Pfizer–BioNTech COVID-19 vaccine (English Wikipedia)
Analysis of information sources in references of the Wikipedia article "Pfizer–BioNTech COVID-19 vaccine" in English language version.
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Im Tiermodell seien nach direkter intravenöser Gabe eines mRNA-Impfstoffs Perimyokarditiden aufgetreten.
[In an animal model, perimyocarditis had occurred after direct intravenous administration of an mRNA vaccine.]
aifa.gov.it
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Vaccine goes bad five days after thawing, requires two shots; Many nations face costly ramp up of cold-chain infrastructure
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books.google.com
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Mice preimmunized with 2 doses of BNT162b2; boosters given at day 104 post Dose 2 | Vaccines administered at 1 mcg dose level; Wild type, Wuhan-Hu-1; LOD ...
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- This is a type of study where researchers recruit two groups: people who test positive for the disease (cases) and those who test negative (controls) (Vandenbroucke 2019). They then survey these individuals for factors which may have affected whether or not they developed the disease (in this case, vaccination status) (Patel 2020). In the case of Lopez Bernal et al, they also assessed which variant each "case" contracted (e.g. alpha [B.1.1.7] or delta [B.1.617.2]) using both RT-PCR testing and whole genome sequencing. To evaluate efficacy, the researchers determined how much less likely a person was to contract each variant based on their vaccination status. In this case, a person who received two doses of the Pfizer vaccine was 93.7% less likely to contract the alpha variant and 88.0% less likely to contract the delta variant, when compared to an unvaccinated person.
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WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Guidance from the US Food and Drug Administration includes this lower limit of 30% as a criterion for vaccine licensure.
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- Abu-Raddad LJ, Chemaitelly H, Butt AA (5 May 2021). "Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants". New England Journal of Medicine. 385 (2). Table 1. doi:10.1056/NEJMc2104974. ISSN 0028-4793. PMC 8117967. PMID 33951357.
- Chung H, He S, Nasreen S, Sundaram ME, Buchan SA, Wilson SE, et al. (August 2021). "Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study". BMJ. 374: n1943. doi:10.1136/bmj.n1943. PMC 8377789. PMID 34417165.
Tables 6 and 7
- Collie S, Champion J, Moultrie H, Bekker LG, Gray G (December 2021). "Effectiveness of BNT162b2 Vaccine against Omicron Variant in South Africa". N Engl J Med (letter). 386 (5): 494–496. doi:10.1056/NEJMc2119270. PMC 8757569. PMID 34965358.
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Tables 6 and 7
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- Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (October 2020). "Phase I–II study of COVID-19 RNA vaccine BNT162b1 in adults". Nature. 586 (7830): 589–593. Bibcode:2020Natur.586..589M. doi:10.1038/s41586-020-2639-4. PMID 32785213. S2CID 221126922.
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A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported
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ncbi.nlm.nih.gov
- Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. (October 2020). "Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates". The New England Journal of Medicine. 383 (25): 2439–50. doi:10.1056/NEJMoa2027906. ISSN 0028-4793. PMC 7583697. PMID 33053279.
- Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (December 2020). "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine". N Engl J Med. 383 (27): 2603–15. doi:10.1056/NEJMoa2034577. PMC 7745181. PMID 33301246.
- Lopez Bernal J, Andrews N, Gower C, Gallagher E, Simmons R, Thelwall S, et al. (August 2021). "Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant". The New England Journal of Medicine. 385 (7): 585–594. doi:10.1056/NEJMoa2108891. PMC 8314739. PMID 34289274.
- Evans SJ, Jewell NP (August 2021). "Vaccine Effectiveness Studies in the Field". The New England Journal of Medicine. 385 (7): 650–651. doi:10.1056/NEJMe2110605. PMC 8314732. PMID 34289269.
- Fowlkes A, Gaglani M, Groover K, Thiese MS, Tyner H, Ellingson K (27 August 2021). "Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance — Eight U.S. Locations, December 2020–August 2021" (PDF). MMWR. Morbidity and Mortality Weekly Report. 70 (34): 1167–9. doi:10.15585/mmwr.mm7034e4. PMC 8389394. PMID 34437521. Archived (PDF) from the original on 5 February 2022. Retrieved 15 September 2021.
- Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, et al. (12 September 2020). "COVID-19 vaccine trials should seek worthwhile efficacy". The Lancet. 396 (10253): 741–743. doi:10.1016/S0140-6736(20)31821-3. ISSN 0140-6736. PMC 7832749. PMID 32861315.
WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Guidance from the US Food and Drug Administration includes this lower limit of 30% as a criterion for vaccine licensure.
- Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, et al. (April 2021). "BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting". New England Journal of Medicine. 384 (15). Table 2. doi:10.1056/NEJMoa2101765. PMC 7944975. PMID 33626250.
- Sheikh A, McMenamin J, Taylor B, Robertson C (14 June 2021). "SARS-CoV-2 Delta VOC in Scotland: demographics, risk of hospital admission, and vaccine effectiveness". The Lancet. 397 (10293). Table S4. doi:10.1016/S0140-6736(21)01358-1. ISSN 0140-6736. PMC 8201647. PMID 34139198.
- Abu-Raddad LJ, Chemaitelly H, Butt AA (5 May 2021). "Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants". New England Journal of Medicine. 385 (2). Table 1. doi:10.1056/NEJMc2104974. ISSN 0028-4793. PMC 8117967. PMID 33951357.
- Chung H, He S, Nasreen S, Sundaram ME, Buchan SA, Wilson SE, et al. (August 2021). "Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study". BMJ. 374: n1943. doi:10.1136/bmj.n1943. PMC 8377789. PMID 34417165.
Tables 6 and 7
- Collie S, Champion J, Moultrie H, Bekker LG, Gray G (December 2021). "Effectiveness of BNT162b2 Vaccine against Omicron Variant in South Africa". N Engl J Med (letter). 386 (5): 494–496. doi:10.1056/NEJMc2119270. PMC 8757569. PMID 34965358.
- Thomas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. (September 2021). "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months". The New England Journal of Medicine. 385 (19): 1761–1773. doi:10.1056/nejmoa2110345. PMC 8461570. PMID 34525277.
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