Bnt162b2 mrna

Manufactured by Pfizer

Sourced in China

BNT162b2 is an mRNA-based vaccine candidate against COVID-19. It is designed to express the SARS-CoV-2 spike protein, which is a key target for antibodies that can neutralize the virus.

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Lab products found in correlation

Mrna 1273, by Moderna (3 mentions) Chadox1 ncov 19, by AstraZeneca (2 mentions) Ad26 cov2 s, by Johnson & Johnson (1 mentions)

14 protocols using bnt162b2 mrna

Longitudinal Study of Pfizer Vaccine Antibodies

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Pfizer vaccine serum was obtained from volunteers who had received either one or two doses of the BNT162b2 vaccine. Vaccinees were Health Care Workers, based at Oxford University Hospitals NHS Foundation Trust, not known to have prior infection with SARS-CoV-2 and were enrolled in the OPTIC Study as part of the Oxford Translational Gastrointestinal Unit GI Biobank Study 16/YH/0247 [research ethics committee (REC) at Yorkshire & The Humber – Sheffield] which has been amended for this purpose on 8 June 2020. The study was conducted according to the principles of the Declaration of Helsinki (2008) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. Written informed consent was obtained for all participants enrolled in the study. Participants were studied after receiving two doses of, and were sampled approximately 28 days (range 25–38), 180 days (range 178–221) and 270 days (range 243–273) after receiving two doses of Pfizer/BioNtech BNT162b2 mRNA Vaccine, 30 micrograms, administered intramuscularly after dilution (0.3 mL each), 17–28 days apart, then approximately 28 days (range 25–56) after receiving a third “booster dose of BNT162B2 vaccine. The mean age of vaccinees was 37 years (range 22–66), 21 male and 35 female.

Dejnirattisai W., Huo J., Zhou D., Zahradník J., Supasa P., Liu C., Duyvesteyn H.M., Ginn H.M., Mentzer A.J., Tuekprakhon A., Nutalai R., Wang B., Dijokaite A., Khan S., Avinoam O., Bahar M., Skelly D., Adele S., Johnson S.A., Amini A., Ritter T., Mason C., Dold C., Pan D., Assadi S., Bellass A., Omo-Dare N., Koeckerling D., Flaxman A., Jenkin D., Aley P.K., Voysey M., Clemens S.A., Naveca F.G., Nascimento V., Nascimento F., Fernandes da Costa C., Resende P.C., Pauvolid-Correa A., Siqueira M.M., Baillie V., Serafin N., Ditse Z., Da Silva K., Madhi S., Nunes M.C., Malik T., Openshaw P.J., Baillie J.K., Semple M.G., Townsend A.R., Huang K.Y., Tan T.K., Carroll M.W., Klenerman P., Barnes E., Dunachie S.J., Constantinides B., Webster H., Crook D., Pollard A.J., Lambe T., Paterson N.G., Williams M.A., Hall D.R., Fry E.E., Mongkolsapaya J., Ren J., Schreiber G., Stuart D.I, & Screaton G.R. (2021). Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. bioRxiv.

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Pfizer Vaccine Antibody Dynamics

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Pfizer vaccine serum was obtained from volunteers who had received two and three doses of the BNT162b2 vaccine. Vaccinees were Health Care Workers, based at Oxford University Hospitals NHS Foundation Trust, not known to have prior infection with SARS-CoV-2 and were enrolled in the OPTIC Study as part of the Oxford Translational Gastrointestinal Unit GI Biobank Study 16/YH/0247 [research ethics committee (REC) at Yorkshire & The Humber – Sheffield] which has been amended for this purpose on 8 June 2020. The study was conducted according to the principles of the Declaration of Helsinki (2008) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. Written informed consent was obtained for all participants enrolled in the study. Participants were sampled approximately 28 days (range 25-38), 180 days (range 178-221) and 270 days (range 243-273) after receiving two doses of Pfizer/BioNtech BNT162b2 mRNA Vaccine, 30 micrograms, administered intramuscularly after dilution (0.3 mL each), 17-28 days apart, then approximately 28 days (range 25-56) after receiving a third "booster" dose of BNT162B2 vaccine. The mean age of vaccinees was 42 years (range 30-59), 10 male and 10 female.

Dejnirattisai W., Huo J., Zhou D., Zahradník J., Supasa P., Liu C., Duyvesteyn H.M., Ginn H.M., Mentzer A.J., Tuekprakhon A., Nutalai R., Wang B., Dijokaite A., Khan S., Avinoam O., Bahar M., Skelly D., Adele S., Johnson S.A., Amini A., Ritter T.G., Mason C., Dold C., Pan D., Assadi S., Bellass A., Omo-Dare N., Koeckerling D., Flaxman A., Jenkin D., Aley P.K., Voysey M., Costa Clemens S.A., Naveca F.G., Nascimento V., Nascimento F., Fernandes da Costa C., Resende P.C., Pauvolid-Correa A., Siqueira M.M., Baillie V., Serafin N., Kwatra G., Da Silva K., Madhi S.A., Nunes M.C., Malik T., Openshaw P.J., Baillie J.K., Semple M.G., Townsend A.R., Huang K.Y., Tan T.K., Carroll M.W., Klenerman P., Barnes E., Dunachie S.J., Constantinides B., Webster H., Crook D., Pollard A.J., Lambe T., Paterson N.G., Williams M.A., Hall D.R., Fry E.E., Mongkolsapaya J., Ren J., Schreiber G., Stuart D.I, & Screaton G.R. (2022). SARS-CoV-2 Omicron-B.1.1.529 leads to widespread escape from neutralizing antibody responses. Cell, 185(3), 467-484.e15.

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COVID-19 Vaccine Side Effects Study

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We studied cohorts from a prospective observational trial of 355 and 1,179 individuals who received their second and third vaccinations, respectively, in Israel with the BNT162b2 mRNA (Pfizer BioNTech) COVID-19 vaccine between January 10, 2021 and September 15, 2021. The cohorts were mostly disjoint, with 116 individuals in both cohorts. Upon enrollment in the study, we collected information on participants’ gender, age, and underlying medical conditions, which consisted of hypertension, diabetes, heart disease, chronic lung disease, immune suppression, cancer, renal failure, body mass index (BMI) > 30 (BMI is defined as weight in kilograms divided by the square of height in meters). We focused on analyzing side effects after the second and third vaccinations.

Guan G., Mofaz M., Qian G., Patalon T., Shmueli E., Yamin D, & Brandeau M.L. (2022). Higher sensitivity monitoring of reactions to COVID-19 vaccination using smartwatches. NPJ Digital Medicine, 5, 140.

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Antibody Response in HCW Post-BNT162b2 Vaccine

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The sera of 1989 HCW with and without pre-existing infection for SARS-CoV-2 (as per former nasal swab positivity) who had received their first vaccine dose (BNT162b2 mRNA, Pfizer-BioNTech) in January 2021 were analysed. Samples were collected before vaccine administration (T0), at the second dose (T1) and three weeks after T1 (T2) and tested for IgG against the Spike glycoprotein (IgG-S), IgG against the Nucleocapsid protein (IgG-N) and IgM against the Spike glycoprotein (IgM-S). All individuals who had received two doses of BNT162b2 vaccine and had complete serological data were included in the study. Among the 1957 individuals having complete information, 84 were negative at the swab test but had positive serology (IgM-S or IgG-S or IgG-N) at T0; they were considered as false negatives in accordance with a recent study¹⁷ (link) and were not included in the present study. Antibody response analyses were conducted on 1584 IN subjects and 289 PI subjects.

Ruggiero A., Piubelli C., Calciano L., Accordini S., Valenti M.T., Carbonare L.D., Siracusano G., Temperton N., Tiberti N., Longoni S.S., Pizzato M., Accordini S., Fantoni T., Lopalco L., Beretta A., Bisoffi Z, & Zipeto D. (2022). SARS-CoV-2 vaccination elicits unconventional IgM specific responses in naïve and previously COVID-19-infected individuals. EBioMedicine, 77, 103888.

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Booster Vaccine Adverse Effects in HCWs

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The study population is identical to the volunteer group of our previous study, who were health care workers of Szigetvár Hospital and received 2 doses of BNT162b2 mRNA (Pfizer/BioNTech, Comirnaty) vaccination between 27 January and 9 May 2021. The adverse reactions following the vaccinations were registered and the anti-SARS-CoV-2 spike Ig level was measured at 14, 30, 60, 90, 120, 150 and 180 days after the 2nd vaccination. Clinical data and details about adverse reactions were collected from medical records and dedicated questionnaire [5 (link)]. After the booster vaccination schedule became available, we contacted the volunteers again to participate in our follow-up study. Local and systemic solicited adverse reactions after the booster dose were recorded. This corresponds to the methodology used in our previous study. Based on the adverse reactions occurring within 7 days after vaccination, two groups were created: (i) symptomatic (side effects within 7 days after the 3rd dose) vs. asymptomatic (no reported side effects 7 days after the 3rd dose). We recorded the type of booster vaccine (heterologous vs. homologous schedules) and any COVID-19 positivity within 3 months following the booster dose.

Kanizsai A., Zavori L., Molnar T., Tőkés-Füzesi M., Szalai Z., Berecz J., Varnai R., Peterfi Z., Schwarcz A, & Csecsei P. (2023). Adverse Reactions after Booster SARS-CoV-2 Vaccination Have Less Impact on Antibody Response than after Basic Vaccination Scheme. Vaccines, 11(1), 182.

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SARS-CoV-2 Vaccine Response in Healthcare Workers

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We analysed the sera of 101 health-care workers with and without preexisting SARS-CoV-2 infection (as per former nasal swab positivity) who received their first vaccine dose (BNT162b2 mRNA, Pfizer-BioNTech) in January 2021. The study was approved by the Ethics Committee of the University of Verona (approval prot. N. 1538) and of the IRCCS Sacro Cuore Don Calabria Hospital (approval prot. N. 50950), and samples were stored in the biobank of the Department of Medicine, University of Verona, and in the Tropica Biobank of the Don Calabria Hospital. All relevant ethical regulations were followed, and all participants provided written informed consent.

Dalle Carbonare L., Valenti M.T., Bisoffi Z., Piubelli C., Pizzato M., Accordini S., Mariotto S., Ferrari S., Minoia A., Bertacco J., Li Vigni V., Dorelli G., Crisafulli E., Alberti D., Masin L., Tiberti N., Longoni S.S., Lopalco L., Beretta A, & Zipeto D. (2021). Serology study after BTN162b2 vaccination in participants previously infected with SARS-CoV-2 in two different waves versus naïve. Communications Medicine, 1, 38.

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Identifying COVID-19 Vaccination and Outcomes

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We identified persons vaccinated against COVID-19 as those who had received a dose of any COVID-19 vaccine: BNT162b2 mRNA (Pfizer-BioNTech, https://www.pfizer.com), mRNA-1273 (Moderna, https://www.modernatx.com), ChAdOx1 nCoV-19 (Oxford-AstraZeneca, https://www.astrazeneca.com), or Ad.26.COV2.S (Janssen/J&J, https://www.janssen.com). The date of vaccination was the date of the first dose administration. We identified COVID-19 infections based on a positive SARS-CoV-2 antigen or reverse transcription PCR test, using the test date as the date of infection; we considered the first infection per person. We defined COVID-19 hospitalizations as hospitalizations with a positive SARS-CoV-2 test result between 21 days before and 3 days after the date of admission. We defined COVID-19–related deaths as deaths occurring <28 days after the date of infection.

Roel E., Raventós B., Burn E., Pistillo A., Prieto-Alhambra D, & Duarte-Salles T. (2022). Socioeconomic Inequalities in COVID-19 Vaccination and Infection in Adults, Catalonia, Spain. Emerging Infectious Diseases, 28(11), 2243-2252.

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COVID-19 Vaccination of Soldiers

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Soldiers agreeing to vaccinate were exclusively administered the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine. The large-majority of soldiers in this study were vaccinated in a COVID-19 vaccination site constructed on the premises of the unit’s base, ensuring close proximity and maximum availability. The vaccination site operated daily during two different sessions, the first between January 3 and 7, 2021 and the second between January 24 and 28, 2021 with the aim of allowing for both doses to be received without need for travel or arrangement by the unit’s soldiers. A small proportion of soldiers (n = 49, 9.5%), unable to complete the two-dose regimen at this vaccination site were referred to other vaccine sites. Doses were administered 21 days apart except in rare cases of soldiers on combat missions or self-quarantine due to close contact exposure.

Talmy T., Cohen B., Nitzan I, & Ben Michael Y. (2021). Primary Care Interventions to Address COVID-19 Vaccine Hesitancy Among Israel Defense Forces Soldiers. Journal of Community Health, 46(6), 1155-1160.

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Heterologous and Homologous COVID-19 Vaccine Boosters

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Volunteers who had received two doses of the inactivated CoronaVac (Sinovac Life Sciences, Beijing, China) (heterologous group; n = 75) vaccine or two doses of the BNT162b2 mRNA (Pfizer-BioNTech) vaccine (homologous group; n = 75) were included in this study, which was carried out from 25 April 2022 to 15 August 2022. The two patient groups are not similar in terms of co-morbidities, which could affect immunoresponses (e.g., immunosuppression, diabetes, etc.). All of these participants preferred the BNT162b2 vaccine as a booster dose. Firstly, we collected peripheral blood samples taken 3 months after the second dose of vaccine. Secondly, we collected peripheral blood samples 1 month after the booster dose.
All participants were asked to complete an additional questionnaire regarding their comorbidities and their history of COVID-19 infection. Their COVID-19 histories were confirmed by their medical history (clinical data and/or PCR results). In addition, age, gender, and comorbidity characteristics were comprehensively evaluated. All volunteers provided written informed consent prior to the study.

Gareayaghi N., Demirci M., Ozbey D., Dasdemir F., Dinc H.O., Balkan I.I., Saribas S., Saltoglu N, & Kocazeybek B. (2022). Comparison of SARS-CoV-2 Antibody Levels after a Third Heterologous and Homologous BNT162b2 Booster Dose. Vaccines, 10(10), 1672.

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Longitudinal Study of COVID-19 Vaccine Responses

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SARS-CoV-2 vaccinations started in the USA at the end of December 2020 with Pfizer-BioNTech BNT162b2 mRNA and Moderna mRNA-1273 vaccine. We conducted a longitudinal study in which participants (ages 21 to 60 years) were recruited among the University of California, Davis staff, before receiving two doses of the Pfizer or Moderna vaccine. The plasma samples were collected from EDTA-treated blood, before or on the day of the first vaccine dose, 4 weeks post-first vaccine dose, and 4 and 26 weeks post-second vaccine dose (n = 18 (Moderna); 3 weeks post-first vaccine dose, and 4 and 26 weeks post-second vaccine dose (n = 35 (Pfizer). Twenty-eight of these healthy subjects participated in the Pfizer vaccine trial in August 2020 in the Sacramento region. All the participants were without a history of SARS-CoV-2 infection at the time of sample collection. Two participants in the Pfizer group became positive for SARS-CoV-2 by RT-PCR three weeks post-second dose vaccination.

Ravindran R., Kang H., McReynolds C., Sanghar G.K., Chang W.L., Ramasamy S., Kolloli A., Kumar R., Subbian S., Hammock B.D., Hartigan-O’Connor D.J., Ikram A., Haczku A, & Khan I.H. (2023). Dynamics of temporal immune responses in nonhuman primates and humans immunized with COVID-19 vaccines. PLOS ONE, 18(10), e0287377.

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