Janssen COVID-19 vaccine

Last updated

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

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, [23] and its Belgian parent company Janssen Pharmaceuticals, [24] subsidiary of American company Johnson & Johnson. [25] [26] [27]

Contents

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. [28] The vaccine requires only one dose and does not need to be stored frozen. [29] [30]

Clinical trials for the vaccine were started in June 2020, with Phase III involving around 43,000 people. [17] 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, [31] [32] [33] 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 [18] [34] and a conditional marketing authorization by the European Medicines Agency (EMA) [4] [35] [36] and the UK Medicines and Healthcare products Regulatory Agency. [14]

Medical uses

The Janssen COVID‑19 vaccine is used to provide protection against infection by the SARS-CoV-2 virus in order to prevent COVID-19 in people aged eighteen years and older. [1] [4]

The vaccine is given by intramuscular injection into the deltoid muscle. The initial course consists of a single dose. [37]

Efficacy

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. [38] Efficacy is closely related to effectiveness, which is generally expected to slowly decrease over time. [39]

Efficacy by variant
Severity of illness Alpha Beta Gamma Delta Lineage B.1 [lower-alpha 1]
Moderate [lower-alpha 2] to severe [lower-alpha 3] Not reported64% (4179%)Not reportedNot reported72% (5882%)
Severe to critical [lower-alpha 3] Not reported82% (4695%)Not reported71% [lower-alpha 4] [lower-alpha 5] 86% (−9 to 100%)

Pharmacology

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] [42] It is similar to the approach used by the Oxford–AstraZeneca COVID-19 vaccine and the Russian Sputnik V COVID-19 vaccine. [43] [44]

Chemistry

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] [42]

Manufacturing

Unpunctured vials may be stored between 9 to 25 °C (48 to 77 °F) for up to twelve hours, [29] [42] and the vaccine can remain viable for months in a standard refrigerator. [45] [46] [47] It is not shipped [29] [48] or stored frozen. [29]

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. [49] In July 2020, the partnership was expanded to include Catalent's facility in Anagni, Italy. [50]

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. [51]

A production line at the Reig Jofre factory View of a production line at the Reig Jofre company's headquarters.jpg
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. [52] 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. [53] [54] Starting in the second quarter of 2021, the factory will produce fifty million COVID-19 vaccine doses a year. [55]

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. [56]

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. [57] [58] [59]

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. [60] 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. [61] 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. [62] In July 2021, the FDA authorized Emergent to resume production (but not distribution) of the Janssen vaccine. [63]

Adverse effects

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." [64]

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. [19] [4] [65]

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. [66] [67] 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 1849 years old and occurs more rarely in other populations (i.e. women 50 years and older, and men of all ages). [68]

Allergic reactions, including anaphylaxis, can occur in rare cases within a few minutes to one hour after receiving a dose. [4] [20]

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). [64]

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. [29] [69] [70] 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. [71]

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." [72]

History

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. [73] [74] [75]

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). [76] [77] 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". [78] In November, Johnson & Johnson announced that Janssen would commit about $604 million and BARDA, $454 million, to fund the ENSEMBLE trial. [79]

Inside of an Emergent BioSolutions facility where, in collaboration with Johnson & Johnson, vaccines are produced Ad26.COV2.S production facility.jpg
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), is responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine. [26] [80] [81] [82]

Clinical trials

Preclinical trials indicate that the vaccine effectively protects hamsters and rhesus macaques from SARS‐CoV‐2. [83]

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. [84] [85] [86]

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. [87] 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. [88] [89] A substudy with 20 participants found that humoral and cell-mediated immune responses, including cytotoxic T cells, lasted for at least 8 months. [90] [ unreliable medical source? ]

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. [91] The trial was paused on 12 October 2020, because a volunteer became ill, [92] [83] 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. [93] [94] 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. [95] During the trial, no anaphylaxis was observed in participants. [95]

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. [96] Early results indicate 85% efficacy against severe/critical disease. [90] [ failed verification ] Plasma from 8 participants showed greater neutralization activity against the Delta variant than against Beta. [90]

Authorizations

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

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 authorization. [53] [97] On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine. [3] [98] The European Commission approved the COVID-19 Vaccine Janssen on 11 March 2021. [4] [36]

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. [45] [48] [99] [100] 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. [42] [101] [102] [103] At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that a EUA for the vaccine be issued. [104] The FDA granted the EUA for the vaccine the following day. [17] [18] [105] 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. [106] [34]

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. [107] 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. [108] [109] [110]

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. [111] [112] The EUA and the fact sheets were updated to reflect the risks of thrombosis-thrombocytopenia syndrome (TTS). [111]

Elsewhere

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. [113]

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. [46] [114] [115] The World Health Organization issued an EUL for the Janssen COVID-19 vaccine Ad26.COV2.S vaccine on 12 March 2021. [116] [117]

On 18 February 2021, the vaccine received emergency authorization in South Africa. [118] [119] [120] On 13 April 2021, South Africa suspended its rollout of the vaccine. [121] The program resumed on 28 April 2021.

On 25 February 2021, Bahrain authorized the vaccine for emergency use. [122] [123]

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. [124]

In late November 2020, Johnson & Johnson submitted a rolling review application to Health Canada for approval of its vaccine. [125]

On 26 March 2021, the vaccine received emergency authorization in Colombia. [126]

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". [127] [128] 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. [129] [130]

On 28 May 2021, the vaccine received conditional marketing authorization in the United Kingdom. [14] [15] [16] [131] [82]

On 10 June 2021, the vaccine received emergency use authorization in Chile. The vaccine will be provided via COVAX. [132]

On 15 June 2021, Malaysia's National Pharmaceutical Regulatory Agency (NPRA) has issued conditional registration for emergency use of the vaccine. [133]

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. [134] [135]

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. [136]

On 7 September 2021, National Agency of Drug and Food Control (BPOM) has issued emergency use authorization in Indonesia. [137]

Further development

Homologous prime-boost vaccination

In October 2021, the FDA and the CDC authorized the use of either homologous or heterologous vaccine booster doses. [138] [139]

Heterologous prime-boost vaccination

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. [138] [139]

Society and culture

Economics

Given the Janssen 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. [140] Since it is a single dose vaccine, it has been a popular vaccine to distribute to the homeless, [141] [142] [143] [144] the incarcerated, [145] [146] [144] and refugee populations. [147] [146] [144] [148] 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 will be more easily transported, stored, and administered. [149] 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. [150] Once it did so, South Africa began vaccination using the Janssen vaccine on 17 February 2021, [120] marking the vaccine's first use outside of a clinical trial. [151]

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. [152] [153] The deal was confirmed on 5 August. [154]

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. [153] 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. [155] 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. [156]

In February 2021, Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization. [95]

In March 2021, 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. [157]

Shipments of the vaccine are 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. [158]

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. [159]

Controversies

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. [160] [161] [162] [163] 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. [164] [165] Some bioethicists dismiss that ethical concerns to using cells derived from ethically compromised sources should be addressed or alternatives sought. [166] 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. [160] [161]

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 ..." [160] [167] However, the key objection to using these vaccines still remains. [168] [167] [169]

In September 2021, after criticism that doses of its single-shot COVID-19 vaccine produced in its 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. [170]

Misinformation

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. [171] [172] [173] [174]

Notes

  1. Wuhan-H1 variant D614G. [40] Corresponds to 96% of the strains the United States during the study.
  2. Generally includes mild symptoms such as olfactory or taste disorders and moderate symptoms such as pneumonia.
  3. 1 2 Generally understood as requiring some form of hospitalization (from supplemental oxygen therapy to ICU admission). The same statistical variable includes cases of death.
  4. A confidence interval was not provided, so it is not possible to know the accuracy of this measurement.
  5. Effectiveness against hospitalization from a preliminary study with 477,000 healthcare workers. [41]

Related Research Articles

An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.

Moderna American biotechnology company innovating on mRNA-based medicines

Moderna, Inc., is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts. It focuses on vaccine technologies based on messenger RNA (mRNA). Moderna's vaccine platform inserts synthetic nucleoside-modified messenger RNA (modRNA) into human cells using a coating of lipid nanoparticles. This mRNA then reprograms the cells to prompt immune responses. Moderna develops mRNA therapeutic vaccines that are delivered in lipid nanoparticles, using mRNA with pseudouridine nucleosides. Candidates are designed to have improved folding and translation efficiency via insertional mutagenesis.

COVID-19 pandemic in the United States Ongoing COVID-19 viral pandemic in the United States

The COVID-19 pandemic in the United States is part of the worldwide pandemic of coronavirus disease 2019. Since January 2020, 45,400,466 confirmed cases have been reported with 735,373 deaths, the most of any country, and the twentieth-highest per capita worldwide. As many infections have gone undetected, the Centers for Disease Control and Prevention (CDC) estimated that, as of May 2021, there could be a total 120.2 million infections in the United States, or more than a third of the total population. COVID-19 is the deadliest pandemic in U.S. history; it was the third-leading cause of death in the U.S. in 2020, behind heart disease and cancer. From 2019 to 2020, U.S. life expectancy dropped by 3 years for Hispanic Americans, 2.9 years for African Americans, and 1.2 years for white Americans. These effects have persisted as U.S. deaths due to COVID-19 in 2021 exceeded those in 2020.

COVID-19 vaccine Vaccine designed to provide acquired immunity against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID‑19). Prior to the COVID‑19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. On 10 January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by 19 March, the global pharmaceutical industry announced a major commitment to address COVID-19. The COVID‑19 vaccines are widely credited for their role in reducing the spread, severity, and death caused by COVID-19.

Moderna COVID-19 vaccine RNA COVID-19 vaccine

The Moderna COVID‑19 vaccine, codenamed mRNA-1273 and sold under the brand name Spikevax, is a COVID-19 vaccine developed by American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). It is authorized for use in people aged twelve years and older in some jurisdictions and for people eighteen years and older in other jurisdictions to provide protection against COVID-19 which is caused by infection by the SARS-CoV-2 virus. It is designed to be administered as two or three 0.5 mL doses given by intramuscular injection at an interval of at least 28 days apart.

COVID-19 drug development Preventative and therapeutic medications for COVID-19 infection

COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research, with 419 potential COVID-19 drugs in clinical trials, as of April 2021.

Convidecia Vaccine against COVID-19

AD5-nCOV, trade-named Convidecia, is a single-dose viral vector vaccine for COVID-19 developed by CanSino Biologics. It conducted its Phase III trials in Argentina, Chile, Mexico, Pakistan, Russia, and Saudi Arabia with 40,000 participants.

Operation Warp Speed American public–private partnership designed to accelerate COVID-19 vaccine development

Operation Warp Speed (OWS) was a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The first news report of Operation Warp Speed was on April 29, 2020, and the program was officially announced on May 15, 2020. It was headed by Moncef Slaoui from May 2020 to January 2021 and by David A. Kessler from January to February 2021. At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team.

Oxford–AstraZeneca COVID-19 vaccine Viral vector vaccine for prevention of COVID-19 by Oxford University and AstraZeneca

The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222, and sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for prevention of COVID-19. Developed in the United Kingdom by the Oxford University and British-Swedish company AstraZeneca, using as a vector the modified chimpanzee adenovirus ChAdOx1. The vaccine is given by intramuscular injection. Studies carried out in 2020 showed that the efficacy of the vaccine is 76.0% at preventing symptomatic COVID-19 beginning at 22 days following the first dose and 81.3% after the second dose. A study in Scotland found that, for symptomatic COVID-19 infection after the second dose, the vaccine is 81% effective against the Alpha variant, and 61% against the Delta variant.

BioNTech German biotechnology company

BioNTech SE is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops pharmaceutical candidates based on messenger ribonucleic acid (mRNA) for use as individualized cancer immunotherapies, as vaccines against infectious diseases and as protein replacement therapies for rare diseases, and also engineered cell therapy, novel antibodies and small molecule immunomodulators as treatment options for cancer.

Casirivimab/imdevimab Antiviral combination medication

Casirivimab/imdevimab, sold under the brand name REGEN-COV among others, is a medicine developed by the American biotechnology company Regeneron Pharmaceuticals. It is an artificial "antibody cocktail" designed to produce resistance against the SARS-CoV-2 coronavirus responsible for the COVID-19 pandemic. It consists of two monoclonal antibodies, casirivimab (REGN10933) and imdevimab (REGN10987) that must be mixed together. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product.

Pfizer–BioNTech COVID-19 vaccine mRNA-based COVID-19 vaccine

The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech and for its development collaborated with American company Pfizer, for support with clinical trials, logistics, and manufacturing. It is authorized for use in people aged twelve years and older in some jurisdictions and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months in Canada.

The COVID-19 vaccination program in the Philippines is an ongoing mass immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country.

History of COVID-19 vaccine development Scientific work to develop a vaccine for COVID-19

COVID-19's caused virus, SARS-CoV-2, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.

COVID-19 vaccination in South Africa Plan to immunize against COVID-19 in South Africa

COVID-19 vaccination in South Africa is an ongoing immunisation campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country.

COVID-19 vaccination in the United States Plan to immunize against COVID-19

The COVID-19 vaccination campaign in the United States is an ongoing mass immunization campaign for the COVID-19 pandemic in the United States. The Food and Drug Administration (FDA) first granted emergency use authorization to the Pfizer–BioNTech vaccine on December 10, 2020; mass vaccinations began on December 14, 2020. The Moderna vaccine was granted emergency use authorization on December 17, 2020, and the Janssen vaccine was granted emergency use authorization on February 27, 2021. By April 19, 2021, all U.S. states had opened vaccine eligibility to residents aged 16 and over. On May 10, 2021, the FDA approved the Pfizer-BioNTech vaccine for adolescents aged 12 to 15. On August 23, 2021, the FDA granted full approval to the Pfizer–BioNTech vaccine for individuals aged 16 and over.

MVC COVID-19 vaccine Vaccine against COVID-19

The MVC COVID-19 vaccine, designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine , is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation in Taiwan, American company Dynavax Technologies and the U.S. National Institute of Health.

Viral vector vaccine Type of vaccine

A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material coding for a desired antigen into the recipient's host cells. As of April 2021, six viral vector vaccines have been authorized for use in human at least one country: four COVID-19 vaccines and two Ebola vaccines.

COVID-19 vaccine clinical research

COVID-19 vaccine clinical research is the clinical research on COVID-19 vaccines, including their efficacy, effectiveness and safety. There are 24 vaccines authorized for use by national governments, with six vaccines being approved for emergency or full use by at least one WHO-recognised stringent regulatory authority; and five of them are in Phase IV. 204 vaccines under clinical trials that have not yet been authorized. There are also nine clinical trials on heterologous vaccination courses.

References

  1. 1 2 3 4 5 "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. 1 2 3 "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. 1 2 3 4 5 6 7 8 9 10 "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. 1 2 3 4 5 "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. 1 2 3 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 2 Protocol VAC31518COV3009; Phase 3" (PDF). Janssen Vaccines & Prevention. Archived from the original on 25 February 2021. Retrieved 26 February 2021.
  7. 1 2 "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. 1 2 3 4 "COVID-19 Vaccine Janssen". Therapeutic Goods Administration (TGA). 25 June 2021. Retrieved 28 August 2021.
  9. 1 2 3 "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. "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.
  13. "Janssen COVID-19 Vaccine monograph" (PDF). Janssen. 5 March 2021. Archived (PDF) from the original on 5 March 2021. Retrieved 5 March 2021.
  14. 1 2 3 "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.
  15. 1 2 "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.
  16. 1 2 "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.
  17. 1 2 3 "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.
  18. 1 2 3 "FDA Letter of Authorization" (PDF). 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)...
  19. 1 2 "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.PD-icon.svgThis article incorporates text from this source, which is in the public domain .
  20. 1 2 "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.
  21. "Johnson & Johnson Covid vaccine approved for general use in South Africa". Archived from the original on 9 May 2021. Retrieved 9 May 2021.
  22. "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.
  23. "Leiden developed Covid-19 vaccine submitted to EMA for approval". 16 February 2021. Retrieved 15 March 2021.
  24. "Clinical trial COVID-19 vaccine candidate underway". Janssen Belgium. Archived from the original on 15 January 2021. Retrieved 13 March 2021.
  25. "EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden". NL Times. Retrieved 12 March 2021.
  26. 1 2 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.
  27. "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.
  28. 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.
  29. 1 2 3 4 5 "Fact Sheet for Healthcare Providers Administering Vaccine and EUA" (PDF). Janssen. Archived from the original on 13 April 2021. Retrieved 13 April 2021.
  30. "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.
  31. 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.
  32. 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.
  33. 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.
  34. 1 2 "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.
  35. "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.
  36. 1 2 "COVID-19 Vaccine Janssen". Union Register of medicinal products. Archived from the original on 11 March 2021. Retrieved 16 March 2021.
  37. 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.
  38. 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.
  39. 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)
  40. 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.
  41. Foley, Katherine (6 August 2021). "J&J shot effective against Delta variant in large South Africa study". POLITICO. Retrieved 12 August 2021.
  42. 1 2 3 4 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.PD-icon.svgThis article incorporates text from this source, which is in the public domain .
  43. "Drug Levels and Effects". COVID-19 vaccines. Bethesda (MD): National Library of Medicine (US). 2006. PMID   33355732 . Retrieved 15 October 2021.
  44. 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.
  45. 1 2 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.
  46. 1 2 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.
  47. 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.
  48. 1 2 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.
  49. 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.
  50. "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.
  51. "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.
  52. 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.
  53. 1 2 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.
  54. "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.
  55. "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.
  56. "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.
  57. "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.
  58. "COVID-19 vaccine: J&J commits 30 million doses for SA". eNCA. Archived from the original on 30 April 2021. Retrieved 31 March 2021.
  59. "'No setbacks.' SA factory on track to produce J&J vaccine". BusinessInsider. Archived from the original on 30 April 2021. Retrieved 31 March 2021.
  60. "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.
  61. 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.
  62. 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.
  63. 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.
  64. 1 2 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.
  65. "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.PD-icon.svgThis article incorporates text from this source, which is in the public domain .
  66. "EUA fact sheet for healthcare providers administering vaccine" (PDF). Janssen Therapeutics. 27 August 2021. Retrieved 4 October 2021.
  67. 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.
  68. "Safety of COVID-19 Vaccines". U.S. Centers for Disease Control and Prevention (CDC). 11 February 2020. Retrieved 13 July 2021.
  69. 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.
  70. "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.
  71. "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.
  72. "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021". European Medicines Agency. 5 August 2021.
  73. "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.
  74. 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.
  75. 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.
  76. 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.
  77. "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.
  78. "Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine". Sky News. Archived from the original on 21 January 2021. Retrieved 22 April 2020.
  79. "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.
  80. "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.
  81. 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.
  82. 1 2 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.
  83. 1 2 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.
  84. 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.
  85. "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.
  86. "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.
  87. "A Study of Ad26.COV2.S in Adults (COVID-19)". ClinicalTrials.gov. Archived from the original on 16 September 2020. Retrieved 19 February 2021.
  88. 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.
  89. "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.
  90. 1 2 3 "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.
  91. "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.
  92. 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.
  93. "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.
  94. 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.
  95. 1 2 3 "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.
  96. "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.
  97. "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.
  98. "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.
  99. "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.
  100. "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.
  101. 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.
  102. 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.
  103. 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.
  104. Lovelace Jr B (26 February 2021). "FDA panel unanimously recommends third Covid vaccine as J&J wins key vote in path to emergency use". Archived from the original on 27 February 2021. Retrieved 27 February 2021.
  105. 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.
  106. 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.
  107. "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.
  108. 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.
  109. 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.
  110. 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.
  111. 1 2 "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.PD-icon.svgThis article incorporates text from this source, which is in the public domain .
  112. "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.PD-icon.svgThis article incorporates text from this source, which is in the public domain .
  113. "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.
  114. 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.
  115. 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.
  116. "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.
  117. "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.
  118. "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.
  119. 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.
  120. 1 2 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.
  121. 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.
  122. 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.
  123. "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.
  124. 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.
  125. 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.
  126. 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.
  127. 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.
  128. 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.
  129. "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.
  130. "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.
  131. "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.
  132. "Instituto de Salud Pública de Chile". Archived from the original on 12 June 2021. Retrieved 10 June 2021.
  133. "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.
  134. "Government agrees in principle to buy Janssen vaccines". Unite against COVID-19. Retrieved 7 July 2021.
  135. "Single-dose Janssen Covid-19 vaccine approved for use in New Zealand". Stuff. 7 July 2021. Retrieved 7 July 2021.
  136. Kumar, Parimal (7 August 2021). "Johnson & Johnson's Single-Dose Covid Vaccine Approved In India". NDTV.com.
  137. "BPOM Terbitkan Izin Penggunaan Darurat Vaksin Covid-19 Produksi Johnson & Johnson dan Cansino". KOMPAS.com (in Indonesian). 7 September 2021. Retrieved 7 September 2021.
  138. 1 2 "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.PD-icon.svgThis article incorporates text from this source, which is in the public domain .
  139. 1 2 "CDC Expands Eligibility for COVID-19 Booster Shots". Centers for Disease Control and Prevention. 21 October 2021. Retrieved 22 October 2021.PD-icon.svgThis article incorporates text from this source, which is in the public domain .
  140. 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.
  141. "Trust and Johnson and Johnson Key To Vaccinating Homeless People". Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  142. 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.
  143. 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.
  144. 1 2 3 Tiffany K (30 April 2021). "The Hot-Person Vaccine". The Atlantic . Archived from the original on 19 May 2021. Retrieved 19 May 2021.
  145. 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.
  146. 1 2 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.
  147. "Vaccination clinic aimed at refugees, immigrants". 17 May 2021. Archived from the original on 18 May 2021. Retrieved 18 May 2021.
  148. Treisman, Rachel (27 August 2021). "The U.S. Has Set up a Mass Vaccination Site for Afghans Arriving in Virginia". NPR.
  149. 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.
  150. 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.
  151. "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.
  152. "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.
  153. 1 2 "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.
  154. "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.
  155. 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.
  156. 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.
  157. "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.
  158. 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.
  159. "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.
  160. 1 2 3 "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.
  161. 1 2 "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.
  162. "PER.C6 Cell Lines - Creative Biolabs". www.gmp-creativebiolabs.com. Retrieved 21 August 2021.
  163. "AdVac and PER.C6 Technology of the Janssen COVID-19 Vaccine". Janssen. 5 August 2021. Retrieved 22 August 2021.
  164. "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.
  165. "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.
  166. "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.
  167. 1 2 "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.
  168. "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.
  169. "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.
  170. 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.
  171. 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.
  172. 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.
  173. "COVID-19 VACCINE MYTHS AND FACTS" (PDF). Los Angeles County Department of Public Health. Retrieved 27 August 2021.
  174. "COVID-19 Vaccine Facts". Centers for Disease Control and Prevention. 18 August 2021. Retrieved 27 August 2021.