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Positive new Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on task Against Delta Variant and Long-lasting durability of Response
Positive new Data because that Johnson & Johnson Single-Shot COVID-19 Vaccine on task Against Delta Variant and Long-lasting to trust of Response
Demonstrated solid neutralizing antibody activity against the Delta (B.1.617.2) variant
Persistent immune responses through at least eight months
NEW BRUNSWICK, N.J., July 1, 2021 – Johnson & Johnson (NYSE: buzzpatterson.com) (the Company) now announced data the demonstrated the single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and also other extremely prevalent SARS-CoV-2 famous variants. In addition, the data showed that the durability of the immune solution lasted with at the very least eight months, the size of time evaluated to date. The 2 preprint examine summaries have been submitted this day to bioRxiv.
“Today’s newly announced research studies reinforce the capability of the Johnson & Johnson COVID-19 vaccine to help protect the health and wellness of civilization globally,” stated Paul Stoffels, M.D., angry Chairman of the executive, management Committee and also Chief scientific Officer in ~ Johnson & Johnson. “We think that ours vaccine offers resilient protection versus COVID-19 and also elicits neutralizing activity against the Delta variant. This adds come the robust body that clinical data supporting our single-shot vaccine’s capability to protect versus multiple variants that concern.”
“Current data because that the eight month studied therefore far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody solution that does no wane; rather, us observe an improvement over time. In addition, us observe a persistent and specifically robust, sturdy cellular immune response,” claimed Mathai Mammen, M.D., Ph.D., an international Head, Janssen research & Development, Johnson & Johnson. “With each new dataset, we build on ours solid foundation of evidence that our single-shot COVID-19 vaccine theatre a crucial role in finishing the pandemic, which continues to evolve and pose new challenges to an international health.”
Demonstrated strong neutralizing antibody activity against the Delta (B.1.617.2) variantA preprint submitted by the firm today come bioRxiv consists of a brand-new analysis native blood samples obtained from a subset of entrants (n=8) in the step 3 ENSEMBLE study. These data verified that the Johnson & Johnson single-shot COVID-19 vaccine elicited neutralizing antibody activity against the Delta different at one even higher level 보다 what was recently observed because that the Beta (B.1.351) different in south Africa wherein high efficacy against severe/critical disease was demonstrated.
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In the ENSEMBLE trial, Johnson & Johnson’s single-dose COVID-19 vaccine to be 85 percent effective against severe/critical disease and demonstrated protection against hospitalization and also death. The vaccine was consistently effective across all areas studied globally, including in southern Africa and Brazil, where there was a high pervasiveness of rapidly emerging Beta and also Zeta (P.2) variants during the study period.
Immune responses persisted v at the very least eight monthsData submitted by Dan Barouch, M.D., Ph.D., that Beth Israel Deaconess Medical facility et al., to bioRxiv from a sub-study that the Johnson & Johnson step 1/2a COVID-19 vaccine research (n=20) confirmed that humoral and cellular immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine lasted with at least eight months, the recent timepoint taped in the study thus far. Data proved that T-cell responses – including CD8+ T-cells that seek out and destroy infected cell – persisted over the eight-month timeframe examined.
A solitary dose the the Johnson & Johnson COVID-19 vaccine created neutralizing antibodies against a variety of SARS-CoV-2 variants of concern, which enhanced over time (the average neutralizing titer at eight months exceeded that average at 29 days), including against the progressively prevalent and much more transmissible Delta (B.1.617.2) variant, the partially neutralization-resistant Beta (B.1.351), the Gamma (P.1) variants and also others, including the Alpha (B.1.1.7), Epsilon (B.1.429), Kappa (B.1.617.1) and also D614G variants, and the original SARS-CoV-2 stress, overload (WA1/2020).
Johnson & Johnson’s single-dose COVID-19 vaccine is now easily accessible in numerous regions and countries top top a not-for-profit basis throughout the emergency pandemic period The vaccine obtained Emergency usage Authorization (EUA) in the United says on February 27 and Conditional Marketing Authorization (CMA) by the european Commission on in march 11, 2021. The civilization Health organization (WHO) approve Emergency use Listing on march 12, 2021 and also the company received one interim recommendation by the strategy Advisory group of professionals (SAGE) on Immunization because that the who on in march 17, 2021. Many more authorizations have been granted in nations worldwide, and also regulatory submissions are ongoing.
Research and also development activities for the this firm COVID-19 vaccine, consisting of the ENSEMBLE clinical trial and also the shipment of doses because that the U.S., have actually been sponsor in component with commonwealth funds native the U.S. Room of Health and also Human Services, Office the the Assistant Secretary because that Preparedness and Response, Biomedical progressed Research and advancement Authority (BARDA), under Contract No. HHSO100201700018C, and also in participation with the nationwide Institute the Allergy and also Infectious conditions (NIAID), part of the national Institutes of wellness (NIH) in ~ the U.S. Department of Health and also Human solutions (HHS).
Johnson & Johnson has worked with BARDA due to the fact that 2015 on innovative remedies for influenza, chemical, biological, radiation and also nuclear threats and emerging transmittable diseases such together Ebola.
Storage and Distribution The Johnson & Johnson COVID-19 single-dose vaccine is compatible through standard vaccine storage and distribution networks with lull of distribution to far areas. The vaccine is estimated to remain stable for 2 years in ~ -4°F (-20°C), and also a best of 4.5 months at regime refrigeration temperatures of 36° to 46°F (2° to 8°C). The company will delivery the vaccine using the very same cold chain modern technologies it provides today come transport various other medicines. The COVID-19 vaccine need to not be re-frozen if dispersed at temperature of 36°F to 46°F (2°-8°C).
For much more information ~ above the company’s multi-pronged technique to help combat the pandemic, visit: www.buzzpatterson.com/covid-19.
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Authorized UseThe Janssen COVID-19 vaccine is authorized for use in the U.S. Under one Emergency usage Authorization (EUA) for energetic immunization to avoid coronavirus condition 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and also older.
Important safety InformationWHAT should YOU point out TO YOUR inoculation PROVIDER before YOU acquire THE JANSSEN COVID-19 VACCINE?Tell the inoculation provider about all the your clinical conditions, including if you:have any allergieshave a feverhave a bleeding disorder or space on a blood thinnerare immunocompromised or room on a medication that affects her immune systemare pregnant or plan to become pregnantare breastfeedinghave received an additional COVID-19 vaccine
WHO need to NOT acquire THE JANSSEN COVID-19 VACCINE?You must not gain the Janssen COVID-19 Vaccine if you:had a severe allergic reaction to any ingredient the this vaccine.
HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?The Janssen COVID-19 Vaccine will be given to you together an injection right into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a solitary dose.
WHAT space THE threats OF THE JANSSEN COVID-19 VACCINE?Side results that have actually been reported with the Janssen COVID-19 Vaccine include:Injection website reactions: pain, redness that the skin, and also swelling.General next effects: headache, feeling really tired, muscle aches, nausea, fever.
There is a remote chance that the Janssen COVID-19 Vaccine could reason a serious allergic reaction. A serious allergic reaction would usually happen within a few minutes come one hour after obtaining a dose of the Janssen COVID-19 Vaccine. Because that this reason, your inoculation provider might ask girlfriend to continue to be at the place where you obtained your vaccine for surveillance after vaccination. Indications of a serious allergic reaction can include:Difficulty breathingSwelling of your face and also throatA rapid heartbeatA negative rash anywhere your bodyDizziness and weakness
Blood clots including blood ship in the brain, abdomen, and also legs in addition to low levels of platelets (blood cells that assist your body prevent bleeding), have developed in some world who have received the Janssen COVID-19 Vaccine. In civilization who occurred these blood clots and low level of platelets, symptom began approximately one come two-weeks following vaccination. Most human being who arisen these blood clots and low level of platelets to be females ages 18 with 49 years. The opportunity of having actually this take place is remote. You have to seek clinical attention best away if you have any type of of the following symptoms after ~ receiving Janssen COVID-19 Vaccine:Shortness that breath,Chest pain,Leg swelling,Persistent ab pain,Severe or persistent headaches or blurred vision,Easy bruising or tiny blood clues under the skin past the website of the injection.
These might not be every the feasible side results of the Janssen COVID-19 Vaccine. Serious and also unexpected impacts may occur. The Janssen COVID-19 Vaccine is still gift studied in clinical trials.
WHAT must I DO about SIDE EFFECTS?If you experience a major allergic reaction, contact 9-1-1, or go to the nearest hospital.Call the vaccination provider or your health care provider if you have any type of side effects that bother you or perform not go away.
Report vaccine side impacts to FDA/CDC Vaccine Adverse occasion Reporting device (VAERS). The VAERS toll-free number is 1-800-822-7967 or report digital to https://vaers.hhs.gov/reportevent.html. Please incorporate “Janssen COVID-19 Vaccine EUA” in the very first line of crate #18 the the report form. In addition, you have the right to report side effects to Janssen Biotech, Inc. At 1-800-565-4008.
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The FDA EUA truth Sheet for health care Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing information are accessible at: www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf.
About Johnson & JohnsonAt Johnson & Johnson, us believe an excellent health is the foundation of colorful lives, prospering communities and forward progress. That’s why for an ext than 130 years, we have aimed come keep people well in ~ every age and also every phase of life. Today, as the world largest and also most broadly-based healthcare company, we room committed to making use of our reach and size for good. We strive come improve accessibility and affordability, create healthier communities, and put a healthy and balanced mind, body and also environment within reach of everyone, everywhere. We room blending ours heart, science and also ingenuity come profoundly adjust the trajectory of health for humanity. Learn much more at www.buzzpatterson.com. Follow us at