SINGLE-DOSE VIRUS VACCINE TO ENTER PHASE 3 TRIALS
Product would have logistical advantage over competitors
The first coronavirus vaccine that aims to protect people with a single shot has entered the final stages of testing in the United States in an international trial that will recruit up to 60,000 participants.
The experimental vaccine being developed by pharmaceutical giant Johnson & Johnson is the fourth vaccine to enter the large, Phase 3 trials in the United States that will determine whether they are effective and safe. Paul Stoffels, chief scientific officer of J&J, predicted that there may be enough data to have results by the end of the year and said the company plans to manufacture 1 billion doses next year.
Three other vaccine candidates have a head start, with U.S. trials that began earlier in the summer, but the vaccine being developed by Janssen Pharmaceutical Companies, a division of J&J, has several advantages that could make it logistically easier to administer and distribute if it is proved safe and effective.
The company is initially testing a single dose, whereas the other vaccines being tested in the United States require a return visit and second shot three to four weeks after the first one to trigger a protective immune response. The J&J vaccine can also be stored in liquid form at refrigerator temperatures for three months, whereas two of the frontrunner candidates must be frozen or kept at ultracold temperatures for long-term storage.
“A single-shot vaccine, if it’s safe and effective, will have substantial logistic advantages for global pandemic control,” said Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, who partnered with J&J to develop the vaccine.
The United States has invested billions of dollars in an array of vaccine technologies, including close to $1.5 billion to support the development of the J&J vaccine and an advance purchase of 100 million doses. The J&J vaccine is the second to use a viral-vector approach, taking a harmless virus and inserting into it a gene that contains the blueprint for a distinctive part of the novel coronavirus.
“It is a really good thing that we have this diversity of platforms because this is a critical crisis in terms of our global circumstance,” said Francis Collins, director of the National Institutes of Health. “Now, here in the U.S. with 200,000 deaths, we want to do everything we can without sacrificing safety or efficacy.”
In a monkey study published in Nature in July, Barouch showed his approach successfully taught the immune system to protect against a real infection. Data from early-stage human trials that included 400 participants in the United States and Belgium was scheduled to be submitted to a pre-print server Wednesday, but Stoffels said that overall, the vaccine showed that it triggered a promising immune response and that side effects of the vaccine were tolerable, including some fevers that resolved within one to two days.