Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Description
The Johnson & Johnson (J&J) Janssen COVID-19 Vaccine (Ad26.COV2.S) vaccine against COVID-19 is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein. This vaccine does not contain adjuvants, preservatives, materials of animal origin, or fetal tissue.
The viral vector used in the 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. For example, on January 6, 2022, a study found Ad26.COV2.S showed a more durable level of protection against breakthrough infections and hospitalizations in line with published evidence of its durable antibody and cellular immune response, although its Vaccine Effectiveness at baseline after a single dose is lower than that for the two-dose mRNA vaccines.
The NEJM published a Correspondence on October 15, 2021: Finding the Ad26.COV2.S vaccine-induced lower initial antibody responses than mRNA vaccines, but the responses were relatively stable over the 8-month follow-up period, with minimal-to-no evidence of decline.
On October 20, 2021, the U.S. FDA authorized a single booster dose of the Janssen COVID-19 Vaccine administered at least two months after completing the single-dose primary regimen to individuals 18 years of age and older. Also, on October 20, 2021, the FDA authorized using a heterologous booster dose for currently available (i.e., FDA-authorized or approved) COVID-19 vaccines.
The WHO's SAGE published a Version #9 updated overview on December 9, 2021. In addition, the EMA Fact Sheet has also been updated. Previously, the EMA announced on December 21, 2021, the risk of very rare events (thrombosis with thrombocytopenia syndrome [TTS], capillary leak syndrome, and Guillain-Barré syndrome) after a booster dose of COVID-19 Vaccine Janssen is unknown. On January 11, 2022, the U.S. FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and for Recipients and Caregivers. These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia.
For the most recent Fact Sheets, please visit www.janssencovid19vaccine.com.
The Janssen COVID-19 (Ad26.COV2.S) Vaccine Accession Number: DB15857; Unique Ingredient Identifier (UII): JT2NS6183B. Anatomical therapeutic chemical code J07BX03. The EMA overview is found at this link. Janssen Biotech Inc. is a Janssen Pharmaceutical Company of Johnson & Johnson, located in New Jersey, USA. - JNJ-78436735, Ad26COVS1, VAC31518. U.S. FDA Concurrence Letter and FAQs. For more information on the Johnson & Johnson Janssen COVID-19 vaccine, visit JnJ.com. J&J and Janssen continue developing the single-dose COVID-19 vaccine per ethical standards and sound scientific principles. Learn more at Janssen.com.
Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Variants of Concern - Omicron
As of January 20, 2022, the U.S. NIH OpenData Portal reported Reported in vitro Therapeutic Activity. Given its recent designation, Omicron/B.1.1.529 therapeutic activity data is currently being reported at a rapid pace. Heather Scobie, Ph.D., MPH, resented an Update on Omicron Variant during the ACIP Meeting on December 16, 2021.
The JAMA published a study on November 2, 2021, that found the Johnson & Johnson adenovirus-based Janssen COVID-19 vaccine is 74% effective in preventing SARS-CoV-2 infection even amid phases of high Alpha (B117) and Delta (B1617.2) variant circulation.
Janssen COVID-19 Vaccine Dosage
The Janssen vaccine is administered as a single (0.5 mL) vaccination. The U.S. 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. And a single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) may be administered to individuals 18 years of age and older as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
Janssen COVID-19 Vaccine Booster (2nd) Dose
The NEJM published an ORIGINAL ARTICLE on January 19, 2022: Immunogenicity and Reactogenicity of Vaccine Boosters after Ad26.COV2.S Priming. The Ad26.COV2.S vaccine had an acceptable safety profile and was immunogenic in healthcare workers who had received a priming dose of Ad26.COV2.S vaccine in this clinical study.
On December 15, 2021, the EMA announced its authorization for Janssen Vaccine boosters and mixing-and-matching dosing for adults. On December 5, 2021, J&J announced preliminary results from a non-peer-reviewed independent phase 2 study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting.
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 analyses of reactogenicity data during the seven days post-booster and the unsolicited A.E.s 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. On October 20, 2021, the FDA issued its authorization.
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. 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. In addition, 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.
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.
Janssen COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Authorization
As of January 20, 2022, the Janssen COVID‑19 Vaccine has not been Approved by the U.S. FDA. The FDA has Authorized the Janssen COVID-19 vaccine through a EUA. And the UK Medicines and Healthcare products Regulatory Agency issued authorization, last updated on November 3, 2021.
In Europe, about 18,700,000 vaccine doses have been given to people in the EU/EEA as of January 2022.
Janssen COVID-19 Vaccine Adolescent Indication
John R. Su, MD, Ph.D., MPH, presented: Adverse events among children ages 5–11 years after COVID-19 vaccination: updates from v-safe and the Vaccine Adverse Event Reporting System, as of Dec 13, 2021.
Janssen COVID-19 Vaccine Use For Pregnant or Lactating Women
The WHO recommends the use of Ad26.COV2.S vaccine in pregnancy only if the benefits of vaccination to pregnant women outweigh the potential risks.
Pregnancy: Available data on Janssen COVID-19 Vaccine administration 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 milk production/excretion. However, as Ad26.COV2.S is not a live virus vaccine; it is biologically and clinically unlikely to pose a risk to the breastfeeding child. Based on these considerations, WHO recommends using this vaccine in breastfeeding women as in non-breastfeeding individuals. WHO does not recommend discontinuing breastfeeding because of vaccination.
Janssen COVID-19 Vaccine For Persons Living With HIV
Among the phase 3 clinical trial participants with well-controlled HIV, there were no reported differences in safety signals. Therefore, HIV-positive persons who are well controlled on highly active antiretroviral therapy and are part of a group recommended for vaccination can be vaccinated. Information and, where possible, counseling about vaccine safety and efficacy profiles in immunocompromised persons should be provided to inform the individual benefit-risk assessment. It is not necessary to test for HIV infection before vaccine administration.
Janssen COVID-19 Vaccine Coadministration With Influenza Vaccines
The WHO says based on limited evidence mainly derived from other COVID-19 vaccines, it is acceptable to co-administer Ad26.COV2.S with an inactivated influenza vaccine. Different arms for injection should be used when both vaccines are delivered during the same visit. Continued pharmacovigilance monitoring is recommended. And no co-administration data are available for other live or inactivated vaccines.
Janssen COVID-19 Vaccine 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.
A history of anaphylaxis to any component of the vaccine is a contraindication to vaccination.
Janssen COVID1-9 Vaccine Side Effects
Based on post-marketing safety surveillance, the following safety concerns were identified: thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barre Syndrome (GBS), and capillary leak syndrome (CLS), reported the WHO on December 9, 2021. 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. Anyone with an acute febrile illness (body temperature over 38.5 ºC) should postpone vaccination until they are afebrile.
On December 16, 2021, the U.S. CDC's ACIP meeting presented: COVID-19 Vaccine Safety Technical Work Group Safety Assessment.
A peer-reviewed study published by the Annals of Internal Medicine on January 18, 2022, found rates for TTS, are rare with 3.83 cases per million vaccine doses (Ad26.COV2.S) administered.
On January 20, 2022, the EMA published its monthly safety update confirming 35,027 suspected side effects reports in the EU/EEA. And following a previous assessment (6 October 2021), in January 2022, the EMA's PRAC finalized the update of the product information on transverse myelitis as a side effect of COVID-19 Vaccine Janssen.
IN the U.S., 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 CPT Code
The American Medical Association offers resources to help identify the appropriate CPT code.
Janssen COVID-19 Vaccine Distribution Agreements
The authorization or approval status of Janssen's COVID-19 vaccine varies by country, says the EMA. Since its marketing authorization in the E.U. from March 11, 2021, until 01 December 2021, almost 18.1 million doses of COVID-19 Vaccine Janssen have been administered in the EU/EEA. As of January 15, 2022, the Janssen COVID-19 vaccine was available in Africa, Europe, India, France, the U.K., the USA and is Listed by the WHO.
Janssen COVID-19 Vaccine 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 Expiry Date: Please verify at https://vaxcheck.jnj
Janssen COVID-19 Vaccine News
January 14, 2022 - France's HAS announced the Janssen COVID-19 vaccine represents an effective alternative and has positioned it in the country's vaccine strategy.
January 11, 2022 - The U.S. FDA announced Fact Sheet revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia, a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.
January 6, 2022 - JNJ announced new results from the largest study to date on the durability of COVID-19 vaccines in the U.S., showing that a single shot of the Johnson & Johnson COVID-19 vaccine resulted in long-lasting protection for up to six months against COVID-19 breakthrough infections, hospitalizations, and intensive care unit admissions.
December 30, 2021 - Johnson & Johnson announced new preliminary results from the South African Phase 3b Sisonke study which showed a homologous booster shot of the Johnson & Johnson COVID-19 vaccine (Janssen, Ad26.COV2.S) demonstrated 85% effectiveness against COVID-19-related hospitalization. The study, conducted by the South African Medical Research Council (SAMRC), showed that the Johnson & Johnson booster reduced the risk of hospitalization from COVID-19 among healthcare workers in South Africa after Omicron became the dominant variant. During the months studied (mid-November to mid-December) the frequency of Omicron increased from 82 to 98% of COVID-19 cases in South Africa.
December 16, 2021 - The U.S. CDC's ACIP meeting presentation slides were published.
December 16, 2021 - The EMA's human medicines committee approved an additional manufacturing site for the production of COVID-19 Vaccine Janssen, developed by Janssen-Cilag International NV. The site is located in Marcy-l'Étoile, France, and operated by Sanofi Pasteur.
December 15, 2021 - The U.S. CDC's ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) published a draft agenda for a meeting on December 16, 2021.
December 15, 2021 - The EMA confirmed human medicines committee concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at least two months after the first dose in adults. This committee also concluded that a booster dose with COVID-19 Vaccine Janssen may be given after two doses of one of the mRNA vaccines.
December 14, 2021 - The U.S. FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Health Care Providers Administering Vaccine and the Fact Sheet for Recipients and Caregivers.
December 14, 2021 - Local media reported 2,011,200 doses of J&J's Janssen vaccine arrived at the Ninoy Aquino International Airport Terminal in the Philippines.
December 5, 2021 - Johnson & Johnson announced preliminary results from an independent non-peer-reviewed study, which showed that a booster shot of the Janssen COVID-19 vaccine, administered at six months after a two-dose primary regimen of Comirnaty (BNT162b2), increased both antibody and T-cell responses. These results demonstrate the potential benefits of heterologous boosting.
November 29, 2021 - Nova Scotia, Canada, is offering healthcare workers the opportunity to receive the Janssen COVID-19 vaccine in place of an mRNA vaccine.
November 24, 2021 - The Janssen Pharmaceutical Companies of J&J announced Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
November 13, 2021 - Manitoba's Health Minister Audrey Gordon tweeted that the first shipment of the Janssen vaccine has arrived and is being distributed to some pharmacies and medical clinics.
November 12, 2021 - Alberta Premier Jason Kenney posted on Facebook the province can now offer a limited supply of the one-dose Johnson & Johnson Janssen COVID-19 vaccine.
November 2, 2021 - The JAMA Network published an Original Investigation: Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19. This comparative effectiveness research study found that, through large-scale longitudinal retrospective curation of electronic health records from the multistate Mayo Clinic Health System, the Ad26.COV2.S vaccine had an effectiveness of 74%. This study's findings are consistent with the clinical trial–reported efficacy of Ad26.COV2.S and the first retrospective analysis, suggesting that the vaccine is effective at reducing SARS-CoV-2 infection, even with the spread of variants such as Alpha or Delta that were not present in the original studies, and reaffirm the urgent need to continue mass vaccination efforts globally.
October 29, 2021 - U.K. media reported the U.K. will donate 20 million Janssen Covid-19 vaccines to developing countries.
October 26, 2021 - A non-peer-reviewed study based in the Netherlands compared Spike S1-specific (S1) IgG antibodies after vaccination with mRNA-based (Comirnaty, Spikevax) or vector-based (Janssen, Vaxzevria) vaccines, using samples from a Dutch nationwide cohort. Nearly all participants seroconverted following vaccination, including seniors.
October 21, 2021 - Johnson & Johnson announced that the U.S. CDC's ACIP recommended its Janssen COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine.
October 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 6, 2021 - The EMA published a Safety Update.
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 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.'
May 6, 2021 - The CDC and the U.S. Food and Drug Administration recommend using 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 20, 2021 - Johnson & Johnson announced that the European Medicines Agency's Pharmacovigilance Risk Assessment Committee has provided updated guidance for using the Company's COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. Accordingly, following the PRAC recommendation, the Company will resume the Janssen COVID-19 vaccine shipment in the European Union, Norway, and Iceland.
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 U.S. 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.
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.
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.
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.
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.
October 8, 2020 - Johnson & Johnson announced the European Commission, acting on behalf of the European Union (E.U.) the Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to the E.U. Member States following approval or authorization from regulators.
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.
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.