J&J tests new two-dose regimen for COVID-19 vaccine candidate

• In addition to the single-dose regimen ENSEMBLE study, Johnson & Johnson (NYSE:JNJ) unit, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The company is investigating multiple doses and dosing regimens to evaluate its long-term efficacy.
• The big pharma’s vaccine, JNJ-78436735, is currently in a major 60,000-subject Phase 3 known as ENSEMBLE assessing whether it can prevent coronavirus infections with a single shot.
• Early data have already shown it can produce an immune response at one dose.
• Phase 3 ENSEMBLE 2 trial will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate versus placebo for the prevention of COVID-19 in up to 30,000 participants, running parallel to its ongoing ENSEMBLE phase 3.
• J&J is already running a one-shot-and-done program, which puts it at an advantage over rivals Pfizer/BioNTech and Moderna, which need two.
• While some drugmakers have been set back by the challenge of manufacturing enough doses, J&J is well on its way to producing 1B doses of its COVID-19 vaccine in 2021 and is looking ahead to 2022, said Paul Lefebvre, vice president of strategic initiatives and COVID-19 vaccine supply chain at J&J's Janssen unit, in an interview.
• Back in April, J&J signed on New Jersey-based CDMO Catalent to lock down manufacturing capacity at its Bloomington, Indiana plant, to hit a manufacturing goal set by January.
• In July, Maryland's Emergent Biosolutions joined the fold, inking a five-year pact to churn out drug substance.
• Also, Johnson & Johnson signed on Michigan's Grand River to meet its 100M dose supply order with the U.S. for $1B, or $10 per dose. Elsewhere, J&J is relying on its own sites in Europe to make drug substance.
• J&J just this week finalized a deal to provide up to 200M doses to Europe, with the option to sell another 200M shots at a later date should the vaccine pass muster in clinical trials.
• Separately, Johnson & Johnson is shipping 30M doses to the U.K.
• The drugmaker also teamed up with Aspen Pharmacare to manufacture J&J's vaccine at its facility in Port Elizabeth, South Africa, and Biological E in August agreed to manufacture the shot in India.
• With those partnerships in place, J&J feels confident it can meet its lofty supply goals.
• "The sheer speed of execution is challenging, and also the sheer volume that we need to produce. I think every manufacturer is facing the same challenges," Lefebvre said.
• Also, J&J has pledged 500M doses to low-income markets starting in mid-2021.
• https://seekingalpha.com/news/3636937-j-and-j-tests-new-two-dose-regimen-for-covidminus-19-vaccine-candidate