Emergent BioSolutions, based in Gaithersburg, Maryland, entered a five-year manufacturing services deal with Janssen Pharmaceutical, a Johnson & Johnson company, to manufacture J&J’s Ad26.COV2-S COVID-19 vaccine. Emergent will handle contract development and manufacturing (CDMO) services in a deal that is valued at about $480 million for the first two years.
Ad26.COV2-S is an investigational SARS-CoV-2 vaccine built using the AdVac recombinant technology. Under its own hyperimmune platforms, Emergent is developing two plasma-based treatment against COVID-19, COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin (COVID-EIG). COVID-HIG is a human plasma-derived therapy candidate and has received $14.5 million in funding from the U.S. Department of Health and Human Services (HHS). It will be studied in two trials by the National Institute of Allergy and Infectious Diseases (NIAID) for possible treatment of COVID-19 in severe hospitalized and high-risk patients.
COVID-EIG is an equine plasma-derived therapy candidate for possible treatment of severe COVID-19 in humans. Both products are expected to begin Phase II trials this year.
Under the deal with J&J, Emergent will offer large-scale drug substance manufacturing of the adenovirus-based COVID-19 vaccine in 2021.
“We are proud to deploy our manufacturing strength to address the COVID-19 pandemic,” said Robert G. Kramer Sr., president and chief executive officer of Emergent. “Advancing this collaboration is one of the ways we live our mission—to protect and enhance life.”
The deal is after and incremental to a contract announced in April for drug substance manufacturing technology transfer services and to reserve specific large-scale manufacturing capacity for the COVID-19 vaccine candidate.
The manufacturing will be conducted at Emergent’s Baltimore Bayview site, a designated Center for Innovation in Advanced Development and Manufacturing (CIAD) by the HHS. It is built for rapid manufacturing of large volumes of vaccines and treatments during public health emergencies.
The original April deal was worth about $135 million and was to manufacture more than one billion doses of the COVID-19 vaccine candidate. At the time, Kramer said, “At a time like this, we all need to be working together to achieve maximum results for public health. Emergent is committed to our mission—to protect and enhance life—by advancing our own therapies and helping partner companies advance their programs as well.”
J&J announced at the end of March that it had identified a lead vaccine candidate and was hoping to start clinical trials in September 2020. The technology they are using, Janssen’s AdVac and PER.C6, were used to develop and manufacture the company’s Ebola vaccine as well as to develop its vaccine candidates for Zika, RSV, and HIV.
The one-billion-dose goal came out of a deal J&J made with the Biomedical Advanced Research and Development Authority (BARDA) that supports the rapid scaling of vaccine manufacturing. J&J and BARDA committed more than $1 billion to co-fund vaccine research, development and clinical testing.
Like most companies involved in developing COVID-19 vaccines, J&J is committing enormous funds to manufacturing huge amounts of vaccines in hopes that they will be effective and safe in clinical trials and can then move very quickly to widespread distribution and dosing. J&J is not as far along in clinical trials as some other companies, including Moderna, Pfizer and BioNTech, Oxford University and AstraZeneca, and China’s Sinovac Biotech.
Sinovac reported positive early data from a Phase I/II clinical trial of CoronaVac on June 15, showing favorable immunogenicity and safety. Pfizer and BioNTech reported early positive data of BNT162 on July 1; AstraZeneca and the University of Oxford’s AZD1222 entered Phase II/III clinical trials in late-May; and Moderna, despite some changes in its clinical trial protocols, is planning to begin a 30,000-patient Phase III trial of mRNA-1273 this month.