Jcovden® Janssen COVID-19 Vaccine 2023
The Jcovden® COVID-19 Vaccine (Ad26.COV2.S) is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized the SARS-CoV-2 spike protein. This Janssen-produced U.S. Food and Drug Administration (FDA)-authorized COVID-19 vaccine does not contain adjuvants, preservatives, materials of animal origin, or fetal tissue.
The viral vector used in the Jcovden Janssen - Johnson & Johnson (J&J) COVID‑19 Vaccine is based on a naturally occurring, low-prevalence human adenovirus known to cause common cold-like symptoms. Deleting a specific gene renders the adenovirus unable to replicate within humans, transforming it into a delivery vehicle for the genetic material encoding the spike protein of the SARS-CoV-2 betacoronavirus. In this form, the vaccine cannot cause COVID‑19 or adenoviral disease.
The Jcovden vaccine leverages Janssen's AdVac and PER.C6® technologies. Janssen's AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified. The AdVac® technology works by using an adenovirus as a vector of an antigen's genetic code to mimic components of a pathogen. The AdVac viral vector technology can induce potent and long-lasting humoral and cellular immune responses, enabling the pursuit of vaccines for disease targets currently unpreventable or untreatable.
Johnson & Johnson announced that the U.S. FDA issued an Emergency Use Authorization (EUA) on February 27, 2021, for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies. On October 20, 2021, the FDA authorized a single booster dose of the Janssen COVID-19 Vaccine, and the FDA authorized a heterologous booster dose for currently available COVID-19 vaccines. On February 11, 2022, the U.S. Centers for Disease Control and Prevention (CDC) issued new guidance for those who received the Jcovden Janssen COVID-19 Vaccine primary series should receive an additional dose and a booster dose for a total of 3 doses to be classified as up to date. And on March 29, 2022, the CDC stated, 'Adult Janssen primary vaccine (2-doses) recipients should preferentially receive a heterologous mRNA vaccine booster dose ≥ two months later.'
The World Health Organization (WHO) Listed the Jcovden COVID-19 vaccine for emergency use in all countries on March 12, 2021. The U.K. granted marketing authorization for the Janssen Covid-19 vaccine on May 28, 2021, and updated it on November 3, 2022. In addition, the European Medicines Agency (EMA) published the latest clinical data EMEA/H/C/005737/II/0033; the EMA overview is found at this link. The authorization or approval status of the Jcovden COVID-19 vaccine varies by country. This country list is updated as additional information becomes available.
The Janssen COVID-19 (Ad26.COV2.S) Vaccine Accession Number: DB15857; Unique Ingredient Identifier: JT2NS6183B. Anatomical therapeutic chemical code J07BX03; KEGG: D12129. The FDA letter of authorization and revised fact sheets are available on the FDA's website and www.janssencovid19vaccine.com.
Janssen Biotech Inc. is a Janssen Pharmaceutical Company of Johnson & Johnson, located in New Jersey, USA. - JNJ-78436735, Ad26COVS1, VAC31518. U.S. FDA Concurrence Letter and FAQs. For more information on the Johnson & Johnson Janssen COVID-19 vaccine, visit JnJ.com. J&J and Janssen continue developing the single-dose COVID-19 vaccine per ethical standards and sound scientific principles. The European Union Intellectual Property Office assigned the JCOVDEN trademark Application Number #018320883. Learn more at Janssen.com.
The Jcovden vaccine is administered as a single (0.5 mL) vaccination.
A single booster dose is recommended at least two months after the second (additional) dose, for a total of 3 doses (1 Janssen vaccine dose followed by one additional mRNA vaccine dose, then one booster dose). mRNA vaccines are preferred for the booster dose. If the Moderna vaccine is used for the booster dose, a 50 µg (0.25 ml) dose should be used.
Jcovden Side Effects
On March 14, 2023, the U.S. FDA revised the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine to include a Warning conveying that reports of adverse events following the use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The FDA stated on May 5, 2022, an updated analysis of Thrombosis and Thrombocytopenia Syndrome (TTS) cases following the administration of the Jcovden Vaccine that was reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. Therefore, the FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered, and the reporting rate of TTS was 0.48 per million doses of vaccine administered.
The EMA's medicines safety committee recommended on April 3, 2022, that small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin, which may result in a rash, pointed or flat, red spots under the skin's surface, and bruising) should be added to the product information of COVID-19 Vaccine Janssen as a possible side effect of unknown frequency. The EMA published its monthly safety update confirming 45,947 suspected side effects, and 308 of these reported a fatal outcome in the EU/EEA. The EMA Fact Sheet was updated.
In addition, the most commonly reported side effects were pain injection site, headache, fatigue, muscle aches, and nausea. Most of these side effects occurred within 1-2 days following vaccination, were mild to moderate, and lasted 1-2 days, stated Janssen's August 2, 2021 update. Anyone with an acute febrile illness (body temperature over 38.5 ºC) should postpone vaccination until they are afebrile. A history of anaphylaxis to any vaccine component is a contraindication to vaccination.
On February 27, 2021, the U.S. FDA issued an emergency use authorization (EAU) enabling the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. Furthermore, on March 11, 2021, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a Positive Opinion to recommend the Conditional Marketing Authorization for its single-dose COVID-19 vaccine candidate, EMEA/H/C/005737, developed by the Janssen Pharmaceutical Companies of J&J, to prevent COVID-19 in individuals 18 years of age and older.
The WHO recommends using the Jcovden vaccine in pregnancy only if the benefits of vaccination to pregnant women outweigh the potential risks.
The Janssen COVID-19 Vaccine includes the following ingredients: recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80, sodium chloride.
Jcovden Cold Storage
The U.S. FDA confirmed on April 18, 2022, the Janssen COVID-19 Vaccine shelf life and Expiry Date: Please verify at https://vaxcheck.jnj
January 23, 2023 - J&J reported a reduction in Jcovden vaccine revenues.
July 19, 2022. - J&J reported contributing to growth were sales of the Jcovden Janssen COVID-19 Vaccine (Ad26.COV2.S) for the prevention of the SARS-CoV-2 virus.
April 19, 2022 - The Company suspended its COVID-19 vaccine sales guidance, citing "global supply surplus and demand uncertainty." According to the J&J earnings release, reported sales of the Janssen COVID-19 vaccine in the U.S. totaled $75 million during Q1 2022, down $25 million compared to Q1 2021.
Jcovden News For 2021 - 2022
December 20, 2022 - UNICEF delivered 100,000 doses of the Jcovden vector-based vaccine to Ukraine as part of the COVAX international initiative. In August 2022, Ukraine received the first shipment of 100,000 doses of Jcovden vaccines.
August 10, 2022 - The JAMA Network published - The durability of Heterologous and Homologous COVID-19 Vaccine Boosts. Conclusions and Relevance Heterologous Ad26.COV2.S boosting was associated with durable humoral and cellular immune responses in individuals who originally received the BNT162b2 vaccine. These data suggest the benefits of heterologous prime-boost vaccine regimens for SARS-CoV-2.
May 25, 2022 - The peer-review journal The JAMA published a Correspondence - Effectiveness of Homologous and Heterologous Covid-19 Boosters against Omicron. For persons who received a single dose of the Ad26.COV2.S vaccine (Johnson & Johnson–Janssen) against Covid-19, a booster dose of an mRNA vaccine at least two months after the primary dose, is recommended.
April 1, 2022 - CDC reported: Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults — VISION Network, 10 States, December 2021–March 2022.
January 14, 2022 - France's HAS announced that the Janssen COVID-19 vaccine represents an effective alternative and has positioned it in its vaccine strategy.
Dits021 - The EMA confirmed human medicines committee concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at least two montmightafter the first dose in adults. This committee also concluded that a booster dose with COVID-19 Vaccine Janssen might be the even after two doses of one of the mRNA vaccines.
November 24, 2021 - The Janssen Pharmaceutical Companies of J&J announced Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
October 21, 2021 - Johnson & Johnson announced that the U.S. CDC's ACIP recommended its Janssen COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine.
October 12, 2021 - The U.S. FDA VRBPAC Briefing Document was posted ahead of the U.S. FDA vaccine commbeforeeting scheduled for 10/14/21.
July 12, 2021 - The U.S. FDA issued a revised EUA regarding vaccine side effects: 'Reports of adverse events following use of the JanssenCOVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.'
April 20, 2021 - Johnson & Johnson announced that the European Medicines Agency's Pharmacovigilance Risk Assessment Committee has provided updated guidance for using the Company's COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. Accordingly, following the PRAC recommendation, the Company will resume the Janssen COVID-19 vaccine shipment in the European Union, Norway, and Iceland.
February 27, 2021 - The U.S. FDA announced it issued an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The FDA determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuing a EUA.
December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: our poskim conclude that, according to the advice of your personal health care provider, the Toation to preserve our lives and the lives of others requires us to vaccinate for COVID-19 as soon as a vaccine becomes available.
October 8, 2020 - Johnson & Johnson announced the European Commission, acting on behalf of the European Union (E.U.) the Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to the E.U. Member States following approval or authorization from regulators.
March 30, 2020 - Johnson & Johnson identified a lead COVID-19 vaccine candidate (with two back-ups), progressing into the first manufacturing steps.
Jcovden COVID-19 Vaccine Clinical Trials
Janssen is investigating multiple dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy. Click here to review the current clinical trials.