Henry Ford Health System is recruiting people 60 and older to be part of a new clinical trial looking at whether Johnson & Johnson’s COVID-19 vaccine, which requires just a single dose, is even more effective when two doses are given.
Both the Pfizer and Moderna vaccines, which are already in use, require two doses to be fully effective.
But Johnson & Johnson says the company’s studies showed its single-dose vaccine was 66% effective overall in preventing “moderate to severe COVID-19.” It’s already submitted that data to the FDA and requested an Emergency Use Authorization, which the agency will consider at the end of this month.
This new Phase 3 trial looks at whether two doses of the J&J vaccine could potentially increase its effectiveness, says Dr. Adnan Munkarah, Henry Ford’s chief clinical officer.
“The question is, if we give two shot, can we enhance that efficacy?” Munkarah said at a Monday press conference. “Can we enhance the protection that the Johnson and Johnson vaccine will deliver to the people who receive it?”
People who aren’t eligible or haven’t been able to get the Pfizer or Moderna vaccine yet may want to consider enrolling in this trial, he suggested – although some participants would receive a placebo during the trial. As a “double-blind” study, participants aren’t told whether they’ve received the real vaccine or the placebo until after the trial ends.
But once it does, those who received a placebo will be invited to get the actual vaccine, same as those who participated in earlier trials.
“Those who got the placebo, once we got the results of the trial, were offered the chance to go ahead and get the vaccine,” Munkarah said. “So I would say there are multiple benefits for people who are not currently scheduled to have their vaccines, to go ahead and pursue and learn about this, and try to enroll in the trial.”
Improving the Johnson & Johnson vaccine’s efficacy is especially crucial as more contagious variants of the COVID-19 vaccine emerge in the United States and elsewhere. The company’s data shows that while the single dose was 72% effective in U.S. patients, it was “66% effective in Latin America and 57% effective in South Africa,” both places where variants have been identified.