New Drug Approvals

Home » CORONAVIRUS » Johnson & Johnson COVID-19 vaccine, JNJ 78436735

Johnson & Johnson COVID-19 vaccine, JNJ 78436735

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Recent Posts

Blog Stats

  • 3,668,285 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,655 other followers

add to any

Share

j-j

Johnson & Johnson COVID-19 vaccine, JNJ 78436735

  • Ad26.COV2.S
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518
  •  UNII: JT2NS6183B
NAMEDOSAGESTRENGTHROUTELABELLERMARKETING STARTMARKETING END  
Covid-19 Vaccine JanssenInjection, suspension0.95 Inf. UIntramuscularJanssen Cilag International Nv2021-03-17Not applicableEU flag 
Janssen COVID-19 VaccineInjection, suspension50000000000 {VP}/0.5mLIntramuscularJanssen Products, LP2021-01-04Not applicableUS flag 
NAMEINGREDIENTSDOSAGEROUTELABELLERMARKETING STARTMARKETING END  
Janssen COVID-19 VaccineAd26.COV2.S (50000000000 {VP}/0.5mL)Injection, suspensionIntramuscularJanssen Products, LP2021-01-04Not applicableUS flag 
FORMROUTESTRENGTH
Injection, suspensionIntramuscular0.95 Inf. U
Injection, suspensionIntramuscular50000000000 {VP}/0.5mL

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).

wdt-10

NEW DRUG APPROVALS

one time

$10.00

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 monohydratetrisodium citrate dihydrateethanol (alcohol), 2-hydroxypropyl-β-cyclodextrin (HBCD) (hydroxypropyl betadex), polysorbate 80sodium chloridesodium 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

 
show  Full authorizationshow  Emergency authorization  Eligible COVAX recipient

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

Notes

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

References

  1. Jump up to:a b c “Janssen COVID-19 Vaccine- ad26.cov2.s injection, suspension”DailyMed. Retrieved 27 February 2021.
  2. ^ “Janssen COVID-19 Emergency Use Authorization (EUA) Official Website”Janssen. 28 February 2021. Retrieved 28 February2021.
  3. Jump up to:a b c “EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen” (Press release). European Medicines Agency (EMA). 16 February 2021. Retrieved 16 February 2021.
  4. Jump up to:a b c d e “A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518COV3001; Phase 3” (PDF). Janssen Vaccines & Prevention.
  5. Jump up to:a b c d “A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE 2 Protocol VAC31518COV3009; Phase 3” (PDF). Janssen Vaccines & Prevention.
  6. Jump up to:a b “Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate”Johnson & Johnson (Press release). Retrieved 23 September 2020.
  7. ^ “Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada”Health Canada. 5 March 2021. Retrieved 5 March 2021.
  8. ^ “Janssen COVID-19 Vaccine monograph” (PDF). Janssen. 5 March 2021.
  9. Jump up to:a b c “FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine”U.S. Food and Drug Administration (FDA) (Press release). 27 February 2021. Retrieved 27 February 2021.
  10. Jump up to:a b c https://www.fda.gov/media/146303/download
  11. Jump up to:a b c “COVID-19 Vaccine Janssen EPAR”European Medicines Agency (EMA). 5 March 2021. Retrieved 16 March 2021.
  12. ^ “A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)”ClinicalTrials.gov. Retrieved 30 January 2021.
  13. ^ “Leiden developed Covid-19 vaccine submitted to EMA for approval”. 16 February 2021.
  14. ^ “Clinical trial COVID-19 vaccine candidate underway”Janssen Belgium. Retrieved 13 March 2021.
  15. ^ “EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden”. NL Times.
  16. Jump up to:a b Saltzman J (12 March 2020). “Beth Israel is working with Johnson & Johnson on a coronavirus vaccine”The Boston Globe.
  17. Jump up to:a b c d e “Fact Sheet for Vaccine Providers & full EUA PI”(PDF). Janssen. Retrieved 28 February 2021.
  18. ^ Commissioner, Office of the (2 March 2021). “FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine”FDA. Retrieved 7 March 2021.
  19. ^ Salzman S (29 January 2021). “Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease”ABC News.
  20. ^ Gallagher J (29 January 2021). “Covid vaccine: Single dose Covid vaccine 66% effective”BBC News. Retrieved 29 January 2021.
  21. ^ Sohn R (29 January 2021). “J&J’s Covid vaccine is 66% effective, a weapon but not a knockout punch”Stat. Retrieved 29 January2021.
  22. ^ Commissioner, Office of the (2 March 2021). “FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine”FDA. Retrieved 7 March 2021.
  23. Jump up to:a b “Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices’ Recommendation to Use Janssen’s COVID-19 Vaccine in People 18 and Older”Centers for Disease Control and Prevention (CDC) (Press release). 28 February 2021. Retrieved 1 March 2021.
  24. ^ “EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU” (Press release). European Medicines Agency (EMA). 11 March 2021. Retrieved 11 March 2021.
  25. Jump up to:a b “COVID-19 Vaccine Janssen”Union Register of medicinal products. Retrieved 16 March 2021.
  26. Jump up to:a b c d FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 (PDF) (Report). U.S. Food and Drug Administration (FDA). Lay summary This article incorporates text from this source, which is in the public domain.
  27. ^ “The tiny tweak behind COVID-19 vaccines”Chemical & Engineering News. 29 September 2020. Retrieved 1 March 2021.
  28. ^ Kramer, Jillian (31 December 2020). “They spent 12 years solving a puzzle. It yielded the first COVID-19 vaccines”National Geographic.
  29. ^ 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”Nature586 (7830): 583–88. Bibcode:2020Natur.586..583Mdoi:10.1038/s41586-020-2607-zPMC 7581548PMID 32731257S2CID 220893461.
  30. Jump up to:a b Johnson CY, McGinley L (4 February 2021). “Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine”The Washington Post.
  31. Jump up to:a b Weintraub K. “One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds”USA Today. Retrieved 25 February 2021.
  32. ^ Mole B (29 January 2021). “COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%”Ars Technica. Retrieved 26 February 2021.
  33. Jump up to:a b Chander V (4 February 2021). “J&J files COVID-19 vaccine application with U.S. FDA”. Reuters. Retrieved 4 February 2021.
  34. ^ Vecchione A (13 March 2020). “J&J collaborates to accelerate COVID-19 vaccine development”NJBIZ. Retrieved 22 April2020.
  35. ^ “Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device”WSPA 7News. 6 April 2020. Retrieved 22 April 2020.
  36. ^ “Coronavirus: Johnson & Johnson vows to make ‘not-for-profit’ vaccine”Sky News. Retrieved 22 April 2020.
  37. ^ “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. Retrieved 28 February 2021.
  38. ^ “FDA grants third COVID-19 vaccine, developed in part at BIDMC, emergency use authorization”Beth Israel Deaconess Medical Center (BIDMC). 27 February 2021. Retrieved 28 February 2021.
  39. ^ Coleman J (10 June 2020). “Final testing stage for potential coronavirus vaccine set to begin in July”TheHill. Retrieved 11 June 2020.
  40. ^ “Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ”FiercePharma. Retrieved 11 June2020.
  41. ^ “Johnson & Johnson to start human testing of COVID-19 vaccine next week”FiercePharma. Retrieved 20 July 2020.
  42. ^ “A Study of Ad26.COV2.S in Adults (COVID-19)”ClinicalTrials.gov. Retrieved 19 February 2021.
  43. ^ Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, et al. (January 2021). “Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine”New England Journal of Medicinedoi:10.1056/NEJMoa2034201PMC 7821985PMID 33440088.
  44. ^ “Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine”Johnson & Johnson (Press release). Retrieved 16 January 2021.
  45. ^ “Fourth large-scale COVID-19 vaccine trial begins in the United States”National Institutes of Health. Retrieved 30 January 2021.
  46. ^ Hughes V, Thomas K, Zimmer C, Wu KJ (12 October 2020). “Johnson & Johnson halts coronavirus vaccine trial because of sick volunteer”The New York TimesISSN 0362-4331. Retrieved 12 October 2020.
  47. ^ “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. Retrieved 28 October 2020.
  48. ^ Edwards E, Miller SG (23 October 2020). “AstraZeneca, Johnson & Johnson resume late-stage Covid-19 vaccine trials”NBC News. Retrieved 28 October 2020.
  49. Jump up to:a b c “Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial”Johnson & Johnson(Press release). Retrieved 1 February 2021.
  50. ^ “A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)”ClinicalTrials.gov. Retrieved 30 January 2021.
  51. ^ Vecchione A (29 April 2020). “Catalent to lead US manufacturing for J&J’s lead COVID-19 vaccine candidate”NJBIZ. Retrieved 13 November 2020.
  52. ^ “J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility”FiercePharma. Retrieved 13 November2020.
  53. ^ “HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses”HHS.gov(Press release). 5 August 2020. Retrieved 6 August 2020.
  54. Jump up to:a b “Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine”Johnson & Johnson (Press release). Retrieved 6 August 2020.
  55. ^ “US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine”Voice of America. Retrieved 5 August 2020.
  56. ^ “Ramping Up COVID-19 Vaccine Fill and Finish Capacity”Contract Pharma. 3 November 2020.
  57. ^ Allen JF (15 December 2020). “Spain’s Reig Jofre to manufacture J&J’s COVID-19 vaccine, shares soar”. Reuters.
  58. Jump up to:a b Guarascio F (13 January 2021). “J&J COVID-19 vaccine could be available in Europe in April: source”. Reuters.
  59. ^ “EMA expected to approve Johnson & Johnson vaccine by March – CEO of Janssen Italy to paper”. Reuters. 10 February 2021. Retrieved 13 February 2021.
  60. ^ Zimmer C, LaFraniere S, Weiland N (13 January 2021). “Johnson & Johnson Expects Vaccine Results Soon but Lags in Production”The New York Times.
  61. ^ Sarah Owermohle, Johnson & Johnson says it can provide 20M vaccine doses by late MarchPolitico (22 February 2021).
  62. ^ France’s Sanofi to help Johnson & Johnson manufacture COVID-19 vaccine, Reuters (22 February 2021).
  63. ^ “Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines”HHS (Press release). 2 March 2021. Retrieved 4 March 2021.
  64. ^ “European Commission authorises fourth safe and effective vaccine against COVID-19”European Commission (Press release). 11 March 2021.
  65. Jump up to:a b “EU-Kommissionen har i dag udstedt en betinget markedsføringstilladelse til Johnson & Johnsons COVID-19- vaccine. Tilladelsen gælder i Danmark”Lægemiddelstyrelsen (in Danish). Retrieved 12 March 2021.
  66. ^ “The Icelandic Medicines Agency have issued a conditional marketing authorisation”covid.is. Retrieved 12 March 2021.
  67. ^ “The European Commission has now approved the Johnson & Johnson vaccine. This means that the vaccine is approved for use in the EU and Norway”vg. Retrieved 12 March 2021.
  68. ^ “Informació en relació amb la vacunació contra la COVID-19”(PDF). Govern d’Andorra. Retrieved 14 March 2021.
  69. ^ “Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use”Reuters. 25 February 2021. Retrieved 25 February 2021.
  70. ^ “Bahrain becomes 1st nation to grant J&J shot emergency use”ABC News. 25 February 2021. Retrieved 25 February 2021.
  71. ^ “Johnson & Johnson COVID-19 vaccine becomes 4th to receive Health Canada approval | CBC News”. Canadian Broadcasting Corporation. Retrieved 5 March 2021.
  72. ^ https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission
  73. ^ “Public Health (Emergency Authorisation of COVID-19 Vaccine) Rules, 2021” (PDF). Government of Saint Vincent and the Grenadines. 11 February 2021. Retrieved 12 February 2021.
  74. ^ “Coronavirus: South Africa rolls out vaccination programme”BBC News. 17 February 2021. Retrieved 19 February 2021.
  75. ^ “Interior Applauds Inclusion of Insular Areas through Operation Warp Speed to Receive COVID-19 Vaccines” (Press release). United States Department of the Interior (DOI). 12 December 2020. Retrieved 13 January 2021.  This article incorporates text from this source, which is in the public domain.
  76. ^ Dorman B (6 January 2021). “Asia Minute: Palau Administers Vaccines to Keep Country Free of COVID”Hawaii Public Radio. Retrieved 13 January 2021.
  77. ^ “WHO approves J&J’s COVID-19 vaccine for emergency listing”. Channel News Asia. 13 March 2021. Retrieved 13 March2021.
  78. ^ “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.
  79. ^ Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Janssen COVID-19 Vaccine Candidate
  80. ^ M, Muvija; Aripaka, Pushkala (11 March 2021). “Europe clears J&J’s single-shot COVID-19 vaccine as roll-out falters”Reuters. Retrieved 16 March 2021.
  81. ^ “FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate” (Press release). U.S. Food and Drug Administration. 4 February 2021. Retrieved 4 February 2021.
  82. ^ “VRBPAC February 26, 2021 Meeting Announcement”. U.S. Food and Drug Administration. Retrieved 19 February 2021.
  83. ^ Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document (PDF) (Report). Janssen Biotech.
  84. ^ Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document Addendum (PDF) (Report). Janssen Biotech.
  85. ^ Christensen J (24 February 2021). “FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization”. CNN.
  86. ^ Lovelace Jr B (26 February 2021). “FDA panel unanimously recommends third Covid vaccine as J&J wins key vote in path to emergency use”.
  87. ^ 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.
  88. ^ Feuer W (28 February 2021). “CDC panel recommends use of J&J’s single-shot Covid vaccine, clearing way for distribution”CNBC. Retrieved 28 February 2021.
  89. ^ “Public Health (Emergency Authorisation of COVID-19 Vaccine) Rules, 2021” (PDF). Government of Saint Vincent and the Grenadines. 11 February 2021. Retrieved 12 February 2021.
  90. ^ Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate, Johnson & Johnson (19 February 2021).
  91. ^ Heeb G. “Johnson & Johnson Applies For Emergency Use Vaccine Approval At W.H.O.” Forbes. Retrieved 25 February2021.
  92. ^ “Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use”Reuters. 25 February 2021. Retrieved 25 February 2021.
  93. ^ “Bahrain becomes 1st nation to grant J&J shot emergency use”ABC News. 25 February 2021. Retrieved 25 February 2021.
  94. ^ South Korea launches review of Johnson & Johnson’s COVID-19 vaccine, Reuters (26 February 2021).
  95. ^ Terry Haig, Novavax submits its vaccine for Health Canada approvalRadio Canada International (1 February 2021).
  96. ^ “Johnson & Johnson COVID-19 vaccine becomes 4th to receive Health Canada approval”CBC.
  97. ^ “SA is the first country to roll out Johnson & Johnson vaccine – what you need to know about the jab”BusinessInsider. 17 February 2021. Retrieved 4 March 2021.
  98. ^ Browdie, Brian (20 February 2021). “South Africa to be first to use Johnson Johnson Covid-19 vaccine”Quartz. Retrieved 4 March2021.
  99. Jump up to:a b Steinhauser G (17 February 2021). “South Africa Rolls Out J&J Covid-19 Vaccine to Healthcare Workers”The Wall Street Journal.
  100. ^ Grady D (29 January 2021). “Which Covid Vaccine Should You Get? Experts Cite the Effect Against Severe Disease”The New York Times. Retrieved 9 February 2021.
  101. ^ Brueck H. “Moderna vaccine creator calls Johnson & Johnson’s competing shot a ‘darn good’ tool to fight the pandemic”Business Insider. Retrieved 9 February 2021.
  102. ^ 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. Retrieved 11 February 2021.
  103. ^ “Johnson & Johnson applies to WHO for emergency use listing of COVID-19 vaccine”. Reuters. 19 February 2021. Retrieved 19 March 2021.
  104. ^ “Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available”. CNN. 3 March 2021. Retrieved 20 March 2021.

External links

Scholia has a profile for Ad26.COV2.S (Q98655215).
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 namesAd26.COV2.S[4][5][6]JNJ-78436735[4][5][6]Ad26COVS1[4][5]VAC31518[4][5]
License dataUS DailyMedJanssen_COVID-19_Vaccine
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusCA: Schedule D; Authorized by interim order [7][8]US: Unapproved (Emergency Use Authorization)[9][1][10]EU: Conditional marketing authorization granted [11]
Identifiers
DrugBankDB15857
UNIIJT2NS6183B
Part of a series on the
COVID-19 pandemic
SARS-CoV-2 (virus)COVID-19 (disease)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 Portal
vte

////////////////Johnson & Johnson,  COVID-19 vaccine, JNJ 78436735, Ad26.COV2.S, JNJ-78436735, Ad26COVS1, VAC31518, vaccine, corona virus, covid 19

#Johnson & Johnson,  #COVID-19 vaccine, #JNJ 78436735, #Ad26.COV2.S, #JNJ-78436735, #Ad26COVS1, VAC31518, #vaccine, #corona virus, #covid 19


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,655 other followers

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 PLUS year tenure till date June 2021, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

Personal Links

View Full Profile →

TWITTER

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: