Just a little more than a month after scoring a contract potentially worth more than $2 billion from the federal government, two European drugmakers have started their anticipated early-phase trial of their vaccine against the virus that causes Covid-19.
British drugmaker GlaxoSmithKline and French pharmaceutical company Sanofi said Thursday that they had initiated the Phase I/II of their of their adjuvanted recombinant protein-based vaccine against the SARS-CoV-2 virus. The trial is enrolling 440 adult healthy volunteers across 11 sites in the U.S. Sanofi said it would lead the effort, while GSK is listed as a collaborator.
According to a description of the trial posted to ClinicalTrials.gov on Thursday, the randomized, controlled study will enroll adults into two age groups – one comprising those 18-49 and the other including those aged 50 and older – who will receive either one or two injections of the vaccine or placebo.
Some vaccines in development against SARS-CoV-2 use a single injection, while others include a primer shot, followed by a subsequent booster shot, sometimes more than 20 days later. For example, Johnson & Johnson is exploring one- and two-dose regimens for its Phase I/II vaccine, Ad26.COV2.S, while Moderna’s mRNA-1273 and Pfizer and BioNTech’s BNT162b2 – both in late-stage development – require booster shots.
Sites currently listed include those in Birmingham, Alabama; Omaha, Nebraska; and Rochester, New York. The study page provides a primary completion date of November, and the companies said they anticipate the first data in December. A Phase III trial would be launched that same month if results from the Phase I/II study are positive. At the end of July, the companies said they had made a deal with the federal government, under the Operation Warp Speed program, to supply 100 million doses of vaccine, with the government providing up to $2.1 billion for development.
“Moving this vaccine candidate into clinical development is an important moment in the progress towards addressing the global pandemic we are all facing,” GSK Vaccines President Roger Connor said in a statement. “This builds on the confidence shown by governments already in the potential of this protein-based adjuvanted vaccine candidate, which utilizes established technology from both companies and can be produced at scale by two of the leading vaccine manufacturers globally.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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