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Janssen COVID-19 Vaccine

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October 21, 2021
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Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Description

The Johnson & Johnson Janssen COVID-19 Vaccine (Ad26.COV2.S, JNJ-78436735Ad26COVS1VAC31518) is composed of a recombinant, replication-incompetent human adenovirus type 26 vector 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 viral vector used in Johnson & Johnson's Janssen COVID‑19 Vaccine is based on a naturally occurring, low-prevalence human adenovirus known to cause common cold-like symptoms. The deletion of 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 Janssen COVID‑19 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 Janssen 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. These are the same technologies Janssen used to develop and manufacture its Ebola vaccine regimen.

Johnson & Johnson (J&J) and Janssen continue developing their single-dose COVID-19 vaccine per ethical standards and sound scientific principles.

On September 21, 2021, J&J announced that a non-peer-reviewed study found the second dose of the Janssen COVID-19 vaccine administered two months after the first dose increases its effectiveness against moderate to severe disease to 94%. The booster 2nd dose was also found well-tolerated. J&J also said that antibody levels quadrupled when a booster dose was administered at 56 days, while they jumped 12-fold when the booster was given at six months. Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, stated in a press release, "Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases."

The Janssen COVID-19 Vaccine may not protect everyone. Therefore, this Fact Sheet may have been updated. For the most recent Fact Sheet, please visit www.janssencovid19vaccine.com. In addition, the EMA Fact Sheet has also been updated.

The U.S. FDA published an update on Johnson & Johnson's Janssen COVID-19 Vaccine Overview on October 20, 2021, including a renewed Concurrence Letter and FAQs.

The NEJM published a Correspondence on October 15, 2021: Findings - These data show differential kinetics of immune responses induced by the mRNA and Ad26.COV2.S vaccines over an 8-month follow-up period. And the Ad26.COV2.S vaccine-induced lower initial antibody responses, but these responses were relatively stable over the 8-month follow-up period, with minimal-to-no evidence of decline.

The Janssen COVID-19 (Ad26.COV2.S) Vaccine Accession Number: DB15857; Unique Ingredient Identifier (UII): JT2NS6183B.  Anatomical therapeutic chemical code J07BX03. The European Medicines Agency overview is found at this linkJanssen Biotech Inc. is a Janssen Pharmaceutical Company of Johnson & Johnson, located in New Jersey, USA.

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) History

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. An amended (EAU) was issued on April 23, 2021. In addition, Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, published July 13, 2021, Addendum #3 (for Area 2, batch GMP12) to the June 11, 2021 memorandum entitled "Assessment of Certain Janssen COVID-19 Vaccine Batches".

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.

J&J announced on March 12, 2021, that the World Health Organization had issued Emergency Use Listing for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. On April 23, 2021, J&J confirmed Janssen vaccine shipments in the USA would resume after an eleven-day 'pause.'

On June 23, 2021, the U.S. CDC published an update to 'J&J's Janssen COVID-19 Vaccine Overview and Safety, which stated 'women younger than 50 years old should especially be aware of the rare risk of blood clots with low platelets after vaccination.'

Johnson & Johnson announced on October 15, 2021, the U.S. FDA Vaccines and Related Biological Products Advisory Committee (ACIP) voted 19-0 to recommend EUA for a booster dose of the Johnson & Johnson Janssen COVID-19 vaccine for adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine. On October 21, Janssen presented: Booster Dose of Janssen COVID-19 Vaccine (Ad26.COV2.S) Following Primary Vaccination during the ACIP meeting.

For more information on Johnson & Johnson's Janssen COVID-19 approach to combatting the pandemic, visit JnJ.com. Learn more at Janssen.com.

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Authorization

The Janssen COVID‑19 Vaccine has not been Approved or licensed by the U.S. FDA. Still, the FDA has Authorized the Janssen COVID-19 vaccine through a EUA for active immunization to prevent COVID‑19 in individuals 18 years of age and older, as of October 20, 2021. On March 11, 2021, the European Medicines Agency recommended granting a conditional marketing Authorization for COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of age. In addition, the UK has authorized a third dose of the Janssen COVID-19 vaccine for teenagers. The WHO interim recommendations updated on June 15, 2021, on the use of the Janssen COVID-19 vaccine were developed based on advice issued by the Strategic Advisory Group of Experts on Immunization. And Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Center for the FDA's Biologics Evaluation and Research issued a EUA Concurrence Letter on July 28, 2021.

Additionally, the African Regulatory Taskforce and WHO have confirmed their authorizations.

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Variants of Concern

A study published by the NEJM on July 14, 2021, showed a single dose of the J&J COVID-19 vaccine Janssen generated neutralizing antibodies against a range of SARS-CoV-2 variants of concern, which increased over time (the average neutralizing titer at eight months exceeded that average at 29 days), including against the increasingly prevalent and more transmissible Delta (B.1.617.2) variant, the partially neutralization-resistant Beta (B.1.351), the Gamma (P.1) variants and others, including the Alpha (B.1.1.7), Epsilon (B.1.429), Kappa (B.1.617.1) and D614G variants, as well as the original SARS-CoV-2 strain (WA1/2020).

"Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane; rather, we observe an improvement over time. In addition, we observe a persistent and particularly robust, durable cellular immune response," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, J&J.

Janssen COVID-19 Vaccine Adolescent (Johnson & Johnson) (Ad26.COV2.S) Indication

The Janssen's COVID-19 vaccine is indicated to prevent infection from SARS-CoV-2 coronavirus, which leads to COVID-19 disease in humans. SARS-CoV-2 belongs to a group of viruses called coronaviruses that attack the respiratory system. Therefore, on May 14, 2021, the U.S. FDA said not to 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).

Whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

On April 2, 2021, J&J confirmed vaccinating adolescent participants in the ongoing Phase 2a clinical trial. The randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) has been ongoing since September 2020. The study now includes adolescents 12 to 17 years of age.

Janssen COVID-19 Vaccine Adolescent (Johnson & Johnson) (Ad26.COV2.S) Use For Pregnant or Lactating Women

Pregnancy: Available data on Janssen COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Lactation: Data are not available to assess the effects of the Janssen COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Dosage

J&J vaccine Ad26COVS1 is administered as a single (0.5 mL) vaccination. The phase 3 ENSEMBLE study evaluated the safety and efficacy of a single vaccine dose of Janssen COVID-19. There are no data available on using the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 vaccine.

The VRBPAC committee unanimously voted on October 15, 2021, recommending the U.S. FDA Authorize a second vaccine dose, either a booster or expanding the primary vaccination series to 2-doses.

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Booster (2nd) Dose

On Oct. 14 and 15, 2021, the U.S. FDA advisory committee will meet to discuss the use of booster doses of the Janssen COVID-19 Vaccine. The VRBPAC issued a report on October 13, 2021, stating, 'The safety database to support the use of a booster dose comes primarily from study COV3009, with smaller contributions from studies COV1001, COV1002, and COV2001. The total number of exposed subjects is 8049. The analyses of reactogenicity data during the seven days post-booster and the unsolicited AEs within 28 days post-booster do not appear significantly different from those for the single-dose primary vaccination and do not raise new safety concerns. The limitations of these data include the length of the follow-up (median of 36 days of blinded follow-up post-dose 2 in study COV3009), and limited safety data are available for a booster dose administered six months after the primary dose (N=17). While the overall size of the database (N=8049) may not be adequate to characterize infrequently occurring serious adverse events, the Sponsor has presented a plan (currently under review by FDA) to continue monitoring safety events following administration of a booster dose if Authorization is granted.

On October 20, 2021, the FDA issued its Authorization.

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Ingredients 

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.

Janssen COVID1-9 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Side Effects

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 and were mild to moderate in severity and lasted 1-2 days, stated Janssen's August 2, 2021 update.

On May 11, 2021, the CDC stated, 'women younger than 50 years old especially should be aware of the rare risk of blood clots with low platelets after vaccination, and that other COVID-19 vaccines are available where this risk has not been seen.' Finally, on July 12, 2021, U.S. FDA issued a Letter to Janssen stating, 'This letter is to notify you that we have reviewed your requested changes and data to support revisions to your Authorized EUA Fact Sheets, as well as FDA-required changes to include new information about Guillain-Barré syndrome and that your request is granted.'

The WHO published updated findings on May 19, 2021, which concluded by saying, 'Based on a careful scientific review of the available information, the subcommittee came to the following conclusions and recommendations the benefits of the J&J COVID-19 vaccine continue to outweigh the risks of thrombocytopenia syndrome.'

On June 7, 2021, the EMA's COVID-19 task force (COVID-ETF) began advising healthcare professionals in the EU to consider recommendations by learned societies when assessing people with signs and symptoms of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Janssen COVID-19. On August 6, 2021, the EMA published recommended updating the product information of COVID-19 Vaccine Janssen to include immune thrombocytopenia as an adverse reaction and a warning to alert healthcare professionals. In addition, the EMA published an update on the safety of COVID-19 Vaccine Janssen on October 1, 2021. On October 6, 2021, the EMA confirmed 23,455 reports of suspected side effects in the EU/EEA.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. However, anyone can submit a report to VAERS, including parents and patients. In addition, healthcare providers are required by law to report to VAERS.

Janssen  COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) CPT Code

The American Medical Association offers resources to help identify the appropriate CPT code.

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Distribution Agreements

The authorization or approval status of Janssen's COVID-19 vaccine varies by country, says the EMA. Unless approved or licensed by the relevant health authority, the product is investigational, and its safety and efficacy have not been established. This country listing will be updated as additional information becomes available. The European Commission granted conditional marketing authorization for the COVID‑19 vaccine developed by Janssen Pharmaceutica NV on March 11, 2021.

The U.S. FDA authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months on June 10, 2021. The decision is based on data from ongoing stability assessment studies, demonstrating that the vaccine is stable at 4.5 months when refrigerated at 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius). Janssen COVID-19 Vaccine Expiry Date: Please verify at https://vaxcheck.jnj 

India's Union Health Minister Mansukh Mandaviya issued a Tweet on August 7, 2021, confirming Johnson & Johnson's single-dose COVID-19 vaccine has been given Emergency Use approval.

As of October 21, 2021, the Janssen COVID-19 vaccine was available in Africa, the USAEurope, the WHO, and the UK.

Janssen  COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Cold Storage

The U.S. FDA confirmed on July 28, 2021, 'confirm that the concurrence on extending the shelf-life from 4.5 months to 6 months when stored at 2-8°C applies to batches that might have expired before the issuance of this concurrence letter provided they have been stored at 2-8°C.'

Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) News

October 21, 2021 - Janssen Pharmaceutical Companies of Johnson & Johnson presented a 'booster dose' updated to the CDC's Advisory Committee on Immunization Practices.

October 20, 2021 - The U.S. FDA announced it took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. A single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least two months after completing the single-dose primary regimen to individuals 18 years of age and older.

October 15, 2021 - The Company presented 'Emergency Use Authorization Amendment for a Booster Dose for the Janssen COVID-19 Vaccine (Ad26.COV2.S)' during the U.S. FDA VRBPAC meeting. This FDA committee voted unanimously for approval.

October 15, 2021 - Narayan Nair, M.D. Division Director– Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, presented 'Review of Post Authorization Safety Data for Janssen COVID-19 Vaccine.'

October 15, 2021 - Sudhakar Agnihothram, B. Pharm., Ph.D. Division of Vaccines and Related Products Applications Office of Vaccines Research and Review/CBER/FDA presented: Janssen COVID-19 Vaccine Application for Emergency Use Authorization of a booster dose.

October 15, 2021 - A Correspondence published by the NEJM comparative kinetics of humoral and cellular immune responses elicited by the two-dose BNT162b2 vaccine (in 31 participants), the two-dose mRNA-1273 vaccine (in 22 participants), and the one-dose Ad26.COV2.S vaccine (in 8 participants).

October 14, 2021 - Artur Belov, Ph.D. FDA/CBER Office of Biostatistics and Epidemiology published: Review of RWE to Assess the Effectiveness of a single dose of Janssen COVID-19 Vaccine (Ad26.COV2.S).

October 13, 2021 - The second dose of the Janssen COVID-19 vaccine is likely beneficial to recipients, confirmed the Food and Drug Administration's VRBPAC. "Although not independently confirmed by the FDA from datasets, summaries of data suggest there may be a benefit in a second dose administered approximately two months after the primary one-dose," the FDA wrote. As a result, the October 15, 2021 VRBPAC meeting is being held to discuss whether the data presented by Janssen support the safety and effectiveness of the Janssen COVID-19 Vaccine for emergency authorized use as a booster dose at least two months after a single-dose primary vaccination and whether the data presented by Janssen support that an interval of at least six months between the primary vaccination and booster dose may result in a more robust booster response.

October 12, 2021 - The VRBPAC Briefing Document was posted ahead of the U.S. FDA vaccine committee meeting scheduled for 10/14/21.

October 5, 2021 - Johnson & Johnson announced it had submitted data to the U.S. Food and Drug Administration to support the use of a booster shot of the Johnson & Johnson Janssen COVID-19 vaccine in individuals 18 years of age and older.

September 29, 2021 - The U.S. FDA published updated information.

September 21, 2021 - Johnson & Johnson (NYSE: JNJ) announced new data from a clinical study that showed the strong and long-lasting protection of its Janssen COVID-19 vaccine and that protection against COVID-19 increases when a booster shot of the vaccine is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.

September 17, 2021 - The U.S. CDC issued an MMWR: Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions. Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%).

September 14, 2021 - Peter Marks, MD, Ph.D., Director, FDA Center for Biologics Evaluation and Research, issued Addendum #5 (for Area 2, batches GMP14 and GMP17) to the June 11, 2021 memorandum entitled "Assessment of Certain Janssen COVID-19 Vaccine Batches."

September 9, 2021 - The U.S. government issued an Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees.

September 8, 2021 - The U.S. FDA authorized the use, under the emergency use authorization for the Janssen COVID-19 vaccine, of one additional batch of vaccine drug substance manufactured at the Emergent facility. To date, a total of six batches of Janssen drug substances that were manufactured at the Emergent facility have been authorized. 

September 2, 2021 - The WHO published 'what you need to know.'

August 25, 2021 - Johnson & Johnson announced data are supporting the use of its Janssen COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine.

August 12, 2021 - "I am pleased to announce that Canada will share an additional 10 million doses of the Janssen vaccine for distribution to low and middle-income countries," Minister of International Development Karina Gould told reporters during a press conference.

August 7, 2021 - The U.S. Embassy in Malawi confirmed the country received 302,400 doses of the Johnson and Johnson vaccine donated by the U.S. government through the United Nations-led COVAX facility, bringing the country's total vaccine doses received so far through COVAX to more than 850,000.

August 7, 2021 - PTI reported Johnson & Johnson's Janssen COVID-19 vaccine had been given Emergency Use approval in India.

August 4, 2021 - CNBC reported Rhode Island-based CVS Health discontinued offering the Johson & Johnson - Janssen Covid-19 vaccine in its thousands of pharmacies in the USA. CVS Health is making the single shots vaccines at almost 1,000 MinuteClinic locations in 25 states and Washington D.C.

August 2, 2021 - The U.S. FDA published an update for the Janssen COVID-19 Vaccine.

July 28, 2021 - Johnson & Johnson Statement on U.S. FDA Approval of Shelf Life Extension for Company's COVID-19 Vaccine: 'We are pleased to confirm the U.S. FDA has extended the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine to six months. The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at six months when refrigerated at 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius). Expiration dates will be updated on www.vaxcheck.jnj, where vaccine providers can confirm the latest expiration dates of our vaccine.'

July 26, 2021 - Canada Health published Available information for JANSSEN COVID-19 VACCINE - Submission control number 246758. Module 2.5 Clinical Overview: Conditional Marketing Authorisation Application.

July 14, 2021 - The EMA published an updated Janssen COVID-19 safety report. As of July 4, 2021, a total of 12,036 cases of suspected side effects with COVID-19 Vaccine Janssen were spontaneously reported to EudraVigilance from EU/EEA countries; 68 of these reported a fatal outcome.

July 14, 2021 – J&J announced interim results from a Phase 1/2a sub-study published in the New England Journal of Medicine demonstrated that both humoral and cellular immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization, the length of time evaluated to date. Data showed that T-cell responses – including the important CD8+ T-cells that seek out and destroy infected cells. The Company announced topline preprint study results from this Phase 1/2a sub-study on July 1, 2021.

July 13, 2021 - The U.S. FDA authorized the Johnson & Johnson COVID-19 vaccine Janssen under the emergency use authorization for an additional batch of vaccine drug substance manufactured at the Emergent facility in Maryland.

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.'

July 9, 2021 - The EMA vaccine committee recommended that capillary leak syndrome be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk. The Committee reviewed 3 cases of capillary leak syndrome in people who had received COVID-19 Vaccine Janssen, which occurred within two days of vaccination. One of those affected had a history of capillary leak syndrome, and two of them subsequently died. 

July 1, 2021 - J&J issued a press release confirming data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date.

July 1, 2021 - South Africa Sisonke investigators reported finding 94% of breakthrough infections are mild, 4% are moderate, and only 2% severe. Co-principal investigator Professor Glenda Gray notes that "the single-dose vaccine, designed for emergency use is safe and easy to use. In addition, we have mounting data to suggest that immunity increases over time and that it retains its efficacy against important variants such as beta and delta."

June 25, 2021 - The EMA's Committee for human medicines has approved an additional manufacturing site to produce COVID-19 Vaccine Janssen, the COVID-19 vaccine developed by Janssen-Cilag International NV. The site, located in Anagni, Italy, is operated by Catalent Anagni SRL.

June 15, 2021 - The U.S. FDA confirmed today it authorized the use, under the emergency use authorization for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. 

June 11, 2021 - The U.S. Food and Drug Administration announced that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore, MD. The FDA's decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that the Janssen vaccine made with this drug substance can be used in the USA or exported to other countries. 

June 10, 2021 - J&J issued a press statement stating: 'We are pleased to confirm the U.S. FDA has authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months.'

June 9, 2021 - Reuter reported, 'Brazil Health Minister Marcelo Queiroga confirmed the first batch of 3 million doses of the Johnson & Johnson Janssen vaccine would arrive in the next few days.'

May 21 - 2021 - Gavi, the Vaccine Alliance, announced that it had signed an advance purchase agreement with Johnson & Johnson for its single-dose Janssen COVID-19 vaccine. The agreement is to commit to purchasing 200 million doses on behalf of the COVAX Facility, with the goal of the vaccines being supplied to Facility participants in 2021.

May 19, 2021 - The WHO issued a statement: Based on a careful scientific review of the available information, the subcommittee came to the following conclusions and recommendations. The benefits of the J&J COVID-19 vaccine continue to outweigh the risks of TTS. As the only single-dose COVID-19 vaccine approved for use to date, the vaccine may be an important tool for accessing difficult-to-reach populations, thus playing a key role in preventing infections and reducing deaths worldwide. However, very rare thromboembolic events, combined with thrombocytopenia, have been reported following vaccination with the J&J vaccine in the United States. 

May 12, 2021 - Spain's Health Ministry and the country's regional governments approved using the Janssen single-dose Covid-19 vaccine among the under-60s.

May 11, 2021 - The U.S. CDC updated its Janssen COVID-19 vaccine page information.

May 7, 2021 - Johnson & Johnson is committed to enabling equitable global access to the Janssen COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending local regulatory authorizations and direct procurement agreements with governments. In December 2020, the Company entered into an agreement in principle supporting COVAX, the global procurement mechanism for COVID-19 vaccines. We expect to enter into an Advance Purchase Agreement (APA) to provide up to 500 million doses of the Janssen vaccine to COVAX through 2022. 

May 6, 2021 - The CDC and the U.S. Food and Drug Administration recommend using Johnson & Johnson's Janssen COVID-19 Vaccine resume in the United States after a temporary pause.

April 23, 2021 - Johnson & Johnson announced that vaccinations with the Company's (Janssen) COVID-19 single-shot vaccine would resume for all adults aged 18 years and older in the USA following a decision from the CDC and FDA.

April 23, 2021 - The U.S. CDC's Advisory Committee on Immunization Practices conducted an emergency meeting regarding the Janssen COVID-19 vaccine 'pause' recommendation. Various clinical presentations focused on rare adverse side effects. As a result, the CDC committee voted to remove the 'pause' recommendation.

April 21, 2021 - The U.S. Food and Drug Administration completed its inspection of Johnson & Johnson vaccine maker Emergent BioSolutions's Bayview facility and "cited several observations concerning whether the facility's processes met our requirements and standards."

April 20, 2021 - Johnson & Johnson (NYSE: JNJ) 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. 

April 20, 2021 - The European Medicines Agency announced it reviewed eight cases of thrombosis in combination with thrombocytopenia in people who received Janssen's COVID-19 vaccine in the USA.

April 16, 2021 - The NEJM published an article: Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination — Response from the Manufacturer. 'At this time, evidence is insufficient to establish a causal relationship between these events and the Ad26.COV2.S vaccine' stated these J&J-related physicians.

April 15, 2021 - A virtual emergency meeting of the U.S. CDC's Advisory Committee on Immunization Practices has been scheduled for April 23, 2021, from 11:00 a.m. to 5:00 p.m. ET. The agenda for this ACIP meeting has not been posted.

April 15, 2021 - The U.S. CDC published an updated 'Recommendation to Pause Use of Johnson & Johnson's Janssen COVID-19 Vaccine.'

April 13, 2021 - J&J issued the following statement: 'The safety and well-being of the people who use our products is our number one priority. We are aware of an infrequent disorder involving people with blood clots combined with low platelets in a small number of individuals who have received our COVID-19 vaccine. The United States Centers for Disease Control and Food and Drug Administration reviewed data involving six reported U.S. cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in using our vaccine. Also, we have been reviewing these cases with European health authorities. As a result, we have decided to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials. At the same time, we update guidance for investigators and participants.'

April 13, 2021 - The Centers for Disease Control and Prevention and the Food and Drug Administration jointly announced a recommendation pausing the use of this vaccine out of an abundance of caution. These US government agencies review data involving six reported cases of a rare and severe type of blood clot in individuals after receiving the Janssen COVID-19 vaccine. Right now, these adverse events appear to be extremely rare, stated these agencies.

April 9, 2021 - The European Medicines Agency announced a safety signal review to assess reports of thromboembolic events in people who received COVID-19 Vaccine Janssen.

April 7, 2021 - South Korea authorized the Janssen COVID-19 vaccine. In addition, the country signed a contract with Janssen for 6 million bottles for its vaccine rollout. The bottles are scheduled to be provided in the third quarter of 2021.

April 2, 2021 - Johnson & Johnson announced that the Janssen COVID-19 vaccine candidate would initially be tested in adolescents aged 16-17 years. Following the initial data review in this Phase 2a trial, the study will be expanded to a larger group of younger adolescents in a stepwise approach. This trial is enrolling participants in Spain and the United Kingdom; enrollment will commence shortly in the United States, the Netherlands, and Canada, with Brazil and Argentina to follow.

March 31, 2021 - The Collegiate Board of Anvisa (Dicol) approved the temporary Authorization for emergency use of the Janssen COVID19 Vaccine vaccine (Ad26.COV2-S, recombinant), developed by Janssen, the pharmaceutical arm of Johnson & Johnson. The Company requested emergency use on March 24th. Anvisa concluded, after analyzing the studies presented, that the vaccine protects against the severe form of the disease and is effective for preventing COVID-19 in adult patients.

March 31, 2021 - Johnson & Johnson announced it has been working directly with governments, health authorities, and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.

March 29, 2021 - Janssen Pharmaceutica NV has agreed with the African Vaccine Acquisition Trust (AVAT) to make up to 220 million doses of its single-shot COVID-19 vaccine candidate to the African Union's 55 member states, with delivery beginning in the third quarter of 2021. AVAT also orders an additional 180 million doses for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful approval or Authorization by the national regulatory authorities of member states.

March 22, 2021 - Swissmedic has temporarily authorized the "Covid-19 vaccine Janssen" developed by the pharmaceutical corporation Johnson & Johnson for people aged 18 and over. Janssen-Cilag AG applied for Authorization. Additionally, the Human Medicines Expert Committee, Swissmedic's external advisory body, voiced its support for this decision during an extraordinary meeting.

March 17, 2021 - The Janssen COVID-19 vaccine was approved for international use by the UN health agency expert advisory board, SAGE, which eased concerns over clotting events associated with some countries without definitive evidence of coronavirus jabs.

March 15, 2021 - Japan-based Takeda Pharmaceutical Company Limited announced an agreement with IDT Biologika GmbH, a contract development and manufacturing organization, to utilize the capacity previously reserved for Takeda's dengue vaccine candidate to manufacture the single-shot COVID-19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. 

March 12, 2021 - The WHO listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen (Johnson & Johnson), for emergency use in all countries and COVAX rollout.

March 12, 2021 - New Jersey-based Johnson & Johnson announced that the World Health Organization had issued Emergency Use Listing for the Janssen COVID-19 Vaccine.

March 11, 2021 - Johnson & Johnson announced that the Committee for Medicinal Products for Human Uss of the European Medicines Agency (EMA) issued a Positive Opinion to recommend the Conditional Marketing Authorization for its single-dose COVID-19 vaccine candidate, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

March 5, 2021 - The U.S. CDC published 'Interim Clinical Considerations for the use of COVID-19 Vaccines Currently Authorized in the United States.' These clinical considerations provide additional information to healthcare providers and public health officials on the use of COVID-19 vaccines.

March 5, 2021 - Health Canada officials held a technical briefing on COVID-19 vaccines. During this meeting, they authorized the Janssen COVID-19 vaccine as the 4th vaccine for use in Canada.

March 2, 2021 - Merck entered into agreements with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support Johnson & Johnson's manufacturing and supply SARS-CoV-2/COVID-19 vaccine. Merck will use its facilities in the United States to produce drug substances and formulate and fill Johnson & Johnson's vaccine vials.

March 2, 2021 - The US CDC's Advisory Committee on Immunization Practices' Interim Recommendation for using Janssen COVID-19 Vaccine — United States, February 2021.

March 1, 2021 - Irving-based McKesson announced today it began distributing the Janssen COVID-19 vaccine received from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

February 27, 2021 - The U.S. Food and Drug Administration 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. The data also show that the vaccine's known and potential benefits outweigh its known and potential risks.

February 26, 2021 - The Janssen Biotech and Johnson and Johnson team presented vaccine efficacy data to the U.S. FDA Vaccines and Related Biological Products Advisory Committee. The FDA established a docket for public comment on this meeting. The docket number is FDA-2021-N-0173. The Committee votes 22-0 supporting the benefits of the experimental vaccine 'outweigh its risks for use in individuals 18 years of age and older.'

February 18, 2021 - The South African government outlined the Mpumalanga provincial COVID-19 vaccine rollout plan to the Portfolio Committee on Health. Head of Department, Dr. Savera Mohangi, said two hospitals were chosen because of their high numbers of healthcare workers who had been exposed to COVID-19. "The vaccination program will have to be implemented in the two hospitals over a maximum of two weeks.

January 29, 2021 - J&J announced Janssen's phase 3 trial results found that the vaccine was 85% effective overall at preventing severe disease, including illnesses requiring hospitalization.

January 13, 2021 - The NEJM published: Interim Results of Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine.

December 29, 2020 - The Philippines has approved a clinical trial for the Covid-19 vaccine of Johnson & Johnson's unit Janssen, the head of its Food and Drug Administration (FDA), said on Tuesday. The trials could begin in the next few weeks, FDA head Rolando Enrique Domingo told a media briefing.

December 24, 2020 - South Korea has signed a deal with Johnson & Johnson's Janssen to import coronavirus vaccines, Prime Minister Chung Sye-kyun told a televised briefing. The government had allocated an additional 1.3 trillion won ($1.2 billion) to next year's budget for vaccines.

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 Torah obligation to preserve our lives and the lives of others requires us to vaccinate for COVID-19 as soon as a vaccine becomes available.

December 15, 2020 - REIG JOFRE Pharmaceutical announced an agreement with the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) to execute the technology transfer to manufacture its investigational COVID-19 vaccine candidate, Ad26.COV2-S.

November 2, 2020 - South Africa-based Aspen Pharmacare Limited announced it has entered into a preliminary agreement with Janssen Pharmaceuticals, Inc. (Johnson & Johnson) for the technical transfer and proposed commercial manufacture of their COVID-19 vaccine candidate, Ad26.COV2-S. Aspen Pharmacare stated 'it will perform formulation, filling and secondary packaging of the vaccine for supply to Johnson & Johnson.

October 12, 2020 - J&J announced it temporarily paused further dosing in all COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following its guidelines, the participant's condition is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board, as well as our internal clinical and safety physicians.

October 8, 2020 - Johnson & Johnson announced the European Commission, acting on behalf of the European Union (EU) 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 EU Member States following approval or Authorization from regulators.

September 25, 2020 - Grand River Aseptic Manufacturing (GRAM) announced agreeing with Janssen Pharmaceuticals, Inc. to support its SARS-CoV-2 vaccine candidate's manufacture.

August 5, 2020 - J&J announced that it would develop and deliver 100 million doses of its coronavirus vaccine for the U.S. government in a deal totaling more than $1 billion. This agreement offers the U.S. the option to order an additional 200 million doses.

July 30, 2020 - A recent study showed that Janssen's investigational vaccine elicited an immune response against SARS-CoV-2 in preclinical, nonhuman research. Based on this preclinical study's positive data, the first-in-human Phase 1/2a clinical trial is underway in the USA and Belgium, with a Phase 3 study expected to commence in September 2020.

April 29, 2020 - Janssen Pharmaceutical Companies of Johnson & Johnson announced Catalent's Biologics business unit would accelerate manufacturing capacity availability and prepare for large-scale commercial manufacturing at its facility in Bloomington, Indiana, of Johnson & Johnson's lead vaccine candidate for COVID-19.

April 23, 2020 - Emergent BioSolutions Inc. announced an agreement to deploy its contract development and manufacturing services to support Johnson & Johnson's lead vaccine candidate for COVID-19 that leverages the AdVac® and PER.C6® technologies from the Janssen Pharmaceutical Companies of Johnson & Johnson. 

March 30, 2020 - Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), progressing into the first manufacturing steps.

Janssen 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.

The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older. The Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination.

Also part of the submission is Phase 1/2a data showing that when a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.