Johnson & Johnson COVID-19 vaccine, JNJ 78436735

Johnson & Johnson COVID-19 vaccine, JNJ 78436735

• Ad26.COV2.S
• JNJ-78436735
• Ad26COVS1
• VAC31518
•  UNII: JT2NS6183B

NAME	DOSAGE	STRENGTH	ROUTE	LABELLER	MARKETING START	MARKETING END
Covid-19 Vaccine Janssen	Injection, suspension	0.95 Inf. U	Intramuscular	Janssen Cilag International Nv	2021-03-17	Not applicable
Janssen COVID-19 Vaccine	Injection, suspension	50000000000 {VP}/0.5mL	Intramuscular	Janssen Products, LP	2021-01-04	Not applicable

NAME	INGREDIENTS	DOSAGE	ROUTE	LABELLER	MARKETING START	MARKETING END
Janssen COVID-19 Vaccine	Ad26.COV2.S (50000000000 {VP}/0.5mL)	Injection, suspension	Intramuscular	Janssen Products, LP	2021-01-04	Not applicable

The Johnson & Johnson COVID-19 vaccine is a human adenovirus viral vector COVID-19 vaccine^[12] developed by Janssen Vaccines in Leiden in The Netherlands,^[13] and its Belgian parent company Janssen Pharmaceuticals,^[14] subsidiary of American company Johnson & Johnson (J&J).^[15][16]

The vaccine is 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 vaccine requires only one dose and does not need to be stored frozen.^[17]

The vaccine started clinical trials in June 2020, with Phase III trials involving around 43,000 people.^[18] On 29 January 2021, Janssen announced that the vaccine was 66% effective in a one-dose regimen in preventing symptomatic COVID-19, with an 85% efficacy in preventing severe COVID-19.^[19][20][21] The most common side effects were pain at the injection site, headache, fatigue, muscle aches and nausea.^[22] Most of these side effects were mild to moderate in severity and lasted one or two days.

The vaccine has been granted an Emergency Use Authorization by the US Food and Drug Administration^[23] and a conditional marketing authorisation by the European Medicines Agency.^[11][24][25]

Ad26.COV2.S is a lead recombinant vaccine candidate that contains an adenovirus serotype 26 (Ad26) vector expressing a stabilized SARS-CoV-2 spike protein. The vaccine was created in collaboration with Johnson and Johnson (J&J), Janssen Pharmaceutical, and the Beth Israel Deaconess Medical Center. This vaccine lead candidate uses Janssen’s AdVac® and PER.C6® technologies. A preclinical study in hamsters infected with SARS-COV-2 infection¹ showed a single immunization with the vaccine elicited neutralizing responses and protected against SARS-CoV-2 induced pneumonia and mortality, providing protection against the disease progression. Follow up preclinical studies in rhesus monkeys² showed that the Ad26 vaccine produced a robust response and provided near perfect protection in nasal swabs and bronchoalveolar lavage following SARS-COV-2 challenge. As of June 2020, a Phase 1/2 clinical trial in adult humans was announced to evaluate the safety, immunogenicity, and efficacy of the ad26.COV.S vaccine in 1045 healthy adults between the ages of 18-55 (NCT04436276).

Description

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.^[26][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.^[27][28][29] 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.^[26][1]

Characteristics

The Johnson & Johnson COVID-19 vaccine can remain viable for months in a standard refrigerator.^[30][31][32] Unlike the Pfizer–BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine, the Johnson & Johnson COVID-19 vaccine is administered as a single dose instead of two separate doses and it is not shipped frozen.^[33][17]

The storage and handling information in the Fact Sheet supersedes the storage and handling information on the carton and vial labels.^[17] The vaccine should not be stored frozen.^[17] Unpunctured vials may be stored between 9 to 25 °C (48 to 77 °F) for up to twelve hours.^[26][17]

Development

During the COVID-19 pandemic, Johnson & Johnson committed over US$1 billion toward the development of a not-for-profit COVID-19 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).^[34][35] Johnson & Johnson stated that 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”.^[36]

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.^[16][37][38]

Clinical trials

Phase I-II

In June 2020, Johnson & Johnson and the National Institute of Allergy and Infectious Diseases (NIAID) confirmed its intention to start a 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.^[39][40][41]

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.^[42] Interim results from the Phase I/IIa trial established the safety, reactogenicity, and immunogenicity of Ad26.COV2.S.^[43][44]

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.^[45] The trial was paused on 12 October 2020, because a volunteer became ill,^[46] but the company said it found no evidence that the vaccine had caused the illness and announced on 23 October 2020, that it would resume the trial.^[47][48] 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.^[49] During the trial, no anaphylaxis was observed in participants.^[49]

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.^[50]

Manufacturing

In April 2020, Johnson & Johnson entered a partnership with Catalent who will provide large-scale manufacturing of the Johnson & Johnson vaccine at Catalent’s Bloomington, Indiana facility.^[51] In July 2020, the partnership was expanded to include Catalent’s Anagni, Italy facility.^[52]

In July 2020, Johnson & Johnson pledged to deliver up to 300 million doses of its vaccine to the U.S., with 100 million upfront and an option for 200 million more. The deal, worth more than $1 billion, will be funded by the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Defense Department.^[53][54] The deal was confirmed on 5 August.^[55]

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.^[56]

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.^[57] If the European Medicines Agency (EMA) grants approval to the vaccine by March 2021, a European Union regulator said that Johnson & Johnson could start supplying vaccines to EU states starting on April 2021.^[58][59]

In August 2020, Johnson & Johnson signed a contract with the U.S. federal government for US$1 billion, agreeing to deliver 100 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.^[54] Under its agreement with the U.S. government, Johnson & Johnson was targeted to produce 12 million doses by the end of February 2021, more than 60 million doses by the end of April 2021, and more than 100 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 12 million doses delivered to the U.S. by the end of February.^[60] In late February 2021 congressional testimony by a company executive, however, Johnson & Johnson indicated that the company could deliver 20 million doses to the U.S. government by the end of March, and 100 million doses in the first half of 2021.^[61]

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 12 million doses of the Johnson & Johnson vaccine per month once authorized.^[62]

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.^[63]

Regulatory approval process

Europe

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.^[58][78] On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine.^[3][79] The Committee for Medicinal Products for Human Use (CHMP) approved the COVID-19 Vaccine Janssen on 11 March.^[11][25] Shipments of the vaccine are scheduled to start in the second half of April, with a commitment to deliver at least 200 million doses to the EU in 2021.^[80]

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.^{[30][33][81][82]} Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization.^[49] 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.^{[83][84][26][85]} At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that a EUA for the vaccine be issued.^[86] The FDA granted the EUA for the vaccine the following day.^[9][10][87] On 28 February, the CDC Advisory Committee on Immunization Practices (ACIP) recommended the use of the vaccine for those aged 18 and older.^[88][23]

Elsewhere

On 11 February 2021, Saint Vincent and the Grenadines issued an EUA for the Johnson & Johnson vaccine, as well as the Moderna vaccine, the Pfizer–BioNTech vaccine, the Sputnik V vaccine, and the Oxford–AstraZeneca vaccine.^[89]

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 500 million doses through 2022 for COVAX.^[90][31][91]

On 25 February 2021, Bahrain authorized the vaccine for emergency use.^[92][93]

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.^[94]

In late November 2020, Johnson & Johnson submitted a rolling review application to Health Canada for approval of its vaccine.^[95] The Canadian government has placed an order with Johnson & Johnson for 10 million doses, with an option to purchase up to 28 million additional doses; on 5 March, the vaccine became the fourth to receive Health Canada approval.^[96]

In February 2021, the vaccine received emergency authorization in South Africa.^[97][98][99]

Deployment and impact

Given the Johnson & Johnson vaccine is a single dose and has a lower cost, it is expected that it will play an important role in low and middle-income countries.^[100] 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.^[101] 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.^[102] Once it did so, South Africa began vaccination using the Johnson & Johnson vaccine on 17 February 2021,^[99] marking the vaccine’s first use outside of a clinical trial.^[103]

Ethical concerns

The United States Conference of Catholic Bishops has expressed ethical concerns about the vaccine due to the use of tissue from aborted fetuses in the 1980s.^[104]

See also

• Adenoviruses as vaccine vectors

Notes

1. ^ US authorization also includes the three sovereign nations in the Compact of Free Association: Palau, the Marshall Islands, and Micronesia.^[75][76]

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External links

Scholia has a profile for Ad26.COV2.S (Q98655215).

• “How the Johnson & Johnson Covid-19 Vaccine Works”. The New York Times.
• “Janssen COVID-19 Vaccine (Johnson & Johnson)”. Centers for Disease Control and Prevention (CDC).

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