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Johnson & Johnson (Janssen Pharmaceuticals, adenovirus vaccine Ad26.COV2-S (JNJ-78436735), PER.C6 cell line, CEPI, BARDA, Beth Israel Deaconess Medical Center)

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Johnson & Johnson (Janssen Pharmaceuticals, adenovirus vaccine Ad26.COV2-S (JNJ-78436735), PER.C6 cell line, CEPI, BARDA, Beth Israel Deaconess Medical Center) Empty Johnson & Johnson (Janssen Pharmaceuticals, adenovirus vaccine Ad26.COV2-S (JNJ-78436735), PER.C6 cell line, CEPI, BARDA, Beth Israel Deaconess Medical Center)

Post by Abacus Wed Dec 23, 2020 9:12 pm

History:
Johnson & Johnson (J&J) is an American multinational corporation founded in 1886.
The Vice President, Adrian Thomas was a "player" in Event 201.
In March 2020 Johnson & Johnson entered into a $456 million partnership with the US government for a COVID-19 vaccine.
The corporation includes some 250 subsidiary companies with operations in 60 countries and products sold in over 175 countries.
Subsidiaries include Janssen Pharmaceutica, McNeil Consumer Healthcare, Vistakon, Neutrogena and DePuy.
In October 2010, J&J acquired Crucell for $2.4 billion and will operate as the centre for vaccines, within the wider Johnson & Johnson pharmaceuticals group.
In January 2017, J&J acquired Swiss biotech drugmaker Actelion.
Johnson & Johnson invested over $1 billion toward development of an alleged 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).
Janssen Pharmaceuticals, 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.

(June 25, 2004) Crucell Discovers Human Monoclonal Antibody that Protects Against SARS
LEIDEN, The Netherlands
Dutch biotechnology company Crucell N.V. (Euronext:CRXL) (Nasdaq:CRXL) announced today the discovery of an antibody for protection against SARS virus infection.
In the next issue of The Lancet medical journal, due for publication on June 26 (Volume 363, pages 2139-2141), study results
will be published reporting that a human monoclonal antibody, discovered with the use of Crucell's MAbstract(R) technology
and produced on the PER.C6(R) cell line, protects ferrets from SARS.
Experiments started in the second quarter of 2003, shortly after the SARS virus was first isolated.
Crucell used inactivated SARS virus particles and the company's proprietary antibody phage-display technology
to isolate human antibodies which blocked virus infection in cell culture.
Subsequently, the best antibody was produced using PER.C6(R) technology
and tested in the ferret model developed by Dr Albert Osterhaus of Rotterdam's Erasmus University Department of Virology.
To date, this model is regarded as the best to mimic human SARS infection.

(July 4, 2006) Human Monoclonal Antibody Combination against SARS Coronavirus: Synergy and Coverage of Escape Mutants
Experimental animal data show that protection against severe acute respiratory syndrome coronavirus (SARS-CoV) infection with human monoclonal antibodies (mAbs) is feasible.
Human mAb CR3014 has been shown to completely prevent lung pathology and abolish pharyngeal shedding of SARS-CoV in infected ferrets.
We generated in vitro SARS-CoV variants escaping neutralization by CR3014, which all had a single P462L mutation in the glycoprotein spike (S) of the escape virus.
A novel mAb, CR3022, was identified that neutralized CR3014 escape viruses, did not compete with CR3014 for binding to recombinant S1 fragments,
and bound to S1 fragments derived from the civet cat SARS-CoV-like strain SZ3. No escape variants could be generated with CR3022.

Part of the direct costs (labor, cell culture material) of the SARS-CoV neutralization experiments
performed with the monoclonal antibodies at the Universities of Frankfurt and Hong Kong
were reimbursed by Crucell Holland BV. Crucell was involved in the design, the analysis of the data, and the publication decision.

(March 8, 2011) Johnson & Johnson Acquires Vaccine Developer Crucell
Johnson & Johnson (J&J) has acquired Netherlands-based biopharmaceutical company Crucell for close to $2.4 billion dollars,
moving J&J prominently into the arena of vaccine development, according to a company press release. This move comes after several years of partnership
between the two companies.  J&J acquired 18% of the company late in 2009, with the goal
of forming a strategic alliance around the discovery, development, and commercialization of monoclonal antibodies (mAbs) and vaccines
for the treatment and prevention of influenza, as well as other diseases.
Before being acquired by J&J, Crucell was the largest independent manufacturer of vaccines.

(May 30, 2014) Bavarian Nordic Announces Appointment of Paul Chaplin, Ph.D. as President & CEO
Bavarian Nordic announced today that Paul Chaplin, Ph.D. has been appointed new President and CEO of the Company.
Prior to joining Bavarian Nordic in 1999, Dr. Chaplin worked in vaccine research with the Institute for Animal Health in UK and CSIRO,
the Cooperative Research Centre for Vaccine Technology in Australia. In 2000, he was appointed head of research
and in 2004 he was appointed Executive Vice President. Amongst others things, he has led the development program for the IMVAMUNE(r) smallpox vaccine
as well as been responsible for the successful collaboration on this and other vaccines with the U.S. Government throughout the years.
Dr. Chaplin holds a Ph.D. in Immunology from Bristol University. He is a British national, born in 1967.

(September 15, 2015) Crucell Holland, Bavarian Nordic to Develop Experimental Ebola Vaccine Regimen for HHS
Crucell Holland will move forward with work to develop experimental vaccine regimen for Ebola under a potential seven-year,
$69 million contract with the preparedness and response unit of the Department of Health and Human Services (HHS).
HHS said Monday the Netherlands-based pharmaceutical company will work with Denmark-based Bavarian Nordic
to develop the Ad26.ZEBOV prime and MVA-BN-Filo boost components of the regimen.
BARDA will provide support for the manufacturing development
of the Ebola vaccine regimen as clinical studies continue in the U.S. and the U.K.

(July 27, 2017) Bavarian Nordic, Johnson & Johnson join forces to develop HIV, HBV shots in $879M deal
It’s clear now that HIV and hepatitis B are two additional infectious diseases Johnson & Johnson kept mum about
when it expanded a vaccine technology deal with Bavarian Nordic in 2015. The two companies have just partnered up
to tackle those two targets using Bavarian Nordic’s MVA-BN vaccine tech. In a deal worth up to $879 million,
the Danish company is granting J&J's Janssen unit the rights to combine MVA-BN with Janssen’s own AdVac platform in the HIV and HBV programs.
Janssen will pay Bavarian Nordic $10 million upfront and up to $836 million in milestones,
while the remaining $33 million will come in the form of an equity investment by Johnson & Johnson Innovation.
Bavarian Nordic will design, produce and deliver whatever MVA is needed based on its platform,
while Janssen will take care of R&D, according to a media aide for the Kvistgaard, Denmark-based company.
A study, carried out by scientists at Beth Israel Deaconess Medical Center, the Walter Reed Army Institute of Research,
together with Janssen and Gilead, combined an adenovirus serotype 26 vector vaccine (based on AdVac)
and an MVA vector vaccine with a TLR7 agonist that works on a protein of the immune system, to be administered alongside antiviral treatments.

(January 2018) Google’s parent firm invests in UK company developing first ever universal flu vaccine
A private UK company developing a vaccine that would be the first in the world to fight all types of flu
has raised £20m from investors including GV, the venture capital arm of Google parent Alphabet.
Vaccitech, a spin-out founded by scientists at Oxford University’s Jenner Institute,
said on Monday the cash would help fund its vaccine through a two-year clinical trial involving more than 2,000 patients,
as well as expand other projects. The group is also running clinical studies on an experimental shot to prevent Middle East Respiratory Syndrome (Mers)
and a therapeutic prostate cancer vaccine for use with an immunotherapy drug.
Vaccitech’s new vaccine works by using proteins found in the core of the virus rather than those on its surface.
Surface proteins stick out like pins from the virus and change all the time, while those in the core are stable.
The vaccine also stimulates T-cells rather than antibodies – an approach that has yet to convince existing flu vaccine manufacturers such as Sanofi, GlaxoSmithKline and CSL’s Seqirus.
Vaccitech’s latest financing round was also supported by Sequoia China and Oxford Sciences Innovation.

(October 25, 2018) Johnson & Johnson steps up vaccines R&D—and prepares for launches—with €72M plant
Johnson & Johnson has big ambitions in vaccines, and to get there, its manufacturing has to measure up.
The small plant acquired in its Crucell purchase just won't support its advancing pipeline candidates
—and certainly not product launches down the road.
That's why the company targeted a new plant in Leiden, the Netherlands, for expansion.
On Thursday, the drugmaker officially opened the site after four years of work. All told, J&J spent about €72 million on the plant,
said Johan Van Hoof, Janssen global therapeutic area head of infectious disease and vaccines.
The small plant acquired in its Crucell purchase just won't support its advancing pipeline candidates—and certainly not product launches down the road.
“The progress we have made … clearly has impressed some key stakeholders in the field and has allowed us to concretely create partnerships”
with groups such as the U.S. agency BARDA, part of the Department of Health and Human Services; the Gates Foundation; and others, Van Hoof said.

(October 30, 2018) J&J unveils new vaccines facility in Leiden, Netherlands
Johnson & Johnson has unveiled a new vaccines facility in Leiden, the Netherlands,
to support the development and roll out of new vaccines on a mass scale for public use globally.
Built by Janssen Vaccines & Prevention, the centre contains new technological and manufacturing platforms
to aid large-scale manufacturing of Janssen vaccines for use in late-stage clinical trials.
Janssen is currently developing investigational vaccines for multiple infectious diseases
such as HIV, respiratory syncytial virus (RSV), influenza, Ebola and Zika.
The vaccines launch facility can also support the company’s efforts for global pandemic preparedness,
including the development of a new Middle East respiratory syndrome (MERS) vaccine in alliance with the Coalition for Epidemic Preparedness Innovations (CEPI).

(December 7, 2018) Janssen, Merck and GE Healthcare join forces in the UK
The Oxford Science Park (TOSP) is to house the Vaccines Manufacturing Innovation Centre (VMIC), the UK's first facility dedicated to the field.
Located on a new plot close to the Magdalen Centre, home to many SMEs, the £66m VMIC addresses the UK’s gap in late-stage vaccine manufacturing process development.
The VMIC is supported by pharma companies Janssen, part of Johnson & Johnson, and Merck.
Expertise and training in state-of-the-art manufacturing equipment will be provided by GE Healthcare.
The University of Oxford, Imperial College and the London School of Hygiene and Tropical Medicine
have established VMIC-UK to run the centre, which is expected to be up and running by the spring of 2022.
Led by the Jenner Institute, a partnership between the University of Oxford and the Pirbright Institute,
the new centre has been awarded funding by UK Research and Innovation (UKRI)
of £66 million through the UK government’s Industrial Strategy Challenge Fund (ISCF) Medicines Manufacturing challenge.

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Post by Abacus Wed Dec 23, 2020 9:18 pm

(January 30, 2020) Johnson & Johnson to develop coronavirus vaccine
Johnson & Johnson announced that it has begun development of a vaccine
for the novel Coronavirus outbreak through its subsidiary, Janssen Pharmaceutical Companies.
“This latest outbreak of a novel pathogen once again reinforces the importance of investing in preparedness, surveillance
and response to ensure the world remains ahead of potential pandemic threats,” said Paul Stoffels,
M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
The vaccine program will leverage Janssen’s AdVac and PER.C6 technologies
that provide the ability to rapidly upscale production of the optimal vaccine candidate.
These are the same technologies that were used in the development and manufacturing of Janssen’s investigational Ebola vaccine,
which is currently deployed in the Democratic Republic of the Congo and Rwanda.
They were also used to construct the Company’s Zika, RSV and HIV vaccine candidates.

(February 12, 2020) J&J allies with BARDA to accelerate coronavirus vaccine program
Johnson & Johnson has teamed up with the U.S. Biomedical Advanced Research and Development Authority (BARDA)
to develop a vaccine against coronavirus. J&J is pooling money and resources
with BARDA in an attempt to accelerate the progress of a vaccine candidate
into phase 1 development.Late last month J&J joined the list of biopharma companies
working to stop the coronavirus now radiating out from Wuhan, China.
Reflecting its broad capabilities, J&J sketched out a multipronged approach
against the virus that positioned it to provide antivirals for use in China
while applying its AdVac and PER.C6 technologies to the development of a vaccine.

The PER.C6 cell line is derived from human embryonic retinal cells, originally from the retinal tissue of an 18 week old fetus aborted in 1985
and further developed and prepared as cell line by transfection with defined E1 region of the adenovirus type 5 followed by selection for transfectants with an immortal phenotype.

Human cell Line: PER C6
Developed in 1985, PER C6 is the growth medium
for a wide variety of human disease-causing viruses
that can be processed into inactivated whole virus,
live-attenuated, live-vector, split, subunit and recombinant vaccines.

President Bush’s Cell-Culture Technology
In April 2002, another supplier Sanofi Pasteur was awarded a $97 million
contract from the US Health and Human Services Department (HHS)
to speed the production process for new cell-culture influenza vaccines.
Sanofi Pasteur will be using PER.C6 cell-culture. The PER.C6-based pandemic flu vaccine
will be the first influenza vaccine developed using human cell production technology.
Herein lies the problem. The PER.C6 human cell-culture comes from an aborted fetus.

(April 23, 2020) Emergent BioSolutions Signs Agreement to be U.S. Manufacturing Partner for Johnson & Johnson’s Lead Vaccine Candidate for COVID-19
Emergent BioSolutions Inc. (NYSE:EBS) today announced an agreement whereby Emergent will deploy its contract development and manufacturing (CDMO) services
to support the manufacturing of Johnson & Johnson’s lead vaccine candidate for COVID-19
that leverages the AdVac® and PER.C6® technologies from the Janssen Pharmaceutical Companies of Johnson & Johnson.
Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services with its molecule-to-market
CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity
to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021.
Large-scale manufacturing of drug substance for Johnson & Johnson’s vaccine candidate will be done at Emergent’s Baltimore Bayview facility,
a Center for Innovation in Advanced Development and Manufacturing (CIADM) designed for rapid manufacturing of vaccines
and treatments in large quantities during public health emergencies. Emergent’s CIADM is a result of a public-private partnership
with the U.S. Department of Health and Human Services (HHS).
“Eight years ago, HHS invested in novel public-private partnerships to create three Centers for Innovation in Advanced Development and Manufacturing or CIADMs
to help strengthen the nation’s biotech infrastructure to prepare and respond to emergencies,”
said Gary Disbrow, Ph.D., acting director of the Biomedical Advanced Research and Development Authority (BARDA).

(April 29, 2020) J&J inks 2nd manufacturing deal to boost capacity for COVID-19 vaccine
J&J signed an agreement Wednesday to ramp up capacity at Catalent's 875,000-square-foot Bloomington, Indiana facility,
the partners said Wednesday. Catalent will hire an additional 300 workers
at the plant starting in July with the goal of reaching 24/7 manufacturing schedules by January.
Leveraging its "deep expertise" in sterile formulation at the Bloomington facility, Catalent brings experience
in drug substance development and manufacturing, and drug product fill/finish to the deal,
the company said. Catalent will also lean on its network of sterile drug facilities in Brussels and Anagni, Italy.

(June 10, 2020) Johnson & Johnson to begin human trials for coronavirus vaccine in late July, earlier than expected
Johnson & Johnson announced Wednesday its early-stage human trial for a potential coronavirus vaccine will begin in the second half of July,
earlier than its initial forecast of September. “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities,
we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant,”
J&J’s Chief Scientific Officer Paul Stoffels said in a press release. The company began developing a Covid-19 vaccine in January.
The company said Wednesday it is committed to the goal of supplying more than 1 billion doses globally through the course of 2021,
provided the vaccine is safe and effective.

(June 18, 2020) EU in advanced talks with Johnson & Johnson on COVID-19 vaccine deal: Sources
The move would be the first arranged by the European Union executive since it was mandated last week by the 27 EU national governments
to use an emergency fund with more than 2 billion euros ($2.3 billion) available
to reach advance purchase or call-option deals with up to six vaccine makers.
The Commission's deal with the U.S. firm Johnson & Johnson is "in the pipeline",
a top health official from an EU member state said, asking to remain anonymous
as was mentioning confidential discussions about vaccines between the EU executive and EU governments.
Johnson & Johnson plans next month to start human clinical trials for its experimental vaccine
against the highly contagious coronavirus, which has infected more than 8.36 million people worldwide, with 447,985 deaths.

(July 6, 2020) Emergent BioSolutions Inks $480M Deal with J&J
Emergent BioSolutions has entered a five-year manufacturing services agreement with Janssen Pharmaceuticals,
one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing
for Johnson & Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac technology.
Emergent will provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years,
valued at approximately $480 million for the first two years.
Activities will be performed at Emergent’s Baltimore Bayview facility, a designated Center for Innovation in Advanced Development and Manufacturing (CIADM)
by the U.S. Department of Health and Human Services (HHS),
designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies.

(July 6, 2020) J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility
On the same day it inked a $480 million order from a Maryland CDMO, J&J announced
it would expand its pact with another manufacturer to scale up production as fast as possible.
J&J has expanded its COVID-19 vaccine manufacturing pact with New Jersey-based Catalent
to include work at the CDMO's Anagni, Italy, facility, a J&J spokesman said Monday.
New Jersey-based J&J initially tapped Catalent in April
to reserve fill-finish capacity for its COVID-19 shot at its Bloomington, Indiana, plant.
As part of that deal, Catalent agreed to hire an additional 300 workers at the plant starting this month,
with the goal of reaching 24/7 manufacturing schedules by January.
In an email, J&J didn't specify what work Catalent would perform at the Anagni site,
but the CDMO previously signed a deal with British drugmaker AstraZeneca to perform fill-finish and packaging duties
for the University of Oxford's adenovirus-based COVID-19 vaccine, AZD1222.

(August 6, 2020) Janssen to supply 100 million Covid-19 vaccine doses to US
Johnson & Johnson (J&J) unit Janssen Pharmaceutical has signed an agreement with the US Government
for the large scale domestic production and supply of 100 million doses of its Covid-19 vaccine candidate, Ad26.COV2.S.
The vaccine, based on Janssen AdVac technology, will be used in the US after it secures regulatory approval or emergency use authorisation.
For this agreement, the US Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD)
have committed to providing more than $1bn.
The government may buy an additional 200 million doses of the vaccine in the future.
Last month, J&J said that the company is in discussions with the Government of Japan, as well as the Bill and Melinda Gates Foundation,
regarding allocations of its Covid-19 vaccine candidate.
The US government already signed similar Covid-19 vaccine supply deals with Sanofi
and GlaxoSmithKline (GSK), as well as Pfizer and BioNTech.

(August 13, 2020) Biological E. inks pacts with Johnson & Johnson, Baylor College of Medicine on vaccine
Pharmaceuticals and biological company Biological E. (BE) has entered into separate agreements with Janssen Pharmaceutica NV and Baylor College of Medicine (BCM) for COVID-19 vaccine.
With Janssen Pharmaceutica, one of the Pharmaceutical companies of Johnson & Johnson,
the agreement is for creation / enhancement of manufacturing capacities for drug substance
and drug product for Johnson & Johnson’s COVID-19 vaccine candidate, Ad26.COV2.S.
Director of BioE Holdings Inc. Narender Dev Mantena, who heads BE’s novel vaccine initiative,
said “we look forward to deploying our manufacturing infrastructure to support Johnson & Johnson’s commitment to global access for its COVID-19 vaccine.”
Another release said the Baylor College of Medicine and BE have signed a licensing agreement for development of a safe,
effective and affordable COVID-19 vaccine. BE has licensed the recombinant protein COVID-19 vaccine candidate developed at Baylor.
According to the release, BE engaged in license negotiations with the BCM Ventures team,
a part of Baylor College of Medicine, after initial discussions on Baylor’s technology.
“We look forward to facilitating the technology transfer for the COVID-19 vaccine to India and for the world,” said Dr. Maria Elena Bottazzi,
associate dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Centre for Vaccine Development.

(August 13, 2020) On heels of U.S. pact, Johnson & Johnson advances COVID vaccine talks with Europe
Just one week after inking a COVID-19 vaccine deal with the U.S. for 100 million doses,
Johnson & Johnson is moving forward with negotiations on a deal twice that size with the European Union.
In details unveiled Thursday, J&J is in talks to supply the EU with 200 million doses
of its coronavirus vaccine candidate—if the program succeeds in testing. Under the proposal, the deal would include an option for an additional 200 million doses.
The move comes right after J&J reached a $1 billion deal for 100 million doses with the United States’ Operation Warp Speed.
Meanwhile, Europe has been negotiating with global pharma giants as well. The EU has already concluded exploratory talks to purchase 300 million doses of the Sanofi/GlaxoSmithKline
candidate if it succeeds. AstraZeneca, another leading COVID-19 vaccine player, pledged 400 million doses
at no profit under a deal with the Inclusive Vaccines Alliance, which is led by Germany, France, Italy and the Netherlands.

(September 23, 2020) J&J’s Janssen Launches Up-to-60,000-Patient Phase III Trial for COVID-19 Vaccine
JNJ-78436735—also called Ad26.COV2.S—is under study in the Phase III ENSEMBLE trial (NCT04505722),
which will enroll volunteers at up to nearly 215 clinical research sites in the U.S. and worldwide.
Janssen is funding the trial along with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID),
and the Biomedical Advanced Research and Development Authority (BARDA).
JNJ-78436735 is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells.
Emerged from vaccine constructs created and tested by J&J with Beth Israel Deaconess Medical Center (BIDMC),
part of Harvard Medical School, using Janssen’s AdVac® and PER.C6® vaccine technology platforms, designed for accelerated vaccine development.
J&J says AdVac offers a key advantage: The vaccine would, at launch, remain stable for two years at -20 °C and at least three months at 2–8° C.
This makes the vaccine candidate compatible with standard vaccine distribution channels
and would not require new infrastructure to get it to patients, the company asserts.

(September 29, 2020) Michigan’s GRAM Inks COVID-19 Vaccine Manufacturing Deal with J&J
Grand River Aseptic Manufacturing (GRAM), based in Grand Rapids, Michigan, inked a deal with Janssen Pharmaceutical,
a Johnson & Johnson company, to support the manufacturing of Janssen’s COVID-19 vaccine candidate.
GRAM is an injectable contract development and manufacturing organization (CDMO).
The agreement with GRAM includes technical transfer and fill-and-finish manufacture of the vaccine candidate.
GRAM is expanding domestic fill-and-finish capacity for COVID-19 vaccines and drugs for companies
that have deals with the federal government’s Operation Warp Speed.
The expansion is partially funded by the Biomedical Advanced Research and Development Authority (BARDA),
part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services(HHS),
in collaboration with the Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).

(October 8, 2020) J&J inks European COVID-19 vaccine supply deal for 200M doses
Two months after concluding exploratory talks over a COVID-19 vaccine supply pact
with officials in Europe, Johnson & Johnson has finalized its deal.
The company will provide 200 million doses of its vaccine
—should it prove safe and effective in testing and win an approval—for an undisclosed price.
The deal also provides an option for an additional 200 million doses.
The European Commission already had supply agreements in place with
AstraZeneca and the Sanofi/GlaxoSmithKline partnership.

(October 12, 2020) Johnson & Johnson pauses dosing of its coronavirus vaccine
Johnson & Johnson announced late Monday it is temporarily pausing recruitment and dosing of its coronavirus vaccine
in clinical trials due to an “unexplained illness in a study participant.”
The company did not disclose more information about the affected individual.
The company noted that in placebo-controlled clinical trials,
it “is not always immediately apparent” if a given individual received the treatment or a placebo.

(October 27, 2020) Stevanato Group, Catalent Partner to Expedite Equipment Installation
Stevanato Group, a producer of glass primary packaging and capabilities for drug delivery systems,
has expanded its longstanding collaboration with Catalent to include the provision and accelerated delivery
of advanced visual inspection systems to help with potential vaccines and biologics to address the pandemic.
Catalent has ordered Plus 400 LKD automatic and PWL semi-automatic visual inspection machines from Stevanato
and will install the equipment at its sites in Bloomington, IN, and Anagni, Italy, to support various customer programs.

(November 2, 2020) South African firm and Johnson & Johnson strike vaccine deal
JOHANNESBURG -- South African pharmaceutical firm Aspen Pharmacare
has announced a deal with U.S. firm Johnson & Johnson to manufacture its COVID-19 vaccine candidate,
if it is approved in South Africa and internationally.
The company said the facility has a capacity to manufacture more than 300 million doses of the vaccine a year.
Johnson & Johnson's test vaccine, Ad26.COV3-S, is one of four different vaccines currently undergoing clinical trials in South Africa.
Johnson & Johnson would be responsible for supplying the vaccine in large batches
and Aspen would put it into vials and package it for individual doses,
pending a final commercial agreement, said the statement issued by Aspen.
In July protesters demonstrated in Johannesburg against vaccine trials of a vaccine being tested by the University of Oxford,
in which about 2,000 people were expected to participate. The protesters told The Associated Press then that people
chosen as volunteers for the trials were from impoverished backgrounds
and not fully aware of the potential risks associated with clinical trials.

(November 14, 2020) J&J’s Covid Vaccine Gets Another $1 Billion Funding Boost
Johnson & Johnson will spend about $604 million expanding its deal with the U.S. government to develop a Covid-19 vaccine,
seeking to catch up with rivals who have forged ahead in the race.
The Biomedical Advanced Research and Development Authority (BARDA) will commit about $454 million
in additional money to the Phase 3 Ensemble trial, which seeks to evaluate the efficacy of the company’s vaccine candidate as a single-dose.
To accelerate the recruitment of participants and cut the trial time in half, J&J has also turned to data experts at UnitedHealth Group Inc.
J&J and Barda, under the U.S. Department of Health and Human Services,
already committed more than $1 billion in March to co-fund the research in an about 50-50 split.

(November 19, 2020) Covid-19: Government agrees in principle to buy Janssen Pharmaceutica vaccines
The New Zealand government has reached an in-principle agreement to purchase doses of a Covid-19 vaccine for the entire population.
If all goes to plan, the first doses - up to two million - would be delivered from the third quarter of 2021.
The government would then have the option to purchase up to three million more doses, which would be delivered throughout 2022.
The vaccine is likely to be single-dose and compatible with standard vaccine distribution channels, so it may be more efficient to administer.
The Pfizer vaccine would be available in the early part of 2021 while the Janssen one would more likely be near the end of the year.

(December 15, 2020) Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine in Barcelona
Spanish pharmaceutical company Reig Jofre said on Tuesday it had reached an agreement with Johnson & Johnson
to produce the U.S. company's experimental COVID-19 vaccine at its plant in Barcelona.
J&J's Janssen subsidiary will transfer the technology required for large-scale manufacture
of the vaccine candidate to Reig Jofre, allowing production to get underway
once the shot receives regulatory approval, the Spanish company said in a statement.
Under the terms of the agreement, Reig Jofre said it will be responsible for the formulation, filling and packaging of the vaccine,
while Janssen will handle distribution. Reig Jofre said last month it would able to produce 50 million doses of COVID-19 vaccine a year
at its new factory without cancelling any existing contracts.





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Post by Abacus Mon Dec 28, 2020 6:21 pm

(December 28, 2020) Korea secures COVID-19 vaccines via deals with Janssen, Pfizer
The Korean government has concluded deals with global pharmaceutical giants Janssen of Johnson and Johnson and Pfizer
to purchase vaccines against COVID-19 for its population. Prime Minister Chung Sye-kyun announced the progress in a press release held on 24 Dec 2020.
"The deal with Janssen will bring in six million doses, or two million more than originally planned.
We will start administering them from next year's second quarter.
Government agreed to import 10 million vaccine doses from Pfizer from the third quarter next year.
Korean government has secured vaccines for ten million people from the COVAX facility along with another 34 million doses from pharmaceutical companies.

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Post by Abacus Tue Feb 09, 2021 8:52 pm

(February 9, 2021) SA turns to J&J vaccine to begin COVID-19 immunisation programme
CAPE TOWN - South Africa has shifted gears and is now hinging its hopes on the single-dose Johnson & Johnson COVID-19 vaccine.
During a World Health Organization (WHO) briefing on Monday, the chairperson of government’s Ministerial Advisory Committee on COVID-19,
Professor Salim Abdool Karim, said that they were scheduled to roll out the AstraZeneca vaccine in just over a week from now.
"Instead of rolling out the AstraZeneca vaccine, we'll be rolling out the Johnson & Johnson vaccine
and that will give us a bit of time and leeway to ensure that we're collecting the necessary data
as we roll out the AstraZeneca in a stepwise process."
ewn.co.za/2021/02/09/sa-turns-to-j-and-j-vaccine-to-begin-covid-19-immunisation-programme






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Post by Abacus Fri Feb 12, 2021 9:11 pm

(February 8, 2021) Verily links with Janssen for at-home COVID-19 immune system study
Verily is teaming up with Johnson & Johnson’s Janssen division to observe
the body’s earliest immune responses to a coronavirus infection,
with people participating in the research from within their own homes.
The study will be launched through Verily’s Project Baseline testing program and aims to collect biological information
and real-world data in the weeks immediately after a person tests positive for COVID-19.
Separately, Verily recently opened up its coronavirus-focused Project Baseline efforts to children as young as four,
while pediatric testing and COVID-19 research has previously been limited.
The program will offer free COVID-19 testing to children through 450 screening sites across 16 states.
fiercebiotech.com/medtech/verily-links-janssen-for-at-home-covid-immune-system-study



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Post by Abacus Thu Feb 18, 2021 8:13 pm

(February 9, 2021) SA turns to J&J vaccine to begin COVID-19 immunisation programme
CAPE TOWN - South Africa has shifted gears and is now hinging its hopes on the single-dose Johnson & Johnson COVID-19 vaccine.
During a World Health Organization (WHO) briefing on Monday, the chairperson of government’s Ministerial Advisory Committee on COVID-19,
Professor Salim Abdool Karim, said that they were scheduled to roll out the AstraZeneca vaccine in just over a week from now.
"Instead of rolling out the AstraZeneca vaccine, we'll be rolling out the Johnson & Johnson vaccine
and that will give us a bit of time and leeway to ensure that we're collecting the necessary data
as we roll out the AstraZeneca in a stepwise process."
ewn.co.za/2021/02/09/sa-turns-to-j-and-j-vaccine-to-begin-covid-19-immunisation-programme

(February 18, 2021) South Africa starts administering Janssen COVID-19 vaccine to health workers
South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country.
Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following its application for EUA in the US.
The first batch of 80,000 doses of the J&J vaccine is being administered to health workers,
having been approved by the SA Health Productions Regulatory Authority (SAHPRA) under the Sinsonke protocol.
The first vaccine was administered yesterday at Khayelitsha District Hospital in Cape Town.
This authorization is for the ‘open label, pragmatic, real world Phase 3b clinical trial’ of the vaccine,
which will investigate the effectiveness of the single-dose vaccine in preventing severe COVID-19, hospitalizations and deaths among vaccinated health workers.
biopharma-reporter.com/Article/2021/02/18/South-Africa-starts-administering-Janssen-COVID-19-vaccine-to-health-workers

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Post by Abacus Mon Feb 22, 2021 9:47 pm

(February 22, 2021) France's Sanofi to help Johnson & Johnson manufacture COVID-19 vaccine
French healthcare company Sanofi SASY.PA will provide COVID-19 vaccine manufacturing
support to U.S. peer Johnson & Johnson JNJ.N, Sanofi said on Monday.
Once authorized, Sanofi will provide Johnson & Johnson access to the established infrastructure
and expertise of its vaccine manufacturing plant in Marcy l'Etoile, France,
to formulate and fill vials of Johnson & Johnson's Janssen COVID-19 vaccine candidate in 2021
at a rate of approximately 12 million doses per month.
nasdaq.com/articles/frances-sanofi-to-help-johnson-johnson-manufacture-covid-19-vaccine-2021-02-22

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Post by Abacus Sun Feb 28, 2021 11:10 am

(February 25, 2021) Bahrain becomes first nation to grant J&J COVID-19 shot emergency use
Bahrain became the first nation to authorize Johnson & Johnson’s new single-dose coronavirus vaccine for emergency use
on Thursday, the government announced, just a day after US regulators concluded the shot offers strong protection against severe COVID-19.
The island kingdom off the coast of Saudi Arabia said it would dole out J&J’s shot
to the most vulnerable people, including older adults and those with chronic conditions, without specifying when.
It was also unclear when doses would be delivered to the country, which already offers vaccines
by state-backed Chinese firm Sinopharm, Pfizer-BioNtech and Oxford-AstraZeneca, as well as Russia’s Sputnik V to its roughly 2 million residents.
arabnews.com/node/1815821/middle-east

(February 27, 2021) FDA authorizes Johnson & Johnson’s single-dose Covid-19 vaccine
The Food and Drug Administration on Saturday issued an emergency authorization
for a Covid-19 vaccine developed by Johnson & Johnson, the third vaccine to be cleared
for use in the United States and the first that requires only one dose.
The vaccine, which has not yet been tested in children or adolescents, was cleared for use in adults aged 18 and older.

The addition of J&J’s vaccine to the arsenal could offer a distinct advantage in the effort to vaccinate large swaths of the American public
as quickly as possible. The single-shot vaccine doesn’t have the same onerous cold-chain requirements
as the two vaccines developed by Moderna and the Pfizer/BioNTech partnership.

The approval for all adults comes despite the fact that the data on elderly adults from the company’s Phase 3 study were limited.
Some of J&J’s data also raised questions about how well the vaccine works in adults 60 and older who have comorbidities,
or underlying medical conditions. The committee ultimately voted unanimously to recommend the vaccine
be used in those 18 or older, without any restrictions on age.
statnews.com/2021/02/27/fda-authorizes-jnj-covid19-vaccine/


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Post by Abacus Wed Mar 03, 2021 9:41 pm

(March 3, 2021) Merck to support manufacturing of Johnson & Johnson’s Covid-19 vaccine
Merck (MSD) has signed an agreement with Janssen Pharmaceuticals (JPI),
one of the Janssen Pharmaceutical Companies of Johnson & Johnson,
to support the manufacturing and supply of its Covid-19 vaccine.
Merck’s US facilities will be utilised for the production of the drug substance,
as well as the formulation and filling of vaccine vials for the Johnson & Johnson vaccine.
Merck became the ninth manufacturer to be part of Johnson & Johnson’s global network,
with the latest manufacturing arrangement encouraging increase in the vaccine production capacity.
The company also entered an agreement with the US Biomedical Advanced Research and Development Authority (BARDA).
pharmaceutical-technology.com/news/merck-manufacturing-covid-19-vaccine/?utm_source=Army%20Technology&utm_medium=website&utm_campaign=Must%20Read&utm_content=Image


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Post by Abacus Thu Mar 11, 2021 10:21 pm

(March 8, 2021) Health Canada authorises J&J’s Covid-19 vaccine for emergency use
Health Canada has authorised an Interim Order (IO) to the Janssen Pharmaceutical (JPI)
Companies of Johnson & Johnson’s (J&J) single-shot vaccine preventing Covid-19 for people aged 18 above.
The company expects to deliver the ten million doses
included in the Advance Purchase Agreement (APA)
with the Government of Canada by the end of the third quarter this year.
pharmaceutical-technology.com/news/company-news/health-canada-jj-vaccine/

(March 11, 2021) EMA approves fourth Covid-19 vaccine, J&J’s single-shot candidate
The European Medicines Agency (EMA) has recommended conditional marketing authorisation
for Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine.
Janssen’s Covid-19 vaccine is the fourth to be recommended for use in adults in the EU;
it follows vaccines produced by Pfizer/BioNTech, Moderna and AstraZeneca/Oxford.
Like the AstraZeneca/Oxford vaccine, it is an adenovirus product and relies on Janssen’s proprietary AdVac platform.
Janssen’s Covid-19 has already received emergency use authorisations in the US and Canada.
J&J has also submitted rolling review submissions in other parts of the world and is seeking emergency use
listing with the World Health Organization.
pharmaceutical-technology.com/news/ema-approves-fourth-covid-19-vaccine-jjs-single-shot-candidate/

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Post by Abacus Tue Mar 16, 2021 9:25 pm

(March 12, 2021) WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19
The World Health Organization (WHO) today listed the COVID-19 vaccine Ad26.COV2.S,
developed by Janssen (Johnson & Johnson), for emergency use in all countries and for COVAX roll-out.
The decision comes on the back of the European Medicines Agency (EMA) authorization, which was announced yesterday.
The vaccine from Janssen is the first to be listed by WHO as a single dose regimen,
which should facilitate vaccination logistics in all countries.
To expedite listing of the vaccine, WHO and a team of assessors from all regions adopted what is called an ‘abbreviated assessment’
based on outcomes of the EMA review, and evaluation of quality, safety and efficacy data focused on low- and middle-income country needs.
who.int/news/item/12-03-2021-who-adds-janssen-vaccine-to-list-of-safe-and-effective-emergency-tools-against-covid-19

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Post by Abacus Tue Mar 16, 2021 10:24 pm

(March 16, 2021) What is J&J Covid vaccine that India’s Bio E will make with US help, the challenges it faces
New Delhi: Under the new vaccine partnership unveiled at the first Quad Summit Friday,
the four-country grouping of India, US, Australia and Japan decided to pool resources and capabilities to roll out 1 billion doses
of Covid-19 vaccines by 2022 as they make efforts to boost post-pandemic recovery.
As part of the plan, the US International Development Finance Corporation (DFC)
will financially assist Hyderabad-based drug maker Biological E
to produce doses of the Covid-19 vaccines developed in the US, including the Johnson & Johnson candidate.
theprint.in/health/what-is-jj-covid-vaccine-that-indias-bio-e-will-make-with-us-help-the-challenges-it-faces/622292/

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Post by Abacus Tue Mar 16, 2021 10:36 pm

(March 16, 2021) Takeda, IDT support manufacturing of J&J's COVID-19 vaccine
Takeda Pharmaceutical Company Limited has announced a reciprocal agreement with IDT Biologika GmbH (“IDT”),
contract development and production, to leverage capacity at IDT previously reserved for Takeda's dengue vaccine candidate (TAK-003)
to produce the single-shot COVID-19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.
With this agreement, Takeda is now supporting global access to three different COVID-19 vaccines.
Takeda previously announced its commitment to providing rapid and sustained access to COVID-19 vaccines in Japan
through partnerships with Novavax and Moderna.
biospectrumasia.com/news/37/17765/takeda-idt-support-manufacturing-of-jjs-covid-19-vaccine.html

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Post by Abacus Sun Apr 11, 2021 2:34 pm

(April 9, 2021) EMA begins investigation of J&J COVID-19 vaccine’s blood clotting potential
The European Medicines Agency (EMA) announced that it is beginning a review of blood clots
appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine.
EMA recently concluded that blood clots associated with low blood platelet levels
were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca.
massdevice.com/ema-begins-investigation-of-jj-covid-19-vaccine-blot-clotting-potential/

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