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COVID-19 VACCINE:

Ad26 alone or with MVA boost

researcher:
Janssen (Johnson & Johnson) + Beth Israel Deaconess Medical Center (Harvard Medical School) + Emergent BioSolutions + Catalent + Sanofi + Merck
https://www.janssen.com/covid19
(Belgium + USA)
vaccine type: Non-replicating viral vector

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 11J&J announced that the European Commission has granted a Conditional Marketing Authorization for its vaccine (by businesswire.com)
Mar 02Merck has entered into multiple agreements to support efforts to help produce J&J's COVID-19 vaccine (by businesswire.com)
Feb 28J&J announced that the US' CDC Advisory Commitee has recommended the company's vaccine for individuals 18+ (by janssen.com)
Feb 27FDA 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 26J&J announced that the FDA and VRBPAC voted to recommend Emergency Use Authorization for the company's vaccine (by jnj.com)
Feb 22Sanofi entered into an agreement with Janssen under which it will support manufacturing J&J's COVID-19 vaccine (by sanofi.com)
Feb 19J&J announced submission to WHO for Emergency Use Listing of its COVID-19 vaccine candidate (by jnj.com)
Feb 17South Africa is the first country in the world to roll out the single-dose Johnson&Johnson vaccine (by businessinsider.co.za)
Feb 16J&J has submitted a conditional Marketing Authorisation Application to EMA seeking authorization for its vaccine (by jnj.com)
Feb 04J&J has submitted an application to the US FDA requesting Emergency Use Authorization for its vaccine candidate (by jnj.com)
Jul 06Emergent will produce drug substance at large scale on a five year agreement with Janssen (by biospace.com)
Apr 151B+ dosis of J&J's vaccine could be produced by Q4 2021 with potential other partners (by bioprocessintl.com)
Mar 30Johnson & 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 29J&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 13J&J's COVID-19 vaccine candidate interim Phase 1/2 Data was published in New England Journal of Medicine (by jnj.com)
Dec 17The 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 15J&J initiated second global Phase 3 clinical trial of its vaccine by enrolling up to 60000 participants worldwide (by jnj.com)
Oct 13J&J temporarily paused dosing its vaccine in all Phase 3 clinical trials due to unexplained illness in a participant (by jnj.com)
Oct 01Data on Janssen's vaccine has shown overall good safety and immunogenicity despite one patient being hospitalized with fever (by sciencemag.org)
Sep 25J&J released details of its Phase 1/2 data showing its single-dose vaccine can stir up sufficient immune response (by endpts.com)
Sep 23J&J today announced the launch of its large scale multi-country Phase 3 trial for its COVID-19 vaccine (by jnj.com)
Sep 23Ad26'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 20J&J aims to start Phase 3 trials in 60000 volunteers in the US, Brazil and Mexico from September (by reuters.com)
Jul 30Phase 1/2 of Ad26 in healthy volunteers has now started in the USA and Belgium (by jnj.com)
Jul 30Ad26 appears to give more protection if given in two doses (by bostonglobe.com)
Jul 16Janssen's vaccine is ready to go into Phase1/2 clinical studies next week (by fiercepharma.com)
Jun 10Johnson&Johnson announced that Phase 1 clinical trials of its vaccine will start in late July (by jnj.com)
Apr 14The 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 03Janssen's vaccine prevented severe clinical disease in preclinical studies on Syrian golden hamsters (by jnj.com)
Sep 03Ad26 vaccine protects against SARS-CoV-2 severe clinical disease in hamsters (by nature.com)
Jul 30Ad26 vaccine's single shot gives protection against SARS-CoV-2 in rhesus macaques (by nature.com)
Mar 30Johnson & Johnson announced the selection of 1 lead candidate vaccine (by jnj.com)
Mar 18J&J is using the same platform of Ebola vaccine, which will allow it to “go very fast" (by fiercebiotech.com)
Mar 13Janssen have started preclinical testing of multiple vaccine candidates (by massdevice.com)
early development updates
Mar 11J&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 05J&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 10US Gov. plans to fund and conduct Phase 3 studies on J&J vaccine starting in September (by wsj.com)
Feb 11BARDA will support Janssen in accelerating vaccine development into clinical studies (by jnj.com)
partnerships:
Sep 25GRAM has entered into an agreement with Janssen to support the manufacture of its vaccine candidate (by prnewswire.com)
Aug 13J&J have tied up with BE for coronavirus vaccine production to be launched in India by mid 2021 (by indiatimes.com)
Aug 05HHS and DOD partner with Johnson & Johnson to produce million of doses of its vaccine (by medicalcountermeasures.gov)
Jul 17J&J is in talks with Japanese government and Gates Foundation to supply doses of its vaccine (by fiercepharma.com)
Apr 29Catalent's partnership with J&J will accelerate manufacturing capacity of the vaccine (by businesswire.com)
Apr 23J&J and Emergent made a $135 million agreement to manufacture the vaccine (by emergentbiosolutions.com)
Mar 13J&J announces collaboration with the Beth Israel Deaconess Medical Center (by jnj.com)



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