing; shortness of breath; nausea or vomiting; abdominal pain; dizziness; lightheadedness; hypotension; or hypoxia.
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2

Booster Vaccine Study in mRNA Primed

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We conducted a phase 2A, open-label, randomised-controlled, proof-of-concept vaccine study at the Leiden University Medical Centre in the Netherlands. Eligible participants were healthy adults aged 18–50 years who have received a primary vaccination series of mRNA-1273 (SpikeVax, Moderna) or BNT162b2 (Comirnaty, Pfizer-BioNTech) mRNA vaccine against SARS-CoV-2. A mid-turbinate/ throat swab was taken to exclude a concurrent SARS-CoV-2 infection before enrolment and during every on-site visit. Main exclusion criteria included a previous microbiological diagnosis of COVID-19 or COVID-19 revaccination less than 3 months ago, autoimmune disease, immunodeficiency, risk factors for developing severe COVID-19, history of severe allergic reaction, use of systemic or topical corticosteroids, bleeding condition, pregnancy and breastfeeding. For women a urine pregnancy test was performed at screening.
All participants provided written informed consent before participation in the study. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice principles. The protocol was approved by the Medical Ethical Committee Leiden, Den Haag, Delft (NL80101.058.22) and registered in the clinicaltrials.gov. The vaccine manufacturer was not involved in this trial.
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3

SARS-CoV-2 Antibody Dynamics

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Patients included in the protocol and concomitantly shown to have positive serology in June 2020 were chosen to be tested using qualitative serological tests to detect antibodies against the SARS-CoV-2 nucleocapsid (Abbott Alinity SARS-Cov-2 IgG assay) and Spike proteins (Wantai SARS-CoV-2 Ab ELISA) every three months, according to the following scheme: in June 2020 (M0), and three (M3), six (M6) and nine months later (M9). Only the serologically positive participants participated in the M3 and M6 samplings. All patients included in the protocol who received two Comirnaty (Pfizer BNT162b2) vaccine doses were also serologically screened to determine the impact of vaccination on the immune response.
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4

Longitudinal Study of COVID-19 Vaccine Responses

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This longitudinal study included 79 Caucasian health care workers followed since March 2020 in the tertiary Ramon y Cajal University Hospital (Madrid, Spain) who were vaccinated with two doses of Comirnaty (mRNA-based BNT162b2, Pfizer-BioNTech) COVID-19 vaccine in February 2021. Twenty-four individuals had specific antibodies and 55 individuals were seronegative. The complete study design is shown in Figure 1A.
Peripheral blood mononuclear cells (PBMC) were isolated from EDTA-blood sample by Ficoll-Paque density gradient centrifugation using lymphocyte separation medium (Corning, New York, NY) and cryopreserved. Plasma samples were stored at −80°C.
All individuals included in the study provided either oral or written informed consent. This study was conducted in accordance with the Declaration of Helsinki (1996), approved by the institutional review boards of our Hospital Ethics Committee (EC162/20), and registered at the clinical trials repository.1 Demographic data including age, sex, race, body mass index (BMI), and comorbidities were recorded for all participants.
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5

COVID-19 Vaccination in RA Patients

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All RA patients aged ≥16 years of the Sint Maartenskliniek (Nijmegen, the Netherlands) were invited to participate in the cohort, if (i) they received at least one dose of rituximab (200 mg, 500 mg or 1000 mg) in the year prior to their first dose of COVID-19 vaccination and (ii) COVID-19 vaccination was performed according to the registered dose and interval. The RTX dose was based on the treating physician’s discretion. At the time of the study, the Dutch national vaccine programme included four vaccines against COVID-19, of which three were two-dose regimens: BNT162b2 (Comirnaty; Pfizer-BioNtech), ChAdOx1 nCoV-19 (Vaxzevria; AstraZeneca) and CX-024414 (Spikevax; Moderna), and one was single-dose: Ad.26.COV2.S (COVID-19 vaccine Janssen) [10 ]. If a COVID-19 infection had occurred in the six months prior to first vaccination, the Dutch government also approved one dose of a two-dose vaccine as fully vaccinated [11 ].
This study has been approved by the ethics committee (CMO Arnhem-Nijmegen, 2021–7406) and the competent authority (CCMO, NL76709.091.21). The study protocol was registered in the Netherlands Trial Register (NL9342) before start. All participants provided written informed consent.
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6

SARS-CoV-2 Antibody Evaluation in Infected and Vaccinated Individuals

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Anonymized blood samples were collected at the laboratory of Virology of the Toulouse University Hospital. Biobanking was done at the Center of Biological Resources of the Toulouse University Hospital (certified according to NF S96-900 standards). All French law ethical requirements were respected.
One hundred sera from patients hospitalized in January 2019 were used as anti-SARS-CoV-2 antibody-negative samples. The two panels of sera from infected patients represented “recent” and “late” infections. All SARS-CoV-2 infections were determined by a positive RT-PCR on a nasopharyngeal sample. Thirty-five recent samples were taken 15 to 35 days postinfection in patients hospitalized with COVID-19 (patients sampled between 1 April 2020 and 23 March 2021). Late samples (150) were taken more than 180 days postinfection in health care workers recovered from a SARS-CoV-2 infection (patients sampled 30 November to 4 December 2020). In this patient cohort, one-third were asymptomatic at the time of diagnosis of SARS-CoV-2 infection (34 (link)). We also established two groups of vaccinated subjects: one had been given two doses of the Comirnaty (Pfizer-BioNTech) vaccine, and the other had had one dose of the Vaxzevria (AstraZeneca) vaccine. Samples were collected at least 1 month after receiving the last dose.
The demographic characteristics of patients are listed in Table 3.
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7

Gam-COVID-Vac Vaccine Heterologous Boosting

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A cohort of 58 volunteers was enrolled at the National Research Center Institute of Immunology of The Federal Medical Biological Agency of Russia. Between January and April 2021, all subjects received two doses of Gam-COVID-Vac vaccine. The first dose was rAd26-based, followed by the rAd5-based second dose 21 days later. Approximately 9 months after the prime, the booster vaccine dose was given. The core cohort participants received a homologous Gam-COVID-Vac (rAd26) boost, whereas the comparison cohort had a heterologous boost with the Pfizer-BioNTech’s Comirnaty.
Written informed consent was obtained from each of the study participants before performing any study procedures. The study protocol was reviewed and approved by the Medical Ethical Committee of Institute of Immunology (#12-1, December 29, 2020).
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8

Efficacy of BNT162b2 Vaccine in Immunocompromised

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We conducted a prospective, open-label clinical trial of BNT162b2 (Comirnaty®, Pfizer/BioNTech) with two doses given to immunocompromised patients and healthy controls at Karolinska University Hospital, Sweden. Evaluated in the study was safety and efficacy.30 (link) The two doses of vaccine were given 21 days apart. Immunocompromised patients (n = 449) had either PID (n = 90), or SID due to infection with HIV infection (n = 90), allogeneic hematopoietic stem cell transplantation (HSCT)/chimeric antigen receptor T (CAR-T) cell therapy (n = 90), solid organ transplantation (SOT) (n = 89), or chronic lymphocytic leukemia (CLL) (n = 90). Healthy controls were age and sex matched (n = 90). The number of available saliva samples in each patient group was 79 in PID group, 80 in HIV group, 74 in HSCT/CART-T group, 83 in SOT group and 88 in CLL group. Eligible were men and women ≥ 18 years of age, with no known history of SARS-CoV-2 infection. The study was approved by the Swedish Medical Product Agency (ID 5.1-2021-5881) and the Swedish Ethical Review Authority (ID 2021-00451 and 2020-06381). All participants provided written informed consent.
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9

COVID-19 Vaccination of Japanese Students

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Osaka Medical and Pharmaceutical University (OMPU) provided mass COVID-19
vaccination to students at Takatsuki Junior and Senior High Schools who were 12
to 18 years old. The family members of the students and staff members at the
schools could also receive the vaccine based on individual preference.
Vaccination was conducted by doctors and nurses affiliated with OMPU. Initially,
two doses of elasomeran (0.1 mg [mRNA-1273] SPIKEVAX®; Moderna, Inc., Cambridge,
MA, USA) were administered at intervals of 27 to 29 days. However, the Ministry
of Health, Labour and Welfare (MHLW) allowed males in their teens and twenties
to be vaccinated with tozinameran at a dose of 0.225 mg (BNT162b2, COMIRNATY®;
Pfizer Inc., New York, NY, USA) as a second dose. This decision was based on the
higher likelihood of developing AEs including myocarditis after receiving
SPIKEVAX® than after receiving COMIRNATY®.9 Therefore, some males
received COMIRNATY® as the second dose. Because this MHLW policy was announced
immediately before the second dose was made available, the vaccine interval was
set at 28 to 33 days even if COMIRNATY® was chosen for the second dose.
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10

SARS-CoV-2 Vaccine Effectiveness Study

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All subjects completed SARS-CoV-2 (64 Comirnaty by Pfizer/BioNTech or 7 Spikevax by Moderna) vaccination. Median time between the last vaccine dose and study examination was 36 days. The time did not significantly differ between groups of patients.
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