Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Food and Drug Administration (FDA), Feb 27, 2021. https://www.fda.gov/media/146304/download
Quote:
"The Janssen COVID-19 Vaccine is a suspension for intramuscular injection administered as a single dose (0.5 mL)." (boldface original).
"Storage Prior to First Puncture of the Vaccine Vial[:] Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to 46°F) and protect from light. Do not store frozen. Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours. The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2°C to 8°C (36°F to 46°F). * * *
"Dosing and Schedule[:] * * * There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 Vaccine.
"WARNINGS[:] Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Janssen COVID-19 Vaccine.
"FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION[:] * * * 13 DESCRIPTION[:] * * * The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein in a stabilized
conformation. The Ad26 vector expressing the SARS-CoV-2 S protein is grown in PER.C6 TetR cells, in [culture] media containing amino acids and no animal-derived proteins. After propagation, the vaccine is processed through several purification steps, formulated with inactive ingredients and filled into vials. Each 0.5 mL dose of Janssen COVID-19 Vaccine is formulated to contain 5×10 (superscript 10) virus particles (VP) * * *
"18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA[:] An ongoing, multicenter, randomized, double-blind, placebo-controlled Phase 3 Study (COV3001) (NCT04505722) is being conducted in the United States, South Africa, Brazil, Chile, Argentina, Colombia, Peru and Mexico to assess the efficacy, safety, and immunogenicity of a single-dose of the Janssen COVID-19 Vaccine for the prevention of COVID-19 in adults aged 18 years and older. * * * A total of 44,325 individuals were randomized equally to receive Janssen COVID-19 Vaccine or saline placebo. Individuals are planned [note 'planned'] to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. * * * Efficacy Against COVID-19[:] * * * The co-primary endpoints evaluated the first occurrence of moderate to severe/critical COVID-19 with onset of symptoms at least 14 days and at least 28 days after vaccination. * * * Table 6: '% Vaccine
Efficacy (95% CI)'[:] 66.9 (59.0; 73.4) * * *
Note:
(a)
(i) On Feb 27, 2021 FDA issued Emergency Use Authorization (EUA), which (for emergency use only) is not the same as approval. So far FDA has issued three EUAs, the other two to Pfizer/BioNTech and Moderna (in that order).
(ii) There is no need to read the rest of this EUA.
(b)
(i) In nature, adenovirus contains a linear double-stranded DNA and might -- just might (so infected persons display no symptoms) cause common cold.
(ii) Johnson & Johnson's vaccine consists of an adenovirus (protein) shell -- as opposed to Coronavirus shell (in part because a lot of research has been done on adenovirus -- with a double-stranded DNA containing genes for Covid-19 spike protein (S) as well as genes to make adenovirus shell.
(c) Johnson & Johnson vaccine has vaccine research and future production at Janssen Pharmaceuticals https://en.wikipedia.org/wiki/Janssen_Pharmaceuticals
(was founded in 1953 by Paul Janssen [in Belgium; who discovered many drugs]; was acquired in 1961 by Johnson & Johnson; current headquarters: Beerse, Belgium (20-mile air distance east of Antwerp, Belgium)
(d) PER.C6 TetR cells are PER.C6 cells modified with TetR.
(i) TetR stands for Tetracycline repressor.
(A) Gomez-Martinez A et al, Generation of Stable Human Cell Lines with Tetracycline-inducible (Tet-on) shRNA or cDNA Expression. Journal of Visualized Experiment 73:50171 (2013) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3622098/
("researchers have adapted the Tetracycline repressor protein (TetR), taken from the E. coli tetracycline resistance operon, to generate very efficient and tight regulatory systems to express cDNAs in mammalian cells")
(B) "TetR is used in artificially engineered gene regulatory networks because of its capacity for fine regulation of promoters. In the absence of Tc [tetracycline] or analogs like ATc, basal expression of TetR-regulated promoters is low, but expression rises sharply in the presence of even a minute quantity of Tc." en.wikipedia.org for "TetR."
What these two say is TetR is a gene coming from E coli 大肠杆菌. This gene amplifies the control of another gen that is the key interest of us. Absent of the antibiotic tetracycline, the gene of our interest produces nothing. However, a trace of racycline will trigger our gene in mass production.
(ii) PER.C6
(A) Gina Kirschweger, Crucell: Biopharmaceuticals-As Human as They Get. Molecular Therapy 1: 5-6 (2003) https://www.cell.com/molecular-t ... fulltext/S1525-0016(02)00045-X
("the Dutch company Crucell, founded in June 2000 and headquartered in Leiden. It was formed through a merger between the Dutch biotech companies IntroGene and UbiSys, which combined IntroGene's human producer cell line, PER.C6, with UBiSys' subtractive phage antibody display selection technology, called MAb'stract, with the officially stated goal to make biotherapeutics 'as human as possible.' * * * PER.C6 cells are immortalized primary human embryonic retinal cells engineered to express Ad 5 E1A and E1B")
(B) Lewis JA et al, Approaches to the Release of a Master Cell Bank of PER.C6 Cells; a Novel Cell Substrate for the Manufacture of Human Vaccines.
Developmental Biology (Basel), 123: 165 (2006) https://pubmed.ncbi.nlm.nih.gov/16566444/
("The PER.C6 cell line was developed at Crucell by the transfection of human primary embryonic retinoblasts with a transgene of E1 constructed with a minimum of E1 coding sequences to preclude homologous recombination generating replication-competent adenovirus, between E1 sequences in PER.C6 and adenovirus vectors with E1 deletions of the same molecular coordinates")
What the preceding two state is this: PER is the acronym for primary embryonic retinoblasts. (Retinoblasts are precursors of retina cells.) All normal animal cells die, but cancerous cells may live forever in artificial environments -- eg, cell culture. Primary cells are normal cells taken from a living things (animal or plant); to make these cells immortal, cancer genes are introduced somehow to the cells (there are many ways).
PER.C6 cells are immortal. More than that, these cells contain E1A and E1B regions of an adenovirus. Because of which the adenovirus vector biologists engineer are intentionally design to lack E1A and E1B, so that these genetically engineered adenovirus will not escape to cause harm to humans. The E is short for early; E1A, E1B, E2, E3 and E4 regions of adenovirus are activated, to produce from these regions proteins that in turn activate production of later-stage viral genes, soon after the virus infects a host.
That alludes to normal distribution 正态分布 with mean of 66.9 and 95% confidence interval from 59.0 to 73.4. 作者: choi 时间: 3-3-2021 13:09
There are several ways to create Covid-19 vaccines.
(1) mRNA for Spike protein: Pfizer/BioNTech; Moderna
(2) vector (adenovirus) containing a double-stranded DNA for S protein only: Johnson & Johnson, Russian (Gamaleya National Research Centre for Epidemiology and Microbiology (NRCEM) ); University of Oxford/AstraZeneca
(3) inactivated Covid-9 virus: SinoVac Biotech Ltd 北京科兴生物制品有限公司
(4) recombinant protein (full-length S protein) together an adjuvant: CoVax (also known as NovaVax) of World Health Organization. Adjuvant makes possible a much smaller dose of protein (which functions as antigen) will create the same effect as larger dose of protein without adjuvant.
Separately I receive the first dose of Moderna vaccine on Feb 17, 2021, to be vaccinated for the second dose four weeks later on Mar 17. I got vaccination early than the population because I live in a homeless shelter. My destination is only 5% of homeless population are willing to be vaccinated.
Massachusetts governors permitted vaccination firstly on Long-term care facilities (nursing homes) and first responders (healthcare providers: doctors, nurses and other hospital workers), police and firefighters. Starting the week of Martin Luther King Day were the second wave of vaccination: prisoners and homeless people in shelters. Followed by people 75 years old and older. Next were 60 years old and older, or people with co-mobilities; Massachusetts are in this stage. School teachers have not been included so far. 作者: choi 时间: 3-3-2021 13:19
Kevin McGill, Catholic Leaders Warn Against 'Morally Compromised' Johnson & Johnson COVID-19 Vaccine. Associated Press, Mar 3, 2021
(paragraph 1: "Roman Catholic leaders in St Louis, New Orleans and elsewhere are advising Catholics that the COVID-19 vaccine from Johnson & Johnson, newly approved for use in the US, is 'morally compromised' because it is produced using a cell line derived from an aborted fetus")
That alludes to PER.C6 cell lines. (A cell LINE is always immortal.) That can not be helped. Come on, where else can one obtain retinoblast cells -- the immature retina calls still dividing. Once a person is born, retina cells (like those in brain or heart) do not divide anymore.