Thematic Analysis

Janssen COVID-19 Vaccine Investigation

Investigation document: Janssen COVID-19 Vaccine Investigation

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JANSSEN COVID-19 VACCINE INVESTIGATION

Investigation Date: December 26, 2025

VACCINE INFORMATION

| Field | Value |

|-------|-------|

| Vaccine Name | Ad26.COV2.S |

| Brand Name | Janssen COVID-19 Vaccine |

| Manufacturer | Janssen Pharmaceuticals (J&J subsidiary) |

| Type | Viral Vector (Adenovirus 26) |

| Doses | Single dose |

| Authorization | FDA Emergency Use Authorization (February 27, 2021) |

PATENT INFORMATION

Key Patent

| Field | Value |

|-------|-------|

| Patent Number | WO2021155323A1 |

| Title | Compositions and methods for preventing and treating coronavirus infection |

| Type | World Intellectual Property Organization (WIPO) |

| Assignee | Janssen Pharmaceuticals |

HHS Contract

According to HHS Contract (October 31, 2020):

> "Ad26.COV2.S has been shown to induce high levels of neutralizing antibodies against SARS-CoV-2 after immunization with a single dose"

BLOOD CLOT / PLATELET SIDE EFFECTS

Thrombosis with Thrombocytopenia Syndrome (TTS)

According to Yale Medicine (May 17, 2023):

> "The clotting condition associated with the J&J vaccine is called thrombosis with thrombocytopenia (TTS). Thrombosis occurs when blood clots form in blood vessels"

CDC Report (2022)

According to CDC MMWR (2022):

> "Cases of thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome have been reported after receipt of Janssen COVID-19 vaccine"

FDA Safety Concern

According to PMC9149044 (Woo, 2022):

> "The FDA has identified a potential safety concern for thrombocytopenia following receipt of Ad.26.COV2.S COVID-19 vaccine"

J&J Official Update (May 5, 2022)

According to Johnson & Johnson press release:

> "Blood clots with low levels of platelets following the Janssen COVID-19 Vaccine have been reported in males and females, across a wide age range"

MECHANISM OF HARM

Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT)

According to American Society of Hematology (May 9, 2022):

> "Patients with isolated thrombocytopenia and continued absence of thrombosis may have post-vaccine ITP and not VITT"

According to PMC10423859 (Sharif-Kashani, 2022):

> "They concluded that the vaccines can result in a rare syndrome that clinically mimics autoimmune heparin-induced thrombocytopenia (aHIT)"

Key Features of TTS

  • Thrombosis - blood clots in unusual locations
  • Thrombocytopenia - low platelet count
  • Primarily affects women
  • Can be fatal

CLINICAL TRIAL DATA

ENSEMBLE Trial (Phase 3)

According to Nature (Magaret, 2024):

> "In the ENSEMBLE randomized, placebo-controlled phase 3 trial (NCT04505722), estimated single-dose Ad26.COV2.S vaccine efficacy (VE) was 56% against moderate to severe COVID-19"

Phase 1 Study

According to JAMA (Stephenson, 2021):

> "A single immunization with Ad26.COV2.S induced rapid binding and neutralization antibody responses as well as cellular immune responses"

REGULATORY ACTIONS

FDA Pause (April 2021)

  • FDA and CDC recommended a pause in use of Janssen vaccine
  • Reason: Reports of rare blood clots with low platelets

Resumed Use with Warning

  • Vaccine use resumed with updated warnings
  • Fact sheet updated to include TTS risk

COMPARISON TO OTHER COVID VACCINES

| Vaccine | TTS Risk | Type |

|---------|----------|------|

| Janssen (J&J) | YES - documented | Viral vector |

| AstraZeneca | YES - documented | Viral vector |

| Pfizer-BioNTech | No TTS | mRNA |

| Moderna | No TTS | mRNA |

KEY SCIENTIFIC REFERENCES

  • Stephenson et al. (2021) - JAMA - Phase 1 immunogenicity study
  • Oliver et al. (2022) - CDC MMWR - Use recommendations
  • Shay et al. (2021) - CDC MMWR - Safety monitoring
  • Woo et al. (2022) - PMC - Thrombocytopenia after vaccine
  • Sharif-Kashani et al. (2022) - PMC - Vaccine-induced thrombosis

JANSSEN BLOOD CLOT TREATMENT: XARELTO

CRITICAL FINDING

Janssen/Johnson & Johnson manufactures BOTH:
  • A vaccine (Ad26.COV2.S) that CAUSES blood clots (TTS)
  • A drug (Xarelto) that TREATS blood clots

XARELTO (Rivaroxaban) INFORMATION

| Field | Value |

|-------|-------|

| Drug Name | Xarelto |

| Generic Name | Rivaroxaban |

| Manufacturer | Janssen Pharmaceuticals, Inc. |

| Type | Oral anticoagulant (blood thinner) |

| US Sales (2024) | ~$2.4 billion |

| Partner | Bayer AG |

Approved Uses

  • Reduce risk of blood clots after knee/hip replacement
  • Treatment of venous thromboembolism (VTE)
  • Reduction in risk of recurrent VTE
  • Reduce risk of stroke in atrial fibrillation
  • Reduce risk of major thrombotic vascular events

PATENT INFORMATION

Key Patents

| Patent | Description |

|--------|-------------|

| US 7,157,456 | Original rivaroxaban disclosure |

| US 9,598,403 B2 | Process for preparation of rivaroxaban |

Patent Status

According to Bloomberg (July 13, 2018):

> "Bayer AG and Johnson & Johnson won a judge's ruling that upheld the validity of a patent on the blood-thinning drug Xarelto"

Generic Entry

According to PharmaPhorium (March 5, 2025):

> "The FDA has approved the first generic versions of Johnson & Johnson's big-selling anticoagulant Xarelto, which brought in nearly $2.4 billion in US sales last year"

THE BUSINESS MODEL CONNECTION

The Cycle

  • Janssen develops COVID-19 vaccine (Ad26.COV2.S)
  • Vaccine causes rare blood clots (TTS - Thrombosis with Thrombocytopenia)
  • Janssen also manufactures Xarelto - a blood clot treatment
  • Patients who develop clots may need Xarelto or similar drugs

Revenue Streams

| Product | Annual Revenue |

|---------|---------------|

| Xarelto | ~$2.4 billion (US) |

| COVID-19 Vaccine | Government contracts |

PEDIATRIC EXPANSION

According to J&J Press Release (June 23, 2021):

> "Janssen Submits New Drug Application to U.S. FDA for XARELTO (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients"

The NDA seeks:

  • Treatment of venous thromboembolism (VTE) in children
  • Reduction in risk of recurrent VTE in pediatric patients

SUMMARY: DISEASE AND TREATMENT PATENTS

| Category | Product | Patent Status |

|----------|---------|---------------|

| Causes Blood Clots | Ad26.COV2.S Vaccine | WO2021155323A1 |

| Treats Blood Clots | Xarelto (rivaroxaban) | US 7,157,456, US 9,598,403 |

Janssen holds patents on BOTH the cause AND the treatment.