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

distribution (started in February 2021):
Afghanistan, Austria, Bahamas, Belgium, Bolivia, Brazil, British Virgin Islands, Bulgaria, Cambodia, Colombia, Croatia, Cyprus, Czechia, Denmark, Djibouti, Egypt, Estonia, France, French Polynesia, Germany, Greece, Haiti, Honduras, Hungary, Iceland, Ireland, Italy, Jamaica, Laos, Latvia, Libya, Lithuania, Luxembourg, Malawi, Malta, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands, Philippines, Poland, Portugal, Romania, Somalia, South Africa, South Korea, Spain, Sudan, Syria, Tanzania, Tunisia, United States, Yemen, Zambia

Distribution updates

Mar 11	J&J announced that the European Commission has granted a Conditional Marketing Authorization for its vaccine (by businesswire.com)
Mar 02	Merck has entered into multiple agreements to support efforts to help produce J&J's COVID-19 vaccine (by businesswire.com)
Feb 28	J&J announced that the US' CDC Advisory Commitee has recommended the company's vaccine for individuals 18+ (by janssen.com)
Feb 27	FDA has issued Emergency Use Authorization for Janssen's vaccine to prevent COVID-19 in individuals 18 years of age and older (by jnj.com)
Feb 26	J&J announced that the FDA and VRBPAC voted to recommend Emergency Use Authorization for the company's vaccine (by jnj.com)
Feb 22	Sanofi entered into an agreement with Janssen under which it will support manufacturing J&J's COVID-19 vaccine (by sanofi.com)
Feb 19	J&J announced submission to WHO for Emergency Use Listing of its COVID-19 vaccine candidate (by jnj.com)
Feb 17	South Africa is the first country in the world to roll out the single-dose Johnson&Johnson vaccine (by businessinsider.co.za)
Feb 16	J&J has submitted a conditional Marketing Authorisation Application to EMA seeking authorization for its vaccine (by jnj.com)
Feb 04	J&J has submitted an application to the US FDA requesting Emergency Use Authorization for its vaccine candidate (by jnj.com)
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 2 (female)

started February 26 2021

with 824 healthy volunteers aged 18-40 (female)

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

Jan 29	J&J's vaccine appears to be safe and effective at preventing nmoderate and severe COVID-19 in adults according to an interim analysis of Phase 3 clinical trial (by nih.gov)
Jan 13	J&J's COVID-19 vaccine candidate interim Phase 1/2 Data was published in New England Journal of Medicine (by jnj.com)
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

Mar 11	J&J announced that the CHMP of the EMA issued a positive opinion to recommend the Conditional Market Authorization for its vaccine (by businesswire.com)
Mar 05	J&J announced that Health Canada has granted an Interim Order authorization for its single-shot vaccine (by janssen.com)

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:

Sep 25	GRAM has entered into an agreement with Janssen to support the manufacture of its vaccine candidate (by prnewswire.com)
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