Johnson & Johnson COVID-19 vaccine

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Johnson & Johnson COVID-19 vaccine
Johnson & Johnson COVID-19 vaccine developed by Janssen.jpg
A vial of Janssen COVID-19 Vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesJanssen COVID-19 Vaccine,[1][2] COVID-19 Vaccine Janssen[3]
Other names
License data
Routes of
administration
Intramuscular
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank
UNII

The 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.[9] 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[10][25] and a conditional marketing authorisation by the European Medicines Agency (EMA).[13][26][27]

Medical uses[edit]

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][13]

Description[edit]

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

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.[29][1]

Characteristics[edit]

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.[33][20]

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

Adverse effects[edit]

The most common side effects were pain at the injection site, headache, fatigue, muscle aches and nausea.[9][11] Most of these side effects occurred within one to two days following vaccination, and were mild to moderate in severity and lasted one to two days.[11][37]

On 13 April 2021, the U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) announced that they would investigate six "extremely rare" cases of cerebral venous sinus thrombosis with low levels of blood platelets experienced by women between the ages of 18 and 48 that had recently received the vaccine in the United States.[38][39][40][41][excessive citations] As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States.[42] Following a safety review, the European Medicines Agency concluded on 20 April 2020 that a possible link to very rare cases of unusual blood clots with low blood platelets existed and decided to list this condition as very rare side effects of the vaccine.[42] The EMA confirmed that the overall benefits of the vaccine in preventing serious COVID-19 outcomes outweigh the risks of side effects.[42]

Development[edit]

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).[43][44] 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".[45]

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][46][47]

Preclinical trials indicate that the vaccine effectively protects hamsters and rhesus macaques from SARS‐CoV‐2.[48]

Clinical trials[edit]

Phase I–II[edit]

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.[49][50][51]

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.[52] 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.[53][54]

Phase III[edit]

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.[55] The trial was paused on 12 October 2020, because a volunteer became ill,[56][48] 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.[57][58] 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.[59] During the trial, no anaphylaxis was observed in participants.[59]

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.[60]

Manufacturing[edit]

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

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.[63][64] The deal was confirmed on 5 August.[65]

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.[66]

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.[67] 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 on April 2021.[68][69] Starting in the in the second quarter of 2021, the factory will produce fifty million COVID-19 vaccine doses a year.[70]

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.[64] 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.[71] 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.[72]

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.[73]

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.[74] 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.[75] 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.[76]

Regulatory approval process[edit]

Authorization and eligibility by country
  Full authorization
  1. European Union[a][13][78]
  2. Switzerland[79][80]
  Emergency authorization
  1. Andorra[81]
  2. Bahrain[82][83]
  3. Brazil[84]
  4. Canada[85]
  5. Colombia[86]
  6. Philippines[87]
  7. Saint Vincent and the Grenadines[88]
  8. South Africa[89]
  9. South Korea[90]
  10. Thailand[91]
  11. United States[b][9][10]
  12. World Health Organization (WHO)[92]
  Eligible COVAX recipient


European Union[edit]

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.[68][93] On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine.[3][94] The European Commission approved the COVID-19 Vaccine Janssen on 11 March 2021.[13][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.[95]

United States[edit]

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][96][97] Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization.[59] 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.[98][99][29][100] At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that a EUA for the vaccine be issued.[101] The FDA granted the EUA for the vaccine the following day.[9][10][102] 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.[103][25]

On 13 April 2021, the CDC and 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.[38] 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.[39][40][41] The agencies stated that these adverse events "appear to be extremely rare", but that the Advisory Committee on Immunization Practices of the CDC would convene on 14 April to investigate the reports.[40] The panel that convened on Wednesday to review the vaccine data ended without voting on a new recommendation, leaving the pause in place as several doctors on the committee indicated they were not comfortable recommending the pause be lifted or recommending it be given only to specific age/gender groups without more data, they will meet again in a week to 10 days to make a final decision.[104]

Elsewhere[edit]

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.[105]

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.[106][35][107]

On 25 February 2021, Bahrain authorized the vaccine for emergency use.[82][83]

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.[108]

In late November 2020, Johnson & Johnson submitted a rolling review application to Health Canada for approval of its vaccine.[109] 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.[110]

In February 2021, the vaccine received emergency authorization in South Africa.[111][112][113] In April 2021, South Africa suspended its rollout of the vaccine.[114]

On 26 March 2021, the vaccine received emergency authorization in Colombia.[86]

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".[115][116]

Deployment and impact[edit]

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.[117] 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.[118] 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.[119] Once it did so, South Africa began vaccination using the Johnson & Johnson vaccine on 17 February 2021,[113] marking the vaccine's first use outside of a clinical trial.[120]

Ethical concerns[edit]

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.[121][122] 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.[123][124] Some bioethicists dismiss that ethical concerns to using cells derived from ethically compromised sources should be addressed or alternatives sought.[125] Others advance 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.[121][122] 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 ..."[121][126] However, the key objection to using these vaccines still remains.[127] 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.[126]

Notes[edit]

  1. ^ The EU authorization covers all European Union member states (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden) and also Iceland, Norway, and Liechtenstein[77]
  2. ^ US authorization also includes the three sovereign nations in the Compact of Free Association: Palau, the Marshall Islands, and Micronesia.

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