Jcovden® COVID-19 Vaccine (Janssen, Johnson & Johnson) For 2022
The Jcovden® COVID-19 Vaccine (Ad26.COV2.S) is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized the SARS-CoV-2 spike protein. This Janssen-produced COVID-19 vaccine does not contain adjuvants, preservatives, materials of animal origin, or fetal tissue.
The viral vector used in the Jcovden Janssen - Johnson & Johnson (J&J) COVID‑19 Vaccine is based on a naturally occurring, low-prevalence human adenovirus known to cause common cold-like symptoms. 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 Jcovden 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 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 more durable protection against breakthrough infections and hospitalizations in line with published evidence of its durable antibody and cellular immune response.
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on February 27, 2021, for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies. On October 20, 2021, the U.S. FDA authorized a single booster dose of the Janssen COVID-19 Vaccine, and the FDA authorized using a heterologous booster dose for currently available COVID-19 vaccines. On February 11, 2022, the CDC issued new guidance for those who received the Jcovden Janssen COVID-19 Vaccine primary series should receive an additional dose and a booster dose for a total of 3 doses to be classified as up to date. And on March 29, 2022, the CDC stated, 'Adult Janssen primary vaccine (2-doses) recipients should preferentially receive a heterologous mRNA vaccine booster dose ≥ two months later.'
The World Health Organization (WHO) Listed the Jcovden COVID-19 vaccine Ad26.COV2.S, developed by Janssen, for emergency use in all countries on March 12, 2021. The WHO's SAGE published a Version #9 updated overview on December 9, 2021. Based on post-marketing safety surveillance, the following safety concerns were identified by the WHO on December 9, 2021: thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barre Syndrome, and capillary leak syndrome.
The U.K. granted marketing authorization for the Janssen Covid-19 vaccine on May 28, 2021, and updated it on Nov. 3, 2022. On March 22, 2022, the EMA published the latest clinical data EMEA/H/C/005737/II/0033; the EMA overview is found at this link.
The authorization or approval status of the Jcovden COVID-19 vaccine varies by country. Unless approved or licensed by the relevant health authority, the product is investigational, and its safety and efficacy have not been established. This country list is updated as additional information becomes available.
On May 5, 2022, the U.S. EUA Fact Sheets and Prescribing Information for Johnson & Johnson's Janssen COVID-19 Vaccine have been updated. For the most recent FDA Fact Sheets, please visit www.janssencovid19vaccine.com. The Janssen COVID-19 (Ad26.COV2.S) Vaccine Accession Number: DB15857; Unique Ingredient Identifier: JT2NS6183B. Anatomical therapeutic chemical code J07BX03; KEGG: D12129.
Janssen Biotech Inc. is a Janssen Pharmaceutical Company of Johnson & Johnson, located in New Jersey, USA. - JNJ-78436735, Ad26COVS1, VAC31518. U.S. FDA Concurrence Letter and FAQs. For more information on the Johnson & Johnson Janssen COVID-19 vaccine, visit JnJ.com. J&J and Janssen continue developing the single-dose COVID-19 vaccine per ethical standards and sound scientific principles. The JCOVDEN trademark was assigned Application Number #018320883 by the European Union Intellectual Property Office. Learn more at Janssen.com.
U.S. FDA Announcement Regarding Jcovden COVID-19 Vaccine (Janssen, Johnson & Johnson)
On May 9, 2022, the FDA limited the authorized use of the Jcovden COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and to individuals 18 years of age and older who elect to receive the Jcovden COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Furthermore, the factors that put an individual at risk for TTS following the vaccine administration remain unknown.
Jcovden COVID-19 Vaccine (Johnson & Johnson) (Ad26.COV2.S) Variants of Concern - Omicron, BA.2
As of May 15, 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 rapidly. On May 5, 2022, the peer-review journal NEJM reported a study based in South Africa that reported after two doses, the vaccine was effective against severe diseases caused by the omicron variant. The national vaccine program in South Africa has distributed 8,477,267 doses of the Ad26.COV2.S vaccine. Among the Ad26.COV2.S vaccine recipients, the vaccine effectiveness against ICU admission or high care was 69% (95% CI, 26 to 87) at 14 to 27 days and 82% (95% CI, 57 to 93) at 1 to 2 months after the second dose.
A study published in the peer-reviewed journal Nature on January 31, 2022, shows that the Jcovden Janssen vaccine provided robust cellular protection against serious illness caused by the highly transmissible Omicron (B.1.1.529) variant. Previously, Heather Scobie, Ph.D., MPH, resented an Update on Omicron Variant during the ACIP Meeting on December 16, 2021. And the JAMA published a study on November 2, 2021, that found the 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.
Jcovden COVID-19 Vaccine Dosage
The Jcovden vaccine is administered as a single (0.5 mL) vaccination. A primary Janssen vaccine dose is recommended for people ages 18 years. On April 7, 2022, the U.S. FDA confirmed information and data to support the extension of the shelf-life of the Janssen COVID-19 Vaccine stored at 2-8oC, from 9 months to 11 months.
Jcovden COVID-19 Vaccine Booster Doses
A single booster dose is recommended at least two months after the second (additional) dose, for a total of 3 doses (1 Janssen vaccine dose followed by one additional mRNA vaccine dose, then one booster dose). mRNA vaccines are preferred for the booster dose. If the Moderna vaccine is used for the booster dose, a 50 µg (0.25 ml) dose should be used.
On May 25, 2022, the JAMA published a Correspondence - the results of this study suggest that a single booster dose of an mRNA Covid-19 vaccine in persons who received primary vaccination with single-dose Ad26.COV2.S provided protection close to that of the three-dose mRNA vaccine regimen and supports the current recommendation of a booster dose of mRNA vaccine at least 2 months after primary vaccination with single-dose Ad26.COV2.S or at least 4 months after an Ad26.COV2.S booster dose.
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.
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.
Jcovden COVID1-9 Vaccine Side Effects
The U.S. FDA stated on May 5, 2022, an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.
The EMA's medicines safety committee recommended on April 3, 2022, that small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin, which may result in a rash, pointed or flat, red spots under the skin's surface, and bruising) should be added to the product information of COVID-19 Vaccine Janssen as a possible side effect of unknown frequency. The EMA published its monthly safety update confirming 45,947 suspected side effects, and 308 of these reported a fatal outcome in the EU/EEA. The EMA Fact Sheet was updated.
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.
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.
Jcovden 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 WHO had issued an Emergency Use Listing for its Janssen COVID-19 vaccine. J&J announced on October 15, 2021, that 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. In October 2021, Janssen presented: Booster Dose of Janssen COVID-19 Vaccine (Ad26.COV2.S) Following Primary Vaccination during the ACIP meeting.
Jcovden 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.
Jcovden 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.
Jcovden COVID-19 Vaccine For Persons Living With HIV
Among 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.
Jcovden COVID-19 Vaccine For Dialysis Patients
Dialysis patients who received an adenovirus vector-based Janssen COVID-19 vaccine (Johnson & Johnson) were found in a study to have similar rates of breakthrough infection, hospitalization, and mortality as dialysis patients who received an mRNA-based vaccine.
Jcovden COVID-19 Vaccine Coadministration With Influenza Vaccines
The WHO says 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.
Jcovden 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 vaccine component is a contraindication to vaccination.
Jcovden COVID-19 Vaccine CPT Code
The American Medical Association offers resources to help identify the appropriate CPT code.
Jcovden COVID-19 Vaccine Distribution Agreements
As of May 2022, Johnson & Johnson has shipped more than 200 million vaccine doses to Africa through a combination of our advance purchase agreements with the African Vaccine Acquisition Trust, South Africa, and Gavi, the Vaccine Alliance, on behalf of the COVAX Facility, along with government donations, and is Listed by the WHO.
Jcovden COVID-19 Vaccine Cold Storage
The U.S. FDA confirmed on April 18, 2022, the Janssen COVID-19 Vaccine shelf life and Expiry Date: Please verify at https://vaxcheck.jnj
Jonson & Johnson Janssen Jcovden COVID-19 Vaccine Revenues
April 19, 2022 - The company announced it is suspending its COVID-19 vaccine sales guidance, citing "global supply surplus and demand uncertainty." According to the J&J earnings release, reported sales of the Janssen COVID-19 vaccine in the U.S. totaled $75 million during Q1 2022, down $25 million compared to Q1 2021.
Jcovden COVID-19 Vaccine News For 2021 - 2022
May 25, 2022 - The peer-review journal The JAMA published a Correspondence - Effectiveness of Homologous and Heterologous Covid-19 Boosters against Omicron. For persons who received a single dose of the Ad26.COV2.S vaccine (Johnson & Johnson–Janssen) against Covid-19, a booster dose of an mRNA vaccine at least two months after the primary dose is recommended.
May 5, 2022 - The FDA and CDC announced they have continuously monitored for and investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 Vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases. The FDA has determined that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.
April 1, 2022 - CDC reported: Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults — VISION Network, 10 States, December 2021–March 2022.
March 8, 2022 - Johnson & Johnson announced the completion of an agreement between Janssen Pharmaceuticals, Inc., and manufacturer Aspen SA Operations Ltd, based in South Africa, to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, to increase COVID-19 vaccination rates across the continent.
February 7, 2022 - @NphcdaNG Tweeted: To support Nigeria's fight against COVID-19, Nigeria, took delivery of 1,936,050 doses of Johnson and Johnson's vaccines donated by the European Union.
February 1, 2022 - About 4 million doses of the Johnson & Johnson's Janssen COVID-19 vaccine arrived in Syria donated by Italy through the COVAX facility.
January 27, 2022 - The Lancet Infectious Diseases published an analysis based on data from 5.3 million people in Italy that found 'weakly rising rates of severe illness were observed for both the mRNA-based and adenovirus-vectored vaccines, with the average rates never exceeding three cases per 10,000 person-months even after nine months from the complete vaccination.'
January 25, 2022 - J&J announced 2021 Full-Year Sales of $93.8 Billion reflecting growth of 13.6%. The Company guides 2022 adjusted operational sales growth of 7.7% and adjusted operational EPS growth of 9.2%. Also contributing to growth were sales of the Janssen COVID-19 Vaccine.
January 24, 2022 - Stripes reported U.S. military personnel stationed in Germany who received only one Janssen COVID-19 dose are no longer considered fully vaccinated under federal German rules. Additionally, people who received the single-dose and a booster (2nd dose) are no longer considered boosted.
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 13, 2021 - The second dose of the Janssen COVID-19 vaccine is likely beneficial to recipients, confirmed the Food and Drug Administration's VRBPAC.
October 12, 2021 - The VRBPAC Briefing Document was posted ahead of the U.S. FDA vaccine committee meeting scheduled for 10/14/21.
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."
July 12, 2021 - The U.S. FDA issued a revised EUA regarding vaccine side effects: 'Reports of adverse events following use of the JanssenCOVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.'
April 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. FDA announced it issued an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The FDA determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuing a EUA.
December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: our poskim conclude that, according to the advice of your personal health care provider, the 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.
Jcovden COVID-19 Vaccine Clinical Trials
Janssen is investigating multiple dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy. Click here to review the current clinical trials.