COVID-19 Vaccine Janssen (Johnson & Johnson) Description
The Johnson & Johnson Janssen COVID-19 (Ad26.COV2.S) 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 of an antigen’s genetic code to mimic components of a pathogen. Antigens 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 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 J&J vaccine 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).
The WHO interim recommendations on the use of the Janssen Ad26.COV2.S (COVID-19) vaccines were developed based on advice issued by the Strategic Advisory Group of Experts on Immunization. This document was updated: Version June 15, 2021.
The Janssen COVID-19 (Ad26.COV2.S) vaccine's Accession Number: DB15857; Unique Ingredient Identifier (UII): JT2NS6183B. Anatomical therapeutic chemical code J07BX03.
The U.S. FDA published on April 27, 2021, Janssen COVID-19 Vaccine revised Frequently Asked Questions. The FDA published an update on Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety for Recipients and Caregivers on July 12, 2021.
COVID-19 Vaccine Janssen (Johnson & Johnson) History
On February 27, 2021, the U.S. Food and Drug Administration (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.
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.'
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 J&J, to prevent COVID-19 in individuals 18 years of age and older.
On June 1, 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.'
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 (Johnson & Johnson) Indication
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. The U.S. FDA said on May 14, 2021, 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 (Johnson & Johnson) Variants of Concern
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.
COVID-19 Vaccine Janssen Adolescent (Johnson & Johnson) Indication
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.
COVID-19 Vaccine Janssen (Johnson & Johnson) Dosage
J&J vaccine Ad26COVS1 (JNJ-78436735) is administered IM as a single vaccination. The phase 3 ENSEMBLE study evaluates the safety and efficacy of a single vaccine dose of Janssen COVID-19.
COVID-19 Vaccine Janssen (Johnson & Johnson) 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.
COVID-19 Vaccine Janssen (Johnson & Johnson) 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 addition, in clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine.
On April 20, 2021, the EMA’s safety committee concluded that a warning about unusual, very rare blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen.
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.'
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 May 26, 2021, the EU country of Belgium suspended Johnson & Johnson's Janssen COVID-19 vaccinations for people under the age of 41 following the first death in Europe from severe side-effects associated with the shot, reported Reuters.
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. TTS requires rapid identification and urgent clinical management. National and international recommendations have been updated with evolving experience from managing TTS and heparin-induced thrombocytopenia and thrombosis, a condition with some similarities to TTS.
The EMA’s safety committee recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 Vaccine Janssen on July 9, 2021. The Committee also recommended that capillary leak syndrome should be added to the product information as a new side effect of the vaccine.
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 EMA published an update on the safety of COVID-19 Vaccine Janssen on July 14, 2021. This document outlines the outcomes from the assessment of emerging worldwide safety data carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). It also contains high-level information from the reporting of suspected adverse reactions, which PRAC takes into account in its assessments (see section 2). 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. Around that time, about 8.5 million doses of COVID-19 Vaccine Janssen had been given to people in the EU/EEA.
COVID-19 Vaccine Janssen (Johnson & Johnson) CPT Code
The American Medical Association offers resources to help identify the appropriate CPT code.
COVID-19 Vaccine Janssen (Johnson & Johnson) 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 temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius). Janssen COVID-19 Vaccine Expiry Date: Please verify at https://vaxcheck.jnj
On June 11, 2021, the EMA stated 'Authorities in the EU are aware that a batch of the active substance for COVID-19 Vaccine Janssen had been contaminated with materials for another vaccine manufactured at the same site. The batch concerned was not intended for the EU market. Based on available information, batches of the vaccine released in the EU are not affected by cross-contamination. However, as a precaution and to safeguard the quality of vaccines, the supervisory authorities1 have recommended not releasing vaccine batches containing the active substance made around the same time that the contamination occurred.
COVID-19 Vaccine Janssen (Johnson & Johnson) News
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 13, 2021 - The U.S. FDA authorized the use, under the emergency use authorization for the Johnson & Johnson COVID-19 vaccine Janssen, of 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 should 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 2 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 for the production of 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 26, 2021 - The Belgimun government issued a statement 'a under 40 age woman was vaccinated through her foreign employer outside the Belgian system and had died in Belgium last week after developing “serious thrombosis and reduced blood platelets.”
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 the use of 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 in support of 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.
May 3, 2021 - As the COVID-19 epidemic in Denmark is currently under control and the vaccination rollout progresses satisfactorily with other available vaccines, the Danish Health Authority has decided to continue the national vaccination campaign without the COVID-19 vaccine from Johnson & Johnson.
April 29. 2021 - Johnson & Johnson is aware of multiple fraudulent campaigns that falsely offer for sale COVID-19 vaccines. At this moment, no individuals or private companies are authorized to offer, advertise, distribute or sell the Janssen COVID-19 vaccine on behalf of Janssen/Johnson & Johnson either directly or indirectly. So far, we are only distributing the Janssen COVID-19 vaccine to government bodies and supranational organizations. Additionally, the Janssen COVID-19 vaccine is not available for online purchase.
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. 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. These very rare types of thrombosis (with thrombocytopenia) included venous thrombosis mostly in unusual sites such as cerebral venous sinus thrombosis and splanchnic vein thrombosis and arterial thrombosis and fatal outcome in one case. All cases occurred in people below 60 years of age, and most were in women within three weeks of the person being vaccinated. The cases reviewed were similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
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.' Of the nearly 7 million doses administered so far in the United States, a small number of cases of a rare and severe type of blood clot have been reported in people after receiving the J&J/Janssen COVID-19 Vaccine. All reports occurred among women between 18 and 48, and symptoms occurred six to 13 days after vaccination. Therefore, healthcare providers are recommended to pause the use of the J&J/Janssen COVID-19 Vaccine. In addition, maintain acute clinical awareness of symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the J&J/Janssen COVID-19 Vaccine.
April 14, 2021 - The U.S. CDC's ACIP committee posted the agenda for the vaccine review meeting. This was a virtual Emergency meeting held on April 14, 2021, from 1:30 p.m. to 4:30 p.m. ET.
April 14, 2021 - Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company 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 extremely rare 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 review 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 6 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 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 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 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. Also, there are rigorous quality checks throughout our vaccine manufacturing processes. A single batch of drug substances was identified through these checks 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 substances, 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 Emergent team's role in supporting the response to COVID-19 and looking 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.
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 allayed concerns over clotting events associated with some countries, without definitive evidence 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 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.
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 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.
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 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 meeting's 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.
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 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.
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 deployment specifics as authorizations are secured and contracts are finalized.
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.
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. After that, 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.
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.
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.
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.
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. In addition, immune responses were similar across the age groups studied, including older adults.
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 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 - 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. 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 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.