Medicine:Johnson & Johnson COVID-19 vaccine

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Short description: Vaccine against COVID-19
Johnson & Johnson COVID-19 vaccine
Johnson & Johnson COVID-19 vaccine developed by Janssen.jpg
A vial of Janssen COVID-19 Vaccine
Vaccine description
Target diseaseSARS-CoV-2
Typeviral
Clinical data
Trade namesJanssen COVID-19 Vaccine,[1][2] COVID-19 Vaccine Janssen[3]
Other names
AHFS/Drugs.comMultum Consumer Information
License data
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
  • CA: Schedule D; Authorized by interim order
  • US: Standing Order; Unapproved (Emergency Use Authorization)[1][7][8][9][10]
  • EU: Conditional marketing authorization granted [11]
  • ZA: Section 21 (EUA)[12][13]
Identifiers
DrugBank
UNII


The Janssen or Johnson & Johnson COVID-19 vaccine is a COVID-19 vaccine[14] that was developed by Janssen Vaccines in Leiden, Netherlands,[15] and its Belgian parent company Janssen Pharmaceuticals,[16] subsidiary of American company Johnson & Johnson.[17][18]

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.[19] The vaccine requires only one dose and does not need to be stored frozen.[20][21]

Clinical trials for the vaccine were started in June 2020, with Phase III trials involving around 43,000 people.[7] 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,[22][23][24] 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[8][25] and a conditional marketing authorisation by the European Medicines Agency (EMA).[11][26][27]

Medical uses

The Johnson & Johnson 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][11]

Description

The vaccine is based on technology similar to the Sputnik V COVID-19 vaccine and the Oxford–AstraZeneca COVID-19 vaccine.[28] Using human adenovirus it is more similar to Sputnik V, but according to the first clinical trials might be less effective.[citation needed] The Johnson & Johnson COVID-19 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.[4][29]

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.[30][31][32] The vaccine also contains the following 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][29]

Characteristics

Unlike several of the other vaccines (such as the Oxford–AstraZeneca, Pfizer–BioNTech, and Moderna vaccines), the Johnson & Johnson vaccine is administered as a single dose instead of as two separate doses.[20][33]

Unpunctured vials may be stored between 9 to 25 °C (48 to 77 °F) for up to twelve hours,[20][29] and it can remain viable for months in a standard refrigerator.[34][35][36] It is not shipped[20][33] or stored frozen.[20]

Adverse effects

The most common side effects of the vaccine in the trials were usually mild or moderate, occurred within 2 days after vaccination and got better within 1 or 2 days.[9][11][37]

Coughing, joint pain, fever, chills, redness, and swelling at the injection site occurred in less than 1 in 10 people.[11] 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.[11] Rare side effects (that occurred in less than 1 in 1,000 people) are hypersensitivity (allergy) and itchy rash.[11]

Formation of blood clots in the blood vessels in combination with low levels of blood platelets (known as Thrombosis with Thrombocytopenia Syndrome, or TTS) occurred in less than 1 in 10,000 people one to two-weeks following vaccination.[9][11][38][39] The CDC found TTS at "a rate of about 7 per 1 million vaccinated women between 18 and 49 years old,"[39] and cautions that "women younger than 50 years old should especially be aware of their increased risk for this rare adverse event. There are other COVID-19 vaccines available for which this risk has not been seen."[39] In particular, "as of April 23, 2021, [TTS] has not been linked to the Pfizer-BioNTech or Moderna COVID-19 vaccines after more than 210 million doses administered."[40]

As with other vaccines, allergic reactions, including anaphylaxis, can occur in rare cases within a few minutes to one hour after receiving a dose.[9][11] The vaccines should be given under close supervision with appropriate medical treatment available.[11]

Development

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).[41][42] 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".[43]

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

Janssen Vaccines, in partnership with Beth Israel Deaconess Medical Center (BIDMC), is responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine.[18][44][45]

Preclinical trials indicate that the vaccine effectively protects hamsters and rhesus macaques from SARS‐CoV‐2.[46]

Clinical trials

Phase I–II

In June 2020, Johnson & Johnson and the National Institute of Allergy and Infectious Diseases (NIAID) confirmed that they plan 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.[47][48][49]

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.[50] 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.[51][52]

Phase III

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 designed 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.[53] The trial was paused on 12 October 2020, because a volunteer became ill,[54][46] but the company said it found no evidence the vaccine had caused the illness and announced on 23 October 2020 that it would resume the trial.[55][56] 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.[57] During the trial, no anaphylaxis was observed in participants.[57]

A second Phase III clinical trial called ENSEMBLE 2 started enrollment on 12 November 2020. ENSEMBLE 2 differs from ENSEMBLE in that its study participants will receive two intramuscular (IM) injections of Ad26.COV2.S, one on day 1 and the next on day 57.[58]

Manufacturing

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.[59] In July 2020, the partnership was expanded to include Catalent's facility in Anagni, Italy.[60]

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.[61][62] The deal was confirmed on 5 August.[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]

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 in the second quarter of 2021, the factory will produce fifty million COVID-19 vaccine doses a year.[68]

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.[62] 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.[69] In February 2021, congressional testimony by a company executive, however, 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.[70]

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.[71]

In March 2021, Johnson & Johnson and Aspen Pharmacare made a deal to manufacture 220 million vaccines at the 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.[72][73][74]

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.[75] 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.[76] 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.[77]

Regulatory approval process

European Union

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 Authorisation Application.[66][78] On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine.[3][79] The European Commission approved the COVID-19 Vaccine Janssen on 11 March 2021.[11][27] Shipments of the vaccine are scheduled to start in the second half of April, with a commitment to deliver at least two hundred million doses to the EU in 2021.[80]

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 end the COVID-19 pandemic.[81]

United States

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.[34][33][82][83] Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization.[57] 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 safety data are consistent with FDA EUA guidance for COVID-19 vaccines.[29][84][85][86] At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that a EUA for the vaccine be issued.[87] The FDA granted the EUA for the vaccine the following day.[7][8][88] 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.[89][25]

On 13 April 2021, the CDC and the FDA issued a joint statement recommending that use of the Johnson & Johnson 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.[90] 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.[91][92][93]

On 23 April, the FDA and the CDC determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.[94][95] The EUA and the fact sheets were updated to reflect the risks of thrombosis-thrombocytopenia syndrome (TTS).[94]

Elsewhere

On 11 February 2021, Saint Vincent and the Grenadines issued an EUA for the Johnson & Johnson vaccine, as well as the Moderna vaccine, the Pfizer–BioNTech vaccine, the Sputnik V vaccine, and the Oxford–AstraZeneca vaccine.[96]

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.[35][97][98]

On 25 February 2021, Bahrain authorized the vaccine for emergency use.[99][100]

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.[101]

In late November 2020, Johnson & Johnson submitted a rolling review application to Health Canada for approval of its vaccine.[102] The Canadian government has 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.[103]

In February 2021, the vaccine received emergency authorization in South Africa.[104][105][106] In April 2021, South Africa suspended its rollout of the vaccine.[107]

On 26 March 2021, the vaccine received emergency authorization in Colombia.[108]

In April 2021, the Australian government stated that it would not be purchasing the Johnson & Johnson vaccine, as it "does not intend to purchase any further adenovirus vaccines at this time".[109][110]

In April 2021, the vaccine received emergency use authorization in the Philippines.[111][112]

Deployment and impact

Given the Johnson & Johnson vaccine is a single dose and has a lower cost, it is expected that it will play an important role in low and middle-income countries.[113] Since its a single dose vaccine, it has been a popular vaccine to distribute to the homeless[114][115][116][117], the incarcerated[118][119][117], and refugee populations.[120][121][117] This is due to the fact that its 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 Johnson & Johnson vaccine will be more easily transported, stored, and administered.[122] 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.[123] Once it did so, South Africa began vaccination using the Johnson & Johnson vaccine on 17 February 2021,[106] marking the vaccine's first use outside of a clinical trial.[124]

Ethical concerns

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 a fetus electively aborted in 1985.[125][126] 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 Johnson & Johnson vaccine.[127][128] Some bioethicists dismiss that ethical concerns to using cells derived from ethically compromised sources should be addressed or alternatives sought.[129] 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.[125][126] 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 ..."[125][130] However, the key objection to using these vaccines still remains.[131] Moreover, the Vatican note makes abundantly clear that such permissibility depends on the absence of less morally objectionable alternatives, which have now become available in many parts of the world.[130]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 "Janssen COVID-19 Vaccine – ad26.cov2.s injection, suspension". U.S. National Institutes of Health. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14a822ff-f353-49f9-a7f2-21424b201e3b. 
  2. ↑ "Janssen COVID-19 Emergency Use Authorization (EUA) Official Website". 28 February 2021. https://www.janssencovid19vaccine.com/hcp.html. 
  3. ↑ 3.0 3.1 3.2 "EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen" (Press release). European Medicines Agency (EMA). 16 February 2021. Retrieved 16 February 2021.
  4. ↑ 4.0 4.1 4.2 4.3 4.4 "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. https://www.jnj.com/coronavirus/ensemble-1-study-protocol. 
  5. ↑ 5.0 5.1 5.2 5.3 "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. https://www.jnj.com/coronavirus/ensemble-2-study-protocol. 
  6. ↑ 6.0 6.1 "Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate". Johnson & Johnson (Press release). Retrieved 23 September 2020.
  7. ↑ 7.0 7.1 7.2 "FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). 27 February 2021. Retrieved 27 February 2021.
  8. ↑ 8.0 8.1 8.2 "FDA Letter of Authorization" (PDF). 27 February 2021. https://www.fda.gov/media/146303/download. "...letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA)..." 
  9. ↑ 9.0 9.1 9.2 9.3 "Janssen COVID-19 Vaccine". 19 March 2021. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine.  This article incorporates text from this source, which is in the public domain.
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  13. ↑ "J&J Covid-19 Vaccine Approved in South Africa for Wider Use" (in en). Bloomberg.com. 2021-04-01. https://www.bloomberg.com/news/articles/2021-04-01/j-j-covid-19-vaccine-approved-in-south-africa-for-general-use. 
  14. ↑ "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)". https://clinicaltrials.gov/ct2/show/NCT04505722. 
  15. ↑ "Leiden developed Covid-19 vaccine submitted to EMA for approval". 16 February 2021. https://nltimes.nl/2021/02/16/leiden-developed-covid-19-vaccine-submitted-ema-approval. 
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  22. ↑ "Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease". ABC News. 29 January 2021. https://abcnews.go.com/Health/johnson-johnson-single-shot-vaccine-85-effective-severe/story?id=75557358. 
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  24. ↑ "J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch". 29 January 2021. https://www.statnews.com/2021/01/29/jj-one-dose-covid-vaccine-is-66-effective-a-weapon-but-not-a-knockout-punch/. 
  25. ↑ 25.0 25.1 "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. Retrieved 1 March 2021.
  26. ↑ "EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU" (Press release). European Medicines Agency (EMA). 11 March 2021. Retrieved 11 March 2021.
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  28. ↑ "Russia's Sputnik V vaccine looks good in early analysis". Ars Technica. 3 February 2021. https://arstechnica.com/science/2021/02/russias-sputnik-v-vaccine-looks-good-in-early-analysis/. 
  29. ↑ 29.0 29.1 29.2 29.3 (PDF) FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 (Report). U.S. Food and Drug Administration (FDA). https://www.fda.gov/media/146217/download.  This article incorporates text from this source, which is in the public domain.
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  32. ↑ "Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques". Nature 586 (7830): 583–88. October 2020. doi:10.1038/s41586-020-2607-z. PMID 32731257. Bibcode: 2020Natur.586..583M. 
  33. ↑ 33.0 33.1 33.2 "J&J files COVID-19 vaccine application with U.S. FDA". Reuters. 4 February 2021. https://www.reuters.com/article/us-health-coronavirus-vaccines-johnson-j-idINKBN2A430V. 
  34. ↑ 34.0 34.1 "Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine". The Washington Post. 4 February 2021. https://www.washingtonpost.com/health/2021/02/04/jj-vaccine-fda/. 
  35. ↑ 35.0 35.1 "One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds". https://www.usatoday.com/story/news/health/2021/02/24/fda-finds-one-dose-j-j-covid-vaccine-meets-criteria-safe-effective/4535542001/. 
  36. ↑ "COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%". 29 January 2021. https://arstechnica.com/science/2021/01/covid-variants-throw-jj-vaccine-a-curveball-lowering-efficacy-to-66/. 
  37. ↑ "Information about the J&J/Janssen COVID-19 Vaccine". U.S. Centers for Disease Control and Prevention (CDC). 31 March 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html.  This article incorporates text from this source, which is in the public domain.
  38. ↑ "COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia". European Medicines Agency. 26 April 2021. https://www.ema.europa.eu/documents/dhpc/direct-healthcare-professional-communication-dhpc-covid-19-vaccine-janssen-link-between-vaccine_en.pdf. 
  39. ↑ 39.0 39.1 39.2 "Safety of COVID-19 Vaccines". CDC. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. 
  40. ↑ "CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume". CDC. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html. 
  41. ↑ "J&J collaborates to accelerate COVID-19 vaccine development". 13 March 2020. https://njbiz.com/jj-collaborates-accelerate-covid-19-vaccine-development/. 
  42. ↑ "Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device". 6 April 2020. https://www.wspa.com/news/prisma-health-collaborates-with-ethicon-inc-to-make-distribute-vesper-ventilator-expansion-splitter-device/. 
  43. ↑ "Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine". https://news.sky.com/story/coronavirus-johnson-johnson-vows-to-make-not-for-profit-vaccine-11966292. 
  44. ↑ "A Beth Israel researcher helped create a COVID-19 vaccine that awaits approval. It could be a 'game changer'". 16 January 2021. https://www.bostonglobe.com/2021/01/16/nation/beth-israel-researcher-awaits-approval-covid-19-vaccine-he-helped-create/. 
  45. ↑ Mitchell, Jacqueline; Meck, Chloe (27 February 2021). "FDA grants third COVID-19 vaccine, developed in part at BIDMC, emergency use authorization". https://www.bidmc.org/about-bidmc/news/2021/01/data-shows-bidmc-vaccine-collab-met-co-primary-endpoints. 
  46. ↑ 46.0 46.1 "Racing to immunity: Journey to a COVID-19 vaccine and lessons for the future". British Journal of Clinical Pharmacology n/a (n/a). December 2020. doi:10.1111/bcp.14686. PMID 33289156. 
  47. ↑ "Final testing stage for potential coronavirus vaccine set to begin in July". 10 June 2020. https://thehill.com/policy/healthcare/501999-final-testing-stage-for-coronavirus-vaccine-could-begin-in-july-report. 
  48. ↑ "Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ". https://www.fiercepharma.com/vaccines/nih-preps-late-stage-studies-moderna-az-and-j-j-coronavirus-vaccines-wsj. 
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  87. ↑ "FDA panel unanimously recommends third Covid vaccine as J&J wins key vote in path to emergency use". 26 February 2021. https://www.cnbc.com/2021/02/26/johnson-and-johnson-covid-vaccine-fda-panel-recommends-emergency-use.html. 
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