JNJ Johnson & Johnson

161.25
-1.72  -1%
Previous Close 162.97
Open 162.12
52 Week Low 133.65
52 Week High 173.65
Market Cap $424,523,934,413
Shares 2,632,706,570
Float 2,631,100,001
Enterprise Value $439,133,189,712
Volume 8,417,746
Av. Daily Volume 7,820,250
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Upcoming Catalysts

Drug Stage Catalyst Date
JNJ-78436735 (Ad26.COV2-S) - (ENSEMBLE-2)
COVID-19 vaccine - two-dose regimen
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Nipocalimab (M281)
generalized myasthenia gravis (gMG)
Phase 2
Phase 2
Phase 2 trial met primary endpoint - June 15, 2020. Phase 3 trial to be initiated 1Q 2021.
JNJ-78436735 (Ad26.COV2-S) - (ENSEMBLE)
COVID-19 vaccine (single dose)
Approved
Approved
Phase 3 data released January 29, 2021. Efficacy rate 66% in overall population, 72% effective in U.S. and 57% in South Africa. EUA Approval by FDA announced February 27, 2021.
DARZALEX (Daratumumab) using ENHANZE
Amyloidosis
Approved
Approved
FDA approval announced January 15, 2021.
Guselkumab
Ulcerative colitis
Phase 2
Phase 2
Phase 2a initiation announced January 17, 2019.
Bermekimab
Systemic Sclerosis
Phase 2
Phase 2
Phase 2 commencement of enrolment announced October 2, 2019.
Daratumumab in combination with pomalidomide and dexamethasone
Multiple myeloma
sNDA Filing
sNDA Filing
sBLA filing announced November 12, 2020.
Amivantamab
Non-small cell lung cancer (NSCLC)
BLA Filing
BLA Filing
BLA filing announced December 3, 2020.
Paliperidone
Schizophrenia
sNDA Filing
sNDA Filing
sNDA filing announced November 2, 2020.
Generic Copaxone
Multiple sclerosis
Approved
Approved
Filed 2007. Approved April 16 2015.
Erdafitinib
Urothelial cancer
Approved
Approved
FDA Approval announced April 12, 2019.
Bermekimab
Atopic Dermatitis (AD)
Phase 2
Phase 2
Phase 2 commencement of enrolment announced November 12, 2019.
Bermekimab
Hidradenitis Suppurativa (HS)
Phase 2
Phase 2
Phase 2 commencement of enrolment announced October 23, 2019.
Darzalex (daratumumab) and Kyprolis (carfilzomib)
Multiple Myeloma
Approved
Approved
FDA approval announced August 20, 2020.
Esketamine
Major depressive disorder (MDD)
Approved
Approved
FDA approval announced August 3, 2020.
Guselkumab
Psoriatic Arthritis
Approved
Approved
FDA Approval announced July 14, 2020.
Guselkumab (NOVA)
Hidradenitis Suppurativa
Phase 2
Phase 2
Phase 2 trial initiation announced November 19, 2018.
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
Approved
Approved
FDA Approval announced May 1, 2020.
IMBRUVICA (ibrutinib) and rituximab
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Approved
Approved
FDA Approval announced April 21, 2020.
Ponesimod
Relapsing multiple sclerosis
NDA Filing
NDA Filing
NDA filing announced March 18, 2020.
STELARA (USTEKINUMAB)
Ulcerative colitis
Approved
Approved
FDA Approval announced October 21, 2019.
XARELTO (rivaroxaban)
Reduce the Risk of Recurrent Venous Thromboembolism (VTE)
Approved
Approved
FDA approval announced October 14, 2019.
STELARA (USTEKINUMAB)
Plaque psoriasis - pediatric
sNDA Filing
sNDA Filing
sBLA filing announced October 7, 2019.
INVOKANA - CREDENCE
Diabetic Kidney Disease
Approved
Approved
FDA Approval announced September 30, 2019.
Daratumumab + VTD
Multiple myeloma - candidates for autologous stem cell transplant (ASCT)
Approved
Approved
FDA Approval announced September 26, 2019.
Apalutamide
Metastatic castration-sensitive prostate cancer (mCSPC).
Approved
Approved
FDA Approval announced September 18, 2019.
DARZALEX (Daratumumab) + pomalidomide and dexamethasone
Relapsed or refractory multiple myeloma
Approved
Approved
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
Daratumumab - MAIA
Newly Diagnosed Multiple Myeloma (NDMM)
Approved
Approved
FDA Approval announced June 28, 2019.
Guselkumab vs Cosentyx - ECLIPSE
Psoriasis
Phase 3
Phase 3
Phase 3 primary endpoint met - December 12, 2018.
Guselkumab (GALAXI 1)
Crohn's disease
Phase 2/3
Phase 2/3
Phase 2/3 trial initiation announced July 11, 2018.
Esketamine
Treatment resistant depression
Approved
Approved
FDA approval announced March 5, 2019.
Guselkumab
Plaque psoriasis
Approved
Approved
Approval announced February 27, 2019.
Apalutamide
Non-metastatic castration-resistant prostate cancer (CRPC)
Approved
Approved
Approval announced February 14, 2018.
INVOKANA CANVAS
Type 2 diabetes
Approved
Approved
FDA Approval announced October 30, 2018.
IMBRUVICA (ibrutinib)
Waldenström’s Macroglobulinemia
Approved
Approved
FDA approval announced August 27, 2018.
D/C/F/TAF
HIV
Approved
Approved
FDA Approval announced July 17, 2018.
IMBRUVICA (ibrutinib)
Diffuse large B-cell lymphoma (DLBCL)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 11, 2018.
Atabecestat
Alzheimer’s disease
Phase 2
Phase 2
Announced May 18, 2018 that dosing will be stopped.
DARZALEX (Daratumumab) - ALCYONE
Frontline multiple myeloma (non-transplant)
Approved
Approved
Approval announced May 7, 2018.
ZYTIGA (abiraterone acetate) - LATITUDE
metastatic hormone-naïve prostate cancer (mHNPC)
Approved
Approved
sNDA approval announced February 8, 2018.
Sirukumab
Rheumatoid arthritis
CRL
CRL
CRL issued September 22, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
Guselkumab
Plaque psoriasis
Approved
Approved
Approval announced July 13, 2017.
SIMPONI ARIA
Ankylosing Spondylitis
Approved
Approved
Approval announced October 20, 2017.
SIMPONI ARIA
Psoriatic arthritis (PsA)
Approved
Approved
Approval announced October 20, 2017.
STELARA (USTEKINUMAB)
Plaque psoriasis
Approved
Approved
Approval announced October 13, 2017.
Imbruvica
Marginal zone lymphoma
Approved
Approved
sNDA filing announced September 26, 2017. Priority Review. Approved January 19, 2017.
XARELTO (rivaroxaban)
Coronary Artery Disease or Peripheral Artery Disease
Phase 3
Phase 3
Phase 3 trial stopped early due to positive efficacy - February 8, 2017.
Imbruvica
Second-line Chronic graft-versus-host disease (GVHD)
Approved
Approved
Approval announced August 2, 2017.
Talacotuzumab
Acute myeloid leukemia (AML)
Phase 3
Phase 3
Phase 3 discontinuation announced October 17, 2017.

Latest News

  1. Up to 400 million doses of the Company's single-shot vaccine candidate will be made available to African Union member states

    Availability of the vaccine is subject to national regulatory approvals

    Data have demonstrated vaccine candidate protects against COVID-19 related hospitalization and death in broad geographic regions, including those with variants of significant concern

    NEW BRUNSWICK, N.J., March 29, 2021 /PRNewswire/ -- Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union's 55 member states…

    Up to 400 million doses of the Company's single-shot vaccine candidate will be made available to African Union member states

    Availability of the vaccine is subject to national regulatory approvals

    Data have demonstrated vaccine candidate protects against COVID-19 related hospitalization and death in broad geographic regions, including those with variants of significant concern

    NEW BRUNSWICK, N.J., March 29, 2021 /PRNewswire/ -- Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union's 55 member states with delivery beginning in the third quarter of 2021. AVAT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful approval or authorization by the national regulatory authorities of AU member states.

    "From the beginning of this pandemic, Johnson & Johnson has recognized that no one is safe until everyone is safe, and we have been committed to equitable, global access to new COVID-19 vaccines," said Alex Gorsky, Chairman and Chief Executive Officer of Johnson & Johnson. "Our support for the COVAX Facility, combined with supplementary agreements with countries and regions, will help accelerate global progress toward ending the COVID-19 pandemic."

    Johnson & Johnson is committed to ensuring equitable global access to its single-shot COVID-19 vaccine candidate on a not-for-profit basis for emergency pandemic use. In December 2020, the Company entered into an agreement in principle with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility, which is supporting the initial vaccination needs of 190 participating economies, including many countries in Africa. The Company and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Company's vaccine to COVAX through 2022.

    Additionally, Johnson & Johnson recognizes the increasingly severe impact of COVID-19 in Africa, as well as the emergence and continued spread of a SARS-CoV-2 variant in the Republic of South Africa that demonstrates increased transmissibility.

    Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

    The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination. Variants observed in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which was identified in 95 percent of the COVID-19 cases in South Africa.

    Manufacturing and Supply Chain Information

    Johnson & Johnson has established a global manufacturing and supply network for its COVID-19 vaccine, collaborating with nine partners across four continents, including Aspen Pharmacare in South Africa. Aspen will support vaccine shipments to the AU member states and will also contribute to global availability of the vaccine.

    The Johnson & Johnson COVID-19 single-shot vaccine is compatible with standard vaccine storage and distribution channels enabling delivery to remote areas. The vaccine is estimated to remain stable for two years at -25 to -15°C, a maximum of three months of which can be at routine refrigeration at temperatures of 2°-8°C. This enables the vaccine to be shipped using the same cold chain technologies used to transport other medicines and vaccines in routine use.

    Johnson & Johnson's COVID-19 Vaccine

    The Johnson & Johnson COVID-19 vaccine uses the AdVac® vaccine platform, a proprietary technology that was also used to develop and manufacture Janssen's European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

    Regulatory Filings  

    The Johnson & Johnson single-shot COVID-19 vaccine was granted Emergency Use Listing from the World Health Organization (WHO) on March 12, Conditional Marketing Authorization from the European Commission on March 11 and Emergency Use Authorization by the U.S. Food and Drug Administration on February 27, 2021. The single-shot COVID-19 vaccine has also been granted Interim Order authorization in Canada, and additional rolling submissions have been initiated in several countries worldwide.

    For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

    Cautions Concerning Forward-Looking Statements

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company, any of the other Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    (PRNewsfoto/Johnson & Johnson)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/johnson--johnson-announces-advance-purchase-agreement-with-the-african-vaccine-acquisition-trust-for-the-companys-covid-19-vaccine-candidate-301257348.html

    SOURCE Johnson & Johnson

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  2. NEW BRUNSWICK, N.J., March 12, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) (the Company) today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.

    Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

    The data also demonstrated…

    NEW BRUNSWICK, N.J., March 12, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) (the Company) today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.

    Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

    The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination.1  Variants observed in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which was identified in 95 percent of the COVID-19 cases in South Africa.

    "From the beginning of the pandemic, we have worked to develop and deliver a vaccine that could protect the health of people everywhere, and today's milestone represents significant progress toward ensuring global access to our single-shot vaccine," said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. "We are moving forward with urgency and purpose to meet our commitments to the global community as we do all we can to help end the pandemic."

    The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and United Nations procurement agencies. The EUL process expedites access to such products in many countries around the world and is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

    "The WHO listing of our single-shot COVID-19 vaccine advances our pledge to help stem this pandemic and our unwavering commitment to equitable access," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. "Achieving this important prerequisite for distributing our vaccine through the COVAX Facility which is co-led by Gavi is a major step forward in making our vaccine accessible for all."

    In December 2020, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility. Johnson & Johnson and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Company's vaccine to COVAX through 2022.2 

    "A single-shot COVID-19 vaccine that can be distributed and stored using established supply chains has the potential to be very meaningful in the face of this global pandemic," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development at Johnson & Johnson. "In addition, the clinical data shared with WHO that informed the Emergency Use Listing demonstrated protection against disease across countries with multiple variants."

    Commitment to Equitable Access

    Equitable access is at the center of Johnson & Johnson's COVID-19 response. The Johnson & Johnson single-shot vaccine candidate and its compatibility with standard vaccine distribution channels align with WHO's recommendations for medical interventions in a pandemic setting, which emphasize ease of distribution, administration, and compliance.

    The Company is committed to ensuring global access to the Johnson & Johnson single-shot COVID-19 vaccine candidate on a not-for-profit basis for emergency pandemic use. In September 2020, Johnson & Johnson joined other life sciences companies and the Bill & Melinda Gates Foundation in signing an unprecedented communiqué which outlined a steadfast commitment to facilitating equitable access to the innovations being developed to fight the pandemic.3 

    Regulatory Filings

    Johnson & Johnson received Emergency Use Authorization (EUA) in the United States on February 274 following a unanimous vote by the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee on February 26, 2021.5 The Company's single-shot COVID-19 vaccine was also granted Interim Order authorization in Canada on March 5, 20216 and Conditional Marketing Authorization (CMA) in the European Union on March 11, 2021.7

    Manufacturing and Supply Chain Information

    The Johnson & Johnson COVID-19 single-shot vaccine is compatible with standard vaccine storage and distribution channels enabling delivery to remote areas.4 The vaccine is estimated to remain stable for two years at -25 to -15°C, and a maximum of three months of which can be at routine refrigeration at temperatures of 2°-8°C.4,8  This enables the vaccine to be shipped using the same cold chain technologies used to transport other medicines and vaccines in routine use.4,9

    Johnson & Johnson's COVID-19 Vaccine

    The Johnson & Johnson COVID-19 vaccine uses the AdVac® vaccine platform, a proprietary technology that was also used to develop and manufacture Janssen's European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.6

    Phase 3 ENSEMBLE Study Design

    The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older.10 The study was designed to evaluate the safety and efficacy of the Company's vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.11 The study enrolled a total of 43,783 participants.

    The trial, conducted in eight countries across three continents,10 includes a diverse and broad population of which 34 percent of participants were over age 60.1 Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.1

    For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

    Cautions Concerning Forward-Looking Statements

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    ______________________________

    1 Janssen. Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial. Available at: https://www.janssen.com/emea/sites/www_janssen_com_emea/files/johnson_johnson_announces_single-shot_janssen_covid-19_vaccine_candidate_met_primary_endpoints_in_interim_analysis_of_its_phase_3_ensemble_trial.pdf  Last accessed: March 2021.

    2 Johnson & Johnson. Johnson & Johnson Announces Agreement in Principle with Gavi to Supply Janssen's COVID-19 Vaccine Candidate to Lower-Income Countries in 2021. Available at: https://www.jnj.com/our-company/johnson-johnson-announces-agreement-in-principle-with-gavi-to-supply-janssens-covid-19-vaccine-candidate-to-lower-income-countries-in-2021. Last accessed: March 2021.

    3 Johnson & Johnson. Johnson & Johnson Joins Other Companies in Signing a Landmark Communiqué on Expanded Global Access for COVID-19. Available at: https://www.jnj.com/latest-news/johnson-johnson-signs-communique-on-expanded-global-access-for-covid-19-vaccines. Last accessed: March 2021.

    4 Johnson & Johnson. Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic. Available at: https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic. Last accessed: March 2021.

    5 Johnson & Johnson. Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee. Available at: https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-u-s-fda-advisory-committee. Last accessed: March 2021.

    6 Johnson & Johnson. Johnson & Johnson COVID-19 Vaccine Granted Authorization under Interim Order by Health Canada For Emergency Use. Available at: https://www.jnj.com/johnson-johnson-covid-19-vaccine-granted-authorization-under-interim-order-by-health-canada-for-emergency-use. Last accessed: March 2021.

    7 Johnson & Johnson. Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission. Available at: https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission

    8 Custers, J., Kim, D., et al. Vaccines based on replication incompetent Ad26 viral vectors: Standardized template with key considerations for a risk/benefit assessment. Vaccine. 2020.

    9 ClinicalTrials.gov. A study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE). Available at: https://clinicaltrials.gov/ct2/show/NCT04505722. Last accessed: March 2021.

    10 ClinicalTrials.gov. A study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE). Available at: https://clinicaltrials.gov/ct2/show/NCT04505722. Last accessed: March 2021.

    11 Johnson & Johnson. COVID-19 Phase 3 study clinical protocol. Available at: https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol. Last accessed: March 2021.

    (PRNewsfoto/Johnson & Johnson)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/johnson--johnson-single-shot-covid-19-vaccine-granted-emergency-use-listing-by-the-world-health-organization-301246502.html

    SOURCE Johnson & Johnson

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  3. Johnson & Johnson (NYSE:JNJ) will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, April 20th to review first-quarter results. Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Christopher DelOrefice, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include Alex Gorsky, Chairman and Chief Executive Officer.

    Investors and other interested parties can access the webcast/conference call in the following ways:

    · The webcast and presentation material are accessible at Johnson & Johnson's website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.

    · By telephone…

    Johnson & Johnson (NYSE:JNJ) will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, April 20th to review first-quarter results. Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Christopher DelOrefice, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include Alex Gorsky, Chairman and Chief Executive Officer.

    Investors and other interested parties can access the webcast/conference call in the following ways:

    · The webcast and presentation material are accessible at Johnson & Johnson's website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.

    · By telephone: for both “listen-only” participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.

    · A replay of the conference call will be available until approximately 12:00 a.m. on May 4, 2021. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13716717.

    · The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.

    · Please refer to www.investor.jnj.com for a complete list of currently planned 2021 earnings webcast/conference calls. Please note the second-quarter date of Wednesday, July 21st, 2021.

    About Johnson & Johnson
    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity

    — WebWireID271424 —


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  4. NEW BRUNSWICK, N.J., Feb. 28, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) (the Company) today announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA).

    "For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and we believe today's recommendation from the CDC to begin use of our vaccine as part of the U.S. national immunization program will add a critical tool in…

    NEW BRUNSWICK, N.J., Feb. 28, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) (the Company) today announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA).

    "For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and we believe today's recommendation from the CDC to begin use of our vaccine as part of the U.S. national immunization program will add a critical tool in the fight against COVID-19," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. "This recommendation follows the FDA's decision to grant an Emergency Use Authorization for our single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic."

    ACIP is a body of independent health experts that advises the CDC on the types of populations and circumstances for which vaccines should be used. The ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services (HHS) for review and adoption.

    The Company's single-shot COVID-19 vaccine received EUA from the FDA on February 27, 2021.  The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

    Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S.

    Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

    Manufacturing and Supply Chain Information

    The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C). The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36°F–46°F (2°-8°C).

    Johnson & Johnson's COVID-19 Vaccine Candidate

    The Company's Janssen COVID-19 vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen's European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

    The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by the FDA through an Emergency Use Authorization (EUA).

    The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information are available here.

    For more information on the single-dose Janssen COVID-19 vaccine, visit: www.janssencovid19vaccine.com.

    Phase 3 ENSEMBLE Study Design

    The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company's vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.

    The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34 percent of participants over age 60.

    The study enrolled 44 percent of participants in the United States. Seventy-four percent of participants in the U.S. are White/Caucasian; 15 percent are Hispanic and/or Latinx; 13 percent are Black/African American; 6 percent are Asian and 1 percent are Native American.

    Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.

    Research and development activities for the Company's COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS). 

    Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola.

    For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

    Authorized Use

    The Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

    Important Safety Information

    WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?

    Tell the vaccination provider about all of your medical conditions, including if you:

    • have any allergies
    • have a fever
    • have a bleeding disorder or are on a blood thinner
    • are immunocompromised or are on a medicine that affects your immune system
    • are pregnant or plan to become pregnant
    • are breastfeeding
    • have received another COVID-19 vaccine

    WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?

    You should not get the Janssen COVID-19 Vaccine if you:

    • had a severe allergic reaction to any ingredient of this vaccine.

    HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?

    The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

    WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?

    Side effects that have been reported with the Janssen COVID-19 Vaccine include:

    • Injection site reactions: pain, redness of the skin, and swelling.
    • General side effects: headache, feeling very tired, muscle aches, nausea, fever.

    There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

    • Difficulty breathing
    • Swelling of your face and throat
    • A fast heartbeat
    • A bad rash all over your body
    • Dizziness and weakness

    These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

    WHAT SHOULD I DO ABOUT SIDE EFFECTS?

    If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

    Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include "Janssen COVID-19 Vaccine EUA" in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech, Inc. at 1-800-565-4008.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

    Cautions Concerning Forward-Looking Statements

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    (PRNewsfoto/Johnson & Johnson)

     

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    SOURCE Johnson & Johnson

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  5. NEW BRUNSWICK, N.J., Feb. 27, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

    This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

    The terms of the EUA allow use of the vaccine…

    NEW BRUNSWICK, N.J., Feb. 27, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

    This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

    The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

    "This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public," said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. "We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world."

    "We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic."

    Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccines to the U.S. government and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC's Advisory Committee on Immunization Practices (ACIP) guidelines.

    Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

    The EUA follows a unanimous vote by the U.S. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), on February 26, 2021.

    "We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single-shot COVID-19 vaccine to protect people around the world," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

    Manufacturing and Supply Chain Information

    The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C). The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36°F–46°F (2°-8°C).

    Johnson & Johnson's COVID-19 Vaccine

    The Company's COVID-19 vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen's European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

    The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID-19.

    The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information available are at https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf.

    Phase 3 ENSEMBLE Study Design

    The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company's vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.

    The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34 percent of participants over age 60.

    The study enrolled 44 percent of participants in the United States. Seventy-four percent of participants in the U.S. are White/Caucasian; 15 percent are Hispanic and/or Latinx; 13 percent are Black/African American; 6 percent are Asian and 1 percent are Native American.

    Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.

    Research and development activities for the Company's COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have been funded in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS). 

    Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola.

    For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

    Authorized Use

    The Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

    Important Safety Information

    WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE JANSSEN COVID-19 VACCINE?

    Tell the vaccination provider about all of your medical conditions, including if you:

    • have any allergies
    • have a fever
    • have a bleeding disorder or are on a blood thinner
    • are immunocompromised or are on a medicine that affects your immune system
    • are pregnant or plan to become pregnant
    • are breastfeeding
    • have received another COVID-19 vaccine

    WHO SHOULD NOT GET THE JANSSEN COVID-19 VACCINE?

    You should not get the Janssen COVID-19 Vaccine if you:

    • had a severe allergic reaction to any ingredient of this vaccine.

    HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?

    The Janssen COVID-19 Vaccine will be given to you as an injection into the muscle.  The Janssen COVID-19 Vaccine vaccination schedule is a single dose.

    WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?

    Side effects that have been reported with the Janssen COVID-19 Vaccine include:

    • Injection site reactions: pain, redness of the skin, and swelling.
    • General side effects: headache, feeling very tired, muscle aches, nausea, fever.

    There is a remote chance that the Janssen COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

    • Difficulty breathing
    • Swelling of your face and throat
    • A fast heartbeat
    • A bad rash all over your body
    • Dizziness and weakness

    These may not be all the possible side effects of the Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.

    WHAT SHOULD I DO ABOUT SIDE EFFECTS?

    If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

    Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

    Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include "Janssen COVID-19 Vaccine EUA" in the first line of box #18 of the report form. In addition, you can report side effects to Janssen Biotech, Inc. at 1-800-565-4008.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

    Cautions Concerning Forward-Looking Statements

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    (PRNewsfoto/Johnson & Johnson)

     

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    SOURCE Johnson & Johnson

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