Johnson & Johnson, Janssen, vaccine, adenovirus, PER.C6, CEPI, BARDA | |
Anonymous Coward (OP) User ID: 77889934 Canada 06/10/2020 03:47 PM Report Abusive Post Report Copyright Violation | CEPI - Coalition for Epidemic Preparedness Innovations is a foundation launched with a key goal of reducing the time to develop vaccines from 10 years to less than 12 months it is funded mostly by Bill & Melinda Gates Foundation and NATO governments, and led by Richard J. Hatchett Richard J. Hatchett, former United States Homeland Security Council member under George W. Bush. Its scientific advisory committee has executives from Pfizer, Johnson & Johnson, and Japan's Takeda Pharmaceutical, among others. [link to wikispooks.com (secure)] |
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Anonymous Coward User ID: 70834416 United States 06/18/2020 03:59 PM Report Abusive Post Report Copyright Violation | (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. [link to economictimes.indiatimes.com (secure)] |
Anonymous Coward User ID: 70834416 United States 06/18/2020 04:03 PM Report Abusive Post Report Copyright Violation | |
Anonymous Coward User ID: 77417287 Netherlands 07/09/2020 04:46 PM Report Abusive Post Report Copyright Violation | 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. [link to www.contractpharma.com (secure)] (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. [link to www.fiercepharma.com (secure)] |
Anonymous Coward User ID: 77417287 Netherlands 07/09/2020 04:47 PM Report Abusive Post Report Copyright Violation | (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. [link to www.sec.gov (secure)] (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. [link to journals.plos.org (secure)] (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. [link to www.biopharminternational.com] |
Anonymous Coward User ID: 75840473 Ukraine 08/06/2020 03:31 PM Report Abusive Post Report Copyright Violation | (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. [link to www.pharmaceutical-technology.com (secure)] |
Anonymous Coward User ID: 77830787 Spain 08/13/2020 03:11 PM Report Abusive Post Report Copyright Violation | (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. [link to www.thehindu.com (secure)] |
Anonymous Coward User ID: 77473709 Netherlands 08/14/2020 03:06 PM Report Abusive Post Report Copyright Violation | (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. [link to www.fiercepharma.com (secure)] |
Anonymous Coward User ID: 77001189 United States 08/19/2020 04:21 PM Report Abusive Post Report Copyright Violation | |
Anonymous Coward User ID: 76319445 Netherlands 09/25/2020 02:52 PM Report Abusive Post Report Copyright Violation | (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). [link to www.globenewswire.com (secure)] |
Anonymous Coward User ID: 76319445 Netherlands 09/25/2020 02:52 PM Report Abusive Post Report Copyright Violation | (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. [link to www.genengnews.com (secure)] |
Anonymous Coward User ID: 77840308 Sweden 09/29/2020 03:08 PM Report Abusive Post Report Copyright Violation | (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). [link to www.biospace.com (secure)] |
Anonymous Coward User ID: 77951552 Netherlands 10/03/2020 05:42 PM Report Abusive Post Report Copyright Violation | (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. [link to www.fiercebiotech.com (secure)] (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. [link to blog.executivebiz.com (secure)] |
Anonymous Coward User ID: 73210103 Netherlands 10/08/2020 03:45 PM Report Abusive Post Report Copyright Violation | 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. [link to www.fiercepharma.com (secure)] |
Anonymous Coward User ID: 77836596 Sweden 10/23/2020 05:40 PM Report Abusive Post Report Copyright Violation | (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. [link to www.politico.com (secure)] |
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Anonymous Coward User ID: 78081433 Netherlands 10/27/2020 05:55 PM Report Abusive Post Report Copyright Violation | (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. [link to www.contractpharma.com (secure)] |
Anonymous Coward User ID: 76780795 Netherlands 11/02/2020 03:49 PM Report Abusive Post Report Copyright Violation | (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. [link to abcnews.go.com (secure)] |
Anonymous Coward User ID: 79417936 United Kingdom 11/04/2020 03:41 PM Report Abusive Post Report Copyright Violation | |
Anonymous Coward User ID: 79964128 Germany 02/12/2021 06:15 PM Report Abusive Post Report Copyright Violation | (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. [link to www.bloomberg.com (secure)] (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. [link to www.rnz.co.nz (secure)] (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. [link to www.channelnewsasia.com (secure)] (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. [link to www.biospectrumasia.com (secure)] |
Anonymous Coward User ID: 79964128 Germany 02/12/2021 06:15 PM Report Abusive Post Report Copyright Violation | (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. [link to www.fiercebiotech.com (secure)] (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." [link to ewn.co.za (secure)] |
Anonymous Coward User ID: 79972814 Germany 02/22/2021 05:25 PM Report Abusive Post Report Copyright Violation | (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. [link to www.biopharma-reporter.com (secure)] (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. [link to www.nasdaq.com (secure)] |
Anonymous Coward User ID: 80009900 Germany 02/28/2021 05:27 AM Report Abusive Post Report Copyright Violation | (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. [link to www.arabnews.com (secure)] (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. [link to www.statnews.com (secure)] |
Anonymous Coward User ID: 77276600 Germany 03/03/2021 04:44 PM Report Abusive Post Report Copyright Violation | 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). [link to www.pharmaceutical-technology.com (secure)] |