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Comirnaty

Manufactured by Moderna
Sourced in United States

Comirnaty is a mRNA-based vaccine product developed by Moderna. It is designed to induce an immune response against the SARS-CoV-2 virus, the causative agent of COVID-19. The core function of Comirnaty is to deliver mRNA encoding the SARS-CoV-2 spike protein to host cells, which then produce the spike protein and elicit an immune response.

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7 protocols using comirnaty

1

Assessing Booster Vaccine Immune Responses

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Prior approval had been granted by institutional review boards (IRBs) under the Agency for Science Technology and Research (A*STAR) to Singapore Immunology Network for the conduct of this study. Healthy donors who were above the age of 21 and due for their COVID-19 vaccine booster were recruited under a Singapore Immunology Network study entitled, “Study of B cell immune responses to SARS-CoV2 vaccine”. These donors either received the mRNA (BNT162b2, Pfizer-BioNTech/COMIRNATY or mRNA-1273, Moderna) or an inactivated virus (CoronaVac, Sinovac or BBIBP-CorV, Sinopharm) vaccine as their third dose booster. These individuals were not infected with SARS-CoV2 before or during the study. Peripheral blood was collected before the booster dose and on day 28 (±5) after the booster. A total of 66 subjects were recruited for this study, 29 males and 37 females. Written informed consent was obtained from all donors in accordance with the Declaration of Helsinki for Human Research.
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2

Antibody Responses in Vaccinated and Exposed Healthcare Workers

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We have tested 103 samples of healthcare workers from the Hospital Clínic in Barcelona, Spain (15 (link)), being 67% female and with a mean (SD) age of 40.6 (10.3) years old. Thirty-six were pre-exposed and unvaccinated; 20 were naïve and vaccinated with two doses of BNT162b2; 27 were vaccinated with one dose of mRNA-1273 (15 pre-exposed and 12 naïve), and 20 were naïve and vaccinated with 2 doses of mRNA-1273 (Supplementary Table 1). Previous exposure was defined as evidence of SARS-CoV-2 seropositivity or rRT-PCR positivity. Participants were recruited at the peak of the first wave of the pandemic in Barcelona, Spain, and followed up for one year. Venous or finger prick blood was collected at different visits after recruitment and immunization with one or two doses of the mRNA-1273 (Spykevax) (16 (link)) or two doses of the BNT162b2 (Comirnaty) (17 (link)), products from Moderna Biotech and Pfizer-BioNTech, respectively. Samples analyzed from the vaccinated participants were collected 10 to 21 days post 1st dose and 10 to 34 days after the 2nd dose. Samples analyzed from the pre-exposed non-vaccinated participants were collected 12 months after recruitment. Ten pre-pandemic samples were also assayed as negative controls. All plasma samples were isolated and cryopreserved at -80°C.
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3

COVID-19 Vaccination Effectiveness Study

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Our outcomes were (i) hospital admission resulting in a stay of 2 nights or more, occurring up to 2 days before or up to 14 days after a new positive COVID-19 test and (ii) death within 0-28 days of a new positive COVID-19 test. Concurrent hospital admissions were aggregated. A new positive COVID-19 test was defined as the first reported positive test within any series of tests, which was at least 90 days after any prior new positive test. Tests may be PCR tests through sentinel surveillance or the national testing process, or via self-administered and self-reported lateral flow tests. Symptom onset dates were not available, so test dates were used as event dates. The exposure of interest was full COVID-19 vaccination following a Comirnaty (Pfizer-BioNTech mRNA vaccine BNT162B2) or Vaxzevria (AstraZeneca ChAdOx1-S COVID-19 Vaccine AZD1222) primary course and including an mRNA, Comirnaty or half-dose Spikevax (Moderna mRNA-1273), third or booster dose. Our dataset included the date and dose of vaccine given, manufacturer and batch number. The specific vaccine was inferred from the batch number if manufacturer was unavailable. The focus periods were 14+ days after a second or third dose, split into 6-week periods: 14-69, 70-125, 126-181, 182+ days after the dose was given.
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4

Immune Responses to COVID-19 mRNA Vaccines

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We followed up a total of 445 health care workers (HCW, n = 353 from hospital6 (link) and n = 92 from primary care7 (link)) in Barcelona, Spain, with different histories of prior COVID-19 exposure. Venous or finger prick blood was collected at different time points before and after immunization with the mRNA-1273 (Spykevax)1 (link) or the BNT162b2 (Comirnaty),8 (link) products from Moderna Biotech and Pfizer-BioNTech, respectively. Plasma was isolated and cryopreserved at -80°C.
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5

GBS Case Definition Validation Protocol

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Two physicians (HL and RS) reviewed and validated the reports according to the internationally accepted GBS case definition of the Brighton Collaboration (BC) [14 (link)]. Level 1 reflects the highest level of diagnostic certainty, and levels 2 and 3 reflect lower levels of diagnostic certainty. In case of insufficient information, additional information was requested from the reporting physicians using a paper-based questionnaire or as medical reports from reporting consumers if contact details were available. Reports of GBS/MFS that did not correspond to levels 1 to 3 and for which complete information on clinical symptoms was not yet available were assigned level 4 of diagnostic certainty. Level 5 reflected the exclusion of GBS/MFS. At the beginning of the vaccination campaign in Germany, the minimum age for which COVID-19 vaccines were available was 16 years (Comirnaty, BNT162b2, BioNTech-Pfizer, Mainz, Germany/New York, United States (US)). From 31 May 2021 and, respectively, 23 July 2021, mRNA-vaccines Comirnaty and Spikevax (mRNA-1273, Moderna, Cambridge, US) could also be used in individuals 12 years and older. Vaxzevria and COVID-19 Vaccine Janssen were available for persons 18 years and older.
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6

COVID-19 Vaccine Administration Protocol

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BNT162b2 licensed by Pfizer-BioNTech (Comirnaty) and mRNA-1273 licensed by Moderna (Spikevax) were stored and applied according to the recommendation of the manufacturers [9 (link), 11–13 ]. Both vaccines were administered on days 0 and 28 into the deltoid muscle (30 μg of BNT162b2 in 0.3 mL or 100 μg of mRNA-1273 in 0.5 mL).
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7

SARS-CoV-2 Vaccination in Denmark

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In Denmark, monitoring of adult individuals with IEI are centralized to one to two Departments of Infectious Diseases per region (there are five regions in Denmark). The first case of SARS-CoV-2 infection in Denmark was detected on 27 February 2020. Vaccination was initiated ultimo December 2020. Individuals assumed to be at increased risk of severe SARS-CoV-2 infection, including individuals with IEI, were among the first to be offered SARS-CoV-2 vaccination (23 ). Comirnaty® from Pfizer/BioNTech and Spikevax® from Moderna were the first vaccines to be approved. As of 1 May 2022, 78% of the 5.8 million living in Denmark have been anti-SARS-Cov-2 vaccinated at least once. In Denmark, the vaccination program has been primarily with the mRNA-based vaccines from Pfizer (Comirnaty®) and Moderna (Spikevax®) with substantially fewer receiving the vector-based vaccines from AstraZeneca (Vaxzeria®) or Janssen (COVID-19 Vaccine Janssen). In Denmark, both vaccination and testing for as well as treatment of SARS-CoV-2 infection are provided free-of-charge.
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