janssen covid-19 vaccine janssen covid-19 vaccine the janssen covid‑19 vaccine, sold under the brand name jcovden, is a covid‑19 vaccine that was developed by janssen vaccines in leiden, netherlands, and its belgian parent company janssen pharmaceuticals, a subsidiary of american company johnson & johnson. "johnson & johnson vaccine" and "johnson & johnson covid-19 vaccine" redirect here. for other j&j corporate vaccination topics, see janssen vaccines, janssen pharmaceuticals, and johnson & johnson. janssen covid-19 vaccinea vial of janssen covid-19 vaccinevaccine descriptiontargetsars-cov-2vaccine typeviral vectorclinical datatrade namesjcovdenother namesad26.cov2.sjnj-78436735ad26covs1vac31518covid-19 vaccine janssenjohnson & johnson covid‑19 vaccineahfs/drugs.commultum consumer informationlicense data eu ema: by inn us dailymed: janssen_covid-19_vaccine pregnancycategory au: b1 routes ofadministrationintramuscularatc codej07bx03 (who) legal statuslegal status au: s4 (prescription only) br: emergency use ca: rx-only / schedule d uk: pom (prescription only) us: ℞-only via standing order; unapproved (emergency use authorization) eu: rx-only za: authorized full list of janssen vaccine authorizationsidentifiersdrugbankdb15857uniijt2ns6183bkeggd12129 part of a series on thecovid-19 pandemicscientifically accurate atomic model of the external structure of sars-cov-2. each "ball" is an atom. covid-19 (disease) sars-cov-2 (virus) cases deaths timeline 2019 2020 january responses february responses march responses april responses may responses june responses july responses august responses september responses october responses november responses december responses 2021 january responses february responses march responses april responses may responses june responses july responses august responses september responses october responses november responses december responses 2022 january responses february responses march responses april responses may responses june responses july responses august responses september responses october responses november december 2023 january february march april may locations by country and territory africa antarctica asia europe north america oceania south america by conveyance cruise ships naval ships international response endemic phase evacuations face masks international aid investigations into origin lockdowns by country misinformation by governments fake treatments social distancing software travel united nations world health organization wto ip waiver undercounting of deaths covid-19 apps zero-covid national responses africa china european union germany ghana india ireland netherlands new zealand nigeria philippines russia sweden uk government us federal government vietnam medical response disease testing breathalyzer development drug development drug repurposing public health mitigation vaccines history research vitt deployment authorizations operation warp speed misinformation and hesitancy us vaccine card vaccine passports current vaccines coronavac covaxin convidecia janssen medigen moderna novavax oxford–astrazeneca pfizer–biontech sinopharm bibp sputnik v variants variants of concern alpha beta gamma delta omicron other variants epsilon zeta eta theta iota kappa lambda mu cluster 5 lineage b.1.617 economic impact and recession arts and culture aviation cannabis cinema films disney fashion financial markets food industry food security journalism music performing arts retail shipping television us sportscasting programs tourism video games by country canada india ireland malaysia new zealand russia uk us by sport association football baseball basketball combat sports cricket disc golf gaelic games gridiron football ice hockey motorsport rugby league impacts animals black people crime death rates by country disability domestic violence emergency evacuations education female environment hospitals language lgbt community long-term care media coverage mental health symptoms migration military notable deaths other health issues politics diplomacy popular culture protests pregnancy prisons religion catholic church hajj science and technology social media strikes suicides telehealth xenophobia and racism society ireland malaysia new zealand russia uk us covid-19 portal it is a viral vector vaccine based on a human adenovirus that has been modified to contain the gene for making the spike protein of the sars-cov-2 virus that causes covid‑19. the body's immune system responds to this spike protein to produce antibodies. the vaccine requires only one dose and does not need to be stored frozen. clinical trials for the vaccine were started in june 2020, with phase iii involving around 43,000 people. on 29 january 2021, janssen announced that 28 days after a completed vaccination, the vaccine was 66% effective in a one-dose regimen in preventing symptomatic covid‑19, with an 85% efficacy in preventing severe covid‑19 and 100% efficacy in preventing hospitalization or death caused by the disease. the vaccine has been granted an emergency use authorization (eua) by the us food and drug administration (fda) and a conditional marketing authorization by the european medicines agency (ema) and the uk medicines and healthcare products regulatory agency. because cases of thrombosis with thrombocytopenia syndrome and guillain-barré syndrome have been reported after receipt of the janssen covid‑19 vaccine, the us centers for disease control and prevention (cdc) recommends "preferential use of mrna covid‑19 vaccines over the janssen covid‑19 vaccine, including both primary and booster doses administered to prevent covid‑19, for all persons aged 18 years of age and older. the janssen covid‑19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mrna covid‑19 vaccines." in february 2022, johnson & johnson announced it has temporarily suspended production of the vaccine though they also noted that it will likely resume at some point in the future and that it will honor all pre-existing contracts that oblige janssen to supply its vaccine by using the millions of already existing vaccine doses in its inventory where requested. medical uses the janssen covid‑19 vaccine is used to provide protection against infection by the sars-cov-2 virus in order to prevent covid‑19 in people aged eighteen years and older. the vaccine is given by intramuscular injection into the deltoid muscle. the initial course consists of a single dose. there is no evidence that a second booster dose is needed to prevent severe disease in healthy adults. on 21 october 2021, the us centers for disease control and prevention (cdc) began recommending a booster dose. efficacy a vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time. efficacy by variant severity of illness delta alpha beta lineage b.1 asymptomatic not reported 74% (65–82%) not reported not reported moderate to severe not reported not reported 64% (41–79%) 72% (58–82%) severe to critical 71% not reported 82% (46–95%) 86% (−9 to 100%) on 15 october 2021, janssen reported at a meeting of the us food and drug administration vaccines and related biological products advisory committee (vrbpac) that a single dose produced durable protection against severe disease and hospitalization for at least 6 months in the united states, even when delta emerged, but also a global decrease in protection against moderate disease attributed to emerging variants outside the us. janssen also reported that a booster dose given 2 months after the primary dose increased efficacy against symptomatic disease to 75% (95% ci, 55–87%) globally and to 94% (59–100%) in the us and that it also increased efficacy against severe disease to nearly 100% (33–100%) globally. pharmacology the vaccine consists of a replication-incompetent recombinant adenovirus type 26 (ad26) viral vector expressing the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) spike (s) protein in a stabilized conformation. the per.c6 cell line derived from human embryonic retinal cells is used in the production (replication) of the ad26 adenovirus vector. it is similar to the approach used by the oxford–astrazeneca covid-19 vaccine and the russian sputnik v covid-19 vaccine which use human embryonic kidney (hek) 293 cells for adenovirus vector replication. the ad26 viral vector lacks the e1 gene required for replication. therefore, it cannot replicate in the human organism. chemistry the vaccine contains the following excipients: citric acid monohydrate, trisodium citrate dihydrate, ethanol (alcohol), 2-hydroxypropyl-β-cyclodextrin (hbcd) (hydroxypropyl betadex), polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid. manufacturing unpunctured vials may be stored between 9 and 25 °c (48 and 77 °f) for up to twelve hours, and the vaccine can remain viable for months in a standard refrigerator. it is not shipped or stored frozen. in april 2020, johnson & johnson entered a partnership with catalent to provide large-scale manufacturing of the johnson & johnson vaccine at catalent's bloomington, indiana facility. in july 2020, the partnership was expanded to include catalent's facility in anagni, italy. in september 2020, grand river aseptic manufacturing agreed with johnson & johnson to support the manufacture of the vaccine, including technology transfer and fill and finish manufacture, at its grand rapids, michigan facility. a production line at the reig jofre factory in december 2020, johnson & johnson and reig jofre, a spanish pharmaceutical company, entered into an agreement to manufacture the vaccine at reig jofre's barcelona facility. in february 2021, sanofi and johnson & johnson struck a deal for sanofi to provide support and infrastructure at sanofi's marcy-l'étoile, france facility to manufacture approximately twelve million doses of the johnson & johnson vaccine per month once authorized. in march 2021, johnson & johnson and aspen pharmacare made a deal to manufacture 220 million vaccines at aspen's gqeberha facility in eastern cape, south africa. they plan to distribute the vaccine to other countries, mainly in africa, and also through the covid-19 vaccines global access (covax) program. in march 2021, merck & co and johnson & johnson struck a deal for merck to manufacture the johnson & johnson vaccine at two facilities in the united states to help expand the manufacturing capacity of the vaccine using provisions of the defense production act. that same month, human error at a plant run by emergent biosolutions in baltimore resulted in the spoilage of up to fifteen million doses of the johnson & johnson vaccine. the error, which was caught before the doses left the plant, delayed expected shipments of the johnson & johnson vaccine within the united states. as the error had involved combining ingredients of the johnson & johnson vaccine with the astrazeneca vaccine, the biden administration gave control of the plant to johnson & johnson and said the plant should produce only the johnson & johnson vaccine to avoid further mix-ups. in july 2021, the fda authorized emergent to resume production (but not distribution) of the janssen vaccine. 400 million doses were destroyed. adverse effects review of vaccine adverse events reporting system (vaers) safety monitoring data by the us centers for disease control and prevention (cdc) through 21 april 2021, (by which time 7.98 million doses of the janssen covid‑19 vaccine had been administered), showed that "97% of reported reactions after vaccine receipt were nonserious, consistent with preauthorization clinical trials data." the most common side effects of the vaccine in the trials were usually mild or moderate, occurred within two days after vaccination, and got better within 1 or 2 days. the most common side effects are pain at the injection site, headache, tiredness, muscle pain, and nausea, affecting more than 1 in 10 people. coughing, joint pain, fever, chills, redness, and swelling at the injection site occurred in less than 1 in 10 people. sneezing, tremor, throat pain, rash, sweating, muscle weakness, pain in the arms and legs, backache, weakness, and feeling generally unwell occurred in less than 1 in 100 people. rare side effects (that occurred in less than 1 in 1,000 people) are hypersensitivity (allergy) and itchy rash. an increased risk of the rare and potentially fatal thrombosis with thrombocytopenia syndrome (tts) has been associated with mainly younger female recipients of the vaccine. this syndrome, marked by formation of blood clots in the blood vessels in combination with low levels of blood platelets 4–28 days after the vaccines administration, occurred at a rate of about 7 per 1 million vaccinated women aged 18–49 years old and it occurs more rarely in other populations (i.e., women 50 years and older and men of all ages). allergic reactions, including anaphylaxis, can occur in rare cases within a few minutes to one hour after receiving a dose. in may 2021, with 7.98 million doses administered, the cdc reported four cases of anaphylaxis after vaccination (none of which resulted in death) and 28 cases of cerebral venous sinus thrombosis (of which three resulted in death). in july 2021, the us fact sheet for the vaccine was updated to indicate that there may be an increased risk of guillain-barré syndrome during the 42 days following vaccination. the european medicines agency (ema) listed guillain-barré syndrome (gbs) as a very rare side effect of covid‑19 vaccine janssen and added a warning in the product information. in august 2021, the pharmacovigilance risk assessment committee (prac) recommended updating the product information to the european medicines agency (ema) that "cases of dizziness and tinnitus (ringing or other noises in one or