Janssen COVID-19 vaccine

The Janssen COVID-19 vaccine, or Johnson & Johnson COVID-19 vaccine, is a COVID-19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands,[27] and its Belgian parent company Janssen Pharmaceuticals,[28] subsidiary of American company Johnson & Johnson.[29][30][31]

Janssen COVID-19 vaccine
Janssen COVID-19 vaccine (2021) F (cropped).jpg
A vial of Janssen COVID-19 Vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesJanssen COVID-19 Vaccine,[1][2] COVID-19 Vaccine Janssen[3][4]
Other names
AHFS/Drugs.comMultum Consumer Information
License data
Pregnancy
category
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
Full list of Janssen vaccine authorizations
Identifiers
DrugBank
UNII
KEGG

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.[3] The body's immune system responds to this spike protein to produce antibodies.[32] The vaccine requires only one dose and does not need to be stored frozen.[33][34]

Clinical trials for the vaccine were started in June 2020, with Phase III involving around 43,000 people.[21] 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[35][36][37] and 100% efficacy in preventing hospitalization or death caused by the disease.[1]

The vaccine has been granted an emergency use authorization by the US Food and Drug Administration[22][38] and a conditional marketing authorization by the European Medicines Agency (EMA)[4][39][40] and the UK Medicines and Healthcare products Regulatory Agency.[18]

Medical usesEdit

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.[1][4]

The vaccine is given by intramuscular injection into the deltoid muscle. The initial course consists of a single dose.[41]

There is no evidence that a second booster dose is needed to prevent severe disease in healthy adults.[41] On 21 October, the CDC began recommending a booster dose.[42]

EfficacyEdit

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[43] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time.[44]

Efficacy by variant[a]
Severity of illness Delta Alpha Gamma Beta Lineage B.1[b]
Moderate[c] to severe[d] Not reported Not reported Not reported 64% (4179%) 72% (5882%)
Severe to critical[d] 71%[e][f] Not reported Not reported 82% (4695%) 86% (−9 to 100%)

On 15 October 2021, Janssen reported at a meeting of the FDA Vaccines and Related Biological Products Advisory Committee 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, 5587%) globally and to 94% (59100%) in the US and that it also increased efficacy against severe disease to nearly 100% (33100%) globally.[48][49]

PharmacologyEdit

The vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein in a stabilized conformation.[5][50] The PER.C6 cell line derived from human embryonic retinal cells is used in the production (replication) of the Ad26 adenovirus vector.[51] It is similar to the approach used by the Oxford–AstraZeneca COVID-19 vaccine and the Russian Sputnik V COVID-19 vaccine[52][53] which use human embryonic kidney (HEK) 293 cells for adenovirus vector replication.[54][55]

The Ad26 viral vector lacks the E1 gene required for replication. Therefore, it cannot replicate in the human organism.[56][57]

ChemistryEdit

The vaccine contains the following excipients (inactive ingredients): citric acid monohydrate, trisodium citrate dihydrate, ethanol (alcohol), 2-hydroxypropyl-β-cyclodextrin (HBCD) (hydroxypropyl betadex), polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid.[1][50]

ManufacturingEdit

Unpunctured vials may be stored between 9 to 25 °C (48 to 77 °F) for up to twelve hours,[33][50] and the vaccine can remain viable for months in a standard refrigerator.[58][59][60] It is not shipped[33][61] or stored frozen.[33]

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.[62] In July 2020, the partnership was expanded to include Catalent's facility in Anagni, Italy.[63]

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.[64]

 
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.[65] If the European Medicines Agency (EMA) grants approval to the vaccine by March 2021, a European Union regulator said Johnson & Johnson could start supplying vaccines to EU states starting in April 2021.[66][67] Starting in the second quarter of 2021, the factory will produce fifty million COVID-19 vaccine doses a year.[68]

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.[69]

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.[70][71][72]

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.[73] 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.[74] 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.[75] In July 2021, the FDA authorized Emergent to resume production (but not distribution) of the Janssen vaccine.[76]

Adverse effectsEdit

Review of Vaccine Adverse Events Reporting System (VAERS) safety monitoring data by the U.S. 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."[77]

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.[23][4][78]

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.[4] 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.[4] Rare side effects (that occurred in less than 1 in 1,000 people) are hypersensitivity (allergy) and itchy rash.[4]

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.[79][80] 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 ages 18–49 years old and occurs more rarely in other populations (i.e., women 50 years and older and men of all ages).[81]

Allergic reactions, including anaphylaxis, can occur in rare cases within a few minutes to one hour after receiving a dose.[4][24]

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).[77]

In July 2021, the U.S. 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.[33][82][83] 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.[84]

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 both ears) are linked to the administration of COVID-19 vaccine Janssen."[85]

HistoryEdit

The stabilized version of the spike protein – that includes two mutations in which the regular amino acids are replaced with prolines – was developed by researchers at the National Institute of Allergy and Infectious Diseases' Vaccine Research Center and the University of Texas at Austin.[86][87][88]

During the COVID-19 pandemic, Johnson & Johnson committed over US$1 billion toward development of a not-for-profit vaccine in partnership with the Biomedical Advanced Research and Development Authority (BARDA) Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).[89][90] Johnson & Johnson said its vaccine project would be "at a not-for-profit level" as the company viewed it as "the fastest and the best way to find all the collaborations in the world to make this happen".[91] In November, Johnson & Johnson announced that Janssen would commit about $604 million and BARDA would commit $454 million to fund the ENSEMBLE trial.[92]

 
Inside of an Emergent BioSolutions facility where, in collaboration with Johnson & Johnson, vaccines are produced

Johnson & Johnson subsidiary Janssen Vaccines, in partnership with Beth Israel Deaconess Medical Center (BIDMC), was responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine.[30][93][94][95]

Clinical trialsEdit

Preclinical trials indicated that the vaccine effectively protected hamsters and rhesus macaques from SARS‐CoV‐2.[96]

Phase I–IIEdit

In June 2020, Johnson & Johnson and the National Institute of Allergy and Infectious Diseases (NIAID) confirmed that they planned to start clinical trials of the Ad26.COV2.S vaccine in September 2020, with the possibility of Phase I–IIa human clinical trials starting at an accelerated pace in the second half of July.[97][98][99]

A Phase I–IIa clinical trial started with the recruitment of the first subject on 15 July 2020 and enrolled study participants in Belgium and the US.[100] Interim results from the Phase I–IIa trial established the safety, reactogenicity, and immunogenicity of Ad26.COV2.S. With one dose, after 29 days, the vaccine ensured ninety percent of participants had enough antibodies required to neutralize the virus. After 57 days, that number reached one hundred percent.[101][102] A substudy with 20 participants found that humoral and cell-mediated immune responses, including cytotoxic T cells, lasted for at least 8 months.[103][unreliable medical source?]

Phase IIIEdit

A Phase III clinical trial called ENSEMBLE started enrollment in September 2020 and completed enrollment on 17 December 2020. It was designed as a randomized, double-blind, placebo-controlled clinical trial intended to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults aged 18 years and older. Study participants received a single intramuscular injection of Ad26.COV2.S at a dose level of 5×1010 virus particles on day one.[104] The trial was paused on 12 October 2020, because a volunteer became ill,[105][96] but the company said it found no evidence that the vaccine had caused the illness and announced on 23 October 2020 that it would resume the trial.[106][107] On 29 January 2021, Janssen announced safety and efficacy data from an interim analysis of ENSEMBLE trial data, which demonstrated the vaccine was 66% effective at preventing the combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers. The interim analysis was based on 468 cases of symptomatic COVID-19 among 43,783 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. No deaths related to COVID-19 were reported in the vaccine group, while five deaths in the placebo group were related to COVID-19.[108] During the trial, no anaphylaxis was observed in participants.[108]

A second Phase III clinical trial called ENSEMBLE 2 started enrollment on 12 November 2020. ENSEMBLE 2 differed from ENSEMBLE in that its study participants received two intramuscular (IM) injections of Ad26.COV2.S, one on day 1 and the next on day 57.[109] Early results indicated 85% efficacy against severe/critical disease.[103][45] Plasma from 8 participants showed greater neutralization activity against the Delta variant than against Beta.[103]

AuthorizationsEdit

  Full authorization
  Full authorization, not used
  Emergency authorization
  Eligible COVAX recipient
  Usage stopped

European UnionEdit

Beginning on 1 December 2020, clinical trial of the vaccine candidate has been undergoing a "rolling review" process by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), a step to expedite EMA consideration of an expected conditional marketing authorization.[66][110] On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine.[3][111] The European Commission approved the COVID-19 Vaccine Janssen on 11 March 2021.[4][40]

United StatesEdit

On 4 February 2021, Janssen Biotech applied to the U.S. Food and Drug Administration (FDA) for an EUA, and the FDA announced that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) would meet on 26 February to consider the application.[58][61][112][113] On 24 February, ahead of the VRBPAC meeting, briefing documents from Janssen and the FDA were issued; the FDA document recommends granting the EUA, concluding that the results of the clinical trials and the safety data are consistent with FDA EUA guidance for COVID-19 vaccines.[50][114][115][116] At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that a EUA for the vaccine be issued.[117] The FDA granted the EUA for the vaccine the following day.[21][22][118] On 28 February, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommended the use of the vaccine for those aged 18 and older.[119][38]

On 13 April 2021, the CDC and the FDA issued a joint statement recommending that use of the Janssen vaccine be suspended, due to reports of six cases of cerebral venous sinus thrombosis—a "rare and severe" blood clot—in combination with low levels of blood platelets (thrombocytopenia), in six women between the ages of 18 and 48 who had received the vaccine.[120] The symptoms occurred 6–13 days after they had received the vaccination, and it was reported that one woman had died and a second woman had been hospitalized in critical condition.[121][122][123]

On 23 April, the FDA and the CDC determined that the recommended pause regarding the use of the Janssen COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.[124][125] The EUA and the fact sheets were updated to reflect the risks of thrombosis-thrombocytopenia syndrome (TTS).[124]

ElsewhereEdit

On 11 February 2021, Saint Vincent and the Grenadines issued an emergency authorization for the Janssen COVID-19 vaccine, as well as the Moderna COVID-19 vaccine, the Pfizer–BioNTech vaccine, the Gam-COVID-Vac vaccine (Sputnik V), and the Oxford–AstraZeneca vaccine.[126]

In December 2020, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance to support the COVAX Facility. On 19 February 2021, Johnson & Johnson submitted its formal request and data package to the World Health Organization for an Emergency Use Listing (EUL); an EUL is a requirement for participation in COVAX. Johnson & Johnson anticipates providing up to five hundred million doses through 2022 for COVAX.[59][127][128] The World Health Organization issued an EUL for the Janssen COVID-19 vaccine Ad26.COV2.S vaccine on 12 March 2021.[129][130]

On 18 February 2021, the vaccine received emergency authorization in South Africa.[131][132][133] On 13 April 2021, South Africa suspended its rollout of the vaccine.[134] The program resumed on 28 April 2021.

On 25 February 2021, Bahrain authorized the vaccine for emergency use.[135][136]

On 26 February 2021, the South Korean Ministry of Food and Drug Safety began a review of Johnson & Johnson's application for approval of its vaccine.[137]

In late November 2020, Johnson & Johnson submitted a rolling review application to Health Canada for approval of its vaccine.[138]

On 26 March 2021, the vaccine received emergency authorization in Colombia.[139]

In April 2021, the Australian government stated that it would not be purchasing the Janssen vaccine, as it "does not intend to purchase any further adenovirus vaccines at this time".[140][141] The Therapeutic Goods Administration granted provisional approval for use of the Janssen vaccine in Australia on 25 June 2021.[8][9]

On 19 April 2021, the vaccine received emergency use authorization in the Philippines.[142][143]

On 28 May 2021, the vaccine received conditional marketing authorization in the United Kingdom.[18][19][20][144][95]

On 10 June 2021, the vaccine received emergency use authorization in Chile. The vaccine will be provided via COVAX.[145]

On 15 June 2021, Malaysia's National Pharmaceutical Regulatory Agency (NPRA) issued conditional registration for emergency use of the vaccine.[146]

On 25 June 2021, COVID-19 Janssen Ad26.COV2.S was granted provisional approval in Australia.[8][9]

On 7 July 2021, the vaccine received provisional approval for use for people aged 18 and above in New Zealand.[147][148]

On 7 August 2021, Health and Family Welfare Minister of India announced that Johnson and Johnson single-dose vaccine was approved for emergency use in India through a supply agreement with homegrown vaccine maker Biological E. Limited.[149]

On 7 September 2021, National Agency of Drug and Food Control (BPOM) issued emergency use authorization in Indonesia.[150]

On 23 November 2021, the vaccine was approved for use in Canada.[14][15]

Further developmentEdit

Homologous prime-boost vaccinationEdit

In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses.[151][152][153]

Heterologous prime-boost vaccinationEdit

In October 2021, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) authorized the use of either homologous or heterologous vaccine booster doses.[151][152] The authorization was expanded to include all adults in November 2021.[153]

Society and cultureEdit

EconomicsEdit

Given the Janssen vaccine is a single dose and has a lower cost, it was expected to play an important role in low and middle-income countries.[154] Since it is a single dose vaccine, it has been a popular vaccine to distribute to the homeless,[155][156][157][158] the incarcerated,[159][160][158] and refugee populations.[161][160][158][162] This is due to the fact that it is difficult for these aforementioned demographics to be contacted for vaccines that require a second dose. With lower costs and lower requirements of storage and distribution in comparison to the COVID-19 vaccines by Pfizer and Moderna, the Janssen vaccine is more easily transported, stored, and administered.[163] South African health minister Zweli Mkhize announced on 9 February 2021 that the country would sell or swap its one million doses of AstraZeneca vaccine.[164] Once it did so, South Africa began vaccination using the Janssen vaccine on 17 February 2021,[133] marking the vaccine's first use outside of a clinical trial.[165]

In July 2020, Johnson & Johnson pledged to deliver up to three hundred million doses of its vaccine to the U.S., with one hundred million upfront and an option for twenty million more. The deal, worth more than $1 billion, is funded by the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense.[166][167] The deal was confirmed on 5 August.[168]

In August 2020, Johnson & Johnson signed a contract with the U.S. federal government for $1 billion, agreeing to deliver one hundred million doses of the vaccine to the U.S. following the U.S. Food and Drug Administration (FDA) grant of approval or emergency use authorization (EUA) for the vaccine.[167] Under its agreement with the U.S. government, Johnson & Johnson was targeted to produce twelve million doses by the end of February 2021, more than sixty million doses by the end of April 2021, and more than one hundred million doses by the end of June 2021. However, in January 2021, Johnson & Johnson acknowledged manufacturing delays would likely prevent it from meeting its contract of twelve million doses delivered to the U.S. by the end of February.[169] In February 2021, through congressional testimony by a company executive, Johnson & Johnson indicated that the company could deliver twenty million doses to the U.S. government by the end of March and one hundred million doses in the first half of 2021.[170]

In February 2021, Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization.[108]

In March 2021, the Canadian government placed an order with Johnson & Johnson for ten million doses, with an option to purchase up to twenty-eight million more; on 5 March, the vaccine became the fourth to receive Health Canada approval.[171]

Shipments of the vaccine were scheduled to start in the second half of April 2021, with a commitment to deliver at least two hundred million doses to the EU in 2021.[172]

The European distribution of the vaccine was slightly delayed until the EMA decided that rare cases of vaccine-induced blood clots did not outweigh the benefits of helping to fight the COVID-19 pandemic.[173]

ControversiesEdit

The United States Conference of Catholic Bishops has expressed concern about the vaccine, because the cell line Per.C6, which is used in development and production, was originally derived from the retinal tissue of an 18-week-old fetus electively aborted in 1985.[174][175][176][177] Although the use of fetal tissue in vaccine development has become common since the 1930s, especially with cell-based vaccines, there are currently alternatives that do not carry the same potential ethical concerns as the Janssen vaccine.[178][179] Some bioethicists dismiss that ethical concerns to using cells derived from ethically compromised sources should be addressed or alternatives sought.[180] Others advance the view that the cells used for COVID-19 vaccines today are thousands of generations removed from their source material and do not contain any fetal tissue.[174][175]

In December 2020, the Vatican published a note approved by Pope Francis, stating that "... all [COVID-19] vaccinations recognized as clinically safe and effective can be used in good conscience ..."[174][181] However, the key objection to using these vaccines still remains.[182][181][183]

In September 2021, after criticism that doses of its single-shot COVID-19 vaccine produced in Aspen Pharmacare’s facility in South Africa were being exported to Europe, millions of doses that had been shipped to Europe and stored in warehouses will be returned to Africa, and newly manufactured doses will be shipped to African countries.[184]

MisinformationEdit

Videos on video-sharing platforms circulated around May 2021 showing people having magnets stick to their arms after receiving the vaccine, purportedly demonstrating the conspiracy theory that vaccines contain microchips, but these videos have been debunked.[185][186][187][188]

NotesEdit

  1. ^ 21 September 2020 to 22 January 2021 in the United States, South Africa and Brazil.[33][45]
  2. ^ Wuhan-H1 variant D614G.[46] Corresponds to 96% of the strains the United States during the study.
  3. ^ Generally includes mild symptoms such as olfactory or taste disorders and moderate symptoms such as pneumonia.
  4. ^ a b Generally understood as requiring some form of hospitalization (from supplemental oxygen therapy to ICU admission). The same statistical variable includes cases of death.
  5. ^ A confidence interval was not provided, so it is not possible to know the accuracy of this measurement.
  6. ^ Effectiveness against hospitalization from a preliminary study with 477,000 healthcare workers.[47]

ReferencesEdit

  1. ^ a b c d e "Janssen COVID-19 Vaccine – ad26.cov2.s injection, suspension". DailyMed. U.S. National Institutes of Health. Archived from the original on 12 May 2021. Retrieved 27 February 2021.
  2. ^ "Janssen COVID-19 Emergency Use Authorization (EUA) Official Website". Janssen. 28 February 2021. Archived from the original on 1 March 2021. Retrieved 28 February 2021.
  3. ^ a b c "EMA receives application for conditional marketing authorization of COVID-19 Vaccine Janssen" (Press release). European Medicines Agency (EMA). 16 February 2021. Archived from the original on 16 February 2021. Retrieved 16 February 2021.
  4. ^ a b c d e f g h i j "COVID-19 Vaccine Janssen EPAR". European Medicines Agency (EMA). 5 March 2021. Archived from the original on 15 March 2021. Retrieved 16 March 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ^ a b c d e "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518COV3001; Phase 3" (PDF). Janssen Vaccines & Prevention. Archived from the original on 18 February 2021. Retrieved 15 February 2021.
  6. ^ a b c d "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE 2 Protocol VAC31518COV3009; Phase 3" (PDF). Janssen Vaccines & Prevention. Archived from the original on 25 February 2021. Retrieved 26 February 2021.
  7. ^ a b "Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate". Johnson & Johnson (Press release). Archived from the original on 23 September 2020. Retrieved 23 September 2020.
  8. ^ a b c d "COVID-19 Vaccine Janssen". Therapeutic Goods Administration (TGA). 25 June 2021. Retrieved 28 August 2021.
  9. ^ a b c "COVID-19 vaccine: Janssen". Therapeutic Goods Administration (TGA). 27 August 2021. Retrieved 28 August 2021.
  10. ^ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=3FBA16FEFCEB4AFBCA2586FF00421EDC&agid=(PrintDetailsPublic)&actionid=1
  11. ^ "TGA grants third provisional approval to COVID-19 vaccine: Janssen". Therapeutic Goods Administration (TGA). 25 June 2021. Retrieved 22 October 2021.
  12. ^ "Brazil health regulator approves emergency use of Johnson & Johnson COVID-19 vaccine". Rio de Janeiro: Reuters. 31 March 2021. Retrieved 1 April 2021.
  13. ^ "Anvisa aprova uso emergencial da vacina da Janssen" [Anvisa approves emergency use of Janssen vaccine] (in Portuguese). Federal government of Brazil. Brazilian Health Regulatory Agency. 31 March 2021. Retrieved 20 November 2021.
  14. ^ a b "Janssen (Johnson & Johnson) COVID-19 vaccine". Health Canada. Retrieved 24 November 2021.
  15. ^ a b "Regulatory Decision Summary - Janssen COVID-19 Vaccine". Health Canada. Retrieved 24 November 2021.
  16. ^ "Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada". Health Canada. 5 March 2021. Archived from the original on 5 March 2021. Retrieved 5 March 2021.
  17. ^ "Janssen COVID-19 Vaccine monograph" (PDF). Janssen. 5 March 2021. Archived (PDF) from the original on 5 March 2021. Retrieved 5 March 2021.
  18. ^ a b c "Regulatory approval of COVID-19 Vaccine Janssen". Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.
  19. ^ a b "One-dose Janssen COVID-19 vaccine approved by the MHRA" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.
  20. ^ a b "Summary of Product Characteristics for COVID-19 Vaccine Janssen". Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.
  21. ^ a b c "FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). 27 February 2021. Archived from the original on 18 March 2021. Retrieved 27 February 2021.
  22. ^ a b c "FDA Letter of Authorization" (PDF). Food and Drug Administration. 27 February 2021. Archived from the original on 10 March 2021. Retrieved 28 February 2021. ...letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA)...
  23. ^ a b "Janssen COVID-19 Vaccine". U.S. Food and Drug Administration (FDA). 19 March 2021. Archived from the original on 7 April 2021. Retrieved 7 April 2021.   This article incorporates text from this source, which is in the public domain.
  24. ^ a b "Janssen COVID-19 Vaccine (Johnson & Johnson) Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older" (PDF). U.S. Centers for Disease Control and Prevention (CDC). Archived (PDF) from the original on 16 April 2021. Retrieved 16 April 2021.
  25. ^ "Johnson & Johnson Covid vaccine approved for general use in South Africa". Archived from the original on 9 May 2021. Retrieved 9 May 2021.
  26. ^ "J&J Covid-19 Vaccine Approved in South Africa for Wider Use". Bloomberg.com. 1 April 2021. Archived from the original on 9 April 2021. Retrieved 9 May 2021.
  27. ^ "Leiden developed Covid-19 vaccine submitted to EMA for approval". 16 February 2021. Retrieved 15 March 2021.
  28. ^ "Clinical trial COVID-19 vaccine candidate underway". Janssen Belgium. Archived from the original on 15 January 2021. Retrieved 13 March 2021.
  29. ^ "EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden". NL Times. Retrieved 12 March 2021.
  30. ^ a b Saltzman J (12 March 2020). "Beth Israel is working with Johnson & Johnson on a coronavirus vaccine". The Boston Globe. Archived from the original on 11 April 2021. Retrieved 25 February 2021.
  31. ^ "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)". ClinicalTrials.gov. Archived from the original on 26 September 2020. Retrieved 30 January 2021.
  32. ^ Malcom K (8 March 2021). "COVID Vaccines: Does it Matter Which One You Get?". Michigan Medicine. Archived from the original on 28 March 2021. Retrieved 30 March 2021.
  33. ^ a b c d e f "Fact Sheet for Healthcare Providers Administering Vaccine and EUA" (PDF). Janssen. Archived from the original on 13 April 2021. Retrieved 13 April 2021.
  34. ^ "Johnson & Johnson's Janssen COVID-19 Vaccine Information". U.S. Centers for Disease Control and Prevention (CDC). 23 March 2021. Archived from the original on 29 March 2021. Retrieved 30 March 2021.
  35. ^ Salzman S (29 January 2021). "Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease". ABC News. Archived from the original on 1 February 2021. Retrieved 1 February 2021.
  36. ^ Gallagher J (29 January 2021). "Covid vaccine: Single dose Covid vaccine 66% effective". BBC News. Archived from the original on 29 January 2021. Retrieved 29 January 2021.
  37. ^ Sohn R (29 January 2021). "J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch". Stat. Archived from the original on 29 January 2021. Retrieved 29 January 2021.
  38. ^ a b "Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices' Recommendation to Use Janssen's COVID-19 Vaccine in People 18 and Older" (Press release). U.S. Centers for Disease Control and Prevention (CDC). 28 February 2021. Archived from the original on 23 March 2021. Retrieved 1 March 2021.
  39. ^ "EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU" (Press release). European Medicines Agency (EMA). 11 March 2021. Archived from the original on 11 March 2021. Retrieved 11 March 2021.
  40. ^ a b "COVID-19 Vaccine Janssen". Union Register of medicinal products. Archived from the original on 11 March 2021. Retrieved 16 March 2021.
  41. ^ a b Interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine (Guidance). World Health Organization. 15 June 2021. WHO/2019-nCoV/vaccines/SAGE_recommendation/Ad26.COV2.S/2021.2.
  42. ^ "CDC Expands Eligibility for COVID-19 Booster Shots". CDC Newsroom. Centers for Disease Control and Prevention. 21 October 2021. Retrieved 19 November 2021.
  43. ^ Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, et al. (12 September 2020). "COVID-19 vaccine trials should seek worthwhile efficacy". The Lancet. 396 (10253): 741–743. doi:10.1016/S0140-6736(20)31821-3. ISSN 0140-6736. PMC 7832749. PMID 32861315. WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure.
  44. ^ Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. (May 2021). "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine. Figure 3. 27 (7): 1205–1211. doi:10.1038/s41591-021-01377-8. ISSN 1546-170X. PMID 34002089. S2CID 234769053.CS1 maint: location (link)
  45. ^ a b Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. (June 2021). "Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19". The New England Journal of Medicine. 384 (23): 2187–2201. doi:10.1056/NEJMoa2101544. PMC 8220996. PMID 33882225.
  46. ^ Zhukova A, Blassel L, Lemoine F, Morel M, Voznica J, Gascuel O (24 November 2020). "Origin, evolution and global spread of SARS-CoV-2". Comptes Rendus Biologies. French Academy of Sciences. 344 (1): 57–75. doi:10.5802/crbiol.29. ISSN 1768-3238. PMID 33274614. S2CID 227283362. Sequences containing the G614 version, together with two mutations at the RNA level, constitute the G clade of GISAID, named B1 by the PANGOLIN system.
  47. ^ Foley, Katherine (6 August 2021). "J&J shot effective against Delta variant in large South Africa study". POLITICO. Retrieved 12 August 2021.
  48. ^ Janssen Biotech (15 October 2021). COVID-19 Vaccine Ad26.COV2.S (PDF). Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 (Briefing). Food and Drug Administration. Retrieved 11 November 2021.
  49. ^ Katella, Kathy (28 October 2021). "Did You Get the Johnson & Johnson Vaccine? Your Booster Is Coming". Yale Medicine. Retrieved 11 November 2021.
  50. ^ a b c d FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 (PDF) (Report). U.S. Food and Drug Administration (FDA). Archived from the original on 29 April 2021. Retrieved 24 February 2021. Lay summary.   This article incorporates text from this source, which is in the public domain.
  51. ^ "Janssen COVID-19 Vaccine (Ad26.COV2.S)". The PER.C6 cell line is used in the production of adenovirus vectors. Derived from human embryonic retinal cells, PER.C6 has been successfully used in Good Manufacturing Practices (GMP) and grow to high densities in serum-free suspension culture. Ad26 vectored COVID-19 vaccine encoding the SARS-CoV-2 spike (S) protein is produced in the PER.C6 TetR Cell Line and by recombinant DNA technology
  52. ^ "Drug Levels and Effects". COVID-19 vaccines. Bethesda (MD): National Library of Medicine (US). 2006. PMID 33355732. Retrieved 15 October 2021.
  53. ^ Mishra SK, Tripathi T (2021). "One year update on the COVID-19 pandemic: Where are we now?". Acta Tropica. Elsevier BV. 214: 105778. doi:10.1016/j.actatropica.2020.105778. ISSN 0001-706X. PMC 7695590. PMID 33253656.
  54. ^ "There are no foetal cells in the AstraZeneca Covid-19 vaccine". fullfact.org. 26 November 2020. Retrieved 21 September 2021.
  55. ^ Moutinho S, Wadman M (30 April 2021). "Is Russia's COVID-19 vaccine safe? Brazil's veto of Sputnik V sparks lawsuit threat and confusion". Science. Retrieved 2 May 2021.
  56. ^ He TC, Zhou S, da Costa LT, Yu J, Kinzler KW, Vogelstein B (March 1998). "A simplified system for generating recombinant adenoviruses". Proc Natl Acad Sci U S A. 95 (5): 2509–14. doi:10.1073/pnas.95.5.2509. PMC 19394. PMID 9482916.
  57. ^ Kovesdi I, Hedley SJ (August 2010). "Adenoviral producer cells". Viruses. 2 (8): 1681–703. doi:10.3390/v2081681. PMC 3185730. PMID 21994701.
  58. ^ a b Johnson CY, McGinley L (4 February 2021). "Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine". The Washington Post. Archived from the original on 5 February 2021. Retrieved 5 February 2021.
  59. ^ a b Weintraub K. "One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds". USA Today. Archived from the original on 25 February 2021. Retrieved 25 February 2021.
  60. ^ Mole B (29 January 2021). "COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%". Ars Technica. Archived from the original on 2 March 2021. Retrieved 26 February 2021.
  61. ^ a b Chander V (4 February 2021). "J&J files COVID-19 vaccine application with U.S. FDA". Reuters. Archived from the original on 5 February 2021. Retrieved 4 February 2021.
  62. ^ Vecchione A (29 April 2020). "Catalent to lead US manufacturing for J&J's lead COVID-19 vaccine candidate". NJBIZ. Archived from the original on 19 November 2020. Retrieved 13 November 2020.
  63. ^ "J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility". FiercePharma. Archived from the original on 25 October 2020. Retrieved 13 November 2020.
  64. ^ "Ramping Up COVID-19 Vaccine Fill and Finish Capacity". Contract Pharma. 3 November 2020. Archived from the original on 28 January 2021. Retrieved 1 February 2021.
  65. ^ Faus J, Allen N (15 December 2020). "Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine, shares soar". Reuters. Archived from the original on 9 February 2021. Retrieved 29 January 2021.
  66. ^ a b Guarascio F (13 January 2021). "J&J COVID-19 vaccine could be available in Europe in April: source". Reuters. Archived from the original on 30 January 2021. Retrieved 29 January 2021.
  67. ^ "EMA expected to approve Johnson & Johnson vaccine by March – CEO of Janssen Italy to paper". Reuters. 10 February 2021. Archived from the original on 12 February 2021. Retrieved 13 February 2021.
  68. ^ "Spain's Reig Jofre to have capacity for 50 million COVID-19 vaccine doses a year". Reuters. 13 November 2020. Archived from the original on 15 April 2021. Retrieved 25 June 2021.
  69. ^ "France's Sanofi to help Johnson & Johnson manufacture COVID-19 vaccine". Reuters. 22 February 2021. Archived from the original on 15 April 2021. Retrieved 1 April 2021.
  70. ^ "Covid-19: SA plans to vaccinate 200 000 people a day - report". News24. Archived from the original on 30 April 2021. Retrieved 31 March 2021.
  71. ^ "COVID-19 vaccine: J&J commits 30 million doses for SA". eNCA. Archived from the original on 30 April 2021. Retrieved 31 March 2021.
  72. ^ "'No setbacks.' SA factory on track to produce J&J vaccine". BusinessInsider. Archived from the original on 30 April 2021. Retrieved 31 March 2021.
  73. ^ "Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines". HHS (Press release). 2 March 2021. Archived from the original on 3 March 2021. Retrieved 4 March 2021.
  74. ^ LaFraniere S, Weiland N (31 March 2021). "Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson". The New York Times. Archived from the original on 1 April 2021. Retrieved 1 April 2021.
  75. ^ Stolberg SG (3 April 2021). "U.S. Taps Johnson & Johnson to Run Troubled Vaccine Plant". The New York Times. Archived from the original on 4 April 2021. Retrieved 4 April 2021.
  76. ^ Condon, Christine (29 July 2021). "Troubled Emergent BioSolutions plant in Baltimore approved to resume production of Johnson & Johnson vaccine". The Baltimore Sun. Retrieved 30 July 2021.
  77. ^ a b Shay DK, Gee J, Su JR, Myers TR, Marquez P, Liu R, et al. (7 May 2021). "Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021" (PDF). MMWR. Morbidity and Mortality Weekly Report. 70 (18): 680–684. doi:10.15585/mmwr.mm7018e2. ISSN 0149-2195. PMID 33956784. S2CID 233983181.
  78. ^ "Information about the J&J/Janssen COVID-19 Vaccine". U.S. Centers for Disease Control and Prevention (CDC). 31 March 2021. Archived from the original on 7 April 2021. Retrieved 7 April 2021.   This article incorporates text from this source, which is in the public domain.
  79. ^ "EUA fact sheet for healthcare providers administering vaccine" (PDF). Janssen Therapeutics. 27 August 2021. Retrieved 4 October 2021.
  80. ^ Cines, Douglas B.; Bussel, James B. (16 April 2021). "SARS-CoV-2 Vaccine–Induced Immune Thrombotic Thrombocytopenia". New England Journal of Medicine. 384 (23): 2254–2256. doi:10.1056/NEJMe2106315. PMC 8063912. PMID 33861524.
  81. ^ "Safety of COVID-19 Vaccines". U.S. Centers for Disease Control and Prevention (CDC). 11 February 2020. Retrieved 13 July 2021.
  82. ^ LaFraniere S, Weiland N (12 July 2021). "F.D.A. Attaches Warning of Rare Nerve Syndrome to Johnson & Johnson Covid Vaccine". The New York Times. Retrieved 13 July 2021.
  83. ^ "Janssen Letter Granting EUA Amendment" (PDF). U.S. Food and Drug Administration (FDA). 12 July 2021. Retrieved 13 July 2021. Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.
  84. ^ "COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect". European Medicines Agency (EMA) (Press release). 22 July 2021. Retrieved 22 July 2021.
  85. ^ "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021". European Medicines Agency. 5 August 2021.
  86. ^ "The tiny tweak behind COVID-19 vaccines". Chemical & Engineering News. 29 September 2020. Archived from the original on 16 February 2021. Retrieved 1 March 2021.
  87. ^ Kramer J (31 December 2020). "They spent 12 years solving a puzzle. It yielded the first COVID-19 vaccines". National Geographic. Archived from the original on 28 February 2021. Retrieved 1 March 2021.
  88. ^ Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, et al. (October 2020). "Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques". Nature. 586 (7830): 583–88. Bibcode:2020Natur.586..583M. doi:10.1038/s41586-020-2607-z. PMC 7581548. PMID 32731257. S2CID 220893461.
  89. ^ Vecchione A (13 March 2020). "J&J collaborates to accelerate COVID-19 vaccine development". NJBIZ. Archived from the original on 22 January 2021. Retrieved 22 April 2020.
  90. ^ "Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device". WSPA 7News. 6 April 2020. Archived from the original on 22 January 2021. Retrieved 22 April 2020.
  91. ^ "Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine". Sky News. Archived from the original on 21 January 2021. Retrieved 22 April 2020.
  92. ^ "Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development" (Press release). New Brunswick, New Jersey: Johnson & Johnson. 14 November 2020. Retrieved 14 August 2021.
  93. ^ "A Beth Israel researcher helped create a COVID-19 vaccine that awaits approval. It could be a 'game changer'". The Boston Globe. 16 January 2021. Archived from the original on 1 March 2021. Retrieved 28 February 2021.
  94. ^ Mitchell J, Meck C (27 February 2021). "FDA grants third COVID-19 vaccine, developed in part at BIDMC, emergency use authorization". Beth Israel Deaconess Medical Center (BIDMC). Archived from the original on 27 February 2021. Retrieved 28 February 2021.
  95. ^ a b Watts M (28 May 2021). "Single shot Johnson & Johnson Covid vaccine approved for use in the UK". London Evening Standard. Archived from the original on 28 May 2021. Retrieved 29 May 2021.
  96. ^ a b Calvo Fernández E, Zhu LY (December 2020). "Racing to immunity: Journey to a COVID-19 vaccine and lessons for the future". British Journal of Clinical Pharmacology. 87 (9): 3408–3424. doi:10.1111/bcp.14686. PMC 7753785. PMID 33289156.
  97. ^ Coleman J (10 June 2020). "Final testing stage for potential coronavirus vaccine set to begin in July". TheHill. Archived from the original on 10 January 2021. Retrieved 11 June 2020.
  98. ^ "Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ". FiercePharma. Archived from the original on 21 January 2021. Retrieved 11 June 2020.
  99. ^ "Johnson & Johnson to start human testing of COVID-19 vaccine next week". FiercePharma. Archived from the original on 22 January 2021. Retrieved 20 July 2020.
  100. ^ "A Study of Ad26.COV2.S in Adults (COVID-19)". ClinicalTrials.gov. Archived from the original on 16 September 2020. Retrieved 19 February 2021.
  101. ^ Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, et al. (13 January 2021). "Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine". New England Journal of Medicine. 384 (19): 1824–1835. doi:10.1056/NEJMoa2034201. PMC 7821985. PMID 33440088.
  102. ^ "Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine". Johnson & Johnson (Press release). Archived from the original on 17 January 2021. Retrieved 16 January 2021.
  103. ^ a b c "Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response" (Press release). 1 July 2021. Retrieved 2 July 2021.
  104. ^ "Fourth large-scale COVID-19 vaccine trial begins in the United States". National Institutes of Health. 22 September 2020. Archived from the original on 30 January 2021. Retrieved 30 January 2021.
  105. ^ Hughes V, Thomas K, Zimmer C, Wu KJ (12 October 2020). "Johnson & Johnson halts coronavirus vaccine trial because of sick volunteer". The New York Times. ISSN 0362-4331. Archived from the original on 22 February 2021. Retrieved 12 October 2020.
  106. ^ "Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S." Johnson & Johnson (Press release). 23 October 2020. Archived from the original on 16 February 2021. Retrieved 28 October 2020.
  107. ^ Edwards E, Miller SG (23 October 2020). "AstraZeneca, Johnson & Johnson resume late-stage Covid-19 vaccine trials". NBC News. Archived from the original on 26 January 2021. Retrieved 28 October 2020.
  108. ^ a b c "Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial". Johnson & Johnson (Press release). Archived from the original on 31 January 2021. Retrieved 1 February 2021.
  109. ^ "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)". ClinicalTrials.gov. Archived from the original on 29 January 2021. Retrieved 30 January 2021.
  110. ^ "Johnson & Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines Agency" (Press release). Johnson & Johnson. 1 December 2020. Archived from the original on 27 January 2021. Retrieved 5 February 2021.
  111. ^ "Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Janssen COVID-19 Vaccine Candidate" (PDF). Archived (PDF) from the original on 28 February 2021. Retrieved 17 February 2021.
  112. ^ "FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate" (Press release). U.S. Food and Drug Administration (FDA). 4 February 2021. Archived from the original on 5 February 2021. Retrieved 4 February 2021.
  113. ^ "Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement". U.S. Food and Drug Administration (FDA). Archived from the original on 16 February 2021. Retrieved 19 February 2021.
  114. ^ Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document (PDF) (Report). Janssen Biotech. Archived from the original on 25 February 2021. Retrieved 25 February 2021.
  115. ^ Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document Addendum (PDF) (Report). Janssen Biotech. Archived from the original on 24 February 2021. Retrieved 25 February 2021.
  116. ^ Christensen J (24 February 2021). "FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization". CNN. Archived from the original on 13 May 2021. Retrieved 24 February 2021.
  117. ^ Lovelace Jr B (26 February 2021). "FDA panel unanimously recommends third Covid vaccine as J&J wins key vote in path to emergency use". CNBC. Archived from the original on 27 February 2021. Retrieved 27 February 2021.
  118. ^ McGinley L, Johnson CY (27 February 2021). "FDA authorizes Johnson & Johnson's single-shot coronavirus vaccine, adding to the nation's arsenal against the pandemic". The Washington Post. Archived from the original on 28 February 2021. Retrieved 27 February 2021.
  119. ^ Feuer W (28 February 2021). "CDC panel recommends use of J&J's single-shot Covid vaccine, clearing way for distribution". CNBC. Archived from the original on 28 February 2021. Retrieved 28 February 2021.
  120. ^ "Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine" (Press release). U.S. Centers for Disease Control and Prevention (CDC). 13 April 2021. Archived from the original on 13 April 2021. Retrieved 13 April 2021.
  121. ^ Weiland N, LaFraniere S, Zimmer C (13 April 2021). "Johnson & Johnson Vaccinations Halt Across Country After Rare Clotting Cases Emerge". The New York Times. Archived from the original on 7 June 2021. Retrieved 13 April 2021.
  122. ^ Erman M, Mishra M (13 April 2021). "U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe". Reuters. Archived from the original on 13 April 2021. Retrieved 13 April 2021.
  123. ^ Howard J. "CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns". CNN. Archived from the original on 7 June 2021. Retrieved 13 April 2021.
  124. ^ a b "FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review". U.S. Food and Drug Administration (FDA) (Press release). 23 April 2021. Archived from the original on 23 April 2021. Retrieved 23 April 2021.   This article incorporates text from this source, which is in the public domain.
  125. ^ "FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review" (Press release). U.S. Centers for Disease Control and Prevention (CDC). 23 April 2021. Archived from the original on 23 April 2021. Retrieved 23 April 2021.   This article incorporates text from this source, which is in the public domain.
  126. ^ "Public Health (Emergency Authorisation of COVID-19 Vaccine) Rules, 2021" (PDF). Government of Saint Vincent and the Grenadines. 11 February 2021. Archived from the original (PDF) on 13 February 2021. Retrieved 12 February 2021.
  127. ^ Johnson & Johnson (19 February 2021). "Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate". Cision PR Newswire. Archived from the original on 19 February 2021. Retrieved 25 June 2021.
  128. ^ Heeb G. "Johnson & Johnson Applies For Emergency Use Vaccine Approval At W.H.O." Forbes. Archived from the original on 20 February 2021. Retrieved 25 February 2021.
  129. ^ "WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19" (Press release). World Health Organization (WHO). Archived from the original on 1 June 2021. Retrieved 30 May 2021.
  130. ^ "WHO recommendation Janssen–Cilag International NV (Belgium) COVID-19 Vaccine (Ad26.COV2-S [recombinant])". World Health Organization (WHO). 12 March 2021. Archived from the original on 8 May 2021. Retrieved 30 May 2021.
  131. ^ "SA is the first country to roll out Johnson & Johnson vaccine – what you need to know about the jab". BusinessInsider. 17 February 2021. Archived from the original on 1 March 2021. Retrieved 4 March 2021.
  132. ^ Browdie B (20 February 2021). "South Africa to be first to use Johnson Johnson Covid-19 vaccine". Quartz. Archived from the original on 3 March 2021. Retrieved 4 March 2021.
  133. ^ a b Steinhauser G (17 February 2021). "South Africa Rolls Out J&J Covid-19 Vaccine to Healthcare Workers". The Wall Street Journal. Archived from the original on 18 February 2021. Retrieved 18 February 2021.
  134. ^ Turner KJ (13 April 2021). "This is why SA is suspending its J&J vaccine roll-out". IOL. Archived from the original on 14 April 2021. Retrieved 14 April 2021.
  135. ^ Barrington L (25 February 2021). "Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use". Reuters. Archived from the original on 10 March 2021. Retrieved 25 February 2021.
  136. ^ "Bahrain becomes 1st nation to grant J&J shot emergency use". ABC News. 25 February 2021. Archived from the original on 10 March 2021. Retrieved 25 February 2021.
  137. ^ Kim C, Cha S (26 February 2021). "South Korea launches review of Johnson & Johnson's COVID-19 vaccine". Reuters. Archived from the original on 27 February 2021. Retrieved 27 February 2021.
  138. ^ Haig T (1 February 2021). "Novavax submits its vaccine for Health Canada approval". Radio Canada International. Archived from the original on 16 February 2021. Retrieved 27 February 2021.
  139. ^ Acosta LJ (25 March 2021). "Colombia grants emergency use for J&J coronavirus vaccine". Reuters. Bogotá. Archived from the original on 25 June 2021. Retrieved 25 March 2021.
  140. ^ Lowrey T (13 April 2021). "Johnson & Johnson's one-dose COVID-19 vaccine won't be coming to Australia due to AstraZeneca similarities". ABC News. Archived from the original on 13 April 2021. Retrieved 13 April 2021.
  141. ^ Karp P (12 April 2021). "Australia won't buy Johnson & Johnson's one-dose Covid vaccine due to AstraZeneca similarities". The Guardian. Archived from the original on 12 April 2021. Retrieved 12 April 2021.
  142. ^ "Covaxin, Janssen approved for emergency use in PH". CNN Philippines. 19 April 2021. Archived from the original on 20 April 2021. Retrieved 19 April 2021.
  143. ^ "Philippines approves emergency use of J&J, Bharat BiotechCOVID-19 vaccines". Reuters. 19 April 2021. Archived from the original on 29 April 2021. Retrieved 29 April 2021.
  144. ^ "Janssen single-dose Covid vaccine approved by UK". BBC News Online. 28 May 2021. Archived from the original on 21 June 2021. Retrieved 28 May 2021.
  145. ^ "Instituto de Salud Pública de Chile". Archived from the original on 12 June 2021. Retrieved 10 June 2021.
  146. ^ "Malaysia Approves Pfizer Jab For Teens, CanSino And J&J Covid-19 Vaccines". CodeBlue. 15 June 2021. Archived from the original on 25 June 2021. Retrieved 17 July 2021.
  147. ^ "Government agrees in principle to buy Janssen vaccines". Unite against COVID-19. Retrieved 7 July 2021.
  148. ^ "Single-dose Janssen Covid-19 vaccine approved for use in New Zealand". Stuff. 7 July 2021. Retrieved 7 July 2021.
  149. ^ Kumar, Parimal (7 August 2021). "Johnson & Johnson's Single-Dose Covid Vaccine Approved In India". NDTV.com.
  150. ^ "BPOM Terbitkan Izin Penggunaan Darurat Vaksin Covid-19 Produksi Johnson & Johnson dan Cansino". KOMPAS.com (in Indonesian). 7 September 2021. Retrieved 7 September 2021.
  151. ^ a b "Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines". U.S. Food and Drug Administration. 21 October 2021. Retrieved 22 October 2021.   This article incorporates text from this source, which is in the public domain.
  152. ^ a b "CDC Expands Eligibility for COVID-19 Booster Shots". Centers for Disease Control and Prevention. 21 October 2021. Retrieved 22 October 2021.   This article incorporates text from this source, which is in the public domain.
  153. ^ a b "Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters". U.S. Food and Drug Administration (FDA) (Press release). 19 November 2021. Retrieved 19 November 2021.   This article incorporates text from this source, which is in the public domain.
  154. ^ Grady D (29 January 2021). "Which Covid Vaccine Should You Get? Experts Cite the Effect Against Severe Disease". The New York Times. Archived from the original on 10 February 2021. Retrieved 9 February 2021.
  155. ^ "Trust and Johnson and Johnson Key To Vaccinating Homeless People". Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  156. ^ Ruiz-Grossman S (4 March 2021). "Johnson & Johnson Vaccine Could Be A 'Game Changer' For Homeless People". HuffPost. Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  157. ^ Wernau J (4 April 2021). "Johnson & Johnson's Covid-19 Vaccine Emerges as Preferred Shot for Homeless". Wall Street Journal. Archived from the original on 18 May 2021. Retrieved 18 May 2021 – via www.wsj.com.
  158. ^ a b c Tiffany K (30 April 2021). "The Hot-Person Vaccine". The Atlantic. Archived from the original on 19 May 2021. Retrieved 19 May 2021.
  159. ^ Carter S (8 March 2021). "Some North Texans Upset COVID-19 Vaccines Going to Homeless, Jailed Populations". Dallas Observer. Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  160. ^ a b Rattner N (17 April 2021). "Johnson & Johnson vaccine pause makes it tougher to immunize hard-to-reach populations against Covid". CNBC. Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  161. ^ "Vaccination clinic aimed at refugees, immigrants". 17 May 2021. Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  162. ^ Treisman, Rachel (27 August 2021). "The U.S. Has Set up a Mass Vaccination Site for Afghans Arriving in Virginia". NPR.
  163. ^ Brueck H. "Moderna vaccine creator calls Johnson & Johnson's competing shot a 'darn good' tool to fight the pandemic". Business Insider. Archived from the original on 8 February 2021. Retrieved 9 February 2021.
  164. ^ Winning A, Roelf W (9 February 2021). "South Africa may sell AstraZeneca shots as it switches to J&J vaccine to fight variant". Yahoo!. Reuters. Archived from the original on 10 February 2021. Retrieved 11 February 2021.
  165. ^ "Johnson & Johnson applies to WHO for emergency use listing of COVID-19 vaccine". Reuters. 19 February 2021. Archived from the original on 9 May 2021. Retrieved 19 March 2021.
  166. ^ "HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses". HHS.gov (Press release). 5 August 2020. Archived from the original on 12 December 2020. Retrieved 6 August 2020.
  167. ^ a b "Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine". Johnson & Johnson (Press release). Archived from the original on 18 February 2021. Retrieved 6 August 2020.
  168. ^ "US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine". Voice of America. Archived from the original on 24 January 2021. Retrieved 5 August 2020.
  169. ^ Zimmer C, LaFraniere S, Weiland N (13 January 2021). "Johnson & Johnson Expects Vaccine Results Soon but Lags in Production". The New York Times. Archived from the original on 15 January 2021. Retrieved 15 January 2021.
  170. ^ Owermohle S (22 February 2021). "Johnson & Johnson says it can provide 20M vaccine doses by late March". Politico. Archived from the original on 23 March 2021. Retrieved 1 April 2021.
  171. ^ "Johnson & Johnson COVID-19 vaccine becomes 4th to receive Health Canada approval". CBC. Archived from the original on 19 March 2021. Retrieved 5 March 2021.
  172. ^ Muvija M, Aripaka P (11 March 2021). "Europe clears J&J's single-shot COVID-19 vaccine as roll-out falters". Reuters. Archived from the original on 15 March 2021. Retrieved 16 March 2021.
  173. ^ "EU regulator finds possible blood clot link with J&J vaccine, but says benefits outweigh risks". CNBC. 20 April 2021. Archived from the original on 24 April 2021. Retrieved 24 April 2021.
  174. ^ a b c "Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available". CNN. 3 March 2021. Archived from the original on 11 March 2021. Retrieved 20 March 2021.
  175. ^ a b "You asked, we answered: Do the COVID-19 vaccines contain aborted fetal cells? | Nebraska Medicine Omaha, NE". www.nebraskamed.com. Archived from the original on 24 March 2021. Retrieved 24 March 2021.
  176. ^ "PER.C6 Cell Lines - Creative Biolabs". www.gmp-creativebiolabs.com. Retrieved 21 August 2021.
  177. ^ "AdVac and PER.C6 Technology of the Janssen COVID-19 Vaccine". Janssen. 5 August 2021. Retrieved 22 August 2021.
  178. ^ "COVID-19 Vaccines and Fetal Tissue: The Science and Controversy Explained". Newsweek. 13 March 2021. Archived from the original on 11 April 2021. Retrieved 12 April 2021.
  179. ^ "Johnson & Johnson COVID vaccine morally wrong? Catholic bishops caution just that". Fox News. 2 March 2021. Archived from the original on 11 April 2021. Retrieved 12 April 2021.
  180. ^ "Abortion opponents protest COVID-19 vaccines' use of fetal cells". Science Magazine. 5 June 2020. Archived from the original on 13 April 2021. Retrieved 12 April 2021.
  181. ^ a b "Note on the morality of using some anti-Covid-19 vaccines (21 December 2020)". www.vatican.va. Archived from the original on 24 March 2021. Retrieved 24 March 2021.
  182. ^ "How making a COVID-19 vaccine confronts thorny ethical issues". Science Magazine. 7 July 2020. Archived from the original on 13 April 2021. Retrieved 12 April 2021.
  183. ^ "Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available". CNN. 3 March 2021. Archived from the original on 11 March 2021. Retrieved 20 March 2021.
  184. ^ Steinhauser, Gabriele (2 September 2021). "EU to Return Millions of Doses of J&J's Covid-19 Vaccine Imported From Africa". Wall Street Journal. ISSN 0099-9660. Retrieved 9 September 2021.
  185. ^ Lee J (14 May 2021). "Do Videos Show Magnets Sticking to People's Arms After COVID-19 Vaccine?". Snopes.com. Archived from the original on 19 May 2021. Retrieved 7 June 2021.
  186. ^ Fichera A (14 May 2021). "Magnet Videos Refuel Bogus Claim of Vaccine Microchips". FactCheck.org. Annenberg Public Policy Center. Archived from the original on 17 May 2021. Retrieved 7 June 2021.
  187. ^ "COVID-19 VACCINE MYTHS AND FACTS" (PDF). Los Angeles County Department of Public Health. Retrieved 27 August 2021.
  188. ^ "COVID-19 Vaccine Facts". Centers for Disease Control and Prevention. 18 August 2021. Retrieved 27 August 2021.

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