J&J Vaccine over view

this is an ongoing paper describing the J&J vaccine for covid19.

I will be adding to this as I go with excerpts from the papers themselves. My initial reaction is good for the use of this vaccine. the vaccine is a standard style vaccine as far as I can tell thus far(inactive virus in a suspended medium) as opposed to a vaccine that modifies the RnA in your body with unknown long term effects.I will be adding in my comments as I go in italicized in parens.

after reading this data so far, this vaccine appears to be safer than other vaccines. tested across the globe, and with the same efficacy as a normal vaccine(67%). there appears to be no nuerological issues. yes there maybe an issue for those that are allergic to the growing agent.

the first part of this includes excerpts from the Jansen press release of the EUA. to be found at https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf?fbclid=IwAR0HgvBeOMLuQtyZfkU06qXC-s7eQkb_rotJN7C5fb_tVFmp1KoQkW-MVeo

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF
THE JANSSEN COVID-19 VACCINE TO PREVENT CORONAVIRUS
DISEASE 2019 (COVID-19)
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization
(EUA) to permit the emergency use of the unapproved product, Janssen COVID-19 Vaccine, for
active immunization to prevent COVID-19 in individuals 18 years of age and older.

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). If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F). If
needed immediately, thaw at room temperature (maximally 25°C/77°F). At room temperature (maximally 25°C/77°F), a carton of 10 vials will take approximately 2 hours to thaw, and an
individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.

(unlike the other “vaccines” this one does not require adding suspension fluids, and comes shipped with full dose vials of 5 doses to a vial)

CONTRAINDICATION
Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine (see Full
EUA Prescribing Information).

Severe allergic reactions, including one case of anaphylaxis in an ongoing open-label study in South Africa, have been reported following the Janssen COVID-19 vaccine administered in
clinical studies.

. A total of 43,783 individuals were enrolled in this study, of whom 21,895 adults aged 18 years and older received the Janssen COVID-19 Vaccine .The safety subset includes 6,736 individuals

Urticaria (all non-serious) was reported in five vaccinated individuals and 1 individual who received placebo in the 7 days following vaccination.

 

(What is urticaria?

Urticaria is also called hives. Hives can change size and shape, and appear anywhere on your skin. They can be mild or severe and last from a few minutes to a few days. Hives may be a sign of a severe allergic reaction called anaphylaxis that needs immediate treatment. Urticaria that lasts longer than 6 weeks may be a chronic condition that needs long-term treatment.)

In addition, an SAE of hypersensitivity, not
classified as anaphylaxis, was reported in 1 vaccinated individual with urticaria beginning two days following vaccination and angioedema of the lips with no respiratory distress beginning
four days following vaccination. The event was likely related to the vaccine.

• Thromboembolic events:
• Deep vein thrombosis: 6 events (2 serious; 5 within 28 days of vaccination) vs.
2 events (1 serious; 2 within 28 days of vaccination).
• Pulmonary embolism: 4 events (3 serious; 2 within 28 days of vaccination) vs. 1 event
(serious and within 28 days of vaccination).
• Transverse sinus thrombosis: 1 event (serious and within 28 days of vaccination) vs.
0.
• Seizures: 4 events (1 serious; 4 within 28 days of vaccination) vs. 1 event (0 serious and
0 within 28 days following vaccination).
• Tinnitus: 6 events (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of
vaccination) vs. 0.

(these dont sound too serious compared to the numbers of 21k injections, though the tinitus is a strange one. and these appear at first glance to be less than the other “vaccines”)

(this is the important part, what is actually in the vaccine)

13 DESCRIPTION
The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent sterile suspension for intramuscular injection. It contains no visible particulates. 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.

(This vaccine called Ad26.COV2.S uses some genetic material from the SARS-CoV-2 virus. More precisely, it uses the genetic code to make the spike protein, the protrusions that can be seen on the surface of the virus. The spike protein is used by many vaccines since this is what the virus uses to bind with human cells and initiate infection.)

(Adenoviruses are common viruses that cause a range of illness. They can cause cold-like symptoms, fever, sore throat, bronchitis, pneumonia, diarrhea, and pink eye (conjunctivitis).)

The Ad26 vector expressing the SARS-CoV-2 S protein is grown in PER.C6 TetR cells

(The PER.C6 cell line is derived from human embryonic retinal cells, originally from the retinal tissue of an 18 week old fetus aborted in 1985, PER.C6 cells grow well in suspension serum-free culture that is free of any animal-derived protein)(note from the readings I have done, no further children were killed after the initial cell line was cultured. I could be wrong but that is what I saw)

, in 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 5×1010 virus particles (VP) and the following inactive ingredients: citric acid monohydrate (0.14 mg), trisodium citrate
dihydrate (2.02 mg), ethanol (2.04 mg), 2-hydroxypropyl-β-cyclodextrin (HBCD) (25.50 mg), polysorbate-80 (0.16 mg), sodium chloride (2.19 mg). Each dose may also contain residual
amounts of host cell proteins (≤0.15 mcg) and/or host cell DNA (≤3 ng).(emp. added)
Janssen COVID-19 Vaccine does not contain a preservative.

The Janssen COVID-19 Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector (not an mRnA but an inactive virus)that, after entering human cells, expresses the SARS-CoV-2 spike (S)
antigen without virus propagation. An immune response elicited to the S antigen protects against
COVID-19.

The median length of follow up for efficacy for individuals in the study was 8 weeks postvaccination. Vaccine efficacy for the co-primary endpoints against moderate to severe/critical
COVID-19 in individuals who were seronegative or who had an unknown serostatus at baseline
was 66.9% (95% CI: 59.0; 73.4) at least 14 days after vaccination and 66.1% (95% CI: 55.0; 74.8)
at least 28 days after vaccination (see Table 6).

(looking at the tables and stuff, it appears to be effective on the known variants of covid)

The EUA follows a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021.

(as compared to the pfizer which had 4 members not recommending it)

I found the following-from

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee | Johnson & Johnson (jnj.com)

Johnson & Johnson is committed to making its COVID-19 vaccine candidate available on a not-for-profit basis(eph added) for emergency pandemic use. The Company is prepared to supply its vaccine immediately upon EUA and expects to deliver enough single-dose vaccine candidate by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-dose vaccines to the U.S. during the first half of 2021.

Johnson & Johnson’s COVID-19 Vaccine Candidate
The Company’s Janssen COVID-19 Vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.

The trial, conducted in eight countries across three continents, includes a diverse and broad population, including 34% of participants over age 60.

The study enrolled 44% of participants in the United States. Seventy-four percent of participants in the U.S. are White/Caucasian; 15% are Hispanic and/or Latinx; 13% are Black/African American; 6% are Asian and 1% are Native American.

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.

Research and development activities for the Janssen COVID-19 vaccine candidate, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have been funded with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).

(iow: this vaccine was fully funded already and will not cost anything)

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