What is the Ad26.COV2.S coronavirus disease 2019 (COVID-19) vaccine?

Answer

Overview

Viral vector vaccine
Shipping and long-term storage: Frozen (-20°C) for up to 2 years
After thawing: Standard refrigerator temperatures (2-8°C) for up to 3 months
Dose: 1 injection

The phase 3 trial (ENSEMBLE) for adenovirus serotype 26 (Ad26) recombinant vector-based vaccine (JNJ-78436735, VAC31518; Johnson & Johnson [Janssen]) was launched in September 2020 in the United States, South Africa, and South America. In December 2020, the trial was fully enrolled. In phase the 1/2a trial (N = 805), neutralizing antibodies against SARS-CoV-2 were detected at day 29 in 90% or more of all participants, regardless of vaccine dose or age group, and reached 100% by day 57, as well as strong T-cell responses and a Th1 response.^[17]

The EMSEMBLE phase 3 trial results were released in late January 2021. Safety and efficacy data are based on 43,783 participants randomized 1:1 accruing 468 symptomatic cases of COVID-19. FDA analysis of the data at Day 28 determined the vaccine was 72% effective in the US, 61% in Latin America, and 64% in South Africa (where the B.1.351 variant was circulating) at preventing moderate-to-severe COVID-19 infection. Importantly, the vaccine was 85% effective in preventing severe disease in all geographic regions. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49. Additionally, the vaccine provided 100% protection against COVID-19 related hospitalization and death at Day 28.^[12]

Additionally, Ad26.COV2.S showed consistent protection across race, age groups, including older adults (participants aged 60 years and older were 34.6% of the vaccine arm), and across all variants and regions studied, including South Africa where nearly all cases of COVID-19 (95%) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage.^[12]

The EUA Fact Sheet for Health Care Professionals states efficacy of the vaccine in older study participants showed no overall differences in safety or efficacy compared with younger participants. At least 28 days post vaccination, efficacy against moderate to severe/critical disease at all study sites (ie, US, Latin America, South Africa) was 66.2% for those aged 60 years and older compared with 66.1% for those aged 18-59 years. In the United States, estimated efficacy was 85.9% at least 28 days after vaccination.

A second phase 3 trial was announced November 16, 2020 to observe effects of 2 doses of the vaccine, instead of just 1 dose.

Did this answer your question?

Yes No

Additional feedback? (Optional)

Thank you for your feedback!

Coronavirus Vaccine Tracker. The New York Times. Available at https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html. 2020 Nov 24; Accessed: November 24, 2020.
McClung N, Chamberland M, Kinlaw K, Bowen Matthew D, Wallace M, Bell BP, et al. The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 27. 69 (47):1782-1786. [Medline]. [Full Text].
ACIP: Health Workers, Long-term Care Residents First Tier for COVID-19 Vaccine. 12/1/2020. Available at https://www.medscape.com/viewarticle/941846.
What Is the Best Strategy to Deploy a Covid-19 Vaccine?. 11/19/2020. Available at https://www.medscape.com/viewarticle/941274.
Thanh Le T, Andreadakis Z, Kumar A, Gómez Román R, Tollefsen S, Saville M, et al. The COVID-19 vaccine development landscape. Nat Rev Drug Discov. 2020 May. 19 (5):305-306. [Medline]. [Full Text].
Lurie N, Saville M, Hatchett R, Halton J. Developing Covid-19 Vaccines at Pandemic Speed. N Engl J Med. 2020 May 21. 382 (21):1969-1973. [Medline]. [Full Text].
Koirala A, Joo YJ, Khatami A, Chiu C, Britton PN. Vaccines for COVID-19: The current state of play. Paediatr Respir Rev. 2020 Sep. 35:43-49. [Medline]. [Full Text].
Jeyanathan M, Afkhami S, Smaill F, Miller MS, Lichty BD, Xing Z. Immunological considerations for COVID-19 vaccine strategies. Nat Rev Immunol. 2020 Oct. 20 (10):615-632. [Medline]. [Full Text].
Polack FP, Thomas SJ, Kitchin N, and the, C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31. 383 (27):2603-2615. [Medline]. [Full Text].
Baden RL, El Sahly HM, Essink B, and the, COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4. 384 (5):403-416. [Medline]. [Full Text].
Widge AT, Rouphael NG, Jackson LA, and the, mRNA-1273 Study Group. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. N Engl J Med. 2020 Dec 3. [Medline]. [Full Text].
COVID-19 vaccine Ad26.COV2.S Sponsor Briefing Document for the FDA Vaccines and Related Biological Products advisory Committee. US Food and Drug Administration. Available at https://www.fda.gov/media/146217/download. 2021 Feb 26; Accessed: February 26, 2021.
Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK phase 3 trial. Novavax. 2021 Jan 28. Available at https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3.
ChAdOx1 nCov-19 provides minimal protection against mild-moderate COVID-19 infection from B.1.351 coronavirus variant in young South African adults. University of Oxford; Medical Sciences Division. 2021 Feb 08. Available at https://www.medsci.ox.ac.uk/news/chadox1-ncov-19-provides-minimal-protection-against-mild-moderate-covid-19-infection-from-b-1-351-coronavirus-variant-in-young-south-african-adults.
Amit S, Regev-Yochay G, Afek A, Kreiss Y, Leshem E. Early rate reductions of SARS-CoV-2 infection and COVID-19 in BNT162b2 vaccine recipients (correspondence. Lancet. 2021 Feb 18. [Full Text].
Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, et al. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med. 2021 Feb 24. [Medline]. [Full Text].
Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, et al. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021 Jan 13. [Medline]. [Full Text].
Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, et al. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10. 383 (24):2320-2332. [Medline]. [Full Text].
Taylor M, Levine D. FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine – sources. Reuters. 2020 Sep 30. Available at https://www.reuters.com/article/us-health-coronavirus-vaccine-astrazenec/exclusive-fda-widens-u-s-safety-inquiry-into-astrazeneca-coronavirus-vaccine-sources-idUSKBN26L3TA.
Voysey M, Clemens SAC, Madhi SA, and the, Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9. 397 (10269):99-111. [Medline]. [Full Text].
Robbins R, Mueller B. After Admitting Mistake, AstraZeneca Faces Difficult Questions about Its Vaccine. The New York Times. 2020 Nov 25. Available at https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html.
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Single dose administration, and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine (preprint). Lancet. 2021 Feb 01. [Full Text].
Galloway SE, Paul P, MacCannell DR, Johansson MA, Brooks JT, MacNeil A, et al. Emergence of SARS-CoV-2 B.1.1.7 Lineage - United States, December 29, 2020-January 12, 2021. MMWR Morb Mortal Wkly Rep. 2021 Jan 22. 70 (3):95-99. [Medline]. [Full Text].
Xie X, Zou J, Fontes-Garfias CR, Xia H, Swanson KA, Cutler M, et al. Neutralization of N501Y mutant SARS-CoV-2 by BNT162b2 vaccine-elicited sera. bioRxiv. 2021 Jan 7. [Medline]. [Full Text].
Liu Y, Liu J, Xia H, Zhang X, Fontes-Garfias CR, Swanson KA, et al. Neutralizing Activity of BNT162b2-Elicited Serum - Preliminary Report. N Engl J Med. 2021 Feb 17. [Medline]. [Full Text].
Muik A, Wallisch AK, Sänger B, Swanson KA, Mühl J, Chen W, et al. Neutralization of SARS-CoV-2 lineage B.1.1.7 pseudovirus by BNT162b2 vaccine-elicited human sera. Science. 2021 Jan 29. [Medline]. [Full Text].
Tada T, Dcosta BM, Samanovic-Golden M, Herati RS, Cornelius A, Mulligan MJ, et al. Neutralization of viruses with European, South African, and United States SARS-CoV-2 variant spike proteins by convalescent sera and BNT162b2 mRNA vaccine-elicited antibodies. bioRxiv. 2021 Feb 7. [Medline]. [Full Text].
Wu K, Werner AP, Koch M, Choi A, Narayanan E, Stewart-Jones GBE, et al. Serum Neutralizing Activity Elicited by mRNA-1273 Vaccine - Preliminary Report. N Engl J Med. 2021 Feb 17. [Medline]. [Full Text].
Emary KRW, Golubchik T, Aley PK, Ariani C, Angus BJ, Bibi S, et al. Efficacy of ChAdOx1 nCoV-19 (AXD1222) vaccine against SARS-CoV-2 VOC 202012/01 (B.1.1.7) (preprint). Lancet. 2021 Feb 04. [Full Text].
Safety, immunogenicity, and efficacy of INO-4800 for COVID-19 in healthy seronegative adults at high risk of SARS-CoV-2 Exposure. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04642638. 2020 Dec 08; Accessed: December 9, 2020.
Tebas, P, Yang S, Boyer JD, Rueschel EL, Patel A Christensen-Quick A, et al. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, phase 1 clinical trial. EClinicalMedicine. 2020 Dec 23. [Full Text].
CVnCoV – CureVac’s mRNA-based vaccine candidate against COVID-19. CureVac. Available at https://www.curevac.com/en/covid-19. 2021 Feb 03; Accessed: February 3, 2021.
GSK and CureVac to develop next generation mRNA COVID-19 vaccines. GlaxoSmithKline. 2021 Feb 03. Available at https://us.gsk.com/en-us/media/press-releases/gsk-and-curevac-to-develop-next-generation-mrna-covid-19-vaccines/.
Sanofi and GSK initiate new phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. Sanofi. 2021 Feb 22. Available at https://www.sanofi.com/en/media-room/press-releases/2021/2021-02-22-11-40-00.
Clover and Dynavax announce planned global phase 2/3 efficacy trial of adjuvanted COVID-19 vaccine candidate. Dynavax. 2021 Feb 01. Available at https://investors.dynavax.com/news-releases/news-release-details/clover-and-dynavax-announce-planned-global-phase-23-efficacy.
A study to evaluate the safety, tolerability, and immunogenicity of UB-612 COVID-19 vaccine. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04545749. 2020 Sep 29; Accessed: December 14, 2020.
HaloVax – VaxCelerate. Hoth Therapeutics. Available at https://hoththerapeutics.com/pipeline/halo-vax/. Accessed: November 21, 2020.
Ufovax announces its self-assembling nanoparticles as the next-generation vaccine solution for COVID-19. Ufovax. 2020 Sep 17. Available at https://www.ufovax.com/ufovax-announces-its-self-assembling-nanoparticles-as-the-next-generation-vaccine-solution-for-covid-19/.
PDS Pipeline Overview – Infectious Disease (PDS0203). PDS Biotechnology. Available at https://www.pdsbiotech.com/pipeline/infectious-disease. Accessed: November 21, 2020.
Medicago and GSK announce start of phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate. Medicago. 2020 Nov 12. Available at https://www.medicago.com/en/newsroom/medicago-and-gsk-announce-start-of-phase-2-3-clinical-trials-of-adjuvanted-covid-19-vaccine-candidate.
Ocugen and Bharat Biotech announce execution of definitive agreement for the commercialization of Covaxin in the US Market. Ocugen, Inc. 2021 Feb 02. Available at https://ir.ocugen.com/news-releases/news-release-details/ocugen-and-bharat-biotech-announce-execution-definitive.
Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15. 396 (10249):479-488. [Medline]. [Full Text].
Piecemeal data releases threaten to undermine Sinovac's COVID-19 vaccine. Reuters. 2020 Dec 28. Available at https://www.reuters.com/article/us-health-coronavirus-sinovac/piecemeal-data-releases-threaten-to-undermine-sinovacs-covid-19-vaccine-idUSKBN2920QQ.
Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatullin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 02. [Full Text].
ImmunityBio and NantKwest announce FDA authorization to study hAd5 T-cell COVID-19 vaccine for combination of subcutaneous, oral and sublingual boost to induce T-cell, mucosal, and antibody immunity. ImmunityBio, Inc. 2021 Feb 11. Available at https://immunitybio.com/immunitybio-and-nantkwest-announce-fda-authorization-to-study-had5-t-cell-covid-19-vaccine-for-combination-of-subcutaneous-oral-and-sublingual-boost-to-induce-t-cell-mucosal-and-antibody-immunity/.
Sanofi’s mRNA COVID-19 vaccine candidate not ready this year – CEO. Reuters. 2021 Feb 13. Available at https://www.reuters.com/article/uk-health-coronavirus-sanofi-vaccines-idUKKBN2AD0PT.
AnGes and Brickell Biotech Announce a Collaboration Agreement for the Development of a Novel DNA Vaccine Candidate for COVID-19 in the U.S. Brickell Biotech. 2020 Sep 08. Available at https://ir.brickellbio.com/news/detail/35/anges-and-brickell-biotech-announce-a-collaboration.
Merck discontinues development of SARS-CoV-2/COVID-19 vaccine candidates; continues development of two investigational therapeutic candidates. Merck. 2020 Jan 25. Available at https://www.merck.com/news/merck-discontinues-development-of-sars-cov-2-covid-19-vaccine-candidates-continues-development-of-two-investigational-therapeutic-candidates/.
Safety and immunogenicity of AdCOVID in Healthy Adults (COVID-19 vaccine study). ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT04679909. 2021 Jan 19; Accessed: February 19, 2021.
Landmark coronavirus study to trial inhaled Imperial and Oxford vaccines. Imperial College London. 2020 Sep 14. Available at https://www.imperial.ac.uk/news/203653/landmark-coronavirus-study-trial-inhaled-imperial/.
Vaxart announces positive preliminary data from phase 1 clinical trial evaluating its oral COVID-19 tablet vaccine candidate. Vaxart, Inc. 2021 Feb 03. Available at https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-positive-preliminary-data-phase-1-clinical.
Kim E, Erdos G, Huang S, Kenniston TW, Balmert SC, Carey CD, et al. Microneedle array delivered recombinant coronavirus vaccines: Immunogenicity and rapid translational development. EBioMedicine. 2020 May. 55:102743. [Medline]. [Full Text].

Media Gallery

of 0

What is the Ad26.COV2.S coronavirus disease 2019 (COVID-19) vaccine?

Answer

Related Questions:

About

Membership

Apps

WebMD Network

Editions

What is the Ad26.COV2.S coronavirus disease 2019 (COVID-19) vaccine?

Answer

Related Questions:

References

Tables

Contributor Information and Disclosures

Find Us On

About

Membership

Apps

WebMD Network

Editions