COVID-19 Vaccine Janssen Description
The Johnson and Johnson Janssen COVID-19 single-shot experimental 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 so that it can no longer replicate in humans and cause disease. Adenoviruses are a group of viruses that can cause the common cold.
The AdVac® technology works by using an adenovirus as a vector (a carrier) of an antigen’s genetic code to mimic components of a pathogen (a bacterium, virus, or other disease-causing organisms). Antigens (components of a pathogen) are produced to mimic the pathogen without causing severe disease.
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 that are currently unpreventable or untreatable.
These are the same technologies Janssen used to develop and manufacture the Ebola vaccine, Ad26.ZEBOV.
Johnson & Johnson (J&J) and Janssen continue developing their COVID-19 vaccine candidate per ethical standards and sound scientific principles.
The Janssen COVID-19 (Ad26.COV2.S) vaccine's Accession Number: DB15857; Unique Ingredient Identifier (UII): JT2NS6183B. The U.S. FDA published on February 27, 2021, Janssen COVID-19 Vaccine Frequently Asked Questions.
The U.S. CDC published an update Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety on March 31, 2021.
COVID-19 Vaccine Janssen History
On February 27, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization allowing 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, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
Previously on September 25, 2020, a non-peer-reviewed study concluded 'the safety profile and immunogenicity after only a single dose supports the further clinical development of Ad26.COV2.S at a dose level of 5x1010 up, as a potentially protective vaccine against COVID-19.' J&J stated 'it anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021 as the Company progresses the clinical development of its Ad26.COV2-S vaccine candidate continues to increase manufacturing capacity, and is in active discussions with global partners to ensure worldwide access.'
On October 23, 2020, Johnson & Johnson announced that it is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.
On December 12, 2020, the European Medicines Agency's human medicines committee (CHMP) confirmed it had started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus.
On December 17, 2020, J&J issued a press release that stated, 'Interim data from the ENSEMBLE phase 3 clinical trial is currently anticipated to be available by the end of January 2021.'
On January 13, 2021, the NEJM published Interim Results of Phase 1–2a Trial,' which stated: 'The interim analysis of our phase 1–2a trial showed that the Ad26.COV2.S vaccine (JNJ-78436735) had an acceptable safety and reactogenicity profile and was immunogenic after a single vaccination with either the low or high dose. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 224 to 354) and reached 100% by day 57 with a further increase in titers (GMT, 288 to 488), regardless of vaccine dose or age group. Titers remained stable until at least day 71. A second dose provided an increase in the titer by a factor of 2.6 to 2.9 (GMT, 827 to 1266). Spike-binding antibody responses were similar to neutralizing-antibody responses. On day 14, CD4+ T-cell responses were detected in 76 to 83% of the participants in cohort 1 and 60 to 67% of those in cohort 3, with a clear skewing toward type 1 helper T cells. CD8+ T-cell responses were robust overall but lower in cohort 3.'
'Our interim analysis indicates that vaccine candidate Ad26.COV2.S is safe and immunogenic in both younger and older adults. In combination with the results in preclinical challenge studies, this finding has supported our decision to proceed with two phase 3 trials to evaluate the efficacy of either a single-dose or two-dose regimen of the lower dose (5×1010 viral particles) of Ad26.COV2.S.'
On January 13, 2021, Johnson & Johnson stated it 'continues to develop and test its COVID-19 vaccine candidate following ethical standards and sound scientific principles. The Company is committed to transparency and sharing information related to its ongoing clinical studies – including the ENSEMBLE study protocol.'
'ENSEMBLE was initiated in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under Other Transaction Agreement HHSO100201700018C, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. On January 29, 2021, the Phase 3 ENSEMBLE clinical trial demonstrated that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
"Our goal all along has been to create a simple, effective solution for the largest number of people possible and to have maximum impact to help end the pandemic,” said Alex Gorsky, Chairman, Board of Directors and CEO, Johnson & Johnson, in a press release. “We’re proud to have reached this critical milestone, and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”
On February 4, 2021, Janssen Biotech, Inc. submitted an application to the U.S. FDA requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. “Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, in a press statement issued on February 4, 2021. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
Johnson & Johnson 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.
For more information on Johnson & Johnson’s Janssen COVID-19 approach to combatting the pandemic, visit JnJ.com. Learn more at Janssen.com.
COVID-19 Vaccine Janssen Indication
Janssen's vaccine candidate (Janssen COVID-19) 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.
The FDA says 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).
COVID-19 Vaccine Janssen Adolescent Indication
On April 2, 2021, Johnson & Johnson confirmed it is vaccinating adolescent participants in the ongoing Phase 2a clinical trial. The study’s goals are to evaluate reactogenicity and immunogenicity of two dose levels of the experimental Janssen vaccine candidate and evaluate potential vaccination schedules at one, two, and three-month intervals in two-dose vaccine regimens.
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.
COVID-19 Vaccine Janssen Dosage
Ad26COVS1 (JNJ-78436735) was evaluated at 2-dose levels in a phase 1 study, administered intramuscularly as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort.
The phase 2 study's primary purpose is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart), Ad26.COV2.S administered IM as a single vaccination and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart).
The phase 3 ENSEMBLE study evaluates the safety and efficacy of a single vaccine dose of Janssen COVID-19.
Ad26.COV2-2 can remain stable for an estimated timeframe of two years at -20°C (-4°F) and can be refrigerated for up to three months at 36–46°F (2–8°C).
COVID-19 Vaccine Janssen 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.
The Archdiocese of New Orleans instructed Catholics on February 26, 2021, that the Janssen COVID-19 vaccine is morally compromised. It uses the abortion-derived cell line in the development and production of the vaccine and the testing. The Archdiocese of St Louis and Debuque, Iowa, issued similar statements on March 4, 2021.
And, the Congregation for the Doctrine of the Faith has judged that ‘when ethically irreproachable Covid-19 vaccines are not available … it is morally acceptable to receive Covid-19 vaccines that have used cell lines from aborted fetuses in their research and production process.’ However, if one can choose among equally safe and effective COVID-19 vaccines, the vaccine with the least connection to abortion-derived cell lines should be chosen.
The frequently asked questions page on the state of Michigan Department of Health and Human Services' COVID-19 vaccine website has been updated to state: The Johnson & Johnson COVID-19 vaccine has been produced by growing the virus in fetal cells during vaccine development and manufacturing (using the PER.C6 line). Even though fetal cells are used to grow the vaccine virus, vaccines do not contain these cells or pieces of DNA.'
COVID-19 Vaccine Janssen Side Effects
The U.S. CDC published Possible Side Effects of COVID-19 vaccines on March 5, 2021.
Adverse reactions reported in a clinical trial following the Janssen COVID-19 Vaccine administration include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema, and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine.
On April 9, 2021, the European Medicines Agency confirmed it had started a review of a safety signal to assess reports of thromboembolic events (formation of blood clots, resulting in the obstruction of a vessel) in people who received COVID-19 Vaccine Janssen. Four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with COVID-19 Vaccine Janssen. One case occurred in a clinical trial, and three cases occurred during the vaccine rollout in the USA. One of them was fatal.
COVID-19 Vaccine Janssen CPT Code
The American Medical Association offers resources to help identify the appropriate CPT code.
COVID-19 Vaccine Janssen Distribution Agreements
The authorization or approval status of Janssen’s COVID-19 vaccine varies by country. 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.
Janssen COVID-19 Vaccine Expiry Date: Please verify at https://vaxcheck.jnj
COVID-19 Vaccine Janssen News
April 9, 2021 - The European Medicines Agency announced it had started a review of a safety signal 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. 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 4, 2021 - VOA News reported the US Department of Health & Human Services had put Johnson and Johnson (J&J) in charge of a Baltimore, MD based plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official stated on April 3, 2021. J&J said it was "assuming full responsibility" for the Emergent BioSolutions facility, reiterating that it will deliver 100 million doses to the government by the end of May 2021.
April 2, 2021 - Johnson & Johnson announced the Janssen COVID-19 vaccine candidate would initially be tested in a small number of adolescents aged 16-17 years. Following the review of initial data in this Phase 2a trial, the study will be expanded to a larger group of younger adolescents in a stepwise approach. This trial is currently 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.
April 1, 2021 - At Emergent, safety and quality are our top priorities. Our Bayview facility has been designed and validated to meet all current Good Manufacturing Practices. In addition, there are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks, a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch, and it will be disposed of properly. Importantly, the quality control systems worked as designed to detect and isolate this single batch. Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process. We continue to manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements. We are very proud of the role the Emergent team is playing in support of the response to COVID-19 and look forward to continuing to do our part to help stem this pandemic.
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. As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality. This quality control process identified one batch of drug substances that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substances for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process. This is an example of the rigorous quality control applied to each batch of a drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration. Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations, and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine. In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April.
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 can order 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 allayed concerns over clotting events being associated by some countries, without definitive evidence, with 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. At the end of a three-month period, the capacity will be returned to Takeda to resume critical manufacturing for the planned launch of its dengue vaccine, subject to regulatory approvals.
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 roll-out. The decision comes on the back of the European Medicines Agency (EMA) authorization, which was announced yesterday. The vaccine from Janssen is the first to be listed by WHO as a single dose regimen, facilitating vaccination logistics in all countries. The company's ample data from large clinical trials also show that it is effective in older populations.
March 12, 2021 - New Jersey-based Johnson & Johnson announced that the World Health Organization (WHO) 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. Data from the Phase 3 ENSEMBLE study showed that the Janssen COVID-19 vaccine was well tolerated and demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine compared to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. The data also demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.“The European Medicines Agency’s recommendation is a landmark moment for Johnson & Johnson and the world,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic.”
March 10, 2021 - CNBC reported the U.S. government plans to buy 100 million additional doses of Johnson & Johnson’s Covid-19 vaccine, two administration sources told NBC News.
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 the use of 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. McKesson has established four dedicated distribution centers specifically used to distribute the Johnson & Johnson COVID-19 vaccine and future refrigerated vaccines. The U.S. government makes all program administration decisions, including where, when, and how many vaccine doses McKesson will distribute.
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 had determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of a EUA. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks. In making this determination, the FDA can assure the public and the medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
February 27, 2021 - Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Janssen COVID-19 Vaccine.
February 27, 2021 - The US Centers for Disease Control and Prevention scheduled an emergency ACIP committee review of the Janssen COVID-19 vaccine for February 28 and March 1, 2021.
February 26, 2021 - Leaders from the U.S. FDA issued the following statement: Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution to execute their plans for timely vaccine distribution.
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 24, 2021 - The U.S. FDA's Vaccines and Related Biological Products Advisory Committee posted the JANSSEN BIOTECH, INC., A PHARMACEUTICAL COMPANY OF JOHNSON & JOHNSON, SPONSOR BRIEFING DOCUMENT ADDENDUM, for COVID-19 Vaccine Ad26.COV2.S VAC31518 (JNJ-78436735). This meeting is scheduled for February 26, 2021. At the time of submission of the EUA application (4 February 2021), the Sponsor included analyzing asymptomatic SARS-CoV-2 infections based on 965 Day 71 serology results. In this addendum, the Sponsor highlights the impact of an updated analysis on asymptomatic SARS-CoV2 infections based on 2,892 Day 71 serology results. This updated analysis has been submitted as a EUA supplement on 12 February 2021. The initial and updated analyses are based on the database cutoff for the primary analysis (22 January 2021). Note that this is still an interim analysis of the Day 71 serology results.
February 19, 2021 - Johnson & Johnson announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing to the World Health Organization for the investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s rolling submission of clinical data to WHO is now complete.
February 18, 2021 - The U.S. FDA's Vaccines and Related Biological Products Advisory Committee will meet on February 26, 2021, in an open session to discuss an emergency authorization for the Janssen Biotech Inc. experimental COVID-19 Vaccine. This authorization would be for active immunization to prevent COVID-19 caused by SARS-CoV-2 in 18 years and older. Materials for this FDA meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.
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. A team of 42 vaccinators will rotate between the two facilities, which researchers from Mzansi Ethical Research Centre will oversee. And the Mzansi Ethical Research Centre has been nominated to oversee the vaccination process in Mpumalanga." The South African Health Products Regulatory Authority (SAHPRA) has approved the vaccine for the program while it processes the full licensing. It is important to understand that the fact that it is not yet licensed does not mean that it is not safe or effective.
February 17, 2021 - The South Africa Department of Health announced an early access COVID-19 vaccine rollout to healthcare workers. South Africa secured the single-dose Johnson & Johnson (Janssen) vaccine for use with up to 500,000 healthcare workers in 18 public sector hospitals across all nine provinces.
February 16, 2021 - Johnson & Johnson announced that Janssen-Cilag International N.V. had submitted a conditional Marketing Authorisation Application to the European Medicines Agency seeking authorization for its investigational single-dose Janssen COVID-19 vaccine candidate. The submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial.
February 15, 2021 - Reuters reported South Africa’s drugs regulator SAHPRA stated it had approved the local implementation of Johnson & Johnson’s COVID-19 vaccine
February 12, 2021 - Local media in Spain reported Johnson & Johnson's COVID-19 vaccine is set to be approved by the EU on March 8 “if everything goes well,” according to Spanish Health Minister Carolina Darias. If the EU gives it the green light, it could be approved a few days later by the European Medicines Agency. Under the existing EU deal, Spain would receive more than 40 million doses of the vaccine.
February 10, 2021 - South African health leaders announced during a digital news conference the country would begin vaccinating people with the Johnson & Johnson vaccine produced by Janssen Pharma.
February 9, 2021 - The University of Kentucky has been selected as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study ENSEMBLE 2, evaluating the safety and efficacy of a two-dose regimen of Janssen’s COVID-19 vaccine candidate. The University was the top enrolling site in the world for the ongoing Phase 3 ENSEMBLE study, which evaluated a single-dose regimen of Janssen’s investigational vaccine.
February 4, 2021 - The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26, 2021, to discuss the request for emergency use authorization for a COVID-19 vaccine from Janssen Biotech Inc. This submission is based on safety and efficacy data from the Phase 3 ENSEMBLE trial.
February 4, 2021 - Johnson & Johnson announced that Janssen Biotech, Inc. had submitted an application to the U.S. FDA requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have the vaccine available to ship immediately upon authorization.
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. In the U.S., the single dose was 72% effective at preventing moderate and severe illness. In Latin America, the effectiveness was lower, at 66%. And in South Africa, the effectiveness fell to 57%. The Company intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship the following authorization immediately. It expects to share more information on the specifics of deployment as authorizations are secured and contracts are finalized. The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.
January 28, 2021 - According to media reports, J&J intends to deliver about 2 million doses of its Covid-19 vaccine, according to a Government Accountability Office report. In an email, a spokesman said that J&J expects to supply 100 million doses to the US government in the first half of 2021.
January 19, 2021 - The Chicago-based American Medical Association (AMA) announced that the Current Procedural Terminology (CPT®) code set is being updated by the CPT Editorial Panel to include vaccine and administration codes that are unique to the experimental COVID-19 vaccine under development by Janssen Pharmaceutica, a division of Johnson & Johnson. The Janssen COVID-19 vaccine joins other COVID-19 vaccines from Pfizer, Moderna, and AstraZeneca that were previously issued unique CPT codes to clinically distinguish each vaccine and immunization administration for better tracking, reporting, and analysis. To ensure accurate coding and reporting of COVID-19 vaccines and immunization services, the AMA offers a new resource to help identify the appropriate CPT code combination for each patient and dose type of the COVID-19 vaccine.
January 13, 2021 - The NEJM published: Interim Results of Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine. The safety and immunogenicity profiles of Ad26.COV2.S supports the further development of this vaccine candidate. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 224 to 354), regardless of vaccine dose or age group. They reached 100% by day 57 with a further increase in titers (GMT, 288 to 488) in cohort 1a. Titers remained stable until at least day 71. A second dose provided an increase in the titer by a factor of 2.6 to 2.9 (GMT, 827 to 1266). Spike-binding antibody responses were similar to neutralizing-antibody responses. On day 14, CD4+ T-cell responses were detected in 76 to 83% of the participants in cohort 1 and 60 to 67% of those in cohort 3, with an apparent skewing toward type 1 helper T cells. CD8+ T-cell responses were robust overall but lower in cohort 3.
January 13, 2021 - Interim Phase 1/2a data were published today in the New England Journal of Medicine, demonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. These interim data were posted by medRxiv in September 2020.
January 5, 2021 - J&J COVID-19 Update: Your Latest Questions About Johnson & Johnson's Investigational Vaccine Candidate Answered.
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 21, 2020 - Mexico’s Deputy Health Minister Hugo Lopez-Gatell said earlier this month at a news conference that hosting the Janssen trial would give the country priority access to the vaccine. Marcelo Ebrard said that Mexico could order 22 million doses under a memorandum of understanding last week.
December 17, 2020 - J&J announced the large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of the investigational Janssen COVID-19 single-dose vaccine candidate is now fully enrolled with approximately 45,000 participants. Interim data from the ENSEMBLE trial is currently anticipated to be available by the end of January 2021. If the data indicate the vaccine is safe and effective, the Company expects to submit an Emergency Use Authorization application to the U.S. FDA in February 2021.
December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: the conclusion of our poskim is 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. The project candidate entails additional investment, already underway, to ensure the new facility complies with the biosafety levels required by the Ad26.COV2-S vaccine candidate. Under the terms of the agreement, REIG JOFRE will be responsible for the formulation, filling, and packaging of the vaccine candidate, then distributed by Janssen. The project candidate entails additional investment, already underway, to ensure the new facility complies with the biosafety levels required by the Ad26.COV2-S vaccine candidate. Under the terms of the agreement, REIG JOFRE will be responsible for the formulation, filling, and packaging of the vaccine candidate, which Janssen will distribute.
December 9, 2020 - Johnson & Johnson is reported to be reducing the size of its pivotal phase 3 study from 60,000 volunteers to 40,000 volunteers. The change is being made possible by the fact that Covid-19 is so pervasive across the country, according to Matthew Herper with StatNews. This study was last updated on December 3, 2020
December 1, 2020 - The European Medicines Agency's human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus.
November 18, 2020 - The Spanish Agency for Medicines and Health Products authorized phase III of the clinical trial in Spain of the Janssen (a Johnson & Johnson company) vaccine. This is the first phase III clinical trial for a vaccine against COVID-19 of this type authorized in Spain. Furthermore, the tests will be conducted in nine hospitals in Spain to recruit eligible volunteers, including people without any chronic diseases and people with concurrent illnesses. Twenty percent of the participants will be under 40 years old, and 30 percent will be over 60 years old, the ministry informed.
November 14, 2020 - Johnson & Johnson announced the expansion to the partnership between its Janssen Pharmaceutical Companies and the Biomedical Advanced Research and Development Authority (BARDA) for the ongoing development of Janssen's 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 23, 2020 - Johnson & Johnson announced today that it is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.
October 12, 2020 - J&J announced it temporarily paused further dosing in all our 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.
October 4, 2020 - J&J announced interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen COVID-19 vaccine candidate (JNJ-78436735). The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all 18 years and older participants and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults.
September 26, 2020 - Interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial - Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate.
September 25, 2020 - Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, after only a single dose, support further clinical development of Ad26.COV2.S at a dose level of 5x1010 vp, as a potentially protective vaccine against COVID-19.'
September 25, 2020 - Grand River Aseptic Manufacturing (GRAM) announced agreeing with Janssen Pharmaceuticals, Inc. to support its SARS-CoV-2 vaccine candidate's manufacture. The Johnson & Johnson vaccine candidate being manufactured at GRAM is being developed, in part, with funding from BARDA. In collaboration with JPEO-CBRND, BARDA is also funding a demonstration of manufacturing capability expected to result in 100 million doses of the investigational vaccine, which the federal government will own.
September 23, 2020 - JNJ announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies.
September 13, 2020 - Janssen Vaccines & Prevention B.V. will begin mid-stage trials of its COVID-19 vaccine in Spain. About 190 people would take part in Spain's trials, which will occur in 3 hospitals and be concluded by September 22, 2020. The Spanish study is part of Phase II trials of the vaccine being carried out in three countries, including the Netherlands and Germany. The phase 2 trials will last two months and include 550 participants in total.
September 3, 2020 - J&J reported Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S prevented severe clinical disease in Syrian golden hamsters upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people.
August 26, 2020 - Johnson & Johnson has added Chile, Argentina, and Peru to the Latin nations to conduct Phase III trials for its vaccine against COVID-19 disease. The company told Reuters it was waiting for regulatory approval in Chile, Argentina, and Mexico.
August 18, 2020 - Brazil's Health regulator Anvisa said it had given the green light for a vaccine study that will see 6,000 people in Brazil volunteer to trial the vaccine contender of Johnson & Johnson’s pharmaceutical subsidiary Janssen.
August 14, 2020 - Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland on a global Phase 3 clinical trial to explore the 2--dose regimen of Janssen’s SARS-CoV-2 vaccine candidate, Ad26.COV2.S. This international study will run parallel to the Phase 3 trial investigating the single-dose regimen of Ad26.COV2.S.
August 9, 2020 - The Kingdom of Saudi Arabia announced it would soon begin a Phase 3 clinical trial of around 5,000 people for the COVID-19 disease preventive vaccine known as Ad5-nCoV.
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 - The 4 Latest Facts About Johnson & Johnson’s Investigational COVID-19 Vaccine.
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 now underway in the USA and Belgium, with a Phase 3 study expected to commence in September 2020.
July 17, 2020 - The NYTimes reports clinical trials of the vaccine will begin in Belgium. Dr. Barouch’s team will soon start up a trial in Boston.
July 16, 2020 - J&J's Wolk said the Phase 1 trial of Ad26COVS1 is expected to enroll more than 1,000 participants, primarily between 18 and 55 years old. However, the company also plans to include a group of people who are 65 years old or older in the early-stage trial. He also said that J&J is in talks with the National Institutes of Health to move up the timeline for the anticipated Phase 3 trial to late September 2020.
July 6, 2020 - Emergent BioSolutions Inc. announced a 5-year manufacturing services agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing for the investigational vaccine, Ad26.COV2-S. Emergent will provide contract development and manufacturing (CDMO) services valued at approximately $480 million for the first two years.
June 10, 2020 - Johnson & Johnson today that through its Janssen Pharmaceutical Companies (Janssen), it has accelerated the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant.
May 28, 2020 - A new article published in The Lancet, The starting line for COVID-19 vaccine development, identifies questions are whether responses are sustained over time and whether they correlate with clinical protection after exposure to a circulating strain of SARS-CoV-2.
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. The collaboration commits joint investment to accelerate the rapid scale-up of segregated manufacturing capacity over the coming months to support Johnson & Johnson’s investigational vaccine candidate's dedicated production.
April 23, 2020 - Emergent BioSolutions Inc. announced an agreement whereby Emergent will 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. Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve specific large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021.
March 30, 2020 - Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. Under an accelerated timeline, the Company aims to initiate a Phase 1 clinical study in September 2020, with clinical data on safety and efficacy expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021. For comparison, the typical vaccine development process involves several various research stages, spanning 5 to 7 years, before a candidate is even considered for approval.
Janssen COVID-19 Vaccine Clinical Trials
Janssen is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy. The Company is studying a single dose of its vaccine candidate in the Phase 3 ENSEMBLE trial, which completed enrollment on December 17, 2020. A two-dose regimen in the Phase 3 ENSEMBLE 2 study is ongoing. In parallel, the Company has also agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland on a separate Phase 3 clinical trial in multiple countries to explore a two-dose regimen of Janssen’s vaccine candidate.
Clinical Trial NCT04535453: The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-65 years or older) and adolescents (12-17 years). Estimated Study Completion Date: December 15, 2021.
Clinical Trial NCT04436276: A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older. The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26COVS1 (JNJ-78436735) at 2 dose levels, administered intramuscularly as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions. The study took place in the USA and Belgium. Estimated Primary Completion Date: September 15, 2021. NEJM analysis was published on January 13, 2021.
Clinical Trial NCT04505722: A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE). Study code: VAC31518COV3001. The approved clinical trial is a phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Ad26.COV2.S prevents SARS-CoV-2-mediated Covid-19 in adults aged 18 years or older. It will be a single dose of the vaccine or placebo. The study foresees the inclusion of up to 60,000 volunteers, across 3 continents, with seven thousand in Brazil, distributed in several regions of the country in the states of São Paulo, Rio Grande do Sul, Rio de Janeiro, Paraná, Minas Gerais, Bahia, and Rio Grande do Norte. Estimated Primary Completion Date: March 10, 2023.