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 which is being developed by pharmaceutical giant Johnson & Johnson (J & J) kicked off with a final 60,000-person trial of a single-shot COVID-19 vaccine that potentially would simplify distribution of millions of doses compared with leading rivals using two doses.
Unlike some of its competitors, Johnson & Johnson’s vaccine does not need to be frozen and may require just one shot instead of two.
The experimental vaccine may have considerable advantages over some of its competitors, experts said. It does not need to be stored in subzero temperatures, and it may require just one dose instead of two.
“It would be fabulous if we had something at a single dose,” said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University, who was not involved in the study.
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.
Whereas Rival vaccines from Moderna Inc, Pfizer Inc and AstraZeneca all require two shots separated by several weeks to trigger a protective immune response which make them much more difficult to administer. The J&J vaccine can also be stored in liquid form at refrigerator temperatures for three months, whereas two of the front-runner 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.
At the news conference, Dr. Stoffels said that Johnson & Johnson would publicly share its protocol for the Phase 3 trial on its website joining the three other vaccine makers that have made these study plans available in recent weeks after calls for increased transparency in the trials.
The goal of the trial is to test whether the vaccine can prevent moderate to severe COVID-19 after a single dose, but it will also look to see if the vaccine can prevent serious disease requiring medical intervention and whether it can prevent milder cases of the virus.
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.