COVID-19 Vaccine: single-dose Ad26 by Janssen (Johnson & Johnson), Beth Israel Deaconess Medical Center (Harvard Medical School), Emergent BioSolutions, Catalent

Distribution updates

limited distribution: Q2 2021
mass distribution: Q4 2021 (1 billion doses)

Jul 06	Emergent will produce drug substance at large scale on a five year agreement with Janssen (by biospace.com)
Apr 15	1B+ dosis of J&J's vaccine could be produced by Q4 2021 with potential other partners (by bioprocessintl.com)
Mar 30	Johnson & Johnson is hopeful to deliver a vaccine for emergency use in early 2021 (by prnewswire.com)

Human Testing updates (clinical trials)

PHASE 1 (Japan)

started August 11 2020

with 250 healthy volunteers aged 20+

trial location: Japan

» clinical trial details

PHASE 1-2 (USA/Belgium)

started July 13 2020

with 1045 healthy volunteers aged 18+

trial location: USA and Belgium

» clinical trial details

PHASE 2

started August 28 2020

with 550 healthy volunteers aged 18+

trial location: several countries

» clinical trial details

PHASE 3

started September 5 2020

with 60000 healthy volunteers aged 18+

trial location: several countries

» clinical trial details

PHASE 3

started November 6 2020

with 30000 healthy volunteers aged 18+

trial location: several countries

» clinical trial details

Dec 17	The large-scale,multi-country Phase 3 trial of Janssen's single-dose vaccine is now fully enrolled with approx. 45000 participants (by jnj.com)
Nov 15	J&J initiated second global Phase 3 clinical trial of its vaccine by enrolling up to 60000 participants worldwide (by jnj.com)
Oct 13	J&J temporarily paused dosing its vaccine in all Phase 3 clinical trials due to unexplained illness in a participant (by jnj.com)
Oct 01	Data on Janssen's vaccine has shown overall good safety and immunogenicity despite one patient being hospitalized with fever (by sciencemag.org)
Sep 25	J&J released details of its Phase 1/2 data showing its single-dose vaccine can stir up sufficient immune response (by endpts.com)
Sep 23	J&J today announced the launch of its large scale multi-country Phase 3 trial for its COVID-19 vaccine (by jnj.com)
Sep 23	Ad26's Phase 3 study is to assess the efficacy and safety for the prevention of SARS-CoV-2 in adults aged 18+ (by jnj.com)
Aug 20	J&J aims to start Phase 3 trials in 60000 volunteers in the US, Brazil and Mexico from September (by reuters.com)
Jul 30	Phase 1/2 of Ad26 in healthy volunteers has now started in the USA and Belgium (by jnj.com)
Jul 30	Ad26 appears to give more protection if given in two doses (by bostonglobe.com)
Jul 16	Janssen's vaccine is ready to go into Phase1/2 clinical studies next week (by fiercepharma.com)
Jun 10	Johnson&Johnson announced that Phase 1 clinical trials of its vaccine will start in late July (by jnj.com)
Apr 14	The human trials of Johnson & Johnson vaccine candidate will begin in September (by jnj.com)

Animal Testing updates (pre-clinical trials)

start date: March 2020

Sep 03	Janssen's vaccine prevented severe clinical disease in preclinical studies on Syrian golden hamsters (by jnj.com)
Sep 03	Ad26 vaccine protects against SARS-CoV-2 severe clinical disease in hamsters (by nature.com)
Jul 30	Ad26 vaccine's single shot gives protection against SARS-CoV-2 in rhesus macaques (by nature.com)
Mar 30	Johnson & Johnson announced the selection of 1 lead candidate vaccine (by jnj.com)
Mar 18	J&J is using the same platform of Ebola vaccine, which will allow it to “go very fast" (by fiercebiotech.com)
Mar 13	Janssen have started preclinical testing of multiple vaccine candidates (by massdevice.com)

early development updates

currently no early development info

funding:

US govt's BARDA

Jun 10	US Gov. plans to fund and conduct Phase 3 studies on J&J vaccine starting in September (by wsj.com)
Feb 11	BARDA will support Janssen in accelerating vaccine development into clinical studies (by jnj.com)

partnerships:

Aug 13	J&J have tied up with BE for coronavirus vaccine production to be launched in India by mid 2021 (by indiatimes.com)
Aug 05	HHS and DOD partner with Johnson & Johnson to produce million of doses of its vaccine (by medicalcountermeasures.gov)
Jul 17	J&J is in talks with Japanese government and Gates Foundation to supply doses of its vaccine (by fiercepharma.com)
Apr 29	Catalent's partnership with J&J will accelerate manufacturing capacity of the vaccine (by businesswire.com)
Apr 23	J&J and Emergent made a $135 million agreement to manufacture the vaccine (by emergentbiosolutions.com)
Mar 13	J&J announces collaboration with the Beth Israel Deaconess Medical Center (by jnj.com)

Ad26 alone or with MVA boost